Supplementary Protection Certificates (SPC): A Handbook 9781472561824, 9781849464864, 9781782251576

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Foreword Supplementary Protection Certificates (SPCs) are often referred to as sui generis protective rights, doing justice both to their meaning and their underlying peculiarities. Since SPCs always refer to approved and marketed medicinal products, their economic significance is prodigious. Even if a SPC is granted for only a few days, this may yield the certificate holder – given the particular characteristics of the pharmaceutical market – revenue amounting to millions. The peculiarity of SPCs is that although it is a property right that is always granted ancillary to a patent, it was created by a European Community Regulation. This explains the ECJ’s competence in SPCs and thus for issues that are inherently similar to those of patent law. In contrast to patent law, there is for SPCs a central judicial authority with nationally diverging interpretations of the Regulation which created the SPC, in its first version on the 18th June 1992. From time to time, the ECJ’s case law poses more questions than are answered, potentially resulting in it being implemented in a variety of different ways by national patent offices and courts. This manual will for the first time cover relevant legislation, as well as case law in connection with SPCs, both at the European and national level in selected European countries, whereas the information presented is from the perspective of pharmaceutical companies. Regarding its application, distinguished patent attorneys and lawyers with relevant and extensive experience from the countries concerned collaborated as regards the issuing, protective effect, term and infringement proceedings of SPCs. The handbook provides, both patent attorneys and lawyers, as well as employees of pharmaceutical companies and patent departments, a profound insight into the field of SPCs for medicinal products; not only at the EU level, but also specifically in Germany, Switzerland, Italy, the United Kingdom, the Netherlands and France. This facilitates a comparison of the legal matter, between the aforementioned countries, as well as in relation to regulations and supplementary case law decisions made at the EU level. Also covered, are the granting practices of national patent offices and the court rulings on SPCs in the ECJ in the aforementioned countries. The ECJ’s decisions on the interpretation of the regulation finally complete the picture and provide the basis for a harmonized application of the law This manual takes account of changes in the law and those decisions at the EU level that are most important for the SPC, in Germany, Switzerland, Italy, the United Kingdom, the Netherlands and France up to mid-2015. Munich, September 2015

Marco Stief Dr. Dirk Bu¨hler

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Contributors Gabor Abbas Gabor Abbas completed a Master degree in molecular biology at the University of Leiden. During his study he worked as a patent assistant at the EPO. After obtaining his M.Sc. degree he commenced working as a trainee patent attorney at Algemeen Octrooien Merkenbureau B.V. (AOMB). During his time at AOMB he qualified as a Dutch and European patent attorney. Gabor was involved in patent matters in the pharmaceutical area including providing advice on and the prosecution of SPC applications. Currently, Gabor is employed as a patent attorney by Shell International B.V. working in the Intellectual Property department of Legal Services. Dirk Bu¨hler Dr Dirk Bu¨hler is a German and European patent attorney and partner in the Munich office of Maiwald Patentanwalts GmbH. Dirk has studied biochemistry at the Free University Berlin, the University of California at Berkeley and the Ruprecht-Karls-Universita¨t Heidelberg and obtained a Ph. D. in cell biology at the Max Planck Institute of Biochemistry. Dirk represents clients in the pharmaceutical and biotech industry ranging from start-ups to large multi-national companies before the EPO and the German courts. His practice focuses on complex prosecution matters and contentious inter partes appeal, nullity and multi-national infringement proceedings. Dirk is an Alumni of the “Studienstiftung des Deutschen Volkes” and the “Boehringer Ingelheim Foundation for Basic Research in Biomedicine”, has lectured patent law at the Management Centre Innsbruck and regularly publishes on various IP topics. Address: Maiwald Patentanwalts GmbH Elisenstraße 3 80335 Munich, Germany Email: [email protected] Tel: +49 (0) 89 747 2600 Matthew Burton Dr Matthew Burton completed his undergraduate and postgraduate studies in chemistry at the University of Durham, UK and University of Wu¨rzburg, Germany. Following his Ph. D. in Chemical Biology, also at the University of Durham, he embarked on post-doctoral research at the University of Eindhoven in The Netherlands. In 2012 Matthew began his career in Intellectual Property in private practice in The Netherlands. Matthew Burton is a trainee Dutch and European Patent Attorney at AOMB IP Consultants. He has experience of patent drafting and prosecution before both the Dutch and European patent offices, as well as litigation before the Dutch court. He advises clients within the chemical sector, specializing in biotech, food, pharma and SPC. Thierry Caen Dr Thierry Caen is a French industrial property attorney and a European patent and trade mark Attorney. He is a Doctor of Pharmacy (Universite´ Louis Pasteur, Stras-

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Contributors

bourg). He also holds an advanced degree in patent litigation in Europe from Strasbourg University (EPI CEIPI course – 2006). He began his intellectual property career as a patent attorney in the patent departments of major French chemical and pharmaceutical groups (1985–1997). He joined Santarelli in 1998 and became a partner in 2004. He is in charge of all of Santarelli’s patent activities in the field of pharmacy, chemistry and biotechnology. Thierry works within a team of seven patent attorneys and patent engineers. He is a member of the French Association for the Protection of Industrial Property, the Association des Praticiens Europe´ens des Brevets, the Licensing Executives Society and the International Association for the Protection of Intellectual Property. He assists his clients in constituting their patent portfolio and is specialised in patent litigation. He also has a particular expertise in the field of supplementary protection certificates (SPCs). Address: Santarelli 49 avenue de la Grande Arme´e 75008 Paris, France Tel: (33) 1 40 55 43 43 (switchboard) Fax: (33) 1 42 67 56 29 Email: [email protected] Website: www.santarelli.com Peter Damerell Peter Damerell is a Senior Associate at Powell Gilbert LLP, a London based specialist intellectual property law firm. Peter has a BA (Hons) degree in Physiological Sciences and an M.Sc. degree in Cellular Physiology from Oxford University. He has practised as a solicitor in the United Kingdom since 2006. He works on a wide range of contentious IP matters, including patent, trade mark, design right and copyright disputes. He has significant experience in handling complex and high value patent litigation before the UK courts. His cases are commonly international in nature, and he often works with legal advisers from across Europe, North America and Japan, contributing to and often co-ordinating multi-jurisdictional patent litigation strategies. Peter has a particular interest in patent/SPC disputes in the Life Sciences field and is experienced in working with a diverse range of technologies, including pharmaceutical products and formulations, biotechnology, and medical devices. Address: Powell Gilbert LLP 85 Fleet Street London EC4Y 1AE United Kingdom Email: [email protected] Tel: +44 (0)20 3040 8000 Kilian Scha¨rli Dr Kilian Scha¨rli is a member of the IP team of Meyerlustenberger Lachenal. He specialises in all areas of intellectual property law (patents, SPCs, designs, trademarks, copyright, licensing and unfair competition), pharmaceutical law and regulatory affairs (medicinal products and drugs). He is experienced in negotiating and drafting IP related contracts and in his capacity as civil law notary, he is responsible for the notarial acts in VIII

Contributors

various national and cross-border IP transactions. Kilian advises clients from the pharmaceutical, engineering, advertising/media and consumer goods industries. Kilian is a frequent speaker and author relating to the IP sector and wrote his doctoral thesis on SPCs for medicinal products. He studied law at the University of Lucerne, Switzerland and at the Peking University, China and holds a Master of Laws degree from the The John Marshall Law School, USA. Address: Meyerlustenberger Lachenal Grabenstrasse 25 6340 Baar/Zug, Switzerland Tel: +41 41 768 11 11 (switchboard) Marco Spadaro Dr Marco Spadaro is a partner in Cantaluppi & Partners and is managing the Milan Office. He has a university degree in Pharmaceutical Chemistry and Technologies – University of Milan. His main practice areas are chemistry, pharmaceuticals, biotech, life sciences, nanotechnologies, composite materials, plant varieties. He has an extensive experience in litigation and is often appointed as Court Appointed Expert in IP-related court matters, where he dealt with cases concerning SPC law. Marco was deeply involved in IP attorney and paralegal education in Italian and European law and practice (tutor for the CEIPI, Strasbourg; European Patent Academy), Selected publications: “How to identify Patent Infringements in the Nanotechnology Sector” in Nanotechnology Commercialization for Managers and Scientists (Helwegen, Escoffier, eds.), Pan Stanford Pub. Marco Stief Marco Stief is a partner in Maiwald’s Munich office. He has extensive experience in national and multi-jurisdictional patent litigation and is listed the IAM 300 as a worldwide leading IP strategist and in the German JUVE-Handbook as a “frequently recommended lawyer” for patent litigation. According to JUVE, clients commend, in particular, his pragmatic approach. He teaches IP and Patent Law at the University of Dresden and Pharmaceutical Law at the University of Marburg. Before joining Maiwald, Marco worked for Clifford Chance and Freshfields and as Director Legal (Global IP & Pharma) for the Fresenius group. He is the author of numerous expert papers as well as being co-author of the Handbook of Patent Law, published in German and English, and co-author and editor of the “Handbuch Pharmavertra¨ge” (Handbook of Pharmaceutical Contracts). Marco, a former Fulbright scholar, studied law at the Universities of Bayreuth and Tu¨bingen and holds a Master of Laws degree from the University of Chicago, USA. Address: Maiwald Patentanwalts GmbH Elisenhof, Elisenstraße 3 80335 Mu¨nchen, Germany E-Mail: [email protected] Tel: +49 (0)89 747266-0 (switchboard) Alex Wilson Alex Wilson is a partner and founder member of Powell Gilbert LLP, a London based specialist intellectual property law firm. Alex has a degree in Biochemistry from University College London and is a Solicitor Advocate before the UK courts. He has practiced as a solicitor in Australia and was also an examiner at the European Patent Office for a number of years. He is a member of IX

Contributors

AIPPI, EPLAW, GRUR and VPP. He regularly lectures on intellectual property matters at conferences and is the author of numerous articles on this subject. He is actively involved in the training of judges for the Unified Patent Court. Alex is most active in the resolution of intellectual property and technology contract disputes particularly in the Life Sciences field. Alex has an international practice acting mainly in matters of a multi-jurisdictional character. He regularly advises clients on international patent enforcement and defensive strategies and coordinates the implementation of those strategies. His fluency in French and German allowed him to spend periods working in leading law firms in Paris and Du¨sseldorf. Address: Powell Gilbert LLP 85 Fleet Street London EC4Y 1AE United Kingdom Email: [email protected] Tel: +44 (0)20 3040 8000 Tom Wittop Koning Dr Tom Wittop Koning is European and Dutch patent attorney and partner of AOMB IP consultants. Tom manages AOMB’s office in The Hague, located just vis-a`vis the The Hague Branch of the European Patent Office. Tom is included in the list of recommended professionals in the 2015 edition of IAM Patent 1000 – The World’s Leading Patent Practitioners. Tom has extensive experience in Dutch and Belgian patent litigation and coordinates multi-jurisdictional cases for international clients. His clients are biotech companies, universities, research institutes, chemical and pharmaceutical companies, food and dairy industries in the Netherlands and abroad. Tom studied biology in Groningen, Netherlands and received his Ph.D. at the University of Berne, Switzerland in 1993, and was a post-doctoral fellow at the Max Planck Institute in Berlin, Germany. Before joining AOMB in 2011, Tom was a partner of the patent law firms EP&C and Zacco in the Netherlands. Address: AOMB IP Consultants Veraartlaan 4, 2288GM Rijswijk, Netherlands email: [email protected] Tel (office) +31402433715

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Abbreviations European Law For full reference to rules of law see Annex B RegSPC ....................................... Regulation 469/2009/EC of 6 May 2009 concerning the Supplementary Protection Certificate [SPC] for medicinal products RegSPC-Plant Protection Regulation 1610/96/EC of 23 July 1996 concerning the creation of an SPC Products ...................................... for plant protection products RegCAP ...................................... Regulation 726/2004/EC of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use RegMPP ...................................... Regulation 1901/2006/EC of 12 December 2006 on medicinal products for paediatric use DirMPH ...................................... Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use DirMPV ...................................... Directive 2001/82/EC of 6 November 2001 on the Community code relating to veterinary medicinal products DirGCP ....................................... Directive 2001/20/EC of 4 April 2001 on the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use EPC .............................................. European Patent Convention TFEU ........................................... Treaty on the Functioning of the European Union CFREU ........................................ Charter of Fundamental Rights of the European Union Other Abbreviations Art. ............................................... AS ................................................. Bd. ................................................ CAS .............................................. Cf./cf. ........................................... CJEU ............................................ CHF ............................................. consid. ......................................... DCI .............................................. EC ................................................ ed. ................................................. EEA .............................................. EEC .............................................. EFTA ........................................... e. g. ............................................... EIPR ............................................ EMA ............................................ EPO ............................................. et seq./et seqq. ........................... EU ................................................ EuZW .......................................... FD-GewRS ................................. GRUR .......................................... GRUR Int. .................................. GRUR-Prax. ............................... i. c. w. ........................................... i. e. ................................................ IIC ................................................

Article Official collection of the Swiss federal law Band Chemical Abstracts Service confer Court of Justice of the European Union Swiss Franc consideration International Non-proprietary Name; also abbreviated as INN European Community edition European Economic Area European Economic Community European Free Trade Association exempli gratia European Intellectual Property Review (journal) European Medicines Agency European Patent Office et sequens/et sequentes European Union Europa¨ische Zeitschrift fu¨r Wirtschaftsrecht (journal) Fachdienst Gewerblicher Rechtsschutz (journal) Zeitschrift GRUR e. V. (journal) Zeitschrift GRUR e. V., internationaler Teil (journal) Zeitschrift GRUR e. V., Praxisteil (journal) in conjunction with id est International Review of Intellectual Property and Competition Law (journal) INN .............................................. International Non-proprietary Name, also abbreviated as DCI IUPAC ........................................ International Union of Pure and Applied Chemistry lit. ................................................. littera

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Abbreviations MA ............................................... Marketing Authorisation Message PatA 1993 .................. Dispatch concerning the amendments of the Federal Act on Patents for Inventions and concerning the federal resolution on the amendments of the European Patent Convention of 18 August 1993, BBI (Bundesblatt) 1993, 706 et seqq. Message PatA 1998 .................. Dispatch concerning the amendments of the Federal Act on Patents for Inventions of 19 January 1998, BBI (Bundesblatt) 1998, 1633 et seqq. Mitt. ............................................. Mitteilungen deutscher Patentanwa¨lte (journal) mn. ............................................... marginal number MPR ............................................. Zeitschrift fu¨r Medizinprodukterecht (journal) NAS ............................................. New Active Substance NCE ............................................. New Chemical Entity No ................................................ Number OJ ................................................. Official Journal p. ................................................... page para./paras. ................................. paragraph(s) PCPIP .......................................... Paris Convention for the Protection of Industrial Property Pharm Ind. ................................. Die Pharmazeutische Industrie (journal) PharmR ....................................... Zeitschrift fu¨r Pharmarecht (journal) resp. ............................................. respectively Rs. ................................................ legal matter/proceeding sic! ................................................ Zeitschrift fu¨r Immaterialgu¨ter-, Informations- und Wettbewerbsrecht (journal) SPC .............................................. Supplementary Protection Certificate SR ................................................. Classified compilation of Swiss federal law TRIPS .......................................... Agreement on Trade-Related Aspects of Intellectual Property Rights v. ................................................... versus ZEuP ............................................ Zeitschrift fu¨r Europa¨isches Privatrecht (journal) ZfZ ............................................... Zeitschrift fu¨r Zo¨lle und Verbrauchsteuern (journal)

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PART I GENERALS OF THE SUPPLEMENTARY PROTECTION CERTIFICATE IN THE EUROPEAN LAW Literature: Adams, Supplementary Protection Certificates: The Challenge to EC Regulation 1768/92, EIPR 1994, 323; Adams, Supplementary Protection Certificates: The “Salt” Problem, EIPR 1995, 277; Adocker/Koller, Nichtigkeit eines erga¨nzenden Schutzzertifikats und deren Geltendmachung, GRUR Int. ¨ [EPC], 2011, 385; Benkard, Patentgesetz, commentary, published by C.H. Beck, 2006; Benkard, EPU commentary, published by C.H. Beck, 2012; Berg, Das AstraZeneca-Urteil des Gerichts der Europa¨ischen Union, EuZW 2011, 91; Beyerlein, Neues zu Arzneimittelpatenten im europa¨ischen und deutschen Recht, PharmR 2007, 271; Beyerlein, Pharma Sector Inquiry – eine Zusammenfassung des Berichts der Europa¨ischen Kommission u¨ber die Untersuchung des Arzneimittelsektors aus patentrechtlicher Sicht, Mitt. 2010, 1; Bra¨ndel, Offene Fragen zum “erga¨nzenden Schutzzertifikat”, GRUR 2001, 875; Bru¨ckner/ von Czettritz, Erga¨nzende Schutzzertifikate, mit pa¨diatrischer Laufzeitverla¨ngerung, commentary, published by Carl Heymanns, 2014; Bru¨ckner/Mu¨ller-Stoy, Supplementary Protection Certificates with Negative Duration?, IIC 2011, 629; Bu¨scher/Dittmer/Schiwy, Gewerblicher Rechtsschutz, Urheberrecht, Medienrecht, commentary, published by Carl Heymann, 2011; Busse, Patentgesetz, commentary, published by C.H. Beck, 2003; Deutsch/Lippert, Kommentar zum Arzneimittelgesetz, commentary, published by C.H. Beck, 2010; Dieners/Reese, Handbuch des Patentrechts, handbook, published by C.H. Beck, 2010; Eggenberger Sto¨ckli/Schaper, Zulassung von Arzneimitteln in Liechtenstein im Spannungsfeld zwischen dem Europa¨ischen und dem Schweizerischen Recht am Beispiel des Erga¨nzenden Schutzzertifikats fu¨r Arzneimittel, PharmR 2008, 35; Fackelmann, Patentschutz und erga¨nzende Schutzinstrumente fu¨r Arzneimittel im Spannungsfeld von Wettbewerb und Innovation, PhD thesis, published by Carl Heymann, 2009; Fuhrmann/Klein/Fleischfresser, Arzneimittelrecht, Handbuch fu¨r die pharmazeutische Rechtspraxis, handbook, published by Nomos, 2010; Fulda/Piening, Patentschutzverla¨ngerung fu¨r Kombinationsprodukte – oder doch nicht?, MPR 2011, 37; Gassner, Erga¨nzende Schutzzertifikate fu¨r Kombinationsprodukte – eine neue Kombinatorik?, PharmR 2011, 361; Go¨tting, Gewerblicher Rechtsschutz, handbook, published by C.H. Beck, 2010; Go¨tting/Meyer/Vormbrock, Gewerblicher Rechtsschutz, handbook, published by Nomos, 2011; Hirsch/Hansen, Der Schutz von Chemie-Erfindungen, Chemie Kommentar zur Rechtsprechung nach dem Deutschen Patentgesetz und dem Europa¨ischen Patentu¨bereinkommen, commentary, published by C.H. Beck, 1995; Hufnagel, Wann endet der Patentschutz? – Hindernisse fu¨r den Markteintritt von Generika, PharmR 2003, 267; Jones, On the Relevance of Supplementary Plant Protection Certificates on the Basis of Marketing Authorizations for Combination Products, GRUR Int. 2011, 1017; Jones/Patten, Supplementary Protection Certificates for Agrochemicals: The Draft EC Regulation, EIPR 1995, 446; Kellner, Salz in der Suppe oder Sand im Getriebe? – Anmerkungen zu Schutzrechtszertifikaten, GRUR 1999, 805; Krauß, Anmerkung zum Urteil des GHEU vom 17.04.2007 – Rs. C-205/05 – Calcitriol, Mitt. 2009, 308; Kraßer, Patentrecht, handbook, published by C.H. Beck, 2009; Kunz-Hallstein, The Compatibility of a Community “Certificate for the Restoration of Protection” with the European Patent Convention, EIPR 90, 209; Mes, Patentgesetz, Gebrauchsmustergesetz, commentary, published by C.H. Beck, 2011; Mu¨hlens, Das erga¨nzende Schutzzertifikat fu¨r Arzneimittel, Mitt. 1993, 213; Mu¨ller, Die Patentfa¨higkeit von Arzneimitteln, PhD thesis, published by Springer, 2003; Osterrieth, Patentrecht, handbook, published by C.H. Beck, 2010; Raff, No Protection for Fruits of Research under the Supplementary Protection Certificate Scheme – The Decision of the Patents Court in Re Aktiebolaget Draco, EIPR 1996, 508; Rehmann, Arzneimittelgesetz, commentary, published by C.H. Beck, 2008; Schennen, Die Verla¨ngerung der Patentlaufzeit fu¨r Arzneimittel im Gemeinsamen Markt, handbook, published by Bundesanzeiger, 1993; Schennen, Auf dem Weg zum Schutzzertifikat fu¨r Pflanzenschutzmittel, GRUR Int. 1996, 102; Schoene, Anmerkung zum Urteil des BGH vom 08.07.2008 – Az. X ZB 1/08 (BGH) – Anti-Helicobacter-Pra¨parat, FD-GewRS 2008, 265823; ¨ , commentary, published by Carl Heymann, 2008; Schwarze/Becker, Schulte, Patentgesetz mit EPU Arzneimittel im Europa¨ischen Binnenmarkt, Sonderhefte Europarecht, Beiheft 2, handbook, published by Nomos, 2007; Sredl, Das erga¨nzende Schutzzertifikat im deutschen Patentnichtigkeitsverfahren, GRUR 2001, 596; Straus, Offene Fragen des erga¨nzenden Schutzzertifikats fu¨r Arzneimittel, GRUR Int. 2001, 591; Suchy, Patentrestlaufzeit neuerer pharmazeutischer Wirkstoffe, GRUR 1992, 7; Wenzel, Rechtliche Bedenken gegen die BGH-Entscheidung “Demonstrationsschrank”, GRUR 2013, 140; Zardi, Les Certificats Comple´mentaires de Protection: l’exception du Liechtenstein, sic! 2003, 654

Marco Stief/Dirk Bu¨hler

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Part I. Generals of the SPC in the EU Content A. Purpose, History and Legal Character of the Certificate . . . . . . . . . . . . . . . . . . . . . . . I. Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1. Background and Economic Relevance of the Supplementary Protection Certificate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2. Area of Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II. Relationship between Grant of the Patent and Authorisation under Pharmaceutical Law . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1. Overview of the Drug Authorisation Procedures. . . . . . . . . . . . . . . . . . . . . . . . 2. Differentiation between Preparatory Actions and Actual Authorisation Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3. The Early Patent Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4. The Reduction of the Patent Duration and its ‘Countermeasures’ . . . . 5. Possible Alternatives to the Supplementary Protection Certificate. . . . . III. History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV. Legal Character. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B. Substantive Granting Prerequisites . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I. General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II. Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III. Basic Patent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1. Discrepancy between Basic Patent and Authorisation . . . . . . . . . . . . . . . . . . 2. Multiple Basic Patents and Patentees. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV. First Marketing Authorisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1. General Principles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2. Senior and Extraterritorial Authorisations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . V. No Earlier Certificate – Multiple SPCs for the same product . . . . . . . . . . . . . C. Calculation of Term . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I. General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II. Relevant Date for the Calculation of Term . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1. Grant of the Basic Patent. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2. Lodging the Basic Patent Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3. Grant of the First Marketing Authorisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III. Negative Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D. Subject Matter and Scope of Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I. General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II. Specific Problems of the Scope of Protection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1. Salt Issue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2. Use Patents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3. Substance Combinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . a) Formulation Patents – Active Ingredient and Adjuvant . . . . . . . . . . . . b) Combinations of pharmaceutically active ingredients . . . . . . . . . . . . . . . c) Products with single active ingredients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E. Rights, Limitations and Obligations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I. Rights of the Certificate Holder. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1. Rights of Use and Exclusivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2. Licenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3. Right to the SPC (Art. 6 RegSPC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II. Limitations and Obligations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F. Grant Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I. General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II. Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1. General Application Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2. Form and Content of the Application. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3. Application Period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4. Application regarding the Term Extension of an SPC . . . . . . . . . . . . . . . . . . 5. Application Fees. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6. Publication of an Application Notice. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III. Grant and Announcement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV. Fees to Maintain the SPC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . G. Expiry, Invalidity and Revocation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I. Reasons for Expiry pursuant to Art. 14 RegSPC . . . . . . . . . . . . . . . . . . . . . . . . . . .

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2 2 2 7 9 11 13 15 19 23 25 27 30 30 31 36 41 43 45 45 49 55 60 60 64 65 66 68 74 79 79 84 84 89 100 101 106 122 125 128 128 129 133 137 139 139 140 141 143 150 153 158 159 161 165 166 167

A. Purpose, History and Legal Character of the Certificate II. Reasons for Invalidity pursuant to Art. 15 RegSPC. . . . . . . . . . . . . . . . . . . . . . . . . III. Revocation of a Term Extension . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV. Announcement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . H. Remedies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

172 176 179 180

Part I sets out both the law applying to the Supplementary Protection Certificate 1 (Certificate or SPC), and general considerations which can be derived from European case law. These general considerations apply in all EU Member States and, where mentioned, for Switzerland. Yet as there is no uniform SPC (and patent) system within the EU1, it is up to national offices to grant SPCs2 and national courts to decide on the enforcement of (even if they can refer questions to the CJEU). This leads to differences in practice, which are addressed in Part II.

A. Purpose, History and Legal Character of the Certificate I. Overview 1. Background and Economic Relevance of the Supplementary Protection Certificate Pharmaceutical companies face a special situation in economically exploiting their 2 newly developed drugs: On the one hand, they need an authorisation under pharmaceutical law in order to market the product for the first time (hereinafter also referred to as marketing authorisation)3, and to this end, they need to undertake time-consuming and cost-intensive clinical trials. On the other hand, they are interested in keeping generic versions of their drugs off the market by way of patent protection. 4 In order to obtain patent protection, it is necessary to file the patent application as 3 soon as possible. This minimizes the risk that third party publications generate prior art which may call the patentability of the invention into question. As a consequence, the patent application is frequently filed prior to the commencement of the clinical trials on the active ingredient required for the marketing authorisation, but in any case, such filing is generally undertaken prior to the conclusion of such clinical trials. The term of a patent is 20 years from the date of filing the application, Art. 63 para. 1 EPC. Typically, it takes three to five years from filing the application to grant of the patent. 5 It is estimated that one in 5.000 to 10.000 tested substances is ultimately approved as a 4 drug and that the costs for developing a new drug are in the range of ~800 million US$.6 The preparatory work and marketing authorisation procedure under pharmaceutical law, 1 The unitary patent is only another option in addition to national and European patents and at the time of writing has not become effective. On 17 December 2012 the Council of the European Union approved two regulations to create a European patent with unitary effect, Regulation (EU) No 1257/2012 and Council regulation (EU) No 1260/2012. On 19 February 2013 25 EU Member States signed the Agreement on a Unified Patent Court. It will need to be ratified by several states at the time of writing. 2 For details see infra mn. 139 et seqq. 3 Fuhrmann/Klein/Fleischfresser/Fleischfresser § 6 mn. 1 et seqq.; Rehmann Before § 21 mn. 2 et seqq. 4 On patent protection for drugs Dieners/Reese/Hufnagel § 14 mn. 1 et seqq.; Mu ¨ller p. 58 et seqq. 5 According to EPO: http://www.epo.org/service-support/faq/own-file_de.html#faq-274 (last accessed on 26 January 2015). 6 Symposium “Erga ¨nzende Schutzzertifikate – geringe Anmeldezahlen, hohe wirtschaftliche Bedeutung” on 17 March 2011 at the German Patent and Trademark Office, Presentation Dr. Martin Gosmann, download at http://www.dpma.de/patent/patentschutz/ergaenzendeschutzzertifikate/index.html.

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which is conducted in parallel to the patent grant procedure by the pharmaceutical company, is concluded on average only ten years after the patent application was filed. This significant difference between the time required to obtain a granted patent and a marketing authorisation leads to a substantial loss of effective patent term reducing the patentee’s chance to get a return on investments as overall turnovers will depend on the remaining effective patent term after market introduction and the overall development of the market. Against this background and in order to provide sufficient incentive for research and development of pharmaceutical active ingredients, the European legislator has created the Supplementary Protection Certificate for medicinal products, which prolongs the lifetime of a patent by a maximum of five years and six months. 7 5 Each day of supplementary protection has great economic relevance. For some drugs 80 % of total turnovers occur during the lifetime of the SPC8. The economic importance of SPCs is highlighted by consequences of generic market entry after expiration of a patent or an SPC. 6 Generic products entail considerably less expenses on research and development than the originator drug (reference drug). This is largely due to the fact that the data of the reference drug can be relied upon for the purposes of obtaining a marketing authorisation for the generic product under pharmaceutical law – so-called referring authorisation9 – so that correspondingly, fewer cost-intensive clinical trials have to be conducted. Due to these cost advantages, generic companies are able to offer considerably cheaper prices and originator products lose up to 80 % of market share after introduction of generic products10. In order to remain competitive, the prices of the reference originator drug moreover rapidly decline after the marketing authorisation of generic products. 11 The economic relevance of the Supplementary Protection Certificate is thus constituted by the fact that it delays – analogously to a patent – the marketing of generic products and the inherent pricing competition. The competition authorities have therefore taken an interest in SPC related activities which give rise to competition concerns. For example, substantial fines have been imposed where a marketing authorisation was withdrawn after SPC expiry in order to hinder referring authorisations, 12 and where misleading representations were made in order to obtain or uphold an SPC and therefore exclude third parties from competition.13

2. Area of Application 7

SPCs are not only granted for medicinal products, i. e. (pharmaceutically) active ingredients or combinations thereof.14 In addition to the RegSPC, another European

7 Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the Supplementary Protection Certificate for medicinal products, OJ L 152 of 16 June 2009, p. 1 et seqq.; hereinafter: Regulation on Supplementary Protection Certificates (RegSPC). 8 Symposium “Erga ¨nzende Schutzzertifikate – geringe Anmeldezahlen, hohe wirtschaftliche Bedeutung” on 17 March 2011 at the German Patent and Trademark Office, Presentation Dr. Arno Hartmann, downlaod at http://www.dpma.de/patent/patentschutz/ergaenzendeschutzzertifikate/index.html. 9 Cf. Art. 10 para. 1 of the Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, OJ L 311 of 28 November 2001, p. 67 et seqq.; hereinafter: Directive on Medicinal Products for Human Use (DirMPH). 10 Data taken from a factsheet of the European Generic Medicines Association, available at http:// www.egagenerics.com/index.php/generic-medicines/facts-and-figures, (last accessed on 15 January 2015). 11 Beyerlein Mitt. 2010, 1, 2. 12 CJEU AstraZeneca v. European Commission, C-457/10, mn. 130 [Annex A1.XXI.]. 13 CJEU AstraZeneca v. European Commission, C-457/10, mn. 96, 98 [Annex A1.XXI.]. 14 Art. 1 lit. b, RegSPC.

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Regulation provides for SPC protection for plant protection products. 15 Thus, only medicinal products and plant protection products are currently eligible for supplementary protection, as in case of both, the same general considerations and justification applies. Both types of product are subject to a lengthy product approval process which can impinge on the effective period of patent exploitation. It has been discussed whether medical devices16 or implantable medical devices17 could 8 be eligible for SPC protection. In Germany, the Federal Patent Court18 accepted that an SPC can be granted for an implantable medical device under specific circumstances, namely where the implantable medical device would comprise a pharmaceutically active substance being subject to regulatory restrictions comparable to DirMPH.19 A similar and even more liberal approach seems to have been taken in The Netherlands 20. In contrast, recent developments indicate that the Intellectual Property Office in the UK will reject SPC requests for any medical devices as such devices per se are not subject to a marketing authorisation under DirMPH21. It is thus currently unclear to what extent SPCs can be obtained on medical devices in Europe. Unless a regulation for SPCs on medical devices would be implemented, one will have to await referrals to the European Court of Justice for guidance. Given that most discussions within the literature and court disputes relate to Supplementary Protection Certificates for medicinal products, the remarks in this handbook are limited to SPCs for medicinal products, i. e. human or veterinary drugs. In line with their relevance for SPCs, paediatric drugs will only be discussed in the context of the calculation of the term. The SPC for plant protection products and the corresponding regulation will largely be left out of consideration. 22

II. Relationship between Grant of the Patent and Authorisation under Pharmaceutical Law The pharmacologically active ingredients contained in a medicinal product are 9 typically patentable, even if merely a new use was discovered. 23 The patent issued, however, does not convey a positive right of use per se; the fact that a patent is granted has no bearing on whether the invention on which it is based requires a regulatory approval for its manufacture and distribution, and it does not replace such approval. 24 15 Regulation of the European Parliament and of the Council No 1610/1996/EC of 23 July 1996 concerning the creation of a Supplementary Protection Certificate for plant protection products, OJ L 198 of 8 August 1996, p. 30 et seqq.; hereinafter: RegSPC-Plant Protection Products. 16 Council Directive No 93/42/EEC of 14 June 1993 concerning medical devices, OJ L 169 12 July.1993, p. 1 et seqq. 17 Council Directive No 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices, OJ L 189 of 20 July 1990, p. 17 et seqq. 18 BPatG 14 W (pat) 12/07 of 26 January 2010 – The implantable medical device contained radioactive Yttrium90-microbeads. Even though the Yttrium90-microbeads were not authorised under DirMPH, marketing of Yttrium90-microbeads were subject to a certification with requirements considered comparable to DirMPH. 19 Art. 3 lit b, RegSPC. 20 Genzyme Biosurgery Corp v. Industrial Propery Office, Court of The Hague, 3 June 2004. An SPC was denied in the same case by the German Federal Patent Court – BPatG 15 W (pat) 25/08 of 4 February 2010 21 Leibniz-Institut fu ¨ r Neue Materialien Gemeinnu¨tzige GmbH, BL O/328/14 of 29 July 2014. 22 Apart from its recitals and stipulations applicable to the RegSPC, cf. recital 17 RegSPC-Plant Protection Products. 23 Article 54 (5) EPC, Mes § 3 mn. 77 et seqq. – First and subsequent medicinal indications. 24 Kraßer § 33 para. 1 lit. c No 1 (p. 744 et seq.); cf. e. g. German patent law: § 9 sentence 1 PatG: “(…) in the scope of applicable law (…)”; some commentaries ignore this aspect, Götting/Meyer/Vormbrock/ Samer § 10 mn. 1, 4 et seqq.; Büscher/Dittmer/Schiwy/Kanz § 9 mn. 4 et seqq.

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As a patent merely rewards the technical achievement, it may be possible, therefore, that the issued patent is economically worthless, for example if the marketing authorisation was denied because the substance protected by the patent does not pass clinical trials due to side effects. This does not contradict the purpose of patent law, either, because the patent as exclusive right merely establishes a monopoly (which can be justified under technical/inventive considerations), and thus a market opportunity.25 Of course, other factors may be necessary to realise this market opportunity, such as compliance with health and safety laws or purely economic influences such as the existence of a market demand. 10 Therefore, pharmaceutical companies as well as all other inventors of drugs require both a patent and a marketing authorisation to establish a market position which is protected from competition.

1. Overview of the Drug Authorisation Procedures For putting medicinal products on the market, a marketing authorisation complying with regulatory requirements is mandatory, Art. 3 para. 1 RegCAP26 and Art. 6 para. 1 DirMPH. While this only refers to the marketing authorisation, in practice, a manufacturing authorisation is also required, Art. 40 para. 1 DirMPH, particularly as many pharmaceutical companies manufacture and distribute their drugs themselves. Each marketing authorisation procedure commences with a marketing authorisation application. Drug manufacturers will have to follow the centralized marketing authorisation by the EMA (formerly EMEA) and the EU Commission, the Mutual Recognition Procedure or the Decentralized Procedure in multiple EU Member States. 12 It has been suggested that over 90 % of the new drugs on the European market are approved by way of the centralized procedure27 even though this figure is open to debate.28 The centralized procedure, just like the Supplementary Protection Certificate, is implemented by a Regulation which applies alongside national law.29 We will focus on the centralised procedure, in particular as it is mandatory for some medicinal products, Art. 3 para. 1 RegCAP. 11

2. Differentiation between Preparatory Actions and Actual Authorisation Procedure 13

The centralized marketing authorisation procedure should take nine months calculated as from the date of applying for the marketing authorisation. 30 The actual entire procedure to be undertaken up to the marketing authorisation – which can be referred to as overall marketing authorisation procedure – does not only consist of the actual governmental marketing authorisation procedure, however. Preparatory activities must be undertaken even prior to submitting the marketing authorisation application, Kraßer § 18 para. 1 lit. a No 2 (p. 302). Regulation No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, OJ L 136 of 30 April 2004, p. 1 et seqq.; hereinafter: Community Approval Procedure Regulation (RegCAP). 27 Fuhrmann/Klein/Fleischfresser/Fleischfresser § 6 mn. 39. 28 Schwarze/Becker/Roth p. 14 refers to the decentralized procedure as standard case; cf. also Fuhrmann/Klein/Fleischfresser/Fleischfresser § 6 mn. 39. 29 In the RegSPC and the RegCAP. 30 Dieners/Reese/Friese § 5 mn. 118, excluding the declaration of intent, which can be filed during the preliminary proceedings, as well. 25 26

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primarily the clinical trials, the results of which form a mandatory part of the marketing authorisation application.31 In addition, prior authorisation of such clinical trials by Ethics Committees und the competent higher federal authorities is required as well as the manufacturing authorisation.32 And finally the relevant investigational medicinal product must first be identified, researched, possibly modified and pre-tested toxicologically.33 These different process stages are generally not individually described in legal literature, 14 so that the impression is created that the “regulatory procedure”, 34 the “administrative procedure”35 or the “public marketing authorisation procedure”36 are to blame for the reduced effective patent duration. However, the preparatory actions to be taken prior to submitting the marketing authorisation application are the most time-consuming, first and foremost the clinical trials which take place in four stages. 37 Three of these are undertaken prior to submitting the marketing authorisation application and generally require a period of 6.5 years.38 It is thus the entire duration of the clinical trials and marketing authorisation procedure which reduces the effective patent term. Yet the reduction of patent duration, of course, depends on at which stage of the approval procedure the inventor resp. the pharmaceutical company decides to file a patent.

3. The Early Patent Application The effective duration of the patent is reduced by the fact that the inventor is 15 factually forced to file the patent application as early as possible for various reasons: 39 Firstly, the state of the art continues to develop during the years of clinical trials, and with every new publication by third parties, the product or its use which are subject of the clinical trials run danger of being no longer novel and/or inventive. Moreover, many active ingredients are filed as Markush claims (generalisation of the structural formula through replacement of specific – but not crucial components – by generic statements such as “R” for organic residues) in order to be able to make a respective substance selection depending on research progress. If filing of the patent application was delayed until the first active ingredients which fall into the scope of the Markush claim are actually identified, one would again run danger that the patent is denied due to lack of novelty or inventive activity. Secondly, conducting comprehensive clinical trials entails the considerable risk that 16 both the purpose and the tested substances of the clinical trials become publicly known despite non-disclosure agreements with the institutions conducting the studies, which would again prejudice novelty of the respective pharmaceutical invention. 31 Art. 3 para. 3 lit. a RegCAP in conjunction with Art. 12 para. 3 subpara. 2 lit. j 3 rd indent DirMPV and Art. 8 para. 3 subpara. 2 lit. i 3rd indent DirMPH. 32 Art. 6 para. 1 sentence 2 RegCAP in conjunction with Art. 9 para. 1 subpara. 2 sentence. 1 DirGCP. 33 Rehmann § 40 mn. 8. 34 Kraßer § 26 para. A2 lit. b No 1 (p. 579 et seq.); better, but still imprecise: Benkard/Grabinski § 16 a mn. 6. 35 Mes § 16 a Rn.4; similarly also Osterrieth mn. 165. 36 Go ¨ tting § 7 mn. 38 at the end. 37 Dieners/Reese/Heil/Lu ¨ tzeler § 4 mn. 100 et seqq. 38 According to Germany, report of the Association of Research-Based Pharmaceutical Companies e. V.: http://www.vfa.de/de/arzneimittel-forschung/so-funktioniert-pharmafoschung/so-entsteht-ein-medikament. html/_1-in-labors-kliniken-wie-ein-neues-medikament-entsteht (last accessed on 24 January 2015). There might be national differences. A breakdown of the drug development time requirements from a European point of view was not available. 39 Factually, protection from competitors is necessary, cf. Hufnagel PharmR 2003, 267, 267; Eggenberger Sto¨ckli/Schaper PharmR 2008, 35, 36.

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Thirdly, new pharmaceutical drugs differ from other products in another important aspect: the economic value of a drug is usually closely linked to few patents. While for example a car often contains many hundreds of patented inventions and the value of a car is substantially co-determined by non-technical factors such as design, the entire value of the marketed drug often lies in one single patent, in particular in case of new active ingredients. The amortization of the costs for development of the active ingredient and the trial – which on average amount to approximately $ 800 million per active ingredient40 – thus lives and dies with patent protection. 18 Under the aforementioned circumstances, delaying filing of the patent application is economically not an option. The early filing date serves to minimize risks and most investigational medicinal products are registered as patents even prior to commencement of the clinical trials. 17

4. The Reduction of the Patent Duration and its ‘Countermeasures’ As the duration of the patent – and thus the maximum possible duration of protection – runs from the day of the application, Art. 63 para. 1 EPC, the entire preparatory process usually takes place within the patent term in addition to the marketing authorisation procedure, if the inventor files the patent at the earliest stage to minimise risks. The period from the design and beginning of the clinical trials – and thus generally the point in time when the patent application is filed – until grant of the marketing authorisation certificate amounts to approximately eight to nine years. 41 20 The protective purpose of patent law is to reward the inventor for his/her intellectual creation by establishing a temporal restriction of competition in form of a monopoly right for his/her benefit in exchange for disclosing the invention to the public.42 The temporal restriction is conceived as a reasonable (i. e. not excessive) compensation of the patent holder for sharing his/her intellectual property with the public.43 The duration of 20 years has been recognized worldwide as appropriate.44 This is not affected by the delay of the protective effects through the grant procedure, either, as it is an inherent part of the 20year period which affects all inventors equally.45 Further, there is in principle the possibility of exploiting the invention prior to the patent grant, and compensation claims may exist as from the time the patent application is filed, Art. 67 para. 2 sentence 3 EPC. 21 This, however, is not the case with inventions concerning drugs. For such inventions, the applicant does not have any possibility of lawfully exploiting the invention to be patented prior to receiving a marketing authorisation. While other inventors thus have amortization possibilities prior to grant and may further obtain a kind of “preliminary patent” by means of a split-off utility model application (in countries where this applies), 46 drug inventors are prohibited by law from marketing their invention during the marketing 19

40 This number is generally given, cf. report of the Association of Research-Based Pharmaceutical Companies e. V.: http://www.vfa.de/en/statistics/innovation (last accessed on 1 September 2013). 41 According to Germany, report of the Association of Research-Based Pharmaceutical Companies e. V.: http://www.vfa.de/de/arzneimittel-forschung/so-funktioniert-pharmafoschung/so-entsteht-ein-medikament. html/_1-in-labors-kliniken-wie-ein-neues-medikament-entsteht (last accessed on 24 January 2015), at the end of the document. A breakdown of the drug development time requirements from a European point of view was not available. 42 Cf. Go ¨ tting § 5 mn. 20. 43 Cf. Kraßer § 26 para. A2 lit. a No 5 (p. 576); cf. Go ¨ tting § 5 mn. 7. 44 Kraßer § 26 para. A2 lit. a No 6 to 8 (p. 577 et seqq.). 45 Cf. Benkard/Grabinski § 9 mn. 2. 46 E. g. in Germany: this is what the utility model results in many cases according to the decision BGH GRUR 2006, 842 – Demonstrationsschrank (headnote), crit. Wenzel GRUR 2013, 140 et seqq.

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authorisation procedure, i. e. generally even after the grant of the patent. 47 As outlined above, these regulatory restrictions on exploiting the invention lead to delays of typically eight to nine years which does not seem commensurate with the 20 year patent term. In order to achieve the aforementioned purpose of patent protection, an extension of the protection duration for the drug is thus necessary. This precisely is achieved by the Supplementary Protection Certificate. Against the above background, pharmaceutical companies usually have an effective 22 duration of their exclusive right of twelve to eleven years48 left. The European regulator assumes a maximum duration of ten years, as it considers “a maximum of fifteen years of exclusivity as from the first marketing authorisation” achieved only by a Certificate which has a duration of “no more than five years”.49 Whether the higher or the lower number is correct does not have to be determined here, as the best case is seldom reached in pharmaceutical practice, in particular as e. g. Fackelmann assumes an average of only eight years.50 At the same time, the legislator has recognized that the patent duration cannot be extended by the entire marketing authorisation period, as only the interests of the patent holder would then be taken into account. 51 However, the interest in free competition,52 just as the financing and supply interests of public health53 demand that the supplementary protection duration is limited to the scope to which the inventor is entitled under consideration of all interests. For this reason, the duration of the supplementary Certificate must be determined individually, but be subject to a cap.54

5. Possible Alternatives to the Supplementary Protection Certificate As an alternative to the Supplementary Protection Certificate, the European legislator 23 could have achieved the aim of promoting research and development of the drug market by other means, as well. For example, increased data exclusivity or market exclusivity as with orphan drugs would have been conceivable. In this context, one must always bear in mind, however, that manufacturers of 24 generic drugs have a cost advantage even if they were not able to refer to the clinical trials of the originator, i. e. if data exclusivity were improved. Even if completely new clinical trials were commenced, each marketing authorisation applicant would already have the know-how of which active ingredient will finally lead to the desired result due to the reference drug already available on the market. Thus, failures would be excluded, which may, however, have led to a substantial cost increase for the originator. Further, market exclusivity in analogy to the orphan drugs regulations would have to be classed as overprotection, because while orphan drugs by their nature generate lower turnover and thus, an additional and considerable incentive to develop and clinically try them is 47 “Erosion of the patent duration” Dieners/Reese/Hufnagel § 14 mn. 165; see also Fackelmann p. 223: “Discrimination a priori”. 48 A similar figure is given by Bru ¨ ckner/von Czettritz Introduction mn. 17, as well. 49 Recitals 9 and 10 RegSPC. 50 This number is based on outdated studies, however, Fackelmann p. 14, 223. On the basis of all years between 7.9 and 12.8 given by Fackelmann p. 14 et seq. with citations, the average value there amounts to approximately 10 years, as well (10.35 years). 51 Recital 10 RegSPC. 52 Art. 34 et seqq. TFEU; this has practical impact e. g. in cases of fraudulent obtaining of certificates, cf. on this Berg EuZW 2011, 91, 92. Cf. e. g. Germany: § 1 UWG; §§ 1, 19 para. 1, 20 para. 1, 36 para. 1 GWB. 53 Art. 168 TFEU; Recital 10 RegSPC. 54 This balancing of interests results as a consequence of the social reasons for restricting property rights, Art. 17 para. 1 sentence 2 in conjunction with para. 2 CFREU.

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necessary, this is not the case with other drugs. The interests of the pharmaceutical industry must be viewed in the light of the competing interests of free competition and public health. Therefore, the Supplementary Certificate insofar seems to be an appropriate solution even with a view to possible alternatives. A mere extension of the patent duration is no alternative. By such an extensions, all active ingredients within the scope of protection would enjoy longer protection, regardless of whether clinical trials were undertaken at all and whether a marketing authorisation was granted. This would also constitute an overprotection. The supplementary protection is therefore rightly linked to the product.

III. History Apart from the aforementioned justification based on the system of patent law, other considerations have been taken into account in introducing the RegSPC: due to the European harmonization and the accompanying tightening of the drug approvals law, the development times for new drugs gradually increased over time, which led to a decline of the number of active ingredients newly placed on the market because of simultaneously increasing development costs.55 It was the intention to counteract this trend by additional research and development incentives. 56 Moreover, there was the desire to remain competitive with Japan and the US by granting additional protection. 57 Further, a time-intensive amendment of European or national patent law, i. e. of the EPC and the national patent laws, was to be avoided in favour of a somewhat expeditious implementation of this project, while on the other hand, a uniform solution was to be found.58 26 Thus, the first version of the RegSPC was adopted on 18 June 1992.59 As not all Member States of the EPC are also a Member State of the EU, Art. 63 EPC was amended by para. 2 lit. b as well as para. 3 and para. 4 on 17 December 1991, in order to avoid substantive conflicts between the European patent and the SPC. Art. 63 EPC in its current version is just as open for protective Certificates in favour of inventions other than medicinal products and plant protection products60. Most recently, the RegSPC 1992 was codified in June 2009 and adjusted to the RegMPP61 which came into effect in 2007. However, the opportunity to clarify the questions regarding the RegSPC which had arisen after many years of legal practice was not used, e. g. by amending the text of the regulation or at least by including the recitals of the RegSPC-Plant Protection Products which also apply to the RegSPC directly in the RegSPC.62 Above and in the following, the term RegSPC refers to the codified version of 2009. The first version will, whenever it is specifically relevant, be referred to as RegSPC 1992. 25

55

Bru¨ckner/von Czettritz Introduction mn. 6 et seqq. Cf. recitals 2 to 5 RegSPC. 57 Hirsch/Hansen p. 268; cf. Mu ¨ ller p. 91; cf. recital 6 RegSPC. 58 Recital 7 RegSPC; cf. Bru ¨ ckner/von Czettritz Introduction mn. 27 et seqq. 59 Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a Supplementary Protection Certificate for medicinal products, OJ L 182 of 2 July 1992, p. 1 et seqq.; hereinafter: Regulation on Supplementary Protection Certificates 1992 (RegSPC 1992). 60 Cf. supra, mn. 8. 61 Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/ EC, Directive 2001/83/EC and Regulation (EC) No 726/2004, OJ L 378 of 27 December 2006, p. 1 et seqq.; hereinafter: Regulation on medicinal products for paediatric use (RegMPP). 62 Bru ¨ ckner/von Czettritz Introduction mn. 68 et seqq. 56

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IV. Legal Character There are basically two possibilities to determine the legal nature of the Supplementary 27 Protection Certificate: either, it is a protection right which corresponds to an already familiar protection right (i. e., in this case, the patent), or it is a protection right sui generis. Supplementary protection is only granted on the basis of a (basic) patent; however, it 28 does not cover the patented invention as such, but only the part which covers a product authorised for the first time, Art. 3 lit. b and d RegSPC. 63 This arises from the fact that generally, more than a single pharmaceutical active ingredient or medicinal products may be within the scope of protection of the patent, in particular if the patent claims use functional definitions for features, ranges or Markush claims, while the marketing authorisation, however, was granted and could be granted only for one (or multiple) drugs with a very specific composition. Thus, in light of the justification of the Certificate, there is no reason to grant supplementary protection to all patented embodiments. It is the intention of Art. 1 to 6 RegSPC to avoid this and to define the justified scope of protection of the Certificate. Thus, the patent is the foundation on which the supplementary protection is based; however, the supplementary protection does not simply replicate all claims of the original patent, but limits them to what is justified by the intention and purpose of the supplementary Certificate, Art. 4 RegSPC. 64 This does not conflict with the fact that insofar, the Certificate grants the same 29 rights as the patent, Art. 5 RegSPC, because only the legal consequences are the same, but not the scope of protection. In particular, the Certificate may at best protect as much, generally less, but never more than the patent. In this context, it is irrelevant whether the basic patent is a product patent or a process or use patent, the subject of which is the product which is to be protected,65 Art. 1 lit. c RegSPC. However, multiple Certificates are conceivable for one basic patent, insofar as e. g. multiple authorised products are specifically protected by the basis patent.66 These SPCs may have different durations. The possibility of various SPCs on the basis of the same basic patent already shows that the SPCs cannot constitute a limited extension of the basic patent. Thus, the Supplementary Protection Certificate is an ancillary protection right sui generis. 63

Cf. Benkard/Ullmann/Grabinski EPC Art. 63 mn. 28. Cf. infra, mn. 46. 65 On the differentiation Dieners/Reese/Hufnagel § 14 mn. 2 et seqq. 66 Cf. infra, mn. 57. 64

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B. Substantive Granting Prerequisites I. General 30

The substantive granting prerequisites for the Supplementary Protection Certificate are set forth in Art. 3 lit. a to d RegSPC. Thus, a Certificate is granted for a product if (i) the product is protected by a basic patent in force, (ii) a valid marketing authorisation was issued for the product as medicinal product pursuant to the DirMPH or the DirMPV, (iii) a Certificate was not issued for the product already and (iv) the authorisation is the first marketing authorisation of this product as a medicinal product. The interpretation of these prerequisites required a large number of CJEU decisions and more are to be expected.1

II. Product In line with the reasons for establishing the SPC Art. 3 lit. a to d RegSPC ensure that only the part of the patented invention which is also authorised as a product is entitled to SPC protection. The term “product” being the central element of supplementary protection is defined in Art. 1 lit. b RegSPC as “active ingredient or combination of active ingredients” and is thus given meaning and limited both by the basic patent and by the approval under pharmaceutical law, cf. Art. 3 lit a and b RegSPC. Insofar, it forms the intersection of both the basic patent and marketing authorisation, cf. Art. 4 RegSPC. 32 Art. 1 lit. b RegSPC focuses on the active ingredient or substance combination of a medicinal product. The term ‘medicinal product’ as such is defined in Art. 1 lit. a RegSPC as substance or combination of substances which may be used to prevent, treat or diagnose human or animal diseases and physical states. Thus, the “product” is constituted by the pharmacologically active ingredient(s) of the authorised medicinal product.2 Therefore, the term “product” is more limited than the actual “medicinal product”, the authorisation of which generally is not limited to the pharmacologically active ingredient(s), but commonly includes further (pharmaceutically inert) excipients, as well. The term “product” may, however, include other variants than the active ingredient(s) specifically listed in the medicinal product authorisation and is independent from the indications stated in the authorisation used by the Certificate applicant, so that it is not bound to the specific content of the marketing authorisation. This is a consequence of the fact that the subject matter of the SPC is limited to any of the uses authorised prior to the expiration of the SPC pursuant to Art. 4 RegSPC.3 If, during the lifetime of the SPC, further uses are authorized for the “product”, i. e. the pharmaceutical active ingredient(s), such uses are covered by the SPC even if they were not mentioned in the original marketing authorisation. Thus, the product is coined both by pharmaceutical law and by patent law considerations, which underscores the interdisciplinary character of the RegSPC, but also causes special problems. 4 33 The question of when a (patented) product differs from the active ingredient(s) authorised under pharmaceutical law is sometimes difficult to answer: the “product” 31

1

See Annex A1 in the table of contents of this book. CJEU Massachusetts Institute of Technology v. Deutsches Patent- und Markenamt, C-431/04 [Annex A1.VII.]. 3 Benkard/Grabinski § 16 a mn. 37; Bru ¨ ckner/von Czettritz/Bru¨ckner Art. 4 mn. 41 with citations. 4 Cf. Bru ¨ ckner/von Czettritz/Bru¨ckner Art. 1 mn. 13. 2

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term of the RegSPC follows neither the “novelty” term of patent law nor the question of when a separate (new) authorisation becomes necessary under pharmaceutical law. Thus, a new product may be constituted within the meaning of patent law even if its chemical molecular formula or constitution is already known, but if there is at least one (other) characteristic parameter which is sufficiently distinct from the state of the art. 5 This can be the case e. g. with enantiomers or polymorphs. Another conceivable situation is that the product protected under patent law is new e. g. due to defined dosage amounts. Within the meaning of pharmaceutical law, a derivative of an active ingredient may 34 already lead to a separate authorisation requirement; however, it does not have to constitute a new product within the meaning of the RegSPC on these grounds. The specific dosage strength authorised under pharmaceutical law is not necessarily tied to the “product” term of the RegSPC, either. Thus, if new salt forms or dosage amounts are authorised, they do not automatically constitute a new product.6 The central importance of the term “product” is also highlighted by Art. 3 lit. c 35 RegSPC, according to which principally only one Certificate may be issued for each product. The legislator seems to have intended just that,7 even if this is not entirely clear from the RegSPC, as Art. 3 lit. c excludes further Certificates for the same product only if prior Certificates have not been issued for this product already. Prior pending Certificate applications would thus be harmless. Multiple CJEU decisions were necessary on the interpretation of Art. 3 lit. c RegSPC; the CJEU now allows multiple Certificates for the same product on the basis of different basic patents held by different patent holders.8

III. Basic Patent As the protected subject matter of the Certificate is usually only a part of the patented 36 invention, a patent must be the basis, Art. 3 lit. a RegSPC. The Certificate is ancillary to the basic patent which may be either a national patent or a European (bundle) patent which was issued with effect for the application state.9 The basic patent must be in force. That means that it would counteract the justification of supplementary protection if the patent was finally revoked or declared invalid or otherwise expired prior to the expiration of the maximum legal duration of 20 years, e. g. due to non-payment of the annual fees. On the one hand, a patent is considered in force even if it is subject to opposition, revocation or nullity proceedings, as the ultimate outcome of the proceedings is not yet known in these cases.10 One the other hand, the final revocation of a patent is a reason to declare invalid the previously issued Supplementary Protection Certificate, as well, Art. 15 para. 1 lit. b and c RegSPC. This must also apply if reasons which would have led to the invalidity of the patent occur only after the expiration of the basic patent, i. e. during the duration of the Certificate, cf. Art. 15 para. 1 lit. b and c RegSPC. The invalidity of the Certificate must then be sought by means of an application, Art. 15 para. 2 RegSPC. As the purpose of the SPC is to extend the effective duration of the underlying patent, 37 albeit partially, the relevant point of time of existence of the basic patent can only be 5

As held in Germany by BGH Trioxan, X ZB 9/70 [Annex A2.I.]. Cf. quotation according to Bru¨ckner/von Czettritz/Bru¨ckner Art. 1 mn. 23. Cf. quotation according to Bru¨ckner/von Czettritz/Bru¨ckner Art. 1 mn. 23. 8 CJEU Biogen v. SmithKlineBeecham Biologicals, C-181/95 [Annex A1.I.]; CJEU AHP Manufacturing v. Bureau voor de Industrie¨le Eigendom [Annex A1.X.]. For details see infra, mn. 44. 9 Bru ¨ ckner/von Czettritz/Bru¨ckner Art. 1 mn. 229. 10 Bru ¨ ckner/von Czettritz/Bru¨ckner Art. 1 mn. 232. 6 7

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the date when the SPC application is filed, cf. Art. 3 at the beginning RegSPC. This can lead to situations in which a Certificate cannot be granted as the authorisation under pharmaceutical law is only granted 20 years after the application of the basic patent, i. e. the patent already expired at the time the application for the SPC is filed. Even though the rationale for implementing the RegSPC suggests that an SPC would be justified under such circumstances, the CJEU considered that – in light of the unambiguous wording of Art. 3 lit. a RegSPC – any redress of this gap of protection would require a modification of the wording of the RegSPC.11 Thus, no SPC is available when the SPC application can be filed only after the basic patent has expired. 38 Basically, every type of basic patent (product patent, method patent or use patent) in force by which the product is protected may be eligible as the basis for a Certificate, Art. 1 lit. c RegSPC. The crucial question in view of Art. 3 lit. a RegSPC is when a product can be considered to be protected by the basic patent. To answer this question, different national courts favoured either the so-called infringement test, i. e. the question whether the authorised active ingredient(s) would be considered to constitute an infringement of the basic patent, or the so-called identification theory, i. e. the question as to what extent the authorised active ingredient(s)would be explicitly specified in the basic patent. 12 The CJEU decided in favour of the identification test so that one has to assess whether the product for which Certificate protection is sought is listed in the claims of the basic patent.13 However, despite recent decisions by the CJEU on this issue the question remains how precisely the product needs to be described in the patent claims.14 39 There are many conceivable situations where one product is protected by various basic patents. One and the same patent holder may e. g. hold two patents with different filing dates of which the older patent protects the product by means of a generic Markush claim, i. e. makes it structurally identifiable without naming it as such, and the younger patent only names the specific product. Additionally, further basic patents are conceivable which protect the manufacture of the product or which focus on the use of the product for the indication stated in the marketing authorisation, cf. Art. 1 lit. c RegSPC. Also, it is conceivable that the basic patent protects a specific galenic formulation of the product. Multiple different products protected by one and the same patent can, in principle, be subject to SPC protection, if they fulfil all necessary provisions, i. e. if they are “protected” by the basic patent (means “specified” in the claims of the patent15) and are subject to a marketing authorisation.16 The CJEU recently confirmed that SPCs for two different products can be obtained for one basic patent, e. g. one SPC for Product 1 comprising active ingredient A and another SPC Product 2 comprising active ingredient B.17 This may not apply where the two different products have at least one active in common, e. g. Product 1 containing active ingredient A and Product 2

11 CJEU Yamanouchi v. Comptroller-General of Patents, Designs and Trademarks, C-110-95 [Annex A1. II.]. 12 Cf. infra, mn 109 et seqq. 13 CJEU Medeva v. Comptroller-General of Patents, Designs and Trade Marks, C-322/10 (1 st headnote) [Annex A1.XIII.]. 14 CJEU Medeva v. Comptroller-General of Patents, Designs and Trade Marks, C-322/10 (1 st headnote) [Annex A1.XIII.]; CJEU Eli Lilly and Company Ltd v. Human Genome Sciences Inc., C-493/12 [Annex A1.XXVI.]. 15 CJEU Medeva v. Comptroller-General of Patents, Designs and Trade Marks, C-322/10 (1 st headnote) [Annex A1.XIII.]; CJEU Daiichi Sankyo Company v. Comptroller-General of Patents, Designs and Trade Marks, C-6/11 (headnote) [Annex A1.XV.]; CJEU University of Queensland v. Comptroller-General of Patents, Designs and Trade Marks, C-630/10 (1st headnote) [Annex A1.XVII.], cf. infra mn. 109 et seqq. 16 Cf. infra, mn 57. 17 CJEU Georgetown University v. Octrooicentrum Nederland, C-484/12 [Annex A1.XXVII.].

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comprising a combination of active ingredients A and B and where the two SPCs would have different terms of duration.18 The selection of the basic patent may be of crucial importance both with respect to 40 the duration of the SPC and the validity of the basic patent, and thus of the Certificate. 19 As the product is only protected within the limits of the basic patent pursuant to Art. 4 RegSPC, and as it is “filtered” from the various patent categories, 20 the selection of the basic patent is also of particular importance. The different scope of different patent categories is imported into the scope of protection conferred by the SPC: a compound patent with absolute compound protection results in an SPC providing the same type of protection for the product, while e. g. a process patent only results in supplementary protection for the product manufactured according to this process. 21

1. Discrepancy between Basic Patent and Authorisation Within the limits of the protection conferred by the basic patent, the SPC protects the 41 authorised pharmaceutically active ingredient(s) only for such uses which are authorised during the lifetime of the SPC, Art. 4 RegSPC. Thus, the patentee runs danger of applying for a marketing authorisation for a product which ultimately may not be within the scope of protection of the basic patent, e. g. because limitations are introduced during patent examination which do not read on the authorised product.22 It may thus miss not only patent protection but also the capability of Certificate protection. Thus, it may not phrase its patent application too specifically, e. g. set the dosage of an active ingredient in a substance combination to a too narrow range. Such range specifications will not be just exemplary but limit the scope of protection of the patent. 23 The patent applicant must also not phrase its application too generally, either, as otherwise it runs danger that its patent may be denied or revoked due to lack of enablement, lack of novelty or lack of inventive step.24 Broad valid claims which do not specifically mention the product in question can moreover pose problems given the CJEU’s preference of the identification theory over the infringement test.25 A product may thus be within the scope of a basic patent; it may however still be not eligible for supplementary protection if it cannot be identified in the patent claims. Another discrepancy between basic patent and authorisation can be conceived as a 42 consequence of the identification theory. If the actual authorised medicinal product lacks e. g. a certain excipient which is claimed by the basic patent as a mandatory feature in addition to the active ingredient and if, at the same time, the active ingredient of the 18

CJEU Actavis v. Sanofi, C-443/12, [Annex A1.XXII.]. Example: If the older basic patent protects the product by means of a Markush claim, a certificate sought therefore may not be issuable and/or legally valid pursuant to the CJEU case law (CJEU Medeva v. Comptroller-General of Patents, Designs and Trade Marks, C-322/10) on substance combinations and Art. 3 lit. a RegSPC. If the younger basic patent protects the specific product, this aspect would not be problematic; however, the question of the validity of the younger basic patent vis-a`-vis the older basic patent arises, in particular whether it is new and inventive if compared to the senior patent. 20 Dieners/Reese/Hufnagel § 14 mn. 166. 21 Bru ¨ ckner/von Czettritz/Bru¨ckner Art. 4 mn. 18 et seqq. with citations. 22 Example in Germany: this happened in BPatG Subdiuretische Dosis, 3 Ni 49/07 [Annex A2.X.]; cf. also BGH GRUR 2002, 523, 525 – Custodiol I; BGH Custodiol II X ZR 73/01 [Annex A2.IV.]. 23 Even a statement in certain embodiment examples on a range specification may be deemed as determining scope of protection, e. g. as an explanation of the term “subdiuretic dosage”, cf. in Germany BPatG Subdiuretische Dosis, 3 Ni 49/07 (2nd and 3rd keynote) [Annex A2.X.]. 24 Go ¨ tting § 10 mn. 28; Art. 100 lit. a and b EPC. 25 CJEU Medeva v. Comptroller-General of Patents, Designs and Trade Marks, C-322/10 (1st headnote) [Annex A1.XIII.], cf. infra, mn. 109 et seqq. 19

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medicinal product is mentioned in the claim of the basic patent, a verbatim reading of Art. 3 lit. a RegSPC suggests that the “product”, i. e. active ingredient would be protected by the basic patent even though the authorised medicinal product (i. e. the active ingredient and the additional excipients) would not be within the scope of the basic patent. It seems questionable whether an SPC would be justified under such circumstances. However, head note 3 of the CJEU decision C-630/10 allows for a reading that a basic patent protecting a method of manufacture may be used for the purposes of Art. 3 lit. a RegSPC as long as the product, i. e. the active ingredient(s) is (are) specified in the claims. According to head note 3 it is irrelevant whether the product can indeed be manufactured by the claimed method.26

2. Multiple Basic Patents and Patentees If there are multiple suitable basic patents prior to the grant of a Supplementary Protection Certificate, a Certificate may be issued for each patent, which results as an inverse consequence of Art. 3 lit. c RegSPC.27 If, however, the holder of multiple patents is the same person, it must make a selection, as can be deduced from Art. 3 para. 2 sentence 1 in conjunction with recital 17 RegSPC-Plant Protection Products. 44 After the grant of an SPC, however, the grant of another SPC for the same product should be excluded, Art. 3 lit. c RegSPC. Yet this clear wording has not been accepted by the CJEU. Thus, it is possible that different patent holders obtain a Certificate for the same product on the basis of different basic patents, even if a Certificate had already been issued for the product in the past.28 Due to the method of calculating the duration pursuant to Art. 13 para. 1 RegSPC, this may lead to the situation that multiple different Certificates for the same product expire at different times.29 The possibility of obtaining multiple SPCs for one product is discussed in more detail below.30 However, it is the current understanding that there can be one SPC per product per patent per patentee. 43

IV. First Marketing Authorisation 1. General Principles 45

Both Art. 3 lit. b and d RegSPC require a valid marketing authorisation referring to the product in order to obtain the SPC. The authorisation must have been granted for the Member State of the Certificate application, as the Certificate is granted through national authorities and accessory to a national patent or the national part of a European patent. 31 26 CJEU University of Queensland v. Comptroller-General of Patents, Designs and Trademarks, C-630/ 10 (3rd headnote) [Annex A1.XVII.]. 27 As Art. 3 lit. c RegSPC refers to “grant”, Benkard/Grabinski, § 16 a mn. 28. Art. 3 para. 2 sentence 2 in conjunction with recital 17 RegSPC-Plant Protection Products may also be referred to in this context, which mentions “pending applications”, which is also prior to the grant of the SPC; Mu¨ller p. 92; Kraßer § 26 para. A2 lit. b No 3 with citations (p. 581 et seqq.); see also Schennen GRUR Int. 1996, 102, 105 et seq. 28 CJEU Biogen v. SmithKlineBeecham Biologicals, C-181/95 [Annex A1.I.]; CJEU AHP Manufacturing v. Bureau voor de Industrie¨le Eigendom, C-482/07 [Annex A1.X.]. 29 Example: Basic patent 1 of patent holder 1 was filed in 2000. Basic patent 2 of patent holder 2 was filed in 2009. The first authorisation for the product is granted in 2015. Due to the maximum duration of the SPC, the certificate on basis of basic patent 1 will expire in the year 2025 after a term of five years. The certificate for the same product on the basis of basic patent 2, however, will expire in 2030 after a term of 1 year. 30 Cf. infra, mn.57. 31 CJEU Yamanouchi v. Comptroller-General of Patents, Designs and Trademarks, C-110/95 (headnote) [Annex A1.II.].

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The marketing authorisation constitutes the counterpart of the basic patent in 46 determining the scope of protection of the Certificate, Art. 4 RegSPC. The patent claims are insofar fictitiously reduced to the authorised uses of the approved medicinal product.32 Thus, if an infringement of the Certificate is asserted, it may not be substantiated by arguing that the infringement form is not covered by the scope of protection of the Certificate, yet by the scope of protection of the basic patent. Products, that might have been protected by the patent, but are not mentioned in the SPC, cannot be claimed protected. The reference in Art. 3 lit. b RegSPC to a marketing authorisation as such ensures 47 that the SPC can only be obtained in a country where a product has been approved. 33 The reference of Art. 3 lit. d RegSPC to the first (of possibly numerous) authorisation(s) intends to ensure that only one SPC per product is granted. However, the CJEU decided that under certain circumstances, namely where a second authorisation is issued for a new indication and where the basic patent protects the specific indication, an SPC can be granted despite the existence of a previous authorisation for the same active ingredient.34 The first authorisation on which the Certificate application is based does not have to be held by the holder of the basic patent.35 A rationale for this discrepancy could be that the patent holder may not want or be able to develop the product itself, but may rather grant a license to do so. Whether this indeed applies is doubtful in view of an obiter dictum by the CJEU.36 It, however, is current practice that patentees can obtain SPCs on the basis of third authorisations. As a consequence even if the SPC applicant has obtained its own marketing authorisation, it might have to state a different one in the application with respect to Art. 3 lit. b and d RegSPC, if its own authorisation is not the first one in relation to the specific country. This is a consequence of the fact that only the basic patent leads to the right to the SPC (not the authorisation) so that multiple basic patents for the same product may lead to multiple SPCs with different expiry dates.37 The Certificate application may not be rejected simply because the holder of the first authorisation refuses to grant the SPC applicant the required authorisation documentation for the application.38 The term “first authorisation” also appears in Art. 13 para. 1 RegSPC in the context of calculating the duration of the SPC.39 In this latter context it, however, refers to the first authorisation within the Community to ensure that all SPCs for a product (and a given basic patent) expire on the same date within the Community, as the first approval always remains the same.40 Further, it must be an authorisation under pharmaceutical law pursuant to the 48 DirMPH or the DirMPV, Art. 3 lit. b RegSPC. If additional approvals are necessary for placing a drug on the market in a Member State, e. g. in the scope of pricing 32 In this way held in Germany by BGH Sumatriptan, X ZB 12/01 [see Annex A2.III.]; BPatG Tenofovir, 15 W (pat) 24/07 (headnote) [Annex A2.XI.]; LG Du¨sseldorf Valsartan, 4 b O 280/10 (2 nd headnote) [Annex A2.XV.]. 33 CJEU Yamanouchi v. Comptroller-General of Patents, Designs and Trademarks, C-110/95, mn. 24 et seq. [Annex A1.II.]. 34 CJEU Neurim Pharmaceuticals v. Comptroller-General of Patents, Designs and Trademarks, C-130/ 11 [Annex A1.XX.], cf. infra, mn. 96 et seqq. 35 CJEU Biogen v. SmithKlineBeecham Biologicals, C-181/95 [Annex A1.I.]. 36 CJEU Eli Lilly and Company Ltd v. Human Genome Sciences Inc., C-493/12 [Annex A1.XXVI.], mn. 43. 37 Cf. supra, mn. 47 et seqq. 38 CJEU Biogen v. SmithKlineBeecham Biologicals, C-181/95 (3 rd Headnote) [Annex A1.I.]. 39 Cf. infra, mn. 69. 40 Cf. Art. 13 para. 1 RegSPC.

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proceedings, they cannot be used for the purposes of the Certificate application and the calculation of the duration.41

2. Senior and Extraterritorial Authorisations The RegSPC must be applicable to the authorised product, Art. 2 RegSPC. In particular, the product for which the SPC is sought must have been subject of a regulatory authorisation procedure conforming to the requirements of the DirMPH or the DirMPV before it was placed on the market for the first. Thus, the authorisation must comply with the requirements of the DirMPH or the DirMPV in terms of quality, efficacy and safety of the drug.42 50 If the product was placed on the market in a Member State without such an authorisation being required under the local national law, in particular in cases in which the time-intensive trials regarding harmlessness and efficacy were not required at all, an SPC cannot be granted even if an authorisation in line with DirMPH or DirMPV was later obtained for e. g. a different use of the product. 43 The Synthon and Generics decisions dealt with cases where the products Memantine and Galantamine had been marketed in some of the member states years before a marketing authorisation in line with DirMPH became necessary. The SPC requests in question were based on later authorisations which had been obtained in compliance with DirMPH. The fact that the CJEU rejected SPCs in such situations underscores the fact that supplementary protection is primarily designed to compensate the time factor of trials required under pharmaceutical law for market entry which in the cases under consideration had occurred within the Community before the new authorisations issued. 51 For calculating the duration of the SPC, authorisations of Member States must be considered which were granted pursuant to their national laws prior to their accession to the EU, as long as such trials had to be conducted and were comparable with the requirements of DirMPH and DirMPV and if the SPC request is filed at a point in time where the respective country has become a member of the EU. This must also apply to countries joining the EU in the future.44 52 With respect to Switzerland, the CJEU decided, that authorisations of that state, if automatically recognised in Liechtenstein, can be deemed the first authorisation within the EU and can thus be the basis for calculating the duration of the SPC.45 Following up on these issues a recent referral to the CJEU addressed inter alia the question of whether a Swiss authorisation (which is automatically deemed valid in Liechtenstein) can still be considered to be the first authorisation in the Community for calculating the duration of the SPC, if the extraterritorial (Swiss) authorisation process was not in line with DirMPH and, if this was not the case, whether such a product in view of its approval in Liechtenstein despite non-compliance with DirMPH is at all eligible for SPC protection.46 In the AstraZeneca decision the CJEU confirmed it previous decision47 and by referring to the Synthon and Generics cases confirmed that a Swiss marketing 49

CJEU Ha¨ssle v. ratiopharm, C-127/00 (2nd headnote) [Annex A1.IV.]. Busse/Hacker Anh § 16 a mn. 96. 43 CJEU Synthon BV v. Merz Pharma GmbH & Co KGaA, C-195/09 (headnote) [Annex A1.XI.]; CJEU Generics (UK) Ltd v. Synaptec Inc., C-427/09 (headnote) [Annex A1.XII.]. 44 Art. 20 lit. b to f, h, k to l RegSPC. 45 See infra, mn. 72. 46 CJEU AstraZeneca v. Comptroller-General of Patents, Designs and Trademarks, C-617/12 [Annex A1.XXIII.]. 47 CJEU Novartis v. Comptroller-General of Patents, Designs and Trademarks, C-207/03 [Annex A1.VI.]. 41 42

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authorisation even if it was not in line with DirMPH would be the first authorisation within the Community (if it was valid in Liechtenstein) and thus had be used for calculating the SPC term. The reasoning was inter alia based on the conclusion that the SPC holder through the authorisation in Liechtenstein had been able to use the invention and that all SPCs for the same product and the same patent should expire on the same date within the Community.48 Currently the situation can be summarised such that (i) the SPC application has to 53 name the first authorisation in the country where protection is sought (ii) the SPC application has to name the first authorisation in the Community for calculating the lifetime of the SPC and (iii) that the product was introduced for the first time only after having obtained an authorisation which is in line with DirMPH or DIMPV. If this is, however, not the case, then an SPC cannot be granted. An authorisation to place the product on the market in the Community within the 54 meaning of Art. 2 RegSPC includes each Member State of the European Union as well as Member States of the EFTA which have ratified the EEA Treaty, i. e. Norway, Iceland and Liechtenstein.49 As Switzerland is an EFTA country but has not ratified the EEA Treaty, it is not subject to the scope of Art. 13 para. 1 RegSPC. 50

V. No Earlier Certificate – Multiple SPCs for the same product The stipulation of Art. 3 lit. c RegSPC aims at a prohibition of double issuance of 55 SPCs. At first glance, it appears as the logical consequence of the justification of the SPC, because only one authorisation process takes place for one and the same product, i. e. only one extension of the duration by means of a Certificate is permissible. However, it is conceivable that different applicants simultaneously develop a new active ingredient and independently own different patents which protect the product. Such applicants can pursue SPC applications for the same product and on the basis of the same authorisation but relying on different basic patents. If Art. 3 lit c RegSPC was taken literally, the outcome of different SPC applications for the same product on the basis of different patents by different patentees would depend on how quickly the respective patent offices would examine the SPC applications. If e. g. the second SPC application was filed at a point in time where the first SPC by a different applicant was already granted, no second SPC could be issued. If the second SPC application was, however, filed at a point in time where the first SPC by a different applicant was still pending, a second SPC could be granted, cf. Art. 3 lit. c RegSPC. The second SPC applicant would thus be dependent on the efficiency of the respective patent office in a given country. Against this background the CJEU decided that a second SPC for the same product can be granted on the basis of a different basic patent to a different applicant even if an earlier SPC has been granted for the same product to another applicant on the basis of a first basic patent.51 There can be thus one SPC per product per patent and patentee. This may also apply if there is an SPC for an authorised product containing a single 56 active ingredient and if subsequently the same patentee on the basis of the same basic patent tries to obtain an SPC for a newly authorised product containing a combination 48 CJEU AstraZeneca v. Comptroller-General of Patents, Designs and Trademarks, C-617/12 [Annex A1.XXIII.], mn. 57. 49 Cf. Kellner GRUR 1999, 805, 808; Zardi sic! 2003, 654, 654 et seqq. 50 Swiss authorisations which are effective in Liechtenstein nee, however, to be considered. Cf. supra mn. 52. 51 CJEU AHP Manufacturing v. Bureau voor de Industrie ¨le Eigendom, C-482/07 [Annex A1.X.].

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of the previously authorised active ingredient and another active ingredient. The CJEU commented on this question first in the Actavis v. Sanofi decision.52 This case concerned an SPC for a combination product with the actives Irbesartan and Hydrochlorothyiazide. The Patentee on the basis of the same patent had previously obtained an SPC for Irbesartan for the mono product and argued that the combination had to be considered as a new “product” so that the authorisation for the combination was the first authorisation for this new (combination) product. The previous SPC for Irbesartan would therefore play no role for the purposes of Art. 3 lit. c RegSPC. In the specific case the SPC for Irbesartan and Hydrochlorothyiazide expired after the SPC for Irbesartan. The CJEU stated that in such situations Art. 3 lit. c RegSPC precludes more than one SPC for Irbesartan.53 It seemed to have played some importance for the CJEU’ reasoning that in the case under consideration the SPC for the combination product had a longer duration than the SPC for the mono product which in the Court’s opinion could raise issues of contributory infringement with respect to the mono product after expiry of the respective SPC.54 Another issue clearly was that the court concluded that it was the intention of the RegSPC to compensate for the core inventive concept (of the basic patent), which the CJEU obviously considered to be the provision of Irbesartan (and not the combination).55 The outcome of the case may, however, have differed if both SPCs had expired on the same date (see next paragraph). The situation may also change if one could argue that the basic patent would protect two independent inventions, e. g. a mono product and a combination product with the latter showing unexpected synergistic effects such that the second active would contribute to the inventiveness of the combination as well. 57 These latter considerations seem to be supported by the case law allowing that multiple SPCs for different products can be obtained by the same patentee on the basis of the same basic patent.56 In the Georgetown II case the applicant sought SPCs for active combinations A, B, C, D and C, D on the basis of the same patent and the same marketing authorisation such that both SPCs expired on the same date. The CJEU concluded that multiple SPCs for different products can in principle be obtained on the basis of the same basic patent if the different products are protected as such within the meaning of Art. 3lit. a RegSPC.57 As this was the case for the combination A, B, C, D and C, D and given that both SPCs would expire on the same date, the CJEU found these SPCs to be in line with Art. 3 lit. c RegSPC. A third SPC for C which was based on the same patent but a different later marketing authorisation and which would have thus expired later was rejected in view of the Actavis v. Sanofi decision.58 The Georgetown II decision suggests that multiple SPCs for different products with different terms can be based on the same patent by the same patentee if there is no overlap for the different products. This would e. g. be the case where the same basic patents separately protects actives A and B and where separate products A and B are authorised at different dates. In view of comments in Actavis v. Sanofi59 and Eli Lilly60 it remains to be seen whether the 52

CJEU Actavis v. Sanofi, C-443/12, [Annex A1.XXII.]. CJEU Actavis v. Sanofi, C-443/12, [Annex A1.XXII.], mn. 42. 54 CJEU Actavis v. Sanofi, C-443/12, [Annex A1.XXII.], mn. 37. 55 CJEU Actavis v. Sanofi, C-443/12, [Annex A1.XXII.], mn. 41 and 42. 56 CJEU Georgetown University v. Octroicentrum Nederland (referred to as Georgetown II in the text), C-484/12 [Annex A1.XXVII]. 57 CJEU Georgetown University v. Octroicentrum Nederland, C-484/12, mn. 30. 58 CJEU Actavis v. Sanofi, C-443/12, [Annex A1.XXII.], cf. supra 56. 59 CJEU Actavis v. Sanofi, C-443/12, [Annex A1.XXII.], mn. 30 and 31. 60 CJEU Eli Lilly and Company Ltd v. Human Genome Sciences Inc., C-493/12, [Annex A1.XXVI.], mn. 43. 53

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grant of the SPCs would depend in such circumstances on whether the applicant had actively taken steps to carry out in-depth research and identify his invention specifically. As Art. 3 lit. c RegSPC no longer prohibits the grant of multiple Certificates for the 58 same product in case of different basic patents with different patentees pursuant even if an SPC was granted already,61 it could be discussed whether Art. 3 lit. c RegSPC can be construed even more liberal. It is conceivable that even one single holder of multiple suitable basic patents may receive multiple Certificates for the same product, if it e. g. transfers one of its basic patents to a third party in due time. Once both applicants have applied for and received an SPC, the third party may retransfer its Certificate to the original holder of the basic patent. It, however, is questionable whether such approaches will be accepted under competition law given that SPC filing strategies have come under scrutiny of the competition authorities.62 It is another question how holders of different basic patents which – while legally 59 separate entities – are factually economically affiliated, e. g. due to their ownership structure, should be treated. Such case constellations may also be relevant under an antitrust perspective. It seems fair assume that further CJEU decisions will be required until the scope of Art. 3 lit. c RegSPC is finally clarified in this regard. 61 62

CJEU AHP Manufacturing v. Bureau voor de Industrie¨le Eigendom, C-482/07 [Annex A1.X.]. CJEU AstraZeneca v. European Commission, C-457/10 [Annex A1.XXI].

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C. Calculation of Term I. General The purpose of the RegSPC is to provide an effective amortisation period of no more than 15 years, while the SPC has a maximum term of five years.1 The CJEU recently confirmed that Art. 13 RegSPC together with recital 9 must be understood such that no SPC term should be longer than 15 years.2 This maximum term can be extended by up to six months in cases of a paediatric authorisation pursuant to the RegMPP. A period of five years between the patent application and the grant of the first authorisation remains unconsidered for purposes of calculating the term, Art. 13 paras. 1 and 2 RegSPC. The reasons for this are not questioned in the literature, 3 even though problems result from this provision, such as e. g. negative terms.4 61 The EU Parliament originally assumed an effective term of eight to twelve years. 5 This corresponds to the current status.6 It is noteworthy that in its proposal for the RegSPC, the Commission once sought an effective term of the patent including the SPC of exactly 16 years, it set the maximum term of the latter to ten years and based the calculation of the term of the SPC on the period between the patent application and the grant of the first authorisation reduced by a period of four years.7 The reasons why this trio of numbers of years (16-10-4) was proposed and in particular why the trio was corrected to 15-5-5 in the RegSPC 1992, which finally came into effect, are neither set forth in any of the official publications.8 Nor does the current literature discuss this.9 62 However, it is a fact that the legislator intended to compensate inventors of medicinal products by the SPC.10 As described in the above sections on the background of the SPC, the individual time disadvantage between grant of the patent and the date of the marketing authorisation cannot fully be included in the term of the SPC because of all the interests involved.11 A precise extension of the effects of patent protection by a period exactly corresponding to the time delay between the grant of the patent and the first authorisation is therefore excluded: On the one hand, it must be taken into account that the time factor of the patent examination process is common to all fields of technology and is not a particularity of pharmaceutical inventions. It must thus remain unconsidered for purposes of calculating the term. In any case, from today’s point of view of the EPO’s granting practice, the blanket reduction of five years appears appropriate, as this corresponds to the general duration of the European patent grant procedure.12 60

1

Recitals 9 and 10 RegSPC. CJEU Merck Canada Inc. v. Accord Healthcare Ltd. and others, C-555/13 [Annex A1.XXVIII.]. 3 Dieners/Reese/Hufnagel, § 14 mn. 172; Benkard/Ullmann/Grabinski EPC Art. 63 mn. 65; Kraßer § 26 para. A2 lit. b No 6 (p. 584). 4 Cf. infra mn 74. 5 OJ C 69 of 18 March 1991, p. 23 left column. 6 At least in the average of 10 years, Fackelmann p. 14 et seq. with citations. 7 OJ C 114 of 8 May 1990, p. 10 right column and p. 12 left column. 8 Also not with regard to the new regulation in 2009, OJ C 152 of 16 June 2009, p. 1; the approach ibidem referred to in fn. 2 is undetectable in the archive of the European Parliament and has not been published in the OJ to date. 9 Kraßer § 26 para. A2 lit. b No 6 (p. 584); cf. Benkard/Grabinski § 16 a mn. 32. 10 Recitals 4 and 5 RegSPC. 11 Cf. recital 10 RegSPC. 12 According to EPO: http://www.epo.org/service-support/faq/own-file_de.html#faq-274 (last accessed on 26 January 2015). 2

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On the other hand, the SPC cannot have an overly long term due to the required 63 balancing of interests – regardless of how much time lapsed until the first authorisation. Thus, a maximum term of five years was set. Further, the similarities to foreign law, in particular that of the USA and of Japan, which also provided for a maximum term of five years, were crucial for this five years period. 13 It is noteworthy that according to Art. 7 paras. 1 and 2 RegSPC an SPC can be filed either within six months of the date of the marketing authorisation or the date of the grant of the patent. An SPC can thus also be obtained in situations in which the marketing authorisation was issued prior to patent grant.14

II. Relevant Date for the Calculation of Term The term of the SPC intends, however, to mirror the specific delay of the market 64 access in the individual case. For this reason, there are two points in time which could mark the commencement of the calculation of the delay, namely the date the basic patent is granted or the date the application of the basic patent is filed. By contrast, the date of the first marketing authorisation (within the European Community) can be the only factor for determining the temporal delay of possible market access ends.

1. Grant of the Basic Patent Delays in the grant procedure should not affect the overall term of patent and 65 Certificate,15 given that such delays are to the disadvantage of the applicant in other technical fields – i. e. outside of the scope of medicinal products – as well. While at least other inventions can already be exploited during the grant procedure, this commonly does not apply to medicinal products. Nor can competitors market a generic version of the patented substance, however, as an authorisation would be necessary there, too, and it is not evident why a third party should be able to complete its trial and authorisation process faster than the originator. The opposite is usually the case: due to the statutorily protected data exclusivity,16 third parties will generally17 not be able to “overtake” the patent applicant prior to its first marketing authorisation. Due to this factual situation, pharmaceutical inventions typically cannot be used prior to the patent grant, which is another reason why the relevant starting date for calculating the SPC term should not be the date of patent grant. Moreover, the SPC is a protection right sui generis, even if it is related to the basic patent and it is not the purpose of the SPC to remedy general problems of patent law. Accordingly, the grant date of the basic patent should not affect the calculation of the SPC’s term and, thus, the decisive starting date for the calculation of the SPC term is the filing date of the patent application.

2. Lodging the Basic Patent Application The term ‘basic patent’ refers to that patent which is selected as such by the 66 Certificate applicant. If the applicant holds multiple suitable basic patents, then it may 13

Hirsch/Hansen p. 268; cf. Mu¨ller, p. 91. Cf. infra 151. 15 Benkard/Grabinski § 16 a mn. 32. 16 On data exclusivity in Community law Mu ¨ ller p. 98 et seqq. 17 In case of a referring authorisation. 14

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Part I. Generals of the SPC in the EU

choose among them. There is no reason to compel the applicant to always select a certain patent.18 The selection of the most senior patent seems generally advantageous, because the related reference to an earlier application date usually results in a longer period of time until the date of the first authorisation (which does not change) – and thus, in a longer term of the SPC. The selection of the most recent patent seems advantageous, as it will still be effective for a longer period to which the SPC term will be added. Selection of the most recent patent will, however, lead to an equivalently reduced SPC term. As the term of the SPC only begins upon expiration of the basic patent, the protective effects of patent and SPC will in a lot of cases consequently end at the same time and the primary consideration will be given to the validity of the basic patent and thus the resulting SPC. 67 If, however, the cap in Art. 13 para. 2 RegSPC to a maximum of five years applies to at least one of the basic patents, the selection of the patent will be of importance concerning the SPC’s term. For example, assuming two patents filed in 2000 and 2005 and one marketing authorization (MA) granted in 2013, the term of the Certificate will be capped to five years based on the first patent and will be three years based on the second patent. This results in a patent and SPC protection until the year 2025 in the first and until 2028 in the second case. In terms of the duration, the patent filed in 2005 would be the better choice as basic patent. An equivalent case is conceivable if the reduction by five years, according to Art. 13 para. 1 RegSPC, leads to a zero or negative term SPC when based on a certain patent, and leads to a positive term SPC when based on a different patent. For example, assuming two patents filed in 2005 and 2009 and one MA granted in 2013, the term of the Certificate will be three years based on the first patent and will be minus one year based on the second one. Patent and SPC protection will end in 2028 in the first case, but in 2029 in the second case as the negative SPC term cannot be subtracted from the patent term of maximum 20 years. Here, the best choice would be the second patent already for its patent term. The second patent could moreover be used to apply for a negative term SPC in case of a paediatric extension according to Art. 13 para. 3 RegSPC. 19 If the negative term is lower than six months, an SPC will provide additional protection for the difference between six months and the negative term.

3. Grant of the First Marketing Authorisation Pursuant to Art. 3 lit. d RegSPC, the first authorisation of the product as a medicinal product in the country for which an SPC is sought20 is relevant for the application of the SPC. This may be a national authorisation, centralised authorisations by the EMA or authorisations issued by an EFTA Member State which also is a member of the EEA. 21 As a result, the applicant does not have a right to choose among multiple marketing authorisations (MA), if it holds or can refer to such. 69 For calculating the term of the SPC, the date of the first marketing authorisation within the European Community has to be taken into account, Art. 13 para. 1 RegSPC.22 This may be a national authorisation, a centralised authorisation by the EMA or authorisations issued by an EFTA Member State which also is a member of 68

18

See also Bru¨ckner/von Czettritz/Bru¨ckner Art. 3 mn. 2. For negative terms see also infra, mn. 76 et seq. 20 CJEU Yamanouchi v. Comptroller-General of Patents, Designs and Trademarks, C-110/95 [Annex A1.II.]. 21 Cf. supra, mn. 51 et seqq. 22 CJEU Ha ¨ssle v. ratiopharm, C-127/00 [Annex A1.IV.]. 19

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the EEA. Swiss authorisations that are valid in Liechtenstein are also relevant in this respect.23 In theory, the relevant date for calculating the term could be the date of issuance, the date of transmission of the authorisation to the applicant, 24 or the date of publication of said authorisation.25 However, with respect to Art. 8 para. 1 lit. b RegSPC – which necessarily can only refer to the date of issuance – and the imperative of uniformly interpreting the legal terms of the RegSPC, the latter opinion is hardly convincing. 26 There is, however, a referral pending whether the date of transmission of the authorisation to the applicant should be used for determining the SPC term.27 The UKIPO considers the date of transmission rather than the date of issuance for the purposes of Art. 13 RegSPC which can give some extra (valuable) days of SPC duration.28 While this practice seems to be followed in e. g. Belgium, other countries resist this approach and use the date of issuance. The referral further asks whether the relevant date (date of issuance or date of transmission) should be determined according to Community law or national law. Independent of the outcome of this referral (date of issuance or date of transmission/ national or Community law) it should be in any case guaranteed that – given that the first authorisation within the Community is taken for the purposes of calculating the term – all SPCs on the basis of the same basic patent in the Community end on the same day and that thus, the free movement of goods and services is not obstructed. 29 This does, of course, not apply if multiple SPCs are granted for the same product on the basis of different basic patents held by different patent holders. 30 Authorisations under medicinal law from Switzerland – which is neither a member of the EU nor of the EEA – may be considered as first MA within the meaning of Art. 13 RegSPC, if they take effect in Liechtenstein given that the RegSPC applies in Liechtenstein as EEA member.31 In this context it does not matter whether a Swiss authorisation which is valid in Liechtenstein was in line with DirMPH or not.32 Whether an MA is the first, is substantively determined by the subject matter of the product for which the SPC application is filed, cf. Art. 8 para. 1 lit. b, c RegSPC.

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III. Negative Terms There are situations where the marketing authorisation is granted in less than 10 74 years. The calculation of the term of the SPC then results in a negative value or in the 23 CJEU Novartis, C-207/03 [Annex A1.VI.], CJEU AstraZeneca v. Comptroller-General of Patents, Designs and Trademarks, C-617/12 [Annex A1.XXIII.], cf. supra mn. 52, for further details in Switzerland see part II. 24 A question dealing with when the authorisation under pharmaceutical law takes effect was referred by the BGH to the CJEU (BGH GRUR 2008, 65 – Porfimer) – albeit in the context of Art. 7 RegSPC – but was later withdrawn, CJEU removal order of 3 September 2008, C-452/07. 25 See infra, mn. 150 et seqq. 26 See infra, mn. 150 et seqq. 27 CJEU Seattle Genetics, (referral) C-471/14 [Annex A1. XXIX.]. 28 BL O/418/13 – GENZYME. 29 CJEU Yamanouchi v. Comptroller-General of Patents, Designs and Trademarks, C-110-95 [Annex A1. II.]. 30 Cf. supra, mn. 55 et seqq. 31 CJEU Novartis, C-207/03 [Annex A1.VI.], CJEU AstraZeneca v. Comptroller-General of Patents, Designs and Trademarks, C-617/12 [Annex A1.XXIII.], cf. supra mn. 52, for further details in Switzerland see part II. 32 CJEU AstraZeneca v. Comptroller-General of Patents, Designs and Trademarks, C-617/12 [Annex A1.XXIII.].

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value zero. The question of whether a Certificate can be granted despite the negative or zero term was submitted to the CJEU. The question is relevant insofar as an SPC can be extended by six months, pursuant to Art. 13 para. 3 sentence 1 RegSPC if paediatric studies are conducted. If the marketing authorisation with respect to the filing date of the basic patent was issued in less than 10 years but after 9 years and 6 months and if it was possible to grant an SPC with a negative term of less than 6 months, such an SPC could be later extended to a maximum of six months.33 75 The purposes of the RegMPP include without limitation the extension of the term of the SPC by six months as a reward for the conduct of paediatric studies. As a result, the maximum term of the SPC is prolonged to five years and six months. SPC terms which would be positive after these six months have been considered are only negative if the question of the grant of the SPC is viewed independently of the extension of the term. If they are considered together, however, there is never a negative term in cases protected under the RegMPP. Thus, it is a mere procedural problem and the CJEU reached the conclusion that the positive term is not a granting prerequisite and that negative term SPCs could generally be issued.34 78 Given that the paediatric studies may even be commenced after the first MA which could lead to a subsequent expansion of the authorised uses e. g. by a ‘paediatric indication’,35 it may be difficult to determine at the time the SPC is granted which basic patent holder may be able to enjoy an extension of the term in the future. Thus, it is theoretically conceivable to request a declaration of intent on whether the SPC applicant to conduct such studies.36 The CJEU, however, apparently does not consider this necessary.37 Rather, a Certificate must be issued in the aforementioned cases, even if its term is negative, unless, of course, the negative amount exceeds six months – because then, the privilege conveyed by the provisions of the RegMPP cannot generate a positive term anymore. The determined negative period must be deducted when calculating the extension.38. The application for a paediatric extension may be made when filing the SPC application, but no later than two years before the expiry of the SPC, Art. 7, para 2 and 3 RegSPC. 33

Cf. recitals 26 and 27 RegMPP. CJEU Merck Sharp & Dohme v. Deutsches Patent- und Markenamt, C-125/10, mn. 30 [Annex A1.XVIII.]; see also opinion of CJEU Advocate General Bot of 9 June 2011, C-125/10, mn. 87 as well as mn. 65; cf. in detail also Mu¨ller-Stoy/Bru¨ckner IIC 2011, 629, 639 et seq. 35 Cf. Art. 8 para. 1 RegMPP. Accordingly, a new paediatric indication as well as new routes of administration and pharmaceutical forms (formulations) are conceivable. 36 Cf. statement of intent provided to the EMA, Dieners/Reese/Friese, § 5 mn. 82. 37 CJEU Merck Sharp & Dohme v. Deutsches Patent- und Markenamt, C-125/10, mn. 19 [Annex A1.XVIII.]. 38 CJEU Merck Sharp & Dohme v. Deutsches Patent- und Markenamt, C-125/10, mn. 42 [Annex A1.XVIII.]. 34

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D. Subject Matter and Scope of Protection I. General The SPC’s subject-matter of protection is the product, i. e. the authorised active ingredient or substance combination, Art. 4 RegSPC. In this context, the protection of the product is limited twofold. Firstly, the product is only protected within the scope of protection conferred by the basic patent; secondly, the protection only covers the uses listed in the marketing authorisation, Art. 4 RegSPC. Thus, the category and the scope of protection of the basic patent are taken into account in determining the SPC’s subject-matter of protection.1 If, for example, the basic patent is a manufacturing process patent, the protection of the Certificate is only conferred to products manufactured according to the patented process. If the basic patent protects a certain galenic preparation of the active ingredient and not the active ingredient as such, the protection of the product conferred by the SPC is limited to this specific formulation. Unless it results from the basic patent, the product protection conferred by the SPC is not limited to the specific form of the active ingredient stated in the MA, e. g. the authorised salt of the active ingredient, but includes the active ingredient as such and its derivatives. The product protection conferred by the SPC, however, is limited to the uses listed in the marketing authorisation in all cases. In case of a basic patent protecting the respective active ingredient and conferring absolute protection, the SPC accordingly only confers appropriated protection of the active ingredient. 2 The authorised uses of the protected product may, however, change during the term of the SPC and lead to an expansion of the scope of protection, namely in cases where additional uses of the product are authorised during the term of the SPC, Art. 4 RegSPC. Such newly authorised uses, however, can only expand the subject-matter of protection if they are covered by the scope of protection of the basic patent. 3 As with European patents, the scope of protection of the SPC needs to be determined by the contents of the patent claims, for the interpretation of which the description and the drawings are to be used, Art. 69 EPC and the protocol on the interpretation of Art. 69 EPC. As the Certificate only confers use-limited product protection, however, the patent claims of the basic patent must be read with the purpose of determining the scope of protection as though they explicitly list the product named in the SPC and the applications listed in the MA.4 The scope of protection may refer to equivalents.5

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83

II. Specific Problems of the Scope of Protection 1. Salt Issue Pharmaceutical active ingredients preferably are patented in such a way that the 84 patent claims specify the name of the active ingredient e. g. the free base, while additionally clearly stating the usual derivatives such as e. g. pharmaceutically acceptable salts of the active ingredient. Sometimes, the patent claims of active ingredient patents only specify the active ingredient, in the form of the free base, and obvious equivalent Busse/Hacker Anh § 16 a mn. 56. Benkard/Grabinski § 16 a mn. 35. 3 Busse/Hacker Anh § 16 a mn. 58. 4 Benkard/Grabinski § 16 a mn. 38. 5 Benkard/Grabinski § 16 a mn. 38. 1 2

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derivatives, i. e. in particular various salt forms, only as embodiment examples. The authorisation, however, may in any case only be granted for a very specific compound – e. g. the hydrochloride salt of the active ingredient, as the clinical trials on the substance to be authorised only study the effects of the specifically tested active ingredient. The regulatory requirements foresee that only the specifically tested active ingredient(s) is/ are authorised and not generally all conceivable derivatives. 6 85 Due to Art. 4 RegSPC, the supplementary protection would then also be limited to the specifically authorised compound.7 This is despite the fact that in light of the meaning of the term “active ingredient” in common parlance and taking into account the semantic context,8 the basic patent may also cover derivatives which are therapeutically substantially equivalent, and thus above all the pharmaceutically acceptable salts. 9 This may lead to unfair results, as patent protection for salts which were not subject to the authorisation process would expire with the basic patent and competitors could then market the medicinal product with these other salts – for which they may moreover generally resort to the referring MA if other salts than the salt forms specifically authorised are used. 10 Conversely, by way of the SPC the patent holder may receive protection for products which are not expressly listed in the basic patent. These case constellations are referred to as ‘Salt Issue’ in the literature and were the subject of the Farmitalia decision by the CJEU in connection with the active ingredient Idarubicin.11 86 In the Farmitalia case, the claim of the basic patent contained the active ingredient Idarubicin. The marketing authorisation related to the product Idarubicin Hydrochloride. After a referral by the German Federal Court of Justice, the CJEU resolved that an SPC may cover a product as medicinal product in all forms subject to the protection of the basic patent, if the product in the form stated within the marketing authorisation is protected by a basic patent in force. Whether a product is protected by a basic patent is determined by the laws governing the basic patent.12 87 Subsequent to the Farmitalia decision, the German courts found the specifically authorised product, i. e. the salt, being covered by the scope of protection of the basic patent, even though the latter only mentioned the free base.13 The discrepancy between the specific product underlying the MA and the wording of the basic patent may become problematic if the derivative in question has an inventive distance to the basic patent. In such cases it may, however, be possible for the patent holder to obtain a separate patent for the derivative and possibly a new SPC, particularly if a separate authorisation was required.14 6 Implemented by the requirement to attach, inter alia, the clinical trial documents to the marketing authorisation application, Art. 3 para. 3 lit. a RegCAP in conjunction with Art. 12 para. 3 subpara. 2 lit. j 3rd indent DirMPV and Art. 8 para. 3 subpara. 2 lit. i 3rd indent DirMPH. 7 Kraßer § 26 para. A2 lit. b No 3 (p. 581 et seqq.). 8 CJEU Massachusetts Institute of Technology v. Deutsches Patent- und Markenamt, C-431/04 (headnote) [Annex A1.VII.]. 9 CJEU Farmitalia v. Deutsches Patent- und Markenamt, C-392/97, mn. 18 [Annex A1.III.]. 10 Different salt forms of the same active ingredient which have the same qualitative and quantitative composition of active ingredients, might sometimes be regarded as medicinal products within the meaning of Art. 10 para. 2 lit. b DirMPH. 11 CJEU Farmitalia v. Deutsches Patent- und Markenamt, C-392/97, mn. 18 [Annex A1.III]. 12 CJEU Farmitalia v. Deutsches Patent- und Markenamt, C-392/97 (1st and 2 nd headnote) [Annex A1.III.]. 13 This outcome was clearly influencecd by the infringement test which was applied by the German courts then. Whether the outcome would have differed in view of the identification theory (cf. infra mn. 109 et seqq.) is doubtful given that the claim mentions Idarubicin. 14 Fackelmann p. 229; Kraßer § 26 para. A2 lit. b No 3 at the end (p. 582 et seq.); Benkard/Ullmann/ Grabinski EPC Art. 63 mn. 34.

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According to the above explanations the scope of the Certificate protection is not 88 necessarily strictly bound to the specific salt form of the active ingredient underlying the marketing authorisation. Conversely, the authorisation under medicinal law of a new salt form does not automatically result in a new product and thus in the possibility of a new SPC, as long as the therapeutic effect is the same as that of the already authorised salt form.

2. Use Patents In view of the CJEU’s construction of the term “product”, it was considered established 89 that another SPC cannot be granted for new indications for an active ingredient or a combination of active ingredients which have already been authorised. 15 Moreover, only one SPC shall be granted for one and the same product, Art. 3 lit. c RegSPC. 16 More recent decisions have call this into question as will be addressed below.17 If a new therapeutic application is discovered for an already known pharmaceutically 90 known active agent, this novel use (or indication) can be the subject of a separate patent.18 If the active agent had been authorised before, a new marketing authorisation will regularly be required for the novel use including clinical trials for the novel use. If no SPC can be obtained for the novel use, a patentee of a pharmaceutical substance patent and/or first medical indication patent would be privileged over patent inventors of the second or further medical indications of the substance without any apparent reasonable cause. The solution of this problem may be (i) to permit multiple Certificates for the same product after all – which was specifically not intended, but is apparently no longer off-limits19 – or (ii) to construe the term “product” accordingly. It moreover appears inconsistent to grant another SPC for a derivative of a product if it 91 is separately claimed by a different patent, while refusing protection of new medical applications of a product which also can be the subject matter of an independent patent. Insofar, the CJEU appears to give priority to substance inventions over novel uses of known substances. The identification of new uses for known substances may, however, have the same importance as the identification of new active ingredients for known indications from a therapeutic point of view. If the RegSPC differentiates between active ingredient and substance combinations, Art. 1 lit. b RegSPC, it also appears purposeful to further differentiate for which use the product is protected by the basic patent and authorised. Patent law allows for independent patent protection of a second medical use, so that it does not appear rationale to exempt this type of invention for purposes of supplementary protection; in particular because a new authorisation process must be undertaken. Hence, at least in case of use patents which are only capable of patent protection due to the novelty of the second medical indication, the “product” within the meaning of Art. 1 lit. b and Art. 3 lit. c RegSPC could be argued to not only relate to the underlying active ingredient(s), but to also take into account (novel and inventive) uses of 15 CJEU Yissum Research and Development Company v. Comptroller-General of Patents, C-202/05 [Annex A1.IX.]. 16 Cf. CJEU Biogen v. SmithKlineBeecham Biologicals, C-181/95 [Annex A1.I.]. 17 CJEU Neurim Pharmaceuticals v. Comptroller-General of Patents, Designs and Trademarks, C-130/ 11 [Annex A1.XX.] and CJEU AHP Manufacturing v. Bureau voor de Industrie¨le Eigendom, C-482/07 [Annex A1.X.]. 18 According to the EPC, it is regarded as independent product patent which hardly implies any practical differences, Mes § 3 mn. 79, whereas the Swiss-type claims mentioned therein are inadmissible: EPO Dosage regime/Abbott respiratory, G 2/08 (headnote), GRUR Int. 2010, 333. 19 Cf. CJEU Biogen v. SmithKlineBeecham Biologicals, C-181/95 [Annex A1.I.]; CJEU AHP Manufacturing v. Bureau voor de Industrie¨le Eigendom, C-482/07 [Annex A1.X.]; cf. supra mn. 44 and 55.

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92

93

94

95

the active ingredient. In this context it is not readily comprehensible why the supplementary protection is by law only a protection of certain uses,20 while for obtaining an SPC it is supposed to be irrelevant whether another use may be patented and authorised. As mentioned the case law by the CJEU is unclear in this respect. Two decisions by the CJEU were broadly understood to preclude SPCs for new therapeutic uses, 21 while a recent decision allows for an SPC in such a situation.22 The decision Pharmacia Italia23 addressed the question of whether, with respect to transitional provisions, a first authorisation for a product could be constituted by an earlier authorisation for a veterinary medicinal product if the subsequent SPC application was filed for a medicinal product for human use. The Court decided that the authorisation for veterinary use would need to be considered as the first authorisation of the product. For both authorisations the product, namely Cabergoline was used as prolactin inhibitor to suppress lactation and one could therefore take the position that no new therapeutic use was at stake. Moreover both authorisations, i. e. for the medicinal product for human use and for the veterinary medicinal product, were based on the same basic patent which claimed Cabergoline24 and there was not an independent patent for the second use (for humans). Nevertheless, the decision was perceived to indicate that a novel use (human v. veterinary application) could not be the basis for arguing that the SPC application was aimed at a new product. In the CJEU’s Yissum decision the CJEU had to deal with an SPC application for a different therapeutic use.25 The active ingredient in question, namely Calcitriol had previously been authorised for intravenous administration to treat hypercalcaemia during dialysis. The new SPC application was based on a basic patent protecting the topical administration of Calcitriol for treatment of skin diseases and the SPC applicant relied on a marketing authorisation for topically using Calcitriol for psoriasis. The CJEU decided that Art. 1 lit. b RegSPC cannot be understood such that the term “product” would comprise a therapeutic use and referred in this context to the Pharmacia Italia. 26 As a consequence a novel therapeutic use of a known pharmaceutically active agent does not allow for the argument that the authorisation pertains to a new product with respect to Art. 1 lit. b RegSPC. Even though there were good reasons why SPC protection for new uses would be justified27 and even though the CJEU in its decision AHP Manufacturing28 had ignored the clear wording of Art. 3 lit. c RegSPC to allow for multiple patent holders to receive a new Certificate for the same product on the basis of different basic patents, even if a Certificate for the product had already been issued in the past, the Pharmacia Italia and Yissum decisions were perceived to preclude SPC protection for new therapeutic uses. The Neurim decision therefore came as a surprise.29 20

Cf. Art. 4 RegSPC. CJEU Yissum Research and Development Company v. Comptroller-General of Patents, C-202/05 [Annex A1.IX.] and CJEU Pharmacia Italia v. Deutsches Patent- und Markenamt, C-31/03 [Annex A1.V.]. 22 CJEU Neurim Pharmaceuticals v. Comptroller-General of Patents, Designs and Trademarks, C-130/ 11 [Annex A1.XX.]. 23 CJEU Pharmacia Italia v. Deutsches Patent- und Markenamt, C-31/03 [Annex A1.V.]. 24 CJEU Pharmacia Italia v. Deutsches Patent- und Markenamt, C-31/03 [Annex A1.V.]. 25 CJEU Yissum Research and Development Company v. Comptroller-General of Patents, C-202/05, mn. 5, 6 [Annex A1.IX.]. 26 CJEU Yissum Research and Development Company v. Comptroller-General of Patents, C-202/05, Reason 19. 27 Cf. supra mn. 91 and 92. 28 CJEU AHP Manufacturing v. Bureau voor de Industrie ¨le Eigendom, C-482/07 [Annex A1.X.]. 29 CJEU Neurim Pharmaceuticals v. Comptroller-General of Patents, Designs and Trademarks, C-130/ 11 [Annex A1.XX.]. 21

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In the Neurim decision the CJEU had to deal with an SPC application for the active 96 ingredient Melatonin. The SPC application was based on a basic patent covering the use of Melatonin for treating insomnia in humans. The marketing authorisation named the same use. However, Melatonin had previously been authorised for treating breeding activity in animals. The case thus differed from Pharmacia Italia in which the previous and novel authorised uses had been covered by the same patent.30 The facts were more comparable to the Yissum case given that the novel authorised use was covered by a patent which did not protect the previous authorised use. The questions referred to the CJEU were however more reminiscent of the Pharmacia Italia case given that they concerned Art. 3 lit d RegSPC whilst the questions referred in Yissum had focused on Art. 1 lit b RegSPC. It may be for these different questions that the CJEU decided in Neurim that an SPC may be obtained for a novel use even where the same active ingredient had been authorised before. According to the decision Art. 3 lit. d RegSPC can to be understood such that the “first authorisation” pertains to the first marketing authorisation for a product for which the use is within the scope of the basic patent.31 In Neurim, the previously authorised use (breeding activity in sheep) did not fall within the scope of the basic patent used for the SPC application. As the CJEU did not address in Neurim its previous Pharmacia Italia and Yissum 97 decisions there is considerable uncertainty under which conditions SPCs can be granted for novel authorised uses. It seems, however, fair to conclude that products with novel authorised uses may be eligible for SPC protection where previously authorised uses of the product in question are not protected by the selected basic patent. Under these circumstances, the previous authorisation would not be considered the first authorisation under Art. 3 lit. d RegSPC. This previous authorisation would also not be the first authorisation within the Community for the purposes of Art. 13 para. RegSPC 32 If the previously authorised use was, however, already protected by the basic patent which is selected for obtaining an SPC on the new use, Art. 3 lit. d RegSPC would probably preclude an SPC.33 As mentioned, uncertainties remain. In the Neurim case, the referral questions inter 98 alia asked whether it would matter that “the limits of protection conferred by the basic patent [selected for obtaining an SPC on the novel use] do not extend to placing the product the subject of the earlier application on the market within the meaning of Article 4?” (emphasis added). This question asks whether it was relevant if the previously authorised use would be within the scope of protection of the selected patent, but was not answered. The wording “within the limits of the protection conferred by the basic patent” used by the CJEU in the first head note of the Neurim decision34 is moreover reminiscent of the infringement test that was, however, rejected by the CJEU in the previous Medeva decision.35 Determining whether a novel 30

Cf. supra mn.93. CJEU Neurim Pharmaceuticals v. Comptroller-General of Patents, Designs and Trademarks, C-130/ 11 (Headnote 1) [Annex A1.XX.]. 32 CJEU Neurim Pharmaceuticals v. Comptroller-General of Patents, Designs and Trademarks, C-130/ 11. Headnote 2 [Annex A1.XX.]. 33 CJEU Pharmacia Italia v. Deutsches Patent- und Markenamt, C-31/03 (Headnote) [Annex A1.V.]. 34 […the mere existence of an earlier marketing authorisation obtained for a veterinary medicinal product does not preclude the grant of a supplementary protection certificate for a different application of the same product for which a marketing authorisation has been granted, provided that the application is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the supplementary protection certificate]; CJEU Neurim Pharmaceuticals v. ComptrollerGeneral of Patents, Designs and Trademarks, C-130/11 (Headnote 1) [Annex A1.XX.]. 35 CJEU Medeva v. Comptroller-General of Patents, Designs and Trademarks, C-322/10 (1 st headnote) [Annex A1.XIII.], cf. infra mn. 109. 31

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authorised product would be within the limits of protection conferred by a basic patent (which seems to underlie the CJEU’s findings in the first head note of Neurim) moreover means to consider the product together with its authorised use. Art. 3 lit. a RegSPC relates, however, to protection of the product as such, i. e. the active ingredient as the CJEU had ruled in Yissum that a novel authorised use has no influence on the understanding of the term “product” under Art. 1 lit. b RegSPC. Other CJEU decisions suggest that a mere reference to a product in a method claim may be sufficient for the product to be protected by the basic patent even if the product cannot be manufactured by the claimed method.36 These latter considerations are difficult to reconcile with the Neurim findings. At the moment there is anything but clear guidance from the CJEU on the interpretation of Art. 3 RegSPC with respect to novel uses. 99 It will therefore most likely require further decisions by the CJEU to clarify when novel uses of a previously authorised product are eligible for SPC protection.

3. Substance Combinations 100

According to Art. 1 lit. b RegSPC, the product is defined as active ingredient or a combination of active ingredients. There have been numerous decisions by the CJEU on what is to be understood by the term “active ingredient” and when an authorised combination of active ingredients can be considered being protected by a basic patent in force as required by Art. 3 lit. a RegSPC.

a) Formulation Patents – Active Ingredient and Adjuvant. Pharmaceutical inventions are not limited to new pharmaceutically active substances as such. There are many patentable inventions on combinations of known pharmaceutically active substances and (pharmaceutically inert) excipients, i. e. the actual dosage form or formulation taken by the patient. By combining the active substance with excipients which are per se pharmacologically inert one may for example obtain a dosage form with longer therapeutic efficacy. Supplementary protection can, however, only be granted for the pharmaceutically active agent the reason being that a combination of a pharmaceutically active agent and a pharmaceutically inert excipient is not supposed to be deemed as a new product even if the excipient influences the pharmacological properties of the pharmaceutically active substance.37 102 The Massachusetts Institute of Technology case concerned the medicinal product Gliadel comprising the pharmaceutically active agent Carmustine in combination with the polymer Polifeprosan which ensured that only therapeutic amounts of Carmustine would be released even though it had no pharmacological activity in itself. As Carmustine had previously been authorised the new authorisation would have only been compliant with Art. 3 lit. d RegSPC if the combination of Carmustine and Polifeprosan was considered as a new product, i. e. a combination of two active ingredients. – The CJEU denied this possibility and construed Art. 1 lit. b RegSPC to refer to pharmaceutically active agents only.38 103 The CJEU’s approach, however, appeared contestable at least insofar as excipients with a substantial influence on the pharmacological effects of the medicinal product are discredited at least in cases in which the excipient leads to a pharmaceutically 101

36 CJEU University of Queensland v. Comptroller-General of Patents, Designs and Trademarks, C-630/ 10 (3rd headnote) [Annex A1.XIII.], cf. supra mn. 42. 37 CJEU Massachusetts Institute of Technology v. Deutsches Patent- und Markenamt, C-431/04, mn. 18 et seqq. [Annex A1.VII.]; Fackelmann p. 229; Schulte/Ku¨hnen § 16 a mn. 7. 38 CJEU Massachusetts Institute of Technology v. Deutsches Patent- und Markenamt, C-431/04, mn. 19 [Annex A1.VII.].

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compatible dosage form of the active agent for the first time and where this active ingredient formulation is protected by a patent and separately authorised, an analogy to combinations of pharmaceutically active agents could be drawn. It appears that this is part of the reason why the Advocate General spoke in favour of the admission of such Certificates in the Massachusetts Institute of Technology case. 39 In the area of vaccines it is moreover common and sometimes decisive for obtaining regulatory approval to use adjuvants (which are per se pharmacologically) inert to provide an effective immune. Such a case was referred by the High Court of England and Wales, but rejected by the CJEU which, by citing the Massachusetts Institute of Technology case, denied SPCs for combinations of an active ingredient and an adjuvant40 or the adjuvant alone as this would not be compliant with Art. 1 lit b. RegSPC.41 The recently decided Forsgren case is interesting given that the product in question 104 was used as an excipient in the authorised medicinal product but (additionally) had pharmacological activity.42 The basic patent was directed at Protein D of Haemophilus influenza. The medicinal product Synflorix was authorised as a vaccine against Streptococcus pneumoniae. Synflorix contained 10 pneumococcal polysaccharide serotypes as active agents of which eight were covalently bound to Protein D of Haemophilus influenza. Protein D was included as a carrier, but not named in the authorisation as an excipient. Protein D was argued to be pharmacologically active against Haemophilus influenza which was a non authorised use. The European Public Assessment Report by the EMA for Synflorix actually stated that the use for Haemophilus influenza was not supported by clinical data.43 The CJEU decided that Protein D despite its covalent attachment to pharmaceutically active pneumococcal polysaccharide serotypes could be regarded as a (separate) active ingredient according to Art. 1 lit. b RegSPC which in principle would thus be eligible for SPC protection in accordance with Art. 3 lit a RegSPC.44 However, given that the pharmacological effect which was attributed to Protein D (vaccination against Haemophilus influenza) did not correspond to the authorised use (vaccination against Streptococcus pneumoniae), the SPC was rejected with respect to Art. 3 lit b. RegSPC. The product within Synflorix to which the authorisation pursuant to Art. 3 lit. b RegSPC was seen to be concerned with were thus the pneumococcal polysaccharide serotypes. It thus seems not possible to obtain SPC for novel formulations if the active 105 ingredient has been previously authorised. It is, however, noteworthy that the Yissum 45 decision on SPCs for novel uses was also concerned with the interpretation of Art. 1 lit. b RegSPC and that its outcome was considered to be the logical consequence of the Massachusetts Institute of Technology case. With the Neurim decision being difficult to reconcile with the Yissum case,46 the question of SPCs for formulation patent may be 39 CJEU Massachusetts Institute of Technology v. Deutsches Patent- und Markenamt, C-431/04, mn. 19 [Annex A1.VII.], opinion of Advocate General Le´ger of 24 November 2005. 40 There is an interesting case in this respect on SPCs for plant protection products. In plant protection it can become necessary to reduce the phytotoxic effects of plant protection products by combining them with a safener. Safeners are comparable to adjuvants in that they modulate the effects of the actual plant protection product. Remarkably, the CJEU decided that a safener can be considered to be a product according to Art. 1 no. 8 and no 3 RegSPC-Plant Protection Products which is the equivalent to Art. 1 lit b RegSPC. See CJEU Bayer Crop Science v. Deutsches Patent- und Markenamt, C-11/13 [Annex A1.XXIV]. 41 CJEU GlaxoSmithKline Biologicals SA v. Comptroller-General of Patents, Designs and Trademarks, C-210/13 [Annex A1.XXV.]. 42 CJEU Arne Forsgren v. O ¨ sterreichisches Patentamt, C-631/13 [Annex A1.XXXII.]. 43 CJEU Arne Forsgren v. O ¨ sterreichisches Patentamt, C-631/13 [Annex A1.XXXII.], mn. 37. 44 CJEU Arne Forsgren v. O ¨ sterreichisches Patentamt, C-631/13 [Annex A1.XXXII.], mn. 35 and 28. 45 Cf. supra mn. 94. 46 Cf. supra, mn. 98.

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reconsidered for specific situations, e. g. if the previously authorised product was not protected by the basic patent used for obtaining an SPC on a newly authorised formulation. Even though the CJEU commented on Neurim in GlaxoSmithKline Biologicals47, one could argue for such case scenarios that the previous authorisation would not be the first authorisation according to Art. 3 lit. d RegSPC. Thus depending on the specific case scenario the door for SPCs on novel formulations may not be completely closed. b) Combinations of pharmaceutically active ingredients. In view of the CJEU’s case law on SPCs for formulations,48 Art. 1 lit. b RegSPC clearly relates to combinations of pharmaceutically active ingredients. It occurs quite frequently that an authorisation is obtained for a combination of pharmaceutically active agents which per se are known and already authorised; the combination nevertheless requires a marketing authorisation. If one takes the position that Art. 1 lit. b RegSPC relates to independent alternatives (mono v. combination products), the newly authorised combination could be considered as constituting a new product, and the authorisation to correspondingly relate to a new product. Under this assumption no problems should arise from Art 3 lit. c or d RegSPC49 with respect to the previously authorised mono products or eventually granted SPCs thereof. It was, however, in the context of combination products that the case law focused on the interpretation of Art. 3 lit. a RegSPC, namely the question by which standard it must be determined whether a combination of active ingredients is protected by a patent within the meaning of Art. 3 lit. a RegSPC. Subsequent decisions then addressed at least the relevance of Art. 3 lit. c RegSPC for combination products in view of previous SPCs for the mono products.50 107 The SPC intends to protect the “product” which is a legal term touching on both patent and pharmaceutical law. The interdisciplinary character of the SPC has to be taken into account when construing Art. 3 lit. b RegSPC.51 A “product” could be protected by a basic patent within the meaning of Art. 3 lit. a RegSPC if the product is within its scope of protection. Accordingly, from a practical point of view a product would fall within the scope of protection of a patent if it was considered as infringing the claim in a hypothetical scenario. Alternatively, a “product” could be protected by a basic patent within the meaning of Art. 3 lit. a RegSPC if the product was positively identified or specified in the claim. The question whether the so-called infringement test or the so-called identification theory should be applied was the subject of many national decisions some of which will be discussed in the subsequent chapters. 52 The decisions of the CJEU which ultimately favoured the identification theory were interestingly concerned with the question when a combination of active ingredients is protected by the basic patent, i. e. identified or specified in the claims. 53 Following the 106

47 CJEU GlaxoSmithKline Biologicals v. Comptroller-General of Patents, Designs and Trademarks, C210/13, reason 43 [Annex A1.XXV.]. 48 Cf. supra, mn. 101 et seqq. 49 Cf. supra, mn. 47, 56 and 57. 50 Cf. supra, mn. 47, 56 and 57, CJEU Actavis v. Sanofi, C-443/12, [Annex A1.XXII.], CJEU Georgetown University v. Octroicentrum Nederland (referred to as Georgetown II in the text), C-484/12 [Annex A1.XXVII]. 51 Refer to mn. 32 et seqq. supra with regard to the term ‘product’. 52 Gassner PharmR 2011, 361 with references to national decisions. 53 CJEU Medeva v. Comptroller-General of Patents, Designs and Trademarks, C-322/10 (1 st headnote) [Annex A1.XIII.]; CJEU Daiichi Sankyo Company v. Comptroller-General of Patents, Designs and Trademarks, C-6/11 (headnote) [Annex A1.XV.]; CJEU University of Queensland v. Comptroller-General of Patents, Designs and Trademarks, C-630/10 (1st headnote) [Annex A1.XVII.]. CJEU Yeda Research and Development Comptroller-General of Patent, Designs and Trade Marks, C518/10 [Annex A1. XVI.].

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CJEU’s endorsement of the identification theory questions arose how specific the claims of a basic patent have to identify the product, irrespective of whether combinations of active ingredients or single active ingredients are at stake: 54 The infringement test was rejected e. g. in Great Britain for case constellations where 108 the basic patent did not make reference to a conceivable substance combination. Thus, an SPC application for the authorised combination of Lanzoprazole and an antibiotic was denied in the Takeda decision55 as the basic patent only mentioned Lanzoprazole and – while it did not exclude the possibility of combinations – did not expressly claim them, either. According to the court, the fact that such combinations would infringe the basic patent was irrelevant with regard to the granting prerequisites of Art. 3 lit. a RegSPC. The infringement test was also not applied in the Gilead decision;56 however, an SPC for the substance combination of Tenofovir and Emtricitabine was granted as a claim of the basic patent referred to a combination of Tenofovir and other optional active ingredients. The Dutch, Swedish and French courts57 mainly tended towards the identification theory applied by the English courts, as well, whereas the German, 58 Swiss and Belgian courts were in favour of the infringement test. As mentioned, this discussion was resolved by the CJEU in favour of the identifica- 109 tion theory. Accordingly, an authorised product is not already “protected” by a basic patent within the meaning of Art. 3 lit. a RegSPC if it is within the scope of protection. As the scope of protection of a patent must be made exclusively according to considerations of patent law, the CJEU considered the infringement test which results from these provisions as going too far if applied to Supplementary Protection Certificates.59 The CJEU rather demands that the product underlying the SPC is “specified” in the 110 patent claims (identification theory).60 The restrictive handling of the legal term “protected by the basic patent” was justified by the CJEU by pointing out that the SPC must be granted according to uniform Community law standards. In addition, the CJEU cited recital 14 of the RegSPC-Plant Protection Products according to which a separate SPC may be granted for derivatives of a certified product if they are specifically claimed by a separate patent, and which also applies to Art. 3 RegSPC due to recital 17 RegSPCPlant Protection Products. Obviously, the CJEU construed this recital to imply that the specification of the product in the basic patent was generally a criterion for protection by the basic patent.61 54 CJEU Eli Lilly and Company Ltd v. Human Genome Sciences Inc., C-493/12 [Annex A1.XXVI.]), cf. infra mn.123. 55 Takeda Chemical Industries Limited SPC Applications in the UK (No 3) [2003] EWHC 649 (Pat), cf. Part II, chap. K, United Kingdom, mn. 11. 56 Gilead Sciences Inc.’s SPC Application in the UK [2008] EWHC 1902 (Pat)., cf. Part II, chap. K, United Kingdom, mn. 13. 57 Gassner PharmR 2011, 361, 363. 58 BGH Anti-Helicobacter-Pra ¨parat, X ZB 1/08 [Annex A2.V.]; Gassner PharmR 2011, 361, 363. 59 CJEU Medeva v. Comptroller-General of Patents, Designs and Trademarks, C-322/10 (1 st headnote) [Annex A1.XIII.]; CJEU Daiichi Sankyo Company v. Comptroller-General of Patents, Designs and Trademarks, C-6/11 (headnote) [Annex A1.XV.]; CJEU University of Queensland v. Comptroller-General of Patents, Designs and Trademarks, C-630/10 (1st headnote) [Annex A1.XVII.]. CJEU Yeda Research and Development Comptroller-General of Patent, Designs and Trade Marks, C518/10 [Annex A1. XVI]. 60 CJEU Medeva v. Comptroller-General of Patents, Designs and Trademarks, C-322/10 (1 st headnote) [Annex A1.XIII.]; CJEU Daiichi Sankyo Company v. Comptroller-General of Patents, Designs and Trademarks, C-6/11 (headnote) [Annex A1.XV.]; CJEU University of Queensland v. Comptroller-General of Patents, Designs and Trademarks, C-630/10 (1st headnote) [Annex A1.XVII.]. CJEU Yeda Research and Development Comptroller-General of Patent, Designs and Trade Marks, C518/10 [Annex A1. XVI]. 61 CJEU Medeva v. Comptroller-General of Patents, Designs and Trademarks, C-322/10, mn. 27 et seq. [Annex A1.XIII.].

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In Medeva, the claims of the basic patent were concerned with methods of making vaccines comprising the antigens Pertactin and FHA against whooping cough. No other antigens were mentioned in the claims or the description. The authorised products in addition to Pertactin and FHA contained antigens inter for diphtheria, meningitis and other diseases.62 The applicant filed SPC requests inter alia for the combination of Pertactin, FHA and the other antigens contained within the product but not mentioned in the patent. Following Medeva, these SPC requests were rejected. 63 112 Medeva is thus understood such that no SPC can be obtained for the combination of A and B where the authorised product comprises the active substance A and B and the basic patent only mentions A. Even though the CJEU in Medeva and the parallel decisions Daiichi Sankyo, University of Queensland, and Yeda64 consistently endorsed the identification theory over the infringement test for the purposes of Art. 3 lit. a SPC, it remained anything but clear how narrowly or broadly “specified in the patent claim” needs to be understood for the purposes of Art. 3 lit. a RegSPC. As mentioned above in the Gilead decision which is pre-Medeva the UK courts granted an SPC for the substance combination of Tenofovir and Emtricitabine on the basis of claim in the basic patent which referred to a combination of Tenofovir and other optional active ingredients.65 This raised the question whether in view of Medeva a claim had to exactly identify both actives (e. g. by INN), whether it was sufficient to functionally recite the active(s) (e. g. as ACE inhibitor), to describe it by a structural formula covering but not individualising the active (e. g. by a Markush formula) or whether the mere reference to a pharmaceutically active ingredient was sufficient if e. g. a more specific definition could be found in the description. There seems to be little chance of the latter to be sufficient, according to the phrase “specified in the wording of the claims” in the head note of the CJEU decision Medeva. 113 But with respect to the other possibilities there was hope for guidance in view of the Actavis v. Sanofi referral by the UK courts.66 This case concerned a combination product with the actives Irbesartan and Hydrochlorothyiazide which is a diuretic. The claims of the basic patent referred to Irbesartan and a diuretic. One of the referral questions clearly addressed the issue whether the specific combination of Irbesartan and Hydrochlorothyiazide can be considered being protected by the basic patent, i. e. being specified in the patent claim. In view of another referral question asking whether an SPC would be in line with Art. 3 lit. c RegSPC given that the same applicant on the basis of the same patent had already obtained an SPC for Irbesartan for the previously authorised mono product, the CJEU did not answer the question regarding Art. 3 lit. a RegSPC. Rather it rejected the SPC request for non-compliance with Art. 3 lit. c RegSPC.67 In a parallel decision which concerned the interpretation of Art. 3 lit. a RegSPC for a basic patent with a claim to any neutrokine-alpha antibody v. a product with the single active ingredient Tabalumab (a Neutrokine-alpha antibody 111

62 CJEU Medeva v. Comptroller-General of Patents, Designs and Trademarks, C-322/10, mn. 13 et seq. [Annex A1.XIII.]. 63 Cf. Part II, chap. K, United Kingdom, mn. 17. 64 CJEU Medeva v. Comptroller-General of Patents, Designs and Trademarks, C-322/10 [Annex A1.XIII.]; CJEU Daiichi Sankyo Company v. Comptroller-General of Patents, Designs and Trademarks [Annex A1.XV.], C-6/11; CJEU University of Queensland v. Comptroller-General of Patents, Designs and Trademarks [Annex A1.XVII.], C-630/10; CJEU Yeda Research and Development Comptroller-General of Patent, Designs and Trade Marks, C518/10 [Annex A1.XVI.]. 65 Cf. supra mn. 108, Gilead Sciences Inc.’s SPC Application in the UK [2008] EWHC 1902 (Pat), cf. Part II, chap. K, United Kingdom mn. 13. 66 CJEU Actavis v. Sanofi, C-443/12 [Annex A1.XXII.]. 67 See supra, mn.56.

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D. Subject Matter and Scope of Protection

of defined sequence), the CJEU ruled, however, that a product can be considered to be protected by the basic patent for the purposes of obtaining an SPC if the functional claim language relates “implicitly, but necessarily and specifically” to the active ingredient.68 The UK courts subsequently considered Tabalumab to be protected by the basic patent within the meaning of Art. 3 lit. a RegSPC.69 Against this background there seems to be a fair chance that the combination product in the Actavis v. Sanofi case would have been considered being protected by the basic patent, Art. 3 lit a. RegSPC. Medeva is remarkable not only for its clear rejection of the infringement test. In 114 Medeva the CJEU did – analogously to the preceding comments – also not rely on purely pharmaceutical law or patent law aspects with regard to the question of when a product is the subject of a marketing authorisation. The CJEU quite generously held that an authorisation for a substance combination in this respect also applies to each sub-combination.70 As held in Georgetown I the individual active ingredients are also deemed as sub-combinations.71 If this (and correspondingly, any other) sub-combination is additionally specified in the patent claims, a separate SPC may thus be granted for it, unless it is already subject of a separate, earlier authorisation, because then, the authorisation relevant would not be the first marketing authorisation within the meaning of Art. 3 lit. d RegSPC. According to Medeva and particularly Georgetown I, it is conceivable in case of 115 specification of a substance combination in the claims of the basic patent, that an SPC is sought for this combination even if the product underlying the authorisation contains additional active ingredients.72 This appears unusual, as – while there would be congruency between the specified active ingredients for the SPC and basic patent – not all active ingredients of the specific product designated in the authorisation are specified in the claims of the basic patent. Thus where a basic patent mentions the combination of A and C and where the authorised product contains A, B, C, and D, an SPC should be possible for the combination of A and C. Such situations may arise in practice particularly in the field of vaccines which Medeva was concerned and where the regulatory authorities may require that multiple actives should be combined in a single vaccine. Whether these aspects of Medeva can therefore be extended to other type of medicinal products remains to be seen. This applies as well to the question whether in cases in which an SPC was granted for 116 a sub-combination of an authorised substance combination on the basis of patent claiming this sub-combination, an infringement of the SPC is constituted by every other substance combination which contains this sub-combination. If the SPC was granted for the combination A and B on the basis of a patent for A and B and an authorisation for A, B and C, the question arises whether the owner of the SPC for A and B may sue against the use of the combination A, B and D. It can be fairly assumed that CJEU decisions will be required to clarify this question. 68 CJEU Eli Lilly and Company Ltd v. Human Genome Sciences Inc., C-493/12 [Annex A1.XXVI.], cf. infa mn. 123. 69 Cf. Part II, chap. K, United Kingdom, mn. 20. 70 CJEU Medeva v. Comptroller-General of Patents, Designs and Trademarks, C-322/10 (2 nd headnote) [Annex A1.XIII.]. 71 CJEU Georgetown University v. Comptroller-General of Patents, Designs and Trademarks, (referred to as Georgetown I in the text) C-422/10 (headnote) [Annex A1.XIV.]; CJEU University of Queensland v. Comptroller-General of Patents, Designs and Trademarks, C-630/10 (2 nd headnote) [Annex A1.XVII.]. 72 CJEU Medeva v. Comptroller-General of Patents, Designs and Trademarks, C-322/10 (2 nd headnote) [Annex A1.XIII.]; CJEU Georgetown University v. Comptroller-General of Patents, Designs and Trademarks, (referred to as Georgetown I in the text) C-422/10 (headnote) [Annex A1.XIV.].

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Similar although not identical issues have been addressed by the CJEU in cases where the SPC was granted on the basis of a product containing a single active ingredient and then enforced against subsequently authorised products containing this active ingredient in combination with another active ingredient. In the Novartis v. Actavis case, the SPC had been granted for the active Valsartan on the basis of an authorisation pertaining to the respective mono product. The question at stake was whether the combination product of Valsartan and Hydrochlorothyiazide was within the scope of protection conferred by the basic patent with respect to Art. 4 and 5 RegSPC. The claims of the basic patent did not explicitly pertain to combination products, but did also not exclude them. Nevertheless, there was congruency between the basic patent and the marketing authorisation for Valsartan. The CJEU found that under such circumstances the combination product would fall within the scope of protection conferred by the SPC for Valsartan under Art. 4 RegSPC.73 In the subsequent Actavis v. Sanofi decision (where the CJEU denied an SPC for the combination of Irbesartan and Hydrochlorothyiazide with respect to Art. 3 lit. c RegSPC as the patentee had previously obtained an SPC for Irbesartan on the basis of the same patent)74 the CJEU referred in its reasoning for rejecting the SPC for Irbesartan and Hydrochlorothyiazide to Novartis v. Actavis pointing out that the SPC owner could enforce the SPC obtained for the mono product also against the combination product. The CJEU obviously thought that against this background a new SPC on the combination with a longer term than the SPC for the mono product would not be commensurate particularly as the SPC for the combination product may raise issues of contributory infringement with respect to the mono product even if the SPC for the latter would have already expired.75 118 A different situation is where the basic patent clearly refers to a combination of active ingredients and where the original marketing authorisation was issued for a medicinal product which contains just one active ingredient, i. e. the authorised product contains active A and the basis patent requires the presence of A and B. Following the Yeda decision, the authorised product is not protected by the basic patent according to Art. 3 lit. a RegSPC.76 119 With respect to Art. 3 lit. a RegSPC it is thus possible to obtain SPCs for combinations of active ingredients or even a single active ingredient when these are specified by the basic patent even if the authorised product contains additional actives, i. e. an SPC can be obtained for a sub-combination of actives identified in the basic patent v. the authorised product. However, where the basic patent refers to combinations of active ingredients and the authorised product contains fewer actives, it is not possible to get an SPC for a sub-combination of in the authorised product v. the basic patent. 120 The above considerations on protection of combination of active ingredients by the basic patent (Art. 3 lit. a RegSPC) do not depend on the category of the basic patent. The same considerations apply if method patents are selected as basic patents. 77 In this context it is again decisive whether the product can be identified in the patent claim and not whether it can be produced by the claimed method.78 117

73 CJEU Novartis v. Actavis, C-574/11, mn. 21; see also parallel referral CJEU Novartis v. Actavis, C442/11, mn. 23. 74 CJEU Actavis v. Sanofi, C-443/12, [Annex A1.XXII.], cf. supra mn. 56. 75 CJEU Actavis v. Sanofi, C-443/12, mn. 36 and 37. 76 CJEU Yeda Research and Development Comptroller-General of Patent, Designs and Trade Marks, C-518/10 [Annex A1.XVI.]. 77 CJEU University of Queensland v. Comptroller-General of Patents, Designs and Trademarks, C-630/ 10 (2nd headnote) [Annex A1.XVII.]. 78 CJEU University of Queensland v. Comptroller-General of Patents, Designs and Trademarks, C-630/ 10 (2nd headnote) [Annex A1.XVII.].

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D. Subject Matter and Scope of Protection

All this shows that the case law by the CJEU on Art. 3 lit. a RegSPC except for its 121 clear rejection of the infringement test has probably led to more open than answered questions. For example, how should an SPC application be dealt with where the claims of the basic patent do not mention the active ingredients, but where these are clearly disclosed in the description so that the patent could be limited to such specific combinations? In such cases the patentee may initiate limitation proceedings before the SPC request is filed.79 Another question is whether, in situations where the claims of the basic patent do not mention the active ingredients and where previously and contrary to Medeva an SPC has been granted for the combination, the claims of such patents can be limited to the combination (provided there is disclosure for the combination in the description) and whether such limitations will have retroactive effect. This issue was addressed by a referral, but not answered by the CJEU 80 so that it is fair to assume that more referrals on Art. 3 lit. a RegSPC are to come for combination products. c) Products with single active ingredients. In Medeva and the parallel decisions 122 Daiichi Sankyo, University of Queensland, and Yeda81 all of which despite different fact patterns were concerned with combinations of active ingredients the CJEU decided in favour of the identification theory v. the infringement theory for the purposes of Art. 3 lit. a SPC.82 It was clear that in view of Medeva and the other decisions the identification theory applies as well to SPCs for products with single active ingredients (mono products) and the question arose whether the basic patent would have to claim the specific authorised active (e. g. name the INN, show the precise structure or list the specific sequence) or whether a generic or functional characterisation of the active in the claims would be sufficient identification. This question is particularly relevant where the granted claims contain a Markush formula covering the active, but where the active is not individualised in the claims or the specification. The German courts that traditionally had applied the infringement test considered in such cases the active to be protected by the basis patent.83 As mentioned above, in Eli Lilly which was concerned with the interpretation of 123 Art. 3 lit. a RegSPC the basic patent had claims to any neutrokine-alpha antibodies. The description did not disclose any specific neutrokine-alpha antibodies. The authorised product had the single active ingredient Tabalumab (a Neutrokine-alpha antibody of defined sequence which was not disclosed in the patent). Against this background the CJEU ruled that a product can be considered as being protected by the basic patent for the purposes of Art. 3 lit. a RegSPC if the functional claim language relates “implicitly, but necessarily and specifically” to the active ingredient.84 The UK courts subsequently considered Tabalumab to be protected by the basic patent within the meaning of Art. 3 lit. a RegSPC.85 It thus seems that as in the past SPCs for active ingredients may be granted even if the basic patent does not claim the authorised product verbatim but uses 79

Art. 105 a EPC. CJEU Actavis v. Boehringer Ingelheim, C-577/13 [Annex A1.XXXI. which lists the referral questions]. 81 CJEU Medeva v. Comptroller-General of Patents, Designs and Trademarks, C-322/10 [Annex A1.XIII.]; CJEU Daiichi Sankyo Company v. Comptroller-General of Patents, Designs and Trademarks [Annex A1.XV.], C-6/11; CJEU University of Queensland v. Comptroller-General of Patents, Designs and Trademarks[Annex A1.XVII.], C-630/10, CJEU Yeda Research and Development Comptroller-General of Patent, Designs and Trade Marks, C518/10[Annex A1.XVI.]. 82 Cf. supra mn. 109 et seqq. 83 BGH Sumatriptan, X ZB 12/01 [Annex A2.III.], which is pre-Medeva. 84 CJEU Eli Lilly and Company Ltd v. Human Genome Sciences Inc., C-493/12 [Annex A1.XXVI.]. 85 Cf. Part II, chap. K, United Kingdom, mn. 20. 80

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Part I. Generals of the SPC in the EU

functional features or Markush formulas. Further referrals will, however, be almost certainly required to determine to what extent this is possible. In this context comments of the CJEU in both Actavis v. Sanofi86 and Eli Lilly87 are remarkable as they seem to suggest that the CJEU in view of the objective of RegSPC may be in favour of a research proviso, The CJEU’s comments can be interpreted to mean that SPCs for products which are not verbatim but only functionally identified in the claims may only be granted if the applicant had actively taken steps to carry out in-depth research and identify his invention specifically. 124 In terms of specific disclosure of single active ingredients by the claims the patent category (As for combination products) does not matter and the same considerations apply if method patents are selected as basic patents.88 The above mentioned referral asking whether claims of patents for which SPCs have been granted and which are not in compliance with Medeva can be limited to the specific active ingredient (provided there is disclosure in the description) and whether such limitations will have retroactive effect was expected be also relevant for mono-products. 89 However, as the CJEU did not answer the referred question, no further guidance is currently available in this request. 86

CJEU Actavis v. Sanofi, C-443/12, [Annex A1.XXII.], mn. 30 and 31. CJEU Eli Lilly and Company Ltd v. Human Genome Sciences Inc., C-493/12 [Annex A1.XXVI.], mn. 43. 88 CJEU University of Queensland v. Comptroller-General of Patents, Designs and Trademarks, C-630/ 10 (2nd headnote) [Annex A1.XVII.]; cf. supra, mn. 21. 89 CJEU Actavis v. Boehringer Ingelheim, C-577/13 [Annex A1.XXXI. which lists the referral questions]. 87

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E. Rights, Limitations and Obligations According to Art. 5 RegSPC, the effects of the SPC correspond to those of the basic 125 patent. As a result, there is an accessory interrelation between the SPC and the basic patent. This interrelation strictly relates to the selected basic patent which protects the inventive technical and which underlies the SPC. The effects of the SPC, however, are subject to the reservation of Art. 4 RegSPC 126 which defines the subject-matter of protection of the SPC. Thus, the effects of the SPC according to Art. 5 RegSPC can principally only take hold within the framework of the subject-matter of protection according to Art. 4 RegSPC. Thus the effects of the SPC correspond to those of the basic patent, but within the scope of protection conferred by the basic patent can only be enforced with respect to the authorised product and the authorised use. Pursuant to Art. 5 RegSPC, the same rights (see infra I. Rights of the Certificate 127 Holder), limitations and obligations (see infra II. Limitations and Obligations) which are conferred by the basic patent are conferred by the SPC.

I. Rights of the Certificate Holder 1. Rights of Use and Exclusivity Just like the patent the SPC confers negative exclusive rights, which typically allow 128 the SPC holder to prohibit any third party from producing, using, selling and offering the subject matter of the SPC. These rights of the SPC holder are enforced by means of the claims under national patent law to which it may be entitled. In addition the SPC confers positive rights of use with regard to the protected teaching (assuming that the same party holds the SPC and the respective marketing authorisation) 1 subject to third party rights, e. g. other patents.

2. Licenses The patent holder may freely dispose of and grant licenses regarding the patent. In 129 view of Art. 5 RegSPC, these rights are also conveyed by the SPC. Accordingly, the SPC constitutes an independent property right.2 The accessorial interrelation between SPC and basic patent regarding validity (as discussed above) thus does not prevent that the holders of the basic patent and of the SPC may differ, and that the latter can be transferred as an independent property right.3 License agreements are subject to national law, as the effects of the basic patent are 130 decisive according to Art. 5 RegSPC. Consequently, there are principally no differences as compared to patent law. However, Art. 5 RegSPC does not resolve the question of whether licenses in the basic patent automatically also cover the SPC. Therefore, national law must be resorted to subsidiarity, as well.4

1

CJEU Biogen v. SmithKlineBeecham Biologicals, C-181/95 [Annex A1.I.], cf. supra mn. 47. Bra¨ndel GRUR 2001, 875, 877. 3 Bra ¨ ndel GRUR 2001, 875, 877. 4 For details see part II. 2

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Part I. Generals of the SPC in the EU

The question of whether the licensor of the basic patent is supposed to be obligated to the licensee to register and maintain the SPC is of particular importance. Due to its in rem exclusivity and the resulting market exclusivity, such an obligation will have to be assumed for exclusive patent licensees.5 132 With regard to other types of licenses, however, there is no consensus on this question.6 As an argument against a general registration and maintenance duty, it is asserted that the non-exclusive licensee – unlike the exclusive licensee – is precisely not granted a privileged legal position as compared to its competitors. According to this opinion, the non-exclusive licensee is able to use the subject of the patent just as it did before after expiration of the basic patent without application of an SPC; thus, its legal position suffers no detriment.7 However, a registration and maintenance obligation could also be denied with regard to the basic patent with the same argument, which is not the case. If the non-exclusive license is considered an in rem right, a separate legal position (as compared to the other competitors) is granted after all, even if the licensees are not entitled to any independent cease and desist or damage claims. Precisely in situations in which only a few competitors were granted a license to use the certified subject in a large market, the licensees obtain a position worthy of protection which would be infringed if the protected subject became generally available upon expiration of the SPC. In case of the exclusive license, this becomes particularly clear. In order to avoid uncertainty, one must therefore assume a general obligation of the licensor to register and maintain an SPC, as well. Of course, this issue is of rather subordinate practical relevance as the licensor usually has an overwhelming interest in registering and maintaining the SPC. 131

3. Right to the SPC (Art. 6 RegSPC) Rights of the Certificate holder do not only arise upon grant of the SPC. As in patent law with respect to the right to the patent (Art. 60 para. 1 sentence 1 EPC), there is a right to the SPC before grant. It is vested in the holder of the basic patent, Art. 6 RegSPC. If multiple patents of different patent holders are eligible, then every holder is entitled to the right to the SPC. 134 In case of multiple potential basic patents of one and the same patent holder, the patentee must make a selection.8 If it transfers one of its patents to a third party, this third party may acquire a separate SPC, provided that the transfer is made prior to the grant of an SPC on the basis of one of the patents originally vested in the same holder. 9 Any transfer of basic patents to another party in order to create different SPCs for the same product on the basis of different patents in the name of different patentees will have to be carefully considered under aspects of competition law given that SPC filing strategies have come under scrutiny of the competition authorities. 10 135 The determination in Art. 6 RegSPC that the right to the SPC is vested in the successor of the basic patent holder in such cases, is redundant insofar as the acquirer becomes the patent holder upon the succession, and subsequently is itself the “holder of the basic patent” within the meaning of Art. 6 RegSPC. The fact that the successor is 133

5

Schennen Art. 6 mn. 4 c; Bru¨ckner/von Czettritz/Bru¨ckner Art. 6 mn. 30. In favour of that kind of obligation Schennen Art. 6 mn. 4 c; dissenting opinion: Bru¨ckner/von Czettritz/Bru¨ckner Art. 6 mn. 29. 7 Bru ¨ ckner/von Czettritz/Bru¨ckner Art. 6 mn. 29. 8 Cf. supra, mn. 43 and 66. 9 Cf. Bru ¨ ckner/von Czettritz/Bru¨ckner Art. 6 mn. 8 with citations. 10 CJEU AstraZeneca v. European Commission, C-457/10 [Annex A1.XXI.], cf. supra mn. 58 and 59. 6

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E. Rights, Limitations and Obligations

nevertheless explicitly mentioned is mainly taken to mean that the right to the SPC can be transferred independently from the basic patent, as well.11 The SPC confers absolute protection upon its grant only. The effects of Art. 5 136 RegSPC do not apply prior to this point in time. Any rights to prohibit any use etc. towards third parties can only be exercised on the basis of the basic patent, but not on the basis of the right to the SPC. Accordingly, the right to the SPC (Art. 6 RegSPC) can be qualified as an imperfect absolute intellectual property right.

II. Limitations and Obligations Limitations and obligations of the basic patent also cover the SPC pursuant to Art. 5 137 RegSPC. It comprises such stipulations which restrict the comprehensive rights of use and exclusivity regarding the protected technical teaching vis-a`-vis everyone or which obligate the holder to take certain actions. These limitations and obligations are substantiated by national law and may include e. g. aspects of compulsory licensing. 12 Yet they do not have to be set forth in the national patent law. It is solely relevant whether these limitations and obligations arising from national law (would) apply to the basic patent as well. Given the nature of the SPC, antitrust restrictions pursuant to Art. 101, 102 TFEU are of particular relevance. 13 As mentioned compulsory licenses (Art. 5 PCPIP, Art. 31 TRIPS) are also deemed as 138 limitations.14 Such a compulsory license can be granted for the SPC even if it did not exist for the basic patent. By contrast, it is unclear whether compulsory licenses in the basic patent continue in the SPC automatically, as well. Yet it would defeat the purpose of the compulsory license if the patent holder could circumvent the compulsory license in the individual case, as the compulsory license was usually granted against its wishes. As the SPC does not constitute a subject-matter of protection independent from the basic patent, it accordingly corresponds to the purpose of the respective compulsory license that it continues in the SPC (as is the majority position in at least the German literature).15 Due to the reservation for the provisions of Art. 4 RegSPC which is contained in Art. 5 RegSPC, however, this does not apply to such compulsory licenses and orders of exploitation which are outside of the pharmaceutical field, 16 i. e. in particular which do not relate to a “product” within the meaning of the RegSPC. Compulsory licenses therefore continue in the SPC without the requirement for an independent legal act. This also applies in case the SPC has been filed after the grant of the compulsory license.17 11 Kraßer § 26 para. A2 lit. b No 2 (p. 580 et seq.); Bra ¨ ndel GRUR 2001, 875, 878; Benkard/Grabinski § 16 a mn. 40; Bru¨ckner/von Czettritz/Bru¨ckner Art. 6 mn. 21; Busse/Hacker Anh § 16 a mn. 68. 12 For details see part II. 13 Bru ¨ ckner/von Czettritz/Bru¨ckner Art. 5 mn. 41. 14 Busse/Hacker Anh § 16 a para 67; Bru ¨ ckner/von Czettritz/Bru¨ckner Art. 5 mn. 37; cf. also Beyerlein PharmR 2007, 271, 271 et seq. 15 Grounds for PatGA ¨ ndG BlPMZ 1993, 205, 208; Busse/Hacker Anh § 16 a mn. 67; Bru¨ckner/von Czettritz/Bru¨ckner Art. 5 mn. 37; dissenting: Bra¨ndel GRUR 2001, 875, 877. 16 Bru ¨ ckner/von Czettritz/Bru¨ckner Art. 5 mn. 39. 17 Schulte/Ku ¨ hnen § 16 a mn. 26.

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F. Grant Procedure I. General 139

According to the current legal situation, neither the Supplementary Protection Certificate nor the basic patent can be granted as a uniform right with EU-wide effect. As mentioned at the very beginning, the unitary patent is only an option for applicants – not mandatory, and in addition no according unitary SPC exists yet. Therefore the holder of a (bundle) patent granted under the EPC is forced to lodge a decentralised application for the supplementary protection, i. e. in each Member State separately, cf. Art. 9 para. 1 RegSPC. A European bundle Certificate with a centralised grant procedure that is comparable to the European patent does not exist yet. Thus, a Certificate previously granted in a Member State is not deemed as a prejudicial prior Certificate in one of the other Member States within the meaning of Art. 3 lit. c RegSPC. 1 Nevertheless, a uniform expiry of the Certificate protection is guaranteed as it directly follows the expiration of the patent term and is calculated based on the first authorisation in the Community, Art. 13 para. 1 RegSPC,2 regardless of the point in time when the Certificate is granted.3

II. Application 140

The formal requirements of the SPC application are governed by Art. 7 to 9 RegSPC. In the course of the codification of RegSPC 1992 in 2009, Art. 7 and 8 RegSPC have also been adjusted slightly; however, substantive amendments have not been made. Art. 9 RegSPC remained unchanged.

1. General Application Requirements According to Art. 6 RegSPC, only the holder of the basic patent may lodge an SPC application.4 Nevertheless, it is sometimes argued that the exclusive licensee is also authorised to lodge an application on behalf of the basic patent holder. 5 142 The general requirements for SPC applications are set forth in national law and the RegSPC only constitutes the basis for the management of SPC applications by the national authorities. Thus, for details of some Member States and Switzerland see part II. 141

2. Form and Content of the Application 143

In accordance with Art. 9 para. 1 sentence 1 RegSPC the application has to be submitted to the respective authority responsible for industrial property rights of the Member State where the basic patent was granted or takes effect and which granted the first marketing authorisation. Art. 9 para. 1 sentence 1 RegSPC allows the Member States discretion to determine another authority for this purpose. Benkard/Grabinski § 16 a mn. 28 with citations. In case multiple national patents exist according to the EPC, the end of the patent term is also uniform, cf. Art. 63 para. 1 EPC. 3 Cf. Supra mn. 52 and 69. 4 See supra mn. 130 et seqq. on the meaning of the appendage “or his successor in title” in Art. 6 RegSPC. 5 Thus Ku ¨ hnen in Schulte § 16 a mn. 20; dissenting opinion Schennen Art. 6 note 4 c. 1 2

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F. Grant Procedure

The contents required for filing the application are primarily set out in Art. 8 RegSPC. According to Art. 8 para. 1 lit. a RegSPC, the Certificate application must contain an application for the grant of the Certificate. This application must provide sufficient information about the person and address of the applicant and/or its agent in accordance with Art. 8 para. 1 lit. a i) and ii) RegSPC. The number and the title of the patented invention have to be recorded on the application, Art. 8 para. 1 lit. a iii) RegSPC. The grant of a Supplementary Protection Certificate is also subject to an authorisation under pharmaceutical law, which must have been granted in the country in which the SPC is requested. According to Art. 8 para. 1 lit. a iv) RegSPC, the number and the point in time of the first authorisation under pharmaceutical law within the meaning of Art. 3 lit. b RegSPC granted in the country of application have to be contained in the application. As a substantive prerequisite for the grant of an SPC, the authorisation still has to be in force at the time the application is being filed (as with the basic patent). For purposes of proof, a copy of the authorisation has to be attached to the application in accordance with Art. 8 para. 1 lit. b RegSPC. The number and the point of time of the authorisation have to be indicated; in addition, the identity and a summary of the criteria of the product in accordance with Art. 11 DirMPH or DirMPV need to be stated. A centralised European authorisation on the basis of the RegCAP substitutes the national authorisation, and is therefore treated like an authorisation granted in the country of application. 6 If a third party authorisation is the basis of the application for the grant of an SPC, the holder of the authorisation may refuse to provide a copy to the holder of the basic patent.7 In this case, the national grant authority is required to procure a copy of the authorisation; it is not permitted to reject the application for this reason alone. 8 If an authorisation under pharmaceutical law was granted in another Member State of the Community before the first authorisation under pharmaceutical law was granted in the country of application, the number and point in time of this authorisation are required to be documented on the application in accordance with Art. 8 para. 1 lit. a iv) RegSPC, as well. If there are multiple authorisations in other member states, one has to indicate only the first authorisation within the Community. This facilitates the calculation of the term according to Art. 13 RegSPC. Further, according to Art. 8 para. 1 lit. c RegSPC, the identity of the product subject to this first authorisation and the legal basis on which the first authorisation procedure was based, must be contained within the application, and a copy of the relevant page of the official journal in which the first authorisation was published must be attached to the application. Authorisations that were granted in Norway, Iceland and Liechtenstein have to be considered in this context, as the RegSPC is applicable in the EEA countries as well. Due to the fact that the Court of Justice of the European Union also considers authorisations under pharmaceutical law from Switzerland that are recognised in Liechtenstein as first authorisations under pharmaceutical law within the meaning of Art. 13 RegSPC,9 the same has to apply to first authorisations within the meaning of Art. 8 para. 1 lit. a iv) RegSPC. The transitional provisions of Art. 20 and 21 RegSPC apply with respect to first authorisations under pharmaceutical law from the new EU Member States which were issued before their accession to the EU. If there is no official publication as defined above, the reduced demonstration requirements under the RegSPC-Plant Protection Products should apply mutatis mutandis to Art. 8 para. 1 lit. c RegSPC 6

Cf. Bru¨ckner/von Czettritz/Bru¨ckner Art. 8 mn. 76. CJEU Biogen v. SmithKlineBeecham Biologicals, C-181/95 (2nd headnote) [Annex A1.I.]. 8 CJEU Biogen v. SmithKlineBeecham Biologicals, C-181/95 (3 rd headnote) [Annex A1.I.]. 9 CJEU Novartis, C-207/03 [Annex A1.VI.]. With respect to the marketing authorisation of pharmaceuticals in Liechtenstein relevant in this context see Eggenberger Sto¨ ckli/Schaper PharmR 2008, 35 et seqq. 7

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144

145

146

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Part I. Generals of the SPC in the EU

according to Recital 17 RegSPC-Plant Protections Products. In this case, any document may be provided that contains the information required.10 148 The product within the meaning of Art. 1 lit. b RegSPC for which protection is being requested, has to be named in the application.11 In this context the product to be protected does not necessarily have to identical to the product referred to in the authorisation under pharmaceutical law,12 so that the applicant may generally choose between all products specified and included in the scope of the protection of the basic patent. In terms of the wording of the product, it needs to be taken into account that – due to the applicability of the national patent law in determining the scope of protection of the basic patent – decisions regarding the question whether the product to be protected is still included in the scope of protection of the basic patent, may vary.13 One should be able to use the wording “Product A (e. g. INN) in all forms being protected by the basic patent”.14 While this wording is accepted in Germany, other patent offices in fact require the naming of the exact authorised product, i. e. the authorised salt. Typically an explanation is further expected why the product is considered as being protected by the basic patent in accordance with Art. 3 lit. a RegSPC. 149 If there are irregularities in the application regarding the prerequisites listed in Art. 8 RegSPC, the applicant is requested by the national authority to rectify the determined irregularities within a certain grace period set by the authority, cf. Art. 10 para. 3 RegSPC in conjunction with Art. 9 para. 1 RegSPC.

3. Application Period In accordance with Art. 7 para. 1 RegSPC, the application must be filed within a deadline of six months as from the date of the grant of the first authorisation under pharmaceutical law. If the deadline was to expire after the expiration date of the basic patent, the SPC application has to be filed before the basic patent expires as otherwise Art. 3 lit. a RegSPC was contravened.15 As the requirement of a basic patent in force is a substantive requirement, non-compliance with this deadline cannot be remedied. 16 If the basic patent is granted only after the authorisation under pharmaceutical law, the deadline of six months commences as from the date of the grant of the basic patent, Art. 7 para. 2 RegSPC. 151 The wording of Art. 7 paras. 1 and 2 RegSPC does not provide the point in time from which the authorisation under pharmaceutical law and/or the basic patent are deemed to be granted, and therefore, the beginning of the application deadline remains unclear. Nor has the CJEU resolved to address whether the point in time of the granting of the authorisation resp. the basic patent is determined by means of the national or the Community law. 152 In principle, the date of issuance, the date of transmission17 or the date of publication of the marketing authorisation could start the deadline of Art. 7 para. 1 RegSPC. There 150

10

Bru¨ckner/von Czettritz/Bru¨ckner Art. 8 mn. 84, 86. Bru¨ckner/von Czettritz/Bru¨ckner Art. 8 mn. 30; Mes § 49 a PatG mn. 14. 12 CJEU I Farmitalia v. Deutsches Patent- und Markenamt, C-392/97 [Annex A1.III.]. 13 CJEU Farmitalia v. Deutsches Patent- und Markenamt, C-392/97 [Annex A1.III.]; Bru ¨ ckner/von Czettritz/Bru¨ckner Art. 8 mn. 41. 14 CJEU Farmitalia v. Deutsches Patent- und Markenamt, C-392/97 [Annex A1.III.]. 15 Cf. supra mn. 37. 16 As held in Germany by BPatG Abamectin, 15 W (pat) 71/97 [Annex A2.VII.]. 17 A question dealing with when the authorisation under pharmaceutical law takes effect was referred by the BGH to the CJEU (BGH GRUR 2008, 65 – Porfimer) but was later withdrawn, CJEU removal order of 3 September 2008, C-452/07. 11

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have been arguments in favour of the publication date of the marketing authorisation as the relevant date of grant (and thus calculating the deadline of Art. 7 para 1 RegSPC), namely that relying on the date of issuance or date of transmission amounts to a de facto reduced deadline for the applicant in those cases in which a third party succeeded in obtaining the authorisation, of which the holder of the basic patent may not be informed prior to the publication and thereby loses valuable time for the application. 18 This view, however, conflicts with the uniform interpretation of the term “grant” required by the CJEU for authorisations under pharmaceutical law within the directive, 19 because Art. 8 para. 1 lit. b RegSPC necessarily relates to the date of issuance. 20 There is, however, a referral pending whether the date of issuance or the date of 153 transmission of the authorisation to the applicant should be used for determining the SPC term and whether the relevant date (date of issuance or date of transmission) should be determined according to Community law or national law.21 Even though this referral is on Art. 13 RegSPC, it should also give guidance for the calculating the deadline of Art. 7 para. 1RegSPC. Concerning European patents, it is undisputed that the date of the mention of the 152 grant according to Art. 97 para. 3 EPC is relevant.22

4. Application regarding the Term Extension of an SPC If clinical studies were carried out in accordance with an approved paediatric 153 investigation plan (PIP) for an authorized drug, the Certificate holder may file for a term extension of the Certificate regarding the product underlying the drug. This provision was introduced in the course of the RegMPP and is intended to promote the development of paediatric drugs. The rewarding effect is enhanced by the fact that the term extension can be granted regardless of whether the paediatric studies succeeded, i. e. resulted in a newly authorised paediatric drug.23 If the applicant or the holder of the SPC desires to file an application for a term 154 extension, the application, in accordance with Art. 9 para. 1 sentence 2 RegSPC, has to be submitted to the same authority that is in charge of applications for Supplementary Protection Certificates. This provision entails the advantage that applications for the grant of an SPC and for its extension can be submitted as simply as possible and simultaneously.24 According to Art. 36 paras. 1 and 3 RegMPP, the term extension of the SPC is only granted if the results of all studies carried out in accordance with an approved paediatric investigation plan are contained in the application for authorisation and if the drug is authorised in all EU Member States. Regardless of whether the SPC has already been granted, the applicant has to provide evidence about the aforementioned prerequisites, Art. 8 paras. 2 and 3 RegSPC. For this purpose a copy of the declaration of compliance granted pursuant to Art. 28 para. 3 RegMPP and reflecting that the market authorisation application is identical to the PIP approved and carried out, is necessary in accordance with Art. 8 para. 2 or 3 in conjunction with Art. 8 para. 1 lit. d i) RegSPC. Bru¨ckner/von Czettritz/Bru¨ckner Art. 7 mn. 49 et seqq. and 62 et seq. Regarding the uniformity of the interpretation in general see CJEU Ha¨ssle v. ratiopharm, C-127/00, mn. 57, 72 [Annex A1.IV.]. 20 BPatG Porfimer, 15 W (pat) 59/03 (keynote) [Annex A2.VIII.]; Benkard/Grabinski § 16 a mn. 41. 21 CJEU Seattler Genetics, (referral) C-471/14 [Annex A1. XXIX.]. 22 Benkard/Grabinski § 16 a mn. 41; Busse/Hacker Anh § 16 a mn. 71; Schennen Art. 7 note 3 et seq.; apparently also Kellner GRUR 1999, 805, 808. 23 Recitals 2 to 4 as well as Art. 36 para. 1 RegMPP. 24 Cf. Art. 7 para. 3 RegSPC. 18 19

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Part I. Generals of the SPC in the EU

In this context, it has to be noted that the marketing authorisation application may also be an application for authorisation of new indications within the meaning of Art. 8 RegMPP, because the applicant of a term extension may be granted even if it already obtained an SPC on the basis of the first marketing authorisation and only carries out paediatric studies afterwards in order to develop a new (paediatric) indication of the product protected by its SPC. 156 Furthermore, the applicant must prove that the product is approved in all the other Member States according to Art. 36 para. 3 RegMPP according to Art. 8 para. 2 in conjunction with Art. 8 para. 1 lit. d ii) RegSPC (if the grant procedure for the SPC is still ongoing) and according to Art. 8 para. 3 in conjunction with Art. 8 para. 1 lit. d ii) RegSPC (if the SPC has already been granted). If the SPC to be extended has already been granted, a copy of the SPC must also be submitted along with the application pursuant to Art. 8 para. 3 RegSPC. If the application for extension was submitted before the grant of the SPC, the application must contain a note reflecting that the SPC application is pending, rather than a copy of the SPC, Art. 8 para. 2 RegSPC. 157 If the application for extension contains errors, the same principles hold which also apply in case of errors in the SPC application pursuant to Art. 10 paras. 6 and 3 RegSPC. The application for a term extension can be filed together with the application for a Supplementary Protection Certificate or during the ongoing application procedure, Art. 7 para. 3 RegSPC. If the Certificate has already been granted, the application shall be filed no later than two years prior to the expiry of the Certificate pursuant to Art. 7 para. 4 RegSPC. 155

5. Application Fees 158

In accordance with Art. 8 para. 4 RegSPC, the Member States may request fees for the application. The payment is due upon the filing of the application or the application for term extension, Art. 8 para. 4 RegSPC in conjunction with Art. 10 para. 3 RegSPC.

6. Publication of an Application Notice Third parties are supposed to be given the opportunity to adjust to the date of expiry of protection as early as possible; e. g. in order to prepare for marketing of their generic products ahead. Thus, Art. 9 para. 2 RegSPC provides for the publication of a notice on the Certificate application which shall be made out by the authority in charge of the grant of the Supplementary Protection Certificate. According to Art. 9 para. 3 RegSPC, a corresponding notice is to be published concerning the application for the extension of the SPC. 160 A notice within the meaning of Art. 9 paras. 2 and 3 RegSPC must contain at least the applicant’s name and address and/or the name and address of at least one of his representatives or authorised recipients and further the number of the basic patent, the title of the invention, the number and date of the marketing authorisation within the meaning of Art. 3 lit. b RegSPC and the product identified by the authorisation. If the first authorisation under pharmaceutical law was granted in a Member State other than the one in which the application is filed, its number and issue date must also be stated according to Art. 9 para. 2 lit. e RegSPC. This also applies mutatis mutandis to the notice regarding an application for a term extension, Art. 9 paras. 3 and para. 2 lit. f RegSPC. 159

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F. Grant Procedure

III. Grant and Announcement The scope of examination of an application principally includes the substantive and formal prerequisites of the grant of the SPC. In this context, Art. 10 para. 5 RegSPC authorises the Member States to waive the examination of the prerequisites mentioned in Art. 3 lit. c and d RegSPC by way of a statutory provision. The decision on the grant of the SPC is decided by way of a decree. According to Art. 10 para. 1 RegSPC, the SPC is granted if the substantive and formal prerequisites for the grant are met. In this case, the applicant is entitled to the grant.25 If substantive prerequisites are not met, the application must be rejected according to Art. 10 para. 2 RegSPC. Regarding the formal prerequisites, one has to differentiate different aspects. 26 If an error concerning a formal prerequisite under Art. 8 RegSPC and brought to the applicant’s attention was not remedied within a term set by the authority, the application is to be denied pursuant to Art. 10 para. 4 RegSPC. The term is a preclusive time limit according to the wording of Art. 10 para. 4 RegSPC, so that it is not possible to file any documents subsequently. However, restitutio in integrum may be granted.27 If the Certificate applicant cannot present a copy of the authorisation under pharmaceutical law pursuant to Art. 8 para. 1 lit. b RegSPC, because, while it holds the basic patent, it does not hold the authorisation, and the authorisation holder refuses to provide a copy to the former, the application shall not be rejected on this ground alone.28 Contrary to the wording of Art. 3 lit. c RegSPC, a Certificate may be granted to the holder of a basic patent even if an SPC was already granted to one or more holders of one or more other basic patents.29 In accordance with Art. 10 para. 6 RegSPC, the aforementioned comments apply mutatis mutandis to the grant and rejection of an application for term extension of the protection. The grant decree determines the content of the SPC. The decree enters into legal force immediately upon the grant.30 If the Certificate is granted, the granting authority must publish the respective announcement in accordance with Art. 11 para. 1 RegSPC. According to the same provision, the announcement must contain the name and address of the Certificate holder or of its representative, the number of the basic patent, the title of the invention, the title and the date of the authorisation under pharmaceutical law as well as the product identified by the authorisation, and, where applicable, the number and date of the first marketing authorisation within the Community and the term of the Certificate. The rejection of the application must also be published in a notice according to Art. 11 para. 2 RegSPC and contain the information listed in Art. 9 para. 2 RegSPC. Due to Art. 11 para. 3 RegSPC, respective announcements concerning the grant or rejection of a term extension of the SPC must also be published.

Mes § 16 a mn. 28. Benkard/Grabinski § 49 a mn. 10; Busse/Hacker Anh § 16 a mn. 88. Benkard/Grabinski § 49 a mn. 10; Busse/Hacker Anh § 16 a mn. 88. 28 CJEU Biogen v. SmithKlineBeecham Biologicals, C-181/95 (3 rd headnote) [Annex A1.I.]. 29 CJEU AHP Manufacturing v. Bureau voor de Industrie ¨le Eigendom, C-482/07 (headnote) [Annex A1.X.]. 30 Mes § 49 a mn. 23. 25 26 27

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161

162

163

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IV. Fees to Maintain the SPC 165

In order to maintain the Supplementary Protection Certificate, annual fees can be requested by the member states pursuant to Art. 12 RegSPC. If the payment deadline expires without payment of the fees, the Certificate expires according to Art. 14 lit. c RegSPC.

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G. Expiry, Invalidity and Revocation Art. 14 RegSPC contains the reasons for the expiry of the SPC and lists four grounds 166 which have an ex nunc effect.1 Art. 15 RegSPC governs the grounds for invalidity which have an ex tunc effect.

I. Reasons for Expiry pursuant to Art. 14 RegSPC According to Art. 14 lit. a RegSPC, the SPC expires at the end of the fixed period as per Art. 13 RegSPC. In accordance with Art. 63 para. 2 EPC, the legal term of the SPC within the meaning of Art. 13 para. 1 RegSPC commences immediately after the patent expired. The legal duration of the SPC in accordance with Art. 13 para. 1 RegSPC is determined by the period between the filing of the application for the basic patent and the moment of the first marketing authorisation within the Community, where five years are deducted from this period in all cases. According to Art. 13 para. 2 RegSPC, however, the term adds up to a maximum of five years as of the moment the SPC comes into effect (plus an additional six month paediatric extensions where applicable). Art. 14 lit. d RegSPC refers to the authorisation in accordance with the DirMPH or DirMPV.2 The SPC will expire if the marketing authorisation lapses. It is the purpose of the provision that the supplementary protection is no longer justified if the beneficiary is not permitted to market the product.3 It has no effect if the authorisation on which the SPC (Art. 3 lit. b, Art. 8 para. 1 lit. a iv) RegSPC) was based, ceases to exist, as long as an authorisation actually exists which the SPC can refer to at a later date, Art. 4 RegSPC.4 Therefore, the wording “authorisation or authorisations” in Art. 14 lit. d RegSPC implies that there is no longer any authorisation, at all.5 The expiry does not enter into force by operation of law.6 Rather, if Art. 14 lit. d sentence 1 RegSPC applies, the competent authority decides ex officio or upon application of a third party, Art. 9 RegSPC. Art. 14 lit. d RegSPC refers to the withdrawal of the authorisation either by the authorisation holder or official authorities. The withdrawal of the authorisation by official authorities may be seen as an actual revocation. Generally a withdrawal by the official authorities will include any official act, which removes the marketing authorisation as per the DirMPH or DirMPV. In contrast to administrative acts with an ex nunc effect, revocations with retroactive effect (ex tunc) imply that the legal validity of the authorisation according to Art. 3 lit. b RegSPC must be considered as absent as from the outset. In these latter cases, the consequence for the Supplementary Protection Certificate is not expiry according to Art. 14 lit. d RegSPC, but invalidity according to Art. 15 lit. a RegSPC.7

Busse/Hacker Anh § 16 a mn. 99. In detail supra, mn. 51. 3 Mu ¨ hlens Mitt. 1993, 213, 218. 4 Schennen Art. 14 para 5; Busse/Hacker Anh § 16 a mn. 100. 5 Busse/Hacker Anh § 16 a mn. 100. 6 Benkard/Ullmann/Grabinski EPC Art. 63 mn. 91. 7 Bra ¨ ndel GRUR 2001, 875, 878; Benkard/Ullmann/Grabinski EPC Art. 63 mn. 91; Benkard/Grabinski § 16 a mn. 44; Bru¨ckner/von Czettritz/Bru¨ckner Art. 14 mn. 35, 38; dissenting Busse/Hacker Anh § 16 a mn. 102. 1 2

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167

168

169

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Part I. Generals of the SPC in the EU 171

It is the prevailing view that a revocation within the meaning of Art. 14 lit. d RegSPC only exists if it is final and absolute, i. e. if it is non-appealable or has been finally judicially determined.8 According to a different opinion, the SPC does not become legally effective (Art. 5 RegSPC) whilst the authorisation is suspended; however, only the legal revocation leads to an expiry.9 How the revocation as an administrative act must be treated, however, is principally determined by national law, with due regard to EU principles (in particular the principles of equivalence and effet utile in accordance with Art. 4 para. 3 TFEU).10

II. Reasons for Invalidity pursuant to Art. 15 RegSPC Art. 15 para. 1 RegSPC gives alternative grounds for invalidity, in which cases the SPC shall be regarded as invalid from the outset (ex tunc). Still, this is subject to a formal procedure according to Art. 15 para. 2 RegSPC. In essence, the grounds for invalidity can be divided into two classes: the irregularities specified in Art. 15 lit. b and c RegSPC directly affect the validity of the basic patent; Art. 15 lit. a RegSPC is based on the granting prerequisites of Art. 3 RegSPC, and thus directly on the SPC as such. Due to the grounds for invalidity according to Art. 15 lit. b and c RegSPC, an accessorial dependence between the SPC and the basic patent is created in the sense that the invalidity of the basic patent also affects the related SPC. 11 173 In terms of the grounds for invalidity under Art. 15 para. 1 lit. a RegSPC, 12 only the time of the application is of importance.13 While the wording of Art. 15 para. 1 lit. a RegSPC suggests the time of the granting, Art. 3 RegSPC, which is authoritative in this respect, refers specifically to the time of the application. Any circumstances which occur at a later stage and concern the validity of the basic patent are subject to Art. 15 para. 1 lit. c RegSPC. A cancellation of the authorisation (Art. 3 lit. b RegSPC) with ex-tunc effect also constitutes a ground for invalidity according to Art. 15 para. 1 lit. a RegSPC and not grounds for expiry (Art. 14 lit. d RegSPC).14 The premature expiry of the basic patent is a ground for invalidity according to Art. 15 para. 1 lit. b RegSPC. In this respect, the statutory term in accordance with Art. 63 para. 1 EPC is decisive. 174 The grounds for invalidity listed in Art. 15 para. 1 RegSPC are non-exhaustive.15 Apart from Art. 15 para. 1 lit. c RegSPC, the invalidity of the Certificate may also result from the fact that the basic patent itself can be cancelled. Any irregularities affecting the legal validity of the basic patent also have an effect on the SPC pursuant to Art. 15 para. 1 lit. c RegSPC. 175 If the term was calculated incorrectly, an action for cancellation can be taken pursuant to Art. 17 para. 2 RegSPC-Plant Protection Products in conjunction with recital 17 RegSPC-Plant Protection Products, regardless of whether a too short term 172

Mu¨hlens Mitt. 1993, 213, 218; Schennen Art. 14 para 5; Busse/Schwendy, 5th ed. (1991), § 16 a mn. 41. Bra¨ndel GRUR 2001, 875, 878; Busse/Hacker Anh § 16 a mn. 101. 10 CJEU i-21 Germany v. Arcor, C-392/04, C-422/04, mn. 57 with citations [Annex A1.VIII.]. 11 Bra ¨ ndel GRUR 2001, 875, 877. 12 Cf. Adocker/Koller GRUR Int. 2011, 385 et seqq.; Straus GRUR Int. 2001, 591, 597 et seqq. 13 Busse/Hacker Anh § 16 a mn. 104. 14 Bra ¨ ndel GRUR 2001, 875, 878; Benkard/Ullmann/Grabinski EPC Art. 63 mn. 91; Benkard/Grabinski § 16 a mn. 44; Bru¨ckner/von Czettritz/Bru¨ckner Art. 14 mn. 35, 38; dissenting opinion Busse/Hacker Anh § 16 a mn. 102. 15 Benkard/Grabinski § 16 a mn. 46; Bru ¨ ckner/von Czettritz/Bru¨ckner Art. 15 mn. 62; dissenting opinion: Bra¨ndel GRUR 2001, 875, 879; cf. CJEU Ha¨ssle v. raiopharm, C-127/00, mn. 80 et seqq. [Annex A1.IV.]; Straus GRUR Int. 2001, 591, 597 et seqq. 8 9

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was calculated to the applicant’s detriment or if third parties seek to claim that an overly long term was calculated.

III. Revocation of a Term Extension Art. 14 and 15 RegSPC have to be distinguished from the revocation of the term 176 extension in accordance with Art. 16 RegSPC. Accordingly, the term extension of six months as per Art. 36 para. 1 RegMPP can be revoked if it does not fulfil the requirements of Art. 36 RegMPP. The application can be submitted by everybody, Art. 16 para. 2 RegSPC. It is not necessary that the applicant demonstrates any specific prerequisites in order to file this application; nor is it subject to a deadline. Only the term extension as, according to Art. 36 para. 1 RegMPP, an independent 177 legally relevant act is being revoked, i. e. cancelled. The systematic comparison of Art. 14 and 15 RegSPC reveals that the legal validity of the SPC as such remains unaffected. 16 It is not explicitly regulated if the revocation takes effect ex nunc or ex tunc. The issue 178 becomes relevant when the extended term has already begun. If the extension was granted contrary to the prerequisites of Art. 36 RegMPP, the grant is directly affected by this error. Thus, Art. 16 RegSPC differs from Art. 14 RegSPC, which provides that the grounds for expiry do not result from mistakes concerning the legal validity of the SPC as such. By contrast, the revocation as per Art. 16 RegSPC therefore has an ex-tunc effect.

IV. Announcement The expiry (Art. 14 lit. b to d RegSPC) and/or the declaration of invalidity (Art. 15 179 RegSPC) are announced by the competent authority according to Art. 17 para. 1 RegSPC. This also applies to the revocation of the extension of the term (Art. 16 RegSPC) in accordance with Art. 17 para. 2 RegSPC. 16

Bru¨ckner/von Czettritz/Bru¨ckner Art. 16 mn. 8.

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H. Remedies 180

The RegSPC does not provide for any definition of legal remedies, but refers to the national law in Art. 19 RegSPC. For details see part II.

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PART II SPECIALITIES IN OTHER JURISDICTIONS I. The SPC in Germany Literature: Alt/Gassner, Das erga¨nzende Schutzzertifikat im Wandel, Mitt. 2009, 16; Bloch/Schmitt, Le certificat comple´mentaire de protection institue´ par le re`glement n 1768–92 du 18 juin 1992, Gazette du Palais 1993, 1280; Bopp/Lux, Das “Salz”-Problem – gelo¨ st?, Anmerkungen zum Idarubicin-Urteil des EuGH vom 16. September 1999, PharmR 2000, 2; Brandt, Die Schutzfrist des Patents, PhD thesis, published by C.H. Beck, 1996; Bru¨ckner, Erga¨nzende Schutzzertifikate fu¨r Arzneimittel in der neueren Rechtsprechung des EuGH, GRUR Int. 2012, 1097; Bundesjustitzministerium, Zur Schaffung eines erga¨nzenden Schutzzertifikats fu¨r Arzneimittel, Aufzeichnung des BJM, GRUR Int. 1991, 32; Drasch, Die Rechtsgrundlagen des europa¨ischen Einheitsrechts im Bereich des gewerblichen Eigentums (Art. 100 a, 235, 36 und 222 EGV), ZEuP 1998, 118; Duvigneau, Die vorgesehene Neuregelung zur Verla¨ngerung der Patentschutzdauer in Australien im internationalen Kontext, Mitt. 1999, 11; Fitzner/ Petri, Neuere Rechtsprechung zum erga¨nzenden Schutzzertifikat, Mitt. 2009, 149; Gassner, Unterlagenschutz im Europa¨ischen Arzneimittelrecht, GRUR Int. 2004, 983; Go¨bel, Erga¨nzende Schutzzertifikate fu¨r Arzneimittel in Europa unter besonderer Beru¨cksichtigung von Deutschland, Pharm. Ind. 1993, 442; Goddar, Die wirtschaftliche Bewertung gewerblicher Schutzrechte beim Erwerb technologieorientierter Unternehmen, Mitt. 1995, 357; Hocks, Schutzzertifikat fu¨r Arzneimittel, PharmR 1991, 322; Hocks, Erga¨nzendes Schutzzertifikat fu¨r Arzneimittel, PharmR 1992, 290; Hufnagel, Ausweitung des Versuchsprivilegs in Europa und den USA, PharmR 2006, 209; Jestaedt, Patentrecht, handbook, published by Carl ¨ nderung der Produktpiraterie-Verordnung, ZfZ 1999, 263; Kau, SchutzHeymanns, 2008; Kampf, Zur A bereich von erga¨nzendem Schutzzertifikat und Grundpatent la¨uft gleich, GRUR-Prax. 2012, 193; KunzHallstein, Institutionelle Fragen einer Revision des Europa¨ischen Patentu¨bereinkommens, GRUR Int. 1991, 351; Ku¨nzel, Erga¨nzendes Schutzzertifikat und Grundpatent – Gleichlauf des Schutzes bei Wirkstoffkombinationen, GRUR-Prax. 2012, 284; Portal, Die Einfu¨hrung erga¨nzender Schutzzertifikate fu¨r Arzneimittel im franzo¨sischen Patentrecht, GRUR Int. 1991, 89; Scheil, Das erga¨nzende Schutzzertifikat, Mitt. 1997, 55; Schoch/Schmidt-Aßmann/Pietzner, Verwaltungsgerichtsordnung: VwGO, commentary, published by C.H. Beck, 2011; Seitz, Anmerkung zum Schlussantrag des Generalanwalts Trstenjak in der Rs. C-322/10 und C-422/10, GRUR-Prax 2011, 321007; Stratmann/Dernauer, Die neue Praxis des DPMA zur Erteilung von erga¨nzenden Schutzzertifikaten fu¨r Pflanzenschutzmittel – eine Frage des Vertrauensschutzes?, Mitt. 2008, 150; Suchy, Patentrestlaufzeit neuerer pharmazeutischer Wirkstoffe, GRUR 1987, 268 Content I. II. III. IV. V.

National Pharmaceutical and Patent Law . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Application of the Art. 3 RegSPC conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Calculation of the term of the SPC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Rights, Limitations and Obligations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . SPC Grant, Termination and Remedies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1. Grant. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2. Termination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1 6 15 17 22 22 36

I. National Pharmaceutical and Patent Law German patents are set out in the German Patent Code (Patentgesetz, PatG). 1 As 1 many of the provisions are identical with or at least similar to the EPC, the focus will be on differences in this chapter part. The patent term begins with the day following the

1

Patent Act of 16 December 1980, German Federal Law Gazette (BGBl.) 1981 I p. 1.

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2

3

4

5

date of the application, § 16 para. 1 sentence 1 PatG. The grant procedure generally takes two to two and a half years from the date of filing the application.2 The national marketing authorisation procedure is mainly ruled in the Arzneimittelgesetz (AMG).3§ 21 para. 1 AMG stipulates the need for a marketing authorisation to place medicinal products on the market,. While § 21 para. 1 AMG refers to the marketing authorisation only, the manufacturing authorisation is just as indispensable in practice, § 13 para. 1 AMG, and required during the approval procedure. 4 The national German marketing authorisation procedure is governed by the AMG and the RulesGCP. It is also harmonized with and based on the DirMPH, DirMPV and DirGCP.5 Each national procedure commences with an application which must be processed within seven months, § 27 AMG. The competent German authority,6 however, has been unable to comply with this deadline for years due to chronic administrative overload; 7 this opens the way to the administrative courts. § 16 a para. 1 sentence 1 PatG refers to the SPCs and declaratively states that an application for additional protection may be made pursuant to “Regulations of the European Community” (including future regulations). § 16 a para. 1 sentence 2, paras. 2 and 3 PatG stipulate the corresponding application of provisions of the PatG (e. g. entitlement of the applicant, effect of the patent etc.) for the Supplementary Protection Certificate to the extent that these provisions are in line with the law of the European Community. § 49 a PatG then governs the grant procedure. Even though the RegSPC, as a European Regulation, is directly effective, §§ 16 a, 49 a PatG were necessary in order to execute the RegSPC to the extent that the EU Member States have discretion, e. g. in Art. 9 para. 1 and Art. 12 RegSPC. The Certificate grants the same rights as a patent, Art. 5 RegSPC, which are the claims (cease and desist, damages, etc.) listed in §§ 139 et seqq. PatG. The scope of protection conferred by the SPC with respect to the product, Art. 4 RegSPC, has to be determined according § 14 PatG, which sets the same standard as Art. 69 EPC. As with the RegSPC, the term of the SPC commences immediately after the patent expired, § 16 a para. 1 sentence 1 PatG. As not all Member States of the EPC are also Member States of the EU, Art. 63 EPC was amended in order to avoid substantive conflicts between the European patent and the SPC. For the same reason, Art. II § 6 a was inserted into the German Gesetz u¨ber ¨ G).8 Internationale Patentu¨bereinkommen (IntPatU

II. Application of the Art. 3 RegSPC conditions 6

With respect to Art. 3 lit. a RegSPC, the German practice had assumed that a basic patent would protect a product if an infringement court would consider the manufacture, offering, placing on the market and the use as well as the import and the 2 According to the German Patent and Trademark Office (DPMA): http://www.dpma.de/patent/faq/ index. html#a9 (last accessed on 2 September 2013). 3 Medicinal Products Act of 12 December 2005, BGBl. I p. 3394. 4 § 13 para. 1 sentence 2 AMG, cf. § 7 para. 4 No 1 lit. d of the German Rules on the Application of Good Clinical Practice during Conduct of Clinical Trials with Medicinal Products for Human Use, BGBl. I p. 2192, hereinafter: German rules on the good clinical practice (RulesGCP). 5 RulesGCP Preamble; Deutsch/Lippert/Deutsch Before §§ 40 et seqq., cf. § 4 mn. 1. 6 According to § 77 para. 1 AMG, the Bundesinstitut fu ¨ r Arzneimittel und Medizinprodukte is responsible, unless the Paul-Ehrlich-Institut or the Bundesamt fu¨r Verbraucherschutz und Lebensmittelsicherheit is responsible, which depends on the type of product to be approved, cf. § 77 paras. 2 and 3 AMG. 7 Deutsch/Lippert/Anker § 27 mn. 2. 8 German Act on International Patent Conventions of 21 June 1976, BGBl. II p. 649; cf. Bru ¨ckner/von Czettritz Introduction mn. 39.

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possession of the product for the aforementioned purposes as an infringement of the basic patent. The CJEU refused this infringement test in the context of substance combinations, and rather endorsed the identification theory by stating that the product subject to the SPC application had to be specified in the wording of the claims.9 The German courts have applied the identification theory in the meantime in few decisions. The German Federal Patent Court (Bundespatentgericht, BPatG) applied the identification theory in the Ranibizumab case.10 MedImmune and the Medical Research Council had obtained an SPC pre-Medeva for Ranibizumab on the basis of a basic patent which was concerned with a general method (so-called phage display approach) for identifying and manufacturing antibodies without any specific reference to the authorised antibody. During parallel infringement proceedings, the District Court of Du¨sseldorf found Ranibizumab to infringe the SPC, i. e. to be within the scope of protection provided by the SPC.11 Shortly thereafter, the BPatG revoked the SPC arguing that following Medeva and Queensland12 the SPC had not been granted in compliance with Art. 3 lit. a RegSPC given that the infringement test could no longer be used and that the claims of the patent would not specify in any way the antibody Ranibizumab.13 The UK courts arrived at the same result.14 The German case law on sub-combinations does not seem to require revision in view 7 of Medeva. In Anti-Helicobacter-Pra¨parat the German Federal Supreme Court (Bundesgerichtshof, BGH) had to decide whether an SPC could be granted in situations where the authorised medicinal product contains a single active ingredient, but where the basic patent requires the presence of a combination of active ingredients. 15 This (pre-Medeva) decision by the BGH to reject SPC applications in such situations is in line with the position taken by the CJEU in Yeda.16 In its (pre-Medeva) decision Sumatriptan the BGH had applied the infringement test 8 and allowed an SPC because the product, even though it was not named per se in the patent claim, was considered to be within the scope of protection conferred by the basic patent. In the specific case, the claim contained a Markush claim which comprised the authorised active agents but which was however not mentioned in any of the dependent claims or the specification.17 After the CJEU refused the infringement test and instead used the identification theory,18 it was doubted whether case situations like in Sumatriptan would have the same outcome post Medeva.19 However, with the Eli Lilly decision allowing for functional characterisation of a product in the claim20, it can well be that the Courts may consider at least Markush claims to implicitly, but necessarily 9 CJEU Medeva v. Comptroller-General of Patents, Designs and Trade Marks, C-322/10 (1 st headnote) [Annex A1.XIII.], cf. supra Part I, chap. D. II. 3. b) mn. 110. et seqq. 10 BPatG Ranibizumab, 3 Ni 28/11 [Annex A2.XII.]. 11 LG Du ¨ sseldorf, 4 a O 143/10, decision of 10 November 2011. 12 CJEU Medeva v. Comptroller-General of Patents, Designs and Trademarks, C-322/10 [Annex A1.XIII.]; CJEU University of Queensland v. Comptroller-General of Patents, Designs and Trademarks[Annex A1.XVII.], cf. supra Part I, chap. D. II. 3. b) mn. 110. et seqq. 13 BPatG Ranibizumab, 3 Ni 28/11 [Annex A2.XII.], decision of 2 May 2012, mn. 2 and 3. 14 Cf. infra chap. K United Kingdom, mn. 19. 15 BGH Anti-Helicobacter-Pra ¨parat, X ZB 1/08 [Annex A2.V.]. 16 CJEU Yeda Research and Development Comptroller-General of Patent, Designs and Trade Marks, C518/10 [Annex A1.XVI.], cf. supra Part I, chap. D. II. 3. b) mn. 118. 17 BGH Sumatriptan, X ZB 12/01 (2nd headnote) [Annex A2.III.]. 18 CJEU Medeva v. Comptroller-General of Patents, Designs and Trade Marks, C-322/10 (1 st headnote) [Annex A1.XIII.], cf. supra Part I, chap. D. II. 3. b) mn. 110 et seqq. 19 Cf. BPatG Ranibizumab, 3 Ni 28/11 [Annex A2.XII.], mn. 2. 20 CJEU Eli Lilly and Company Ltd v. Human Genome Sciences Inc., C-493/12 [Annex A1.XXVI.], cf. supra Part I, D. II. 3. c) mn. 122 et seqq.

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and specifically disclose all compounds covered by the formula. Thus, at least for case situations as in Sumatriptan the outcome may be the same irrespective of whether the infringement test or identification theory is applied. 21 9 It will also be interesting to see how the German courts will apply the Medeva and Eli Lilly decisions22 to cases where an SPC is sought for a combination product where the basic patent specifically mentions to one of the active ingredients and otherwise just refers to additional pharmaceutically active agents. In its (pre-Medeva) decision Tenofovir, the BPatG allowed an SPC for the substance combination of Tenofovir and Emtricitabine as the combination would be within the scope of the basic patent even if the combination was not specifically mentioned.23 The BPatG thus applied the infringement test. Interestingly in the UK an SPC was allowed (also pre-Medeva) by applying the identification test.24 Given that the Eli Lilly decision suggests quite some flexibility in specifying a (combination of) product(s) in a claim in order to comply with Art. 3 lit. a. RegSPC, the outcome of the Tenofovir decision may not have differed post-Medeva and post-Eli Lilly. 10 The German courts consider that limitation proceedings which aim at introducing claims focussing on specific combinations in order to comply with Medeva have retroactive effect (ex tunc). In the Telmisartan case25 an SPC had been granted pre-Medeva for the combination of Telmisartan and Hydrochlorothyiazide by applying the infringement test. As the originally granted claims had not mentioned combinations with Hydrochlorothyiazide, the patentee had initiated limitation proceedings introducing a dependent claim explicitly naming combinations with Hydrochlorothyiazide in order to comply with Medeva. Other than the UK courts26 the BPatG considers the possibility of limitation proceedings with ex tunc effect for a granted SPC to be a question of national law. The SPC was ultimately revoked for non-compliance with Art. 3 lit. c RegSPC following the CJEU’s decision Actavis v. Sanofi.27 As in the Actavis v. Sanofi case an SPC had been previously granted for the Telmisartan on the basis of the same basic patent. 11 The ‘Salt Issue’ was the subject of numerous decisions by the BGH and the CJEU in connection with the active ingredient Idarubicin.28 After the CJEU had determined that the SPC protects a product in all forms enjoying protection by the basic patent and that the question of whether a product is protected according to Art. 3 lit. a RegSPC has to be determined according to national law, an SPC for Idarubicin was granted. 29 The authorised product (i. e. Idarubicin) must thus be stated in the granted SPC,30 as it is the starting point of the supplementary protection. It is however not necessary to refer to the specific salt form (i. e. Idarubicin Hydrochloride). 31

21

Cf. mn. 193 et seq. CJEU Medeva v. Comptroller-General of Patents, Designs and Trade Marks, C-322/10 (1 st headnote) [Annex A1.XIII.], cf. supra Part I, chap. D. II. 3. b) mn. 110 et seqq., CJEU Eli Lilly and Company Ltd v. Human Genome Sciences Inc., C-493/12 [Annex A1.XXVI.], cf. supra Part I, chap. D. II. 3. c) mn. 122 et seqq. 23 BPatG Tenofovir, 15 W (pat) 24/07 (headnote) [Annex A2.XI.]. 24 Gilead Sciences Inc.’s SPC Application in the UK [2008] EWHC 1902 (Pat). Cf. supra Part I, chap. D. II. 3. b) mn. 108. et seqq.and chap. K. United Kingdom II. mn. 13. 25 BPatG 3 Ni 5/13 [Annex A2.XIV.]. 26 CJEU Actavis v. Boehringer Ingelheim, C-577/13 [Annex A1.XXXI which lists the referral questions]. 27 CJEU Actavis v. Sanofi, C-443/12, [Annex A1.XXII.], cf. supra Part I, chap. D. II. 3. b) mn. 113 et seqq. 28 Cf. supra, Part I, chap. D. II. 1. mn. 84 et seqq. 29 BGH GRUR 2000, 683 – Idarubicin II (headnote); BGH Idarubicin III, X ZB 21/00 [Annex A2.II.]. 30 BGH Sumatriptan, X ZB 12/01 (headnote) [Annex A2.III.]. 31 BGH GRUR 2000, 683 – Idarubicin II (headnote). 22

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In the (pre-Medeva) decision Insulin Glargine the BPatG allowed an SPC for Insulin 12 Glargine on the basis of a basic patent claiming different forms of insulin by a sequence (comparable to a Markush claim with a limited number of embodiments). 32 The claims of the basic patent moreover required that the claimed product would be blocked at its C-terminus by specifically listed blocking groups. The authorised product Insulin Glargine fulfilled the sequence requirements but contained at its C-terminus an amino acid which did not belong to the blocking groups recited by the claim. Following, the Farmitalia33 decision and its implementation by the BGH34, the BPatG allowed an SPC as the authorised product would be within the scope of the basic patent under the doctrine of equivalence. It seems fair to assume that the German courts will continue following this approach post-Medeva. As long as the active ingredient is considered to be specified in some detail in the claims of the basic, an SPC may thus be obtained for the specific authorised form of such active ingredient as long as the specific authorised form is considered to be within the scope of the basic patent. Even if a new salt form is protected by a basic patent and that salt form is subject to a 13 new marketing authorisation, an SPC may not be granted pursuant to Art. 3 lit d. SPC if a previous marketing authorisation for a different salt form of the same active agent is considered to relate to the same product. In the decision Doxorubicin 35 the BGH refused allow an SPC for the active ingredient doxorubicin sulphate, as a senior authorisation had already been granted for the active ingredient doxorubicin hydrochloride. Even though the BGH did not doubt that doxorubicin sulphate could have improved efficacy and reduced side effects compared to doxorubicin hydrochloride, it concluded that the pharmacological activity would be provided in both cases by doxorubicin. As a consequence, the marketing authorisation for doxorubicin sulphate would not be the first marketing authorisation for the product as required by Art. 3 lit. d RegSPC. The first marketing authorisation was the authorisation for doxorubicin hydrochloride. Another decision on Art. 3 lit. d RegSPC deals with the question of whether an 14 earlier marketing authorisation for a racemic mixture of an active ingredient is constitutes the first marketing authorisation with respect to a later authorised enantiomer.36 An SPC had been granted on the basis of a marketing authorisation for the enantiomer escitalopram and a basic patent focussing specifically on this enantiomer. The racemic mixture citalopram had been previously authorised for the same medical use. The plaintiff argued that the SPC should be revoked as escitalopram and citalopram would have the same pharmacological properties so that the authorisation for escitalopram was not the first authorisation according to Art. 3 lit. d RegSPC. The SPC was maintained as the court was not convinced by the presented evidence that escitalopram and citalopram had the same efficacy. The decision was not appealed. If the marketing authorisation is granted only after the expiration of the twenty-year patent duration, supplementary protection is principally no longer possible, as the basic patent is not in force at the time of the Certificate application. 37

32

BPatG Insulin Clargine 14 W (pat) 13/07 [Annex A2.XIII.]. CJEU Farmitalia v. Deutsches Patent- und Markenamt, C-392/97, mn. 18 [Annex A1.III]. 34 BGH GRUR 2000, 683 – Idarubicin II (headnote); BGH Idarubicin III, X ZB 21/00 [Annex A2.II.]. 35 BGH Doxorubicin, X ZB 4/08 [Annex A2.VI.]. 36 BPatG 3 Ni 22/10. 37 BPatG Abamectin, 15 W (pat) 71/97 (headnote) [Annex A2.VII.]; Benkard/Ullmann/Grabinski EPC Art. 63 mn. 18; CJEU Yamanouchi v. Comptroller-General of Patents, Designs and Trademarks, C-110/ 95 [Annex A1.II.], cf. supra Part I, chap. B III. mn. 37. 33

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III. Calculation of the term of the SPC With respect to Art. 13 para. 1 RegSPC the first marketing authorisation within the Community can also be an authorisation of Member States that were granted pursuant to their national laws prior to their accession to the EU, as long as clinical trials – the most time-spending factor – had to be conducted. This was held in Germany by the BPatG in Finasterid.38 This position seems confirmed by the Astra Zeneca decision39 as it should not make a difference in this respect whether Community law on drug approval was not followed due to authorisation prior to EU accession or due to not being a Member State (like Switzerland). 16 Regarding the calculation of the SPCs’ term, according to the practice of the German competent authority, the German Patent and Trademark Office (Deutsches Patent- und Markenamt, DPMA), the date of the marketing authorisation grant – i. e. the date of issuance by the authorising agency – and not the date of service to the applicant, the date of publication or the date of preliminary authorisation, if any,40 is decisive. 15

IV. Rights, Limitations and Obligations The SPC confers the same negative exclusivity rights as stated for patents in § 9 sentence 2 PatG, i. e. no party should be allowed to make, offer, use, etc. the patented invention without the consent of the patentee. As defined for patents, cf. § 9 sentence 1 PatG, in principle, the SPC confers a positive right of use, provided there are no intervening third party rights. As according to Art. 5 RegSPC the SPC shall have the same effects as the basic patent, § 10 PatG will applies with respect to contributory infringement. The rights conferred by the SPC can be enforced under §§ 139 et seqq. PatG. Whether this is a result of § 16 a para. 2 PatG 41 or Art. 5 RegSPC has no practical relevance. 18 Just like patents, SPCs can be transferred, licensed, etc., cf. § 15 paras. 1 and 2 PatG. Art. 5 RegSPC does not resolve the question of whether licenses in the basic patent automatically also cover the SPC. Licenses which are valid for a specific patent will also apply to the supplementary protection unless the parties agree that the license expires upon commencement of the Certificate protection, and consequently, does not cover the SPC.42 There is thus an accessorial interrelation between the supplementary protection and the patent with regard to licenses, as well. 19 As there is no statutory stipulation, the parties can and should agree on whether the licensee must pay separate license fees for the SPC. 43 In addition, the same rights and obligations that exist during the regular term of the basic patent, in principle, apply during the duration of the SPC under the license agreement. If the SPC is transferred to a third party, existing licenses are protected pursuant to § 16 a para. 2 in conjunction with § 15 para. 3 PatG.44 17

38

BPatG Finasterid, 3 Ni 2/06 (headnote) [Annex A2.IX.]; cf. Art. 3 lit. b sentence 2 RegSPC 1992. CJEU AstraZeneca v. Comptroller-General of Patents, Designs and Trademarks, C-617/12 [Annex A1.XXIII.], cf. supra Part I, chap. B. IV. 2. mn. 52 and 54. 40 Cf. DPMA SPC guidelines No 3.2.1.3; see also Schulte/Ku ¨ hnen § 16 a mn. 13; Benkard/Ullmann/ Grabinski EPC Art. 63 mn. 68. 41 As proposed by Busse/Hacker Anh § 16 a mn. 64. 42 Grounds for PatGA ¨ ndG BlPMZ 1993, 205, 210; Mu¨hlens Mitt. 1993, 213, 216. 43 Grounds for PatGA ¨ ndG BlPMZ 1993, 205, 208, 210; Bru¨ckner/von Czettritz/Bru¨ckner Art. 5 mn. 32. 44 Benkard/Grabinski § 16 a mn. 39. 39

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Limitations and obligations of the SPC also include antitrust restrictions pursuant to 20 § 20 of the Gesetz gegen Wettbewerbsbeschra¨nkungen (GWB).45 Limitations within the meaning of Art. 5 RegSPC firstly relate to the limitations contained in §§ 11–13 PatG which deals inter alia with the research exemption privilege as well as to compulsory licenses, § 24 PatG. Whether limitations or obligations of the basic patent extend to the SPC primarily depends on whether they both relate to the same subject-matter of protection.46 Prior rights of use in the basic patent continue in the SPC.47 Limitations due to existing license agreements are subject to § 16 a para. 3 PatG. Orders of exploitation (§ 13 PatG) continue in the SPC without the requirement for 21 an independent legal act, just like compulsory licenses.48 This also applies in cases where the SPC has been filed after the issuance of the order of exploitation. 49 A commitment to license the basic patent which is published in the register (§ 23 PatG) will continue for the SPC, cf. § 16 a para. 3 PatG.

V. SPC Grant, Termination and Remedies 1. Grant The formal requirements of the SPC application are partially specified under §§ 19 22 to 21 Patentverordnung (PatV).50 Other national provisions relating to the application can be found in §§ 16 a and 49 a PatG. In Germany, the DPMA guidelines on the examination procedure for Supplementary Protection Certificates contain detailed advice concerning the application for an SPC and the filing of the extension of a Certificate for which an application has already been lodged or has already been granted.51 If the application is filed in accordance with the formal requirements of Art. 7 to 9 RegSPC and §§ 29 to 21 PatV, and if the substantive granting prerequisites are also fulfilled, the application constitutes a right to the grant or extension of the Supplementary Protection Certificate pursuant to § 49 a para. 2 sentence 1 PatG. Consequently, the granting of the SPC is a non-discretionary decision.52 If the applicant has neither a legal residence, head office nor a branch in Germany, it 23 has to appoint a domestic agent in accordance with § 16 a para. 2 in conjunction with § 25 PatG. In this respect and concerning all other general application requirements, reference is made to the comments on patent law, which apply mutatis mutandis in this context. The application must be lodged in written form, § 19 para. 1 sentence 1 PatV. Fax transmission is accepted in order to fulfil the required written form, cf. § 11 para. 1 DPMAV.53 If the application is submitted via fax, however, it is at the discretion of the DPMA to request submission of the original version. Pursuant to § 3 para. 3 PatV, an 45 Act against Restraints of Competition of 26 June 2013, BGBl. I p. 1750; Bru ¨ ckner/von Czettritz/ Bru¨ckner Art. 5 mn. 41. 46 BGH Sumatriptan, X ZB 12/01 [Annex A2.III.]. 47 Schennen Art. 5 mn. 5 a; Busse/Hacker Anh § 16 a mn. 67; Bru ¨ ckner/von Czettritz/Bru¨ckner Art. 5 mn. 31. 48 Busse/Hacker Anh § 16 a mn. 67; Bru ¨ ckner/von Czettritz/Bru¨ckner Art. 5 mn. 37; cf. mn. 139 f. 49 Schulte/Ku ¨ hnen § 16 a mn. 26. 50 Regulation concerning the procedure of patent cases before the German Patent and Trade Mark Office of 1 September 2003, BGBl. I p. 1702. 51 Available on the DPMA website: http://www.dpma.de/docs/service/formulare/patent/p2799.pdf (last accessed on 2 September 2013). 52 BGH Idarubicin III, X ZB 21/00 [Annex A2.II.]. 53 Bylaws of the German Patent and Trade Mark Office of 1 April 2004, BGBl. I p. 514.

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24

25

26

27

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29

electronic filing of the application is not possible. The official forms issued by the DPMA have to be used for the application, § 19 para. 1 sentence 1 PatV. 54 The DPMA is the competent authority for SPC applications regardless of whether these are based on national patents or European patents with effect in Germany, § 49 a ¨ G in conjunction with § 49 a PatG. The applications for PatG and Art. II § 6 a IntPatU SPCs cannot be submitted to patent information centres (PATLIB centres). 55 In principle, the application has to be drawn up in German. Translations of those documents required for the application are subject to the same prerequisites as the German translations required for the grant of a patent, according to § 19 para. 1 sentence 2 in conjunction with § 14 para. 1 and § 14 para. 3 to 5 PatV. § 19 para. 1 sentence 1 PatV provides detailed information on the application contents required to meet the prerequisites of Art. 8 para. 1 lit. a i) and ii) RegSPC and refers to § 4 para. 2 No 1, 4 and 5 PatV. The required information about the applicant or its agent corresponds to the information that is required for a patent application. As the application must be based on either a German or European patent with effect in Germany, the number and the title of the patented invention have to be recorded on the application, Art. 8 para. 1 lit. a iii) RegSPC. Further, information on why the product is protected by the basic patent must be provided with the application in accordance with § 19 para. 2 PatV. Irregularities in the application regarding the prerequisites listed in Art. 8 RegSPC are requested to be resolved by the DPMA. Due to § 49 a para. 2 sentence 2 PatG, the same applies in the case of irregularities referring to the prerequisites set forth in §§ 19 to 21 PatV. In both cases, the time allowed for a response shall be no less than two months according to § 49 a para. 2 sentence 2 PatG. Failing to respond within the deadline basically results in a rejection of the application. Regarding the application deadline, the DPMA also considers the issuance date of the authorisation under pharmaceutical law as the relevant date of the MA grant. 56 With regard to the grant of the basic patent, some literature considers that a German patent within the meaning of Art. 7 para. 2 RegSPC is granted once the decision of grant was issued pursuant to § 49 PatG.57 In contrast, the DPMA considers the publication date of the grant in the German Patent Gazette as authoritative. 58 The end of the deadline is calculated pursuant to § 16 a para. 2 PatG. If the deadline is not met, restitutio in integrum is possible according to §§ 16 a para. 2 in conjunction with 123 PatG. If the applicant or the holder of the SPC desires to file an application for a term extension, the application also has to be submitted to the DPMA. According to the guidelines of the DPMA, an opinion by the Paediatric Committee within the meaning of Art. 23 para. 2 RegMPP cannot replace the required declaration of compliance even if it demonstrates that the studies carried out by the applicant comply with the approved paediatric investigation plan.59 If the application for extension contains errors, the same principles hold which also apply in the case of errors in the SPC application pursuant to § 49 a PatG in conjunction with Art. 10 paras. 6 and 3 RegSPC. For reasons of legal 54 Download available on the DPMA website: http://www.dpma.de/docs/service/formulare/patent/ p2008.pdf (last accessed 2 September 2013). 55 See DPMA SPC guidelines No 3.2.1. 56 DPMA SPC guidelines No 3.2.3. 57 Benkard/Grabinski § 16 a mn. 41; Schulte/Ku ¨ hnen § 16 a mn. 21; apparently also Kellner GRUR 1999, 805, 808. 58 DPMA SPC guidelines No 3.2.3; also Busse/Hacker Anh § 16 a mn. 71 and Schulte/Ku ¨hnen § 16 a mn. 21 in conjunction with § 58 mn. 17. 59 DPMA SPC guidelines No 4.1.5; Bru ¨ ckner/von Czettritz/Bru¨ckner Art. 8 mn. 93.

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certainty, the DPMA has to select the period for a response such that a decision on the extension can be made no later than by the date of expiry of the SPC.60 The application fee in Germany is determined by the fee schedule No 311 500 to the Patentkostengesetz (PatKostG)61 and can be found both on the application form and the DPMA pamphlet A 9510.62 Currently, the fee amounts to 300 euro. Another fee of 100 euro is charged for the application for an extension of the Supplementary Protection Certificate if the application is filed together with the application for the SPC. If the SPC has already been granted, the fees for filing an application for extension amount to 200 euro. The payment is due according to Art. 8 para. 4 RegSPC in conjunction with Art. 10 para. 3 RegSPC. The contrary provision in § 6 para. 1 sentence 1 PatKostG is not applicable in this respect due to the priority of the RegSPC, cf. § 16 a para. 2 at the beginning PatG. Failure to pay the fee results in the same consequences as formal irregularities, Art. 10 para. 4 RegSPC and § 49 a paras. 2 and 3 PatG. The DPMA publishes a pertinent notice in part 7 a of the Patent Gazette 63 and in the patent register after application for the SPC and/or extension of the SPC. 64 § 49 a para. 1 PatG provides that the grant procedure is carried out by the DPMA. Pursuant to § 49 a para. 5 sentence 2 PatG, § 46 PatG applies mutatis mutandis to investigations and hearings in the course of the proceeding. The German legislator has not exercised its right to waive the examination of the prerequisites in Art. 3 lit. c and d RegSPC so that these prerequisites are subject to the examination, as well. Pursuant to § 49 a para. 5 sentence 2 in conjunction with § 47 para. 1 sentence 1 PatG, the grant decree must be issued in writing and served to the parties ex officio. If the application is rejected or if other persons are involved in the grant procedure, the decree must be substantiated according to § 49 a para. 5 sentence 2 in conjunction with § 47 para. 1 sentence 1 and 3 PatG. Otherwise, § 47 PatG shall apply to the grant procedure due to § 49 a para. 5 sentence 2 PatG. The grant decree must contain all necessary information, such as, for example, the specific product for which the Certificate is granted or the term of the Certificate. 65 Information serving to define the subject matter of the proceeding or to inform the public, i. e. information listed in Art. 8 para. 1, Art. 9 para. 2 and Art. 11 para. 1 RegSPC does not have to be included. 66 If the Certificate refers to an active ingredient other than the one stated on the authorisation under pharmaceutical law, the grant must clearly reflect to what extent the protection claim was granted.67 The application for a precisely specified substance cannot be denied on the sole ground that an alternative version filed without a precise specification of the active ingredient to be protected was preferable. 68 According the publication of a notice on the grant or rejection, § 30 para. 1 sentence 2 PatG requires that the announcement also includes the date of the commencement and of the expiry of the Certificate. In Germany, such publication is made in the patent register in accordance with § 30 para. 1 sentence 1 PatG.

60

DPMA SPC guidelines No 4.1.5. See Annex to § 2 para. 1 Patent Cost Law of 13 December 2001, BGBl. I p. 3656. 62 Both available on the DPMA website: http://www.dpma.de/docs/service/formulare/patent/p2008.pdf and http://www.dpma.de/docs/service/formulare_eng/allgemein_eng/a9510_1.pdf (last accessed on 2 September 2013). 63 Note from the President of the DPMA in BlPMZ 1995, 229. 64 § 30 para. 1 PatG. 65 BGH Idarubicin III, X ZB 21/00 [Annex A2.II.]; BGH Sumatriptan, X ZB 12/01 [Annex A2.III.]. 66 BGH Idarubicin III, X ZB 21/00 [Annex A2.II.]. 67 BGH Idarubicin III, X ZB 21/00 [Annex A2.II.]; BGH Sumatriptan, X ZB 12/01 [Annex A2.III.]. 68 BGH Idarubicin III, X ZB 21/00 (headnote) [Annex A2.II.]. 61

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31 32

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The annual fees have to be paid to the DPMA pursuant to § 16 a para. 1 sentence 2 PatG. The amount of the fees is set forth in the fee schedule No 312 210 et seq. 69

2. Termination 36

37

38

39

40

41

42

43

As in general, the SPC in a German law context can be terminated either by expiry, invalidity or revocation. In Germany, announcements of expiry, invalidity or revocation are published in the patent register, § 30 PatG.70 In case of a renunciation of the Certificate holder (which constitutes expiry, Art. 14 lit. b RegSPC) written form is required, § 16 a para. 2 in conjunction with § 20 para. 1 No 1 PatG.71 The renunciation has to be declared before the DPMA. A formal legitimisation (§ 30 para. 3 sentence 2 PatG) is not mandatory.72 As per § 16 a para. 2 in conjunction with § 20 para. 2 PatG,73 only the DPMA can ascertain the expiry based on late payment of the annual fee (Art. 14 lit. c RegSPC) determined in accordance with Art. 12 RegSPC. If Art. 14 lit. d sentence 1 RegSPC applies, the patent division of the DPMA adjudicates the expiry ex officio or upon application of a third party (Art. 9 RegSPC in conjunction with § 49 a para. 1 PatG). § 20 para. 2 PatG does not apply; the infringement court may also review the matter in the course of a litigious proceeding. 74 Any official act, which removes the marketing authorisation as per the DirMPH or DirMPV, is considered to be a withdrawal of the marketing authorisation under Art. 14 lit. d RegSPC so that it also covers orders pursuant to § 30 AMG. Such withdrawals have ex nunc effect while ex tunc revocations are subject to invalidity. In case of grounds for invalidity, the declaratory decision by the BPatG according to §§ 16 a para. 2, 81 et seq. PatG is required in Germany. This is different from grounds of expiry, where the patent division of the DPMA decides rather than the BPatG by way of legal action. Grounds for the premature expiry of the basic patent, which is a ground for invalidity of the SPC, are e. g. mentioned in § 20 PatG. The declaration of invalidity of the basic patent (§ 22 PatG) is subject to Art. 15 para. 1 lit. c RegSPC, not to Art. 15 para. 1 lit. b RegSPC. Other grounds for invalidity follow from § 16 a para. 2 in conjunction with §§ 22, 81 para. 1 sentence 3 PatG.75 If there are no other provisions in the RegSPC, the relevant rules of procedure of national law apply according to §§ 16 a, 49 a PatG. Especially this also applies to legal remedies. The procedures before the BPatG (§ 16 a para. 2 in conjunction with §§ 65– 99 PatG) and before the BGH (§ 16 a para. 2 in conjunction with §§ 100–122 a PatG) are admissible against the decisions of the competent authority in accordance with Art. 9 para. 1 RegSPC, i. e. in Germany the DPMA. According to national law, one has the right to appeal before the BGH (§§ 110 et seq. PatG) decisions by the authorities listed in Art. 15 para. 2 and Art. 16 para. 2 RegSPC, namely the patent appeal courts of the BPatG (§§ 16 a para. 2, 81 et seq. PatG). If the Certificate is claimed void, it can be declared by way of legal action before the BPatG, Art. 15 para. 2 RegSPC in conjunction with §§ 16 a para. 2, 81 et seq. PatG, 69

BGBl. I 2001 p. 3659. DPMA SPC guidelines No 2.5 and No 4.5. 71 Busse/Hacker Anh § 16 a mn. 99. 72 Schennen Art. 14 mn. 3; Busse/Hacker Anh § 16 a mn. 99; Bru ¨ ckner/von Czettritz/Bru¨ckner Art. 14 mn. 9. 73 Busse/Hacker Anh § 16 a mn. 99; Bru ¨ ckner/von Czettritz/Bru¨ckner Art. 14 mn. 13. 74 Schennen Art. 14 mn. 6; Busse/Hacker Anh § 16 a mn. 103. 75 Grounds PatGA ¨ ndG BlPMZ 1993, 205, 209; see also Sredl GRUR 2001, 596, 596 et seqq. 70

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however, there is no way to oppose its grant before court. As the national law does not provide for any separate remedy for the case that the SPCs’ term has been calculated incorrectly, the correction has to be claimed by an action for a declaration of invalidity.76 Other errors than those which are based on the incorrect statement as to the first MA in the SPC application can be corrected in obvious cases only, in accordance with §§ 16 a para. 2, 99 para. 1 PatG in conjunction with § 319 Zivilprozessordnung (ZPO).77 76 77

Busse/Hacker Anh § 16 a mn. 112; Benkard/Grabinski § 16 a mn. 48. Code of Civil Procedure of 5 December 2005, BGBl. I p. 3202; Busse/Hacker Anh § 16 a mn. 108.

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J. The SPC in the United Kingdom Literature: Antcliff, Article 3(a) SPC Regulation – guidance on obtaining SPCs based on functional claims, B.S.L.R. 2014, 14(1) 25–27; Brown/Curley, Reflections on the Erbitux decision: combination products, combination therapies and SPCs, B.S.L.R. 2010, 11(2), 54–58; CIPA Guide to the Patents Acts by the Chartered Institute of Patent Attorneys, 7th edition, 2011, published by Sweet & Maxwell; Cohen/ England, Vaccines and SPCs: the CJEU reaches a fork in the road, B.S.L.R. 2013, 13(2), 35–48; England, The meaning of “active ingredient” for SPC protection is again uncertain, B.S.L.R. 2014, 14(1), 21–24; Miller/Burkill/Birss/Campbell, Terrell on the Law of Patents, 17 th edition, 2011, published by Sweet & Maxwell; Moore/Turnbull, Paediatric extension applications: substance and timing, J.I.P.L.P. 2010, 5(3), 134–136; Moss/Lundie-Smith, Can the SPC Regulation be rendered fit for purpose? The Court of Appeal refers more questions to the CJEU, EIPR 2011, 33(12), 771–779; Needle, Patent decisions: supplementary protection certificates (SPCs) – can an SPC be based on a third party MA?, C.I.P.A.J. 2012, 41(8), 470– 471; Ribbons/Eyre-Brook, Beware the unwritten requirements for obtaining SPCs, C.I.P.A.J. 2014, 43(3), 159–162; Snodin, IPO decisions: UK IPO changes practice on SPC term calculation, C.I.P.A.J. 2013, 42(11), 656–658; Snodin/Miles, De´ja` vu at the ECJ?, J.I.P.L.P. 2011, 6(8), 513–515; Tumbridge, Extending patent protection – should we be counting sheep?, C.I.P.A.J. 2011, 40(4), 226–229. Content I. National Law relating to SPCs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II. Application of the Art. 3 RegSPC conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1. Article 3(a) RegSPC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2. Article 3(b) RegSPC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3. Article 3(c) RegSPC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4. Article 3(d) RegSPC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5. Third party MAs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III. SPC application procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1. Applications for SPCs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2. Applications for SPC extensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV. Invalidation of SPCs and/or SPC extensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1 4 10 25 28 33 39 42 42 55 59

I. National Law relating to SPCs Patent law in the UK is primarily set out in the Patents Act 1977. Although, as a European Regulation, the RegSPC is directly effective, there is specific legislation in the UK in relation to SPCs. The Patents (Compulsory Licensing and Supplementary Protection Certificates) Regulations 2007 (SI 2007/3293) (the “2007 Regulations”) amended the Patents Act 1977 by introducing s.128B and Schedule 4A. Schedule 4A of the Patents Act 1977 sets out how the provisions of the Patents Act 1977 relating to patents apply to SPCs. In addition, rule 116 of the Patents Rules 2007 (SI 2007/3291) relates to applications for SPCs, and the fees payable in relation to SPCs are set out in the Patents (Fees) Rules 2007 (SI 2007/3292). Where neither the 2007 Regulations nor the Patents Rules 2007 provide a specific procedure for SPCs, the provisions of the Patents Act 1977 and the Patents Rules 2007 apply to SPCs and applications for SPCs as they do for patents and patent applications. 2 In the UK1, SPCs are granted by the UK Intellectual Property Office (the “IPO”). Such SPCs have effect in the United Kingdom – i. e. Great Britain (England, Scotland and Wales) and Northern Ireland. 3 Marketing authorisations for medicinal products may be granted for the UK only, in which case they take the form of a “Product Licence” issued under the Medicines Acts, 1

1 The Courts of England and Wales, Scotland and Northern Ireland have jurisdiction to hear matters relating to SPCs in the UK. Although this chapter refers to decisions of the UK Court for convenience, the decisions referred to are of the Court of England and Wales.

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or a “Marketing Authorisation” issued under the Medicines for Human Use (Marketing Authorisation etc) Regulations 1994 (SI 1994/3144). Such Product Licences and Marketing Authorisations are granted by the Medicines and Healthcare Products Regulatory Agency of the Department of Health (the “MHRA”). Details of Marketing Authorisations and Product Licences granted by the MHRA are available on the MHRA’s website. Alternatively, authorisations may be granted on an EU-wide basis by the European Commission following a favourable opinion from the EMA. The IPO treats such authorisations as equivalent to national authorisations.

II. Application of the Art. 3 RegSPC conditions As explained in Part I, chapter B above, the conditions set out in Art. 3(a)-(d) 4 RegSPC must be satisfied in order for an SPC to be granted. There have been numerous cases before the UK Courts relating to the interpretation 5 and application of these conditions. In recent years, in attempting to consider the issues raised in such cases, the UK Courts have considered that the RegSPC is not acte claire and numerous references have been made to the CJEU. Indeed a large proportion of CJEU case law on SPCs has come from referrals from the UK Courts. Where the cases before the UK Courts result from appeals made against rejections of SPC applications by the IPO, the IPO generally plays an active role in such legal proceedings in order to try to ensure that the IPO’s perspective in considering SPC applications is taken into account. Although the CJEU’s judgments and reasoned orders appear to have enabled the 6 particular disputes with which they were concerned to be resolved, the UK Courts have struggled in applying the CJEU’s guidance to subsequent disputes. Mr Justice Arnold of the Patents Court has been particularly outspoken in his judgments about his frustrations resulting from the CJEU’s judgments and reasoned orders. The principal frustrations arise from a perceived lack of clarity in the CJEU’s guidance, which makes it difficult to apply to future disputes. This has been compounded by the CJEU’s refusal to answer the general questions that have been referred by the UK Courts, with the CJEU instead focusing on the more specific questions based on the particular facts arising in the cases referred. By way of example, in Novartis 2, Mr Justice Arnold reviewed the CJEU’s judgment in Medeva3 and commented at paragraph 42: “As a separate point, it will be noted that the Court did not actually answer question 1. I have to say that, as the national judge who made one of the references before the Court, I am disappointed by this. One of the reasons for the multiplicity of references was the need of the national courts for clear guidance as to the criteria to be applied in deciding whether a product is “protected by a basic patent” within the meaning of Article 3(a). As I shall discuss below, not only has the Court not answered the question referred, but also the guidance it has provided is not sufficiently clear to enable future disputes to be resolved.” In the subsequent GlaxoSmithKline4 case, in which Mr Justice Arnold made a further 7 reference to the CJEU, he concluded his judgment by stating: “Finally, I would observe that this is the third time in six months that I have had to refer questions of interpretation of the SPC Regulation to the CJEU. I do so with 2 Novartis Pharmaceuticals UK Limited v (1) Medimmune Limited and (2) Medical Research Council [2012] EWHC 181 (Pat); [2012] F.S.R. 23 [Annex A3.VIII.]. 3 Case C-322/10 Medeva v Comptroller General of Patents [Annex A1.XIII.]. 4 Glaxosmithkline Biologicals SA v Comptroller-General of Patents, Designs and Trade Marks [2013] EWHC 619 (Pat); [2013] R.P.C. 26 [Annex A3.XIII.].

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considerable regret. That this should be necessary demonstrates the dysfunctional state of the SPC system at present. This is primarily due to the poor drafting of the SPC Regulation and to the failure of the European Commission, Council and Parliament to revise it to address the problems which have emerged. Matters have not been assisted, however, by the fact that the Court of Justice’s recent case law interpreting the SPC Regulation has not provided the level of clarity and consistency that is required.” Given the UK Courts’ view of the lack of clarity in the CJEU’s judgments and reasoned orders to date, it seems very likely that the UK Courts will consider it necessary to make yet further references to the CJEU, particularly in relation to the Art. 3 RegSPC conditions. References to the CJEU can cause a substantial delay in resolving disputes, and users of the SPC system in the UK should therefore be aware of the potentially long timeframes that may result where an SPC application raises unresolved issues. The timeframe of UK proceedings is minimised by the speed of proceedings and the practice of the judges of the first instance Patents Court making references to the CJEU in appropriate cases, rather than always deferring the decision as to whether to make such references to the Court of Appeal. Further, the availability of expedited appeals from the IPO to the Patents Court and the Court of Appeal also mitigates the delays which can result from referrals to the CJEU. 9 The approach of the IPO and the UK Courts to the interpretation and application of the Art. 3 RegSPC conditions is set out below. As the judgments and reasoned orders of the CJEU are discussed in Part I, these are not discussed in detail in this chapter. 8

1. Article 3(a) RegSPC Art. 3(a) RegSPC requires that “the product is protected by a basic patent in force” at the date of the application. Of the four Art. 3 RegSPC conditions, this has resulted in the most disputes before the IPO and the UK Courts. The majority of the disputes regarding Art. 3(a) RegSPC have concerned SPC applications for products that consist of a combination of active ingredients, including multi-disease vaccines. The Takeda 5, Gilead6, Astellas7, Medeva8, Yeda9, Daiichi Sankyo10 and Actavis11 cases all fall within this category. More recently, Art. 3(a) RegSPC disputes have arisen in relation to products comprising a single active ingredient, such as the Novartis 12 and Lilly13 cases. 11 In Takeda14, Takeda had obtained an SPC for the anti-ulcer agent lansoprazole, based on a patent containing claims to lansoprazole and a marketing authorisation for lansoprazole. Takeda subsequently obtained a patent for the use of lansoprazole for 10

5 Takeda Chemical Industries Ltd v Comptroller General of the Patent Office (No.3) [2003] EWHC 649 (Pat); [2004] R.P.C. 3 [Annex A3.V.]. 6 Gilead Sciences, Inc’s SPC Applications [2008] EWHC 1902 (Pat) [Annex A3.VI.]. 7 Astellas Pharma Inc v Comptroller-General of Patents [2009] EWHC 1916 (Pat) [Annex A3.VII.]. 8 Medeva BV v Comptroller General of Patents, Designs and Trade Marks [2010] EWCA Civ 700; [2010] R.P.C. 27 [Annex A3.II.] and [2012] EWCA Civ 523; [2012] R.P.C. 26 [Annex A3.IV.]. 9 Yeda Research and Development Company Ltd v Comptroller General of Patents [2010] EWHC 1733 (Pat), [2010] R.P.C. 29 10 Daiichi Sankyo Company Ltd v Comptroller General of Patents [2010] EWHC 2897 (Pat). 11 Actavis Group PTC EHF and Actavis UK Limited v Sanofi and Sanofi Pharma Bristol-Myers Squibb SNC [2012] EWHC 2545 (Pat); [2013] R.P.C. 24 [Annex A3.X.]. 12 Novartis Pharmaceuticals UK Limited v (1) Medimmune Limited and (2) Medical Research Council [2012] EWHC 181 (Pat); [2012] F.S.R. 23 [Annex A3.VIII.]. 13 Eli Lilly & Company v Human Genome Sciences Inc [2012] EWHC 2290 (Pat) [Annex A3.IX.], [2012] EWHC 2857 (Pat) [Annex A3.XI.] and [2014] EWHC 2404 (Pat) [Annex A3.XV.]. 14 Takeda Chemical Industries Ltd v Comptroller General of the Patent Office (No.3) [2003] EWHC 649 (Pat); [2004] R.P.C. 3 [Annex A3.V.].

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the manufacture of a medicament for preventing or treating infectious diseases caused by Helicobacter pylori. After carrying out additional research to show that lansoprazole was effective in eliminating Helicobacter pylori when used in combination with any two of three particular antibiotics – clarithromycin, amoxicillin and metronidazole – it obtained a variation to its marketing authorisation to add the eradication of Helicobacter pylori as a new therapeutic indication for lansoprazole when used in combination with such antibiotics. Takeda then filed six SPC applications for combinations of lansoprazole with two of these antibiotics. All SPC applications cited the varied marketing authorisation and either the first patent (which contained claims to lansoprazole itself) or the second patent (which contained claims to the use of lansoprazole for the manufacture of a medicament for preventing or treating infectious diseases caused by Helicobacter pylori). The IPO refused all of the applications on the basis of either Art. 3(a) or Art. 3(b) of RegSPC, and Takeda appealed the decision to the Patents Court. In relation to the Art. 3(a) RegSPC issues, neither basic patent claimed or disclosed 12 the use of lansoprazole with any other active ingredient. Takeda argued that the basic patents “protected” the combinations of lansoprazole and antibiotics because sales of such combinations would infringe the basic patents – the so-called “infringement test”. Mr Justice Jacob (as he then was) of the Patents Court rejected this approach, stating (at paragraph 10) that “it is sleight-of-hand to say that the combination is protected by the patent … the patent is not of course for any such “combination””. He further held that this position was absolutely clear, and refused to make a reference to the CJEU. In Gilead15, Gilead appealed against the rejection by the IPO of its SPC application 13 for a combination of tenofovir and emtricitabine. Gilead’s patent included a claim to tenofovir, but also disclosed combinations of tenofovir and other active ingredients and included a claim to the combination of tenofovir (amongst other compounds) and “optionally other active ingredients”. Mr Justice Kitchin (as he then was) of the Patents Court reversed the decision, holding the combination of tenofovir and emtricitabine was “protected” by the basic patent. He considered that this case could be distinguished from Takeda because the patent specifically disclosed and claimed tenofovir in combination with other active ingredients, even though emtricitabine itself was not specifically disclosed. He rejected the IPO’s contention that the skilled person would have attached no particular significance to the claim in question, would not have considered it inventive and would not have thought it was the result of any significant research effort. He commented that the scheme of RegSPC is to provide a simple and straightforward system for the grant of SPCs, which would not be achieved if it was necessary to embark upon an analysis of whether the patent or the claim in issue is obvious or invalid for any other reason or to investigate the extent of research that lies behind it. Gilead had also argued that Takeda was wrongly decided. As he considered that this case could be distinguished from Takeda, Mr Justice Kitchin did not need to decide this point, but he suggested that the issue of whether the infringement test was the correct approach merited consideration by the Court of Appeal and also possibly by the CJEU. In Astellas16, the applicant appealed against the rejection by the IPO of its SPC 14 application for a combination of emodepside and praziquantel on the basis of a basic patent that disclosed and claimed emodepside but did not disclose or claim praziquantel or a combination of emodepside and praziquantel. Astellas argued that Takeda was wrongly decided, and that the infringement test should be applied. Mr Justice Arnold of the Patents Court was not convinced that Takeda was wrongly decided, but he agreed 15 16

Gilead Sciences, Inc’s SPC Applications [2008] EWHC 1902 (Pat) [Annex A3.VI.]. Astellas Pharma Inc v Comptroller-General of Patents [2009] EWHC 1916 (Pat) [Annex A3.VII.].

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with Mr Justice Kitchin that the issue merited further consideration by the Court of Appeal and possibly the CJEU. He considered whether to make a reference to the CJEU but, as he was not confident that the Court of Appeal would make a reference, he decided that the decision whether to refer should be left to the Court of Appeal (although in the end the case did not reach the Court of Appeal). 15 In Medeva17, a case regarding a multi-disease vaccine, the Court of Appeal finally decided to make a reference to the CJEU regarding what is meant in Art. 3(a) RegSPC by “the product is protected by a basic patent”. Medeva’s patent disclosed and claimed a method of making a vaccine against Bordetella pertussis (whooping cough) comprising two particular antigens known as pertactin and filamentous haemagglutinin (FHA). The basic patent did not disclose other antigens, such as those against diphtheria, tetanus, meningitis or polio. As a result of national health policy, all of the marketing authorisations for vaccines included antigens in addition to pertactin and FHA. Medeva filed five SPC applications. Both the IPO and the Patents Court rejected Medeva’s SPC applications on the basis that in all of the applications there was a mismatch between the active ingredients protected by the basic patent and the active ingredients in the vaccine or medicinal product for which the relevant marketing authorisations had been given, such that either Art. 3(a) or Art. 3(b) RegSPC was not satisfied. On appeal, Medeva argued that the infringement test should be adopted in relation to determining whether Art. 3(a) RegSPC was satisfied, and the Court of Appeal decided to refer a number of questions to the CJEU. 16 Further references to the CJEU relating to Art. 3(a) RegSPC were made by the UK Courts in University of Queensland18, Daiichi Sankyo19 and Yeda20. In the CJEU judgment in the Medeva21 case, and the reasoned orders in the Yeda22, University of Queensland23 and Daiichi Sankyo24 cases, the CJEU rejected the infringement test. It held that, for the purposes of Art. 3(a) RegSPC, active ingredients must be “specified” or “identified” in the wording of the claims of the basic patent in order to be “protected” by the basic patent. 17 The Court of Appeal in Medeva25 then considered how the CJEU’s judgment should be applied to Medeva’s SPC applications. The Court of Appeal considered that it was clear that the CJEU had rejected the infringement test, at least in the context of combination products, and that the issue for the national courts was to determine which active ingredients are specified in the wording of the claims. Uncertainty remained as to what ‘specified’ or ‘identified’ meant, particularly in non-combination cases. The Court of Appeal stated as follows at paragraph 33: “The ambit of “specified” may range from express naming, through description, necessary implication to reasonable interpretation. Where on that scale the dividing line is to be drawn will necessitate further references in due course in the light of the facts of 17

Medeva BV v Comptroller General of Patents [2010] EWCA Civ 700; [2010] R.P.C. 27 [Annex A3.II.]. On appeal from University of Queensland & CSL Limited BL O/335/10. 19 Daiichi Sankyo Company Ltd v Comptroller General of Patents [2010] EWHC 2897 (Pat). 20 On appeal from Yeda Research and Development Company Ltd v Comptroller General of Patents [2010] EWHC 1733 (Pat), [2010] R.P.C. 29. 21 Case C-322 Medeva BV v Comptroller-General of Patents, Designs and Trade Marks [Annex A1.XIII.]. 22 Case C-518/10 Yeda Research and Development Comptroller-General of Patents, Designs and Trade Marks [Annex A1.XVI.]. 23 Case C-630/10 University of Queensland v Comptroller-General of Patents, Designs and Trade Marks [Annex A1.XVII.]. 24 Case C-6/11 Daiichi Sankyo Co v Comptroller-General of Patents, Designs and Trade Marks [Annex A1.XV.]. 25 Medeva BV v Comptroller General of Patents [2012] EWCA Civ 523; [2012] R.P.C. 26 [Annex A3.IV.]. 18

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the cases in which the issue arises. The problem for Medeva in this case is that wherever the dividing line is to be drawn the active ingredients relating to vaccines against diphtheria, tetanus, meningitis and polio are excluded.” A further reference to the CJEU concerning Art. 3(a) RegSPC in the context of 18 combination products was made by the Patents Court in Actavis26. Sanofi owned a patent covering irbesartan, which included a claim to a pharmaceutical composition containing irbesartan (amongst other compounds) “in association with a diuretic”. In 1999, on the basis of this patent, Sanofi had obtained an SPC for irbesartan and also an SPC for the combination of irbesartan and the diuretic hydrochlorothiazide (HCT). Actavis sought revocation of the combination SPC on the basis, amongst other things, that the combination of irbesartan and HCT is not “protected” by the patent, as it is not identified or specified in the wording of the claims. Mr Justice Arnold considered it necessary to make a further reference to the CJEU to resolve this dispute, because the CJEU did not answer all of the questions posed previously and did not provide a clear test which could be applied to cases such as this. In the hope that the CJEU would answer a general question, Mr Justice Arnold repeated the question that he had asked numerous times previously (albeit slightly rephrased): “What are the criteria for deciding whether ‘the product is protected by a basic patent in force’ in Article 3(a) of the Regulation?”. Mr Justice Arnold also provided his own suggested answer to the question. He set out his view that the answer is that the product must infringe because it contains an active ingredient, or a combination of active ingredients, which embodies the “inventive advance” of the basic patent. In this case, he had decided that the inventive advance consisted generally of a medicinal product whose active ingredient is one of the compounds set out in a formula, including irbesartan, but did not include medicinal products whose active ingredients are irbesartan and a diuretic because the combination, as distinct from irbesartan alone, did not embody the “inventive advance”. Unfortunately, the CJEU declined expressly to answer the question regarding Art. 3(a) in its judgment27. This was because a question had also been referred regarding Art. 3(c) RegSPC (which is discussed below) and the CJEU held that Art. 3(c) RegSPC would not be satisfied so considered it unnecessary to answer the question regarding Art. 3(a) RegSPC. The issue of whether it is necessary to consider the “inventive advance” of a basic 19 patent also arose in Actavis v Boehringer28. In that case, Boehringer owned a patent that contained claims to telmisartan alone and claims to the combination of telmisartan and HCT. The patent had been relied on as the basic patent for SPCs covering telmisartan alone, as well as the combination. Whilst the CJEU’s decision in the Actavis v Sanofi reference was outstanding, Mr Justice Birss of the Patents Court referred a number of questions to the CJEU, including whether it was necessary to consider whether the combination of active ingredients A and B is a distinct and separate invention from that of A alone. The CJEU delivered its ruling in Actavis v Boehringer on 12 March 2015 29. The CJEU decided that, where a basic patent includes a claim to a product comprising an active ingredient which constitutes the sole subject-matter of the invention, for which the holder of that patent has already obtained an SPC, as well as a subsequent 26 Actavis Group PTC EHF and Actavis UK Limited v Sanofi and Sanofi Pharma Bristol-Myers Squibb SNC [2012] EWHC 2545 (Pat); [2013] R.P.C. 24 [Annex A3.X.]. 27 Case C-443/12 Actavis Group PTC EHF and Actavis UK Limited v Sanofi and Sanofi Pharma BristolMyers Squibb SNC [Annex A1.XXII.]. 28 Actavis Group and Actavis UK v Boehringer Ingelheim Pharma [2013] EWHC 2927 (Pat) [Annex A3.XIV.]. 29 Case C-577/13 Actavis Group and Actavis UK v Boehringer Ingelheim Pharma [Annex A1.XXXI.].

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claim to a product comprising a combination of that active ingredient and another substrate, Art 3(a) and (c) RegSPC preclude the holder from obtaining a second SPC for that combination. Although this decision is limited to combination products, it is questionable whether this approach is consistent with the purpose of the SPC scheme being to provide a simple and straightforward system for the grant of SPCs (as noted by Mr Justice Kitchin in Gilead). 20 In Novartis30, MedImmune and the Medical Research Council had obtained in 2011 (prior to the CJEU’s judgment in Medeva) an SPC for ranibizumab, an anti-vascular endothelial growth factor antibody, based on a basic patent which contained a claim to a general method of producing a molecule with binding specificity for a particular target and a marketing authorisation for ranibizumab owned by Novartis. Novartis sought a declaration that the SPC was invalid on the basis that the claim did not specify or identify the individual antibody ranibizumab, contrary to Art. 3(a) RegSPC. Although Novartis disputed whether the patent was valid and whether ranibizumab was a product obtained by the claimed process, the assessment of whether the SPC application complied with Art. 3(a) RegSPC was considered on the assumption that the patent was valid and that ranibizumab was obtained directly by means of the patented process within the meaning of s.60(1)(c) Patents Act 1977. MedImmune’s position was that the law remained unclear and a further reference to the CJEU was required. Mr Justice Arnold found that, although the test laid down in Medeva and the cases which followed it is unclear save in its rejection of the infringement case in combination cases, Art. 3(a) RegSPC was not satisfied in this case. In doing so, he relied on the CJEU’s reasoned order in University of Queensland31. In University of Queensland, one of the questions referred related to whether, where a basic patent has claims to ‘a process to obtain a product’, the ‘product’ has to be obtained directly by means of that process. In response to this question, the CJEU stated in paragraph 40 of its order that Art. 3(a) RegSPC “precludes a SPC being granted for a product other than that identified in the wording of the claims of that patent as the product deriving from that process” (emphasis added). Mr Justice Arnold concluded that the CJEU had laid down a narrow rule in the case of process claims, such that the product needs to be identified in the wording of the claim as the product deriving from the process in question. In this case, the claim merely identified the product of the method as “a molecule with binding specificity for a particular target”, which covers millions of different molecules and is not even limited to antibodies. Although ranibizumab was to be treated as falling within this class of molecules, there was nothing at all in the wording of the claim or the specification of the patent to identify ranibizumab as the product of the process in question. It remains to be seen whether this approach to SPCs based on process claims will be upheld – the Court of Appeal in this case held that the patent was invalid and, therefore, the parties agreed that it was not necessary to go on and consider whether Mr Justice Arnold’s approach in relation to the SPC issues was correct. 21 In Lilly32, Human Genome Sciences’ patent included a claim to an isolated antibody or portion thereof that binds specifically to the full length Neutrokine-a polypeptide or the extracellular domain of the Neutrokine-a polypeptide. Lilly wished to market a pharmaceutical composition containing an antibody that binds specifically to the 30 Novartis Pharmaceuticals UK Limited v (1) Medimmune Limited and (2) Medical Research Council [2012] EWHC 181 (Pat); [2012] F.S.R. 23 [Annex A3.VIII.]. 31 Case C-630/10 University of Queensland, CSL Ltd v Comptroller General of Patents, Designs and Trade Marks [Annex A1.XVII.]. 32 Eli Lilly & Company v Human Genome Sciences Inc [2012] EWHC 2290 (Pat) [Annex A3.IX.] and [2012] EWHC 2857 (Pat) [Annex A3.XI.].

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polypeptide referred to in the claim. Lilly sought a declaration that any SPC that Human Genome Sciences may seek to obtain based on this basic patent and any marketing authorisation that Lilly may in the future obtain for its antibody product would not comply with Art. 3(a) RegSPC because the active ingredient of Lilly’s product (i. e. the specific antibody) was not specified in the wording of the claims. Lilly argued that antibody claims need to contain a structural, rather than functional, definition in order for the antibody to be specified/identified in the wording of the claims. In its judgment, the CJEU confirmed again that the infringement test, in itself, is not enough to satisfy Art. 3(a) RegSPC, but held that Art. 3(a) does not, in principle, preclude the grant of an SPC based on a functional claim provided that “the claims relate implicitly but necessarily and specifically” to the active ingredient in question, applying Art. 69 EPC and its Protocol to interpret the claims in the usual way. The CJEU also indicated that it could not provide further guidance to the UK Court as it does not have jurisdiction to interpret the provisions of the EPC. The Lilly case returned to the UK Patents Court in May and June 2014. 33 The Court 22 once again stated that the CJEU’s decision does not give the clear guidance which the reference was designed to obtain, which was emphasised in this case by the fact that both parties had applied to the Court for judgment in their favour relying on the CJEU’s decision. The UK Court held that it was, however, clear from the CJEU’s decision at least that the CJEU clearly held that functional definitions can, in principle, be sufficient to bring an active ingredient within the protection of a basic patent. In relation to the condition that the “claims relate implicitly but necessarily and specifically” to the active ingredient, the UK Court held that the correct reading of the CJEU’s decision required an application of the relevant rules (i. e. Article 69 EPC or Section 125 Patents Act 1977) to ascertain the extent of the invention and what the claims relate to. If the active ingredient is covered by the claims, it is protected for the purposes of Art. 3(a) RegSPC, subject to a proviso. The proviso is that a product is not protected within the meaning of Art. 3(a) solely by virtue of a claim containing general wording that extends the claim beyond its principal scope (such as “comprises”). Lilly’s claim for declaratory relief was refused. Following these judgments and reasoned orders, the IPO’s practice as at July 2015 (as 23 set out in the IPO’s Manual of Patent Practice) is that, in the absence of further guidance from the Courts, a product is considered to be specified or identified in the wording of the claims of the basic patent if, having regard to the normal rules of claim construction, it is (i) indicated in a claim; (ii) encompassed by a Markush formula; (iii) shown to result directly from the process protected by a basic patent; or (iv) encompassed by a functional definition. In relation to (iii) and (iv), the IPO may require the applicant to provide evidence that this is the case, such as in the form of a statutory declaration. An important point for applicants to note is that, where the product is disclosed in 24 the description of the basic patent, but not specified/identified in the wording of a claim, the IPO allows the applicant to apply to amend the claims of the basic patent in order for the product to be specified/identified in the wording of a claim. Such an amendment application can be made by the owner of the basic patent either before or after the SPC application is filed. Furthermore, where the product is not specified/identified in the wording of a claim of the basic patent, but an SPC was granted before the CJEU’s judgment in Medeva, the patent owner could still apply to amend the basic patent pursuant to s.27 Patents Act 1977 in order to satisfy the Art. 3 RegSPC conditions. 33

Eli Lilly & Company v Human Genome Sciences Inc [2014] EWHC 2404 (Pat) [Annex A3.XV.].

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Consistent with Art. 105 a and 68 EPC, s.27 Patents Act 1977 provides that an amendment to a patent has retrospective effect, so the patent is deemed always to have been in the amended form. The Patents Court referred questions to the CJEU in Actavis v Boehringer34 regarding this practice, in particular whether a patent that has been amended after the SPC application is filed complies with the requirement of Art. 3(a) RegSPC that the product is protected by the basic patent at the date on which the SPC application is filed. Mr Justice Birss of the Patents Court expressed his view that there is no good reason why this procedure adopted by the IPO should lead to any difficulty or any problem with SPCs that result. In its decision on 12 March 201535, the CJEU declined to answer the questions regarding amendment.

2. Article 3(b) RegSPC Art. 3(b) RegSPC requires that “a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/ EC or Directive 2001/83/EC” at the date of the application. 26 Following the CJEU’s judgments in Medeva36 and University of Georgetown37, the IPO will grant SPCs for a product consisting of a single active ingredient or a combination of active ingredients specified in the wording of the claims of the basic patent relied on where the medicinal product of the marketing authorisation also contains additional active ingredients. 27 The IPO notes in its Manual of Patent Practice that although Art. 3(b) RegSPC requires a valid authorisation to have been granted, it does not appear to be necessary that the authorisation shall still be in force at the date of the application – i. e. it may be withdrawn or have lapsed. 25

3. Article 3(c) RegSPC Art. 3(c) RegSPC requires that “the product has not already been the subject of a certificate” at the date of the application. 29 Whilst this may appear to prevent the grant of more than one SPC for the same product, the IPO’s approach to Art. 3(c) RegSPC has historically been that it precludes the grant of more than one SPC per product per patent but, following the CJEU’s judgment in AHP38, it does not preclude the grant of an SPC to a holder of a basic patent for a product if, at the time of the SPC application, one or more SPCs have already been granted to one or more holders or one or more other basic patents. 30 In Takeda39, the IPO held that an SPC could be granted for a combination product where an SPC had already been granted for one of the products in isolation. However, following the CJEU’s judgment in Medeva40 that “only one certificate may be granted for the basic patent”, many commentators considered that it would no longer be possible to obtain SPCs for more than one product per patent, even when the basic 28

34 Actavis Group and Actavis UK v Boehringer Ingelheim Pharma [2013] EWHC 2927 (Pat) [Annex A3.XIV.]. 35 Case C-577/13 Actavis Group and Actavis UK v Boehringer Ingelheim Pharma [Annex A1.XXXI.]. 36 Case C-322 Medeva BV v Comptroller-General of Patents, Designs and Trade Marks [Annex A1.XIII.]. 37 Case C-422/10 Georgetown University, University of Rochester, Loyola University of Chicago v Comptroller-General of Patents [Annex A1.XIV.]. 38 Case C-482/07 AHP Manufacturing BV v Bureau voor de Industrie ¨le Eigendom [Annex A1.X.]. 39 Takeda Chemical Industries Ltd’s Applications [2004] R.P.C. 2 [Annex A3.XVI.]. 40 Case C-322 Medeva BV v Comptroller-General of Patents, Designs and Trade Marks [Annex A1.XIII.].

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patent contained claims that specified/identified more than one product. A similar issue arose in Actavis41, where, as discussed above, Sanofi had obtained an SPC for a single active ingredient and then a second SPC for a combination of active ingredients based on the same basic patent. Mr Justice Arnold referred a question to the CJEU and a similar question was referred from the district court of The Hague in another case involving Georgetown University. The CJEU considered the Actavis42 and Georgetown University43 cases at the same 31 hearing and issued judgments in both cases on 12 December 2013. The CJEU held that, where a basic patent protects several different ‘products’ within the meaning of Art. 3(a) RegSPC, it is in principle possible to obtain several different SPCs in relation to each of those different products. In the Georgetown University case, it was stated to be common ground that Georgetown University’s patent protected (within the meaning of Art. 3(a) RegSPC) both (i) a vaccine comprising HPV-16 and (ii) a vaccine comprising HPV-16 and HPV-18. In such circumstances, the CJEU concluded that Art. 3(c) did not preclude SPCs being granted for both products. In the Actavis case, however, where an SPC had already been granted on the basis of the basic patent for irbesartan alone, the CJEU stated that Art. 3(c) would preclude an SPC being granted for the combination of irbesartan and HCT on the basis of the same patent, on the basis that the CJEU concluded that the combination of irbesartan and HCT was not protected by the basic patent within the meaning of Art. 3(a). It remains to be seen how these CJEU judgments will be interpreted and applied by 32 the UK Courts.

4. Article 3(d) RegSPC Art. 3(d) RegSPC requires that the authorisation referred to in Art. 3(b) is “the first 33 authorisation to place the product on the market as a medicinal product”. The key CJEU reference in relation to Art. 3(d) RegSPC is Neurim 44, which also 34 resulted from a referral from the UK Courts. In this case, Neurim applied for an SPC for melatonin (a natural hormone) based on a basic patent covering the use of appropriate formulations of melatonin for human use as a medicine in insomnia and a marketing authorisation covering such use. However, a third party, Hoechst, owned an earlier patent and a marketing authorisation for the use of melatonin in regulating the seasonal breeding activity of sheep. The IPO rejected Neurim’s application on the basis that Art. 3(d) RegSPC was not satisfied, as Neurim’s marketing authorisation was not the first marketing authorisation to place melatonin on the market as a medicinal product. Neurim’s position was that the first marketing authorisation for the purposes of Art. 3(d) RegSPC is the first marketing authorisation that falls within the scope of the basic patent. In this case, the earlier marketing authorisation for the use of melatonin in regulating the seasonal breeding activity of sheep was not a use that would fall within the scope of Neurim’s patent, so should be ignored. Neurim appealed the IPO’s decision to the Patents Court, but this appeal was 35 dismissed. However, on further appeal, the Court of Appeal45 stated that it agreed with 41 Actavis Group PTC EHF and Actavis UK Limited v Sanofi and Sanofi Pharma Birstol Myers Squibb SNC [2012] EWHC 2545 (Pat); [2013] R.P.C. 24 [Annex A3.X.]. 42 Case C-443/12 Actavis Group PTC EHF and Actavis UK Ltd v Sanofi [Annex A1.XXII.]. 43 Case C-484/12 Georgetown University v Octooicentrum Nederland [Annex A1.XXVII]. 44 Case C-130/11 Neurim Pharmaceuticals (1991) Ltd v Comptroller General of Patents [Annex A1.XX.]. 45 Neurim Pharmaceuticals (1991) Ltd v Comptroller General of Patents [2011] EWCA Civ 228; [2011] R.P.C. 19 [Annex A3.III.].

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Neurim’s approach but considered that the position was not acte claire and referred questions to the CJEU regarding the interpretation of Art. 3(d) RegSPC. 36 The CJEU concluded that “…the mere existence of an earlier marketing authorisation (obtained for a veterinary medicinal product) does not preclude the grant of a supplementary protection certificate for a different application of the same product for which a marketing authorisation has been granted, provided that the application is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application of the supplementary protection certificate”. The reasoning of the CJEU, in particular paragraphs 25 and 26 of the judgment, demonstrates that the CJEU agreed with Neurim’s approach that the “first authorisation” for the purposes of Art. 3(d) RegSPC should be interpreted as the first valid marketing authorisation for a product which contains that product and is within the scope of protection of the basic patent. 37 Following the Neurim judgment, the IPO’s practice (as set out in its Manual of Patent Practice as at July 2015) is that: “Whereas the first marketing authorisation for the product regardless of use or indication will normally constitute the first marketing authorisation having regard to Article 3(d); C-130/11, Neurim Pharmaceuticals (1991) Ltd v Comptroller General of Patents delineates circumstances where an earlier marketing authorisation for the same product will not contravene Article 3(d). In cases similar to Neurim it may be necessary to ask the applicant to show that the indication in the marketing authorisation is within the scope of protection of the basic patent, in accordance with paragraph 26 of the judgment. The scope of an SPC granted having regard to the Neurim judgment will extend only to the authorised use, paragraph 25 of the judgment. However practice dictates that we will not seek to define this use in the product definition at item 6 of form SP1” 38

It remains to be seen how the CJEU’s judgment in Neurim will be interpreted by the UK Courts, particularly in relation to facts that differ from those in the Neurim case, including where the earlier marketing authorisation is for a first human use of a product and the subsequent marketing authorisation is for a subsequent human use. Based on the CJEU’s reasoning in paragraphs 25 and 26 of the CJEU’s judgment, it is possible that the earlier marketing authorisation could be disregarded for the purposes of Art. 3(d) RegSPC if such use would not fall within the scope of protection of the patent being relied on for the application (such as patents protecting a second or subsequent medical use of the product).

5. Third party MAs 39

In the Novartis46 case discussed above, MedImmune had obtained an SPC for ranibizumab on the basis of an MA owned by Novartis. There was no connection between the parties and, in fact, MedImmune alleged that sales of Novartis’s ranibizumab product infringed the SPC. Although neither side raised the point, Mr Justice Arnold stated the following in his judgment: “… in the present case the SPC is based upon a product obtained by means of an allegedly infringing process and upon a marketing authorisation obtained by an alleged infringer of the Patent. It might be thought that it was not the purpose of the Regulation to enable a patent owner to obtain an SPC in such circumstances, since the owner has not 46 Novartis Pharmaceuticals UK Limited v (1) Medimmune Limited and (2) Medical Research Council [2012] EWHC 181 (Pat); [2012] F.S.R. 23 [Annex A3.VIII.].

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been delayed in getting the product to market by the need to get a marketing authorisation, and therefore no extension to the term of the patent is needed to compensate him for that delay. Counsel for MedImmune accepted that it was not clear from the judgment of the Court of Justice in Case C-181/95 Biogen Inc. v SmithKline Biologicals SA [1997] ECR I386 that this was permissible.” In the Lilly47 case discussed above, Lilly raised this point to argue that any SPC 40 applied for by HGS on the basis of any marketing authorisation that Lilly may obtain for its product would be invalid. After hearing argument on the point, Mr Justice Warren of the Patents Court expressed the view that the holder of a basic patent could apply for an SPC in reliance on an marketing authorisation granted to a third party having no connection of any sort with the patent holder, and, although he did not make a decision as to whether the issue was acte claire, he decided not to exercise his discretion to refer the issue to the CJEU. The IPO’s Manual of Patent Practice as at July 2015 refers to Mr Justice Warren’s decision in this case, indicating that the IPO’s current practice is likely to be consistent with this. It remains to be seen whether parties will seek to revisit this issue in other cases, given 41 the view expressed by Mr Justice Arnold in Novartis.

III. SPC application procedure 1. Applications for SPCs Applications for SPCs in the UK are made by filing the prescribed form (Form SP1) with the IPO, together with the prescribed application fee (currently  250). As set out in Art. 7 RegSPC, the applicant is required to provide details of the “product” for which the SPC is sought, the “basic patent”, the first UK authorisation and, where different from the first UK authorisation, the first authorisation in the EU. The description of the “product” need not be restricted solely to the form referred to in the marketing authorisation. A certificate may be granted for a compound optionally in derivative form to the extent that derivatives are protected by the basic patent. Examples of wording that have been accepted by the IPO include: “X optionally in the form of the hydrochloride”, “X optionally in the form of a pharmaceutically acceptable salt such as the hydrochloride” and “X optionally in the form of a pharmaceutically acceptable salt”. As well as identifying the “basic patent”, the applicant is required to provide details explaining why the product is protected by the basic patent, such as, for example, indicating how the product is derived from a general formula in a claim. The applicant is also required to provide a copy of the first or each UK authorisation – i. e. a copy of the Product Licence or Marketing Authorisation granted by the MHRA or the European Commission. Where the SPC applicant is not the holder of the marketing authorisation, providing a copy of the marketing authorisation can sometimes be problematic. Following the CJEU’s decision in Biogen48, the IPO accepts that an SPC application can not be refused solely on the ground that the applicant is unable to provide a copy of the authorisation where the owner of the basic patent and the holder of the marketing authorisation are different persons. However, the IPO considers that it is not sufficient for the applicant merely to ask the IPO to obtain a copy of the authorisation without first having established his own inability to do so. Therefore, if an 47 48

Eli Lilly & Company v Human Genome Sciences Inc [2012] EWHC 2290 (Pat) [Annex A3.IX.]. Case C-181/95 Biogen Inc v SmithKline Beecham Biologicals SA [Annex A1.I.].

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applicant is unable to obtain a copy of the authorisation from the person holding it, the IPO requires the applicant to prove that they have been unable to obtain a copy and to provide information available from the authority that issued the authorisation that will allow the IPO to verify the identity of the product and the date of the authorisation. The IPO will then ask the issuing authority to supply a copy of the relevant documents. In accordance with Art. 7 RegSPC, the application must be lodged within six months of date of grant of either the first UK authorisation (Art. 7(1)) or, if later, the date of grant of the basic patent (Art. 7(2)). The approach used by the IPO to determine the relevant dates under Art. 7(1) and Art. 7(2) RegSPC is summarised below: a. For Art. 7(1) RegSPC, the relevant date depends on whether the authorisation is granted by the MHRA or the European Commission. Where the authorisation is granted by the European Commission, the IPO’s practice changed on 20 November 2013. Prior to that date, the relevant date was taken to be the date of the Commission decision to approve the medicinal product. However, from 20 November 2013 onwards, the IPO treats the date of notification as the relevant date. The date of notification is the date that the applicant for the authorisation is notified of the decision by the European Commission, and is recorded in the Official Journal of the European Union. For authorisations granted by the MHRA, the IPO in Abbott49 took the view that the relevant date is the actual date of grant of the authorisation and not the date of publication of grant in the relevant Official Gazette. b. For Art. 7(2) RegSPC, the date of grant for a European Patent granted by the EPO is the date the grant is mentioned in the European Patent Bulletin. For patents granted by the IPO, the relevant date is taken to be the date of publication of the notice of grant in the Patents Journal. The IPO will publish details of the application in the Patents Journal, and update its online register to show that the application has been made. Applications are numbered in a yearly sequence e. g. SPC/GB99/001 and the granted certificate retains this number. The IPO will then examine the application. This consists of an initial examination to check that the formalities have been complied with, followed by a substantive examination to determine whether the conditions in Art. 3 RegSPC are satisfied. The approach of the IPO and the UK Courts to the Art. 3 conditions is discussed above. There can be a delay of many months before the IPO commences the examination procedure. Applications for which the basic patent is about to expire take precedence. An applicant may request accelerated examination, in which case they are required to provide a reasoned statement for the request. Third parties can file written observations before an SPC is granted, which the examiner is required to consider. If the examiner considers that all of the Art. 3 RegSPC conditions are satisfied, he will grant the SPC, and the SPC takes effect at the end of the lawful term of the basic patent. If the SPC is granted after the basic patent expires, it will be granted retrospectively to the day after the basic patent expires. In such circumstances, the SPC applicant would not be able to commence infringement proceedings until the SPC is granted, but, once granted, the SPC owner would be able to claim damages for the period between publication of the SPC application and grant of the SPC, provided that the acts complained of would have infringed both the SPC as granted and the SPC in the form for which the SPC application was made (if different). If the examiner considers that any of the Art. 3 RegSPC conditions are not met, he will issue an examination report and the applicant will be given a chance to respond. 49

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Where the examiner, having reviewed any submissions from the applicant, considers that the application does not meet the conditions of RegSPC, he will send an official letter setting out the examiner’s opinion, the reasons for that opinion and explaining that the IPO will reject the application under Art. 10(2) or 10(4) RegSPC unless the applicant requests a hearing. These hearings are taken by a senior officer of the IPO, and a decision of the IPO will be issued following the hearing. The decision to grant or reject an application is published in the Patents Journal. 53 Decisions of the IPO can be appealed to the Patents Court, as has taken place in 54 many of the cases referred to above concerning the Art. 3 RegSPC conditions, such as Takeda, Gilead and Astellas.

2. Applications for SPC extensions Applications for SPC extensions are made by filing the prescribed fee (Form SP4) with the IPO, together with the prescribed application fee (currently  200). In accordance with Art. 8 RegSPC, the application should be accompanied by (i) a copy of the statement indicating compliance with an agreed paediatric investigation plan (PIP), as referred to in Art. 36(1) RegMPP; and (ii) proof of possession of authorisations to place the product on the market of all other member states, as referred to in Art. 36(3) RegMPP. Art. 36(2) RegMPP states that a statement of compliance in the marketing authorisation shall be used for the purpose of the statement of compliance referred to in Art. 36(1) RegMPP (and referred to in Art. 8 RegSPC). These requirements were considered by the Court of Appeal in du Pont50. Du Pont had filed an application for an extension of its SPC for losartan, but, at the time of making the application, although the Paediatric Committee had provided a statement indicating that the PIP had been complied with, the marketing authorisations containing the statement of compliance had not been granted. The IPO rejected the application, on the basis that the requirements in Art. 8 RegSPC had not been complied with (because the marketing authorisations containing the compliance statement had not been granted) and du Pont’s appeal against the rejection was dismissed by the Patents Court. The Court of Appeal agreed with the IPO that the requirements had not been complied with, but considered that the deficiencies in du Pont’s application were irregularities that could subsequently be cured pursuant to Art. 10(3) RegSPC. The marketing authorisations containing the compliance statement were available by the time the matter came before the Court of Appeal, and the SPC extension was granted. Examination of the application for an extension will be conducted in the same matter as applications for SPCs, as discussed above. Any decision by the IPO to reject an extension can be appealed to the Patents Court, as took place in the du Pont case.

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IV. Invalidation of SPCs and/or SPC extensions A third party seeking to invalidate an SPC may commence invalidity proceedings 59 before either the IPO or the UK Courts. Any party has standing to commence such an action. In England and Wales, such applications must be brought before the Patents Court or the Intellectual Property Enterprise Court, both of which are specialist courts within the High Court of England and Wales. In addition, if proceedings for infringement of the SPC have been commenced in the Patents Court or Intellectual Property 50 E I Du Pont Nemours & Co. v UK Intellectual Property Office [2009] EWCA Civ 966, [2010] R.P.C. 6 [Annex A3.I.].

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Enterprise Court, the alleged infringer may file a counterclaim in the infringement proceedings seeking that the SPC be revoked. The general practice of the UK Courts is not to bifurcate infringement and validity issues, therefore these issues are usually considered together within the same proceedings. 60 The IPO also offers the service of providing non-binding opinions in relation to SPCs.51 Parties may request such an opinion in relation to whether a proposed act would amount to infringement of an SPC or whether an SPC is valid. This is a low cost option which can be of assistance for example in the context of negotiations but does not bind the court in any subsequent proceedings. 61 Proceedings regarding SPCs are also possible in the courts of Scotland and Northern Ireland.52 62 Pursuant to Art. 16 RegSPC, the IPO and the UK courts also have the power to revoke a paediatric extension if it was granted contrary to the provisions of Art. 36 RegMPP. In Dr Reddy’s53, the Patents Court clarified that it has a discretion, rather than an obligation, to revoke the paediatric extension in such circumstances. In that case, Dr Reddy’s application to set aside the SPC extension granted to Pfizer for atorvastatin was refused. 51

Section 74A Patents Act 1977. As far as the authors are aware, there have not been any such cases. 53 Dr Reddy’s Laboratories (UK) Ltd and Dr Reddy’s Laboratories Ltd v Warner-Lambert Company LLC [2012] EWHC 3715 (Pat); [2013] R.P.C. 31 [Annex A3.XII.]. 52

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K. The SPC in France Literature: Schmitt, Bloch Premie`re de´cision relative aux certificats comple´mentaires de protection rattache´s a` un brevet, Gazette du Palais du 24 au 26 octobre 1993; Berthet, Les obstacles juridiques a` l’essor des ge´ne´riques, e´dition de sante´, 1998; Pollaud-Dulian, Droit de la Proprie´te´ Industrielle, 1999, pp. 533–538; INPI La proce´dure française de de´livrance des certificats comple´mentaires de protection, compte-rendu de re´union du 12 de´cembre 2002; Couste´ and Jonque`res, The Supplementary Protection Certificate in France, Patent World No. 159, February 2004; Schmitt, Un CCP peut-il eˆtre obtenu quand la spe´cialite´ de l’AMM de re´fe´rence porte sur une composition de plusieurs principes actifs qui ne sont pas tous revendique´s clairement dans les bases, Proprie´te´ Industrielle, juillet-aouˆt 2011; Le Bihan, Sergheareart, Certificats Comple´mentaires de Protection: trois nouvelles pierres a` l’e´difice jurisprudentiel, Proprie´te´ Industrielle n 3, 2014; Caen, ECJ Rules on SPCs – and French courts react” IAM Yearbook 2015. Content I. French national patents and pharmaceutical law . . . . . . . . . . . . . . . . . . . . . . . . . . . II. The conditions for obtaining an SPC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1. Article 3(a) of the Regulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2. Article 3(b) of the Regulation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3. Article 3(c) of the Regulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4. Article 3(d) of the Regulation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III. Grant procedure for SPCs in France . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV. Scope of protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . V. Duration of SPCs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VI. Waiver of SPCs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VII. Paediatric extensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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I. French national patents and pharmaceutical law French patents are governed by the Code de la Proprie´te´ Intellectuelle (CPI). The 1 examination proceedings are generally straightforward. The French IP Office (INPI) issues a Preliminary Search Report drawn up by the European Patent Office (EPO) which, in nature and presentation, is similar to the search reports issued by the EPO. The applicant has three months to reply to the search report, when documents are cited as being relevant. At that time, the applicant has the opportunity to amend the application claims. Save in exceptional circumstances, a French patent is then granted. Prior to entry into force of the Community Regulation on SPCs, France already had 2 its own legislation for SPCs on drugs (or “medicinal products” in Community law terminology). This law, enacted on June 25, 1990, was substituted on 2nd January, 1993 by the Community Regulation 1768/92 of June 18, 1992. The last French SPCs granted under the former law continued to take effect until 2009. According to French law, national SPCs expired 17 years after the Marketing Authorization or seven years after expiry of the patent, which is a longer period than the one afforded by the EC Regulation. It is interesting to note that under the regime of that national law, the protection 3 conferred by the SPC was determined by the scope of the SPC claims, and was not therefore limited solely to the product of the reference Marketing Authorization 1. Such an SPC could therefore protect several different products, provided that each of them had been authorized. 1

Court of Appeal of Paris, Bayer AG v. Directeur de l’INPI, 29th June 2001.

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The national provisions relative to the procedure for obtaining a Marketing Authorization are stipulated in the Public Health Code (CSP) and, more specifically, in the First Book of that Code. The definition of a medicament is set out in Article L.5111-111 of the CSP. Today, as in numerous European countries, reference medicaments are generally authorized in accordance with centralized European procedure. 5 Even though there are no longer any French SPCs in force, the French IP Code still includes provisions relative to national SPCs2. Articles L. 611–2 and R. 617–2 indicate all the other Articles of the IP Code that apply not only to patents but also to SPCs. 6 The French IP Office has however taken the position that the Articles of the IP Code relative to national SPCs did not necessarily apply to Community SPCs. More particularly, the French IP Office considers that for Community SPCs, reference should be made to Article 19 of Regulation (EC) No 469/09 under which the national provisions relating to patents apply directly to SPCs only in the absence of procedural provisions in the Regulation. 4

II. The conditions for obtaining an SPC 1. Article 3(a) of the Regulation 7 8

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According to Article 3(a) of the Regulation, an SPC may be granted if the product is protected by a basic patent in force. Contrary to the position taken in other EU Member States, and in particular in Germany, the test of infringement has never been upheld in France as sufficient to consider that a product is protected by the basic patent. The question of how to construe the term “protected” has been debated in France mainly in relation to combinations of active ingredients. As a matter of fact, when an application is made for an SPC in relation to a single active ingredient, it is generally considered by both the French IP Office and by French courts that it suffices for the active ingredient to be within the scope of the claim for it to be considered as protected. Thus, if the claims of the patent protect a family of products including the product for which the SPC application was made, the SPC is granted by the French IP Office and considered as valid by the French courts. Therefore, it was not required that the product be explicitly identified or mentioned in the patent claims or description. In the Bayer case3, the claims of the basic patent protected the product flufenacet alone. The Marketing Authorization invoked in support of the SPC application had been allowed for an association between flufenacet and another active ingredient, metosulam. The SPC had been filed for the flufenacet product alone. Curiously, the French IP Office considered that the product to which the SPC was directed should not be flufenacet alone, but in fact the flufenacet + metosulam association concerned by the Marketing Authorization. The French IP Office then granted the SPC for that association, without the agreement of the applicant. The Court of Appeal of Paris found that flufenacet alone should be protected. The decision for grant by the French IP Office was thus overturned, and the SPC re-granted for flufenacet alone. The question is frequently more complex when SPC protection is sought for an association of active ingredients, in relation to a Marketing Authorization for that association, but based on a patent claiming only one of the active ingredients of the association. 2 3

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IP Code, Article L. 611–2, L. 611–3, R. 617–1 and R. 617-2. Court of Appeal of Paris, Bayer AG v. Directeur de l’INPI, 10th September 2003.

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Thus, an SPC sought for an association between the active ingredients ritonavir and lopinavir was rejected by the French IP Office on the grounds that the claims of the basic patent protected ritonavir alone. The Court of Appeals of Paris4 approved the French IP Office’s decision by finding that an SPC can only be granted on condition that the composition of active ingredients is protected by the basic patent “which means that it must be claimed as such”. The Court of Appeals of Paris however considered that an SPC sought for an association of active ingredients was acceptable when the claims of the basic patent protected one of the active ingredients of the association as such, in combination with a carrier, when the patent description specifies that a carrier can be any other active ingredient5. These decisions were rendered before the recent CJEU decision in the Medeva 6 and Eli Lilly7 cases. However, after this CJEU decision, the French IP Office and French Courts have maintained the position on this matter they had taken in the “ritonavir” case. Thus, the French Supreme Court8 considered that an SPC for the association between the antihypertensive telmusartan and the diuretic HCTZ, cannot be the subject of an SPC since there was no claim relating to such an association, but only claims for the product telmusartan alone. The fact that the patent referred to diuretics in general, in its description, but not explicitly to HCTZ, was considered as being insufficient for the SPC to be granted. When a granted patent only includes claims referring to a single active ingredient, without making reference to the association thereof with another active ingredient, an association then cannot, in principle, give rise to the granting of a valid SPC. Nevertheless, if the association is referred to in the patent description, it may be envisioned to limit the claims so that said association is identified therein. The French IP Office and Courts long refused to allow amendment of a claim relating to an active ingredient, to add to that active ingredient another active ingredient referred to solely in the patent description, considering that amendment not to be a limitation of the patent. The Supreme Court of Appeals however found that such an amendment did indeed constitute a limitation, such that in future, it should be possible to make such amendments for the purpose of obtaining an SPC for an association of active ingredients, which was not initially claimed in the granted patent9. But the limitation must be made when the SPC application is still pending before the French IP Office. Indeed, the Court of Appeal of Paris, which handles appeals against the decisions rendered by the French IP Office, can only decide on the facts which were presented before the French IP Office. This means that, if the limitation is made after the SPC has been rejected, the Court of Appeal cannot take the limitation into consideration10. The interpretation of the term “protected” concerned in Article 3(a) of the Regulation will certainly further change on account of the recent CJEU decision in the Eli Lilly Court of Appeal of Paris, Abbott Laboratories v. Directeur de l’INPI, 19th January 2005. Court of Appeal of Paris, Syngeta Participations AG v. Directeur de l’INPI, 9th December 2005. 6 CJEU, Medeva v. Comptroller – General of Patents, Designs and Trademarks, C-322/10 [Annex A1.XIII.]. 7 CJEU, Eli Lilly v. Human Genome Sciences, Inc., C-493/12 [Annex A1.XXVI.]. 8 Supreme Court of Appeal (Cour de Cassation), Boehringer Ingelheim v. Directeur de l’INPI, 26 th November 2013. 9 Supreme Court of Appeal (Cour de Cassation) of Paris, Syngenta v. Directeur de l’INPI, 19 th March 2013, and in the same case, Court of Appeal of Paris, 25th October 2013 [Annex A4.II.]. 10 Court of Appeal of Paris, Syngenta v. French IP Office, 30 May 2014. 4 5

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case11. No decision has been handed down by the French IP Office or the French courts concerning the interpretation of that decision. It is true that such decisions at national level will be necessary, since the Court of Justice did not clearly explain when an active ingredient may be considered to be covered in a manner sufficiently “specific” to be “protected” by a patent and serve as a basis for an SPC12.

2. Article 3(b) of the Regulation According to Article 3(b) of the Regulation, in order for an SPC to be granted, it is necessary for the product to have obtained a Marketing Authorization as a medicinal product, in accordance with Directive 2001/83/EC, or Directive 2001/82/EC. 22 The Court of Appeal of Paris considered that an SPC could not be granted for an active ingredient to which the Marketing Authorization did not explicitly relate. Thus, when the Marketing Authorization concerns a salt of an active ingredient and the SPC application had been made in relation to another salt of that active ingredient, the French IP office took the position that an SPC application cannot be granted as being not in conformity with article 3 (b). It has been held that the fact that the salt concerned in the Marketing Authorization was transformed in the medicinal product into another salt, namely, the one protected by the basic patent is not sufficient. The Court of Appeal confirmed the position of the French IP Office and found that the SPC could only be granted for the salt explicitly concerned by the Marketing Authorization 13. 21

3. Article 3(c) of the Regulation According to Article 3(c) of the Regulation, an SPC may be granted if the product has not already been the subject of an SPC. 24 The applicant for an SPC may make reference to a Marketing Authorization of which it is the holder, or to that of its licensee. However, the French IP Office does not examine the matter of whether the holder of the Marketing Authorization has given permission to the patent proprietor to file an SPC making reference thereto. In practice, this leads to the granting of SPCs based on marketing authorizations belonging to a competitor of the SPC proprietor. 25 The question of the validity of an SPC granted on the basis of a Marketing Authorization belonging to a third party has already been raised before the French courts, but no answer has been provided by the Judge14. To date, it would appear that the French IP Office has not changed its practice on this question, despite the recent Lilly decision by the CJEU, which noted that to obtain an SPC a patent proprietor should not be able to rely on the Marketing Authorization for a medicinal product developed by a third party, otherwise the purpose of the Regulation would be undermined (point 43 of the order). 26 Nevertheless, in accordance with CJEU case law15, the French IP Office accepts to grant SPCs for the same product if they are based on different patents, belonging to distinct proprietors. 23

11

CJEU, Eli Lilly and Company Ltd. v. Human Genome Sciences, Inc., C-493/12 [Annex A1.XXVI.]. “Certificats Comple´mentaires de Protection: trois nouvelles pierres a` l’e´difice jurisprudentiel” AnneCharlotte Le Bihan and Eric Serghearaert, Proprie´te´ Industrielle, No. 3, March 2014, pages 7–12 [a translation of the title of this work being “Supplementary Protection Certificates: three new stones in the case law edifice”]. 13 Court of Appeal of Paris, Alza Corporation v. INPI, 11 th May 2011. 14 First Instance Court of Paris, ALK Abello A/S v. SA. Stallerge `nes, 7th October 2009. 15 CJEU, AHP Manufacturing B.V. v. Bureau for Voorde Indurstrie ¨le Eigendom, 3rd September 2009, C482/07 [Annex A1.X.]. 12

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4. Article 3(d) of the Regulation Lastly, according to Article 3(d), in order for the SPC to be granted the Marketing 27 Authorization must be the first for the product in France. The French IP Office does examine this point, by carrying out checks with the health authorities, or, for SPCs relative to plant protection products, with the Ministry of Agriculture. In order to be considered as a first Marketing Authorization in France, the Marketing 28 Authorization upon which the SPC is based must not be distinguished from an earlier Marketing Authorization uniquely on account of the presence of different excipients, even if those different excipients lead to a different effect for the active ingredient. What is required is for the product covered by the Marketing Authorization to consist of an active ingredient or an association of active ingredients, that is to say a product which of itself confers a therapeutic effect of its own in relation to the particular indication 16. However, it is to be expected that the French IP Office will now grant SPCs making 29 reference not only to the first Marketing Authorization for the product as such, but also for later marketing authorizations granted for the same product, but for a different application, this being in accordance with the Neurim decision17 of the Court of Justice. As it happens, this decision of the Court of Justice has been rapidly applied by French courts18.

III. Grant procedure for SPCs in France In order to obtain the grant of an SPC by the French IP Office, the applicant must file an application for grant and pay a grant fee19. The application must include the following information: – the identity of the basic patent, – the date and number of the Marketing Authorization in or for France and, if applicable, the date and number of the Marketing Authorization in the European Economic Area, – the International Non-proprietary Name (INN) of the product for which the protection is sought, – the name and the address of the SPC applicant, – as may be required, the link between that product and the basic patent. It is also important for the SPC applicant to be the true proprietor of the basic patent. The Court of Appeal of Paris indeed found that an SPC could not be asserted if it had been filed by the former proprietor of the basic patent, even if the latter was the proprietor registered on the National Register of Patents20. When a patent is assigned, it is also recommended that the assignment be registered on the National Register of Patents in order for the SPC application to be filed in the name of the registered proprietor. The SPC application is published within a short period (generally 3 to 4 weeks) of its filing date. The SPC application is examined by an examiner of the French IP Office for its conformity with the provisions of Article 3 of the Regulation. Formal objections may First Instance Court of Paris, ALK Abello A/S v. SA. Stallerge`nes, 7th October 2009. CJEU, Neurim Pharmaceuticals v. Comptroller General of Patents, C-130/11 [Annex A1.XX.]. 18 Court of Appeal of Paris, Merck v. Directeur Ge ´ne´ral de l’INPI, 15th February 2013 [Annex A4.IV.]. 19 On 1st November 2014, this fee amounts to 500 Euros. 20 Court of Appeal of Paris, Laboratorios Almirall S.A. v. Mylan S.A.S., 25 th November 2009. 16 17

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also be raised by the Examiner. The SPC applicant is given a non-extendible period of two months from the date of reception of notification by the examiner of those objections to file its arguments or to make the required amendments to the request for grant. The examiner may raise objections as to the definition of the product, in particular in relation to its conformity with the product name in the Marketing Authorization. The French IP Office attaches importance to the product name as given in the Marketing Authorization, even though a certain degree of latitude is given. Thus, if the product in the Marketing Authorization is a product in its free form, it is generally authorized to define the product of the SPC not only as the free form, but also in the form of one of its derivatives, for example its salts and its esters, provided that those forms are protected by the basic patent. It is perfectly possible to amend the definition of the product in response to an examiner’s objection. If the examiner considers that the response of the applicant to his objections is insufficient, he then issues a draft decision to reject the SPC application. A period of two months is given to the applicant to reply to the objections raised in the draft rejection decision. If, once again, the examiner considers that his objections remain founded despite the applicant’s arguments, a rejection decision is issued. It is possible to appeal to the Court of Appeal of Paris against rejection decisions of the French IP Office within one month, extended by two months for foreign entities. The decision of the Court of Appeal may itself be submitted to the authority of the Supreme Court of Appeal. Appeals against decisions by the Director of the French IP Office do not have the character of a full rehearing. Thus, the Court of Appeal will rule on the basis of the same documents as those produced during the examination procedure of the SPC, without, in principle, any possibility of adding thereto. When the SPC application gives rise to no objections, the SPC may be granted rapidly by the French IP Office, for example with a period of approximately 6 months. The procedure may take much longer in case of difficulty. There are no provisions in the IP Code for third party observations against an SPC application. The French IP Office therefore considers that such third party observations are not admissible. Nevertheless, such observations are filed, and the French IP Office forwards them to the SPC applicant, purely by way of information. The observations do not form part of the publicly accessible file. The French IP Office generally manages to grant or reject SPC applications before expiry of the basic patent. However, it is possible for the French IP Office’s decision to be reached after expiry of the patent.

IV. Scope of protection According to article 4 of regulation 469/2009, the protection conferred by the basic patent extends to the product, covered by the authorization to place the medicinal product on the market and for any use of the product as a medicinal product that has been authorized before the SPC expiry date. 46 According to article 5, regarding the effect of the certificate, and subject to the provisions of article 4, the certificate shall confer the same rights as conferred by the basic patent and shall be subject to the same limitations and the same obligations. 45

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The rights conferred by a patent in France are provided by article L.613-3 CPI. 47 According to this provision, save the content of the patent proprietor, the following acts are forbidden: manufacture, offer, putting on the market, use, importation, exportation, transshipment, or the holding for seas purposes the product subject of the patent. 21 As article 5 of the regulation provides that the certificate confers the same rights as 48 the basic patent, one should have thought that the above mentioned act of infringement provided by French law also applies to SPCs. However, French Courts, in several decisions, have considered that the rights afforded by SPCs should be limited to offering and putting on the market the product, but not the other acts of infringement, which are forbidden with respect to patents22. This narrow construction of the regulations provisions was not followed in another case23. The Court of Appeal of Paris indeed considered that the infringer was forbidden to manufacture, offer, put on the market, use, import and hold generic medicaments protected by an SPC. These latter decisions seem to be more consistent with the wording of article 5 of regulation 469/2009. Furthermore, it is now clear that in France, the scope of protection of an SPC granted 49 for a product A extends to any medicament containing product A and any other active substance. This was clarified by the French Supreme Court24 in perfect consistency with the CJEU caselaw25.

V. Duration of SPCs The French IP Office determines the term of SPCs in two different manners. When the SPC has a term of less than five years, the French IP Office considers that its date of expiry falls on the anniversary of the Marketing Authorization. When the term of the SPC is five years, the French IP Office considers that its expiry falls on the day before the anniversary of the filing date of the patent. This difference in calculation has not given rise to any decision by a French court. The decision to grant an SPC may be the subject of an appeal by third parties, if the date of the first Marketing Authorization in the EEA, indicated in the granted SPC, proves to be incorrect, as provided by the Article 17(2) of Regulation (EC) No 1610/96 for plant protection products (which also applies to SPCs for medicinal products, according to Article 17 of Regulation (EC) No 1610/9626). As of 1st November, 2009, such appeals have to be made to the Court of Appeal of Paris alone. An SPC can be granted even if its duration is less than the basic patent to which it refers. There is an interest for the patent proprietor to obtain the grant of such SPCs with negative duration, when pædiatric extensions based on the SPC can be granted. However, as pædiatric extensions provide effects for a period of 6 months after the SPC has expired, only SPCs expiring six months before the basic patent are granted by the French IP Office. The Court of Appeal of Paris has considered than an SPC negative 21 Article L.113-3 CPI was amended on 11th March 2014 to add, among the act of infringement, exportation and transshipment. 22 First instance Court of Paris, E.I. Du Pont De Nemours and Company, v. S.A.S. Mylan, 12 th February 2010.; Court of Appeal of Paris E.I. Du Pont De Nemours and Company, v. S.A.S. Mylan, 15th March 2011; First Instance Court of Paris, Novartis v. Actavis, 28th January 2011; Court of Appeal of Paris Novartis v. Actavis, 16th September 2011. 23 Court of Appeal of Paris, Novartis v. Mylan, 21 st March 2012. 24 Supreme Court, Novartis v. Actavis, 15 th January 2013. 25 CJEU Novartis A. G. v. Actavis UK Ltd, 9th February 2012, case C–442/11 [Annex A1.XIX.]. 26 Court of Appeal of Nancy, Allerbio v. Directeur de l’INPI and Stallerge `nes, 14th June 2010 [Annex A4.III.].

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50

51

52

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for 7, 5 months cannot confer an actual positive protection27. Therefore, the French IP Office can refuse such SPCs. 54 Renewal fees must be paid to maintain the SPC, when the SPC enters into force. These fees should, at the latest, be paid on the anniversary of the filing date of the basic patent. The French Patent Office also accepts that a one-off payment of all of the SPC renewal fees be made in the year preceding the entry into force of the SPC (article R.617-1 CPI). This possibility is however very rarely chosen by SPC proprietors.

VI. Waiver of SPCs 55 56

57

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59

The SPC proprietor may willingly relinquish its SPC rights. The question however arises as to the effective date of this waiver. In this connection, article L. 613–24 CPI states, first paragraph, that the patent proprietor may, at any time, relinquish its patent. The fourth paragraph of article L. 613–24 states that “the effective date of the waiver is retroactive to the filing date of the patent”. In accordance with article 19 of the Regulation, the provisions of article L. 613– 24 should apply to SPCs. Consequently, relinquishing an SPC must, as is the case when relinquishing a patent, take effect as from the SPC filing date 28 (ex nunc). But if the provisions of article L. 613–24 CPI were applied, would not they contradict article 14 of the Regulation? This article states that an SPC will lapse if the SPC holder surrenders it. It seems that this provision should be interpreted as meaning that the waiver of the SPC takes effect as from the date of the waiver (ex nunc). At least, this is a position taken by the Dutch Octrooicentrum Nederland, as expressed in the CJEU decision in case C-484/1229. Thus, it appears that the date at which the surrender of an SPC takes effect still needs to be decided by the French Court or, possibly also, the CJEU.

VII. Paediatric extensions For a pædiatric extension to be granted by the French IP Office, the applicant should submit the following documents and information: – a copy of the granted SPC, – a copy of the statement indicating compliance with an agreed completed Pædiatric Investigation Plan (the “compliance statement”), – when applicable, a copy of the national Marketing Authorizations in all the Member States, in accordance with article 8(d) (i) and (ii) of the Regulation, – the name of the applicant. 61 The French IP Office request form comprises two boxes that should be checked by the applicant to declare that the medicinal product is not an orphan drug, and it does not benefit from a one-year extension of the period of protection of the Marketing Authorization. 60

Court of Appeal of Paris, F. Hoffman-La Roche AG v. INPI, 5th July 2013 [Annex A4.V.]. This provision was amended by the Act of 4th August 2008. Indeed, prior to this amendment, the waiver of a title took effect from the publication date of the waiver, not the filing date of the title. 29 CJEU, Georgetown University, v. Octrooicentrum Nederland, C-484/12 (12 th December, 2013) [Annex A1.XXVII.], see point 24. 27 28

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The French Patent Office examiner may raise objections against the pædiatric 62 extension if one of the above-mentioned conditions has not been fulfilled. The applicant has a two-month deadline to overcome this objection. Lastly, a fee must be paid when filing the pædiatric application30. 63 If one of the documents or information is missing at the filing date, the French 64 examiner issues a communication for irregularities, with a two-month time-limit to reply. This time-limit may be extended once by two months. Afterwards, if the applicant has not satisfactorily replied to the Examiner’s request, a draft decision to refuse the pædiatric extension is issued. A further two months are given to reply. The draft decision to refuse becomes definitive if the applicant still has not complied with the examiner’s request31. 30 31

On 1st November 2014, this fee amounts to 450 Euros. Court of Appeal of Paris, Otzuka Pharmaceuticals Ltd., 23rd September 2014.

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L. The SPC in Italy Content I. II. III. IV. V.

National Pharmaceutical and Patent Law. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . SPC Obtaining Provisions and Term. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Subject Matter and Scope of Protection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Rights, Limitations and Obligations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . SPC Grant, Termination and Remedies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1. Grant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2. Termination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1 8 13 17 23 23 36

I. National Pharmaceutical and Patent Law Italian patents are ruled in the Codice della Proprieta` Industriale (CPI-Industrial Property Code).1 The Industrial Property Code is in conformity with the provisions of the EPC. The IPC provides specific rulings with respect to national patents, European patents, international applications (PCT), patent rights, enforcement and civil procedure before the Courts for infringement and validity. The patent lasts 20 years starting from the filing date and cannot be renewed nor extended (Art. 60). 2 The grant procedure provides for a Search Report and a Written Opinion on patentability prepared by EPO2. The Applicant must file a reply and/or amendments to the application (description, claims and drawings) within three months from the publication of the application, i. e. 21 months from the filing date3. Failure to comply with this requirement causes the application to be rejected. The application is then examined and the Office decides on the grant or refusal. Before deciding on refusal, the Office can provide the applicant a further opportunity to provide comments. The grant procedure generally lasts two and a half to three years from the application of the patent. Exclusive rights are conferred by the grant of the patent. However, said rights start from the filing date. The effects of the patent start from the publication of the application (18 months from the filing date or 90 days from the filing date if the applicant requested earlier publication). 3 The national marketing authorisation (MA) procedure is governed by Agenzia Italiana del Farmaco (AIFA) an independent Authority operating under the direction of the Ministery of Health. The national procedure for the grant of the Marketing Authorization (Autorizzazione all’Immissione in Commercio – AIC) has its basic law in the implementation of the EC Directive 2001/834. 4 Alternative procedures for obtaining an MA is the mutual recognition, which allows to extend the MA obtained in a Country member of European Union and can be used only for traditional drugs, or the centralized procedure before European Medicine Agency (EMA). 1

1 Legislative Decree 10 February 2005, Decree of Ministery of Economical Development 13 January 2010 (Implementing Regulation). 2 Art. 24, Legislative Decree of Ministery of Economical Development 13 January 2010 (Implementing Regulation). 3 Art. 172(2) CPI, Art. 173(4) CPI. 4 Legislative Decree of 29 december 2007, n. 274.

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If the drug is reimbursed by the National Health Service, the price is negotiated 5 between the drug manufacturer/seller and the AIFA. Of course innovative drugs have a higher price, which will have a substantial reduction when the drug will become a generic one. Therefore SPC protection has great economic relevance for the drug seller. Generic drugs (also known as “generics”) can obtain a Marketing Authorization demonstrating bioequivalence with the original drug. Generics can be marketed after the expiration of the patent or the relevant SPC. Price reduction is not lower than 20 % 5. Generic drugs (officially named as “equivalents”) were introduced in 1995 by Law n. 549 of 28.12.1995. Subsequent laws provide further provisions. It is worthy to remember that in Italy patenting drugs was excluded in the first patent 6 law6. This prohibition was declared unconstitutional by the Constitutional Court in 19787. Italian Patent Law was modified deleting the prohibition to patenting drugs. Since Italy is one of the major pharmaceutical markets in Europe, patents relating to pharmaceuticals rose consistently. The first SPC law was issued in 19918. This Law provided for the application and grant of an SPC (Certificato Complementare di Protezione – CCP). SPC could be applied for any patent relating to a medicament, a product comprised in the composition of a medicament, the use of a product as medicament, a process for the preparation of a medicament. Application for the SPC was subject to the grant of the first MA. The application had to be filed within 180 days from the Ministerial Decree granting the MA, in any case before 180 days before the expiration of the patent. In case the MA was granted before the grant of the patent, application for SPC could be filed within six months from the grant of the patent. The application had to be for one SPC and one patent. In case the applicant or other subjects related to the applicant were proprietors of other Italian, European or International patent applications/patents relating to the same medicament, such applications/patents had to be identified in the application. Italian Patent and Trademark Office – IPTO (Ufficio Italiano Brevetti e Marchi – UIBM) examined the application from a formal point of view. The application was published within one month of the filing date of the application. If the application was formally compliant, IPTO granted the SPC. Grant notice was published within one month from the decision to grant. If the application was not compliant with the Law, the application was rejected. Appeal against rejection was available. The SPC had the same effects and obligations of the basic patent, limited to the part(s) referred to the medicament object of the MA. The extension of protection was for the period lapsed between the filing date of the patent application and the date of the Decree granting the MA for a maximum period of 18 years. This means that the patent could be extended up to 38 years. A provisional rule provided that proprietors of patents or patent applications having a MA granted before the coming into force of this Law could file SPC applications within 180 days of the coming into force of this Law, in any case before 180 days before the expiration of the patent. EC Regulation 469/2009, 1901/2006 and 1610/96 were introduced in the CPI with the 7 Legislative Decree n. 131 of 13 August 2010. Therefore, SPC law in Italy is fully harmonized with EC Law. With the same Legislative Decree n. 131, the regimen of SPC provided by the previous Law was modified. Article 81(4) CPI states that to the purpose to progressively 5

Source Ministery of Health. Art. 14(1) Royal Decree n. 1129, 29 June 1939. 7 Decision 20/1978 of Constitutional Court [Annex A5.I.]. 8 Law n. 349 of 19 October 1991. 6

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adjust the duration of the “old” SPCs to the provisions of EC Law, the “old” SPC duration will be reduced by six months for every calendar year, starting from 1 st January 2000, till the complete alignment to the EC Regulations. Article 81(5) CPI allows third subjects willing to produce for exportation active ingredients protected by “old” SPCs to start negotiations with the proprietor of the SPC for a voluntary, non-exclusive license for exportation to those countries where there is no patent protection, in conformity with the legislation of that Country. The license will expire together with the expiration of the SPC.

II. SPC Obtaining Provisions and Term 8

9

10

11

12

The Italian practice assumed that a basic patent would protect a product if an infringement Court would consider the manufacture, offering, placing on the market and the use as well as the import and the possession of the product for the aforementioned purposes as an infringement of the basic patent. This is due to the interpretation of Art. 5 of the EC Regulation 469/2009 that the SPC produces the same effects of the basic patent. The famous CJEU Medeva decision9 has generated relevant jurisprudence in the case of SPC covering substance combinations, especially for those cases wherein a second SPC has been obtained on the same basic patent. The first SPC was obtained for the patented product and the second one for a combination of the patented product with an additional active ingredient.10 The Court of Milan recognized that different SPCs can be obtained for different products on the same basic patent. It is sufficient that the combination, albeit generically, is claimed. However, the most recent CJEU decision C-443/12 affected the subsequent jurisprudence. A marketing authorisation granted for the first time should also be seen in authorisations of a State who is not part of EU, but is part of EFTA (European Free Trade Agreement), for example Switzerland. 11. If the Marketing Authorization concession is granted only after the expiration of the twenty-year patent duration, supplementary protection is no longer possible, as the basic patent is not in force anymore at the time of the Certificate application. For the calculation of the SPCs’ term, according to the practice of the Italian Patent and Trademark Office, the date to be considered, other than the obvious one of the expiration of the patent, is the date of the publication of the marketing authorisation grant on the Official Gazette. This calculation was not so obvious under the previous, national Law on SPC (Law 349/1991, 19/10/1991). Italian Patent Office used to calculate the duration of the SPC using the date of the Ministerial Decree granting the Marketing Authorization and not the date of publication of the Decree on the Official Gazette of the Republic of Italy (Gazzetta Ufficiale della Repubblica Italiana). Since in many cases there was a considerable delay between the date of the Ministerial Decree and the one of the Official Gazette, some patent proprietors argued against this calcuation method. The question was settled by the Board of Appeal (Commissione dei Ricorsi), ruling that the calculation started from the publication of the MA on the Official Gazette.12 IPTO had to recalculate a 9 CJEU Medeva v. Comptroller-General of Patents, Designs and Trade Marks, C-322/10 [Annex A1.XIII.]. 10 Court of Milan 57598-1/2012 Sanofi vs Teva [Annex A5.II.]. 11 Commissione dei Ricorsi case 6895, 20/06/2002 [Annex A5.V.]. 12 Commissione dei Ricorsi 6353, 19/04/1996 [Annex A5.VI.].

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number of SPCs and re-publish the corrected dates. This had also an impact on the term for filing the SPC application, in the sense that the due date of six months for filing the SPC application had to be calculated starting from the publication of the Marketing Authorization on the Official Gazette and not from the date of the Ministerial Decree.

III. Subject Matter and Scope of Protection The scope of protection of an SPC, although clearly stated both in the Italian national 13 Law and in the EU Regulation, arose a consistent discussion with IPTO. Many drugs are claimed in the respective patent as compounds per se, but the claims also cover derivatives of the compound commonly used in pharmaceuticals. This is the so-called ‘Salt and Ester Problem’. The question started when IPTO issued SPC certificates quoting the active ingredient of the marketed medicament as stated in the Marketing Authorization. For example, a drug was marketed as “chloride”, and it was so cited in the SPC certificate. Patent proprietors raised the question that the scope of protection of the SPC had not to be limited only to the specific salt (or ester) actually marketed, but that the effects of the SPC had to be referred to the basic patent claims. This point of view was also based on the EC Regulation 1610/96 (SPC for plant protection products) and the opinion of European Commission of 19/09/1997. The matter was settled by some Decisions of the Board of Appeal (Commissione dei Ricorsi), stating that SPC protection is extended also to salts and esters of the active ingredient, provided they are claimed in the basic patent.13 There is no need that the SPC certificate mentions any of “derivatives”, “esters”, “salts”. However, the product as specified in the Marketing Authorization will be cited in the SPC certificate,14 The problem of substance combinations has been faced by Italian Courts different 14 times. The Court of Rome decided that a patent covering a process for the preparation of clavulanic acid was a valid basic patent for a SPC protecting the combination clavulanic acid and amoxicillin. The Court reasoned that the patent covered an active ingredient (claiming a process for its preparation) of the medicine object of the marketing authorization, therefore it conferred to the SPC the same protective rights of the patent15. A very recent decision from the Court of Milan16 faced the problem of substance 15 combination in the Sanofi case. This case relates to the SPC granted for the combination of Irbesartan and Hydrochlorotiazide, a case discussed also in several European Courts and now object of the recent CJEU C-443/12. The Court of Milan decided on several important points in the matter of SCPs. First, according to the Judges, Article 3 a of EC Regulation 469/2009 does not rule that the specific identification and description of every single active ingredient making the combination is a requirement of validity for an SPC covering said combination. This reasoning is made in analogy with the practice to grant SPCs for patents claiming a general formula, where the product object of the SPC can be detected, even though this product is not specifically claimed, and, it must be accepted that well-known active ingredients (hydrochlorotiazide) can be indicated in a generic way in a claim of the basic patent (a diuretic, in this case). Another point argued by the Judges is that the medicinal product having Irbesartan as the only active 13

Commissione dei Ricorsi 6491 of 16/12/1997 and 6497 of 17/01/2000 [Annex A5.VII.]. Ibid. 15 Tribunale di Roma 19/05/2003 [Annex A5.III.]. 16 Court of Milan 14635/2012 29/12/2012 – DOC Generici vs Sanofi [Annex A5.II.]. 14

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ingredient is different from the medicinal product containing the combination Irbesartan and Hydrochlorotiazide, since the latter required further clinical studies and needed a distinct marketing Authorization. Then the Judges review some CJEU decisions on the SPC matter. According to the Judges, decision C-392/97 (Farmitalia) provides that the SPC can protect the product, as medicinal product, in every form falling within the breadth of protection of the basic patent, without requiring the explicit indication of the components of the active ingredient object of the SPC. The Medeva decision (C-322/ 10), and in analogy the Daichii decision (C-6/11), is not applicable in this circumstance, because it relates to a different circumstance, since the related SPCs comprised also active ingredients which were not mentioned in the basic patent at all. The Judges conclude that there are no indications in the CJEU case law that every single component of the combination of active ingredients covered by the SPC be explicitly named in the claims of the basic patent, therefore the basic patent is valid in view of the patent law. Further, the Judges observe that the Medeva decision does not forbid to obtain more than one SPC for a single basic patent (citing also the Biogen decision C-181/95). 16 The recent CJEU decision C-443/1217 on substance combinations, specifically on the Irbesartan-hydrochlorotiazide case, is leading to a further elaboration in the jurisprudence. This decision was issued before the final decision by the Judges of the Court of Milan. In July 2014, the Court of Milan issued the final decision on this matter. 18 The Court acknowledged the binding character of a decision by the CJEU on the same subject matter, even if the court proceedings started before the CJEU ruling. Therefore, the only possible conclusion for the Court of Milan, due to the binding character of the CJEU decision, was to declare the invalidity of SPC directed to the combination of Irbesartan and Hydrochlorotiazide.

IV. Rights, Limitations and Obligations The exclusive right conferred by the SPC is as provided by the EC Regulations 469/ 2009, 1901/2006 and 1610/96, cf. Art. 61 CPI (introduced in the Law by Legislative Decree n. 131 of 13 August 2010) However, the provision regarding the SPCs granted under the old Law n. 349/1991 is more articulate. Art. 81(2) CPI extends the duration of the basic patent for the period of time between the filing date of the patent application and the date of the decree granting the marketing authorization. We have seen before (187) that the Board of Appeal (Commissione dei Ricorsi) ruled that the date for the calculation of the SPC duration is the one of the Official Gazette of Republic of Italy where said decree is published. In no case, the SPC can last more than 18 years after the expiry of the basic patent (Art. 81(3)). However, paragraph 4 of the same article makes a special provision in order to harmonize the previous Law n. 349/1991 and the EC Regulation n. 1768/1992. To this purpose, starting from January 1st 2004, the duration of an SPC granted under the old law will be reduced by six months for every calendar year until its duration is into conformity with EC Regulation. 18 If a third party intends to manufacture a medicinal product covered by an SPC granted under old Law n.349/1991 only for exportation purpose, this party can start negotiations with the SPC holder, with the assistance of the Ministry of Economic Development, for a voluntary, non exclusive license. 17

17 18

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CJEU Actavis vs. Sanofi, C-443/12 [Annex A1.XXII.]. Court of Milan 10 July 2014 [Annex A5.IV.].

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Italian Patent Law (CPI) does not explicitly provide that licenses for the basic patent automatically also extend to the SPC. In the negotiation of a license on a patent, its extension to a related SPC should be regulated in the agreement. Article 70 CPI, providing for the grant of a compulsory licence in case the patented invention should not be carried out at all or in an insufficient amount with respect to the needs of the Country, should cover also SPC. Obtaining a marketing authorization, a requirement for SPC application, should not be seen as a sufficient carrying out of the invention. Therefore, SPC regiment is subject to two kinds of license: a) voluntary license for exportation (but this is only for SPC granted under the “old” law) and b) compulsory license (this is for SPC granted for both old national law and EC Regulation).19 Licenses and transfer of rights on an SPC are subject to the same provisions for patents. Transfer of rights and licenses must be recorded before IPTO. 20 Limitations and obligations of the SPC are the same of the basic patent, but restricted only to the subject matter protected by the SPC. This should automatically be reflected on a license agreement, which should be terminated at the expiration of the patent at the latest for those subject matter covered by the patent but not by the SPC and should continue till the expiration or maintenance of the SPC for the subject matted covered by the patent as far as it is extended by the SPC. However, specific and clear clauses should be drafted in the license agreement.

19

20

21 22

V. SPC Grant, Termination and Remedies 1. Grant The formal requirements of the SPC application are ruled by Art. 163 CPI. IPTO 23 does not require a specific form for filing the application. An application for the grant of an SPC can be freely written, but the information requested by Art. 163 must be provided. Essential information are the identification of the applicant, number of the basic patent, title of the invention, number and date of the marketing authorization and the indication of the product as it appears in the marketing authorization, number and date of the first marketing authorization in the EEC, if any. IPTO does not examine the SPC application as of the substantial requirements, 24 namely its grounds of validity. IPTO is not entitled to do so. Therefore, validity of an SPC can be challenged only before a Court. IPTO performs a formal and administrative examination, checking that the requirements of Art. 163 CPI are met, namely, the identification of the applicant, the basic patent, the marketing authorization, the product named in the marketing authorization. Although there are no specific provisions in the Law, an application for SPC should enclose a copy of the basic patent, of the marketing authorization, of the summary of the characteristics of the product and any other documentation the applicant deems useful. The application must be filed in written form with IPTO. The application cannot be 25 filed with the Chamber of Commerce Industry and Craftsmanship. The application can also be filed by postal service. The date of filing is the date of receipt at IPTO. At present, on line filing is not available for SPC. The applicant must have its residence or must elect a domicile in Italy. Although it is not compulsory to appoint an agent, in case the applicant is not resident, nor has a domicile in Italy, appointment of an agent is 19 20

Art. 70, 72, 73, 199, 200 CPI. Art. 138 CPI.

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26

27 28

29

30 31

32

33

advisable. Appointment of an agent shall meet the same requirements as a patent application.21 The application must be in Italian. The application can also be filed in any language, in this case, an Italian translation must be filed within a two-month term established by IPTO22. However, in order to expedite the prosecution, it is advisable to file the translation as soon as possible. The translation can be declared to be into conformity with the original application by the applicant or its agent. IPTO can ask for a sworn translation23. The application content is substantially the same as the one required by RegSPC 24. Irregularities in the application. In case the applicant cannot be identified or cannot be reached, IPTO declares the application cannot be received 25. If the applicant can be reached, IPTO invites it to remedy within two months from the date of receipt of IPTO invitation.26 In case the remedy is received within the due date or earlier, the date of filing is the date of receipt by IPTO. However, late filing of the power of attorney or the indication of domicile or the proof of the payment of the relevant fees, does not change the filing date27. Extension of time is available for filing the power of attorney, but not for the Italian translation. Failing to file the Italian translation makes the application not receivable and the IPTO will declare so with notification to the applicant or its representative. Appeal is admitted.28 The application deadline is six months from the date of publication of the Marketing Authorization on the Official Gazette of Republic of Italy, in case of a national MA, or on the EU Official Gazette in case of a Community MA. In case MA is granted before the grant of the basic patent, the relevant date for determining the deadline for filing the SPC application is the date of the grant of the Italian patent as stated on the Certificate of Grant or the date of publication of the grant on the European Patent Register. Failing to meet the deadline for filing an SPC application can be remedied by restitutio in integrum.29 An extension of an SPC for paediatric indication can be made as provided by RegSPC. The application fee is determined by the fee schedule published on the Official Gazette of the Republic of Italy 06.04.2007, n. 81. The fees must be paid before filing and the proof of payment must be enclosed with the application. Failing to do so, makes the application not acceptable. Late payment of the fees is not admitted. The proof of payment can be filed later, and the filing date will not be affected. IPTO publishes the application of the SPC, usually within one month from the filing date.30 The file of the SPC is open to public inspection with some limitations. The Decree of Marketing Authorization and the Summary of the Product Characteristics are excluded from public inspection, except their abstracts, if present. 31 The Certificate of Grant is sent to the SPC owner or its Agent. The Certificate of Grant contains all the information presented in the application and provided by the 21

Art. 201 CPI. Art. 148(5) CPI, Art. 6 Implementing Regulation. 23 Art. 6 Implementing Regulation. 24 Art 163 CPI. 25 Art. 148(1) CPI. 26 Art. 148(2) CPI. 27 Art. 148(4) CPI. 28 Art. 5 Implementing Regulations. 29 Art. 193 CPI. 30 Art. 196 CPI. 31 Art. 33 Implementing Regulation. 22

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SPCReg. The specific product for which the Certificate is granted is specified according to the wording of the Marketing Authorization. The Certificate of Grant also states the date of the commencement and of the expiry 34 of the Certificate. The grant of the SPC is published in the patent register, also available on IPTO website (http://www.uibm.gov.it/uibm/dati/Default.aspx) The annual fees shall be paid to the IPTO with the same formalities as the annual 35 fees for patents (schedule of fees published on the Official Gazette of the Republic of Italy 06.04.2007, n. 81).32 The same remedies are also applicable.33

2. Termination As for patents, an SPC can be terminated either by expiry, invalidity or revocation. Lapse of SPC occurs also for failing to pay renewal fees or by withdrawal of the SPC application34 Relevant information and declarations are effected by IPTO through the entry and publication in the patent register. The SPC owner can file a written declaration of renunciation.35 The declaration will be published on the Register.36 A formal legitimisation is not mandatory, unless third parties are involved in the ascertainment of the right.37 In case of grounds for invalidity, a law suit must be opened before the competent Court. IPTO is not entitled to examine and decide validity of an SPC. In case of grounds for invalidity of the basic patent, the Court decision declaring the nullity of the patent shall also declare the nullity of the SPC. The Court decision will be transmitted to IPTO and the nullity of the patent and of the SPC will be annotated in the Register.38 Third party observations against the grant or validity of an SPC can be filed with IPTO. This is not provided by CPI, but IPTO will transmit these observations to the SPC applicant or owner and will set a due date for filing a reply. Not filing a reply will not cause the application deemed to be withdrawn nor is a ground for rejection. The IPTO will not stop the procedure for grant. Any reply filed by the SPC applicant/owner will not be transmitted to the third party. Both observations filed by a third party and any reply by the applicant/owner are not available to the public. Any action against the validity of an SPC must be brought before the competent Court, Specialized Section for Enterprise Matter39. The competent Court is determined by the domicile of the SPC owner. In case of appointment of an agent, the domicile is the one of the Agent. 32

Art. 227 CPI and Art. 38 Implementing Regulation. Art. 193 CPI. 34 Art. 172 CPI. 35 Art. 78 CPI. 36 Art. 32 Implementing Regulations. 37 Art. 78(2) CPI. 38 Art. 185 and 197 CPI. 39 Law Decree 24.01.2012, n.1. To date the Courts and Courts of Appeal of Bari, Bologna, Catania, Firenze, Genova, Milano, Napoli, Palermo, Roma, Torino, Trieste and Venezia and further the Courts of the Capital Cities of the Regions. 33

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M. The SPC in The Netherlands Content I. National Pharmaceutical and Patent Law. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1. Patents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2. NLOC and Dutch patent register . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3. Medicines Evaluation Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II. SPC Obtaining Provisions and Term in the Dutch Context . . . . . . . . . . . . . . 1. Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2. Publication. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3. Grant procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4. Third party observations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III. Subject Matter and Scope of Protection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1. Product protected . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2. One SPC per patent?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3. Further medical use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV. Rights, Limitations and Obligations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . V. License . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VI. Termination and Remedies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VII. Court proceedings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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I. National Pharmaceutical and Patent Law 1. Patents Dutch patents are governed by the Dutch Patent Act of 1995 (Rijksoctrooiwet 1995, (ROW)). Since the ROW has been harmonized with the Patent Law Treaty (PLT), most requirements for Dutch Patent applications correspond to those for European Patent applications. 2 With the introduction of the Dutch Patent Act in 1995, the Dutch patent system changed from a grant procedure with substantive examination to a registration system. Patent applications can be filed at the Netherlands Patent Office (NL Octrooicentrum; NLOC) in Dutch, or in English accompanied by Dutch claims. A search report and written opinion is issued, where after the applicant gets a term to file voluntary amendments. After this term lapses, but not earlier than 18 months after the earliest priority date, the patent is granted and both entered in the Dutch patent register and published in the Dutch Patent Bulletin. Grant can however be accelerated upon request of the applicant. After grant, a deed of limitation of protection can be filed at the NLOC (Art 63 ROW). Patent related cases, including revocation and infringement cases, are exclusively dealt with by the Court of the Hague (Article 80(1) ROW). 1

2. NLOC and Dutch patent register NLOC is responsible for the grant of Dutch patents (Article 15 ROW). NLOC is further responsible for issuing validity opinions for Dutch patents in case validity of a Dutch patent is challenged (Article 84 ROW). NLOC can however not revoke a Dutch patent. Revocation is reserved for the court of the Hague. 4 NLOC further issues search reports in case an applicant requests NLOC to draft a search report for a Dutch patent application and is further responsible for the Dutch patent register (Article 19 ROW). 3

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The Dutch patent register is freely available via the internet, requires no registration 5 and is available in Dutch and English. The register shows all the bibliographic information, expiration date and current status and for the recent cases also provides the content of the file, such as translation of claims, SPC application, office actions and filed responses (Article 21(1) ROW).

3. Medicines Evaluation Board The national marketing authorizations are issued by the Medicines Evaluation Board 6 (MEB, Dutch: College ter Beoordeling van Geneesmiddelen, CBG). The MEB assesses and monitors the efficacy, risks and quality of human and veterinary medicinal products, and the safety of novel foods for human consumption. Once a medicinal product is authorized, it is registered and given foods for human consumption. Once a medicinal product is authorized, it is registered and given an ‘RVG’ number. The MEB also maintains a database containing the authorized medicines. Corresponding market authorizations (herein also ‘MA’) can be searched by brand name or the active ingredient of a medicine or using the RVG/EU numbers. In order to start the registration procedure, a dossier for the evaluation of a medicinal 7 product has to be submitted with the MEB. This dossier, which has to meet current European requirements concerning content and layout, consists of five modules: Module 1 contains administrative data, including the Summary of Product Characteristics, the package leaflet and the labelling text, module 2 includes the summaries of the chemical-pharmaceutical, pharmacological-toxicological and the clinical-pharmacological dossier, module 3 consists of the chemical-pharmaceutical data, module 4 consists of pharmaco-logical toxicological data and, module 5 the clinical-pharmacological data. After submission of the dossier, the MEB has 210 days to reach a final decision. This 8 period may be interrupted in order to allow the applicant to answer questions raised during the procedure. The procedure also allows for oral explanation. After a positive final decision the marketing authorization is issued including the Summary of Product Characteristics, the package leaflet and the labelling text.

II. SPC Obtaining Provisions and Term in the Dutch Context 1. Application An SPC is requested with NLOC (Article 91 ROW and Article 9(1) of Regulation 9 (EC) No 469/2009 (hereafter the SPC Regulation)) with a form available on the NLOC website and can be filed by ordinary mail or facsimile. Online filing is not available for SPC applications. The application can be filed in Dutch or English (Article 93 and Article 24(3) ROW). On the application form, the basic patent, the marketing authorization(s) and the product have to be identified. The product has to be identified by its chemical name (both systematic and trivial nomenclature are allowed) and has to correspond to the product identified in the MA. Further, the applicant and where applicable, the agent has to be identified. The product specification of the marketing authorization also has to be enclosed. Further Article 92 ROW requires that proof of payment of a fee for filing an SPC application, is enclosed. When the application does not meet the requirements of Article 8 of the SPC Regula- 10 tion, Article 92 ROW (proof of payment of fee) and/or Article 93 ROW (language) NLOC will issue an office action indicating the missing information within 2 months of the filing date and will give the applicant a term to file the missing information (Article 94 ROW). Tom Wittop Koning/Gabor Abbas/Matthew Burton

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2. Publication 11

The application is published as quickly as possible in the Dutch patent register. This normally takes no more than 2 weeks. The entry in the register also identifies the basic patent and references to the one or more SPC applications will be added to the entry of the basic patent. The application is also published in the Dutch Patent Bulletin.

3. Grant procedure The grant procedure of Dutch SPCs is governed by the ROW (Articles 90–98), the SPC Regulation and Dutch administrative law (Algemene wet Bestuursrecht; AwB). After filing of an SPC application, NLOC examines whether or not the application meets the requirements of the SPC Regulation and if it does, grants an SPC. If the application does not meet the requirements NLOC will issue a first office action identifying the deficiencies and setting a period for response. Normally, the period for responding to the office action is 2 or 3 months from the dispatch date. The office action often also comprises a provisional invitation for an interview with the examiner in case the response does not take away the deficiencies. In case evidence has to be provided which the applicant does not want to have published in the register it can indicate upon filing which parts of the filed documents should not be entered in the public part of the register. An extension can be requested if necessary, but it is up to the examiners discretion to grant an extension. 13 In case the application is rejected, NLOC issues a first decision (beschikking) setting out the reasons of rejection. The applicant can object against this first decision by filing a notice of objection (bezwaarschrift) within 6 weeks calculated from the dispatch date and a fee has to be paid. After receipt of the Notice, NLOC will issue Summons to attend Oral proceedings. Contrary to the initial examination, the appeal procedure is conducted by a three or four remembered board. Within six weeks after Oral Proceedings, NLOC has to issue a second reasoned decision (beschikking op bezwaar). The second decision is open to appeal before the court of The Hague. 14 Dutch administrative law (AwB) also provides for an option to skip the objection procedure and to address an appeal to court directly. A request must be filed at the NLOC and is only possible if NLOC determines that the case is suitable to be directed to court directly and to skip the objection procedure. A request to skip the objection procedure has to be made in the Notice of objection (Art. 7:1 (1e) AwB). 15 The Council of State ruled in the Syngenta v. NLOC case on 18th February 2015 that when an SPC has been granted based on an incorrect first market authorization, an appeal can be filed even after the 6-week deadline for filing an appeal according to Dutch administrative law has passed.1 The Council of State decision is based on a broad intrepetation of Article 17(2) of Regulation 1610/96 which interpreation is in consistant with the supranational nature of Regulation 1610/96, the general objective and purpose of this Regulation and the principle of Loyalty in EU Law (Article 4 (3) TEU). 12

4. Third party observations 16

Dutch administrative law also allows for third parties to file observations. Third party observations can be filed anonymously, by straw-man or identifying the party and can be filed in Dutch and English. Generally, administrative law allows third parties to file a 1

Syngenta v. NLOC [Annex A6.XIII.].

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notice of objection against a first decision, which would provide a form of opposition. However, the Dutch administrative court ruled that the SPC Regulation does not allow for opposition against a granted SPC or Pediatric Extension, and hence third parties cannot object against a decision to grant an SPC or Pediatric Extension (Actavis v. NLOC2). The court highlighted that Article 16.2 of the SPC regulation stipulates that any person may submit an application for revocation of the extension of the duration to the body responsible under national law for the revocation of the corresponding basic patent. That body under Dutch patent law is the Court of The Hague. If a third party filed observations before grant of the SPC while identifying itself, 17 NLOC will notify this party about the outcome of the proceedings by providing a copy of the decision to grant or the decision to reject the application (Article 4:8 AwB) (see for example Dutch SPC case 300381 (‘Bayer’)). This third party will also be party to possible further objection procedures. As such, a known third party will be invited by NLOC to respond to the notice of objection and to arguments filed by the applicant, within six weeks of the mailing date of the invitation. Regarding the calculation of the SPCs’ term, according to the practice of NLOC, the 18 grant date of the marketing authorization – i. e. the issue date by the authorizing agency – is decisive.

III. Subject Matter and Scope of Protection 1. Product protected NLOC does not give indications about the scope of protection of a patent. As such, the infringement test was never adopted by NLOC in order to establish whether or not the basic patent claims (i. e. protects) the product, to be protected by the SPC. Instead, NLOC used the subject matter test, wherein disclosure of the subject matter of the SPC in the description of the basic patent (including common general knowledge) is sufficient, in order to establish whether or not an SPC could be granted for a product (as in the Paroxetine case NLOC, BIE 1994/No. 106/373-4). In the Medeva case3, the ECJ concluded that regarding Article 3(a) of the SPC Regulation, the competent industrial property office of a Member State should only grant a supplementary protection certificate relating to active ingredients when identified in the wording of the claims of the basic patent. This ruling forced the NLOC to limit the subject matter test to the wording in the claims only. For example, if the claims of a basic patent would cover a composition comprising a compound A, and the specification explicitly discloses a composition of compounds A and B, an SPC could previously be obtained for this combination if an MA has been issued for this combination. However, under the Medeva doctrine an SPC will not be granted since one of the active ingredients is not explicitly covered by the claims. Due to the practice of NLOC before Medeva, there are SPCs which at the date of filing of the SPC application were not protected by the basic patent, but having basis for the product in the specification of the basic patent. An attempt can be made to introduce protection for the product by filing amended claims in a post grant deed of limitation (Article 63 ROW) which explicitly covers the product.

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Actavis v. NLOC [Annex A6.IV.]. CJEU Medeva v. Comptroller-General Patents, Designs and Trademarks, C-322/10 [Annex A1.XIII.].

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Article 3(a) of the SPC Regulation rules that the product has to be protected by the basic patent at the time of filing the SPC application, the amendments to bring the product explicitly mentioned in the claims may have to be made prior to filing the SPC application. For the patent rights, NLOC accepts a retroactive effect of post-grant limited claims in conformity with the nullification of protection by the court (Article 75(5)-(7) ROW). The effect of such retroactive effect of the limitation is that the claims as amended post grant are deemed to have existed in amended form since the date of filing of the patent application and therewith comply with Article 3(a) of the Regulation In Dutch SPC case 300095 (‘Boehringer’), an SPC was granted to the combination of the benzoimidazole Telmisartan in combination with the diuretic hydrochlorothiazidin. The claims of the granted patent however did relate to imidazoles and the preparation thereof, but not to combinations with other compounds. Such compounds were mentioned in the description. The patentee amended claims by introducing such combinatory claims, and removed, as limitation, the claim directed to the method of preparation of the imidazoles. As a result, the patent claims are now in conformity with the Medeva doctrine 4. However, As NLOC does not re-examine granted SPC on own motion, it is still not resolved whether said limitation is in line with Article 3(a) of the Regulation. At first sight, the retroactive effect of the limitation after filing the SPC application seems to provide protection at the time of filing the SPC application. This however seems to be detrimental to the legal certainty for third parties. Furthermore the requirement of protection by the basic patent at the time of filing the SPC application originates from the Regulation and not from Dutch patent law. The Regulation seems to provide for no interpretation of “at the time of filing” but the actual time of filing and the circumstances at that time. Hence, in the post Medeva era, it is questionable whether post grant limitation as in the above Boehringer case will actually meet the requirements of Article 3(a) of the Regulation, that a certificate shall be granted if the product is protected by a basic patent in force at the filing date of the SPC application, as a combination of compounds was not claimed at the time the SPC was filed. In attempt to introduce subject matter in the claims post grant, care should also be taken that such introduction may involve broadening of protection instead of limitation. Further, such option is only open if the basic patent is still in force. In the ECJ case Eli Lilly5, the referring patents court of the UK wanted clarification on what are the criteria for deciding whether “the product is protected by a basic patent in force” in Article 3(a) of the SPC Regulation (and 2 other questions). On December 13, 2013 the court handed down its preliminary decision. The court explained that Article 3(a) of the SPC Regulation must be interpreted as meaning that, in order for an active ingredient to be regarded as ‘protected by a basic patent in force’ within the meaning of that provision, it is not necessary for the active ingredient to be identified in the claims of the patent by a structural formula. Where the active ingredient is covered by a functional formula in the claims of a patent issued by the EPO, Article 3(a) of that Regulation does not, in principle, preclude the grant of an SPC for that active ingredient. In this situation it is required that it is possible to reach the conclusion on the basis of those claims, interpreted, amongst other things, in the light of the description of the invention, as required by Article 69 of the EPC and the Protocol on the interpretation of that provision, that the claims relate, implicitly but necessarily and specifically, to the active ingredient in question. 4 5

Yeda v. NLOC [Annex A6.XI.]. CJEU Eli lilly and Company Ltd. v. Human Genome Science Inc., C-493/12 [Annex A1.XXVI.].

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Based on this decision, NLOC may relax the current Medeva practice of granting 30 SPCs as discussed previously in this chapter, but be more stringent than the pre-Medeva era, since there are some additional requirements to take into account to reach the conclusion which active ingredient is meant. Since the ECJ refers to Article 69 and its protocol it is likely that the grant requirements conceding protection will be similar to the pre-Medeva era with the exception of the requirement that the claims have to relate, implicitly but necessarily and specifically, to the active ingredient in question. Regarding SPC applications directed to medical devicies, the Dutch courts have 31 provided a first ruling in the Genzyme Biosugery6 case. The court decided that the deciding factor as to whether an SPC for a medical device can be granted is whether the medical device which incorporates the active ingredient has undergone the extensive and lengthy testing procedure according to section 7.4 of Annex 1 of Directive 93/42 EEC. Only in cases where the safety, quality and use of the active ingredient (wherefore an SPC is granted), are examined by analogy to the methods reported in Directive 75/ 318 EEC (superseded by Directive 2001/83 EC) is it justified to grant an SPC, as would be done for medicinal products according to the authorization procedures according to Directive 65/65 EEC or 81/851 EEC (now Directive 2001/83 or Directive 2001/82 EC respectively). The court therefore referred the case back to NLOC to re-examine whether the testing procedure was in accordance with the conditions stipulated by the SPC Regulations. Such an interpretation is consistent with the wording of Article 3 (b) of the SPC 32 Regulation in which the words “a valid authorization … has been granted in accordance with Directive 2001/83 or Directive 2001/82 EC.” This decision provides support for the principle that medical devices qualify for SPC protection on the proviso that the testing procedures are analogous to those of Directive 2001/83 EC.

2. One SPC per patent? In the Dutch summary proceedings case Sanofi v. Teva7 the court held the SPC with 33 respect to the combination product Ibersartan/HCTZ valid. In the basic patent of Sanofi, a generic combination of Ibersartan and a diuretic was claimed, but neither the claims nor the description mentioned the diuretic HCTZ as a possible diuretic compound. In light of the claims, the summary proceedings court reasoned, by performing the infringement test, that both Ibersartan and the combination Ibersartan/HCTZ are protected by the basic patent. Hence the court concluded that the SPC with respect to the combination product is valid. In appeal, however, the court of appeal in its judgment (Teva v. Sanofi)8 referred to 34 ECJ cases Medeva and Georgetown I9, and decided that only one SPC per patent can be granted in cases where the SPC is based on a market authorization for a combination medicinal product, in which the active ingredient is explicitly covered by the basic patent and a further active ingredient not explicitly claimed or protected as such by the basic patent. The ruling of the appeal court thus overturned the ruling in first instance. This Dutch decision is in conformity with the later Actavis ruling handed down by 35 the ECJ on December 13, 2013, wherein the ECJ court specifies when only one SPC per patent can be granted under the circumstances of this case. 6

Genzyme Biosurgery v. NLOC [Annex A6.I.]. Sanofi v. Teva [Annex A6.V.]. 8 Teva v. Sanofi [Annex A6.X.]. 9 CJEU Georgetown University v. Comptroller General Patents, Designs and Trademarks, C-422/10 [Annex A1.XIV.]. 7

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This decision hence has the object of preventing a proprietor to obtain separate SPCs for a product with a compound A and a product containing compound A and B. The reasoning being that the SPC for A alone provides SPC (on the same basic patent) protection for the actual invention protected by the basic patent whereas compound B is not protected as such by the basic patent and hence should not provide a further option for additional protection for the basic patent. Although the appeal court in the Netherlands reached the same verdict as the ECJ Actavis10 case, it is an interesting discussion whether the recent Eli Lilly ruling would now give support regarding an SPC for a combination product where one of the compounds is only described functionally, i. e. as diuretic, as the summary proceedings court in The Netherlands found. Applying the Eli Lilly11 ruling, the question arises as to whether the skilled person would, implicitly but necessarily and specifically, understand that the term diuretic relates to the active ingredient (HCTZ) in question. The consequences of the wording “where the active ingredient is covered by a functional formula in the claims of a patent” and how this relates to the interpretation in the Actavis ruling of the same date is thus likely to lead to more challenges in the patent courts. A further referral to the ECJ, also important in this discussion, is the case of Georgetown II12. This case concerns several SPCs relying on one basic patent. Five questions have been referred to the court of which the first question relates to the situation wherein the basic patent protects several products based on active ingredients separately or combinations thereof. Also in this case, the referring court wanted to know whether or not Article 3(c) of the SPC Regulation precludes the patentee from being granted SPCs for each of the protected products. The ECJ answered that where the patentee for a product consisting of a combination of several active ingredients has already obtained a supplementary protection certificate for that combination of active ingredients, Article 3(c) of the SPC Regulation does not preclude the proprietor from also obtaining a supplementary protection certificate for one of those active ingredients which, individually, is also protected as such by that patent. This ruling hence allows for mono products and combination products protected by one basic patent to obtain an SPC each. The requirement being that the active ingredients are protected separately and in combination by the basic patent. This ruling would also exclude two SPCs for the earlier Dutch Teva v. Sanofi case since HCTZ is not protected separately by the basic patent but merely identified by its genus as an additional active ingredient in a dependent claim.

3. Further medical use 41

Relevant are the ECJ decisions Yissum13 and the later Neurim14 decision. According to Yissum, the term ‘product’ as used in the SPC Regulation means the active ingredient or combination of active ingredients of a medicinal product and that the concept of ‘product’ has to be interpreted strictly to mean ‘active substance’ or ‘active ingredient’, i. e. not allowing the grant of an SPC on medical uses, as such use does not reflect a ‘product’. However, the later Neurim decision did open the possibility to obtain an SPC for a further medical use. 10

CJEU Actavis v. Sanofi, C-443/12 [Annex A1.XXII.]. CJEU Eli lilly and Company Ltd. v. Human Genome Science Inc., C-493/12 [Annex A1.XXVI.]. CJEU Georgetown University v. Octrooicentrum Nederland, C-484/12 [Annex A1.XXVII]. 13 CJEU Yissum Research and Development Company v. Comptroller-General of Patents, C-202/05 [Annex A1.IX.]. 14 CJEU Neurim Pharmaceuticals v. Comptroller-General of Patents, Designs and Trademarks, C-130/ 11 [Annex A1.XX.]. 11 12

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At present, NLOC has provided a first decision wherein Neurim is ignored, and Yissum is still followed. (Dutch SPC300552 case ‘Allergan’). As the product itself received a market authorization prior to January 1, 1985, Article 19 of the transitional provision EU 1798/92 (now the SPC Regulation) became relevant for the Allergan case. Article 19(1) of 1768/92 allows for a product which, on the date on which this Regulation entered into force, is protected by a valid basic patent and for which the first authorization to place it on the market as a medicinal product in the Community was obtained after 1 January 1985 to be granted a certificate. In the Synthon15 decision of the ECJ it becomes clear that products having an MA issued prior to January 1, 1985, are to be excluded from obtaining an SPC. Further, the District Court of the Hague decided in the case of SKF v. Centrafarm 16 that Regulation 1768/92 does not apply to products for which a market authorization was issued prior to January 1, 1985. Based on these two rulings, NLOC is currently of the opinion that no SPC can be granted for any product for which a market authorization was issued prior to January 1, 1985. In the Allergan case, an SPC application was filed identifying the product as a purpose limited product (i. e. including the further medical use) and relying on a basic patent protecting the further medical use and an MA for the further medical use. NLOC rejected the application for an SPC based on the further medical use since the product description did not comply with the requirements of the Yissum ruling that product means strictly ‘active substance’ or ‘active ingredient’ and that, if a basic patent protects a second medical use of an active ingredient, that use does not form an integral part of the definition of the product. The Neurim decision, of a later date than Yissum, and relevant for cases identifying the first marketing authorization for a further medical use and confirming that said authorization should be regarded as the first marketing authorization on which the application relies was evaluated as incidental and ignored by the NLOC. By NLOC’s adhering to the Yissum decision as established case law and judging the Neurim decision as incidental in the Allergen case, no SPC protection for further medical use products based on a product for which an MA has been issued prior to January 1, 1985 is available in the Netherlands. Further, the strict application of the Yissum doctrine by NLOC in the Allergen case also seems to preclude the grant of any SPC for medical use products in other cases, the active ingredients of which received a first authorization after January 1, 1985, since NLOC, referring to Yissum, prohibits to include a use in the product description in the SPC application. It is to be noted that the present situation has not been decided over in procedures other than examination by NLOC.

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IV. Rights, Limitations and Obligations Article 97 ROW indicates that Articles 64 to 69 ROW relating to a Dutch patent as 49 an object of property, apply to Dutch SPCs. Article 64(1) ROW provides for the transfer of Dutch patents and entitlement to 50 Dutch patents. More precisely the possibility of a transfer of a Dutch patent application is not mentioned. Mentioning that applications can be transferred is important since the Dutch civil code states that rights can only be transferred in case the law provides for this (BW 3:83(3)). Article 64(2) ROW however indicates that a transfer of 15 16

CJEU Synthon BV v. Merz Pharma GmbH & Co KGaA, C-195/09 [Annex A1.XI.]. SKF v. Centrafarm [Annex A6.VII.].

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an application can be en-tered into the Dutch patent register, indirectly indicating that an application can be trans-ferred. 51 The same articles apply to Dutch SPCs. Further, Article 6 of the SPC Regulation named “entitlement to a certificate”, specifies that a certificate shall be granted to the holder of the basic patent or his successor in title. In line with this article and as mentioned previously NLOC will only grant an SPC to an applicant which corresponds to the patentee of the basic patent. This implies that an SPC application cannot be transferred without transferring the basic patent simultaneously. However, after grant an SPC can be transferred separately pursuant to Article 64(1) ROW. 52 The assignment of an SPC may be entered in the patent register (Article 64(2)) and is thus not obligatory. However only after entry in the patent register will the assignment take effect vis-a`-vis third parties. The submission required for the assignment of the SPC is effected by means of a deed containing a declaration by the proprietor of the SPC that he assigns the SPC to the assignee and a declaration of the assignee that he accepts the assignment. Both parties are entitled to have the assignment entered in the register (Article 65(3) ROW). In case there are no reservations with respect to the assignment made in the deed, the reservation will be considered unrestricted (Article 65(2) ROW).

V. License 53

Article 56 ROW allows for licenses to be issued by the patentee. Following Article 5 of the SPC Regulation, a certificate shall confer the same rights as conferred by the basic patent and hence licenses can also be issued for Dutch SPCs. Unless specified in the license agreement, the license applies to all the exclusive rights (of Article 53 ROW) conferred by the SPC on its proprietor (Article 56(1) ROW). Further, a license will only have effect vis-a`-vis third parties when entered in the patent register (Article 56(2) ROW). In case there is shared ownership of a certificate and there is no agreement between the owners stating otherwise, a license can only be granted to a third party if all owners give their consent (Article 66(1) and (2) ROW).

VI. Termination and Remedies The Dutch patent register indicates the expiration date of an SPC. The date given is the last date on which the SPC is valid. 55 Regarding the calcuation of the duration of an SPC, according to the practices of NLOC, the date of issuance of a central European market authorization, and not the date of notification of the issuance of such a market authorization, is decisive. 17 56 The NLOC will enter the lapse of an SPC on own motion after the end of the maximum duration (Article 14 a of the SPC Regulation) or in case the annuity fee is not paid in time (Article 14c). With respect to surrender by the holder, (Article 14 b), NLOC will register the deed of surrender unless, by virtue of documents entered in the patent register, third parties have registered rights in the patent or have received licenses or have commenced legal proceedings concerning the patent, and these persons have not consented to the surrender (Article 5 of the SPC Regulation and Article 63 ROW). In the case of withdrawal of the Market authorization (Article 14d), NLOC will register the lapse upon request. 54

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CJEU Seattle Genetics, (referral) C-471/14 [Annex A1. XXIX.].

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In case a period (such as the 6 months period for filing an SPC application, filing a 57 response to an office action, payment of the annual fee) is missed, re-establishment of rights is possible (Article 23(1) ROW). This entails proving that despite taking all due care required by the circumstances, the applicant has not been able to observe a time limit with respect to the office. The rights will be re-established by the Office, if failure to observe the time limit pursuant to this Act has directly led to the loss of any right or means of redress. The request shall be filed as soon as possible, but in any case not more than a year after expiry of the time limit that was not observed. The omitted act has to be completed together with the request (Article 23(3) ROW). Two examples of cases which involve re-establishment of SPC rights in the Nether- 58 lands are as follows: in the first case (SPC application 300152) the request for reestablishment was filed after expiry of the 12 month period for filing a request and therewith rejected. The second case (SPC application 300394) related to a late filed application. In this second case the notification date of the issuance of the MA on September 30, 2008 was forwarded to the applicant on March 3, 2009. The application was filed on July 7, 2009 within a 6 months calculated from the mailing date. NLOC subsequently issued an office action indicating that an SPC cannot be granted since the application was filed after March 30, 2010 i. e. 6 months calculated from the issue date of the MA. After filing a request for re-establishment and arguing that one cannot be assumed to have obtained a MA without being notified about it. NLOC decided, however, that even though the applicant was notified late (i. e. March 3, 2009) about the issuance of the MA, the issue date remains to be the date of grant according to Article 7(1) of the SPC Regulation and hence the request was revoked.

VII. Court proceedings Under Dutch civil law summary proceedings (kort geding) are possible in case of in- 59 fringement of an SPC. Normally, summary proceedings are only allowed in case of urgent matters. Infringement is considered to be an urgent matter and as such the summary proceedings are available for these cases. With a summary proceedings a preliminary decision can be obtained in a relatively short time. A further advantage of the Dutch summary proceedings is that the court holds itself 60 competent to receive cases in which at least a Dutch defendant is accused of crossborder infringement and will provide a preliminary decision in case necessary (APE v. PTC18, Court of the Hague, April 23, 2013). For patent and SPC procedures in first instance it can be requested that the 61 proceedings are conducted according to the accelerated regime. 19 The request is made with the Court of the Hague prior to summoning the opposing party. The accelerated procedure can allow for a decision in first instance within a year. 18 19

APE v. PTC [Annex A6.IX.]. Mylan B.V. v. Janssen Pharmaceuticals Inc. [Annex A6.VI.].

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N. The SPC in Switzerland Literature: Bertschinger, Quasi-Verla¨ngerung des Patentschutzes: Erga¨nzende Schutzzertifikate, in: Bertschinger, Christoph/ Mu¨nch, Peter/ Geiser, Thomas (editors), Schweizerisches und europa¨isches Patentrecht, Handbu¨cher fu¨r die Anwaltspraxis, Bd. VI, Basel 2002; Calame, Erga¨nzende Schutzzertifikate fu¨r Arzneimittel: Staatsvertrag mit Liechtenstein angepasst, Urteil des EuGH vom 21. April 2005 (verbundene Rechtssachen C-207/03 und C-252/03), in: sic! 2005, p. 694 et seqq.; Friedli/Kohler, Erga¨nzende Schutzzertifikate fu¨r die Arzneimittel – Aktueller Stand der Praxis in der Schweiz, in: sic! 2011, p. 92 et seqq.; Gasser, Das erga¨nzende Schutzzertifikat, in: von Bu¨ren, Roland/ David, Lucas (editors), Schweizerisches Immater¨ , Schweizerisches ialgu¨ter- und Wettbewerbsrecht, Bd. IV, Basel 2006, p. 683 et seqq.; Heinrich, PatG/EPU Patentgesetz, Europa¨isches Patentu¨bereinkommen, Kommentar in synoptischer Darstellung, 2. ed., Bern 2010; Holzer/Scha¨rli, EuGH: Erga¨nzende Schutzzertifikate fu¨r Wirkstoffkombinationen? Urteile des EuGH vom 24. November 2011, “Medeva” (Rs. C-322/10) und “Georgetown” (Rs. C-422/10), in: sic! 2012, p. 284 et seqq.; Junod, La jurisprudence europe´enne re´cente sur le certificat comple´mentaire de protection, in: sic! 2014, p. 350 et seqq.; Pedrazzini/Hilti, Europa¨isches und schweizerisches Patent- und Patentprozessrecht ¨ 2000, der Patentgesetzrevision 2007/2008 sowie der reorganisierten (unter Beru¨cksichtigung des EPU Bundesrechtspflege), 3. ed., Bern 2008; Ritscher/Scha¨ rli, Besprechung, Kommentar von Christopher Bru¨ckner, Erga¨nzende Schutzzertifikate – mit pa¨diatrischer Laufzeitverla¨ngerung, in: sic! 2012, p. 595 et seq.; Scha¨rli, Das erga¨nzende Schutzzertifikat fu¨r Arzneimittel, Diss., Zurich 2013; Stieger, Anmerkungen zum Urteil des BGer vom 29. April 2008, No. 4a_52/2008, “Alendronsa¨ure II”, in: sic! 2008, p. 643 et seqq.1 Content I. Sources of Law and Legislative History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1. Patent Law . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2. Pharmaceutical Law. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3. Legislative History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II. Substantive Granting Prerequisites . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1. Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2. The Term “Product”. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . a) General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . b) Derivatives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . c) New Dosages and Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3. Protection by a Basic Patent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . a) General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . b) Patent for Combination Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4. First MA of the Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . a) General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . b) MA for Combination Products. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5. First SPC for the Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6. Time Limit for Filing the Application. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III. Application, Examination, Grant, and Remedies. . . . . . . . . . . . . . . . . . . . . . . . . . . 1. Application and Fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2. Examination and Announcement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . a) Entrance Examination. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . b) Technical Examination. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3. Grant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4. Remedies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV. Subject-Matter of Protection and Effects. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1. Subject-Matter of Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2. Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . V. Term of Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1. General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2. Paediatric Extension . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VI. Premature Lapse and Suspension. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VII. Nullity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VIII. Swiss Federal Patent Court. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

1 1 6 8 11 11 14 14 17 19 23 23 25 28 28 36 39 44 46 46 49 49 51 54 56 58 58 63 66 66 68 71 73 77

The author thanks Celine Herrmann, MLaw for her valuable assistance for this publication.

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I. Sources of Law and Legislative History 1. Patent Law Switzerland is a member of the European Patent Convention (“EPC”)2 and of the Patent Cooperation Treaty (“PCT”)3. Swiss patents are governed by the Patents Act (“PatA”)4 and the Patent Ordinance (“PatO”)5. Additionally, the Swiss Federal Institute of Intellectual Property (“Institute”) has issued Guidelines for the examination of national patent applications (“Guidelines of the Institute”)6. Most of the Swiss provisions are identical to the ones contained in the EPC. For that reason, differences will be the focus in this part. Switzerland and Liechtenstein form a unified territory for patent protection purposes and have the same patent regulations based on a bilateral patent treaty 7. A Swiss patent or SPC is valid in Liechtenstein also. The designation of one country includes the other country as well; they cannot be designated separately. Patent applications in Switzerland are subject to limited examination only. The Institute does not examine novelty and inventive step as part of the national examination process8. Switzerland can, however, be designated in a European patent application. Since European patent applications are examined for novelty and inventive step, that procedure will lead to a fully examined patent in Switzerland. The official languages of the Institute are German, French and Italian. The substantive examination of a patent usually takes place three to four years after an application for a patent has been filed. An expedited procedure is available for those who wish to have their patent granted more quickly9. In Switzerland, the SPC is governed by Articles 140 a – 140 m, 146 and 147 PatA. The implementing provisions are stipulated in Art. 127 a – 127 n PatO. Additionally, the Institute has published important Guidelines so as to maintain a standardized exam practice. The Guidelines are legally binding for the Institute only 10.

1

2

3

4

5

2. Pharmaceutical Law The national marketing authorization procedure is mainly governed by the Ther- 6 apeutic Products Act (“TPA”)11 and the Medicinal Products Ordinance (“OMP”)12 and based on these requirements, an approval to place medicinal products on the market 2 Convention on the Grant of European Patents signed in Munich on 5 October 1973 (EPC; SR 0.232.142.2). 3 Patent Cooperation Treaty signed in Washington on 19 June 1970 (PCT; SR 0.232.141.1). 4 Federal Act on Patents for Inventions of 25 June 1954 (PatA; SR 232.14). 5 Federal Ordinance on Patents for Inventions of 19 October 1977 (PatO; SR 232.141). 6 Guidelines for the examination of national patent applications from the Swiss Federal Institute of Intellectual Property of 1 July 2011 (see unofficial English translation in Appendix “Selected Legal Sources in Switzerland”), available under: (last visited: 3 January 2015). 7 Supplementary Agreement between the Swiss Confederation and the Principality of Liechtenstein to the Agreement of 22 December 1978 concerning the protection of patents (Patent Protection Treaty; SR 0.232.149.514.0). 8 Art. 59, para. 4 PatA. 9 Art. 63 PatO. 10 Guidelines of the Institute, § 13, p. 106 et seqq. 11 Federal Act on Medicinal Products and Medical Devices of 15 December 2000 (TPA; SR 812.21). 12 Federal Ordinance on Medicinal Products of 17 October 2001 (OMP; SR 812.212.21).

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will be issued13. The Swiss Agency for Therapeutic Products (“Swissmedic”) is the Swiss authority responsible for the authorization and supervision of medicinal products. 7 The medicinal products may be placed on the market only if their quality, safety and effectiveness are sufficiently evaluated and proven14. If the prerequisites are fulfilled, Swissmedic will grant the marketing authorization (“MA”), specify the authorized method of sale and approve the information for healthcare professionals and the patient information.

3. Legislative History Based on the legislative support of the pharmaceutical industry in the United States, Japan, and the European Economic Area (“EEA”), Switzerland has decided to introduce the SPC in order to avoid an economic disadvantage of an important industry. The Swiss legislature decided to adopt the same substantive solution as was chosen in the European Community (“EC”)15. On 1 September 1995, the new Articles 140 a – 140 m, 146 and 147 PatA concerning the SPC came into force16. 9 In order to remain competitive in the field of plant protection and to be consistent with the provisions of the European Union (“EU”), the Swiss legislature decided also to introduce the SPC for plant protection products as well. The new Art. 140 n PatA was created with a focus on harmonizing it with the corresponding RegSPC-Plant Protection Products17. At the same time, Switzerland implemented the existing SPC case law. On 1 May 199918, the revised or newly created Articles 140 a, 140 c para. 2 and 3, 140 k para. 1 lit. a, 140 n, 146 and 147 PatA came into force 19. 10 Since the establishment of the SPC, Switzerland has been seeking legal harmonization with the EU20. In 2010, the Federal Administrative Court held in the Etanercept decision that a Swiss legal provision that has been copied from European law on purpose should be interpreted in conformity with European law, subject to Swiss methodology21. 8

II. Substantive Granting Prerequisites 1. Overview 11

The Institute grants an SPC upon application for an active ingredient or the combination of active ingredients (“product”) of medicinal products or plant protection products22. The substantive prerequisites for an SPC in Switzerland are as follows: (i) the product must be protected by a basic patent23; (ii) a valid Swiss MA must have been issued for the product24; 13

Art. 9 TPA. Art. 1 TPA. 15 Message PatA 1993, p. 711 et seq. 16 AS 1995, 2879 et seqq. 17 Message PatA 1998, p. 1636 et seqq. 18 AS 1999, 1363 et seqq. 19 Cf. Gasser, p. 689 et seq. 20 Scha ¨ rli, mn. 433. Nonetheless, there are substantive differences or ambiguities: e. g. paragraph 19 et seqq. (term “product”); paragraph 25 et seqq. (infringement test); paragraph 28 et seqq. (Swiss MA); paragraphs 26, 39, and 43 (number of SPCs per basic patent). 21 Decision of the Federal Administrative Court of 13 September 2010, BVGE 2010/48, “Etanercept”, consid. 3, published in sic! 2010, p. 113 et seqq [Annex A7.III]. 22 Art. 140 a and 140 n PatA. With regard to plant protection products the Articles 140 a para. 2 to 140 m apply by analogy. 23 Art. 140 b para. 1 lit. a PatA. 24 Art. 140 b para. 1 lit. b PatA. 14

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(iii) the authorization must be the first MA for this product as a medicinal product 25; (iv) an SPC has not yet been issued for this product26. In principle, the substantive prerequisites in Switzerland correspond to the prerequi- 12 sites in the RegSPC27. Therefore, the differences will be the main focus of this part. According to the Panitumumab decision of the Swiss Federal Administrative Court of 13 18 August 2011, the fundamental idea of the SPC – compensating at least partially for the disadvantages resulting from the long MA procedure – should always be accommodated in the interpretation of the SPC regime28.

2. The Term “Product” a) General. The “product” is defined as an active ingredient or a combination of 14 active ingredients of medicinal products29. The term “product” is not to be interpreted as the pharmaceutical speciality that is authorized, but rather as the active ingredient or the combination of active ingredients that is used in such a medicinal product30. In order to obtain an alignment with the case law of the CJEU31, it is planned that the 15 term “combination of active ingredients” will be specified in a new third paragraph of Art. 140 a PatA in the course of the current revision of the TPA. The new Art. 140 a para 3 PatA is expected to read as follows: “A combination of active ingredients is a combination of several substances, all of which have a therapeutic effect on the organism” (unofficial translation)32. In order to prevent uncertainties with regard to the product, the designation in the 16 SPC application must be unambiguous. It must include the chemical substance or substances in accordance with the official registration certificate only. Pursuant to the Guidelines of the Institute, the following designations are possible: The systematic chemical name (e. g. from CAS or IUPAC), the International Non-proprietary Name (INN also abbreviated as DCI), the designation on the registration certificate, the entry in the Index Nominum or the designation on the list of pharmaceutical substances. According to the Guidelines, the Institute does not accept ambiguous designations and trademark names because the latter designate a pharmaceutical speciality and not the active ingredient or the combination of active ingredients. Furthermore, designations of the medicinal product are not permitted either33. b) Derivatives. Derivatives of the active ingredient, in particular salt forms and ester, 17 are generally treated in Switzerland as products that are identical to the active ingredient. These forms of the active ingredient serve the purpose of handling the active ingredient in the production, processing, administration or the stabilization of the active ingredient 34. 25

140 b para. 2 PatA. 140 c para. 2 PatA. 27 Gasser, p. 695 et seqq.; Scha ¨ rli, mn. 195 et seqq. 28 Decision of 18 August 2011 of the Swiss Federal Administrative Court, No. B-3245/2010, “Panitumumab”, consid. 2.1, published in sic! 2012, p. 48 et seqq. [Annex A7.I.]; decision of the Federal Appeal Commission for Intellectual Property of 30 April 1999, No. PA 03/97, “Ciclosporin”, consid. 4, published in sic! 1999, p. 449 et seqq [Annex A7.IX.]. 29 Art. 140 a para. 2 PatA. 30 Message PatA 1993, p. 729; Friedli/Kohler, p. 93. 31 Judgement of the CJEU of 4 May 2006, Massachusetts Institute of Technology, C-431/04 [Annex A1.VII.]; confirmed in the order of the CJEU of 14 November 2013, Glaxosmithkline Biologicals SA v Comptroller General of Patents, Designs and Trade Marks, C-210/13 [Annex A1.XXV.]. 32 Friedli/Kohler, p. 96; Scha ¨ rli, mn. 87 et seqq., 174 et seqq., and 433. 33 Guidelines of the Institute, § 13.1, p. 106. 34 Guidelines of the Institute, § 13.1, p. 106 et seq.; Scha ¨ rli, mn. 100 et seq. 26

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An active ingredient and a derivate of that substance may, however, on an exceptional basis be viewed as different products if the derivate creates another pharmacological effect than the active ingredient itself. In this situation, the derivative may constitute a new patentable active ingredient 35.

c) New Dosages and Indications. Since the SPC is not granted for the pharmaceutical speciality, varying doses or new indications of an already known active ingredient generally cannot serve as a basis for a new SPC. Consequently, new dosages and indications of an already known active ingredient normally do not lead to a new product in Switzerland36. 20 The former Federal Appeal Commission for Intellectual Property held in the Differin Gel decision of 21 January 2005 that the terms “first MA” (in the sense of Art. 140 f PatA) and “admission” (in the sense of Art. 12 OMP) must be distinguished. Whereas Art. 12 OMP stipulates that a new admission is required in cases of “considerable modifications”, which includes not only the modification of the active ingredients, but also the modification of the pharmaceutical form of the medicinal product, an MA in the sense of Art. 140 a PatA refers to the active ingredient(s) of the product exclusively. Therefore, the Court held that every modification of the pharmaceutical form of a medicinal product will require a new authorization to place the product on the market, which is, however, not to be considered a “first MA” in the sense of Art. 140 b para. 2 PatA37. 21 In Switzerland however, the mere existence of identical active ingredients does not necessarily mean that they constitute the same product in the sense of the SPC regime (Art. 140 b para. 2 PatA; first MA for the product). If, based on an already known product, a new invention is made (e. g. a new indication38 or a more effective dose39), and if there is a patent claim for this new invention, this new invention may constitute the basis for a new, independent product, for which another SPC can be granted 40. This does not result in one applicant being granted several SPCs for the same product. The consequence is rather that one compound can be divided into several products in the sense of the SPC regulation. 22 In Neurim the CJEU considered that it may be possible for an SPC to be granted for an authorized indication (indication Y) of a known active ingredient based on a patent 19

Guidelines of the Institute, § 13.1, p. 106 et seq.; Friedli/Kohler, p. 94; Scha¨ rli, mn. 102, 189. Guidelines of the Institute, § 13.1, p. 107; Friedli/Kohler, p. 93; Scha¨rli, mn. 112. 37 Decision of the former Federal Appeal Commission for Intellectual Property of 21 January 2005, No. PA02/03, “Differin Gel”, consid. 3, published in sic! 2005, p. 590 et seqq [Annex A7.VIII.]. 38 Decision of the former Federal Appeal Commission for Intellectual Property of 30 April 1999, No. PA03/97, “Ciclosporin”, consid. 4, published in sic! 1999, p. 449 et seqq. [Annex A7.IX.], where the former authority held that the terms “active ingredient” and “combination of active ingredients” require a differentiated interpretation. In the pharmaceutical field, the mere existence of the same active ingredients does not necessarily mean that it is the same product. Rather, the specific combination of the active ingredient is decisive with regard to the grant of an SPC. Further, the former authority ruled that the Institute is to act on the assumption of the validity of the specified basic patent during the examination procedure. Thus, the former authority reached the conclusion that in case of a product patent, the Institute is to act on the assumption that it contains a new product. 39 Decision of the Federal Supreme Court of 17 November 1998, No. 4A.7/1998, “Arzneimittel”, consid. 3, published in sic! 1999, p. 153 et seqq. [Annex A7.VI.], where the Court stipulated that the term “combination of active ingredients” is to be construed in a differentiated way and cannot be considered in a schematic way. The mere existence of the same active ingredients does not necessarily lead to the products being the same one. A new combination of active ingredients differing from an already earlier patented and as a medicinal product authorized product only in its dosage can therefore constitute an independent product in the sense of the SPC regime. Furthermore, the Court held that the Institute has to act on the assumption of the validity of the specified basic patent during the examination procedure as long as there is no civil judgment declaring it invalid. 40 Guidelines of the Institute, § 13.1, p. 107; Friedli/Kohler, p. 93 et seq.; Scha ¨ rli, mn. 112 et seqq. 35 36

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limited to indication Y, even if an MA has already been granted for the active ingredient for an earlier indication (indication X). The CJEU considered that, in such a situation, only the MA for Y would be considered the first MA for that product41. Hence, in order to overcome objections regarding the first MA for the product, applicants have the possibility to restrict the scope of protection of the basic patent, so that the subject matter of the earlier MA is excluded42.

3. Protection by a Basic Patent a) General. The SPC is granted if, at the time of the application, the product as such, 23 a process for manufacturing it or a use of it is protected by the basic patent 43. Under current law it is not necessary that the product is mentioned specifically in a patent claim or in the description. The product must, however, clearly fall within the scope of protection of a patent claim, e. g. by means of a Markush formula or of a definition of its properties44. According to the Guidelines of the Institute, merely mentioning the product in the description (e. g. as additional information) is not sufficient. If the product is mentioned in the description of the function of a patent claim only45, this is not sufficient either because the active ingredient itself is not protected 46. The basic patent can be either a Swiss or a European patent designating Switzerland. 24 Further, the basic patent must be in force at the time of the SPC application 47. b) Patent for Combination Products. The Swiss and European granting practice for 25 combination products diverge on the question whether a product, for which an SPC has been applied for, is protected by a basic patent. Currently, Switzerland still uses the so called infringement test48. Based on this test, it must be examined whether the product would fall within the scope of protection of the basic patent regarded as a fictitious infringement matter. This has the far reaching consequence, as shown hereinafter, that in certain situations different SPCs may be granted for the same basic patent in Switzerland and in the EU49.

41 Judgment of the CJEU of 19 July 2012, Neurim Pharmaceuticals (1991) Ltd v Comptroller-General of Patents, C-130/11 [Annex A1.XX.]. 42 Example: Patent: “A for indication Y”; earlier MA: “A for indication X”; later MA: “A for indication Y”. The first MA which is within the scope of protection of the basic patent is the first MA. In this example, the first MA is the later MA “A for indication Y”. However, this has only effects for patents which are not directed to the compound per se. 43 Art. 140 b para. 1 lit. a PatA. 44 Cf. Heinrich, Art. 140 b mn. 1 et seq. 45 The Institute provides the following example: “disposable syringe for the administration of the active ingredient B”. 46 Guidelines of the Institute, § 13.2.1, p. 107. 47 Art. 140 b para. 1 lit. a i. c. w. Art. 110 PatA/Art. 2 para. 2 EPC; Guidelines of the Institute, § 13.2.1, p. 107. 48 The Institute is currently considering a change in practice by going away from the infringement test to a wide patent claim-related interpretation pursuant to the new case law of the CJEU. However, even after the judgement of the CJEU of 12 December 2013, Eli Lilly and Company Ltd v Human Genome Sciences Inc., C-493/12 [Annex A1.XXVI.], it is still not clear what “the claims relate, implicitly but necessarily and specifically, to the active ingredient in question” exactly means. A Markush formula is admissible in the claims. Functional claims are admissible in principle; however, according to the CJEU this has to be decided in accordance with Art. 69 EPC and the protocol on the interpretation of that provision. Putting the onus on the national courts is unlikely to lead to consistent decisions across the EU. In the judgement of the CJEU of 12 December 2013, Actavis v Sanofi, C-443/12 [Annex A1.XXII.], the question regarding the wording of the claims (diuretic drug) has not been answered. 49 Holzer/Scha ¨ rli, p. 284 et seqq.; Scha¨rli, mn. 218 et seqq.

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Decision

Patent

MA

SPC

Medeva et al.50 (CJEU)

A+B

A+B+C

SPC for A + B No SPC for A and/or B No SPC for A + B + C

Fosinopril

A

A+B

SPC for A + B (6¼ CJEU)

Panitumumab

A+B

A

No SPC for A (= CJEU)

On 10 July 1998, the Federal Supreme Court decided in Fosinopril that an SPC may be granted for a combination of active ingredients even if only one of the active ingredients is protected by the patent claims51. Furthermore, the Court held that if an SPC has already been granted for a single active ingredient (the Mono SPC), this does not preclude the grant of an SPC for the combination of said active ingredient with another active ingredient (the Combo SPC) if the other requirements are fulfilled, even if both products are based on the same basic patent52. 27 In the Panitumumab decision of the Swiss Federal Administrative Court of 18 August 2011, the patentee applied for an SPC for its product Panitumumab based on its patent on therapeutic combinations of a monoclonal antibody against the human receptor for epidermal growing factor with antineoplastic agents. The Institute rejected the SPC application, arguing that the product “Panitumumab” differed from the basic patent, which claimed a combination of a monoclonal antibody (such as Panitumumab) with an antineoplastic active ingredient, and thus, the application of the patentee would not meet the requirements of Art. 140 b para. 1 lit. a PatA. The patentee appealed the decision of the Institute with the Swiss Federal Administrative Court, which rejected the appeal, arguing that if the key aspect of an invention is the combination of various compounds, an individual compound does not constitute an embodiment of the invention. Further, the Court stated that every additional element which is important for the patented invention limits the scope of protection of the basic patent 53. 26

4. First MA of the Product 28

a) General. The SPC is granted if, at the time of the application, an official MA has been granted for placing the product on the market in Switzerland as a medicinal product54. The SPC is granted based on the first authorization only55. 50 Judgment of the CJEU of 24 November 2011, Medeva BV v Comptroller General of Patents, Designs and Trade Marks, C-322/10 [Annex A1.XIII.]. 51 Decision of the Federal Supreme Court of 10 July 1998, BGE 124 III 375 et seqq., “Fosinopril”, consid. 2, published in sic! 1998, p. 594 et seqq [Annex A7.VII.]. 52 Decision of the Federal Supreme Court of 10 July 1998, BGE 124 III 375 et seqq., “Fosinopril”, consid. 4, published in sic! 1998, p. 594 et seqq. [Annex A7.VII.]; see divergent judgement of the CJEU of 12 December 2013, Actavis v Sanofi, C-443/12 [Annex A1.XXII.], where the CJEU held that an SPC for A + B was not possible based on the same basic patent as was used for the SPC for A. The Institute intends to implement the judgement of the CJEU of 12 December 2013, Actavis v Sanofi, C-443/12 [Annex A1.XXII.] in Switzerland; accordingly, the Mono SPC would exclude another Combo SPC, which is also covered by the scope of protection of the Mono SPC, as far as the active ingredients used do not have their own inventive qualities. Cf. also paragraph 43 and footnote 290. 53 Decision of 18 August 2011 of the Swiss Federal Administrative Court, No. B-3245/2010, “Panitumumab”, consid. 5.1–5.3 and consid. 6, published in sic! 2012, p. 48 et seqq [Annex A7.I.]. 54 Art. 140 b para. 1 lit. b PatA. 55 Art. 140 b para. 2 PatA.

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Since Switzerland is neither a member of the EU nor of the EEA, it does not acknowledge MAs that are granted in the EU or in the EEA. The Guidelines of the Institute therefore set forth that the copy of the first MA, which must be enclosed with the application for the SPC, must be the first MA of the product in Switzerland. The document submitted to the Institute does not need to be a copy of the actual registration certificate, it is sufficient to enclose a copy of a public announcement with the same content, e. g. of the Swissmedic Journal. The MA must still be in force at the time of the SPC application and an SPC cannot be granted if the relevant MA has been renounced or if the MA applies to “export” only (so-called “export specialty”)56. Since Liechtenstein is a member of the EEA and since it automatically accepts Swiss MAs (in principle), the CJEU has held in several decisions that a Swiss MA triggers the deadline for the SPC application in the EEA as well57. However, in reaction to these decisions of the CJEU, Switzerland and Liechtenstein entered into an agreement on 1 July 2005 which delays the automatic effect of Swiss MAs in Liechtenstein for NCEs. This agreement has been extended several times and it is still in force 58. The automatic recognition of Swiss MAs in Liechtenstein is delayed by a period of 12 months according to the wording of the agreement. However, an earlier or later recognition, regularly until the grant of an MA for the same NCE in the EEA, reflects the praxis of the office of public health in Liechtenstein59. Nonetheless, there is still a potential risk that an already known active ingredient is regarded as a new product in the sense of the SPC regime (e. g. a new indication of an already known active ingredient60) and that the effects of this new product cannot be delayed with Liechtenstein’s NCE negative-list because the new product is no NCE. 61 The MAs are granted by the following authorities in Switzerland: Human and veterinary medicines (apart from immunobiological preparations for animals)

Swiss Agency for Therapeutic Products (Swissmedic)62

Immunobiological preparations for animals

Federal Veterinary Office63

Plant protection products

Federal Office for Agriculture 64

Guidelines of the Institute, § 13.2.2, p. 108. Judgment of the CJEU of 21 April 2005, Novartis AG, University College London and Institute of Microbiology and Epidemiology v Comptroller-General of Patents, Designs and Trade Marks for the United Kingdom, C-207/03 and Ministre de l’E´conomie v Millennium Pharmaceuticals Inc., C-252/03 [Annex A1.VI.]; Order of the CJEU of 14 November 2013, AstraZeneca AB v Comptroller General of Patents, Designs and Trade Marks, C-617/12 [Annex A1.XXIII.]. 58 Cf. Supplementary Agreement of 21 May 2012 (SR 0.812.101.951.41). 59 Scha ¨ rli, mn. 287 et seqq.; This practice was confirmed orally by the office of public health in Lichtenstein and is consistent with the NCE negative-list. 60 See Judgment of the CJEU of 19 July 2012, Neurim Pharmaceuticals (1991) Ltd v ComptrollerGeneral of Patents, C-130/11 [Annex A1.XX.]. 61 In order to avoid unpleasant surprises, it is advisable to clarify this issue in advance with Liechtenstein’s authorities. 62 The webpage is available under: (last visited: 3 January 2015). 63 The webpage is available under: (last visited: 3 January 2015). 64 The webpage is available under: (last visited: 3 January 2015). 56 57

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29

30

31

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The Guidelines of the Institute stipulate that the relevant MA is the first MA in the entire field of human and veterinary medicine, or of plant protection products, respectively. MAs of new indications, modified pharmaceutical forms or new formulations of already known products are usually not considered to be first MAs, provided that they do not concern a new product. The decisive factor in this respect is the definition of the term “product”65. 34 The Institute examines the MA and makes inquiries with the relevant authority, in particular if the active ingredients are not designated as NAS or NCE. The Institute considers both registered medicines and medicines that are not registered anymore 66. 35 According to the Etanercept decision of the Swiss Federal Administrative Court of 19 September 2010, it is the owner of the basic patent who is entitled to an SPC and not the one who obtained the MA and has borne the costs in that respect 67. 33

36

b) MA for Combination Products. With regard to an SPC application for an active ingredient or a combination of ingredients, the MA to be filed may contain either that active ingredient or combination of ingredients only or other active ingredients in addition68. The Guidelines of the Institute stipulate the following: SPC application

Patent

MA

SPC for

A

A

A+B

A

A

A

A + B (earlier) A (later)

A (based on the MA for A)

If there is an SPC application and a basic patent for an active ingredient A, but an MA for several active ingredients only (e. g. A + B), an SPC can be granted for the active ingredient A69. 38 If there is an SPC application for an active ingredient A, and if – apart from the MA for A – there are other MAs for A as a component of a combination of active ingredients (e. g. A + B), the Guidelines of the Institute stipulate that in this situation, the relevant MA is the one for A as the sole active ingredient, even if the MA for the combination of active ingredients is older70. 37

5. First SPC for the Product 39

Art. 140 c para. 2 PatA stipulates that only one SPC shall be granted for each product. However, in the event that two or more proprietors of a patent file applications for the same product based on different patents and no SPC has been granted yet, Art. 140 c para. 3 PatA sets forth that an SPC may be granted to each applicant. Art. 140 c para. 2 PatA is to be understood as meaning that an SPC may only be granted once per product and applicant71. 65

For the term “product” see above paragraph 19 et seqq. Guidelines of the Institute, § 13.2.2, p. 108. 67 Decision of 19 September 2010 of the Swiss Federal Administrative Court, No. BVGE 2010/48, “Etanercept”, consid. 5.4, published in sic! 2011, 113 et seqq.; Heinrich, Art. 140 c mn. 1 et seq [Annex A7.III.]. 68 Cf. Scha ¨ rli, mn. 271 et seqq. 69 Guidelines of the Institute, § 13.2.2, p. 109. 70 Guidelines of the Institute, § 13.2.2, p. 109. 71 Cf. judgements of the CJEU of 12 December 2013, Eli Lilly and Company Ltd v Human Genome Sciences Inc., C-493/12 [Annex A1.XXVI.], Actavis v Sanofi, C-443/12 [Annex A1.XXII.], and Georgetown 66

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Several SPCs can be granted for one product if the applications are based upon 40 different patents belonging to various proprietors. However, pursuant to Art. 140 c para. 3 PatA, the earlier application or applications must still be pending at the time of the filing of the application. As a consequence, the Institute always awaits the expiry of the time limit of six months before granting an SPC72. The condition stated in Art. 140 c para. 3 PatA, requiring that “no SPC has been granted”, refers to the same applicant only. Therefore, the prohibition only refers to the grant of another SPC for the same product on the basis of another basic patent to an applicant who has already obtained an SPC for the product in question73. However, it is possible that a patent is granted to the patentee after the first MA has 41 been granted. The Swiss Federal Administrative Court ruled in the Etanercept decision that if the patentee files an SPC application within six months of the grant of the patent,74 an SPC will be granted to said patentee even if an SPC has already been granted to one or more patentees for the same product at the time of the SPC application75. Furthermore, the Court held that the grant of an SPC can be refused so as to avoid abuses of rights, for instance if an applicant delays the first MA or the grant of his patent with the sole intention of obtaining a longer commercial life according to Art. 140 f para. 1 lit. b PatA, if he delays the grant procedure on purpose or if he tries to obtain an additional SPC by fraud through a front man76. As a consequence of Art. 140 c PatA, a patentee submitting several SPC applications for 42 the same product based on different patents must select one of these applications during the examination procedure77. The Federal Administrative Court held in the Exenatide decision that the application procedure is generally to be conducted in an expeditious and rather suspension-adverse way, not only in the interest of the applicant, but also in the interest of third parties78. Further, the Court held that the interests of manufacturers of generics were met not only by restricting the scope of protection of the SPCs, but also by providing that a decision concerning the SPC is to be made as early as possible79. Hence, the Institute will not grant a request by the applicant to suspend the examination procedure in order to gain time for the selection of the application 80. University, C-484/12 [Annex A1.XXVII.], where the CJEU held that principally several SPCs can be granted to the holder of one basic patent if that patent covers several products In the light of Actavis v Sanofi, C443/12 [Annex A1.XXII.] it is advisable to claim a new active ingredient (A) or its combination with other substances (e. g. A + B), respectively, in two different patents. At this stage, however, it is unclear whether a divisional patent or an application pursuant to Art. 54 para. 3 EPC is sufficient. If the first SPC is directed to the combination, a second SPC directed to the single compound can be granted, pursuant to Georgetown University, C-484/12 [Annex A1.XXVII.]. For the deviations in Switzerland see footnote 271. 72 The application for the grant of an SPC must be filed within six months of the first MA in Switzerland pursuant to Art. 140 f para. 1 lit. a PatA. 73 Scha ¨ rli, mn. 305 et seqq. 74 Art. 140 f para. 1 lit. b PatA. 75 Decision of 19 September 2010 of the Swiss Federal Administrative Court, No. BVGE 2010/48, “Etanercept”, consid. 8.1, published in sic! 2011, 113 et seqq [Annex A7.III]. This resolves the conflict between the wording of Art. 140 c para. 3 and that of Art. 140 f para. 1 lit. b of the PatA. 76 Decision of 19 September 2010 of the Swiss Federal Administrative Court, No. BVGE 2010/48, “Etanercept”, consid. 8.2, published in sic! 2011, 113 et seqq [Annex A7.III]. With regard to fraud through a front man, see Scha¨rli, mn. 316 et seqq. 77 In practice, however, this requirement does not always work properly. 78 Decision of 20 October 2010 of the Federal Administrative Court, No. B-1019/2010, “Exenatide”, consid. 4.2, published in sic! 2011, p. 249 et seqq [Annex A7.II.]. 79 Decision of 20 October 2010 of the Federal Administrative Court, No. B-1019/2010, “Exenatide”, consid. 4.3, published in sic! 2011, p. 249 et seqq. [Annex A7.II.]; see also decision of 19 September 2010 of the Swiss Federal Administrative Court, No. BVGE 2010/48, “Etanercept”, consid. 5.3 and 6.1, published in sic! 2011, 113 et seqq [Annex A7.III.]. 80 Guidelines of the Institute, § 13.2.4, p. 109.

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The Guidelines of the Institute stipulate that if an SPC has been granted for an active ingredient A, another SPC can be granted for a combination of active ingredients containing A, because the latter constitutes another product. According to the Institute, the same applies if the order is reversed, even if the basic patent is the same 81.

6. Time Limit for Filing the Application The application for the grant of an SPC must be filed within six months of the first MA in Switzerland or within six months of the grant of the basic patent if the patent was granted later than the first MA. In the event that the time limit is not met, the Institute rejects the SPC application82. 45 In order to ensure an optimal SPC protection, a close coordination and cooperation between the patent- and MA-departments of a company is crucial. The patent-portfolio and the MAs of competitors need to be considered with the utmost care. 44

III. Application, Examination, Grant, and Remedies 1. Application and Fees The SPC application must contain the following information: a) the request for the grant of the SPC83; b) a copy of the first MA in Switzerland84; c) a copy of the medicinal information which has been approved by Swissmedic85. 47 The request for the grant of an SPC must contain the following information: a) the name or business name and address of the applicant and, if applicable, the address for service in Switzerland; b) if the applicant has appointed a representative in Switzerland, its name, address and, if applicable, the address for service in Switzerland; c) the number of the basic patent; d) the title of the invention protected by the basic patent; e) the date of the first MA in Switzerland; f) an identification of the product indicated by the authorization and its registration number86. 48 As of January 2014, the fees for an SPC amount to CHF 2’500 for the registration and annual renewal fees are assessed beginning from the 1st year after filing, starting at CHF 950 and increasing annually by CHF 50. The annual fees must be paid in advance in one single payment for the full term of the SPC87. 46

81 Guidelines of the Institute, § 13.2.4, p. 110. With regard to the permissible number of SPCs per basic patent, see footnotes 271 and 290. 82 Art. 140 f PatA. Cf. decision of the Federal Appeal Commission for Intellectual Property of 21 January 2005, No. PA 02/03, “Differin Gel”, consid. 2, published in sic! 2005, p. 590 et seqq. [Annex A7.VIII.]. 83 The application form is available under: (last visited: 3 January 2015). 84 Cf. paragraph 29. 85 Art. 127 b PatO. 86 Art. 127 c PatO. 87 Fees of the Swiss Federal Institute of Intellectual Property of 28 April 1997 (SR 232.148; IGE-GebO); Art. 140 h para. 2 PatA.

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SPC Age

1

2

3

4

5

CHF 2’500 (registration fee)

CHF 950

CHF 1’000

CHF 1’050

CHF 1’100

CHF 1’150

2. Examination and Announcement a) Entrance Examination. After receipt of the SPC application, the Institute performs 49 an initial “entrance” examination to determine whether the application is within the time limit for the filing88 and whether the application contains all the necessary information pursuant to Art. 127 b and 127 c PatO. If the application does not fulfil the requirements, the Institute sets a time limit of two months for the completion of the application by the applicant. If this deadline is not met, the Institute rejects the application 89. After a successful initial examination, the Institute publishes a reference for the SPC 50 application, containing the information mentioned in Art. 127 d para. 2 PatO, in the IP rights database “Swissreg”90. b) Technical Examination. In a second “technical” examination, the Institute as- 51 sesses whether the prerequisites for the grant of an SPC are fulfilled 91. If one of the prerequisites is not fulfilled, the Institute issues a technical objection, in which case the applicant is informed about the relevant issue92. At the same time, the applicant is given the opportunity to substantiate why the prerequisites for the grant of the SPC are fulfilled, contrary to the opinion of the Institute. Pursuant to the Guidelines of the Institute, minor modifications can be settled on the phone93. The Institute grants a time limit of three months for the applicant to file his 52 statement. In the event that the deadline is not met or that the reasons provided by the applicant are not sufficient, the Institute will decide upon the further course of action, i. e. usually on the rejection or the dismissal of the application. However, the applicant must always have had the possibility to make a statement. In exceptional cases, a second objection with a shorter time limit of two months is possible 94. In analogy to the substantive examination of patent applications, the time limits for 53 the statements of the applicant can be extended95.

3. Grant If the prerequisites for the grant of an SPC are fulfilled96, the Institute grants the SPC 54 by entering it in the patent register97. The grant of the SPC is published with the following information: a) the number of the basic patent tagged with a supplement; b) the name or business name and address of the owner of the SPC; 88

Cf. paragraph 44. Art. 127 e PatO. 90 The register is available under: (last visited: 3 January 2015). 91 Art. 127 f PatO. For the requirements for the grant of an SPC see above paragraph 11 et seqq. 92 E. g. the missing connection to the basic patent or the fact that the MA is not the first one. 93 Guidelines of the Institute, § 13.3, p. 110. 94 Guidelines of the Institute, § 13.3, p. 110. 95 Art. 12 Para. 2 PatO. 96 For the requirements for the grant of an SPC see above paragraph 11 et seqq. 97 Art. 140 g PatA; Art. 127 g para. 1 PatO. Pursuant to Art. 127 h PatO, the dismissal of an application for the grant, the premature lapse, the nullity and the suspension of an SPC will also be published. 89

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c) d) e) f) g) h) i)

if applicable, the name and address of the representative; the date of filing of the application; the number of the basic patent; the title of the invention protected by the basic patent; the date of the first MA in Switzerland; a denomination of the product covered by the MA and its registration number; the date of expiry of the term of protection of the SPC98. 55 According to Art. 127 i para. 2 PatO, the dossier of the SPC is accessible for everyone for inspection.

4. Remedies An appeal against a rejection or a dismissal by the Institute can be lodged with the Federal Administrative Court within the time limit of 30 days99. 57 An appeal against the decision of the Federal Administrative Court can be lodged with the Federal Supreme Court. Such an appeal must be filed within 30 days of the service of the preceding judgment100. 56

IV. Subject-Matter of Protection and Effects 1. Subject-Matter of Protection The protection of an SPC extends, within the limits of the scope of protection conferred by the basic patent, to any use of the product as a medicinal product that has been authorized before the expiry of the SPC101. Hence, the protected subject-matter of the SPC – the product – is restricted both by the basic patent and the issued MAs. De facto, the SPC leads to an extension of the protection term of the basic patent within the limits of the issued MAs102. 59 As a result of the restriction by the basic patent, everything which is outside the scope of protection of the patent must continue to be patent free. Within the limits of the basic patent, the scope of protection of the SPC also covers all of the modified forms of the product which fall under the term “product”. This way, it is ensured that all patentprotected forms of the same product are protected under the SPC as well. 60 As a result of the restriction by the MAs, the protection provided by the SPC is always limited to a specific purpose. This purpose limitation covers all further usages of the same product as a medicinal product which are authorized prior to the expiry of the SPC. It does not matter whether these subsequent MAs are granted to the owner of the SPC or to third parties103. 61 In the Fosinopril decision of 10 July 1998, the Federal Supreme Court held that the protection conferred by an SPC does not exceed the protection granted by its basic patent. The Court specified that the scope of protection of an SPC is narrower than the one of its basic patent because an SPC cannot be obtained for the patented invention 58

98

Art. 127 g para. 2 PatO; further information regarding the register in Art. 127 k PatO. Art. 31 of the Federal Law on the Federal Administrative Court of 17 June 2005 (VGG; SR 173.32) i. c. w. Art. 5 of the Federal Law on Administrative Procedure of 20 December 1968 (VwVG; SR 172.021), Art. 59 a, para 3 and Art. 140 m of the PatA. 100 Art. 72 et seqq. of the Federal Law on the Federal Court of 17 June 2005 (BGG; SR 173.110). 101 Art. 140 d para. 1 PatA. 102 Cf. Heinrich, Art. 140 d PatA, mn.1 et seqq. 103 Cf. Scha ¨ rli, mn. 354 et seqq. 99

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itself, but rather for a specific product manufactured in application of the invention and authorized in Switzerland as a medicinal product104. In the Fluoxetin decision of 27 May 1999, the same Court held that if the basic patent 62 is a process patent, the SPC protects the active ingredient only insofar as it was produced according to the patented process105.

2. Effects The SPC grants the same rights as the patent and is subject to the same restrictions. 63 Within the limits of the basic patent and the MA, the effects of the SPC are equal to those of the basic patent106. Therefore, an SPC has the same legal effect – the right of exclusivity – as a patent107. The SPC confers on its proprietor the right to prohibit others from using the protected product commercially. Said use includes, in particular, the manufacturing, storage, offering, placing on the market, importing, exporting and carrying in transit, as well as the possession for any of these purposes 108. Like a patent, an SPC can be transferred and licensed109. Entries in the register concerning the grant of rights relating to the basic patent and 64 restrictions on disposals ordered by courts or law enforcement authorities with regard to the basic patent apply to the SPC to the same extent as to the basic patent 110. Legal and contractual restrictions of the basic patent also apply to the SPC 111. That applies to the contractual licenses112 that have been granted, prior user rights113, and dependent rights in particular114. With regard to the permitted use of patented inventions for experimental purposes, 65 the same rules apply, in principle, to SPCs115.

V. Term of Protection 1. General The SPC takes effect upon expiry of the maximum term of the patent for a period 66 equal to the period which elapsed between the date of filing according to Art. 56 PatA and the date of the first MA in Switzerland, minus five years116. In Switzerland, the SPC is valid for no more than five years117. The objective of this provision is to ensure an effective total protection period of 15 years118. 104 Decision of the Federal Supreme Court of 10 July 1998, BGE 124 III 375 et seqq, “Fosinopril”, consid. 3, sic! 1998, p. 594 et seqq [Annex A7.VII.]. 105 Decision of the Federal Supreme Court of 27 May 1999, No. 4P.11/1999, “Fluoxetin”, consid. 2, published in sic! 1999, p. 655 et seqq [Annex A7.V.]. 106 Cf. Art. 140 d para. 2 PatA. 107 Heinrich, Art. 140 d N1 et seq. 108 Art. 8 PatA. 109 Articles 33 and 34 PatA. Gasser, p. 693. 110 Art. 127 k para. 4 PatO. 111 Bertschinger, mn. 10.29; Gasser, p. 707 et seq. 112 Art. 34 PatA. 113 Art. 35 para. 1 and 2 PatA. 114 Art. 36 PatA. 115 Heinrich, Art. 140 d PatA N8 et seq. 116 Art. 140 e para. 1 PatA. 117 Art. 140 e para. 2 PatA. In the future, plus an additional 6 months for paediatric extension, see paragraph 68 et seqq. 118 Message PatA 1993, p. 711; Scha ¨ rli, mn. 47 et seqq; Gasser, p. 710.

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Pursuant to Art. 140 e para. 3 PatA, the Federal Council is authorized to specify that the MA granted in the EEA constitutes the first MA for the purpose of calculating the term of protection if said MA is granted before the first MA in Switzerland. So far, the Federal Council has not made use of this authorization.

2. Paediatric Extension In accordance with the Institute’s practice until recently, SPCs were only granted if the period between the patent application and the first MA in Switzerland was longer than five years, i. e. if it leads to an actual extension of the term of protection. In cases in which an MA had already been granted within five years of the patent application, an SPC was, until recently, not granted due to the lack of a legitimate interest in obtaining an SPC having a negative term119. 69 As part of the ongoing revision of the Therapeutic Products Act, a six-month extension to the term of SPCs (“paediatric extension”)120 is planned in order to compensate for the additional costs in connection with the development of medicinal products for children. Since this extension will be accorded to SPCs already granted only, even an SPC having a negative or zero term will be beneficial. 70 With regard to medicinal products for paediatric use, a harmonization with European law is desirable and should therefore be strived for. According to the Institute, Art. 140 e para. 1 PatA would then be interpreted in accordance with the practice of the CJEU 121, so that an SPC would also be granted for active ingredients and combinations of active ingredients if the period between the patent application and the date of the first MA in Switzerland is less than five years. The Institute specified that the calculation of the starting point for a future paediatric extension will be carried out in rigorous application of the wording of Art. 140 e para. 1 PatA122. 68

VI. Premature Lapse and Suspension The SPC lapses if the owner surrenders it by means of a written declaration to the Institute, if the annual fees are not paid in due time, or if the MA is withdrawn 123. The reasons for the premature lapse of an SPC correspond to those for patents 124, with the additional reason arising from the dependence of the SPC on the MA125. 72 If the MA is suspended, the SPC is suspended as well, which means that the SPC does not unfold its legal effects. Suspension does not interrupt the term of the SPC. The authority granting the authorizations will notify the Institute of any withdrawal or suspension of the MA126. 71

119 Cf. decision of the Federal Supreme Court of 17 November 1998, No. 4A.7/1998, “Arzneimittel”, consid. 2, published in sic! 1999, p. 153 et seqq [Annex A7.VI.]. 120 See the new, yet to be introduced, Art. 140 n PatA. 121 Judgment of the CJEU of 8 December 2011, Merck Sharp & Dohme Corp. v German Patent and Trade Mark Office, C-125/10 [Annex A1.XVIII.], in which the CJEU decided that an SPC can also be granted if the period between the patent application and the MA is less than five years. 122 New Institute practice, cf. sic! 2012; p. 5 et seq. 123 Art. 140 i para. 1 PatG. 124 Art. 15 PatA. Cf. decision of the Federal Supreme Court of 17 November 1998, No. 4A.7/1998, “Arzneimittel”, consid. 3, published in sic! 1999, p. 153 et seqq. [Annex A7.VI.], in which the court held that the Institute is to act on the assumption of the validity of the specified basic patent during the examination procedure as long as there is no civil judgment declaring it invalid. 125 Heinrich, Art. 140 i PatA, mn. 1. 126 Art. 140 i para. 2 and 3 PatG; Gasser, p. 716.

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VII. Nullity The SPC is null and void if it was granted even though the prerequisites for the grant of the SPC were not fulfilled127. The SPC is also null and void if the patent lapses before the expiry of its maximum term or if the patent is declared invalid128. Furthermore, the SPC is void if the patent is limited to the extent that the product for which the SPC was granted is no longer covered by the patent claims. The SPC is also void if after the lapse of the patent, there are grounds which would have justified the declaration of nullity of the patent 129. Any person may bring an action to have the SPC declared void before the authority responsible for declaring the nullity of the patent130. In the Alendronsa¨ure II decision of 29 April 2008 of the Federal Supreme Court, the plaintiffs claimed the nullity of the defendant’s SPC in a nullity proceeding, claiming that the basic patent was invalid.131 In his reply, the defendant demanded that the basic patent be limited in order to be valid. He argued that after the limitation, the SPC would be based on a valid basic patent and would thus be valid as well. The Commercial Court of Zurich held that the patent’s – undisputed – invalidity could not be remedied by means of a limitation. The Federal Supreme Court rejected the Commercial Court’s view and held that a limitation is permitted in the event of the partial nullity of a patent according to Art. 27 para. 1 PatA. It thus granted the appeal and cancelled the decision of the Commercial Court of Zurich. In a first step, the Federal Supreme Court ruled that a party does have a protected interest in a declaratory judgement concerning the validity of an SPC for its term of protection even if the term of protection of the SPC has expired 132. Furthermore, the Court held that in a nullity proceeding against an SPC, it is necessary to examine preliminarily whether the limited basic patent still covers the product for which the SPC was granted 133.

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VIII. Swiss Federal Patent Court The Swiss Federal Patent Court started its operations on 1 January 2012. The Court 77 has exclusive subject matter jurisdiction for almost all civil patent and SPC disputes, in particular for actions concerning the validity of a claim and infringement actions. It is also responsible for temporary measures before lis pendens applies to such actions. Furthermore, the Court decides on the enforcement of its decisions 134. Switzerland does not have a bifurcated system. This means that an alleged SPC 78 infringer can either claim that the allegedly infringed SPC is not valid or file a nullity counterclaim with the Court. The Court deals with infringement and nullity arguments simultaneously. 127

Art. 140 b, Art. 140 c para. 2, Art. 146 para. 1 or Art. 147 para 1 PatA. See above paragraph 11 et

seqq. 128

Cf. Art. 15 PatA. Art. 140 k para. 1 PatA; Gasser, p. 717. 130 Art. 140 k para. 2 PatA. 131 Decision of the Federal Supreme Court of 29 April 2008, No. 4A_52/2008, “Alendronsa ¨ ure II”, consid. 2, published in sic! 2008, p. 643 et seqq. [Annex A7.IV.]. 132 Decision of the Federal Supreme Court of 29 April 2008, No. 4A_52/2008, “Alendronsa ¨ ure II”, consid. 1.2, published in sic! 2008, p. 643 et seqq [Annex A7.IV.]. 133 Decision of the Federal Supreme Court of 29 April 2008, No. 4A_52/2008, “Alendronsa ¨ ure II”, consid. 2, published in sic! 2008, p. 643 et seqq [Annex A7.IV.]. 134 Art. 26 of the Federal Act on the Federal Patent Court of 20 March 2009 (PatCA; SR 173.41). 129

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The Court’s system of two permanent judges and 36 non-permanent judges, of whom 25 possess a technical background and 11 enjoyed legal training, proved to be a success in practice. The non-permanent judges are appointed on a case-by-case basis according to their expertise. Proceedings thus far have generally been concluded swiftly. It is not an overstatement to say that the Court was able to live up to the expectations of the Swiss and international patent law community.

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ANNEXES Annex A Selected Decisions of the European and Swiss Case Law A1. Court of Justice of the European Union* I. Biogen v. SmithKlineBeecham Biologicals, C-181/95 of 23 January 1997 1. Where a medicinal product is covered by several basic patents, Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products does not preclude the grant of a supplementary protection certificate to each holder of a basic patent. 2. Regulation No 1768/92 does not require the holder of the marketing authorization to provide the patent holder with a copy of that authorization, referred to in Article 8(1)(b) of the Regulation. 3. Where the basic patent and the authorization to place the product on the market as a medicinal product are held by different persons and the patent holder is unable to provide a copy of that authorization in accordance with Article 8(1)(b) of Regulation No 1768/92, an application for a certificate must not be refused on that ground alone. Grounds: (…) (28) Consequently, where a product is protected by a number of basic patents in force, which may belong to a number of patent holders, each of those patents may be designated for the purpose of the procedure for the grant of a certificate. Under Article 3(c) of the Regulation, however, only one certificate may be granted for each basic patent. (…)

II. Yamanouchi v. Comptroller-General of Patents, Designs and Trademarks, C-110/95 of 12 June 1997 The grant of a supplementary protection certificate pursuant to Article 19 of Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products is, in accordance with Article 3(b) of that regulation, conditional on a valid authorization to place the product on the market as a medicinal product having been granted in the Member State in which the application is submitted and at the date of that application. Grounds: (…) (24) However, the effect of Articles 8(1)(a)(iv) and (b), 9(2)(d) and 11(1)(d) is that the first marketing authorization in the Community is not intended to take the place of the marketing authorization provided for in Article 3(b) of the regulation, that is to say,

*

Head notes only, unless grounds are expressly referenced.

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the authorization granted by the Member State in which the application is submitted; instead, it constitutes a further condition applying in the event that the latter authorization is not the first authorization to place the product on the market as a medicinal product in the Community. The first marketing authorization in the Community therefore serves a purely temporal purpose. (25) By referring to the first marketing authorization in the Community, the regulation is designed to exclude the possibility that, in Member States in which there has been significant delay in the grant of authorization to place a given product on the market, a certificate can still be granted even though that is no longer possible in the other Member States in which the authorization in question has been granted before expiry of the deadline. The regulation is thus intended to prevent the grant of certificates whose duration varies from one Member State to another. In those circumstances, Article 19(1) cannot be construed as meaning that the existence of an authorization in the Member State in which the certificate is sought is of no relevance. (…)

III. [Idarubicin] Farmitalia v. Deutsches Patent- und Markenamt, C-392/97 of 16 September 1999 1. On a proper construction of Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products and, in particular, Article 3(b) thereof, where a product in the form referred to in the marketing authorisation is protected by a basic patent in force, the supplementary protection certificate is capable of covering the product, as a medicinal product, in any of the forms enjoying the protection of the basic patent. 2. In order to determine, in connection with the application of Regulation No 1768/ 92 and, in particular, Article 3(a) thereof, whether a product is protected by a basic patent, reference must be made to the rules which govern that patent. Grounds: (…) (18) In that regard, all the interested parties who have submitted observations have maintained, in particular, that while the certificate could protect only the particular salt form of the active ingredient mentioned as the active constituent in the marketing authorisation, whereas the basic patent protects the active ingredient as such as well as salts thereof, including the one which is the subject matter of the marketing authorisation, any competitor would be able, after the basic patent had expired, to apply for and, in some circumstances, obtain marketing authorisation for a different salt of the same active ingredient, formerly protected by that patent. It would therefore be possible for medicinal products which were, in principle, therapeutically equivalent to that protected by the certificate to compete with the latter. The result would be to frustrate the purpose of Regulation No 1768/92, which is to ensure the holder of the basic patent of exclusivity on the market during a given period extending beyond the period of validity of the basic patent. (…)

IV. [Omeprazol] Ha¨ssle v. ratiopharm, C-127/00 of 11 December 2003 1. Consideration of the second question referred has disclosed no factor capable of affecting the validity of Article 19 of Council Regulation (EEC) No 1768/92 of 18 June 126

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1992 concerning the creation of a supplementary protection certificate for medicinal products. 2. So far as concerns medicinal products for human use, the concept of first authorisation to place … on the market … in the Community in Article 19(1) of Regulation No 1768/92 refers solely to the first authorisation required under provisions on medicinal products, within the meaning of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products, granted in any of the Member States, and does not therefore refer to authorisations required under legislation on pricing of or reimbursement for medicinal products. 3. A supplementary protection certificate which, contrary to the requirements of Article 19 of Regulation No 1768/92, has been delivered where the first marketing authorisation in the Community was obtained prior to the relevant date fixed by that provision is invalid pursuant to Article 15 thereof. Grounds: (…) (57) There is thus nothing to justify the words authorisation to place … on the market being interpreted differently depending on which provision of Regulation No 1768/92 they appear in. In particular, those words cannot be construed as having a different meaning according to whether they appear in Article 3 or Article 19, especially when it is apparent from Article 8(1)(a)(iv) and (c) that the marketing authorisation referred to in Article 3(b) may also be the first marketing authorisation in the Community. (…) (72) In that connection, as stated in paragraph 57 of the present judgment, the words first authorisation to place … on the market must not be interpreted differently depending on the provision of Regulation No 1768/92 in which they appear. The same is particularly true of the words first authorisation to place … on the market … in the Community (see, to that effect, Yamanouchi Pharmaceutical, cited above, paragraphs 23 and 24). (…) (80) By its third question, the national court is asking, in essence, whether a certificate which, contrary to Article 19 of Regulation No 1768/92, has been delivered where the first marketing authorisation in the Community was obtained prior to the relevant date fixed by that provision is invalid pursuant to Article 15 of that regulation or whether all that is necessary is to rectify the duration of its validity. (…) (88) It follows that, when a mistake has been committed regarding the date of the first marketing authorisation in the Community but that date is subsequent to the relevant date fixed in Article 19(1) of Regulation No 1768/92, so that the article is not infringed, it is necessary only to rectify the date of expiry of the certificate (see, in that connection, recital 17 and Article 17(2) of Regulation No 1610/96). (89) However, where a mistake has been committed regarding the date of the first marketing authorisation in the Community and it appears that that date is in point of fact prior to the relevant date fixed in Article 19(1) of Regulation No 1768/92, so that the article has been infringed, the certificate must be declared invalid pursuant to Article 15 of that regulation. (90) Article 19 of Regulation No 1768/92 cannot be interpreted independently but must be interpreted in conjunction with Article 3 thereof. However, as the Commission

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rightly pointed out, infringement of Article 19 is comparable to the case of the certificate being issued contrary to the requirements of Article 3. (…)

V. Pharmacia Italia v. Deutsches Patent- und Markenamt, C-31/03 of 19 October 2004 The grant of a supplementary protection certificate in a Member State of the Community on the basis of a medicinal product for human use authorised in that Member State is precluded by an authorisation to place the product on the market as a veterinary medicinal product granted in another Member State of the Community before the date specified in Article 19(1) of Council Regulation No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products.

VI. [Novartis] Novartis v. Comptroller-General of Patents, Designs and Trademarks, C-207/03, Ministre de’Economie v. Millenium Pharmaceuticals, C-252/03 of 24 January 2005 In so far as an authorisation to place a medicinal product on the market issued by the Swiss authorities and automatically recognised by the Principality of Liechtenstein under that State’s legislation is the first authorisation to place that product on the market in one of the States of the European Economic Area, it constitutes the first authorisation to place the product on the market within the meaning of Article 13 of Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products, as it is to be read for the purposes of the application of the Agreement on the European Economic Area.

VII. Massachusetts Institute of Technology v. Deutsches Patentund Markenamt, C-431/04 of 4 May 2006 Article 1(b) of Council Regulation No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products, in the version resulting from the Act concerning the conditions of accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden and the adjustments to the Treaties on which the European Union is founded, must be interpreted so as not to include in the concept of ‘combination of active ingredients of a medicinal product’ a combination of two substances, only one of which has therapeutic effects of its own for a specific indication, the other rendering possible a pharmaceutical form of the medicinal product which is necessary for the therapeutic efficacy of the first substance for that indication. Grounds: (…) (18) In this case, it is important to note that it is common ground, as the file in this case shows, that the expression ‘active ingredient’ is generally accepted in pharmacology not to include substances forming part of a medicinal product which do not have an effect of their own on the human or animal body.

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(19) In that regard, attention must be drawn to the fact that in point 11 of the Explanatory Memorandum to the Proposal for a Council Regulation (EEC), of 11 April 1990, concerning the creation of a supplementary protection certificate for medicinal products (COM(90) 101 final), to which the French Government referred in its oral observations, it is specified that ‘[t]he proposal for a Regulation therefore concerns only new medicinal products. It does not involve granting a [SPC] for all medicinal products that are authorised to be placed on the market. Only one [SPC] may be granted for any one product, a product being understood to mean an active substance in the strict sense. Minor changes to the medicinal product such as a new dose, the use of a different salt or ester or a different pharmaceutical form will not lead to the issue of a new [SPC].’ (20) Therefore, the definition of ‘product’ in Article 1(b) of Regulation No 1768/92 does not in any way conflict with that referred to by the Commission in point 11 of that explanatory memorandum. (21) In fact, it is apparent from that memorandum that the pharmaceutical form of the medicinal product, to which an excipient may contribute, as noted by the Advocate General in point 11 of his Opinion and the French Government at the hearing, does not form part of the definition of ‘product’, which is understood to mean an ‘active substance’ or ‘active ingredient’ in the strict sense. (22) In addition, reference can be made to Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products (OJ 1996 L 198, p. 30), recital 4 in the preamble to which states that innovation in the plant protection sector requires a level of protection which is equivalent to that granted to medicinal products by Regulation No 1768/92. Under Article 1(8) of Regulation No 1610/96, ‘product’ is defined as the active substance or combination of active substances of a plant protection product. An active substance, under Article 1(3), is defined as a substance having general or specific action against harmful organisms or on plants. (23) In this connection, in point 68 of the Explanatory Memorandum to the Proposal for a European Parliament and Council Regulation (EC), of 9 December 1994, concerning the creation of a supplementary protection certificate for plant protection products (COM(94) 579 final), it is stated that: – it would not be acceptable, in view of the balance required between the interests concerned, for the total duration of protection granted by the SPC and the patent for one and the same product to be exceeded; – that might be the case if one and the same product were able to be the subject of several successive SPCs; – that calls for a strict definition of the product; – if an SPC has already been granted for the active substance itself, a new SPC may not be granted for that substance, whatever changes may have been made regarding other features of the plant protection product (use of a different salt, different excipients, different presentation, etc.); – in conclusion, it should be noted that, although one and the same substance may be the subject of several patents and several marketing authorisations in one and the same Member State, the SPC will be granted for that substance only on the basis of a single patent and a single authorisation, namely the first granted in the Member State concerned. (24) Thus, the first sentence of Article 3(2) of Regulation No 1610/96 itself provides that the holder of more than one patent for the same product is not to be granted more than one SPC for that product. As set out in recital 17 in the preamble to that

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regulation, the detailed rules in Article 3(2) thereof, in particular, are also valid, mutatis mutandis, for the interpretation of Article 3 of Regulation No 1768/92. (…)

VIII. i-21 Germany v. Arcor, C-392/04, C-422/04 of 19 September 2006 1. Article 11(1) of Directive 97/13/EC of the European Parliament and of the Council of 10 April 1997 on a common framework for general authorisations and individual licences in the field of telecommunications services precludes the application of a fee for individual licences calculated by taking into account the regulatory body’s general administrative costs linked to implementing those licences over a period of 30 years. 2. Article 10 EC, read in conjunction with Article 11(1) of Directive 97/13, requires the national court to ascertain whether legislation which is clearly incompatible with Community law, such as that on which the fee assessments at issue in the main proceedings are based, constitutes manifest unlawfulness within the meaning of the national law concerned. If that is the case, it is for the national court to draw the necessary conclusions under its national law with regard to the withdrawal of those assessments. Grounds: (…) (57) It must be borne in mind that, according to settled case-law, in the absence of relevant Community rules, the detailed procedural rules designed to ensure the protection of the rights which individuals acquire under Community law are a matter for the domestic legal order of each Member State, under the principle of the procedural autonomy of the Member States, provided that they are not less favourable than those governing similar domestic situations (principle of equivalence) and that they do not render impossible in practice or excessively difficult the exercise of rights conferred by the Community legal order (principle of effectiveness) (see, inter alia, C-8/98 Preston and Others [2000] ECR I-3201, paragraph 31, and Case C-201/02 Wells [2004] ECR I723, paragraph 67). (…)

IX. Yissum Research and Development Company v. Comptroller-General of Patents, C-202/05 of 17 April 2007 Article 1(b) of Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products, in the version resulting from the Act concerning the conditions of accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden and the adjustments to the Treaties on which the European Union is founded, is to be interpreted as meaning that in a case where a basic patent protects a second medical use of an active ingredient, that use does not form an integral part of the definition of the product. Grounds: (…) (5) Since 19 July 1989, Yissum has been the holder of a European patent entitled ‘Cosmetic and dermatological compositions containing l-alpha-hydroxycholecalciferol’. That patent particularly concerns a composition, for use in topical treatment of skin disorders, containing a compound of l-alpha-hydroxycholecalciferol or of 1-alpha, 25130

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dihydroxycholecalciferol, commonly known as ‘calcitriol’. The patent also covers the same composition in conjunction with a carrier suitable for the manufacture of a cream, an ointment or a lotion. (6) On 12 December 2001, Galderma Ltd was granted authorisation in the United Kingdom to place Silkis ointment on the market. That authorisation covers calcitriol as active ingredient, and liquid paraffin, white soft paraffin and alpha-tocopherol as carriers. It also states that the ointment is authorised for ‘topical treatment of plaque psoriasis (psoriasis vulgaris) with up to 35 % of body surface area involvement’. (…) (17) It is clear from Massachusetts Institute of Technology, and, in particular, from paragraphs 19, 21, 23 and 24 of that judgment that the concept of ‘product’ referred to in Article 1(b) of Regulation No 1768/92 must be interpreted strictly to mean ‘active substance’ or ‘active ingredient’. (…) (19) Moreover, the same interpretation can be inferred from paragraph 20 of the judgment in Case C-31/03 Pharmacia Italia [2004] ECR I-10001, in which the Court held that ‘the decisive factor for the grant of the certificate is not the intended use of the medicinal product and … the purpose of the protection conferred by the certificate relates to any use of the product as a medicinal product without any distinction between use of the product as a medicinal product for human use and as a veterinary medicinal product’. (…)

X. AHP Manufacturing v. Bureau voor de Industrie¨le Eigendom, C-482/07 of 3 September 2009 Article 3(c) of Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products, considered in the light of the second sentence of Article 3(2) of Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products, must be interpreted as not precluding the grant of a supplementary protection certificate to the holder of a basic patent for a product for which, at the time the certificate application is submitted, one or more certificates have already been granted to one or more holders of one or more other basic patents.

XI. [Memantine] Synthon v. Merz Pharma, C-195/09 of 28 July 2011 1. Article 2 of Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products, as amended by the Act concerning the conditions of accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden and the adjustments to the Treaties on which the European Union is founded, must be interpreted as meaning that a product, such as that at issue in the main proceedings, which was placed on the market in the European Community as a medicinal product for human use before obtaining a marketing authorisation in accordance with Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products, as amended by Council Directive 89/341/EEC of 3 May 1989, and, in particular, without undergoing safety and efficacy testing, is not 131

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within the scope of Regulation No 1768/92, as amended, and may not, therefore, be the subject of a supplementary protection certificate. 2. A supplementary protection certificate granted for a product outside the scope of Regulation No 1768/92, as amended, as that scope is defined in Article 2 of that regulation, is invalid.

XII. [Galantamin] Generics UK v. Synaptech, C-427/09 of 28 July 2011 A product, such as that at issue in the main proceedings, which was placed on the market in the European Community as a medicinal product for human use before obtaining a marketing authorisation in accordance with Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products, as amended by Council Directive 89/341/EEC of 3 May 1989, and, in particular, without undergoing safety and efficacy testing, is not within the scope of Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products, as amended by the Act concerning the conditions of accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden and the adjustments to the Treaties on which the European Union is founded, as that scope is defined in Article 2 of that regulation, as amended, and may not be the subject of a supplementary protection certificate.

XIII. Medeva v. Comptroller-General of Patents, Designs and Trademarks, C-322/10 of 24 November 2011 1. Article 3(a) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as precluding the competent industrial property office of a Member State from granting a supplementary protection certificate relating to active ingredients which are not specified in the wording of the claims of the basic patent relied on in support of the application for such a certificate. 2. Article 3(b) of Regulation No 469/2009 must be interpreted as meaning that, provided the other requirements laid down in Article 3 are also met, that provision does not preclude the competent industrial property office of a Member State from granting a supplementary protection certificate for a combination of two active ingredients, corresponding to that specified in the wording of the claims of the basic patent relied on, where the medicinal product for which the marketing authorisation is submitted in support of the application for a supplementary protection certificate contains not only that combination of the two active ingredients but also other active ingredients. Grounds: (…) (13) On 26 April 1990, Medeva filed an application for a European patent, registered by the European Patents Office (EPO) under EP number 1666057, for a method for the preparation of an acellular vaccine against Bordetella pertussis (whooping cough agent), also known as ‘Pa’, consisting of a combination of two antigens as active ingredients, namely pertactin and filamentous haemagglutinin (‘filamentous haemagglutinin antigen’), in such a ratio as to provide a synergistic effect in vaccine potency. The patent was granted by the EPO on 18 February 2009 and expired on 25 April 2010. 132

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(…) (23) The Court therefore concluded at paragraph 27 of that judgment that, in the absence of European Union harmonisation of patent law, the extent of patent protection can be determined only in the light of the non-European Union rules governing patents. (24) It should be noted that Regulation No 469/2009 establishes a uniform solution at European Union level by creating a SPC which may be obtained by the holder of a national or European patent under the same conditions in each Member State. It thus aims to prevent the heterogeneous development of national laws leading to further disparities which would be likely to create obstacles to the free movement of medicinal products within the European Union and thus directly affect the establishment and functioning of the internal market (see Case C-350/92 Spain v. Council [1995] ECR I1985, paragraphs 34 and 35; Case C-127/00 Ha¨ssle [2003] ECR I-14781, paragraph 37; and Case C-482/07 AHP Manufacturing [2009] ECR I-7295, paragraph 35). (…) (27) That approach is also borne out by the second subparagraph of paragraph 20 of the explanatory memorandum to the proposal for Council Regulation (EEC) of 11 April 1990 concerning the creation of a supplementary protection certificate for medicinal products (COM(90) 101 final) (‘the explanatory memorandum’), which, in so far as concerns what is ‘protected by the basic patent’, refers expressly and solely to the wording of the claims of the basic patent. That interpretation also accords with that given in recital 14 in the preamble to Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products (OJ 1996 L 198, p. 30), which refers to the need for ‘products’ to be ‘the subject of patents specifically covering them’. (…)

XIV. Georgetown University v. Comptroller-General of Patents, Designs and Trademarks, C-422/10 of 24 November 2011 Article 3(b) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that, provided the other requirements laid down in Article 3 are also met, that provision does not preclude the competent industrial property office of a Member State from granting a supplementary protection certificate for an active ingredient specified in the wording of the claims of the basic patent relied on, where the medicinal product for which the marketing authorisation is submitted in support of the supplementary protection certificate application contains not only that active ingredient but also other active ingredients.

XV. Daiichi Sankyo Company v. Comptroller-General of Patents, Designs and Trademarks, C-6/11 of 25 November 2011 Article 3(a) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as precluding the competent industrial property office of a Member State from granting a supplementary protection certificate relating to active ingredients which are not identified in the wording of the claims of the basic patent relied on in support of the application for such a certificate. 133

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XVI. Yeda Research and Development Company, Aventis Holdings v. Comptroller-General of Patents, Designs and Trademarks, C-518/10 of 25 November 2011 Article 3(a) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as precluding the competent industrial property office of a Member State from granting a supplementary protection certificate where the active ingredient specified in the application, even though identified in the wording of the claims of the basic patent as an active ingredient forming part of a combination in conjunction with another active ingredient, is not the subject of any claim relating to that active ingredient alone.

XVII. University of Queensland v. Comptroller-General of Patents, Designs and Trademarks, C-630/10 of 25 November 2011 1. Article 3(a) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as precluding the competent industrial property office of a Member State from granting a supplementary protection certificate relating to active ingredients which are not identified in the wording of the claims of the basic patent relied on in support of the application for such a certificate. 2. Article 3(b) of Regulation No 469/2009 must be interpreted as meaning that, provided the other requirements laid down in Article 3 are also met, that provision does not preclude the competent industrial property office of a Member State from granting a supplementary protection certificate for an active ingredient specified in the wording of the claims of the basic patent relied on where the medicinal product for which the marketing authorisation is submitted in support of the supplementary protection certificate application contains not only that active ingredient but also other active ingredients. 3. In the case of a basic patent relating to a process by which a product is obtained, Article 3(a) of Regulation No 469/2009 precludes a supplementary protection certificate being granted for a product other than that identified in the wording of the claims of that patent as the product deriving from the process in question. Whether it is possible to obtain the product directly as a result of that process is irrelevant in that regard.

XVIII. Merck Sharpe & Dohme v. Deutsches Patent- und Markenamt, C-125/10 of 8 December 2011 Article 13 of Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products, as amended by Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006, read in conjunction with Article 36 of Regulation No 1901/2006, must be interpreted as meaning that medicinal products can be the object of the grant of a supplementary protection certificate where the period that has elapsed between the date of lodging the basic patent application and the first marketing authorisation in the European Union is less than five years. In such a case, the period of the paediatric extension provided for by the latter regulation starts to run from the date determined by deducting from the patent expiry date the difference between five years and the duration

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of the period which elapsed between the lodging of the patent application and the grant of the first marketing authorisation. Grounds: (…) (19) Merck submits that even if the SPC cannot result in a positive duration, it can nevertheless have a zero or negative duration. The reason for its application for the SPC is that it wishes to be able to request, at a later date, an extension of the SPC. A paediatric investigation plan was authorised, to that effect, by the competent authority on 27 March 2009 and the studies prescribed in that plan must be completed by 2017. (…) (25) Moreover, even if the duration of the paediatric extension is provided for by Article 13(3) of Regulation No 1768/92, the conditions of its application are established by Article 36 of Regulation No 1901/2006. Therefore, it is in light of those two regulations that the question posed by the national court must be answered. (…) (30) As regards, firstly, the overall scheme of Regulation No 1768/92, it must be noted that Article 10 thereof provides that, where the application for an SPC and the product to which it relates meet the conditions laid down by that regulation, the competent authority shall grant the SPC. It must be noted that the positive duration of the SPC does not figure among the basic conditions for obtaining such a certificate, set out in Article 3 of Regulation No 1768/92, or among the procedural conditions, referred to in Articles 7 to 9 thereof. (…) (42) Therefore, where the duration of an SPC is negative, it cannot be rounded to zero. The period of the paediatric extension provided for by Regulation No 1901/2006 starts to run from the date determined by deducting from the patent expiry date the difference between five years and the duration of the period which elapsed between lodging the patent application and obtaining the first marketing authorisation. (…)

XIX. Novartis v. Actavis Deutschland, C-574/11 of 9 February 2012 [and with the same result: Novartis v. Actavis UK, C-442/11 of 9 February 2012] Articles 4 and 5 of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that, where a ‘product’ consisting of an active ingredient was protected by a basic patent and the holder of that patent was able to rely on the protection conferred by that patent for that ‘product’ in order to oppose the marketing of a medicinal product containing that active ingredient in combination with one or more other active ingredients, a supplementary protection certificate granted for that ‘product’ enables its holder, after the basic patent has expired, to oppose the marketing by a third party of a medicinal product containing that product for a use of the ‘product’, as a medicinal product, which was authorised before that certificate expired.

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XX. Neurim Pharmaceuticals v. Comptroller-General of Patents, Designs and Trademarks, C-130/11 of 19 July 2012 (1) Articles 3 and 4 of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that, in a case such as that in the main proceedings, the mere existence of an earlier marketing authorisation obtained for a veterinary medicinal product does not preclude the grant of a supplementary protection certificate for a different application of the same product for which a marketing authorisation has been granted, provided that the application is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the supplementary protection certificate. (2) Article 13(1) of Regulation (EC) No 469/2009 must be interpreted as meaning that it refers to the marketing authorisation of a product which comes within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the supplementary protection certificate. (3) The answers to the above questions would not be different if, in a situation such as that in the main proceedings where the same active ingredient is present in two medicinal products having obtained successive marketing authorisations, the second marketing authorisation required a full application in accordance with Article 8(3) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, or if the product covered by the first marketing authorisation of the corresponding medicinal product is within the scope of protection of a different patent which belongs to a different registered proprietor from the SPC applicant. Grounds: (…) [25] Therefore, if a patent protects a therapeutic application of a known active ingredient which has already been marketed as a medicinal product, for veterinary or human use, for other therapeutic indications, whether or not protected by an earlier patent, the placement on the market of a new medicinal product commercially exploiting the new therapeutic application of the same active ingredient, as protected by the new patent, may enable its proprietor to obtain an SPC, the scope of which, in any event, could cover, not the active ingredient, but only the new use of that product. [26] In such a situation, only the MA of the first medicinal product, comprising the product and authorised for a therapeutic use corresponding to that protected by the patent relied upon for the purposes of the application for the SPC, may be considered to be the first MA of ‘that product’ as a medicinal product exploiting that new use within the meaning of Article 3(d) of the SPC Regulation. (…)

XXI. AstraZeneca v. European Commission, C-457/10 of 6 December 2012 (…) Grounds: (…) [96] Thus, by making misleading representations to those patent offices, by concealing the existence of that French technical authorisation and deliberately leading them to 136

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believe that the date of 21 March 1988 corresponded to the Luxembourg technical authorisation and that that latter was the first MA in the Community, AZ knowingly accepted that those offices granted it SPCs which they would not have issued had they known of the existence of the French technical authorisation and which would have been shown to be unlawful in the event that the alternative interpretation proposed by AZ was not followed by the national courts or the Court of Justice. (…) [98] Regarded in the light of the facts found by the General Court, which the appellants have expressly stated that they are not calling into question, the third ground of appeal raised by them is tantamount to an argument that where an undertaking in a dominant position considers that it can, in accordance with a legally defensible interpretation, lay claim to a right, it may use any means to obtain that right, and even have recourse to highly misleading representations with the aim of leading public authorities into error. Such an approach is manifestly not consistent with competition on the merits and the specific responsibility on such an undertaking not to prejudice, by its conduct, effective and undistorted competition within the European Union. (…) [130] However, contrary to what the appellants submit, conduct like that impugned in the context of the second abuse – consisting in the deregistration, without objective justification and after the expiry of the exclusive right to make use of the results of the pharmacological and toxicological tests and clinical trials granted by Directive 65/65, of the MAs for Losec capsules in Denmark, Sweden and Norway, by which AZ intended, as the General Court held at paragraph 814 of the judgment under appeal, to hinder the introduction of generic products and parallel imports – does not come within the scope of competition on the merits. (…)

XXII. Referral: Actavis UK v. Sanofi, C-443/12 of 3 October 2012 (1) What are the criteria for deciding whether “the product is protected by a basic patent in force” in Article 3(a) of Regulation 469/2009/EC (“the Regulation”)? (2) In a situation in which multiple products are protected by a basic patent in force, does the Regulation, and in particular Article 3(c), preclude the proprietor of the patent being issued a certificate for each of the products protected? Grounds: (…) [30] However, in circumstances such as those in the main proceedings, even if the condition laid down in Article 3(a) of Regulation No 469/2009 were satisfied, for the purpose of the application of Article 3(c) of that regulation, it cannot be accepted that the holder of a basic patent in force may obtain a new SPC, potentially for a longer period of protection, each time he places on the market in a Member State a medicinal product containing, on the one hand, the principle active ingredient, protected as such by the holder’s basic patent and constituting, according to the statements of the referring court, the core inventive advance of that patent, and, on the other, another active ingredient which is not protected as such by that patent. [31] The SPC is designed simply to re-establish a sufficient period of effective protection of the basic patent by permitting the holder to enjoy an additional period of exclusivity on the expiry of his patent, which is intended to compensate, at least in part, for the delay to the commercial exploitation of his invention by reason of the time which has elapsed between the date on which the application for the patent was filed 137

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and the date on which the first MA in the European Union was granted (Case C-229/09 Hogan Lovells International [2010] ECR I-11335, paragraph 50, and Georgetown University, paragraph 36). (…) [36] In such a situation, Article 13 of Regulation No 469/2009 dictates that, upon expiry of the initial SPC, the holder thereof may no longer, in connection with the basic patent used as the basis for the grant of the SPC, oppose the marketing by third parties of the active ingredient which was the subject of the protection conferred by that SPC. This means that, after that date, it must be possible for third parties to place on the market not only medicinal products consisting of the formerly protected active ingredient but also any medicinal product containing that active ingredient in combination with another active ingredient that is not protected as such by the basic patent or any other patent. [37] Moreover, with regard to the second SPC granted in the main proceedings, the possibility cannot be ruled out that, under national law which provides a degree of protection against indirect infringement, an SPC relating to the irbesartan-hydrocholorothiazide combination may permit the holder to oppose the marketing of a medicinal product containing the active ingredient irbesartan, as a single active ingredient or in combination with another active ingredient. In such a situation, the second SPC may in fact confer upon its holder, albeit partially and indirectly, further protection for irbesartan, extending de facto the protection it enjoyed as a result of the grant of the first SPC relating to that active ingredient, under the conditions referred to at paragraph 35 above. Thus, in view of the consequences of it being granted, in terms of the extension of protection, the situation outlined above confirms that an SPC such as the second SPC at issue in the main proceedings cannot be issued. (…) [41] It should be recalled that the basic objective of Regulation No 469/2009 is to compensate for the delay to the marketing of what constitutes the core inventive advance that is the subject of the basic patent, namely, in the main proceedings, irbesartan. In the light of the need, referred to in recital 10 in the preamble to that regulation, to take into account all the interests at stake, including those of public health, if it were accepted that all subsequent marketing of that active ingredient in conjunction with an unlimited number of other active ingredients, not protected as such by the basic patent but simply referred to in the wording of the claims of the patent in general terms, such as, in the case of the patent in the main proceedings, ‘beta-blocking compound’, ‘calcium antagonist’, ‘diuretic’, ‘non-steroidal anti-inflammatory’ or ‘tranquilizer’, conferred entitlement to multiple SPCs, that would be contrary to the requirement to balance the interests of the pharmaceutical industry and those of public health as regards the encouragement of research within the European Union by the use of SPCs. [42] It follows that, in such a situation, Article 3(c) of Regulation No 469/2009 precludes a patent holder from obtaining, on the basis of one and the same basic patent, more than one SPC in connection with irbesartan, since such SPCs would in fact be connected, wholly or in part, with the same product (see, to that effect, with regard to plant protection products, Case C-258/99 BASF [2001] ECR I-3643, paragraphs 24 and 27). On the other hand, if a combination consisting of an innovative active ingredient in respect of which an SPC has already been granted and another active ingredient, which is not protected as such by the patent in question, is the subject of a new basic patent within the meaning of Article 1(c) of that regulation, the new patent could, in so far as it covered a totally separate innovation, confer entitlement to an SPC for that new combination that is subsequently placed on the market. (…) 138

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XXIII. Referral: AstraZeneca v. Comptroller-General of Patents, Designs and Trademarks, C-617/12 of 18 December 2012 (1) Is a Swiss marketing authorisation not granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83/EC, but automatically recognised by Liechtenstein, capable of constituting the ‘first authorisation to place the product on the market’ for the purposes of Article 13(1) of Regulation 469/2009/EC? (2) Does it make a difference to the answer to the first question if: (a) the set of clinical data upon which the Swiss authority granted the marketing authorisation was considered by the European Medicines Agency as not satisfying the conditions for the grant of a marketing authorisation pursuant to Regulation 726/2004/EC; and/or (b) the Swiss marketing authorisation was suspended after grant and was only reinstated following the submission of additional data? (3) If Article 13(1) of Regulation 469/2009 refers solely to marketing authorisations granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83/EC, does the fact that a medicinal product was first placed on the market within the EEA pursuant to a Swiss marketing authorisation automatically recognised in Liechtenstein which was not granted pursuant to Directive 2001/83/EC render that product ineligible for the grant of a supplementary protection certificate pursuant to Article 2 of Regulation 469/2009? Grounds: (…) [57] In any event, in the main proceedings, according to the referring court, there may have been indirect sales of Iressa via wholesalers on the basis of the authorisation of 2 March 2004 issued by SwissMedic and, subsequently, following the suspension of that authorisation, Astrazeneca may have supplied Iressa to individual patients with the specific approval of SwissMedic. It follows that, with the grant of that Swiss authorisation, that company was in a position, in one of the EEA States, to start capitalising on its investments in research that culminated in the grant of its patent, which justifies that authorisation being regarded, as the Court held in Novartis and Others, as the first authorisation to place that medicinal product on the market for the purpose of Article 13(1) of Regulation No 469/2009, applied in the context of the EEA Agreement. (…)

XXIV. Referral: Bayer CropScience v. Deutsches Patent- und Markenamt, C-11/13 of 6 December 2012 Are the terms ‘product’ in Article 3(1) and Article 1.8 and ‘active substance’ in Article 1.3 of that regulation to be interpreted as covering a safener?

XXV. Referral: GlaxoSmithKline Biologicals v. Comptroller-General of Patents, Designs and Trademarks, C-210/13 of 21 March 2013 (1) Is an adjuvant which has no therapeutic effect on its own, but which enhances the therapeutic effect of an antigen when combined with that antigen in a vaccine, an ‘active ingredient’ within the meaning of Article 1(b) of Regulation 469/2009/EC?

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(2) If the answer to question 1 is no, can the combination of such an adjuvant with an antigen nevertheless be regarded as a ‘combination of active ingredients’ within the meaning of Article 1(b) of Regulation 469/2009/EC?

XXVI. Eli Lilly and Company Ltd. V. Human Genome Sciences Inc., C-493/12 of 12 December 2013 Article 3(a) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that, in order for an active ingredient to be regarded as ‘protected by a basic patent in force’ within the meaning of that provision, it is not necessary for the active ingredient to be identified in the claims of the patent by a structural formula. Where the active ingredient is covered by a functional formula in the claims of a patent issued by the European Patents Office, Article 3(a) of that regulation does not, in principle, preclude the grant of a supplementary protection certificate for that active ingredient, on condition that it is possible to reach the conclusion on the basis of those claims, interpreted inter alia in the light of the description of the invention, as required by Article 69 of the Convention on the Grant of European Patents and the Protocol on the interpretation of that provision, that the claims relate, implicitly but necessarily and specifically, to the active ingredient in question, which is a matter to be determined by the referring court. Grounds: (…) [43] In the light of the objective of Regulation No 469/2009, the refusal of an SPC application for an active ingredient which is not specifically referred to by a patent issued by the EPO relied on in support of such an application may be justified – in circumstances such as those in the main proceedings and as observed by Eli Lilly – where the holder of the patent in question has failed to take any steps to carry out more in-depth research and identify his invention specifically, making it possible to ascertain clearly the active ingredient which may be commercially exploited in a medicinal product corresponding to the needs of certain patients. In such a situation, if an SPC were granted to the patent holder, even though – since he was not the holder of the MA granted for the medicinal product developed from the specifications of the source patent – that patent holder had not made any investment in research relating to that aspect of his original invention, that would undermine the objective of Regulation No 469/2009, as referred to in recital 4 in the preamble thereto. (…)

XXVII. Georgetown University v. Octroicentrum Nederland (referred to as Georgetown II in the text) C-484/12 of 12 December 2013 In circumstances such as those in the main proceedings, where, on the basis of a basic patent and a marketing authorisation for a medicinal product consisting of a combination of several active ingredients, the patent holder has already obtained a supplementary protection certificate for that combination of active ingredients, protected by that patent within the meaning of Article 3(a) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products, Article 3(c) of that regulation must be interpreted as not precluding the proprietor from also obtaining a supplementary 140

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protection certificate for one of those active ingredients which, individually, is also protected as such by that patent.

XXVIII. Merck Canada Inc. v. Accord Healthcare Ltd. and others, C-555/13 of 13 February 2014 Article 13 of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products, read in conjunction with recital 9 to the same regulation, must be interpreted as meaning that it precludes the holder of both a patent and a supplementary protection certificate from relying on the entire period of validity of such a certificate, calculated in accordance with Article 13, in a situation where, pursuant to such a period, it would enjoy a period of exclusivity as regards an active ingredient, of more than 15 years from the first authorisation to be placed on the market, in the European Union, of a medicinal product consisting of that active ingredient, or containing it.

XXIX. Referral: Seattle Genetics, C-471/14 of 15 October 2014 Is the date of the first authorisation to place the product on the market in the Community pursuant to Article 13(1) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products determined according to Community law or does that provision refer to the date on which the authorisation takes effect under the law of the Member State in question? If the Court’s answer is that the date referred to in Question 1 is determined by Community law, which date must be taken into account — the date of authorisation or the date of notification?

XXX. Novartis v. Actavis Deutschland, C-574/11 of 9 February 2012 Articles 4 and 5 of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that, where a ‘product’ consisting of an active ingredient was protected by a basic patent and the holder of that patent was able to rely on the protection conferred by that patent for that ‘product’ in order to oppose the marketing of a medicinal product containing that active ingredient in combination with one or more other active ingredients, a supplementary protection certificate granted for that ‘product’ enables its holder, after the basic patent has expired, to oppose the marketing by a third party of a medicinal product containing that product for a use of the ‘product’, as a medicinal product, which was authorised before that certificate expired.

XXXI. Actavis v. Boehringer Ingelheim, C-577/13 of 14 November 2013 (1)(a) If a patent does not, upon grant, contain a claim that explicitly identifies two active ingredients in combination, but the patent could be amended so as to include such a claim could this patent, whether or not such an amendment is made, be relied upon as a 141

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“basic patent in force” for a product comprising those ingredients in combination pursuant to Article 3(a) of Regulation No 469/2009/EC (“the Regulation”)? (b) Can a patent that has been amended after the grant of the patent and either (i) before and/or (ii) after grant of the SPC be relied upon as the “basic patent in force” for the purposes of fulfilling the condition set out in Article 3(a) of the Regulation? (c) Where an applicant applies for an SPC for a product comprised of active ingredients A and B in circumstances where, (i) after the date of application for the SPC but before the grant of the SPC, the basic patent in force, being a European Patent (UK) (the “Patent”) is amended so as to include a claim which explicitly identifies A and B; and (ii) the amendment is deemed, as a matter of national law, always to have had effect from the grant of the Patent; is the applicant for the SPC entitled to rely upon the Patent in its amended form for the purposes of fulfilling the Art 3(a) condition? 2. For the purposes of determining whether the conditions in Article 3 are made out at the date of the application for an SPC for a product comprised of the combination of active ingredients A and B, where (i) the basic patent in force includes a claim to a product comprising active ingredient A and a further claim to a product comprising the combination of active ingredients A and B and (ii) there is already an SPC for a product comprising active ingredient A (“Product X”) is it necessary to consider whether the combination of active ingredients A and B is a distinct and separate invention from that of A alone? 3. Where the basic patent in force “protects” pursuant to Article 3(a): (a) A product comprising active ingredient A (“Product X”); and (b) A product comprising a combination of active ingredient A and active ingredient B (“Product Y”). And where: (c) An authorisation to place Product X on the market as a medicinal product has been granted; (d) An SPC has been granted in respect of Product X; and (e) A separate authorisation to place Product Y on the market as a medicinal product has subsequently been granted. Does the Regulation, in particular Articles 3(c), 3(d) and/or 13(1) of the Regulation preclude the proprietor of the patent being issued with an SPC in respect of Product Y? Alternatively, if an SPC can be granted in respect of Product Y, should its duration be assessed by reference to the grant of the authorisation for Product X or the authorisation for Product Y? 4. If the answer to question (1)(a) is in the negative and the answer to question l(b)(i) is positive and the answer to question (l)(b)(ii) is negative, then in circumstances where: (a) in accordance with Art 7(1) [of the] Regulation, an application for an SPC for a product is lodged within six months of the date on which a valid authorisation to place that product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC; (b) following the lodging of the application for the SPC, the competent industrial property office raises a potential objection to the grant of the SPC under Article 3(a) of the Regulation; (c) following and in order to meet the aforesaid potential objection by the competent industrial property office, an application to amend the basic patent in force relied upon by the SPC applicant is made and granted; 142

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(d) upon amendment of the basic patent in force, said amended patent complies with Article 3(a); does the SPC Regulation prevent the competent industrial property office from applying national procedural provisions to enable (a) suspension of the application for the SPC in order to allow the SPC applicant to apply to amend the basic patent, and (b) recommencement of said application at a later date once the amendment has been granted, the said date of recommencement being – after six months from the date on which a valid authorisation to place that product on the market as a medicinal product was granted but – within six months of the date on which the application to amend the basic patent in force was granted?

XXXII. Arne Forsgren v. Comptroller-General of Patents, Designs and Trademarks, C-631/13 of 15 January 2015 (1) Articles 1(b) and 3(a) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as not precluding, in principle, the possibility that an active ingredient can give rise to the grant of a supplementary protection certificate where the active ingredient is covalently bound to other active ingredients which are part of a medicinal product. (2) Article 3(b) of Regulation No 469/2009 must be interpreted as precluding the grant of a supplementary protection certificate for an active ingredient whose effect does not fall within the therapeutic indications covered by the wording of the marketing authorisation. Article 1(b) of Regulation No 469/2009 must be interpreted as meaning that a carrier protein conjugated with a polysaccharide antigen by means of a covalent binding may be categorised as an ‘active ingredient’ within the meaning of that provision only if it is established that it produces a pharmacological, immunological or metabolic action of its own which is covered by the therapeutic indications of the marketing authorisation, a matter which it is for the referring court to determine, in the light of all the facts of the dispute in the main proceedings. Grounds: (…) [25] It follows that the term ‘active ingredient’, for the purposes of applying Regulation No 469/2009, concerns substances producing a pharmacological, immunological or metabolic action of their own. Since Regulation No 469/2009 does not draw any distinction according to whether an active ingredient is covalently bound with other substances, it is not appropriate to exclude, on that ground, the grant of an SPC for such an active ingredient. (…) [28] Accordingly, the answer to Question 1 is that Articles 1(b) and 3(a) of Regulation No 469/2009 must be interpreted as not precluding, in principle, the possibility that an active ingredient can give rise to the grant of an SPC where the active ingredient is covalently bound to other active ingredients which are part of a medicinal product. (…) [37] As was pertinently noted by the referring court, the wording of Annex I to the marketing authorisation for Synflorix makes it clear that the therapeutic indications for which Synflorix was authorised are restricted to ‘active immunisation against invasive 143

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disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants and children from 6 weeks up to 2 years of age’; that annex further states that ‘there is insufficient evidence that Synflorix provides protection against … non-typeable Haemophilus influenzae’. It should further be noted that the European Public Assessment Report prepared by the European Medicines Agency (‘EMEA’) as part of the assessment of the application for a marketing authorisation for Synflorix (Assessment report for Synflorix, procedure No EMEA/H/C/000973; ‘the European Public Assessment Report’) states in that regard that ‘[s]ince the claim for protection against [acute otitis media] caused by non-typeable H. influenzae at this stage is not supported by clinical data there is no need for an assay of the protein D content in the specification at the level of the drug product. (…)

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A2. German Courts* Federal Court of Justice (Bundesgerichtshof, BGH) I. Trioxan, X ZB 9/70 of 6 July 1971 1. Patent protection of a macromolecular chemical compound is not precluded by the fact alone that the compound cannot be identified by a complete and exact structural formula. 2. In such cases it is required and sufficient to describe the patent claim with as many information as necessary about the characteristics of a macromolecular compound of unknown structure to be able to differ its inventive character by reliably ascertainable (measurable) parameters from other reliably ascertainable parameters of macromolecular compounds not claimed, and to be able to reliably judge the prerequisites for patentability. 3. A product claim that identifies a chemical compound by the manufacturing process (product-by-process-claim), is permitted in cases where neither the structural formula of the compound is known, nor an identification of the compound by means of reliably ascertainable parameters is possible.

II. Idarubicin III, X ZB 21/00 of 17 July 2001 The application for an SPC for a specifically named substance cannot be refused on the ground alone, a version claimed in the alternative without specification of the active ingredient to be protected would be preferable.

III. Sumatriptan, X ZB 12/01 of 29 January 2002 1. A granted SPC has to specify precisely the product (active ingredient or combination of active ingredients according to Art. 1 lit. b RegSPC 1992) covered by the SPC. 2. The SPC can also be granted for an active ingredient not specified in the basic patent, if it is covered by the scope of protection of one claim of the basic patent. In this case it is not relevant whether the basic patent could be reduced to this active ingredient or whether this would be, due to lack of disclosure of the specific active ingredient, an inadmissible additional subject matter.

IV. Custodiol II, X ZR 73/01 of 12 March 2002 The case law saying that the protective effect of a patent whose claim contains numeric expressions or stated measurements cannot be extended to ranges substantially deviating from those in the patent claim if this numeric expressions or stated measurements ground the novelty of the patent (cf. BGH GRUR 1984, 425 [427] – Bierkla¨rmittel), only applies to patents whose scope of protection hasn’t already to be judged by means of Art. 69 EPC or § 14 PatG 1981. The binding nature of numeric expressions or *

Headnotes only.

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stated measurements within the patent claim has de lege lata not to be judged by the question, what relation they have to the state of the art. Yet this does not preclude to interpret such data also by consideration of indications of the state of the art given in the patent description.

V. Anti-Helicobacter-Pra¨parat, X ZB 1/08 of 8 July 2008 If the marketing authorisation for a medicinal product has been issued for a single active ingredient only, even if an application in combination with the other active ingredients of a substance combination is mentioned in the authorisation, an SPC for the substance combination cannot be granted, even though if the basic patent protects the substance combination.

VI. Doxorubicin, X ZB 4/08 of 14 October 2008 For the judgement of the question, whether an active ingredient is a different one than the one a marketing authorisation has been issued for, enhancing the effectiveness alone is not decisive.

Federal Patent Court (Bundespatentgericht, BPatG) (Headnotes or keynotes by the authors only)

VII. Abamectin, 15 W (pat) 71/97 of 21 June 1999 1. A supplementary protection certificate for medicinal products can only be granted if all prerequisites mentioned in Art. 3 [RegSPC] are fulfilled in the Member State of application and at the time of application. Therefore, the lack of basic patent in force cannot be healed by restitutio in integrum if in consequence of an overly long approval procedure the marketing authorisation was issued after expiry of the basic patent. Injustice in such cases also is beyond the limits of development of the law by judges and must be for the legislator. 2. In individual cases, due to the obligations of the DPMA to give information and to give opportunity to submit observations in accordance with § 139 ZPO and § 42 para. 3 sentence 2 PatG and § 48 PatG, it may be appropriate to make reference to legal elements or to an intended change of the yet perceptible legal position of the DPMA [with further legal references].

VIII. Porfimer, 15 W (pat) 59/03 of 23 June 2005 Assuming the wording of the [RegSPC] the time of issuance of the marketing authorisation is the time of issuance by the competent authority, i. e. the date to be found on the approval notification. The decisiveness of this date directly results from Art. 8 para. 1 lit. b [RegSPC] requiring the SPC application to contain “a copy of the authorisation to place the product on the market, as referred to in Article 3(b), in which

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the product is identified, containing in particular the number and date of the authorisation and the summary of the product characteristics listed in Article 11 of [DirMPH] or Article 14 of [DirMPV]”.

IX. Finasterid, 3 Ni 2/06 of 15 March 2007 A marketing authorisation issued under the national laws of Austria before its accession to the European Union can with regard to the fiction of Art. 3 lit. b sentence 2 [RegSPC 1992] be assumed as the first authorisation in the Community under Art. 13 para. 1 [RegSPC 1992] in terms of a calculation of term according an SPC filed after Austria’s accession to the European Union.

X. Subdiuretische Dosis, 3 Ni 49/07 of 16 June 2009 1. Whether the product approved by a valid marketing authorisation is protected by a basic patent in force is to be judged by the provisions applicable to the basic patent, in the decided case by Art. 69 EPC. 2. If the basic patent granted for a product containing a loop diuretic with subdiuretic dosage does not provide a specific numerically assignable range of dosage, and if the only numerical values are given in the embodiment examples of combination products containing the loop diuretic Piretanid as 1 mg resp. 5 mg Piretanid, the term “subdiuretic dosage” given in the patent claim in accordance with the description and examples of the patent reveals to the person skilled in the art as a quantity of the active ingredient, that has no diuretic effect on its own and in any case is not larger than 5 mg. 3. A product containing 6 mg Piretanid in accordance with the marketing authorisation, is not covered by the scope of the basic patent.

XI. Tenofovir, 15 W (pat) 24/07 of 12 May 2011 The Certificate does not constitute an own subject-matter of protection independent of the basic patent, but effects an extension of the patent term within the limits of the authorised product. The SPC therefore is to be seen as a segment of the patent protected beyond the usual term of a patent.

XII. Ranibizumab, 3 Ni 28/11 of 2 May 2012 1. In the decisions [C-322/10, Annex A1.XIII.] and [C-630/10, Annex A1.XVII.] the CJEU has supplemented its former legislation [with further references] with the clarification that a supplementary protection certificate for medicinal products can in accordance with Art. 3 lit. a [RegSPC] only be granted for active ingredients specified in the wording of the claims of the basic patent. 2. According the grant of an SPC for medicinal products it can’t be proceeded – as in former legislation [with further references] – on the basis of the scope of protection of the basic patent, but it is decisive whether the active ingredient and/or its composition, that is subject matter of the SPC application, is specified in the wording of the claims of the basic patent. 147

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3. The requirement of specification of the active ingredients in the wording of the claims of the basic patents with regard to supplementary protection certificates is applicable to both substance combinations and preparations of single-active ingredients.

XIII. Insulin Glargine 14 W (pat) 13/07 of 31 May 2011 The decision of the Patent Office dated April 26th, 2007 is repealed and the protection certificate shall be issued for the product “Insulin Glargine” for the period from 21 st July 2007 to 20th July 2012.

XIV. Telmisartan, 3 Ni 5/13 of 4 February 2013 1. A supplementary protection certificate is void, if it relates to a combination of active ingredients from an active substance, protected as such, by the basic patent and another long-known active substance; and if a supplementary protection certificate had previously been issued only for the active substance, protected as such, which granted the holder the same rights as for the basic patent, namely, also for the use of a combination of the two active substances (ECJ Case No. C-443/12 Actavis ./. Sanofi). This is true even if the other active ingredient is explicitly identified in a claim of the basic patent. 2. A (national) restriction of the basic patent, retroacts to or before the date of the application of the protection certificate concerned. The retroactive effect of the restriction is also essential for the evaluation of the nullity of the protection certificate. 3. It is for the national courts to decide on individual cases based on the ECJ’s interpretation of provisions of Community law. 4. Decisions of the European Court of Justice cannot be the subject of a preliminary ruling. 5. A preliminary ruling is only admissible in the case of pertinence to the ruling of the questions referred to the court.

Du¨sseldorf Regional Court (LG Du¨sseldorf) (Keynotes by the authors only)

XV. Valsartan, 4 b O 280/10 of 8 March 2011 1. To ensure an adequate level of protection of the authorised product, a person holding a patent and also holding an SPC shall be guaranteed an exclusive right for the duration of 15 years. 2. If the basic patent protects other products resp. active ingredients that are not subject matter of the SPC, an exemption from the principle of Art. 5 [RegSPC] is stipulated, that the protective effects of basic patent and SPC are the same. With regard to the ascertainment of the subject matter of an SPC, the patent claims are to be seen fictitiously as mentioning only the active ingredient specified in the SPC which leads to a hypothetic product-bound and purpose-bound patent claim.

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3. An SPC granted for a single-active ingredient doesn’t preclude a simultaneously existing protection of a substance combination. As the [RegSPC] differs between active ingredient and substance combination, it does not follow that a substance combination cannot be subject matter of an SPC granted on the basis of an authorisation issued for a single-active ingredient. 4. The exclusion of double grants does not preclude that a product falls in the scope of protection of different Certificates. On and the same matter may infringe several protection rights to the extent their scopes of protection form an intersection.

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A3. UK Courts* Court of Appeal of England & Wales I. E I Du Pont Nemours & Co. v UK Intellectual Property Office [2009] EWCA Civ 966, [2010] R.P.C. 6 (1) Art. 8(d) RegSPC requires that an application for a paediatric extension must contain a marketing authorisation including a statement in accordance with Art. 28(3) RegMPP; a statement from the Paediatric Committee indicating that a Paediatric Investigation Plan has been complied with is insufficient. (2) However, failure to comply with this requirement (including when the marketing authorisation including the Art. 28(3) RegMPP statement was not available at the date of the application for an extension) is an irregularity that can be rectified subsequently pursuant to Art. 10(3) RegSPC.

II. Medeva BV v Comptroller General of Patents, Designs and Trade Marks [2010] EWCA Civ 700; [2010] R.P.C. 27 (1) A reference to the CJEU is required in respect of what is meant in Art. 3(a) RegSPC by “the product is protected by a basic patent in force” and whether Art. 3(b) permits the grant of a SPC for a single active ingredient (or combination of active ingredients) where the basic patent protects the single active ingredient or (combination of active ingredients) but the approved medicinal products contains additionally one or more other active ingredients. (2) A decision on these questions is necessary for the Court of Appeal to give judgment in this case for the following reasons: First, there is substantial doubt whether the judgment of the CJEU in Farmitalia Carlo Erba SRL’s SPC Application [1999] ECR I5553 (Farmitalia) answered any of the questions. Second, though Jacob J. in Takeda Chemical Industries Ltd v Comptroller General of the Patent Office (No.3) [2003] EWHC 649 (Pat) considered the issues on Article 3(a) to be acte claire because of the decision of the Swedish Courts to which he referred this may not now be the position in Norway or Germany. Third, both Kitchin J. in Gilead Sciences, Inc’s SPC Applications [2008] EWHC 1902 (Pat) and Arnold J. in Astellas Pharma Inc v Comptroller-General of Patents [2009] EWHC 1916 considered that at least some of the issues which arise on this appeal are not acte claire. Fourth, the repeated emergence of these or similar issues in this jurisdiction, notwithstanding the judgment of the CJEU in Farmitalia indicates the need for the definitive answers which only the CJEU can give. Fifth, Farmitalia was in any event decided ten years ago and this is a rapidly developing area of jurisprudence

III. Neurim Pharmaceuticals (1991) Ltd v Comptroller General of Patents [2011] EWCA Civ 228; [2011] R.P.C. 19 (1) A reference to the CJEU is required in respect of whether, when a marketing authorisation (A) has been granted for a medicinal product comprising an active ingredient, Art. 3(d) RegSPC is to be construed as precluding the grant of an SPC based on a later marketing authorisation (B) which is for a different medicinal product *

Keynotes by the authors only.

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comprising the same active ingredient where the limits of the protection conferred by the basic patent do not extend to placing the product the subject of the earlier MA on the market within the meaning of Art. 4 RegSPC. (2) The reference is required because there is much endeavour to find new uses for known active ingredients. If second medical use patents could not get the benefit of an SPC, then the RegSPC will not have achieved its key objects for large areas of pharmaceutical research and, accordingly, would not be fit for purpose.

IV. Medeva BV v Comptroller General of Patents, Designs and Trade Marks [2012] EWCA Civ 523; [2012] R.P.C. 26 (1) Following the CJEU’s judgment in this case (Case C-322/10), the issue for the national court is to determine which active ingredients are specified in the wording of the claims. The ambit of “specified” may range from express naming, through description, necessary implication to reasonable interpretation. Where on that scale the dividing line is to be drawn will necessitate further references in due course in the light of the facts of the cases in which the issue arises. (2) In this case, however, wherever the dividing line is to be drawn the active ingredients relating to vaccines against diphtheria, tetanus, meningitis and polio are excluded. These active ingredients cannot be said to be “specified” in the wording of the claims solely because the use of the word “comprising” in the claims does not exclude other elements.

High Court of England & Wales V. Takeda Chemical Industries Ltd v Comptroller General of the Patent Office (No.3) [2003] EWHC 649 (Pat); [2004] R.P.C. 3 (1) Art. 3(a) RegSPC does not permit SPCs to be granted for combinations of active ingredients (specifically the anti-ulcer agent lansoprazole with two antibiotics selected from clarithromycin, amoxycillin and metronidazole) where the basic patent relates only to one of the active ingredients (specifically the use of lansoprazole for the manufacture of a medicine for preventing or treating infectious diseases caused by Helicobacter pylori). The combinations are not “protected” by the basic patent for the purposes of Art. 3(a) RegSPC simply because the sale of the combinations would infringe the patent; what is protected is only the lansoprazole element of the combinations. (2) The Swedish Courts have come to a similar decision; a reference to the CJEU is not required as the point is acte claire.

VI. Gilead Sciences, Inc’s SPC Applications [2008] EWHC 1902 (Pat) (1) Art. 3(a) RegSPC does permit an SPC to be granted for a combination of active ingredients (specifically the antiretrovirals tenofovir and emtricitabine) where the basic patent contains a claim directed to a composition comprising tenofovir (amongst other compounds) together with a carrier and “optionally other active ingredients”. This case can be distinguished from Takeda Chemical Industries Ltd v Comptroller General of the

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Patent Office (No.3) [2003] EWHC 649 (Pat) (Takeda) on the basis that the basic patent contains a claim directed to a combination of active ingredients. (2) The argument that the skilled person would have attached no particular significance to the claim to the combination is rejected. The scheme of the RegSPC is to provide a simple and straightforward system for the grant of SPCs based only upon a consideration of the requirements laid down in the RegSPC and it can be no part of a determination as to whether a product is protected by a basic patent to embark upon an analysis of whether the patent or the claim in issue is obvious or invalid for any other reason. (3) The question of whether the decision in Takeda is correct merits further consideration by a higher court and perhaps even the CJEU (which has not yet considered how the requirements of the RegSPC are to be interpreted in the case of a medicinal product consisting of a combination of active ingredients where only one is claimed in the basic patent). It is, however, not necessary to do so in this case.

VII. Astellas Pharma Inc v Comptroller-General of Patents [2009] EWHC 1916 (Pat) (1) Art. 3(a) RegSPC does not permit an SPC to be granted for a combination of active ingredients (specifically emodepside and praziquantel) where the basic patent does not disclose or claim praziquantel or a combination of emodepside and praziquantel. What is protected is only the emodepside element of the combination. (2) There is a distinction between the scope of protection and the question of infringement, and it is not clear that the CJEU either endorsed or rejected the infringement case in Farmitalia Carlo Erba SRL’s SPC Application [1999] ECR I5553. There are arguments in favour of the infringement test which do not appear to have been considered in Takeda Chemical Industries Ltd v Comptroller General of the Patent Office (No.3) [2003] EWHC 649 (Pat) that merit further consideration by a higher court and perhaps the CJEU. However, the decision whether to make a reference should be left to the Court of Appeal.

VIII. Novartis Pharmaceuticals UK Ltd v MedImmune Ltd [2012] EWHC 181 (Pat); [2012] F.S.R. 23 (1) The test set out by the CJEU in Medeva (Case C-322/10) and its progeny for determining whether a product was protected by a patent is unclear, particularly in precisely what was meant by “specified or identified in the wording of the claims”. It was inevitable that there would have to be further references to the CJEU to obtain clarification. (2) However, the test laid down by the CJEU in University of Queensland for process claims was narrower than that in Medeva for product claims, as it required the product to be identified in the wording of the claim as the product deriving from the process. There was nothing in the claims or specification of the patent in suit to identify ranibizumab as the product of the process in question. The SPC is therefore invalid.

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IX. Eli Lilly & Company v Human Genome Sciences Inc [2012] EWHC 2290 (Pat) (1) The Patents Court has jurisdiction to grant a declaration that any SPC that may be granted in the future based on a marketing authorisation that may be granted in the future is invalid. (2) The holder of a basic patent could apply for an SPC in reliance on an MA granted to a third party having no connection of any sort with that holder. The issue is sufficiently clear to allow this court to decline to make a reference.

X. Actavis Group PTC EHF and Actavis UK Limited v Sanofi and Sanofi Pharma Bristol-Myers Squibb SNC [2012] EWHC 2545 (Pat); [2013] R.P.C. 24 (1) A further reference to the CJEU is required in relation to the interpretation of Art. 3(a) in the context of combination products and Art. 3(c) RegSPC where multiple products are protected by the claims of a basic patent. (2) The reference in relation to Art. 3(a) RegSPC is required because the CJEU did not answer questions in previous references and the rulings it did make did not provide a clear test which can be applied to cases such as this. Confirmation that the test is not clear is provided by the fact that courts in France, Germany and the Netherlands have already given divergent rulings in parallel cases to this one. Arnold J. expressed his view that to satisfy Art. 3(a) RegSPC a product must infringe a patent because it contains an active ingredient, or a combination of active ingredients, which embodies the inventive advance (or technical contribution) of the basic patent. Where the product is a combination of active ingredients, the combination, as distinct from one of them, must embody the inventive advance of the basic patent. (3) The reference in relation to Art. 3(c) RegSPC is required because it cannot safely be assumed that the EJEU did not intend to change the law as to whether more than one SPC can be granted per basic patent in Medeva merely because it did not say so explicitly.

XI. Eli Lilly & Company v Human Genome Sciences Inc [2012] EWHC 2857 (Pat) (1) A further reference to the CJEU is required in relation to the criteria for deciding whether “the product is protected by a basic patent in force” in Art. 3(a) RegSPC, particularly in the circumstances of this case where the product is not a combination product. A specific question in relation to the facts of this case is required, namely “on the case of a claim to an antibody or a class of antibodies, is it sufficient that the antibody or antibodies are defined in terms of their binding characteristics to a target protein, or is it necessary to provide a structural definition for the antibody or antibodies, and if so, how much?”. The CJEU will be asked to link this case to the Actavis v Sanofi reference.

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XII. Dr Reddy’s Laboratories (UK) Ltd and Dr Reddy’s Laboratories Ltd v Warner-Lambert Company LLC [2012] EWHC 3715 (Pat); [2013] R.P.C. 31 (1) The Patents Court has jurisdiction under Art. 16(1) RegSPC to set aside an SPC extension that has been granted contrary to the provisions of Art. 36 RegMPP but is not under an obligation to do so.

XIII. Glaxosmithkline Biologicals SA v Comptroller-General of Patents, Designs and Trade Marks [2013] EWHC 619 (Pat); [2013] R.P.C. 26 (1) A reference to the CJEU is required in relation to whether an adjuvant which has no therapeutic effect on its own, but which enhances the therapeutic effect of an antigen when combined with that antigen in a vaccine, is an ‘active ingredient’ within the meaning of Art. 1(b) RegSPC and, if not, whether the combination of such an adjuvant with an antigen nevertheless can be regarded as a ‘combination of active ingredients’ within the meaning of Art. 1(b) RegSPC. (2) The reference is required because this issue is not acte claire and there is a divergence of interpretation between the different national authorities on this point. (3) Arnold J. expressed his view that the RegSPC was intended to provide a simple and predictable system that could be operated by the competent authorities of the Member States, and in particular the national patent offices, in a uniform manner. To achieve those objectives, it is necessary to have bright-line rules. Article 1(b) is such a rule. The CJEU was correct to hold in Case C-31/03 Pharmacia Italia SpA [2004] ECR I-10001, Case C-431/04 Massachusetts Institute of Technology [2006] ECR I-4089 and Case C-202/05 Yissum Research and Development Company of the Hebrew University of Jerusalem v Comptroller-General of Patents [2007] ECR I-2839 that it should be strictly interpreted. The result of a strict interpretation is to deny extended protection for what may well be meritorious inventions, but the price of not adopting a strict interpretation is a level of uncertainty and inconsistency which is unacceptable. (4) Arnold J. also observed that this is the third time in six months that he has had to refer questions of interpretation of the RegSPC to the CJEU and that the fact that this should be necessary demonstrates the dysfunctional state of the SPC system at present. This is primarily due to the poor drafting of the RegSPC and to the failure of the European Commission, Council and Parliament to revise it to address the problems which have emerged. Matters have not been assisted, however, by the fact that the CJEU’s recent case law interpreting the RegSPC has not provided the level of clarity and consistency that is required.

XIV. Actavis Group and Actavis UK v Boehringer Ingelheim Pharma [2013] EWHC 2927 (Pat) (1) A further reference to the CJEU is required in relation to the application of Art. 3 RegSPC to combination products, in circumstances where a basic patent “protects” a product containing active ingredient A (Product X) and a product comprising a combination of active ingredient A and active ingredient B (Product Y) and an SPC has already been granted in respect of Product X.

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(2) In addition, questions are referred regarding the effect of amending claims of a basic patent after grant to identify explicitly active ingredients in combination in order to fulfil the condition set out in Art. 3(a) RegSPC.

XV. Eli Lilly & Company v Human Genome Sciences Inc [2014] EWHC 2404 (Pat) (1) The CJEU’s judgment in this case does not give the clear guidance which the reference was designed to obtain, as demonstrated by the fact that both parties considered that the CJEU’s judgment supported their positions. In particular, it is disappointing that the CJEU did not give express guidance in its judgment about what it meant by “specified” in Medeva (Case C-322/10) or “identified” in the subsequent cases when it must have been obvious from the reference that this was what was being sought. (2) The CJEU has clearly held that functional definitions can, in principle, be sufficient to bring an active ingredient within the protection of a basic patent. This is on the condition that the “claims relate implicitly but necessarily and specifically” to the active ingredient. (3) The correct reading of the CJEU’s judgment requires an application of the relevant rules (i. e. Art. 69 EPC or section 125 Patents Act 1977) to ascertain the extent of the invention and what the claims relate to. If the active ingredient in question is covered by the claims, it is protected for the purposes of Art. 3(a) – subject to a proviso. This proviso is explained at paragraph 66 of the CJEU’s judgment and is necessary to reflect the approach of the CJEU in Medeva in relation to products containing combinations of active ingredients. A product is not protected within the meaning of Art. 3(a) solely by virtue of a claim containing general wording that extends the claim beyond its principle scope (such as “comprises”). However, in the absence of such extending words, the Court held that “the claims have a focussed scope and the question is simply whether the product falls within the scope of the claims” (paragraph 66). (4) Lilly had conceded, during the course of these proceedings, that tabalumab falls within the scope of claim 13 of the patent and the proviso did not apply since there were no extending words. Tabalumab was therefore “protected by” the patent within the meaning of Art. 3(a).

Comptroller of Patents XVI. Takeda Chemical Industries Ltd’s Applications [2004] R.P.C. 2 (1) Art. 3 RegSPC does not impose a condition that only one certificate should be granted per basic patent. In Case C–181/95 Biogen Inc v SmithKline Beecham Biologicals SA [1997] R.P.C. 833 (Biogen), where the CJEU stated “Under Article 3(c) [RegSPC], however, only one certificate may be granted for each basic patent”, the CJEU meant that if a patent holder has more than one patent for the same product, he should not be able to obtain more than one SPC for that product. (2) Accordingly, the earlier grant of an SPC for a product which was the single active ingredient, lansoprazole, does not preclude the grant of SPCs, based on the same basic patent, for products which are combinations of lanzoprazole with specific antibiotics.

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XVII. Abbott Laboratories’ SPC Application [2004] R.P.C. 20 (1) Art. 7(1) RegSPC requires that SPC applications be lodged within six months of the date of grant of a marketing authorisation, not the date of publication of the notification of grant. (2) However, the period specified in Art. 7(1) of the Regulation is extendible, in the Comptroller’s discretion, under r.110(1) of the Patents Rules 1995.

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A4. French Courts* Supreme Court I. Decision of 3 April 2007 of the Supreme Court of Paris, “Diagnosis of AIDS” 1. Chiron Corp. filed an SPC application based on a Marketing Authorization granted for a diagnostic kit for AIDS. The French IP Office rejected the SPC application and Chiron Corp. filed an appeal against this decision. 2. Chiron Corp. contended that according to article 1(a) of regulation 1068/92, the term “medicinal product” must be understood as covering any substance presented as capable of being administered to a patient for establishing a diagnosis. The Court of Appeal considered that the diagnostic kit which was the subject of the Marketing Authorization was not a product to be administered, but one that is useful for in vitro diagnosis. 3. Therefore, the Court of Appeal upheld the French IP Office decision to refuse the SPC application. 4. The Supreme Court rejected the appeal formed by Chiron Corp., confirming the Court of Appeal decision.

II. Decision of 19 March 2013 of the Supreme Court, “azoxystrobine + folpel” 1. In 1997, Syngenta filed a first SPC for azoxystrobine, which was granted. Then, on the basis of the same patent, Syngenta filed a second SPC for the combination “azoxystrobine +folpel”. This second SPC referred to a Marketing Authorization for this combination of products. 2. This SPC application was rejected by the French IP Office which considered that it contravened article 3(a) of Regulation 1610/96 since the basic patent claims cover one of the active ingredients, but not a combination. The SPC application was therefore rejected by the French Patent Office. 3. Next, Syngenta proceeded with a limitation of the claims of its patent at the French Patent Office, to protect a combination of active substances. 4. However, the French IP Office rejected the limitation since it considered that amending a claim for a product A by incorporating therein a product B could not constitute a limitation. An appeal against this decision was filed before the Court of Appeal of Paris, which confirmed the decision to refuse the limitation rendered by the Patent Office. 5. However, the French Supreme Court, in its decision of 19th March 2013, overturned the decision of the Court of Appeal and considered that the limitation was acceptable. 6. Syngenta then requested the Court of Appeal of Paris to grant its SPC on the basis of the limited claims. 7. The Court considered that it had to render a decision on the SPC application on the sole basis of the facts that were presented to the French IP Office. As the limitation was made after the French IP Office had rejected the SPC, the Court of Appeal could not take the limitation into consideration. Therefore, the SPC application was considered as not acceptable, in spite of the limitation. *

Headnotes only.

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Court of Appeal of Nancy III. Decision of 14June 2010 of the Court of Appeal of Nancy, “Extract of Timothy-Grass” 1. Stallergenes filed an SPC application on the basis of its patent and its competitor’s Marketing Authorization ALK-Abello A/S. The French IP Office granted the SPC and ALK-Abello filed an appeal against this decision on the basis of article 17(2) of Regulation 1610/96, and recital 17 thereof which provides that article 17(2) applies to SPCs for medicinal products. 2. ALK-Abello A/S contended that the SPC granted to Stallergenes did not refer to the first Marketing Authorization granted for the product Timothy-Grass in the European Union as a previous Danish Marketing Authorization had been granted well before for this product. 3. The Court of Appeal actually considered that the Marketing Authorization of the granted SPC was not the first one in the European Union and cancelled the French IP Office decision to grant the SPC. 4. This decision shows that it is possible for third-parties to oppose the grant of an SPC before the Court of Appeal, when the SPC was not granted with the proper Marketing Authorization.

Court of Appeal of Paris IV. Decision of 15 February 2013 of the Court of Appeal of Paris, “varicellazoster virus” 1. On 16 November 2006, Merck filed an SPC application in France for a pharmaceutical specialty with the varicella-zoster virus as the active ingredient. The Marketing Authorization was for a vaccine to prevent herpes zoster. The French IP Office rejected the SPC application because a former Marketing Authorization had been granted for the same active ingredient to prevent varicella. 2. The French IP Office decision was brought before the Court of Appeal of Paris, which accepted to stay the proceedings until the CJEU issued its decision in the Neurim case (C-130/11). 3. After the Neurim decision was rendered, the Court of Appeal overturned the French IP Office decision, and considered that the product to prevent herpes zona is different from a product to prevent varicella.

V. Decision of 5 July 2013 of the Court of Appeal of Paris, “Peginterferon alpha 2a” 1. F. Hoffmann-La Roche AG filed an SPC application for the product Peginterferon alpha 2 a, which referred to a Marketing Authorization granted on 5 July 2001. The basic patent was filed on 22 May 1997. 2. In the weeks following the grant of the SPC, the SPC proprietor informed the French IP Office that the SPC expiry date had to be corrected. It was indeed determined from the European Union Marketing Authorization, although a Swiss Marketing Authorization had been previously granted.

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3. However, as the new SPC expiry date was earlier than the patent expiry date, the French IP Office did not correct the SPC as granted, but withdrew the decision to grant. The SPC proprietor filed an appeal against this withdrawal decision. 4. The Court of Appeal of Paris took into consideration the CJEU decision in case C125/10 which provides that an SPC having a negative duration may be granted. However, in the present case, the Court of Appeal noted that if the SPC was granted, it would expire more than six months before the patent expiry date. As a result, the SPC could not anyhow benefit from a pædiatric extension. 5. Therefore, the Court of Appeal rejected the Appeal filed by F. Hoffmann-La Roche AG.

VI. Decision of 11September 2013 of the Court of Appeal of Paris, “perflutren” 1. The company Lantheus filed an SPC for the product perflutren. The French IP Office refused the SPC application as a previous Marketing Authorization for perflutren had already been granted. 2. Lantheus contended that the previous Marketing Authorization was for perflutren within human albumin microspheres, whereas the Marketing Authorization on which was based the SPC application was for perflutren in lipidic microspheres, the therapeutic properties of both products being different. Furthermore, Lantheus contended that the product of the previous Marketing Authorization did not fall within the scope of the basic patent. 3. The Court of Appeal considered that the use of the product which was the subject of the two Marketing Authorizations was to establish a diagnosis by echocardiography, so that the application of both these products was the same. Therefore, the Court considered that the conditions of Article 3(d) of the Regulation were not met, and confirmed the French IP Office decision.

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A5. Italian Courts* I. Decision 20/1978 Constitutional Court [The prohibition for patenting medicaments and the processes directed to their production is not only founded on specific reasons which now do no more correspond to reality, but neither it can be said to be coherent with the general interest of the safeguard of public health, which Art. 32 of Italian Constitution refers to. It is therefore an unjustified derogation to the “par condicio” of industrial inventors, concerning both the personal right to the acknowledgement of the right of inventorship and to the economic situations of advantage which the right of exclusive provides; on the other hand, it disadvantages the entrepreneurs of the pharmaceutical field with respect to the ones of others fields, and further hinders the advancement of scientific and technical research, which is a duty of the Republic. Therefore, the first paragraph of Article 14 of the Royal Decree, 29th July 1939, n. 1127 (Text of Legal Provisions in Matter of Patents for Industrial Inventions) is constitutionally unlawful – contrary to Articles 3, 41 and 9 of Italian Constitution]

II. Court of Milan Irbesartan Hydrochlorotiazide 57598/12 of 22/12/2012 [In other words, a “basic patent” can give rise to as many Complementary Protection Certificates as many “products” are protected by the patent, (page 11) […] the two CCPs of Sanofi relate to two “products” which are different between them, i. e. “irbesartan” and “irbesartan and hydrochlorothiazide” (page 12) […]…]

III. Court of Rome case 23499 of 19/05/2003 [while the patent can have as its object a medicament, a product comprised in the composition of the medicament, the use of a product as medicament, a process for the manufacturing, the marketing authorization, whose reason is the safeguard of public health, has only the medicament as its object (page 8) […] if the object of the patent is a process, the patent owner has the right to prevent third parties, unless by his consent, even only to “apply the process”, being in any case infringement of the patent (page 11) […] …]

IV. Court of Milan case 57598/2012 of 10 July 2014 [In conclusion, this Board believes that the provisions of the ECJ decision [C-443/12] must be complied with and that SPC ‘653, granted lacking the requirement of Art. 3(c) Reg. 469/2009, as interpreted by ECJ with the Actavis Decision, must be declared null.…]

V. Commissione dei Ricorsi case 6895 of 20/06/2002 [a Marketing Authorization granted in compliance with the legislation of EFTA States is to be considered equivalent […] to the one granted incompliance with the EU Directives mentioned in Art. 3 Reg. 1768/1992…] *

Headnotes and relevant passages only.

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VI. Commissione dei Ricorsi case 6353 of 19/04/1996 [For being able to enforce any right of protection and lapse of such a right, it is necessary that its owner can know the condition upon which he can exercise it. In the present case, this knowledge can be achieved only when the grant of the Marketing Authorization is published in the Official Gazette…]

VII. Commissione dei Ricorsi case 6491 of 16/12/1997 and 6497 of 17/01/2000. [The Director of the Patent Office acknowledged that SPC extends its protection to salts and esters…] [The SPC confers the same protection of the basic patent and is valid, on condition that there is a Marketing authorization of a medicine that contains as active ingredient a substance claimed in the basic patent or one of its different salts (salts and esters), if claimed.

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A6. Dutch Courts* District Court of The Hague, Administrative Law Division I. Genzyme Biosurgery v. NLOC of 3 June 2004 An SPC can be granted for a medical device. The mere fact that in art. 2 of the SPCRegulation no reference is made to Directive 93/42/EEC does not necessarily prohibit the SPC-Regulation from being applied. Only if the safety, quality and usefulness of the substance (for which the SPC is requested), taking into account the intended purpose of the device, have been verified by analogy with the appropriate methods specified in Directive 75/318/EEC (now also 2001/83/EC), it can be justified that an SPC be granted in view of the delay accompanying market authorization procedures, as is the case for medicinal products that have been subjected to procedures of the Directive 65/65/EEC.

II. Stallergenes v. NLOC of 4 November 2009 The court noted that no SPC should be granted when the patent proprietor is not the holder of the market authorization for the medicinal product protected by the basic patent. As the SPC applicant had itself not conducted the pharmaceutical research necessary to obtain the market authorization, it cannot be said that the development of the product described by the patent had been delayed by the application for a market authorization. A grant would not be in line with the aim of the SPC regulation. The description of the active ingredient under the heading “qualitative and quantitative composition” of the market authorization is decisive in order to answer the question of what the ‘product’ should be within the meaning of the SPC Regulation. Where a market authorization has already been issued for an active ingredient, no SPC can be granted.

III. Aventis v. NLOC of 28 May 2008 The basic patent protects the combination of a specific antibody such as cetuximab with an anti-neoplastic agent such as irinotecan; not the substance cetuximab alone. The grant of an SPC for cetuximab alone was therefore rightly refused.

IV. Actavis v. NLOC of 23 September 2009 The court held that it is not possible for third parties to oppose the grant of an SPC. The effect of article 18 of the SPC-Regulation is limited by article 19 (2) which explicitly excludes opposition against the decision to grant a certificate.

*

Headnotes and relevant passages only.

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District Court of The Hague, Civil Law Division V. Sanofi v. Teva of 14 September 2012 (later revoked, see Teva v. Sanofi of 27 August 2013) The combination irbesartan/HCTZ falls under the scope of protection of the basic patent and is a different product to irbesartan. The combination SPC does not contravene the purpose of the SPC-Regulation because the combination irbesartan/HCTZ according to the definition of “product” in the sense of the SPC-Regulation, means a different product, and not just another means of administering irbesartan, which also requires a separate market authorization.

VI. Mylan B.V. v. Janssen Pharmaceuticals Inc. of 11 December 2013 In this case Mylan challenged the validity of an SPC (in force) based on the lack of inventive step of the basic patent (expired). Based on the objections of Mylan, the SPC was revoked since the invention of the basic patent is obvious to a person skilled in the art. The basic patent is not revoked since it expired and Mylan provided no evidence or explanation why revocation would be of interest.

Court of Appeal of The Hague, Civil Law Division VII. SKF v. Centrafarm of 19 May 1994 SPC Regulation 1768/92 is not applicable to medicinal products for which a markt authorization was issued before 1 January 1985. No SPC can therefore be granted in such a case.

VIII. Pfizer v. UVIT & Pfiver v. VGZ of 24 July 2012 Health insurance companies, in the case at hand UVIT and VGZ who send invitations to pharmaceutical companies to make an offer and to negotiate a supplier agreement, are acts which are not considered trading. The court ruled that sending an invitation by a health insurance company is not eliciting or inciting patent infringement. Bidding by the potential suppliers within the patent term is an infringing act. Provoking such acts could in principle be unlawful, There was however no proof that any infringing offers to supply were made during the SPC term.

IX. APE v. PTC of 23 April 2013 The Court of Appeal upheld the decision of the summary proceedings judge to hold himself competent to receive cases in which at least a Dutch defendant is accused of cross-border infringement.

X. Teva v. Sanofi of 27 August 2013 Only one SPC per patent can be granted in cases where the SPC is based on a market authorization for a combination medicinal product, in which the active ingredient is explicitly covered by the basic patent and a further active ingredient not explicitly 163

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claimed or protected as such by the basic patent. The ruling of the appeal court thus overturned the ruling in first instance.

Council of State XI. Yeda v. NLOC of 19 August 2009 No broad product description allowable for a monoclonal antibody. The District court ruling was confirmed in that the case at hand differs considerably from the situation as evaluated in the Farmitalia-decision and that NLOC had therefore no reason to depart from the description of the active ingredient in the market authorization regarding the product description of the SPC granted to Yeda.

XII. Yeda v. Aventis en NLOC of 27 May 2009 The District Court has rightfully found that the Patent Office was not obligated to issue a Supplementary Protection Certificate for the medicinal product cetuximab. Article 73 (1) of the Dutch Patents Act 1995 on indirect infringement, does not in all circumstances protect the patentee against the sale or distribution of cetuximab, an essential means regarding the patented combination of cetuximab and irinotecan.

XIII. Syngenta v. NLOC of 18 February 2015 4.1 The Council of State concluded that article 17(2) of the of Regulation (EC) no. 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products (OJ 1996 L 198/30; hereinafter referred to as: ‘the Regulation’), provides for the possibility of appeal aimed at extending the duration of a supplementary protection certificate if the date of the first authorization for placing the product on the market in the Community as stated in the application for the certificate proves to be incorrect. Article 17(2) of the Regulation does not prescribe a time limit for filing this appeal. Contrary to paragraph 1, this provision does not include a reference to appeals under national law either. In introducing the appeal in paragraph 2 the Council considered it important that the relevant authorities do not check whether the date of the first authorization used to calculate the expiry date of the certificate is correct. As such, a considerable period of time may have elapsed since the grant of the certificate before it becomes clear that the expiry date of the certificate is incorrect. The Division infers from this that the purpose of this provision was to introduce an appeal that is not subject to a time limit.

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A7. Swiss Courts Federal Administrative Court I. “Panitumumab”, No. B-3245/2010, Decision of 18 August 2011 of the Federal Administrative Court1 Before the expiration of its patent on therapeutic combinations of a monoclonal antibody against the human receptor for epidermal growing factor with antineoplastic agents, the patentee applied for an SPC for its product “Panitumumab” with the Institute. The Institute rejected the application, arguing that the product “Panitumumab” differed from the basic patent, which claimed a combination of a monoclonal antibody (such as “Panitumumab”) with an antineoplastic active ingredient. Therefore, the application of the patentee would not meet the requirements of Art. 140 b para. 1 lit. a PatA. The patentee appealed against the decision of the Institute with the Swiss Federal Administrative Court, which rejected the appeal with the following arguments: Art. 140 a et seqq. PatA: The fundamental idea of the SPC – the compensation of the disadvantages due to the long-lasting admission procedure for medicines – must always be accommodated in the interpretation of the relevant legal norms (consid. 2.1). Art. 140 b para. 1 lit. a PatA: It is possible to obtain an SPC for a product that is the result of the use of the invention only. Therefore, the SPC must relate to an application of the invention within the scope of protection of the basic patent, although it does not need to be the patented object (consid. 2.3). Art. 140 b para. 1 lit. a PatA: If the key aspect of an invention is the combination of various compounds, an individual compound does not constitute an embodiment of the invention. Every additional element which is important for the patented invention limits the scope of protection of the basic patent. The mere fact that it is possible to administer the individual active ingredients separately according to a dependent patent claim does not change that (consid. 5.1–5.3 und consid. 6).

II. “Exenatide”, No. B-1019/2010, Decision of 20 October 2010 of the Federal Administrative Court2 In 2007, Amylin Pharmaceuticals applied for two SPCs for the active ingredient “Exenatide”: one based on a European patent covering a certain dose of exendines and the other one based on a European patent covering the use of exendines. The Institute responded that only one SPC could be granted for each product. Amylin thereupon requested that both application procedures be suspended until the decision of the EPO with regard to the opposition formed against the first of the two patents. Due to the opposition, Amylin argued, it was not certain which patent was more suitable as a basic patent for the SPC. The Institute denied the request for the suspension of the procedures, against which Amylin appealed before the Federal Administrative Court. The Federal Administrative Court rejected the appeal based on the following grounds:

1 Decision of 18 August 2011 of the Federal Administrative Court, No. B-3245/2010, “Panitumumab”, published in sic! 2012, p. 48 et seqq. 2 Decision of 20 October 2010 of the Federal Administrative Court, No. B-1019/2010, “Exenatide”, published in sic! 2011, p. 249 et seqq.

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Art. 140 m, Art. 59 a para. 3, Art. 46 a, Art. 47 PatA; Art. 127 a para. 2, Art. 127 e para. 3, Art. 127 f para. 2, Art. 62 para. 1 PatO: The application procedure is generally to be conducted in an expeditious and rather suspension-adverse way, not only in the interest of the applicant, but also in the interest of third parties (consid. 4.2). Art. 140 b para. 2, Art. 140 f para. 1 lit. a, Art. 140 e para. 1 PatA; Art. 127 b para. 2 PatO: The interests of manufacturers of generics were met not only by restricting the scope of protection of the SPC, but also by providing that a decision on the SPC is to be made as early as possible (consid. 4.3).

III. “Etanercept”, BVGE 2010/48, No. B-3064/2008, Decision of 13 September 2010 of the Federal Administrative Court3 In the case at hand, the patent was not granted to the claimant until 13 years after filing the patent. Meanwhile, three other patents with similar active ingredients had been granted. A company related to the claimant obtained the MA of the product “Enbrel” containing the active ingredient “Etanercerpt”, which was protected by all of the four aforementioned patents. Based on that MA, the owners of the other three patents applied for an SPC under Art. 140 a et seqq. PatA before the Institute, which were granted. The claimant applied for an SPC as well but the Institute rejected the application, arguing that an SPC had already been granted in the sense of Art. 140 c para. 3 PatA. The claimant appealed against said decision before the Swiss Federal Administrative Court, which admitted the appeal with the following arguments: Art. 140 a PatA: A Swiss legal provision that was copied from European law on purpose must – subject to the Swiss methodology – be interpreted in conformity with European law (consid. 3). Art. 140 a, Art. 140 b PatA: The term “active ingredient” is narrower than “patented invention”, but broader than the term “medicinal product”, which is again broader than the term “first MA” (consid. 5.1). Art. 140 f, Art. 140 b para. 2 PatA: The regulation of the protection by SPC at a very early stage is in the interest of the competitors; it is not solely an implementation rule (consid. 5.3 und consid. 6.1). Art. 140 c para. 1 PatA: The owner of the patent is the one who is entitled to an SPC, not the one who obtained the MA and bore the costs (consid. 5.4). Art. 140 c para. 3 PatA: This provision is to be construed as meaning that an SPC can be granted to every applicant not having received an SPC for the same product yet, even if other applicants have already received an SPC (consid. 8.1). Art. 2 para. 2 Civil Code; Art. 140 f para. 1 lit. b PatA: The grant of an SPC can be refused so as to avoid abuses of rights, for instance if an applicant delays the first MA or the grant of his patent with the sole intention of obtaining a longer commercial life according to Art. 140 f para. 1 lit. b PatA, if he delays the grant procedure on purpose or if he tries to obtain an additional SPC by fraud through a front man (consid. 8.2).

3 Decision of 13 September 2010 of the Federal Administrative Court, BVGE 2010/48, cf. No. B-3064/ 2008, “Etanercept”, published in sic! 2011, p. 113 et seqq.

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Federal Supreme Court IV. “Alendronsa¨ure II”, No. 4A_52/2008, Decision of 29 April 2008 of the Federal Supreme Court4 The two plaintiffs claimed the nullity of the SPC of the defendant in a nullity proceeding, claiming that the basic patent was invalid. In his reply, the defendant demanded that the basic patent be limited in order to be valid. He concluded that after the limitation, the SPC was based on a valid basic patent and thus valid as well. The Commercial Court of Zurich held in a decision dated 19 December 2007 that the patent’s – undisputed – invalidity could not be met by means of a limitation. The Federal Supreme Court rejected the Commercial Court’s view and held that a limitation was permitted in the event of a partial nullity of the patent according to Art. 27 para. 1 PatA. It thus admitted the appeal and overruled the decision of the Commercial Court of Zurich based on the following grounds: Art. 74 in conjunction with Art. 26 PatA: There is a protected interest in the declaratory judgement concerning the validity of the SPC for its term of protection, even if the term of protection of the SPC has expired (consid. 1.2). Art. 140 k para 1 lit. d and e, Art. 140 d para 1, Art. 27 PatA: In a nullity proceeding against an SPC, it must be examined preliminarily whether the basic patent that is to be limited still covers the product for which the SPC was granted (consid. 2).

V. “Fluoxetin”, No. 4P.11/1999, Decision of 27 May 1999 of the Federal Supreme Court5 The claimant requested a preliminary injunction against the defendant due to the latter’s alleged infringement of the claimant’s SPC covering the process for manufacturing the active ingredient fluoxetin. The judge granting the preliminary injunction did not expressly state in his order that the infringement of the protected process by equivalent means would also be considered an infringement of the SPC, albeit an amendment request by the claimant in that respect. The claimant thus appealed against the preliminary injunction before the Swiss Federal Supreme Court, which held: Art. 140 d PatA: The scope of protection of the SPC cannot exceed the one of the basic patent. If the basic patent is a process patent, the SPC protects the active ingredient only insofar as it was produced according to the patented process (consid. 2).

VI. “Arzneimittel”, No. 4A.7/1998, Decision of the Federal Supreme Court of 17 November 19986 The claimant applied for a SPC on 12 October 1995 for the combination of the active ingredients “Desogestrel and Ethinyl estradiol” which was protected by a European patent filed in 1981. The Institute rejected the application, arguing that a first MA in the sense of Art. 140 b para. 2 PatA was missing because a product containing the same 4 Decision of the Federal Supreme Court of 29 April 2008, No. 4A_52/2008, “Alendronsa ¨ ure II”, published in sic! 2008, p. 643 et seqq. 5 Decision of the Federal Supreme Court of 27 May 1999, No. 4P.11/1999, “Fluoxetin”, published in sic! 1999, p. 655 et seqq. 6 Decision of the Federal Supreme Court of 17 November 1998, No. 4A.7/1998, “Arzneimittel”, published in sic! 1999, p. 153 et seqq.

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active ingredients had already been authorised in 1982. The claimant appealed against the decision of the Institute before the former Federal Appeal Commission for Intellectual Property, which granted the appeal and instructed the Institute to grant the SPC. The former Federal Department of Justice and Police appealed against said decision before the Federal Supreme Court, which rejected the appeal based on the following considerations: Art. 140 b, Art. 140 e para. 1 PatA: Protection by a SPC subsequent to the expiry of patent protection remains out of consideration if the period between the filing date and the date of the first MA is less than five years (consid. 2). 7 Art. 140 a para. 1 PatA: The term “combination of active ingredients” is to be construed in a differentiated way and cannot be considered in a schematic way. The mere existence of the same active ingredients does not necessarily lead to the products being the same one. A new combination of active ingredients differing from an already earlier patented and as a medicinal product authorised product only in its dosage can therefore constitute an independent product in the sense of the PatA (consid. 3). Art. 140 k para. 1 lit. c PatA: The Institute is to act on the assumption of the validity of the specified basic patent during the examination procedure as long as there is no civil judgment declaring it invalid (consid. 3).

VII. “Fosinopril”, 124 III 375, Decision of the Federal Supreme Court of 10 July 19988 Based on its European patent, the claimant filed an application for an SPC for the combination of the active ingredients “Fosinopril and Hydrochlorothiazide”. The Institute rejected the application, stating that the combination of the two active ingredients fosinopril and hydrochlorothiazide was not protected by the basic patent. The claimant appealed against the decision of the Institute before the former Federal Appeal Commission for Intellectual Property, which granted the appeal and instructed the Institute to grant the SPC. The Federal Department of Justice and Police appealed against said decision before the Federal Supreme Court, which rejected the appeal due to the following considerations: Art. 140 b PatA: An SPC can be claimed for a product which is authorised as a medicinal product and which consists of two active ingredients even if the basic patent claims and describes only one of the two active ingredients (consid. 2). Art. 140 b, Art. 140 d PatA: The protection of an SPC does not exceed the protection granted by its basic patent. The scope of protection of an SPC is narrower than the one of its basic patent because an SPC cannot be obtained for the patented invention itself, but rather for a specific product manufactured in application of the invention and authorised in Switzerland as a medicinal product (consid. 3). Art. 140 a para. 2 PatA9: Only one SPC is granted per product. If an SPC has already been granted for an active ingredient,that does not preclude the grant of an SPC for the combination of said active ingredient with another active ingredient if the other requirements are fulfilled. The combination of the two active ingredients is another product (consid. 4).

7 See the change of practice of the Institute of June 2012 (N 68 et seqq.), according to which an SPC can now also be granted in the case of a negative protection period. 8 Decision of the Federal Supreme Court 124 III 375 et seqq, “Fosinopril”, sic! 1998, p. 594 et seqq. 9 Cf. Art. 140 c para. 2 PatA in the version of 9 October 1998, in force since 1 May 1999.

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Federal Appeal Commission for Intellectual Property VIII. “Differin Gel”, No. PA 02/03, Decision of 21 January 2005 of the Federal Appeal Commission for Intellectual Property10 The claimant had applied for an SPC based on a MA for “differin cre`me” dated 15 December 1999. The Institute objected and pointed out that the first MA for “differin gel” had been granted on 8 August 1995. The claimant subsequently requested a correction of his application, replacing the filed MA by other MAs granted on 8 August 1995. The claimant argued that the correction was justified because of an error committed by his assignee who had omitted to inform him about the interpretation of the Institute of the requirement of the “first MA”. Alternatively, the claimant argued that a new MA had been necessary for the “cre`me” product, which was not the same product as the one covered by the first MA, and the claimant contested the Institute’s competence to determine the definition of “first MA”. The Institute rejected the application for the SPC due to the expiry of the time limit according to Art. 140 f para. 2 PatA. The claimant appealed against that decision, which was rejected by the former Federal Appeal Commission for Intellectual Property for the following reasons: Art. 140 f para. 2 PatA: The expiry of the time limit of six months stipulated in Art. 140 f PatA leads to forfeiture, which is why the application will be rejected (consid. 2). Art. 140 b, Art. 140 f PatA: The Institute must examine whether the conditions for the grant of an SPC are fulfilled. It is obliged to examine whether the time limit set out in Art. 140 b PatA was met and to determine which MA is the one that was granted first for the medicinal product (consid. 3). Art. 140 a, Art. 140 b, Art. 140 f PatA; Art. 12 OMP: The terms “first MA” (in the sense of Art. 140 f PatA) and “admission” (in the sense of Art. 12 OMP) must be distinguished. Whereas Art. 12 OMP stipulates that a new admission is required in cases of “considerable modifications”, which includes not only the modification of the active ingredients, but also the modification of the pharmaceutical form of the medicinal product, a MA according to Art. 140 a PatA depends on the active ingredients of the product exclusively. Therefore, every modification of the pharmaceutical form of a medicinal product will lead to a new marketing authorisation to place the product on the market, which is not to be considered as “first MA” in the sense of Art. 140 b para. 2 PatA though (consid. 3).

IX. “Ciclosporin”, No. PA 03/97, Decision of the former Federal Appeal Commission for Intellectual Property of 30 April 199911 Following the application of the claimant for a SPC concerning the active ingredient “Ciclosporin”, the Institute argued that the first MA had been granted on 18 December 1982 already, and not on 8 November 1995 as filed by the claimant. According to the Institute, the reason was that a “product” in the sense of the SPC regime did not mean an authorised pharmaceutical speciality, but rather an active ingredient. Consequently, 10 Decision of the Federal Appeal Commission for Intellectual Property of 21 January 2005, No. PA 02/ 03, “Differin Gel”, published in sic! 2005, p. 590 et seqq. 11 Decision of the Federal Appeal Commission for Intellectual Property of 30 April 1999, No. PA 03/97, “Ciclosporin”, published in sic! 1999, p. 449 et seqq.

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the time for applying for the SPC had elapsed and the Institute was obliged to reject the application. The claimant appealed against that decision before the former Federal Appeal Commission for Intellectual Property, which granted the appeal for the following reasons: Art. 140 a PatA: SPC are supposed to compensate at least partially for the disadvantages resulting from the long MA procedure for medicinal products. When interpreting the provisions concerning SPCs, this fundamental idea must be kept in mind (consid. 4). Art. 140 a para. 1 PatA: The term “combination of active ingredients” requires a differentiated interpretation. In the pharmaceutical field, the mere existence of the same active ingredients does not necessarily mean that it is the same product. Rather, the specific combination of the active ingredient is decisive with regard to the grant of an SPC. The same applies to the term “active ingredient” (consid. 4). Art. 140 a, Art. 140 b PatA: The Institute is to act on the assumption of the validity of the specified basic patent during the examination procedure. In the case of a product patent, the Institute is thus to act on the assumption that it contains a new product (consid. 4b).

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Annex B Selected Legal Sources B1. International Treaties EPC: European Patent Convention, OJ EPO Special edition No 1/2007 Article 54. Novelty (1) An invention shall be considered to be new if it does not form part of the state of the art. (2) The state of the art shall be held to comprise everything made available to the public by means of a written or oral description, by use, or in any other way, before the date of filing of the European patent application. (3) Additionally, the content of European patent applications as filed, the dates of filing of which are prior to the date referred to in paragraph 2 and which were published on or after that date, shall be considered as comprised in the state of the art. (4) Paragraphs 2 and 3 shall not exclude the patentability of any substance or composition, comprised in the state of the art, for use in a method referred to in Article 53(c), provided that its use for any such method is not comprised in the state of the art. (5) Paragraphs 2 and 3 shall also not exclude the patentability of any substance or composition referred to in paragraph 4 for any specific use in a method referred to in Article 53(c), provided that such use is not comprised in the state of the art. Article 63. Term of the European patent (1) The term of the European patent shall be 20 years from the date of filing of the application. (2) Nothing in the preceding paragraph shall limit the right of a Contracting State to extend the term of a European patent, or to grant corresponding protection which follows immediately on expiry of the term of the patent, under the same conditions as those applying to national patents: (a) in order to take account of a state of war or similar emergency conditions affecting that State; (b) if the subject matter of the European patent is a product or a process for manufacturing a product or a use of a product which has to undergo an administrative authorisation procedure required by law before it can be put on the market in that State. (3) Paragraph 2 shall apply mutatis mutandis to European patents granted jointly for a group of Contracting States in accordance with Article 142. (4) A Contracting State which makes provision for extension of the term or corresponding protection under paragraph 2(b) may, in accordance with an agreement concluded with the Organisation, entrust to the European Patent Office tasks associated with implementation of the relevant provisions.

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Article 138. Revocation of European patents (1) Subject to Article 139, a European patent may be revoked with effect for a Contracting State only on the grounds that: (a) the subject matter of the European patent is not patentable under Articles 52 to 57; (b) the European patent does not disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art; (c) the subject matter of the European patent extends beyond the content of the application as filed or, if the patent was granted on a divisional application or on a new application filed under Article 61, beyond the content of the earlier application as filed; (d) the protection conferred by the European patent has been extended; or (e) the proprietor of the European patent is not entitled under Article 60, paragraph 1. (2) If the grounds for revocation affect the European patent only in part, the patent shall be limited by a corresponding amendment of the claims and revoked in part. (3) In proceedings before the competent court or authority relating to the validity of the European patent, the proprietor of the patent shall have the right to limit the patent by amending the claims. The patent as thus limited shall form the basis for the proceedings.

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B2. European Primary Law TFEU: Consolidated Version of the Treaty on the Functioning of the European Union, OJ C 115 of 9 May 2008, p. 47 et seqq. (extract) Article 34 (ex Article 28 TEC) Quantitative restrictions on imports and all measures having equivalent effect shall be prohibited between Member States. Article 35 (ex Article 29 TEC) Quantitative restrictions on exports, and all measures having equivalent effect, shall be prohibited between Member States. Article 36 (ex Article 30 TEC) The provisions of Articles 34 and 35 shall not preclude prohibitions or restrictions on imports, exports or goods in transit justified on grounds of public morality, public policy or public security; the protection of health and life of humans, animals or plants; the protection of national treasures possessing artistic, historic or archaeological value; or the protection of industrial and commercial property. Such prohibitions or restrictions shall not, however, constitute a means of arbitrary discrimination or a disguised restriction on trade between Member States. Article 37 (ex Article 31 TEC) 1. Member States shall adjust any State monopolies of a commercial character so as to ensure that no discrimination regarding the conditions under which goods are procured and marketed exists between nationals of Member States. The provisions of this Article shall apply to any body through which a Member State, in law or in fact, either directly or indirectly supervises, determines or appreciably influences imports or exports between Member States. These provisions shall likewise apply to monopolies delegated by the State to others. 2. Member States shall refrain from introducing any new measure which is contrary to the principles laid down in paragraph 1 or which restricts the scope of the articles dealing with the prohibition of customs duties and quantitative restrictions between Member States. 3. If a State monopoly of a commercial character has rules which are designed to make it easier to dispose of agricultural products or obtain for them the best return, steps should be taken in applying the rules contained in this Article to ensure equivalent safeguards for the employment and standard of living of the producers concerned. Article 168 (ex Article 152 TEC) 1. A high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities. Union action, which shall complement national policies, shall be directed towards improving public health, preventing physical and mental illness and diseases, and obviating sources of danger to physical and mental health. Such action shall cover the fight against the major health scourges, by promoting research into their causes, their

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transmission and their prevention, as well as health information and education, and monitoring, early warning of and combating serious cross-border threats to health. The Union shall complement the Member States’ action in reducing drugs-related health damage, including information and prevention. 2. The Union shall encourage cooperation between the Member States in the areas referred to in this Article and, if necessary, lend support to their action. It shall in particular encourage cooperation between the Member States to improve the complementarity of their health services in cross-border areas. Member States shall, in liaison with the Commission, coordinate among themselves their policies and programmes in the areas referred to in paragraph 1. The Commission may, in close contact with the Member States, take any useful initiative to promote such coordination, in particular initiatives aiming at the establishment of guidelines and indicators, the organisation of exchange of best practice, and the preparation of the necessary elements for periodic monitoring and evaluation. The European Parliament shall be kept fully informed. 3. The Union and the Member States shall foster cooperation with third countries and the competent international organisations in the sphere of public health. 4. By way of derogation from Article 2(5) and Article 6(a) and in accordance with Article 4(2)(k) the European Parliament and the Council, acting in accordance with the ordinary legislative procedure and after consulting the Economic and Social Committee and the Committee of the Regions, shall contribute to the achievement of the objectives referred to in this Article through adopting in order to meet common safety concerns: (a) measures setting high standards of quality and safety of organs and substances of human origin, blood and blood derivatives; these measures shall not prevent any Member State from maintaining or introducing more stringent protective measures; (b) measures in the veterinary and phytosanitary fields which have as their direct objective the protection of public health; (c) measures setting high standards of quality and safety for medicinal products and devices for medical use. 5. The European Parliament and the Council, acting in accordance with the ordinary legislative procedure and after consulting the Economic and Social Committee and the Committee of the Regions, may also adopt incentive measures designed to protect and improve human health and in particular to combat the major cross-border health scourges, measures concerning monitoring, early warning of and combating serious cross-border threats to health, and measures which have as their direct objective the protection of public health regarding tobacco and the abuse of alcohol, excluding any harmonisation of the laws and regulations of the Member States. 6. The Council, on a proposal from the Commission, may also adopt recommendations for the purposes set out in this Article. 7. Union action shall respect the responsibilities of the Member States for the definition of their health policy and for the organisation and delivery of health services and medical care. The responsibilities of the Member States shall include the management of health services and medical care and the allocation of the resources assigned to them. The measures referred to in paragraph 4(a) shall not affect national provisions on the donation or medical use of organs and blood.

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CFREU: Charter of Fundamental Rights of the European Union, OJ C 364 of 18 December 2000, p. 1 et seqq. (extract) Article 17. Right to property 1. Everyone has the right to own, use, dispose of and bequeath his or her lawfully acquired possessions. No one may be deprived of his or her possessions, except in the public interest and in the cases and under the conditions provided for by law, subject to fair compensation being paid in good time for their loss. The use of property may be regulated by law in so far as is necessary for the general interest. 2. Intellectual property shall be protected.

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B3. European Regulations egSPC: Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the Supplementary Protection Certificate for medicinal products, OJ L 152 of 16 June 2009, p. 1 et seqq. (codified version, extract) Recitals (1) Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products has been substantially amended several times. In the interests of clarity and rationality the said Regulation should be codified. (2) Pharmaceutical research plays a decisive role in the continuing improvement in public health. (3) Medicinal products, especially those that are the result of long, costly research will not continue to be developed in the Community and in Europe unless they are covered by favourable rules that provide for sufficient protection to encourage such research. (4) At the moment, the period that elapses between the filing of an application for a patent for a new medicinal product and authorisation to place the medicinal product on the market makes the period of effective protection under the patent insufficient to cover the investment put into the research. (5) This situation leads to a lack of protection which penalises pharmaceutical research. (6) There exists a risk of research centres situated in the Member States relocating to countries that offer greater protection. (7) A uniform solution at Community level should be provided for, thereby preventing the heterogeneous development of national laws leading to further disparities which would be likely to create obstacles to the free movement of medicinal products within the Community and thus directly affect the functioning of the internal market. (8) Therefore, the provision of a supplementary protection certificate granted, under the same conditions, by each of the Member States at the request of the holder of a national or European patent relating to a medicinal product for which marketing authorisation has been granted is necessary. A regulation is therefore the most appropriate legal instrument. (9) The duration of the protection granted by the certificate should be such as to provide adequate effective protection. For this purpose, the holder of both a patent and a certificate should be able to enjoy an overall maximum of 15 years of exclusivity from the time the medicinal product in question first obtains authorisation to be placed on the market in the Community. (10) All the interests at stake, including those of public health, in a sector as complex and sensitive as the pharmaceutical sector should nevertheless be taken into account. For this purpose, the certificate cannot be granted for a period exceeding five years. The protection granted should furthermore be strictly confined to the product which obtained authorisation to be placed on the market as a medicinal product. (11) Provision should be made for appropriate limitation of the duration of the certificate in the special case where a patent term has already been extended under a specific national law.

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Article 1. Definitions For the purposes of this Regulation, the following definitions shall apply: (a) ‘medicinal product’ means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals; (b) ‘product’ means the active ingredient or combination of active ingredients of a medicinal product; (c) ‘basic patent’ means a patent which protects a product as such, a process to obtain a product or an application of a product, and which is designated by its holder for the purpose of the procedure for grant of a certificate; (d) ‘certificate’ means the supplementary protection certificate; (e) ‘application for an extension of the duration’ means an application for an extension of the duration of the certificate pursuant to Article 13(3) of this Regulation and Article 36 of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use. Article 2. Scope Any product protected by a patent in the territory of a Member State and subject, prior to being placed on the market as a medicinal product, to an administrative authorisation procedure as laid down in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use or Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products may, under the terms and conditions provided for in this Regulation, be the subject of a certificate. Article 3. Conditions for obtaining a certificate A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application: (a) the product is protected by a basic patent in force; (b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/ EC, as appropriate; (c) the product has not already been the subject of a certificate; (d) the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product. Article 4. Subject matter of protection Within the limits of the protection conferred by the basic patent, the protection conferred by a certificate shall extend only to the product covered by the authorisation to place the corresponding medicinal product on the market and for any use of the product as a medicinal product that has been authorised before the expiry of the certificate.

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Article 5. Effects of the certificate Subject to the provisions of Article 4, the certificate shall confer the same rights as conferred by the basic patent and shall be subject to the same limitations and the same obligations. Article 6. Entitlement to the certificate The certificate shall be granted to the holder of the basic patent or his successor in title. Article 7. Application for a certificate 1. The application for a certificate shall be lodged within six months of the date on which the authorisation referred to in Article 3(b) to place the product on the market as a medicinal product was granted. 2. Notwithstanding paragraph 1, where the authorisation to place the product on the market is granted before the basic patent is granted, the application for a certificate shall be lodged within six months of the date on which the patent is granted. 3. The application for an extension of the duration may be made when lodging the application for a certificate or when the application for the certificate is pending and the appropriate requirements of Article 8(1)(d) or Article 8(2), respectively, are fulfilled. 4. The application for an extension of the duration of a certificate already granted shall be lodged not later than two years before the expiry of the certificate. 5. Notwithstanding paragraph 4, for five years following the entry into force of Regulation (EC) No 1901/2006, the application for an extension of the duration of a certificate already granted shall be lodged not later than six months before the expiry of the certificate. Article 8. Content of the application for a certificate 1. The application for a certificate shall contain: (a) a request for the grant of a certificate, stating in particular: (i) the name and address of the applicant; (ii) if he has appointed a representative, the name and address of the representative; (iii) the number of the basic patent and the title of the invention; (iv) the number and date of the first authorisation to place the product on the market, as referred to in Article 3(b) and, if this authorisation is not the first authorisation for placing the product on the market in the Community, the number and date of that authorisation; (b) a copy of the authorisation to place the product on the market, as referred to in Article 3(b), in which the product is identified, containing in particular the number and date of the authorisation and the summary of the product characteristics listed in Article 11 of Directive 2001/83/EC or Article 14 of Directive 2001/82/EC; (c) if the authorisation referred to in point (b) is not the first authorisation for placing the product on the market as a medicinal product in the Community, information regarding the identity of the product thus authorised and the legal provision under which the authorisation procedure took place, together with a copy of the notice publishing the authorisation in the appropriate official publication; (d) where the application for a certificate includes a request for an extension of the duration: 178

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(i) a copy of the statement indicating compliance with an agreed completed paediatric investigation plan as referred to in Article 36(1) of Regulation (EC) No 1901/2006; (ii) where necessary, in addition to the copy of the authorisation to place the product on the market as referred to in point (b), proof of possession of authorisations to place the product on the market of all other Member States, as referred to in Article 36(3) of Regulation (EC) No 1901/2006. 2. Where an application for a certificate is pending, an application for an extended duration in accordance with Article 7(3) shall include the particulars referred to in paragraph 1(d) of this Article and a reference to the application for a certificate already filed. 3. The application for an extension of the duration of a certificate already granted shall contain the particulars referred to in paragraph 1(d) and a copy of the certificate already granted. 4. Member States may provide that a fee is to be payable upon application for a certificate and upon application for the extension of the duration of a certificate. Article 9. Lodging of an application for a certificate 1. The application for a certificate shall be lodged with the competent industrial property office of the Member State which granted the basic patent or on whose behalf it was granted and in which the authorisation referred to in Article 3(b) to place the product on the market was obtained, unless the Member State designates another authority for the purpose. The application for an extension of the duration of a certificate shall be lodged with the competent authority of the Member State concerned. 2. Notification of the application for a certificate shall be published by the authority referred to in paragraph 1. The notification shall contain at least the following information: (a) the name and address of the applicant; (b) the number of the basic patent; (c) the title of the invention; (d) the number and date of the authorisation to place the product on the market, referred to in Article 3(b), and the product identified in that authorisation; (e) where relevant, the number and date of the first authorisation to place the product on the market in the Community; (f) where applicable, an indication that the application includes an application for an extension of the duration. 3. Paragraph 2 shall apply to the notification of the application for an extension of the duration of a certificate already granted or where an application for a certificate is pending. The notification shall additionally contain an indication of the application for an extended duration of the certificate. Article 10. Grant of the certificate or rejection of the application for a certificate 1. Where the application for a certificate and the product to which it relates meet the conditions laid down in this Regulation, the authority referred to in Article 9(1) shall grant the certificate. 2. The authority referred to in Article 9(1) shall, subject to paragraph 3, reject the application for a certificate if the application or the product to which it relates does not meet the conditions laid down in this Regulation.

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3. Where the application for a certificate does not meet the conditions laid down in Article 8, the authority referred to in Article 9(1) shall ask the applicant to rectify the irregularity, or to settle the fee, within a stated time. 4. If the irregularity is not rectified or the fee is not settled under paragraph 3 within the stated time, the authority shall reject the application. 5. Member States may provide that the authority referred to in Article 9(1) is to grant certificates without verifying that the conditions laid down in Article 3(c) and (d) are met. 6. Paragraphs 1 to 4 shall apply mutatis mutandis to the application for an extension of the duration. Article 11. Publication 1. Notification of the fact that a certificate has been granted shall be published by the authority referred to in Article 9(1). The notification shall contain at least the following information: (a) the name and address of the holder of the certificate; (b) the number of the basic patent; (c) the title of the invention; (d) the number and date of the authorisation to place the product on the market referred to in Article 3(b) and the product identified in that authorisation; (e) where relevant, the number and date of the first authorisation to place the product on the market in the Community; (f) the duration of the certificate. 2. Notification of the fact that the application for a certificate has been rejected shall be published by the authority referred to in Article 9(1). The notification shall contain at least the information listed in Article 9(2). 3. Paragraphs 1 and 2 shall apply to the notification of the fact that an extension of the duration of a certificate has been granted or of the fact that the application for an extension has been rejected. Article 12. Annual fees Member States may require that the certificate be subject to the payment of annual fees. Article 13. Duration of the certificate 1. The certificate shall take effect at the end of the lawful term of the basic patent for a period equal to the period which elapsed between the date on which the application for a basic patent was lodged and the date of the first authorisation to place the product on the market in the Community, reduced by a period of five years. 2. Notwithstanding paragraph 1, the duration of the certificate may not exceed five years from the date on which it takes effect. 3. The periods laid down in paragraphs 1 and 2 shall be extended by six months in the case where Article 36 of Regulation (EC) No 1901/2006 applies. In that case, the duration of the period laid down in paragraph 1 of this Article may be extended only once. 4. Where a certificate is granted for a product protected by a patent which, before 2 January 1993, had its term extended or for which such extension was applied for, under national law, the term of protection to be afforded under this certificate shall be reduced by the number of years by which the term of the patent exceeds 20 years. 180

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Article 14. Expiry of the certificate The certificate shall lapse: (a) at the end of the period provided for in Article 3; (b) if the certificate holder surrenders it; (c) if the annual fee laid down in accordance with Article 12 is not paid in time; (d) if and as long as the product covered by the certificate may no longer be placed on the market following the withdrawal of the appropriate authorisation or authorisations to place on the market in accordance with Directive 2001/83/EC or Directive 2001/82/EC. The authority referred to in Article 9(1) of this Regulation may decide on the lapse of the certificate either of its own motion or at the request of a third party. Article 15. Invalidity of the certificate 1. The certificate shall be invalid if: (a) it was granted contrary to the provisions of Article 3; (b) the basic patent has lapsed before its lawful term expires; (c) the basic patent is revoked or limited to the extent that the product for which the certificate was granted would no longer be protected by the claims of the basic patent or, after the basic patent has expired, grounds for revocation exist which would have justified such revocation or limitation. 2. Any person may submit an application or bring an action for a declaration of invalidity of the certificate before the body responsible under national law for the revocation of the corresponding basic patent. Article 16. Revocation of an extension of the duration 1. The extension of the duration may be revoked if it was granted contrary to the provisions of Article 36 of Regulation (EC) No 1901/2006. 2. Any person may submit an application for revocation of the extension of the duration to the body responsible under national law for the revocation of the corresponding basic patent. Article 17. Notification of lapse or invalidity 1. If the certificate lapses in accordance with point (b), (c) or (d) of Article 14, or is invalid in accordance with Article 15, notification thereof shall be published by the authority referred to in Article 9(1). 2. If the extension of the duration is revoked in accordance with Article 16, notification thereof shall be published by the authority referred to in Article 9(1). Article 18. Appeals The decisions of the authority referred to in Article 9(1) or of the bodies referred to in Articles 15(2) and 16(2) taken under this Regulation shall be open to the same appeals as those provided for in national law against similar decisions taken in respect of national patents. Article 19. Procedure 1. In the absence of procedural provisions in this Regulation, the procedural provisions applicable under national law to the corresponding basic patent shall apply to the certificate, unless the national law lays down special procedural provisions for certificates. 181

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2. Notwithstanding paragraph 1, the procedure for opposition to the granting of a certificate shall be excluded. Article 20. Additional provisions relating to the enlargement of the Community Without prejudice to the other provisions of this Regulation, the following provisions shall apply: (a) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained after 1 January 2000 may be granted a certificate in Bulgaria, provided that the application for a certificate was lodged within six months from 1 January 2007; (b) any medicinal product protected by a valid basic patent in the Czech Republic and for which the first authorisation to place it on the market as a medicinal product was obtained: (i) in the Czech Republic after 10 November 1999 may be granted a certificate, provided that the application for a certificate was lodged within six months of the date on which the first market authorisation was obtained; (ii) in the Community not earlier than six months prior to 1 May 2004 may be granted a certificate, provided that the application for a certificate was lodged within six months of the date on which the first market authorisation was obtained; (c) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained in Estonia prior to 1 May 2004 may be granted a certificate, provided that the application for a certificate was lodged within six months of the date on which the first market authorisation was obtained or, in the case of those patents granted prior to 1 January 2000, within the six months provided for in the Patents Act of October 1999; (d) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained in Cyprus prior to 1 May 2004 may be granted a certificate, provided that the application for a certificate was lodged within six months of the date on which the first market authorisation was obtained; notwithstanding the above, where the market authorisation was obtained before the grant of the basic patent, the application for a certificate must be lodged within six months of the date on which the patent was granted; (e) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained in Latvia prior to 1 May 2004 may be granted a certificate. In cases where the period provided for in Article 7(1) has expired, the possibility of applying for a certificate shall be open for a period of six months starting no later than 1 May 2004; (f) any medicinal product protected by a valid basic patent applied for after 1 February 1994 and for which the first authorisation to place it on the market as a medicinal product was obtained in Lithuania prior to 1 May 2004 may be granted a certificate, provided that the application for a certificate was lodged within six months from 1 May 2004; (g) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained after 1 January 2000 may be granted a certificate in Hungary, provided that the application for a certificate was lodged within six months from 1 May 2004;

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(h) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained in Malta prior to 1 May 2004 may be granted a certificate. In cases where the period provided for in Article 7(1) has expired, the possibility of applying for a certificate shall be open for a period of six months starting no later than 1 May 2004; (i) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained after 1 January 2000 may be granted a certificate in Poland, provided that the application for a certificate was lodged within six months starting no later than 1 May 2004; (j) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained after 1 January 2000 may be granted a certificate in Romania. In cases where the period provided for in Article 7(1) has expired, the possibility of applying for a certificate shall be open for a period of six months starting no later than 1 January 2007; (k) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained in Slovenia prior to 1 May 2004 may be granted a certificate, provided that the application for a certificate was lodged within six months from 1 May 2004, including in cases where the period provided for in Article 7(1) has expired; (l) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained in Slovakia after 1 January 2000 may be granted a certificate, provided that the application for a certificate was lodged within six months of the date on which the first market authorisation was obtained or within six months of 1 July 2002 if the market authorisation was obtained before that date. Article 21. Transitional provisions 1. This Regulation shall not apply to certificates granted in accordance with the national legislation of a Member State before 2 January 1993 or to applications for a certificate filed in accordance with that legislation before 2 July 1992. With regard to Austria, Finland and Sweden, this Regulation shall not apply to certificates granted in accordance with their national legislation before 1 January 1995. 2. This Regulation shall apply to supplementary protection certificates granted in accordance with the national legislation of the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Malta, Poland, Slovenia and Slovakia prior to 1 May 2004 and the national legislation of Romania prior to 1 January 2007. Article 22. Repeal Regulation (EEC) No 1768/92, as amended by the acts listed in Annex I, is repealed. References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex II. Article 23. Entry into force This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

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RegSPC-Plant Protection Products: Regulation of the European Parliament and of the Council No 1610/1996/EC of 23 July 1996 concerning the creation of a Supplementary Protection Certificate for plant protection products, OJ L 198 of 8 August 1996, p. 30 et seqq. (extract) Recitals (1) Whereas research into plant protection products contributes to the continuing improvement in the production and procurement of plentiful food of good quality at affordable prices; (2) Whereas plant protection research contributes to the continuing improvement in crop production; (3) Whereas plant protection products, especially those that are the result of long, costly research, will continue to be developed in the Community and in Europe if they are covered by favourable rules that provide for sufficient protection to encourage such research; (4) Whereas the competitiveness of the plant protection sector, by the very nature of the industry, requires a level of protection for innovation which is equivalent to that granted to medicinal products by Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products (4); (5) Whereas, at the moment, the period that elapses between the filing of an application for a patent for a new plant protection product and authorisation to place the said plant protection product on the market makes the period of effective protection under the patent insufficient to cover the investment put into the research and to generate the resources needed to maintain a high level of research; (6) Whereas this situation leads to a lack of protection which penalizes plant protection research and the competitiveness of the sector; (7) Whereas one of the main objectives of the supplementary protection certificate is to place European industry on the same competitive footing as its North American and Japanese counterparts; (8) Whereas, in its Resolution of 1 February 1993 (5) on a Community programme of policy and action in relation to the environment and sustainable development, the Council adopted the general approach and strategy of the programme presented by the Commission, which stressed the interdependence of economic growth and environmental quality; whereas improving protection of the environment means maintaining the economic competitiveness of industry; whereas, accordingly, the issue of a supplementary protection certificate can be regarded as a positive measure in favour of environmental protection; (9) Whereas a uniform solution at Community level should be provided for, thereby preventing the heterogeneous development of national laws leading to further disparities which would be likely to hinder the free movement of plant protection products within the Community and thus directly affect the functioning of the internal market; whereas this is in accordance with the principle of subsidiarity as defined by Article 3 b of the Treaty; (10) Whereas, therefore, there is a need to create a supplementary protection certificate granted, under the same conditions, by each of the Member States at the request of the holder of a national or European patent relating to a plant protection product for which marketing authorisation has been granted is necessary; whereas a Regulation is therefore the most appropriate legal instrument;

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(11) Whereas the duration of the protection granted by the certificate should be such as to provide adequate, effective protection; whereas, for this purpose, the holder of both a patent and a certificate should be able to enjoy an overall maximum of fifteen years of exclusivity from the time the plant protection product in question first obtains authorisation to be placed on the market in the Community; (12) Whereas all the interests at stake in a sector as complex and sensitive as plant protection must nevertheless be taken into account; whereas, for this purpose, the certificate cannot be granted for a period exceeding five years; (13) Whereas the certificate confers the same rights as those conferred by the basic patent; whereas, consequently, where the basic patent covers an active substance and its various derivatives (salts and esters), the certificate confers the same protection; (14) Whereas the issue of a certificate for a product consisting of an active substance does not prejudice the issue of other certificates for derivatives (salts and esters) of the substance, provided that the derivatives are the subject of patents specifically covering them; (15) Whereas a fair balance should also be stuck with regard to the determination of the transitional arrangements; whereas such arrangements should enable the Community plant protection industry to catch up to some extent with its main competitors, while making sure that the arrangements do not compromise the achievement of other legitimate objectives concerning the agricultural policy and environment protection policy pursued at both national and Community level; (16) Whereas only action at Community level will enable the objective, which consists in ensuring adequate protection for innovation in the field of plant protection, while guaranteeing the proper functioning of the internal market for plant protection products, to be attained effectively; (17) Whereas the detailed rules in recitals 12, 13 and 14 and in Articles 3 (2), 4, 8 (1) (c) and 17 (2) of this Regulation are also valid, mutatis mutandis, for the interpretation in particular of recital 9 and Articles 3, 4, 8 (1) (c) and 17 of Council Regulation (EEC) No 1768/92. Article 1. Definitions For the purposes of this Regulation, the following definitions shall apply: 1. ‘plant protection products’: active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to: (a) protect plants or plant products against all harmful organisms or prevent the action of such organisms, in so far as such substances or preparations are not otherwise defined below; (b) influence the life processes of plants, other than as a nutrient (e. g. plant growth regulators); (c) preserve plant products, in so far as such substances or products are not subject to special Council or Commission provisions on preservatives; (d) destroy undesirable plants; or (e) destroy parts of plants, check or prevent undesirable growth of plants; 2. ‘substances’: chemical elements and their compounds, as they occur naturally or by manufacture, including any impurity inevitably resulting from the manufacturing process; 3. ‘active substances’: substances or micro-organisms including viruses, having general or specific action:

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4. 5. 6. 7. 8. 9.

10.

(a) against harmful organisms; or (b) on plants, parts of plants or plant products; ‘preparations’: mixtures or solutions composed of two or more substances, of which at least one is an active substance, intended for use as plant protection products; ‘plants’: live plants and live parts of plants, including fresh fruit and seeds; ‘plant products’: products in the unprocessed state or having undergone only simple preparation such as milling, drying or pressing, derived from plants, but excluding plants themselves as defined in point 5; ‘harmful organisms’: pests of plants or plant products belonging to the animal or plant kingdom, and also viruses, bacteria and mycoplasmas and other pathogens; ‘product’: the active substance as defined in point 3 or combination of active substances of a plant protection product; ‘basic patent’: a patent which protects a product as defined in point 8 as such, a preparation as defined in point 4, a process to obtain a product or an application of a product, and which is designated by its holder for the purpose of the procedure for grant of a certificate; ‘certificate’: the supplementary protection certificate.

Article 3. Conditions for obtaining a certificate 1. A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted, at the date of that application: (a) the product is protected by a basic patent in force; (b) a valid authorisation to place the product on the market as a plant protection product has been granted in accordance with Article 4 of Directive 91/414/EEC or an equivalent provision of national law; (c) the product has not already been the subject of a certificate; (d) the authorisation referred to in (b) is the first authorisation to place the product on the market as a plant protection product. 2. The holder of more than one patent for the same product shall not be granted more than one certificate for that product. However, where two or more applications concerning the same product and emanating from two or more holders of different patents are pending, one certificate for this product may be issued to each of these holders. Article 8. Content of the application for a certificate 1. The application for a certificate shall contain: (a) a request for the grant of a certificate, stating in particular: (i) the name and address of the applicant; (ii) the name and address of the representative, if any; (iii) the number of the basic patent and the title of the invention; (iv) the number and date of the first authorisation to place the product on the market, as referred to in Article 3 (1) (b) and, if this authorisation is not the first authorisation to place the product on the market in the Community, the number and date of that authorisation; (b) a copy of the authorisation to place the product on the market, as referred to in Article 3 (1) (b), in which the product is identified, containing in particular the number and date of the authorisation and the summary of the product characteristics listed in Part A.I (points 1–7) or B.I (points 1–7) of Annex II to Directive 91/414/EEC or in equivalent national laws of the Member State in which the application was lodged;

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(c) if the authorisation referred to in (b) is not the first authorisation to place the product on the market as a plant protection product in the Community, information regarding the identity of the product thus authorized and the legal provision under which the authorisation procedure took place, together with a copy of the notice publishing the authorisation in the appropriate official publication or, failing such a notice, any other document proving that the authorisation has been issued, the date on which it was issued and the identity of the product authorized. 2. Member States may require a fee to be payable upon application for a certificate. Article 17. Appeals 1. The decisions of the authority referred to in Article 9 (1) or of the body referred to in Article 15 (2) taken under this Regulation shall be open to the same appeals as those provided for in national law against similar decisions taken in respect of national patents. 2. The decision to grant the certificate shall be open to an appeal aimed at rectifying the duration of the certificate where the date of the first authorisation to place the product on the market in the Community, contained in the application for a certificate as provided for in Article 8, is incorrect. RegMPP: Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending regulation (EEC) No 1768/92, directive 2001/20/EC, directive 2001/83/EC and Regulation (EC) No 726/2004, OJ L 378 of 27 December 2006, p. 1 et seqq. (extract) Recitals (1) Before a medicinal product for human use is placed on the market in one or more Member States, it generally has to have undergone extensive studies, including preclinical tests and clinical trials, to ensure that it is safe, of high quality and effective for use in the target population. (2) Such studies may not have been undertaken for use in the paediatric population and many of the medicinal products currently used to treat the paediatric population have not been studied or authorised for such use. Market forces alone have proven insufficient to stimulate adequate research into, and the development and authorisation of, medicinal products for the paediatric population. (3) Problems resulting from the absence of suitably adapted medicinal products for the paediatric population include inadequate dosage information which leads to increased risks of adverse reactions including death, ineffective treatment through under-dosage, non-availability to the paediatric population of therapeutic advances, suitable formulations and routes of administration, as well as use of magistral or officinal formulations to treat the paediatric population which may be of poor quality. (4) This Regulation aims to facilitate the development and accessibility of medicinal products for use in the paediatric population, to ensure that medicinal products used to treat the paediatric population are subject to ethical research of high quality and are appropriately authorised for use in the paediatric population, and to improve the information available on the use of medicinal products in the various paediatric populations. These objectives should be achieved without subjecting the paediatric population to unnecessary clinical trials and without delaying the authorisation of medicinal products for other age populations.

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(26) For products falling within the scope of the requirement to submit paediatric data, if all the measures included in the agreed paediatric investigation plan are complied with, if the product is authorised in all Member States and if relevant information on the results of studies is included in product information, a reward should be granted in the form of a 6-month extension of the supplementary protection certificate created by Council Regulation (EEC) No 1768/92 (1). Any decisions by Member States’ authorities as regards the setting of prices for medicinal products or their inclusion in the scope of national health insurance schemes have no bearing on the granting of this reward. (27) An application for an extension of the duration of the certificate pursuant to this Regulation should only be admissible where a certificate is granted pursuant to Regulation (EEC) No 768/92. (28) Because the reward is for conducting studies in the paediatric population and not for demonstrating that a product is safe and effective in the paediatric population, the reward should be granted even when a paediatric indication is not authorised. However, to improve the information available on the use of medicinal products in the paediatric population, relevant information on use in paediatric populations should be included in authorised product information. Article 8 In the case of authorised medicinal products which are protected either by a supplementary protection certificate under Regulation (EEC) No 1768/92, or by a patent which qualifies for the granting of the supplementary protection certificate, Article 7 of this Regulation shall apply to applications for authorisation of new indications, including paediatric indications, new pharmaceutical forms and new routes of administration. For the purposes of the first subparagraph, the documents referred to in Article 7(1) shall cover both the existing and the new indications, pharmaceutical forms and routes of administration. Article 23 1. The competent authority responsible for granting marketing authorisation shall verify whether an application for marketing authorisation or variation complies with the requirements laid down in Articles 7 and 8 and whether an application submitted pursuant to Article 30 complies with the agreed paediatric investigation plan. Where the application is submitted in accordance with the procedure set out in Articles 27 to 39 of Directive 2001/83/EC, the verification of compliance, including, as appropriate, requesting an opinion of the Paediatric Committee in accordance with paragraph 2(b) and (c) of this Article, shall be conducted by the reference Member State. 2. The Paediatric Committee may, in the following cases, be requested to give its opinion as to whether studies conducted by the applicant are in compliance with the agreed paediatric investigation plan: (a) by the applicant, prior to submitting an application for marketing authorisation or variation as referred to in Articles 7, 8 and 30, respectively; (b) by the Agency, or the national competent authority, when validating an application, as referred to in point (a), which does not include an opinion concerning compliance adopted following a request under point (a); (c) by the Committee for Medicinal Products for Human Use, or the national competent authority, when assessing an application, as referred to in point (a),

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where there is doubt concerning compliance and an opinion has not been already given following a request under points (a) or (b). In the case of point (a), the applicant shall not submit its application until the Paediatric Committee has adopted its opinion, and a copy thereof shall be annexed to the application. 3. If the Paediatric Committee is requested to give an opinion under paragraph 2, it shall do so within 60 days of receiving the request. Member States shall take account of such an opinion. Article 28 1. Applications may be submitted in accordance with the procedure laid down in Articles 5 to 15 of Regulation (EC) No 726/2004 for a marketing authorisation as referred to in Article 7(1) of this Regulation which includes one or more paediatric indications on the basis of studies conducted in compliance with an agreed paediatric investigation plan. Where authorisation is granted, the results of all those studies shall be included in the summary of product characteristics and, if appropriate, in the package leaflet of the medicinal product, provided that the competent authority deems the information to be of use to patients, whether or not all the paediatric indications concerned were approved by the competent authority. 2. Where a marketing authorisation is granted or varied, any waiver or deferral which has been granted pursuant to this Regulation shall be recorded in the summary of product characteristics and, if appropriate, in the package leaflet of the medicinal product concerned. 3. If the application complies with all the measures contained in the agreed completed paediatric investigation plan and if the summary of product characteristics reflects the results of studies conducted in compliance with that agreed paediatric investigation plan, the competent authority shall include within the marketing authorisation a statement indicating compliance of the application with the agreed completed paediatric investigation plan. For the purpose of the application of Article 45(3), this statement shall also indicate whether significant studies contained in the agreed Paediatric Investigation Plan have been completed after the entry into force of this Regulation. Article 36 1. Where an application under Article 7 or 8 includes the results of all studies conducted in compliance with an agreed paediatric investigation plan, the holder of the patent or supplementary protection certificate shall be entitled to a six-month extension of the period referred to in Articles 13(1) and 13(2) of Regulation (EEC) No 1768/92. The first subparagraph shall also apply where completion of the agreed paediatric investigation plan fails to lead to the authorisation of a paediatric indication, but the results of the studies conducted are reflected in the summary of product characteristics and, if appropriate, in the package leaflet of the medicinal product concerned. 2. The inclusion in a marketing authorisation of the statement referred to in Article 28(3) shall be used for the purposes of applying paragraph 1 of this Article. 3. Where the procedures laid down in Directive 2001/83/EC have been used, the sixmonth extension of the period referred to in paragraph 1 shall be granted only if the product is authorised in all Member States.

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4. Paragraphs 1, 2 and 3 shall apply to products that are protected by a supplementary protection certificate under Regulation (EEC) No 1768/92, or under a patent which qualifies for the granting of the supplementary protection certificate. They shall not apply to medicinal products designated as orphan medicinal products pursuant to Regulation (EC) No 141/2000. 5. In the case of an application under Article 8 which leads to the authorisation of a new paediatric indication, paragraphs 1, 2 and 3 shall not apply if the applicant applies for, and obtains, a one-year extension of the period of marketing protection for the medicinal product concerned, on the grounds that this new paediatric indication brings a significant clinical benefit in comparison with existing therapies, in accordance with Article 14(11) of Regulation (EC) No 726/2004 or the fourth subparagraph of Article 10(1) of Directive 2001/83/EC.

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RegCAP: Regulation No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, OJ L 136 of 30 April 2004, p. 1 et seqq. (extract) Article 3 1. No medicinal product appearing in the Annex may be placed on the market within the Community unless a marketing authorisation has been granted by the Community in accordance with the provisions of this Regulation. 2. Any medicinal product not appearing in the Annex may be granted a marketing authorisation by the Community in accordance with the provisions of this Regulation, if: (a) the medicinal product contains a new active substance which, on the date of entry into force of this Regulation, was not authorised in the Community; or (b) the applicant shows that the medicinal product constitutes a significant therapeutic, scientific or technical innovation or that the granting of authorisation in accordance with this Regulation is in the interests of patients or animal health at Community level. Immunological veterinary medicinal products for the treatment of animal diseases that are subject to Community prophylactic measures may also be granted such authorisation. 3. A generic medicinal product authorised by the Community may be authorised by the competent authorities of the Member States in accordance with Directive 2001/83/ EC and Directive 2001/82/EC under the following conditions: (a) the application for authorisation is submitted in accordance with Article 10 of Directive 2001/83/EC or Article 13 of Directive 2001/82/EC; (b) the summary of the product characteristics is in all relevant respects consistent with that of the medicinal product authorised by the Community except for those parts of the summary of product characteristics referring to indications or dosage forms which were still covered by patent law at the time when the generic medicine was marketed; and (c) the generic medicinal product is authorised under the same name in all the Member States where the application has been made. For the purposes of this provision, all the linguistic versions of the INN (international non-proprietary name) shall be considered to be the same name. Article 6 1. Each application for the authorisation of a medicinal product for human use shall specifically and completely include the particulars and documents as referred to in Articles 8(3), 10, 10 a, 10 b or 11 of, and Annex I to, Directive 2001/83/EC. The documents must include a statement to the effect that clinical trials carried out outside the European Union meet the ethical requirements of Directive 2001/20/EC. These particulars and documents shall take account of the unique, Community nature of the authorisation requested and, otherwise than in exceptional cases relating to the application of the law on trade marks, shall include the use of a single name for the medicinal product. The application shall be accompanied by the fee payable to the Agency for the examination of the application.

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2. In the case of a medicinal product for human use containing or consisting of genetically modified organisms within the meaning of Article 2 of Directive 2001/18/ EC, the application shall be accompanied by: (a) a copy of the competent authorities’ written consent to the deliberate release into the environment of the genetically modified organisms for research and development purposes where provided for in Part B of Directive 2001/18/EC or in Part B of Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms; (b) the complete technical dossier supplying the information required by Annexes III and IV to Directive 2001/18/EC; (c) the environmental risk assessment in accordance with the principles set out in Annex II to Directive 2001/18/EC; and (d) the results of any investigations performed for the purposes of research or development. Articles 13 to 24 of Directive 2001/18/EC shall not apply to medicinal products for human use containing or consisting of genetically modified organisms. 3. The Agency shall ensure that the opinion of the Committee for Medicinal Products for Human Use is given within 210 days after receipt of a valid application. The duration of the analysis of the scientific data in the file concerning the application for marketing authorisation must be at least 80 days, except in cases where the rapporteur and co-rapporteur declare that they have completed their assessment before that time. On the basis of a duly reasoned request, the said Committee may call for the duration of the analysis of the scientific data in the file concerning the application for marketing authorisation to be extended. In the case of a medicinal product for human use containing or consisting of genetically modified organisms, the opinion of the said Committee shall respect the environmental safety requirements laid down by Directive 2001/18/EC. During the process of evaluating applications for marketing authorisations for medicinal products for human use containing or consisting of genetically modified organisms, the rapporteur shall carry out necessary consultations of bodies that the Community or Member States have set up in accordance with Directive 2001/18/EC. 4. The Commission shall, in consultation with the Agency, Member States and interested parties, draw up a detailed guide regarding the form in which applications for authorisation are to be presented.

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B4. European Directives DirMPH: Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, OJ L 311 of 28 November 2001, p. 67 et seqq. (codified version, extract) Article 8 1. In order to obtain an authorisation to place a medicinal product on the market regardless of the procedure established by Regulation (EEC) No 2309/93, an application shall be made to the competent authority of the Member State concerned. (…) 3. The application shall be accompanied by the following particulars and documents, submitted in accordance with Annex I: (…) (i) Results of: – pharmaceutical (physico-chemical, biological or microbiological) tests, – pre-clinical (toxicological and pharmacological) tests, – clinical trials. (ia) A detailed description of the pharmacovigilance and, where appropriate, of the risk-management system which the applicant will introduce. (ib) A statement to the effect that clinical trials carried out outside the European Union meet the ethical requirements of Directive 2001/20/EC. (…) Article 10 (…) 2. For the purposes of this Article: (…) (b) ‘generic medicinal product’ shall mean a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies. The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy. In such cases, additional information providing proof of the safety and/or efficacy of the various salts, esters or derivatives of an authorised active substance must be supplied by the applicant. The various immediate-release oral pharmaceutical forms shall be considered to be one and the same pharmaceutical form. Bioavailability studies need not be required of the applicant if he can demonstrate that the generic medicinal product meets the relevant criteria as defined in the appropriate detailed guidelines. (…) Article 11 The summary of the product characteristics shall contain, in the order indicated below, the following information:

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1.

name of the medicinal product followed by the strength and the pharmaceutical form. 2. qualitative and quantitative composition in terms of the active substances and constituents of the excipient, knowledge of which is essential for proper administration of the medicinal product. The usual common name or chemical description shall be used. 3. pharmaceutical form. 4. clinical particulars: 4.1. therapeutic indications, 4.2. posology and method of administration for adults and, where necessary for children, 4.3. contra-indications, 4.4. special warnings and precautions for use and, in the case of immunological medicinal products, any special precautions to be taken by persons handling such products and administering them to patients, together with any precautions to be taken by the patient, 4.5. interaction with other medicinal products and other forms of interactions, 4.6. use during pregnancy and lactation, 4.7. effects on ability to drive and to use machines, 4.8. undesirable effects, 4.9. overdose (symptoms, emergency procedures, antidotes). 5. pharmacological properties: 5.1. pharmacodynamic properties, 5.2. pharmacokinetic properties, 5.3. preclinical safety data. 6. pharmaceutical particulars: 6.1. list of excipients, 6.2. major incompatibilities, 6.3. shelf life, when necessary after reconstitution of the medicinal product or when the immediate packaging is opened for the first time, 6.4. special precautions for storage, 6.5. nature and contents of container, 6.6. special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product, if appropriate. 7. marketing authorisation holder. 8. marketing authorisation number(s). 9. date of the first authorisation or renewal of the authorisation. 10. date of revision of the text. 11. for radiopharmaceuticals, full details of internal radiation dosimetry. 12. for radiopharmaceuticals, additional detailed instructions for extemporaneous preparation and quality control of such preparation and, where appropriate, maximum storage time during which any intermediate preparation such as an eluate or the ready-to-use pharmaceutical will conform with its specifications. For authorisations under Article 10, those parts of the summary of product characteristics of the reference medicinal product referring to indications or dosage forms which were still covered by patent law at the time when a generic medicine was marketed need not be included.

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DirMPV: Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products, OJ L 311 of 28 November 2001, p. 1 et seqq. (extract) Article 12 1. For the purposes of obtaining a marketing authorisation in respect of a veterinary medicinal product, other than under the procedure established by Regulation (EEC) No 2309/93, an application shall be lodged with the competent authority of the Member State concerned. In the case of veterinary medicinal products which are intended for one or more foodproducing species but whose pharmacologically active substances have not yet been included, for the species in question, in Annexes I, II or III to Regulation (EEC) No 2377/90, a marketing authorisation may not be applied for until after a valid application has been made for the establishment of maximum residue limits in accordance with that Regulation. At least six months shall elapse between a valid application for the establishment of maximum residue limits and an application for a marketing authorisation. However, in the case of veterinary medicinal products referred to in Article 6(3), a marketing authorisation may be applied for without a valid application in accordance with Regulation (EEC) No 2377/90. All the scientific documentation necessary for the demonstration of the quality, safety and efficacy of the veterinary medicinal product, as provided for in paragraph 3, shall be submitted. (…) 3. The application for marketing authorisation shall include all the administrative information and scientific documentation necessary for demonstrating the quality, safety and efficacy of the veterinary medicinal product in question. The file shall be submitted in accordance with Annex I and shall contain, in particular, the following information: (…) (j) results of: – pharmaceutical (physico-chemical, biological or microbiological) tests, – safety tests and residue tests, – pre-clinical and clinical trials; – tests assessing the potential risks posed by the medicinal product for the environment. This impact shall be studied and consideration shall be given on a case-by-case basis to specific provisions seeking to limit it. (…) DirGCP: Directive 2001/20/EC of 4 April 2001, of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, OJ L 121 of 1 May 2001, p. 34 et seqq. (extract) Article 9. Commencement of a clinical trial 1. Member States shall take the measures necessary to ensure that the procedure described in this Article is followed for commencement of a clinical trial. The sponsor may not start a clinical trial until the Ethics Committee has issued a favourable opinion and inasmuch as the competent authority of the Member State concerned has not informed the sponsor of any grounds for non-acceptance. The procedures to reach these decisions can be run in parallel or not, depending on the sponsor. (…) 195

B5. National Law I. Germany GG: Basic Law for the Federal Republic of Germany of 23 May 1949, BGBl. 1949 p. 1 (extract) Art. 14 (1) Property and the right of inheritance shall be guaranteed. Their content and limits shall be defined by the laws. (2) Property entails obligations. Its use shall also serve the public good. (3) Expropriation shall only be permissible for the public good. It may only be ordered by or pursuant to a law that determines the nature and extent of compensation. Such compensation shall be determined by establishing an equitable balance between the public interest and the interests of those affected. In case of dispute concerning the amount of compensation, recourse may be had to the ordinary courts. PatG: Patent Act of 16 December 1980, BGBl. 1981 I p. 1 (extract) §3 (…) (4) Where this use is not part of the state of the art, such substances and substance mixtures as cited in subsection (3) for a specific use in one of the processes cited in Section 2a(1), No 2, shall not be excluded from protection by subsections (1) and (2) either. (…) §6 The right to a patent shall belong to the inventor or his successor in title. If two or more persons have jointly made an invention, the right to the patent shall belong to them jointly. If a number of persons have made an invention independently of each other, the right shall belong to that person who first files an application for the invention with the Patent Office. §9 A patent shall have the effect that the patentee alone shall be authorized to use the patented invention within the applicable laws. A third party not having the consent of the patentee shall be prohibited 1. from making, offering, putting on the market or using a product which is the subject matter of the patent, or from importing or possessing said product for such purposes; 2. from using a process which is the subject matter of the patent, or, when said third party knows or it is obvious from the circumstances that use of the process without the consent of the patentee is prohibited, from offering the process for use within the territory to which this Act applies;

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3. from offering, putting on the market or using or importing or possessing for such purposes the product produced directly by a process which is the subject matter of the patent. § 10 (1) A patent shall have the further effect that any third party not having the consent of the patentee shall be prohibited from offering or supplying within the territory to which this Act applies to any other persons, other than such persons authorized to use the patented invention, means relating to an essential element of said invention for use of the invention within the territory to which this Act applies, if said third party knows or it is obvious from the circumstances that such means are suitable and intended for use of the invention. (2) Subsection (1) shall not apply when the means are products generally available in commerce, except if said third party intentionally induces the person supplied to commit acts prohibited by the second sentence of Section 9. (3) Persons performing the acts referred to in Section 11, nos. 1 to 3, shall not be considered within the terms of subsection (1) as persons entitled to use the invention. § 11 The effects of a patent shall not extend to: 1. acts done privately for non-commercial purposes; 2. acts done for experimental purposes relating to the subject matter of the patented invention; 2a. the use of biological material for breeding, discovery and development of a new plant variety type; 2b. studies and trials and the resulting practical requirements necessary for obtaining a marketing authorization to place a medicinal product on the market in the European Union or a marketing approval for a medicinal product in the Member States of the European Union or in third countries; 3. the extemporaneous preparation of medicinal products in individual cases in a pharmacy in accordance with a medical prescription, or acts concerning the medicinal products so prepared; (…) § 12 (1) A patent shall have no effect against a person who, at the time of filing the application, had already begun to use the invention in Germany, or had made the necessary arrangements to do so. Said person shall be entitled to use the invention for the needs of his own business in his own workshops or the workshops of others. This right may only be bequeathed or transferred together with the business. If the applicant or his predecessor in title, before applying for a patent, disclosed the invention to other persons and reserved his rights in the event of a patent being granted, said person learning of the invention as a result of such disclosure cannot invoke measures under the provisions of the first sentence, which he has taken within six months after the disclosure. (2) When the patentee is entitled to a priority right, the date of the prior application shall be decisive and not the date of application referred to in subsection (1). However, this provision shall not apply to nationals of a foreign country that does not guarantee reciprocity in this respect, when said national has claimed the priority of a foreign application. 197

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§ 14 The scope of protection conferred by a patent or a patent application shall be determined by the patent claims. Nevertheless, the description and drawings shall have to be consulted when interpreting the claims. § 15 (1) The right to a patent, the right to the grant of a patent and the rights to be derived from a patent shall pass to the heirs. These rights may be assigned to others with or without restrictions. (2) The rights under subsection (1) may be licensed in whole or in part, exclusively or non-exclusively, for the whole or part of the territory to which this Act applies. Should a licensee breach a restriction of his license covered by the first sentence, the right conferred by the patent may be asserted against him. (3) The assignment of rights or the grant of a license shall not affect licenses previously granted to other parties. § 16a (1) Subject to regulations of the European Communities concerning the creation of supplementary protection certificates, notification of which must be made in the Federal Law Gazette [Bundesgesetzblatt], supplementary protection may be requested for a patent that shall follow immediately upon the expiry of the term of the patent under Section 16(1). Annual fees shall have to be paid for supplementary protection. (2) Unless otherwise provided by the laws of the European Communities, the provisions of this Act concerning the entitlement of the applicant (Sections 6 to 8), the effects of the patent and exceptions thereto (Sections 9 to 12), the order to use the patent, and compulsory licenses (Sections 13, 24), scope of protection (Section 14), licenses and their registration (Sections 15, 30), lapse of the patent (Section 20), nullity (Section 22), willingness to grant licenses (Section 23), domestic representatives (Section 25), the Patent Court and proceedings before the Patent Court (Sections 65 to 99), proceedings before the Federal Court of Justice (Sections 100 to 122a), reinstatement (Section 123), obligation to abide by the truth (Section 124), electronic documents (Section 125a), the official language, service of documents and legal assistance (Sections 126 to 128), infringements (Sections 139 to 141 a, 142 a and 142b), concentration of actions and allegation of entitlement to a patent (Sections 145 and 146) shall apply mutatis mutandis to supplementary protection. (3) Licenses and declarations under Section 23 that are effective for a patent shall also apply to supplementary protection. § 20 (1) A patent shall lapse if 1. the patentee relinquishes it by written declaration to the Patent Office; 2. the declarations prescribed in Section 37(1) are not made in due time after service of the official notification (Section 37(2)) or 3. the annual fee or the difference are not paid in due time (Section 7(1), Section 13(3) or Section 14(2) and (5) Patent Cost Act [Patentkostengesetz], Section 23(7), sentence 4, of this Act). (…)

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§ 24 (1) A non-exclusive authorization to commercially use an invention shall be granted by the Patent Court in individual cases in accordance with the following provisions (compulsory license) if 1. the person seeking a license has unsuccessfully endeavoured during a reasonable period of time to obtain from the patentee consent to use the invention under reasonable conditions usual in trade; and 2. public interest commands the grant of a compulsory license. (…) § 30 (1) The Patent Office shall maintain a Register in which shall be recorded the titles of patent applications, the files of which may be inspected by any person, and of granted patents, supplementary protection certificates (Section 16a) and the names and addresses of applicants or patentees and their representatives, possibly appointed under Section 25, or authorized parties for service, whereby it shall suffice to enter either one representative or one authorized party for service. The commencement, expiration, lapse, order of limitation, revocation, declaration of nullity of patents and supplementary protection certificates (Section 16a) as well as the filing of oppositions and nullity actions shall also be recorded therein. (…) (3) (…) As long as the change has not been recorded, the former applicant, patentee, representative or authorized party for service shall remain subject to the rights and obligations as provided in this Act. § 33 (1) As of the date of publication of the notification pursuant to Section 32(5), the applicant can demand from that person who has used the subject matter of the application, although he knew or should have known that the invention used by him was the subject matter of the application, compensation appropriate to the circumstances; further claims shall not be permitted. (2) No claim to compensation shall arise if the subject matter of the application is obviously not patentable. (3) The provisions of Part 5 of Book 1 of the Civil Code [Bu¨rgerliches Gesetzbuch] shall apply mutatis mutandis to the period of limitation, subject to the proviso that the period of limitation shall commence at the earliest one year after the grant of the patent. Should the obligated person have gained something due to the infringement and at the cost of the entitled person, Section 852 of the Civil Code shall apply mutatis mutandis. § 49a (1) Should the person registered as patentee request supplementary protection, the Patent Division shall examine whether the application complies with the relevant Council regulation of the European Communities and with subsection (5) and Section 16 a. (2) If the application satisfies those requirements, the Patent Division shall grant a supplementary protection certificate for the duration of its term. In the contrary case, the Patent Division will invite the applicant to rectify any defect within a time limit to be set by the Patent Division, which shall be of at least two months. If the defects are not remedied, the Patent Division shall reject the application by a decision. 199

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(3) Where a regulation of the European Communities provides for an extension of the term of a supplementary protection certificate, subsections (1) and (2) shall apply mutatis mutandis. (4) The Patent Division shall decide by order on the requests provided in the regulations of the European Communities 1. to correct the term of a supplementary protection certificate if the date of the first authorization for marketing a product in the application for the certificate is incorrect; 2. to revoke the extension of the term of a supplementary protection certificate. (5) Section 34(6) shall apply. Sections 46 and 47 shall apply to the proceedings before the Patent Division. § 81 (1) Proceedings regarding a declaration of nullity of a patent or a supplementary protection certificate or regarding the grant or withdrawal of a compulsory license or regarding the adaptation of the remuneration determined by a judgment for a compulsory license shall be instituted by bringing legal action. The action shall be directed against the person recorded in the Register as patentee or against the holder of the compulsory license. An action against a supplementary protection certificate may be joined with an action against the underlying patent and may also be based on the fact that there is a nullity ground with respect to the underlying patent (Section 22). (…) § 139 (1) Any person who uses a patented invention in contravention of Sections 9 through 13 may, if there is danger of repetition, be sued by the injured party for injunctive relief. This claim shall also apply if there is a danger of first perpetration. (2) Any person who intentionally or negligently undertakes such an act shall be liable to the injured party for compensation of the damages incurred thereby. When assessing the damages, the profit which the infringer has made by infringing the right may also be taken into account. The claim for compensation of damages may also be calculated on the basis of the amount the infringer would have had to pay as an adequate remuneration had he obtained the authorization to use the invention. (3) Where the subject matter of a patent is a process for obtaining a new product, the same product made by another shall, in the absence of proof to the contrary, be deemed to have been made using the patented process. When taking contrary evidence, the legitimate interests of the defendant in protecting his manufacturing and business secrets are to be taken into account. § 140 If, prior to the grant of the patent, rights based on an application, the files of which may be inspected by any person (Section 31(1), second half of sentence 2, and (2)), are asserted in court proceedings, and if deciding the lawsuit depends on whether there is a claim under Section 33(1), the court may order that the proceedings be stayed until a decision on grant of the patent is rendered. If a request for examination has not been filed pursuant to Section 44, the court must, upon the request of the adversary, set a time-limit to the party claiming rights from the application for filing the request for examination. If the request for examination is not filed within said time-limit, the rights derived from the application may not be asserted in the lawsuit. 200

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§ 146 Any person who places on articles or their packaging a designation of such a nature as to create the impression that the articles are protected by a patent or a patent application pursuant to this Act, or any person who uses a designation of such a nature in public advertisements, on signboards, on with-compliment cards or in similar announcements shall be required to give, on demand, to any person having a legitimate interest in knowing the legal situation, information as to the patent or patent application upon which the use of said designation is based. AMG: Medicinal Products Act of 12 December 2005, BGBl. I p. 3394 (extract) §1 It is the purpose of the present Act to guarantee, in the interest of furnishing both human beings and animals with a proper supply of medicinal products, safety in respect of the trade in medicinal products, ensuring in particular the quality, efficacy and safety of medicinal products in accordance with the following provisions. §4 (…) (23) A clinical trial on human beings is any investigation on human subjects intended to investigate or verify the clinical or pharmacological effects of medicinal products, or to identify adverse reactions or to study the absorption, distribution, metabolisation or excretion, with the aim of ascertaining the safety or efficacy of the medicinal product. Sentence 1 does not apply to non-interventional trials. A non-interventional trial is a study, in the context of which findings resulting from persons’ treatment with medicinal products are analysed using epidemiological methods; the treatment, including the diagnosis and monitoring, shall not follow a predetermined trial protocol but shall result exclusively from current medical practice; in so far as a medicinal product requiring a marketing authorisation or a medicinal product requiring an authorisation pursuant to Section 21 a sub-section 1 is concerned, this shall be conducted, moreover, according to the specifications regarding its use contained in the marketing authorisation or authorisation. (…) § 13 (1) Any person who manufactures: 1. medicinal products within the meaning of Section 2 sub-section 1 or sub-section 2 number 1, 2. test sera, test antigens, 3. active substances, which are of human, animal or microbial origin or are manufactured using genetic engineering, or 4. other substances of human origin intended for the manufacture of medicinal products on a commercial or professional basis shall require an authorisation by the competent authority. The same shall also apply to legal persons, non-incorporated associations and companies established under civil law which manufacture medicinal products for distribution to their members. Sentence 1 shall apply mutatis mutandis to a trial on the basis of which the release of the medicinal product is explained. This shall be without prejudice to Section 14 sub-section 4. (…) 201

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§ 21 (1) Finished medicinal products which are medicinal products as defined in Section 2 sub-section 1 or sub-section 2 number 1, may only be placed on the market within the purview of the present Act, if they have been authorised by the competent higher federal authority or if the European Community or the European Union has granted an authorisation for them to be placed on the market pursuant to Article 3 paragraph 1 or 2 of Regulation (EC) No 726/2004 also in conjunction with Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12th December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378 of 27.12.2006, p. 1) or Regulation (EC) No 1394/2007. The same shall apply to medicinal products which are not finished medicinal products and which are intended for administration to animals, provided they are not intended for distribution to pharmaceutical entrepreneurs holding an authorisation for the manufacture of medicinal products. (…) § 22 (…) (2) Furthermore, the following information shall be submitted: (…) 3. the results of clinical trials or other medical, dental or veterinary tests, (…) § 24a The applicant can refer to the documents referred to in Section 22 sub-sections 2, 3, 3 c and Section 23 sub-section 1, including the expertise report referred to in Section 24 sub-section 1 sentence 2 submitted by an earlier applicant (previous applicant), if he/she submits the previous applicant’s written agreement, including confirmation that the documents referred to meet the requirements of the Guidelines for the Testing of Medicinal Products pursuant to Section 26. The previous applicant shall respond to a request for agreement, within a period of three months. A partial reference is not admissible. § 24b (1) In the case of a generic medicinal product within the meaning of sub-section 2, reference can be made, without the previous applicant’s agreement, to the documents referred to in sentence 1 of Section 22 sub-section 2 sentence 1 numbers 2 and 3 and Section 23 sub-section 1, including the expert report referred to in Section 24 subsection 1 sentences 2 to 4 for the previous applicant’s medicinal product (reference medicinal product), provided that the reference medicinal product has been authorised for at least eight years or was authorised at least eight years previously; this shall also apply to authorisation in another Member State of the European Union. A generic medicinal product authorised pursuant to this provision shall not be placed on the market until ten years have elapsed following the first authorisation of the reference medicinal product. The period referred to in sentence 2 shall be extended to a maximum of eleven years if, during the first eight years of authorisation, the marketing authorisation holder obtains authorisation for one or more new therapeutic indications which during the scientific evaluation conducted prior to their authorisation by the 202

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competent higher federal authority are held to bring significant clinical benefit in comparison with existing therapies. (…) § 27 (1) The competent higher federal authority shall reach its decision on the application for a marketing authorisation within a period of seven months. The decision on the recognition of a marketing authorisation shall be taken within a period of three months following receipt of the assessment report. An assessment report is to be drawn up within a period of three months. (…) §§ 40–42a [General conditions for the clinical trial, Special conditions for the clinical trial, Ethics committee procedure, procedure for authorisation by the higher federal authority, Withdrawal, revocation and suspension of the authorisation or of the favourable opinion] (…) § 78 (1) The Federal Ministry of Economics and Technology is hereby empowered to fix, in agreement with the Federal Ministry and, as far as medicinal products intended for administration to animals are concerned, in agreement with the Federal Ministry of Agriculture, Food and Consumer Protection, by ordinance subject to the approval of the Bundesrat: 1. price margins for medicinal products which are distributed in wholesale commerce or in pharmacies or which are re-sold by veterinarians, 2. prices for medicinal products which are manufactured and distributed in pharmacies or by veterinarians, as well as for the containers in which they are supplied, 3. prices for particular services rendered by pharmacies in connection with the dispensing of medicinal products. (…) UWG: The Act against Unfair Competition of 3 March 2010, BGBl. I p. 254 (extract) § 1. Purpose of the Act This Act shall serve the purpose of protecting competitors, consumers and other market participants against unfair commercial practices. At the same time, it shall protect the interests of the public in undistorted competition. GWB: Act against Restraints of Competition of 26 June 2013, BGBl. I p. 1750 (extract) § 1. Prohibition of Agreements Restricting Competition Agreements between undertakings, decisions by associations of undertakings and concerted practices, which have as their object or effect the prevention, restriction or distortion of competition, shall be prohibited.

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§ 19. Abuse of a Dominant Position (1) The abusive exploitation of a dominant position by one or several undertakings is prohibited. (…) § 20. Prohibition of Discrimination, Prohibition of Unfair Hindrance (1) Dominant undertakings, associations of competing undertakings within the meaning of §§ 2, 3, and 28 (1) and undertakings which set retail prices pursuant to § 28 (2), or § 30 (1) sentence 1, shall not directly or indirectly hinder in an unfair manner another undertaking in business activities which are usually open to similar undertakings, nor directly or indirectly treat it differently from similar undertakings without any objective justification. (…) § 36. Principles for the Appraisal of Concentrations (1) A concentration that would significantly imped effective competition, especially which is expected to create or strengthen a dominant position, shall be prohibited by the Bundeskartellamt. This does not apply if: 1. the undertakings concerned prove that the concentration will also lead to improvements of the conditions of competition and that these improvements will outweigh the disadvantages of dominance or (…) RulesGCP: Rules on the Application of Good Clinical Practice during Conduct of Clinical Trials with Medicinal Products for Human Use of 19 October 2012, BGBl. I p. 2192 (extract) § 7. Submission of Application (…) (4) The following shall also be submitted to the competent Federal authority: 1. The dossier concerning the investigational medicinal product, with the following content: (…) d) Manufacturing permit, (…)

II. United Kingdom Patents Act 1977 (extract) § 128B. Supplementary protection certificates (1) Schedule 4A contains provision about the application of this Act in relation to supplementary protection certificates and other provision about such certificates. (2) In this Act a “supplementary protection certificate” means a certificate issued under— (a) Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products, or

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(b) Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products. Schedule 4A Supplementary Protection Certificates References to patents etc 1.— (1) In the application to supplementary protection certificates of the provisions of this Act listed in sub-paragraph (2)— (a) references to a patent are to a supplementary protection certificate; (b) references to an application or the applicant for a patent are to an application or the applicant— (i) for a supplementary protection certificate, or (ii) for an extension of the duration of a supplementary protection certificate; (c) references to the proprietor of a patent are to the holder of a supplementary protection certificate; (d) references to the specification of a patent are to the text of a supplementary protection certificate; (e) references to a patented product or an invention (including a patented invention) are to a product for which a supplementary protection certificate has effect; (f) references to a patent having expired or having been revoked are to a supplementary protection certificate having lapsed or having been declared invalid; (g) references to proceedings for the revocation of a patent are to proceedings— (i) for a decision that a supplementary protection certificate has lapsed, or (ii) for a declaration that a supplementary protection certificate is invalid; (h) references to the issue of the validity of a patent include the issue of whether a supplementary protection certificate has lapsed or is invalid. (2) The provisions referred to in sub-paragraph (1) are— section 14(1), (9) and (10) (making of application); section 19(1) (general power to amend application before grant); sections 20A and 20B (reinstatement of applications); section 21 (observations by third party on patentability); section 27 (general power to amend specification after grant); section 29 (surrender of patents); sections 30 to 36, 37(1) to (3) and (5) to (9) and 38 (property in patents and applications, and registration); sections 39 to 59 (employees’ inventions, licences of right and compulsory licences and use of patented inventions for services of the Crown); sections 60 to 71 (infringement); section 74(1) and (7) (proceedings in which validity of patent may be put in issue); section 75 (amendment of patent in infringement or revocation proceedings); sections 103 and 105 (privilege for communications relating to patent proceedings); section 108 (licences granted by order of comptroller); sections 110 and 111 (unauthorised claim of patent rights or that patent has been applied for); section 116 (immunity of department as regards official acts); sections 117 to 118 (administrative provisions); section 123 (rules); section 130 (interpretation). 205

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2.— (1) In the case of the provisions of this Act listed in sub-paragraph (2), paragraph 1 applies in relation to an application for a supplementary protection certificate only if the basic patent expires before the certificate is granted. (2) The provisions referred to in sub-paragraph (1) are— section 20B(3) to (6A) (effect of reinstatement under section 20A); section 55(5) and (7) (use of patented inventions for services of the Crown); section 58(10) (disputes as to Crown use); section 69 (infringement of rights conferred by publication of application); section 117A(3) to (7) (effect of resuscitating a withdrawn application under section 117). References to this Act etc 3.— (1) In the provisions of this Act listed in sub-paragraph (2)— (a) references to this Act include the Medicinal Products Regulation and the Plant Protection Products Regulation, and (b) references to a provision of this Act include any equivalent provision of the Medicinal Products Regulation and the Plant Protection Products Regulation. (2) The provisions referred to in sub-paragraph (1) are— sections 20A and 20B (reinstatement of applications); section 21 (observations by third party on patentability); section 69 (infringement of rights conferred by publication of application); section 74(1) and (7) (proceedings in which validity of patent may be put in issue); sections 97 to 99B, 101 to 103, 105 and 107 (legal proceedings); section 116 (immunity of department as regards official acts); sections 117 and 118 to 121 (administrative provisions); section 122 (Crown’s right to sell forfeited articles); section 123 (rules); section 124A (use of electronic communications); section 130 (interpretation). Other references 4.— (1) In the application of section 21(1) (observations by third party on patentability) to supplementary protection certificates, the reference to the question whether the invention is a patentable invention is to the question whether the product is one for which a supplementary protection certificate may have effect. (2) In the application of section 69(2) (conditions for infringement of rights conferred by publication of application) to supplementary protection certificates, the condition in paragraph (b) is that the act would, if the certificate had been granted on the date of the publication of the application, have infringed not only the certificate as granted but also the certificate for which the application was made. Fees 5. — A supplementary protection certificate does not take effect unless— (a) the prescribed fee is paid before the end of the prescribed period, or (b) the prescribed fee and any prescribed additional fee are paid before the end of the period of six months beginning immediately after the prescribed period. 206

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Interpretation 6.— (1) Expressions used in this Act that are defined in the Medicinal Products Regulation or the Plant Protection Products Regulation have the same meaning as in that Regulation. (2) References in this Act to, or to a provision of, the Medicinal Products Regulation or the Plant Protection Products Regulation are to that Regulation or that provision as amended from time to time. 7.— In this Act— (a) “the Medicinal Products Regulation” means Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products, and (b) “the Plant Protection Products Regulation” means Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products. Patents Rules SI 2007/3291 (extract) Rule 116.— Supplementary protection certificates (1) An application for— (a) a supplementary protection certificate shall be made on Patents Form SP1; and (b) an extension of the duration of a supplementary protection certificate under Article 8 of the Medicinal Products Regulation shall be made on Patents Form SP4. (2) The period prescribed for the purposes of paragraph 5(a) of Schedule 4A to the Act is— (a) three months ending with the start date; or (b) where the certificate is granted after the beginning of that period, three months beginning immediately after the date the supplementary protection certificate is granted. (3) The comptroller must send a notice to the applicant for the certificate— (a) before the beginning of the period of two months immediately preceding the start date; or (b) where the certificate is granted as mentioned in paragraph (2)(b), on the date the certificate is granted. (4) The notice must notify the applicant for the certificate of— (a) the fact that payment is required for the certificate to take effect; (b) the prescribed fee due; (c) the date before which payment must be made; and (d) the start date. (5) The prescribed fee must be accompanied by Patents Form SP2; and once the certificate has taken effect no further fee may be paid to extend the term of the certificate unless an application for an extension of the duration of the certificate is made under the Medicinal Products Regulation. (6) Where the prescribed fee is not paid before the end of the period prescribed for the purposes of paragraph 5(a) of Schedule 4A to the Act, the comptroller shall, before the end of the period of six weeks beginning immediately after the end of that prescribed period, and if the fee remains unpaid, send a notice to the applicant for the certificate. 207

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(7) The notice shall remind the applicant for the certificate— (a) that payment is overdue; and (b) of the consequences of non-payment. (8) The comptroller must send the notices under this rule to— (a) the applicant’s address for service; and (b) the address to which a renewal notice would be sent to the proprietor of the basic patent under rule 39(3). Patents (Fees) Rules 2007/3292 (extract) Rule 6.— Supplementary protection certificates (1) The prescribed fee payable for a supplementary protection certificate to take effect is set in accordance with paragraph (2). (2) Where the certificate expires during the period of one year beginning with— (a) the start date, the fee is \$L600; (b) the first anniversary of the start date, the fee is \$L1,300; (c) the second anniversary of the start date, the fee is \$L2,100; (d) the third anniversary of the start date, the fee is \$L3,000; or (e) the fourth anniversary of the start date, the fee is \$L4,000. (3) The period in paragraph (2) shall be calculated without reference to any extension of the duration of a supplementary protection certificate under Article 13(3) of the Medicinal Products Regulation 1. (4) The additional fee prescribed for the purposes of paragraph 5(b) of Schedule 4A to the Act (supplementary protection certificates) shall be half the prescribed fee. (5) In this rule “start date” is the first day following the day on which the basic patent expires.

III. France French Intellectual Property Code L611-6 The right to the industrial property title referred to in Article L.611-1 shall belong to the inventor or his successor in title. If two or more persons have made an invention independently of each other, the right to the industrial property title shall belong to the person who can prove the earliest date of filing. In actions before the Director of the National Institute of Industrial Property, the applicant shall be deemed to have a right to the industrial property title. L612-21 The National Institute of Industrial Property shall publish, under the conditions defined by Conseil d’Etat decree, by a notice in the Official Bulletin of Industrial Property, by making available to the public the full text or by dissemination through a data-bank or distribution on a data medium: 1. the file of each application for a patent or a utility certificate on expiry of 18 months from the date of filing or from the priority date, where priority has been claimed, or at the simple request of the applicant prior to expiry of that period;

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2. each application for a supplementary protection certificate, attached to the patent application to which the certificate relates or, where the latter application has already been published, as of its filing, with an identification in such case of the patent to which the certificate relates; 3. any subsequent procedural act; 4. any grant of such title; 5. the acts referred to in Article L613-9; 6. the date of the authorization referred to in Article L611-3, with an identification of the corresponding patent. L613-2 The extent of the protection afforded by the patent shall be determined by the claims. Nevertheless, the description and drawings shall serve to interpret the claims. Where the subject matter of the patent relates to a process, the protection afforded by the patent shall extend to the products directly obtained by such process. L613-3 The following shall be prohibited, save consent by the owner of the patent: a) The making, offering, putting on the market, using, importing, exporting, transshipment, or holding for the aforesaid ends of the product which is the subject matter of the patent; b) Using a process which is the subject matter of the patent or, when the third party knows or when the circumstances make it obvious that the use of the process is prohibited without the consent of the owner of the patent, the offer of its use on French territory; c) The offering, putting on the market, using, importing, exporting, transshipment or holding for the aforesaid ends of the product obtained directly by the process which is the subject matter of the patent. L613-4 1. It shall also be prohibited, save consent by the owner of the patent, to supply or offer to supply, on French territory, to a person other than a person entitled to work the patented invention, the means of implementing, on that territory, the invention with respect to an essential element thereof where the third party knows, or it is obvious from the circumstances, that such means are suited and intended for putting the invention into effect. 2. Paragraph 1 shall not apply where the means of implementation are staple commercial articles, except where the third party induces the person supplied to commit acts prohibited by Article L613-3. 3. Persons carrying out the acts referred to in items (a), (b) and (c) of Article L.613-5 shall not be deemed persons entitled to work the invention within the meaning of paragraph 1.” L613-5 The rights afforded by the patent shall not extend to: a) Acts done privately and for non-commercial purposes; b) Acts done for experimental purposes and which relate to the subject matter of the patented invention;

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c) The extemporaneous preparation by unit of medicines in a pharmacy for a medical prescription, or to acts concerning the medicines so prepared. d) To the research and assays required for the purposes of obtaining a marketing authorization for a medicine, as well as to the acts necessary for their performance and to obtaining the authorization; d bis) To the acts necessary for obtaining the advertising permit referred to in Article L.5122-9 of the Code of Public Health; e) To the items intended to be launched into outer space introduced onto French territory. L613-7 Any person who, within the territory in which this Book applies, at the filing date or priority date of a patent was, in good faith, in possession of the invention which is the subject matter of the patent shall enjoy a personal right to work that invention despite the existence of the patent. The right afforded by this Article may only be transferred together with the business, the enterprise or the part of the enterprise to which it belongs. L613-8 The rights deriving from a patent application or a patent shall be assignable in whole or in part. They may be subject in whole or in part to the grant of an exclusive or non-exclusive license to work the invention. The rights afforded by the patent application or the patent may be invoked against a licensee who exceeds any of the limits on his license stipulated in accordance with the foregoing paragraph. Subject to the cases referred to in Article L611-8, assignment of the rights referred to in the first paragraph shall not affect the rights acquired by third parties prior to the date of assignment. The acts referred to in the first two paragraphs which comprise assignment or license shall be executed in writing, on pain of nullity. L613-9 In order to be asserted against third parties, all acts transferring or modifying the rights attached to a patent application or to a patent must be recorded on the National Register of Patents, held by the National Institute of Industrial Property. However, prior to its recordation, an act may be asserted against a third party who acquired rights after the date of that act, but who had knowledge of that act on acquiring those rights. A licensee who is party to a license agreement not recorded on the National Register of Patents shall also be admissible to participate in the infringement proceedings instituted by the owner of the patent in order to obtain compensation for the injury specific to itself. L613-25 A patent shall be declared invalid by court decision: a) If its subject matter is not patentable under the terms Articles L. 611–10, L. 611–11 and L. 611–13 to L. 611-19;

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b) If it does not disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art; c) If its subject matter extends beyond the content of the application as filed, or, where the patent was granted on the basis of a divisional application, if its subject matter extends beyond the content of the initial application as filed; d) If, after limitation, the extent of the protection afforded by the patent has been increased. If the grounds for invalidity affect the patent only in part, the invalidity shall declared in the form of a corresponding limitation of the claims. In proceedings for invalidity of a patent, its owner shall be entitled to limit the patent by amending the claims; the patent so limited shall be the subject of the invalidity proceedings instituted. A party which, during the same proceedings, makes several limitations to its patent dilatorily or abusively, may be ordered to pay a civil fine of up to 3 000 euros, without prejudice to damages which may be claimed. L615-3 Any party having the capacity to take action for infringement may petition the civil court having jurisdiction in summary proceedings for an order, if necessary subject to liquidated damages for failure to comply, against the alleged infringer or intermediaries whose services it uses, for any measure intended to forestall an imminent breach of the rights afforded by the intellectual property or to prevent the continuation of alleged infringing acts. The civil court having jurisdiction may also order any urgent measures upon petition when circumstances require those measures not to be ordered in adversarial proceedings, in particular where any delay would cause irreparable harm to the holder of an intellectual property right. In summary proceedings or upon petition, the civil court may only order the requested measures if the evidence that is reasonably accessible to the plaintiff makes it likely that its rights are being breached or that such a breach is imminent. The court may order an injunction against the continuation of the alleged infringing acts, make that continuation of the alleged infringing acts subject to the provision of a guaranty intended to ensure possible compensation of the plaintiff or order seizure or the delivery up to a third party of the products suspected of breaching the rights conferred by the intellectual property, to prevent their entry or movement within commercial channels. If the plaintiff provides justification of circumstances of such a nature as to compromise the recovery of damages, the court may order the precautionary seizure of movable and immovable property of the alleged infringer, including the blocking of its bank accounts and other assets, in accordance with common law. To determine which property may be the subject of the seizure, it may order the production of banking, financial, accounting or commercial documents or the access to the relevant information. The court may also grant the plaintiff a provisional award when the existence of its injury is not seriously contestable. In summary proceedings or upon petition, the court may make the execution of the measures it has ordered subject to the provision by the plaintiff of guaranties intended to ensure possible compensation of the defendant if the action for infringement is later held to be unfounded or if the measures are rescinded. When the measures taken for cessation of a breach of the rights are ordered prior to the institution of proceedings on the merits, the plaintiff shall, within a period set by regulation, either institute civil or criminal proceedings, or file a complaint with the 211

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Director of Public Prosecutions. Failing which, upon request by the defendant and without the defendant being required to justify its request, the ordered measures shall be rescinded, without prejudice to the damages which may be claimed. L615-5 Proof of the infringement may be furnished by any means. To that and, any person having the capacity to take action for infringement shall have the right to have carried out, at any location, either the detailed description, with or without the taking of samples, or the actual seizure of the alleged infringing products or processes and of any document relating thereto, by any bailiffs, who may be assisted by experts designated by the petitioner, by virtue of an order rendered upon petition by the competent civil court. The order may authorize the real seizure of any document relating to the alleged infringing products or processes in the absence of these latter. The court may order, for the same probative ends, the detailed description or the real seizure of the equipment or instruments used to manufacture or distribute the products or to implement the alleged infringing processes. It may make the execution of the measures it has ordered subject to the provision by the plaintiff of guaranties intended to ensure possible compensation of the defendant if the action for infringement is later held to be unfounded or if the seizure is rescinded. Failing the institution of civil or criminal proceedings on the merits by the plaintiff, within a period set by regulation, the entirety of the seizure, including the description, shall be rescinded upon request of the party that underwent the seizure, without that party being required to justify its request and without prejudice to the damages which may be claimed. R617-1 The filing fee for a supplementary protection certificate shall not cover the first annual fee. The payment of annual fees shall become due on the last day of the month of the anniversary date of the filing of the application for the basic patent. Overall payment of all annual fees may be accepted if made within the year preceding the entry into effect of the certificate. Public Health Code Article L5121-10 For a generic specialty defined at paragraph (5) of Article L. 5121–1, the marketing authorization may be issued prior to the expiry of the intellectual property rights attached to the specialty of reference concerned. The applicant for this authorization shall inform the owner of those rights concomitantly with the filing of the application. When the National Agency for the Safety of Medicines and Healthcare Products has granted such a marketing authorization, it shall provide notification thereof to the owner of the marketing authorization of the specialty of reference. The Director General of the Agency shall record the generic specialty on the List of the Generic Groups after a period of sixty days from having provided notification, to the owner of the marketing authorization of the specialty of reference, of the granting of the marketing authorization for the generic specialty. Nevertheless, save consent by owner of the intellectual property rights, the commercialization of that generic specialty shall only take place after expiry of those rights. Prior to that commercialization, the holder of the marketing authorization of the generic specialty shall inform the Director General of the Agency of the indications,

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pharmaceutical forms and doses of the specialty of reference for which the intellectual property rights have not expired. Solely for the purposes of informing the public thereof, the Director General of the National Agency for the Safety of Medicines and Healthcare Products shall make available to the public the list of the items of intellectual property concerning a specialty of reference if the holder of the marketing authorization for that specialty provides him therewith for that purpose. The pharmaceutical company is solely responsible for the accuracy of the information supplied. Framework Agreement LEEM and CEPS Article 3 Companies exploiting specialties for which they hold one or more patents or Supplementary Protection Certificates (SPCs) may declare to the Committee (the CEPS) the intellectual property rights under consideration and their expiry dates. The Committee will make these declarations available to any pharmaceutical company that applies for them. No registration of a generic specialty on the list of specialties reimbursable to persons covered by public health insurance and, where applicable, on the list of pharmaceutical specialties that are certified for local authorities and various public services, will be published more than 6 months before the declared date on which the intellectual property rights will expire if this has been notified to the Committee. However, a pharmaceutical company which considers that it can market the generic specialties concerned without infringing the declared rights may apply for the corresponding generic specialty to be registered. In this case, it must inform the Committee, which without delay informs the company exploiting the specialty mentioned in the first paragraph above and implements the registration procedure.

IV. Italy Legislative Decree 10 February 2005 (CPI) Art. 70 (Compulsory License by lack of carrying out): (1) After three years from the grant of the patent or four years after the filing date of the application, if the latter term expirers after the former term, in case the owner of the patent of his successor in right, directly or by means of one or more licensees, has not carried out the patented invention, manufacturing in the territory of the State or importing goods manufactured in a Member State of European Union or the Economic European Space or in a Member State of the World Trade Organization, or has carried out the invention in an amount such that it results in severe imbalance with the needs of the Country, a compulsory license for the non exclusive use of the same invention can be granted to any party who requests so. (2) The compulsory license referred to in Subsection (1) can equally be granted when the carrying out of the invention is suspended or reduced for more than three years such that it results in severe imbalance with the needs of the Country. (3) The compulsory license is not granted if the insufficient or lacking carrying out is due to reasons independent from the willing of the owner of the patent or his successor in right. The lack of financial means and, when the same product is exported, the lack of demand in the internal market of the patented product or obtained with the patented process are not comprised in the said reasons. 213

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(4) The grant of the compulsory license does not exempt the owner of the patent or his successor in right from the obligation to carry out the invention. The patent will lapse if the invention is not carried out within two years from the date of grant of the first compulsory license or is carried out in in an amount such that it results in severe imbalance with the needs of the Country. Art. 72 (Common provisions): (1) Whoever applies for the grant of a compulsory license within the provisions of Articles 70 and 71, must show to have previously asked the owner of the patent and to have been unable to obtain from the owner a contractual license at fair conditions. (2) The compulsory license can be granted only under payment by the licensee to the owner of the patent or his successors in right, of an equitable remuneration and on condition that the applicant for the license provides sufficient guarantees for a sufficient carrying out of the invention according to the conditions established in the license. (3) The compulsory license cannot be granted when the applicant turns out to be infringer of the patent, unless he proves his good faith. (4) The compulsory license cannot be granted when the applicant turns out to be infringer of the patent, unless he proves his good faith. […] Art. 73 (Revocation of the compulsory license): (1) The compulsory license is revoked with a decree of the Ministry of Economic Development, when the conditions established for the carrying out of the invention are not fulfilled, or the licensee has not paid the remuneration as agreed. […] Art. 78 (Surrender): (1) The owner can surrender the patent by an act received by the Italian Patent and Trademark Office, to be annotated in the Register of Patents. (2) whenever, in relation to the patent, acts or decisions conferring or ascertain property rights of third parties or judicial requests by which conferring or ascertainment of said rights are requested, surrender shall have no effect unless accompanied by the written consent of said third parties. Art. 81(4) (Supplementary Certificate under the provisions of Law 19 October 1991, n. 349 and voluntary license on active ingredients arbitrated by the Ministry): […] to the purpose to gradually harmonize the duration of supplementary and patent protection to the one provided by Community Law, the provisions of the Law 19 October 1991, n. 349, and by Regulation (CEE) n. 1768/1992 of the Council, of 18 June 1992, are implemented through a progressive reduction of supplementary protection equal to six months for each solar year, starting from 1 January 2004, until the complete harmonization with European Law. Art. 81(5): Third parties, willing to manufacture for exportation active ingredients protected by Supplementary Certificates granted under the Law 19 October 1991, n. 349, are allowed to start with owners of the above Supplementary Certificates, at the Ministry of

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Economic Development, a procedure for the release of non-exclusive voluntary licenses, upon payment, within the provisions of the relevant Law in force. Art. 138 (Registration): (1) By registration with Italian Patent and Trademark Office, shall be publicly available: (a) the acts between living persons, either under payment or free of charge, which transfer in whole or in part the rights on industrial property titles; […] Art. 148 (Admissibility and integration of applications and filing date): (1) Applications for patent and registration and renewal referred to on Art. 147(1) are not admitted if the applicant cannot be identified or cannot be reached […]. Non admissibility, unless provided by Subsection (3), is so declared by Italian Patent and Trademark Office. (2) Italian Patent and Trademark Office shall invite the applicant to make the necessary integrations, subjet to the payment of a fee in case of late payment, within two months from the date of the invitation is it is ascertained that: […] e) the proof of payment of the prescribed fees within the term provided by Art. 226; e-bis) a domicile in Italy or the appointment of an authorized representative is not shown. (3) If the applicant complies with the Office invitation within the term referred to in Subsection (2) or complies spontaneously to the relevant integration, the Office shall acknowledge as filing date, and its legal effects, the date of receipt of the requested integration and shall communicate so to the applicant. If the applicant does not comply with the Office invitation within the term referred to in Subsection (2), […]the Office shall declare the non admissibility of the application under the provisions of Subsection (1). (4) However, if the integration relates only the proof of payment of the fee within the prescribed term, or the indication of domicile or of the authorized representative in Italy and said proof or indication is filed within the term of Subsection (2), the Office shall acknowledge as filing date the date of receipt of the application. (5) All the applications, requests and appeals referred to in Article 147, with the enclosed acts, shall be written in Italian language. Of acts in a language different from Italian, an Italian translation shall be provided. The translation can be declared to be into conformity with the original text by the applicant or an authorized representative […]. […] Art. 163 (Application for Supplementary Certificate for medicinal products and for phytosanitary products): (1) The application for certificate shall be filed with Italian Patent and Trademark Office referring to the Marketing Authorization of the product. (2) The Italian Patent and Trademark Office shall publish at least the following details concerning the application for certificate: a) name and address of the applicant: b) number of the basic patent: c) title of the invention; 215

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d) number and date of the Marketing Authorization, as well as the indication of the product as mentioned in the same Authorization; e) if appropriate, number and date of the first Marketing Authorization, in the Community. Art. 172(2): (Withdrawal, corrections, integrations of the application): 2. Before Italian Patent and Trademark Office has provided on the grant of the title or decided about a request or an appeal, or, in any case, before the Board of Appeal, wherein an appeal was filed, has decided, the Applicant can correct in its nonsubstantial aspects, the originally filed application or any other request referring to it, as well as, in case of application of a patent for invention or utility model, to complete also with new examples or to limit the originally filed description, claims and drawings and, in case of application for trademark, to limit or specify the originally listed product and services. Art. 173(4): (Objections): 4. When the due date has elapsed without a reply to the objections has been filed, the application or the request is rejected by order, to be notified to the owner of the application or of the request by registered mail with advice of delivery. However, if the objection relates a priority claim, the lacking reply will involve only the loss of such a right. Art. 185 (Public availability): (1) The original titles of industrial property shall be signed by the Director of the competent Office or by an Officer appointed by him. (2) The titles of industrial property shall be marked by an identification number, according to the type and date of grant and shall contain: a) the date and number of the application; b) Surname, name, domicile of the owner, […]; c) Surname, name, domicile of the appointed representative, if any; d) Surname, name, domicile of the inventor […]; e) details of priority right; […] Art. 193 (Re-establishment) (1) The applicant or the owner of a industrial property right who, in spite of having used the diligence required by the circumstances, was unable to comply with a term before the Italian Patent and Trademark Office or the Board of Appeal, shall be reestablished in his rights if the non-compliance has as a direct consequence the rejection of the application or of a request relating to it, or the lapse of the title of industrial property or the loss of any other right or a means of redress. (2) Within the term of two months from the removal of the cause of non-compliance, the omicted act shall be performed and the request for re-establishment shall be filed, with the indication of the facts and the reasons and suitable documentation. The application shall not be admitted if a year lapsed from the non complied term. In case of missing payment of a maintenance or renewal fee, said one year period will start from the day of the due date of the term whatever useful for the payment of the fee. In this case, the proof of the payment of the due fee, incuding the surcharge, shall be enclosed.

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(3) Before refusal of the request, the applicant or owner of the right of industrial property may, within the term established by the Office, file his own arguments and conclusions. (4) The provisions of this Article are not applicable to the terms referred to in Subsection (2), the term assigned for divisional application […]. (5) […] (6) Whoever, in good faith, started serious and effective preparation or started using the object of third party’s industrial property in the period running from the loss of exclusive or the right of acquire it and the re-establishment pursuant to Subsection (1), can: a) in case of invention […] carry out free of charge within the limits of pre-use; b) […] Art. 196 (Registration procedure) (1) To the request of registration, referred to in Subsection (2) of Art. 195, it shall be enclosed: a) copy of the act showing the change of ownership or of the act which constitutes or modifies or extinguishes the personal or real possession rights or of guarantee referred to in Subsection (1), a), b) and c) and i) of Art. 138, or copy of the minutes and decisions referred to in Subsection (1), d), e), f), g) and h) of Art. 138, […] or in case of assignment or grant of a license, a declaration of assignment or license signed by the Assignor and the Assignee listing the rights object of the assignment or license. [….] b) the document showing the payment of the prescribed fee. […] Art. 197 (Annotations): (1) [deleted] (2) Change of name or domicile of the owner of a title of industrial property or of his authorized representative, if any, shall be notified to the Office by means of annotation on the Register referred to in Art. 185. […] (6) Declarations of surrender, even partial, of a title of industrial property signed by the owner and decisions declaring nullity or lapse of titles of industrial property received by Italian Patent and Trademark Office shall be annotated on the collection of originals and they shall be mentioned on the Official Bulletin. Art. 199 (Procedure for compulsory license): (1) Whoever wishes to obtain the compulsory license provided by Art. 70 and 71 of Heading II, Section IV for the non exclusive use of industrial invention or utility model shall file reasoned request to Italian Patent and Trademark Office, showing the amount and modes of payment of remuneration. The Office shall give prompt notice to the patent owner and to the ones who have acquired rights on the patent on the basis of recorded or annotated acts. […] Art. 200 (Procedure for voluntary license on active ingredients): (1) The application for compulsory license on active ingredients, enclosing the proof of payment od the fees as provided by the Decree of the Ministry of Manufacturing

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Activities referred to on Article 226 [Rules relating to Fees], must contain the following information: a) name or business name and domicile or legal seat of the applicant the voluntary license; b) name of the active ingredient; c) details of the protection, number of the patent and of the Supplementary Protection Certificate; d) details of the Italian pharmaceutical manufacturing Company, duly authorized by the Ministry of Health, where the active ingredient is to be manufactured. (2) The applicant shall further send, by registered letter with advice of delivery, or any other means ensuring the delivery of the communication, to the Italian Patent and Trademark Office (IPTO) the application enclosing the English translation with the elements provided in Subsection (1). (3) IPTO will give prompt notice by registered letter with advice of delivery, or any other means ensuring the delivery of the communication, of the request to the interested parties and those who have rights on the patent or the Supplementary Certificate on the basis of recorded or annotated acts. (4) If within ninety days from the date of receipt of the application, extendable on agreement of the parties, the same parties reach an agreement on the royalty, copy of the same shall be transmitted, with the same procedure, to the Ministry of Economic Development – IPTO. If within the subsequent thirty days, the Office does not communicate any objection to the parties, the voluntary license agreement is intended reached. (5) In case the parties inform IPTO that it was not possible to reach an agreement, the Office will start the procedure of conciliation as provided by Subsection 6 and subsequent. (6) By its own Decree, the Ministry of Economic Development appoints a Board having the task of examining the request of voluntary license for which n agreement was not reached by the parties. (7) The Board consists of six members and the same number of substitutes of which: a) two representatives of Ministry of Economic Development; b) one representative of Ministry of Health; c) one representative of Italian Medicine Agency; d) one representative of SPC owners, on proposal of the mostly represented Trade Associations: e) one representative of pharmaceutical active principle on proposal of the mostly represented Trade Associations. (8) Within thirty days from the communication received by IPTO of the unsuccessful achievement of agreement between the parties, the Board provides summoning of the parties with the purpose to find a hypothesis of agreement directed to meet the needs of the same parties, guaranteeing in any case a fair remuneration of the subject granting the voluntary license, by indicating a reasonable royalty, determined according to the needs of international competition of the active principle manufacturers. (9) Whenever, notwithstanding Ministry mediation, the license agreement is not settled, the Ministry of Economic Development, where the juridical requirements are envisaged, provides for the transmission of the acts of the proceedings to the Italian Competition Authority

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Art. 201 (Representation): (1) No one is obliged to be represented by an authorized representative in the proceedings before the Italian Patent and Trademark Office; natural and legal persons can act through an employee, even if not authorized, or by means of an employee of another company linked under the provisions of Article 205(3). (2) The appointment of one or more representatives, if not done in the application, or by separate authentic or certified act, may be done with specific power of attorney, subject to the payment of a prescribed fee. (3) The appointment or the power can relate to one or more applications or in general professional representation for every proceedings before Italian Patent and Trademark Office and the Board of Appeal, in this case, each subsequent application, request or appeal, the representative shall refer to the appointment or power of attorney. (4) The appointment can be conferred only to representatives named in a list established with the Counsel of the Institute of Industrial Property Consultants. (4-bis) Citizens of European Union authorized for the same profession in another Member State can be enrolled in the list according to the procedure pursuant to Legislative Decree 9 November 2007, n. 206. (5) [deleted] (6) The appointment can also be conferred to an Attorney-at-Law enrolled in his professional list. Art. 227 (Maintenance fees for the titles of industrial property) (1) All the fees provided for the maintenance of the titles of industrial property shall be paid in advance within the month corresponding to the one in which the application was filed, after the period covered by the previous payment has occurred. […] (5) The delay in the payment after six month shall cause the lapse of the industrial property right. Decree of Ministery of Economical Development 13 January 2010 (Implementing Regulation) Art. 5 (Non admissibility): (1) Applications, requests and appeals written in a language different from Italian and not bearing the Italian translation provided for by Art. 148(5) of the Code [CPI] are not admitted. (2) The Italian Patent and Trademark Office, once non admissibility has been ascertained, declares so pursuan to Art, 148(1) of the Code and sends a communication to the applicant assigning a term for filing an appeal before the Board of Appeal pursuant to Art. 135(1) of the Code. Art. 6 (Translation into Italian language): (2) The Italian Patent and Trademark Office may request that a true translation by means of a sworn translation before a Court be filed. Art. 24: (Prior art search) European Patent Office (EPO) is the competent Authority for prior art search with respect to applications for a patent for industrial invention filed with Italian Patent and Trademark Office. The procedures are established by a dedicate Convention signed 219

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between the Ministry of Economical Development – Italian Patent and Trademark Office and the European Patent Organization. Art. 33 (Inspections and copies) (1) Under the provisions of Art. 186(2) and (3) of the Code, all documents in the file of an application, a patent, a registration or a request, can be inspected and copied, provided that confidentiality has not been requested or the provisions of exclusion of the right of inspection apply according the law in force. (2) In matter of Supplementary Certificates, the Marketing Authorization Decrees with the enclosed Summary of the Technical Characteristics of the Product are excluded from inspection. Only the abstract of the Decrees can be inspected and copied, if present. Art. 38 (Fees and maintenance fees) (1) The payment is yearly for the patents of invention and every five years for utility models and designs and models. […] Legislative Decree of 29 December 2007, n. 274 Corrective Provisions to the Legislative Decree 24 April 2006, n. 219, Concerning the Implementation of Directive 2001/83/CE Relating to a Communitary Code concerning medicines for human use Law n. 549 of 28.12.1995 Royal Decree n. 1129, 29 June 1939. Law n. 349 of 19 October 1991 (Provisions for the Grant of a Supplementary Protection Certificate for Medicines or the Relevant Components, protected by a Patent Article 1: Section 1: The owners of patent for industrial invention, having its effects in Italy and having as its object a medicine, a product comprised in the composition of a medicine, a use of a product as medicine or a process for its manufacture, can obtain a Supplementary Protection Certificate after having obtained the registration for marketing the said medicament allowed under the provisions of the Article 162 of the unified text of health laws approved with the Royal Decree of 27 July 1934, n. 1265, as substituted by Article 4 of the Law 1 May 1941, n. 422. Section 2: The application for Supplementary Protection Certificate shall be filed by the owner of the patent with Central Patent Office within and not later than one hundred eighty days from the date of the Ministry Decree by which the first Marketing Authorization is granted, referred to Section 1, and, in any caser, at least one hundred eighty days before the expiration of the patent. If the first Marketing Authorization, referred to Section 1, is granted before the grant of the patent, the application for Supplementary Protection Certificate shall be filed within and not later than six months from the date of the date of grant of the patent. The application shall be directly filed with the Central Patent Office and must contain the indications and documents referred in the Royal Decree of 5 February 2950, n. 244, and subsequent modifications and integrations.

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Section 4: To the Supplementary Protection Certificate and to the applications for its grant, the same juridical regime, with the same exclusive rights and obligations, of the patent and applications for a patent are applied. The Supplementary Protection Certificate provides the same effects of the patent which it relates to limitedly to its part or parts referred to the medicament object of the Marketing Authorization. Section 5: The effects of the Supplementary Protection Certificate start from the moment in which the patent arrives at the end of its legal term and extend for a duration equal to the period of time between the filing date of the patent application and the date of the Decree by which the first Marketing Authorization for the medicament is granted. In any case, the Supplementary Protection Certificate cannot last more than eighteen years from the expiration date of the patent. If the application for the Supplementary Protection Certificate was filed within the due terms and published in the monthly Bulletin and at the expiration date of the patent, the Supplementary Protection Certificate has not yet been granted, the same effects of the Supplementary Certificate are provisionally conferred to the application. The exclusive rights provided by subsection 4 are conferred by the grant of the Supplementary Protection Certificate. Legislative Decree n. 131 of 13 August 2010 Art. 61 (Supplementary Protection Certificate for medicinal products and phytosanitary products (1) Reserved the right for the provisions relating to Supplementary Certificates referred to by Art. 81, Subsections 1 to 4, the Supplementary Certificates for medicinal products and the Supplementary Certificates for phytosanitary products, are granted by Italian Patent and Trademark Office under the provisions of Regulations (CE) n. 469/ 2009, (CE) n. 1901/2006 and (CE) n. 1610/96 and provide the same effects ruled by said Regulations. Law Decree 20.01.2012, n.1 Art. (1.3) Sections specialized in matter of enterprise are also established by the Courts and Couts of Appeal having their seat in the Capital Cities of each Region […]. For the territory of Vallè d’Aoste, the specialized sections by the Court and Court of Appeal of Turin are competent. The specialized section in matter of enterprise is also established by the Court and Court of Appeal of Brescia. […]

V. Netherlands Kingdom Act of 15 December 1994, containing rules in respect of patents (the Dutch Patents Act; ROW 1995) Chapter 2. Processing of patent applications § 1. General Provisions Article 15 1. An Office has been charged with implementing this Kingdom Act and other duties imposed under or by virtue of the law or binding international obligations. The Office is the Netherlands Patent Office (Octrooicentrum Nederland). The Office is an institution of the Netherlands and it shall also serve, insofar as patents are involved, as the central

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depository for the Netherlands and the Netherlands Antilles within the meaning of Article 12 of the Paris Convention for the Protection of Industrial Property of 20 March 1883, as revised in Stockholm, Sweden, on 14 July 1967 (Treaty Bulletin 1969, 144). 2. The structure and working methods of the Office will be determined by Our Minister. Article 19 1. The Office shall be responsible for maintaining a patent register from which the current status with respect to patent applications and patents can be derived and from which information can be provided to third parties for that purpose. 2. Particulars concerning patent applications and patents shall be recorded in the register by virtue of this Kingdom Act. The register shall be open to inspection by any person, free of charge. 3. Additional regulations may be stipulated by general order in council for the Kingdom with respect to the register. Such regulations may provide that the registration of given particulars will be dependent upon the payment of an amount by the individual requesting the registration. 4. In return for payment of amounts to be set under or by virtue of a general order in council for the Kingdom, any individual may request written information regarding or certified extracts from the patent register or documents relating to a patent application or patent entered in the patent register, as well as copies of the latter documents. Article 21 1. As from the time at which the patent application is entered in the patent register any party may inspect, free of charge, all the documents pertaining to the application or the patent granted as a result of such an application that the Office has received or has sent to the applicant or to third parties in the context of the provisions contained in this Kingdom Act. As soon as possible, but in any event not before the application is entered in the patent register, the Office shall give notice of those documents in the journal referred to in Article 20. Article 23 1. If, despite taking all due care as required under the circumstances, the applicant for or holder of a patent or the holder of a European patent has not been able to observe a term with respect to the Office or the office referred to in Article 99, at his request the Office shall restore his rights if the failure to observe the term pursuant to this Kingdom Act has directly led to the loss of any right or means of redress. 2. The first paragraph shall not apply in respect of a failure to file the patent application within the term stipulated in Article 9(1) or a failure to observe with the term referred to in paragraph (3) below. 3. If a request relates to a failure to observe a term within the meaning of Article 9(6), (7) or (8), the request shall be submitted within two months after the term in question has lapsed. Other requests shall be filed as soon as possible, but in any event not more than one year after the term that was not observed has lapsed. The omitted act must be performed simultaneously with the request. An amount to be set by general order in council for the Kingdom must be paid upon filing the request. 4. The Office shall record the restoration in the patent register. 5. A party will remain authorised, notwithstanding the patent, to continue performing the acts stipulated in Article 53(1) if the party in question has commenced, in or for 222

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his business, manufacturing or using an item in respect of which a patent is in force as a result of the restoration or has commenced implementing his decision to do so within the Netherlands or the Netherlands Antilles in the period between the loss of rights or means of redress and the restoration to the prior situation. Article 55(2) and (4) shall apply mutatis mutandis § 2 Grant Article 24 3. The application and the other documents shall be in Dutch or in English, with the exception of the claims, which must be in Dutch. Chapter 3. Provisions Governing European Patents Article 49 1. With due observance of the provisions contained in this Kingdom Act, European patents shall have the same legal consequences and shall be governed by the same legal provisions as patents granted under Article 36 of this Kingdom Act, as from the date on which the notification of the grant is published in accordance with Article 97(3) of the European Patent Convention. Chapter 4. Legal effects of the patent § 1. Rights and obligations of the patent holder Article 56 1. The right to perform acts prohibited to any person other than the patent holder by virtue of Article 53 may be acquired from the patent holder by means of a licence. That right shall extend to all acts referred to in the aforementioned Article and shall remain in force as long as the patent is in effect, unless a less extensive right has been granted under the licence. 2. A licence shall be created by an agreement, by an accepted testamentary disposition or, in accordance with Articles 57 and 58, by a decision rendered by Our Minister or by a court decision that has become final and has acquired the force of res judicata. A licence created by an agreement or an accepted testamentary disposition shall have effect towards third parties after the title has been entered in the patent register. A fee shall be due for that entry, to be set by general order in council for the Kingdom. 3. If the right to a fee in respect of a licence passes to another party in accordance with Article 75(8) or Article 78(4), the successor in title shall be entitled to a part of the total fee paid or to be paid for the licence in proportion to the period during which the licence should continue to have effect under normal circumstances. If the amount still to be paid by the licensee is insufficient to provide the successor in title with that which he is due, the latter may seek redress for the shortfall from his predecessor. Article 63 1. A patent holder may relinquish his patent in whole or in part. The relinquishment of the patent shall be effective retroactively in accordance with Article 75(5) to (7). 2. The relinquishment shall be effected by registering a deed to that effect in the patent register. The Office shall not register the deed as long as there are persons who, by virtue of documents entered in the patent register, have registered rights in respect of 223

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the patent or have received licences or have commenced legal proceedings concerning the patent and such persons have not consented to the surrender. § 3. The patent as a component of assets Article 64 1. The patent and the right to obtain a patent shall be assignable or otherwise transferable in full or joint ownership. 2. The Office may enter in the patent register the assignment and other transfer of the patent or of the right ensuing from the patent application. A fee, to be set by general order in council for the Kingdom, shall be due for such an entry. Article 65 1. The transfer required for the assignment of the patent or the rights arising from a patentapplication shall be effected by means of a deed containing a declaration by the patent holder that he assigns the patent or the rights arising from the patent application to the assignee and a declaration by the assignee that he accepts the assignment. 2. Any reservation relating to the assignment must be specified in the deed; in the absence of any such reservation, the assignment shall be deemed to be unrestricted. 3. The assignment shall take effect towards third parties only after an entry has been made concerning the deed in the patent register. Both parties shall be equally entitled to have the entry made in the register. 4. Article 88 of Book 3 of the Dutch Civil Code shall apply. Article 66 1. If various persons are jointly entitled to the patent, their mutual relationship shall be governed by an agreement made between them. 2. If no such agreement has been made or if the agreement does not provide otherwise, any person entitled to the patent shall have the right to perform the acts referred to in Article 53 and to take action in accordance with Articles 70 to 73 against any such act, as well as against the acts referred to in Article 73(1) and (2) if they were performed by a party who was not entitled to do so; however, a licence or consent as referred to in Article 73(2) may be granted only with the joint consent of the persons entitled to the patent. 3. The persons entitled to the patent shall be jointly and severally liable with respect to the payment of the fee referred to in Article 61. Article 67 1. A pledge on a patent shall be established by a deed and shall be effective against third parties only after the Office has entered it in the patent register. 2. The pledgee is required to sign a declaration, to be sent to the Office for registration, in which he elects an address for service in The Hague. If he has not elected an address for service in The Hague, the Office shall be deemed to be the elected address for service. 3. Stipulations in the deed of pledge concerning licences to be granted after registration shall take effect, also towards third parties, from their date of their entry in the patent register. Stipulations concerning fees for licences granted prior to registration shall take effect towards the licensee after he has been served with a bailiff’s writ.

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4. The Office shall enter in the patent register any deeds from which it appears that the right of pledge has ceased to exist or has ceased to have effect. Article 68 1. In the event of an attachment in respect of a patent, the writ of attachment shall be entered in the patent register and the provisions contained in the Dutch Code of Civil Procedure (Wetboek van Burgerlijke Rechtsvordering) governing an attachment under a warrant of execution and a prejudgment attachment of real property shall apply mutatis mutandis, subject to the condition that the writ of attachment contains a description of the patent instead of the nature and location of the real property. 2. Alienation, encumbrance, an administrative order in respect of or the granting of a licence taking effect after the writ of attachment has been registered may not be invoked against the attaching creditor. 3. Licence fees that have not been paid prior to the entry of the writ of attachment shall be included in the attachment of the patent after the licensee has been served with notice of the registered attachment. Those fees must be paid to the civil-law notary on whose behalf the writ is served, provided that the licensee has been expressly notified hereof when served with the notice and subject to the rights of third parties, which the judgment creditor must honour. Any amount paid to the civil-law notary shall fall under the proceeds referred to in Article 69(2). Articles 475 i, 476 and 478 of the Dutch Code of Civil Procedure shall apply mutatis mutandis. 4. The registration of the writ of attachment may be revoked: a. pursuant to a written declaration, offered for registration by the bailiff, that he is discontinuing the attachment on the instructions of the attaching creditor or that the attachment has expired; or b. pursuant to a court decision, offered for registration, lifting the attachment or establishing or leading to the expiry of the attachment. 5. Articles 504 a, 507 a, 538 to 540, 726(2) and 727 of the Dutch Code of Civil Procedure shallapply mutatis mutandis in respect of the attachment of a patent. Article 69 1. The sale of a patent by a pledgee or attaching creditor for the purposes of recovering a claim shall take place in public before an authorised civil-law notary. Articles 508, 509, 513(1), 514(2) and (3), 515 to 519, and 521 to 529 of the Dutch Code of Civil Procedure shall apply mutatis mutandis, on the understanding that the relevant provisions contained in those Articles governing mortgages and mortgagees apply in respect of the pledges on the patent and the pledgees. 2. Articles 551 to 552 of the Dutch Code of Civil Procedure shall apply mutatis mutandis with respect to the distribution of the proceeds. Chapter 5. Invalidation and claim Article 75 5. A patent shall be deemed from the outset not to have had any or some of the legal effects specified in Articles 53, 53 a, 71, 72 and 73 to the extent that the patent has been wholly or partially invalidated.

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6. The retroactive effect of the invalidation shall not extend to: a. a decision, other than one granting injunctive relief, relating to acts that infringe the exclusive right of the patent holder referred to in Article 53 and 53 a or relating to the acts referred to in Articles 71, 72 and 73 that have acquired the force of res judicata and have been enforced prior to the invalidation; or b. any agreement concluded prior to the invalidation insofar as it has been performed prior to the invalidation; however, in the interest of equity the repayment of sums paid under the agreement may be claimed to the extent justified under the circumstances. 7. For the purposes of paragraph (6)(b), the conclusion of an agreement shall also be deemed to include a licence created in another manner provided for in Article 56(2), 59 or 60. Chapter 6. Disputes concerning patent rights Article 80 1. The District Court of The Hague shall have exclusive jurisdiction in the first instance in respect of: a. actions to determine the absence of legal effect, the invalidation or the loss of legal effect of a patent or to determine claims to entitlement to a patent as referred to in Articles 10, 75, 77 and 78; b. actions claiming entitlement to European patent applications; c. actions seeking the grant of a licence as referred to in Article 58(1); and d. actions seeking a remuneration award as referred to in Articles 58, 59 and 60. 2. The District Court of The Hague and that Court ruling in summary proceedings shall have exclusive jurisdiction in the Netherlands in the first instance with respect to: a. the actions referred to in Articles 70, 71, 72 and 73; and b. actions instituted by a party other than the patent holder to obtain a ruling that certainacts performed that party do not constitute an infringement of a patent Chapter 6. Disputes concerning patent rights Article 84 1. Any party may request the Office in writing to provide an advisory report on the applicability of the grounds for invalidation specified in Article 75(1) to a patent granted on the basis of this Act. 2. The request shall contain a substantiated indication of the objections derived from Article 75(1) in respect of the patent granted concerning which an advisory report is requested. 3. Rules concerning the fee to be paid for an advisory report shall be enacted under or by virtue of a general order in council for the Kingdom. Chapter 7. Supplementary protection certificates For the purposes of this Chapter, with the exception of Article 98 and the provisions based on it: ‘Regulation’ means Regulation (EEC) No. 1768/92 of 18 June 1992 on the creation of a supplementary protection certificate for medicinal products (Official EC Journal L 182), as most recently amended by Regulation No. 1901/2006 of the European Parliament and the Council of the European Union of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No. 1768/92, Directive

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B5.V. The Netherlands

2001/20/EC, Directive 2001/83/EC and Regulation (EC) No. 726/2004 (Official EC Journal L 378); ‘Basic patent’ means a patent as referred to in Article 1(c) of the Regulation; ‘Certificate’ means a supplementary protection certificate as referred to in Article 1(d) of the Regulation; ‘Request for an extension of the term of a certificate’: a request for an extension of the term of a certificate that has already been granted as referred to in Article 1(e) of the Regulation. Article 91 The application for a certificate and for an extension of the term of a certificate shall be filed with the Office. Article 92 Upon application for a certificate and for an extension of the term of a certificate, proof must be provided that an amount has been paid to the Office in accordance with a rate to be set by general order in council for the Kingdom. Article 93 Articles 24(3), 26 and 38(1) of this Kingdom Act shall apply mutatis mutandis with respect to applications for a certificate and for an extension of the term of a certificate. Article 94 If the provisions contained in Article 8 of the Regulation or Articles 92 and 93 of this Kingdom Act have not been complied with, the Office shall so inform the applicant in writing within one month of the filing of the application for a certificate or the request for an extension of the term of a certificate, stating the requirements that have not been met. Article 95 In order to maintain a supplementary protection certificate, an amount to be set by general order in council for the Kingdom shall be paid to the Office each year as from the year in which the legal term of the basic patent has expired. That amount shall be paid no later than on the last day of the month in which the legal term of the basic patent has expired. Articles 61(3) and 62 of this Kingdom Act shall apply mutatis mutandis. Article 96 1. The notifications required by Articles 9(2) and (3), 11 and 16 of the Regulation shall be published in the journal referred to in Article 20 of this Kingdom Act. 2. The Office shall record the information specified in Articles 9(2) and (3), 11 and 16 of the Regulation in the patent register. Article 97 Articles 64 to 69 inclusive shall apply mutatis mutandis in respect of certificates. Article 98 If a regulation other than a regulation established by the Council of the European Communities concerning supplementary protection certificates as referred to in Article 90 is required in the interest of proper implementation, it shall be enacted by general 227

Annex B Selected Legal Sources

order in council for the Kingdom. Such a regulation may provide for the levy of fees, insofar as that is permitted under the regulation concerned. GENERAL ADMINISTRATIVE LAW ACT (AWB) CHAPTER 7 SPECIAL PROVISIONS CONCERNING OBJECTIONS AND ADMINISTRATIVE APPEALS Division 7.1 Notice of objection preceding appeal to an administrative court Article 7:1 1. The one who has the right to appeal against an order to an administrative court shall lodge an objection against the order before lodging an appeal, unless the order: (a) has been made in respect of an objection or an administrative appeal; (b) is subject to approval; (c) is one approving another order or refusing such approval; or (d) was prepared in accordance with one of the procedures provided in division 3.4. (e) the decision has been taken on the basis of a ruling wherein the administrative court under article 8.72, fourth paragraph, subsection 1,12 has determined that division 3.413 is entirely or partially dispensed with, (f) the appeal is directed against the failure to provide a decision in due time, (g) the decision has been taken on the basis of a stipulation as cited in the accompanying Regulations to this law, wherein direct appeal or the decision is otherwise provided for in the Regulations. 2. An appeal may be lodged against the decision on the objection in accordance with the regulations which govern the lodging of an appeal against the order against which the objection was made CHAPTER 4 SPECIAL PROVISIONS CONCERNING ORDERS Title 4.1 Administrative decisions Division 4.1.2 Preparation Article 4:8 1. Before making an administrative decision about which an interested party who has not applied for the administrative decision may be expected to have reservations, an administrative authority shall give that interested party the opportunity to state his views, if: (a) the administrative decision is based on information about facts and interests relating to the interested party, and (b) this information was not supplied in the matter by the interested party himself. 2. Subsection 1 shall not apply if the interested party has not complied with a statutory obligation to supply information

12 13

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Note from author: regulations regarding appeal in first instance. Note from author: regulations regarding appeal preparations.

B5.VI. Switzerland

VI. Switzerland Excerpt of the Patent Act14 Seventh Title:15 Supplementary Protection Certificates16 Section 1: Supplementary Protection Certificates for Medicinal Products17 Art. 140a18 A. Principle 1 The Institute shall on application grant a supplementary protection Certificate (Certificate) for the active ingredients or combination of active ingredients of medicinal products. 2 Active ingredients or combinations of active ingredients are referred to in this Section as products.

Art. 140b B. Conditions 1

2

The Certificate is granted if, at the time of the application: a. the product as such, a process for manufacturing it or a use of it is protected by a patent; b. official authorisation has been granted for placing the product on the market in Switzerland as a medicinal product. It is granted based on the first authorisation.

Art. 140c C. Right 1

The proprietor of the patent has the right to the Certificate. Only one Certificate shall be granted for each product. 19 3 In the event that two or more proprietors of a patent file applications for the same product based on different patents and no Certificate has yet been granted, the Certificate may be granted to each applicant.20 2

14

Unofficial translation. Inserted by No 1 I of the Federal Act of 3 Feb. 1995, in force since 1 Sept.1995 (AS 1995 2879; BBl 1993 III 706). 16 Amended by No I of the Federal Act of 9 Oct. 1998, in force since 1 May 1999 (AS 1999 1363; BBl 1998 1633). 17 Title inserted by No I of the Federal Act of 9 Oct. 1998, in force since 1 May 1999 (AS 1999 1363; BBl 1998 1633). 18 Amended by No I of the Federal Act of 9 Oct. 1998, in force since 1 May 1999 (AS 1999 1363; BBl 1998 1633). 19 Inserted by No I of the Federal Act of 9 Oct. 1998, in force since 1 May 1999 (AS 1999 1363; BBl 1998 1633). 20 Inserted by No I of the Federal Act of 9 Oct. 1998, in force since 1 May 1999 (AS 1999 1363; BBl 1998 1633). 15

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Art. 140d D. Subject-matter of protection and effects 1 The protection of a Certificate extends, within the limits of the scope of protection conferred by the patent, to any use of the product as a medicinal product that has been authorised before the expiry of the Certificate. 2 The Certificate grants the same rights as the patent and is subject to the same restrictions.

Art. 140e E. Term of protection 1

The Certificate takes effect on expiry of the maximum term of the patent for a period equal to the period which elapses between the date of filing under Article 56 and the date of the first authorisation to place the product on the market as a medicinal product in Switzerland, minus five years. 2 It is valid for no more than five years. 3 The Federal Council may specify that the authorisation granted in the European Economic Area (EEA) constitutes the first authorisation within the meaning of paragraph 1 if it is granted earlier than the first authorisation in Switzerland. Art. 140 f E. Time limit for filing the application 1

The application for the grant of a Certificate must be filed: a. within six months of the first authorisation to place the product on the market in Switzerland as a medicinal product; b. within six months of the grant of the patent if this was granted later than the first authorisation. 2 In the event that the time limit is not met, the Institute shall refuse the application. Art. 140g G. Grant of the Certificate The Institute grants the Certificate by entering it in the Patent Register. Art. 140h H. Fees 1

The Certificate is subject to the payment of an application fee and renewal fees. The renewal fees must be paid in advance in one single payment for the full term of the Certificate.21 3 …22 2

21 Amended by No I of the Federal Act of 22 June 2007, in force since 1 July 2008 (AS 2008 2551; BBl 2006 1). 22 Repealed by No I of the Federal Act of 22 June 2007, in force since 1 July 2008 (AS 2008 2551; BBl 2006 1).

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B5.VI. Switzerland

Art. 140i I. Premature lapse and suspension 1

The Certificate lapses where: a. the owner surrenders it by a written declaration to the Institute; b. the annual fees have not been paid in due time; c. the authorisation to place the product on the market as a medicinal product is withdrawn. 2 If the authorisation is suspended, the Certificate is also suspended. Suspension does not interrupt the term of the Certificate. 3 The authority that grants authorisations shall notify the Institute of any withdrawal or suspension of the authorisation. Art. 140k K. Nullity 1

The Certificate is null and void where: a.23 it was granted contrary to Article 140 b, Article 140 c paragraph 2, Article 146 paragraph 1 or Article 147 paragraph 1; b. the patent lapses before its maximum term expires (Article 15); c. the patent is declared null and void; d. the patent is limited to the extent that the product for which the Certificate was granted is no longer covered by the claims; e. after the lapse of the patent, grounds exist which would have justified the declaration of nullity of the patent under letter c or a limitation under letter d. 2 Any person may bring an action to have the Certificate declared null and void before the authority responsible for declaring the nullity of the patent. Art. 140l L. Procedure, Register, Publications 1

The Federal Council shall lay down the procedure for the grant of Certificates and for their entry in the Patent Register and the Institute’s publications. 2 It shall take account of the regulations of the European Community. Art. 140m M. Applicable law Insofar as the provisions concerning the Certificate do not contain any regulations, the provisions of the first, second, third and fifth Titles of this Act apply by analogy.

23 Amended by No I of the Federal Act of 9 October 1998, with effect from 1 May 1999 (AS 2008 2551; BBl 1998 1633).

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Section 2:24 Supplementary Protection Certificates for Plant Protection Products Art. 140n 1 The Institute shall on application grant a supplementary protection Certificate (Certificate) for active ingredients or combination of active ingredients of plant protection products. 2 Articles 140 a paragraph 2 to 140 m apply by analogy.

Final Title: Final and Transitional Provisions25 Art. 14626 C. Supplementary protection Certificates for plant protection products I. Authorisation prior to entry into force 1 A supplementary protection Certificate may be granted for any product which, on the Amendment to this Act of 9 October 199827 coming into force, is protected by a patent and for which an authorisation to place it on the market in accordance with Article 140 b was granted after 1 January 1985. 2 The application for the grant of a Certificate must be filed within the six months of the Amendment to this Act of 9 October 1998 coming into force. In the event that the time limit is not met, the Institute shall refuse the application. Art. 14728 II. Lapsed patents 1 Certificates may also be granted on the basis of patents that have lapsed at the end of their maximum term between 8 February 1997 and the Amendment to this Act of 9 October 199829 coming into force. 2 The term of protection of the Certificate is calculated in accordance with Article 140 e; its effects do not begin until the publication of the application for the grant of a Certificate. 3 The application must be filed within two months of the Amendment to this Act of 9 October 1998 coming into force. In the event that the time limit is not met, the Institute shall refuse the application. 4 Article 48 paragraphs 1, 2 and 4 apply correspondingly for the time period between the lapse of the patent and the publication of the application.

24 Inserted by No I of the Federal Act of 9 Oct. 1998, in force since 1 May 1999 (AS 1999 1363; BBl 1998 1633). 25 Amended by No I of the Federal Act of 17 Dec. 1976, in force since 1 Jan. 1978 (AS 1977 1997; BBl 1976 II 1). 26 Inserted by No I of the Federal Act of 3 Feb. 1995 (AS 1995 2879; BBl 1993 III 706). Amended by No I of the Federal Act of 9 Oct. 1998, in force since 1 May 1999 (AS 1999 1363; BBl 1998 1633). 27 AS 1999 1363. 28 Inserted by No I of the Federal Act of 3 Feb. 1995 (AS 1995 2879; BBl 1993 III 706) Amended by No I of the Federal Act of 9 Oct. 1998, in force since 1 May 1999 (AS 1999 1363; BBl 1998 1633). 29 AS 1999 1363; BBl 1998 1633.

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Excerpt of the Patent Ordinance30 Tenth Title:31 Supplementary Protection Certificates for Medicinal and Plant Protection Products32 First Chapter: Scope of Application Art. 127a 1) This title applies to supplementary protection certificates for medicinal and plant protection products.33 2) The other provisions of this ordinance apply insofar as the seventh title of the Patent Act or this title does not determine otherwise.

Second Chapter: Application for the Grant of a Certificate Art. 127b: Application; Fee 1)

2)

The application must contain: a. the request for the grant of the Certificate; b.34 a copy of the first official authorisation for placing the product on the market in Switzerland; c.35 a copy of the medicinal information or instruction for use of plant protection products, respectively, which was approved by the competent authority. The application fee must be paid within the time limit fixed by the Institute. 36

Art. 127c: Content of the Application The request for the grant of a Certificate must contain the following information: a.37 the name or business name and address of the applicant and, if applicable, the address for service in Switzerland; b.38 if the applicant has appointed a representative in Switzerland, its name, address and, if applicable, address for service in Switzerland; c. the number of the patent on which the application is based (basic patent); d. the title of the invention protected by the basic patent; e. the date of the first official authorisation for placing the product on the market in Switzerland; f. an identification of the product indicated by the marketing authorisation and its registration number; g. …39

30

Unofficial translation by the author. Inserted by No. 1 of the Ordinance of 17 May 1995, in force since 1 September 1995 (AS 1995 3660). 32 Amended by No. 1 of the Ordinance of 31 March 1999, in force since 1 May 1999 (AS 1999 1443). 33 Amended by No. 1 of the Ordinance of 31 March 1999, in force since 1 May 1999 (AS 1999 1443). 34 Amended by No. 1 of the Ordinance of 21 May 2008, in force since 1 July 2008 (AS 2008 2585). 35 Amended by No. 1 of the Ordinance of 21 May 2008, in force since 1 July 2008 (AS 2008 2585). 36 Amended by No. 1 of the Ordinance of 25 October 1995, in force since 1 January 1996 (AS 1995 5164). 37 Amended by No. 1 of the Ordinance of 11 May 2011, in force since 1 July 2011 (AS 2011 2247). 38 Amended by No. 1 of the Ordinance of 11 May 2011, in force since 1 July 2011 (AS 2011 2247). 39 Repealed by No. 1 of the Ordinance of 3 December 2004 (AS 2004 5025). 31

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Annex B Selected Legal Sources

Art. 127d: Publication of a Reference to the Application 1)

A reference to the application shall be published. The following information shall be published: a. the name or business name and address of the applicant; b. if applicable, the name and address of the representative; c. the filing date of the application; d. the number of the basic patent; e. the title of the invention protected by the basic patent; f. the date of the first official authorisation for placing the product on the market in Switzerland; g. a denomination of the product covered by the marketing authorisation and its registration number. 3) The publication takes place after the conclusion of the assessment pursuant to Article 127 e. 2)

Third Chapter: Assessment of the Application Art. 127e: Assessment on the Occasion of the Filing of the Application 1)

After receipt of the application, the Institute assesses whether the time limit for the filing and the requirements set forth in Articles 127 b and 127 c are met. 2) If the application does not fulfil the requirements mentioned in paragraph 1, the Institute sets a time limit of two months for the completion of the application by the applicant. 3) If this time limit is not met, the Institute shall refuse the application. Art. 127 f: Assessment of the Requirements for the Grant of a Certificate 1)

The Institute assesses whether the requirements for the grant of a Certificate (Art. 140 b und 140 c para. 2 and 3 of the Act) are met. 40 2) If the requirements are not met, the Institute shall dismiss the application. Fourth Chapter: Grant of a Certificate Art. 127g 1)

If the requirements for the grant of a Certificate are met, the Certificate shall be granted by entering it in the patent register. 2) The grant of a Certificate shall be published with the following information: a. the number of the basic patent tagged with an annex; b. the name or business name and address of the owner of the Certificate; c. if applicable, the name and address of the representative; d. the filing date of the application; e. the number of the basic patent; f. the title of the invention protected by the basic patent; g. the date of the first official authorisation for placing the product on the market in Switzerland; h. a denomination of the product covered by the marketing authorisation and its registration number; g. the date of expiry of the term of protection of the Certificate. 40

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Amended by No. 1 of the Ordinance of 31 March 1999, in force since 1 May 1999 (AS 1999 1443).

B5.VI. Switzerland

Fifth chapter: Publication of a rejection of an Application, of a Premature Lapse, Nullity and Suspension of the Certificate Art. 127h 1)

The rejection of an application, the premature lapse, the nullity and the suspension of a Certificate shall be published. 2) The following information shall be published: a. the number of the basic patent tagged with an annex; except in case of the rejection of the application for the grant of a Certificate; b. the name or business name and address of the applicant or owner of the Certificate; c. the number of the basic patent; d. the title of the invention protected by the basic patent; e. the date of the first official authorisation for placing the product on the market in Switzerland; f. a denomination of the product covered by the marketing authorisation and its registration number; g. the date of the rejection of the application, premature lapse, nullity or suspension of the Certificate. Sixth Chapter: Dossier and Register Art. 127i: Dossier 1) 2) 3)

The dossier of a Certificate shall be attached to the dossier of the basic patent. The dossier of the Certificate shall be accessible to everyone for inspection. The Certificate shall receive the number of the basic patent tagged with an annex.

Art. 127k: Register 1) The entries concerning the Certificate shall be made on the register sheet of the basic patent. 2) The following information shall be entered: a. the number of the basic patent tagged with an annex; b. the name or business name and address of the owner of the Certificate; c. if applicable, the name and address of the representative; d. the filing date of the application; e. the number of the basic patent; f. the title of the invention protected by the basic patent; g. the date of the first official authorisation for placing the product on the market in Switzerland; h. a denomination of the product covered by the marketing authorisation and its registration number; i. the date of the grant of the Certificate; k. the date of expiry of the protection of the Certificate; l. rights granted and restrictions upon the disposal ordered by courts and law enforcement authorities; m. modifications concerning the validity of the Certificate or the right to the Certificate; n. modifications concerning the place of residence or registered office of the owner of the Certificate; o. modifications concerning the identity of the representative or his/her place of residence or registered office.

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Annex B Selected Legal Sources 3). The Institute may register or pencil in further information which it considers useful. 4). Entries which concern the grant of rights to the basic patent and restrictions upon the disposal ordered by courts or law enforcement authorities with regard to the basic patent apply to the Certificate to the same extent as to the basic patent.

Seventh Chapter: Fees Art. 127l:41 Annual Fees 1)

The annual fee for one part of a year amounts to one twelfth of the annual fee owed for the respective year for each complete or started month of the term of protection of the Certificate, brought up to a round figure of Swiss francs. 2) The annual fees will be due on the last day of the month in which: a. the term of protection of the Certificate starts; b. the Certificate is granted if that occurs after the expiry of the maximum term of the patent. 3) They are to be paid on the last day of the sixth month after the due date at the latest; if the payment takes place later than on the last day of the third month after the due date, a surcharge is to be paid. Art. 127m: Refund of Annual Fees 1) In case of the nullity of a Certificate, the annual fees will be refunded for the period between the legally binding determination of nullity of the Certificate and the point in time when its term would have ended. 2) In case of a relinquishment of a Certificate, the annual fees will be refunded for the part of the term of the Certificate for which the Certificate is relinquished. 3) In case an official authorisation for placing a product on the market is repealed, the annual fees will be refunded for the part of the term of the Certificate during which the marketing authorisation is repealed. 4) In case an official authorisation for placing a product on the market is suspended, the annual fees will be refunded for the period during which the marketing authorisation is suspended. 5) In all of these cases, annual fees will be refunded for entire years only. 6) Refunds take place upon request only; such request is to be filed within two months as from: a. the determination of nullity of the Certificate; b. the relinquishment of the Certificate; c. the repeal of the official marketing authorisation according to paragraph 3; d. the end of the suspension of the official marketing authorisation according to paragraph 4.

41

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Amended by No. 1 of the Ordinance of 21 May 2008, in force since 1 July 2008 (AS 2008 2585).

B5.VI. Switzerland

Guidelines of the Institute42 13. Supplementary Protection Certificates43 [Page 106 of the Guidelines of the Institute] The Institute shall on application grant a supplementary protection Certificate (“SPC”) for active ingredients or the combination of active ingredients (referred to as “products” in connection with the SPC) of medicinal products (Art. 140 a PatA) or plant protection products (Art. 140 n PatA). The SPC is granted if the following conditions are met: There must be an official MA for the product as a medicinal product or a plant protection product in Switzerland and this product must be protected by a patent (Art. 140 b Para. 1 PatA). The SPC is granted based on the first MA (Art. 140 b Para. 2 PatA). When the Institute receives the application documents, these are being verified by the administration. The complete dossier shall contain: the application for the SPC; a copy of the first official MA and proof of the product being on the market. At the beginning of the substantive examination, the examinant must determine what exactly the product is, or rather how it is defined (see Chapter 13.1). Afterwards, the following questions must be answered: – Is the product protected by a patent? – Which one is the first official MA for the product? – Has the time limit for filing the application been met? – Has an SPC already been granted for the product? 13.1 The Product The product is defined as an active ingredient or a combination of active ingredients (Art. 140 a Para. 2 PatA). Therefore, the term “product” in Art. 140 b PatA is not to be interpreted as the pharmaceutical speciality such as authorised, but rather as the active ingredient (or the combination of active ingredients) that is used in such a medicinal product (see message of 18 August 1993, p. 24). In order to prevent uncertainties with regard to the products, the designation in the application must be unambiguous. It must comprise only the chemical substance (or the substances) in accordance with the official registration certificate. The following designations are possible: The systematic chemical name (e. g. from CAS or IUPAC), the INN (International Non-proprietary Name; also abbreviated as DCI), the designation on the registration certificate, the entry in the Index Nominum or on the list of pharmaceutical substances. Ambiguous designations and trademark names are not accepted because the latter designate a pharmaceutical speciality and not the active ingredient or the combination of active ingredients. In analogy, designations of the medicinal product such as “nasal administration of the active ingredient A” are not permitted either. Salt Forms and Ester [Page 107 of the Guidelines of the Institute] When there are multiple MAs for various salt forms or ester of one active ingredient, they are usually considered to be one chemical combination, or rather the same product. 42

Unofficial translation by the author. The original document in German is available under: (last visited: 3 January 2015). 43

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Annex B Selected Legal Sources

These salts or esters, respectively, serve the handling of the active ingredient in production, processing or administration (such as improving solubility) or the stabilization of the active ingredient. For example, if there are three MAs for carboxylic acid, the first one as free acid, the second one as sodium salt and the third one as potassium salt, the relevant MA is the one that was granted first. But if the salt form (or the counter ion, respectively) or the ester group has an influence upon the pharmacological effect in the body, that will be considered a new invention. The modified effect due to the specific salt or ester form must result from the patent. Varying Doses Since SPCs are not granted for the pharmaceutical speciality, varying doses (or new indications, see below) cannot serve as a basis for an SPC. However, the mere existence of identical active ingredients does not necessarily mean that they are the same product. If, based on an already known product (active ingredient or a combination of active ingredients), a new invention is made (such as a more effective dose), and if there is a product claim for this new invention in the basic patent, this new invention may constitute the basis for a new, independent product, for which an SPC can be granted as well. Therefore, the condition is that there is a congruent official MA for the new, patented product (decision of the Federal Supreme Court of 17 November 1998, No. 4A.7/1998, “Arzneimittel”, published in sic! 1999, p. 153 et seqq. [Annex A7.VI.]). New Indications In analogy to modified doses, active ingredients for which another invention concerning a new indication is patented, can be considered independent products (decision of the former Federal Appeal Commission for Intellectual Property of 30 April 1999, No. PA03/97, “Ciclosporin”, published in sic! 1999, p. 449 et seqq. [Annex A7.IX.]). 13.2 Examination criteria 13.2.1 Is the Product Protected by a Patent? The active ingredient or the combination of active ingredients must be protected either as a compound in a product claim, in the form of a process for its production or as a use by a patent (basic patent). It is not necessary that the product is specifically mentioned in a patent claim or the description. But it must clearly fall within the scope of protection of a patent claim, e. g. by being included in a Markush formula or by being defined by its properties (“bronchodilator with the following properties:…”). The mere mention in the description (e. g. as additional information) is not sufficient. If the product is mentioned in the declaration of the function of a patent claim only (“disposable syringe for the administration of the active ingredient B”), this is not sufficient either because the active ingredient itself is not protected. [Page 108 of the Guidelines of the Institute] An SPC is granted for a combination of active ingredients even if only one of the active ingredients is protected by the patent claims (decision of the Federal Supreme Court of 10 July 1998, BGE 124 III 375 et seqq., “Fosinopril”, published in sic! 1998, p. 594 et seqq. [Annex A7.VII.]). A basic patent may be either a Swiss or a European patent designating Switzerland.

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B5.VI. Switzerland

The SPC is granted if the patent is in force at the time of the application (Art. 140 b para. 1 lit. a PatA), which is examined by the administration when receiving the application. 13.2.2 Which One is the First Authorisation of the Product? The copy of the first official MA, which must be enclosed with the application for the SPC, must be the first MA of the product in Switzerland (but not in the EU). This MA does not need to be the actual registration certificate, it is sufficient to enclose a copy of a public announcement with the same content, e. g. of the Swissmedic Journal. It must always be the first MA in the entire field of human and veterinary medicine, respectively of plant protection products. Authorisations of new indications, modified pharmaceutical forms (decision of the former Federal Appeal Commission for Intellectual Property of 21 January 2005, No. PA02/03, “Differin Gel”, published in sic! 2005, p. 590 et seqq. [Annex A7.V.]) or new formulations (e. g. modification of auxiliary substances) are not considered to be first MAs, unless certain conditions are fulfilled (see Chapter 13.1, p. 106). The decisive factor in this respect is the examiner’s definition of the product. The MAs are granted by the following authorities: Human and veterinary medicines (apart from immunobiological preparations for animals) Immunobiological preparations for animals Plant protection products Swiss Agency for Therapeutic Products (Swissmedic) Federal Veterinary Office Federal Office for Agriculture The Institute examines the MA with the respective authority, in particular if the active ingredients are not designated as “New Active Substance (NAS)” or “New Chemical Entity (NCE)”. For the examination of the first MA, both registered medicines and medicines that are not registered anymore must be considered. An official MA must be in force at the time of the application, but it does not need to be identical to the first MA, which is the case for example if the formulation was changed. An SPC cannot be granted if an official MA was renounced or if there is only a MA with the notation “for export” (so-called “export speciality”) or if there is a MA which does not authorise the product as a medicinal product or a plant protection product. [Page 109 of the Guidelines of the Institute] If the number of active ingredients in the official MA differs from the one in the application, the following cases must be distinguished: – If there is an application for an SPC and a basic patent for an active ingredient A, but only one MA for several active ingredients exists (e. g. A + B), the SPC is granted for the active ingredient A only. – If there is an application for an SPC for an active ingredient A, and if – apart from the MA for A – there are other MAs for A as a component of a combination of active ingredients, the relevant MA is the one for A as the sole active ingredient, even if the first MA for the combination of active ingredients is older.

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Annex B Selected Legal Sources

13.2.3 Was the Application Submitted within the Time Limit? The application for the grant of an SPC must be filed within six months of the first MA or within six months of the grant of the basic patent (Art. 140 f PatA). This time limit is examined by the administration when receiving the application. If the date of the first MA must be corrected, it is the responsibility of the examiner to verify whether the time limit was met nevertheless. If the date of the first MA must be changed in a way that leads to the time limit not being met, the application is rejected, naturally after having given the applicant the opportunity to make a statement. 13.2.4 Has an SPC Already Been Granted for the Product? In principle, if an SPC has already been granted for a product, another SPC cannot be granted for the same product (Art. 140 c Para. 2 PatA). Accordingly, a patentee submitting several applications for the same product based on different basic patents must select one of these applications during the examination procedure. Applications by the applicant demanding the suspension of the examination procedure so as to gain time for the selection cannot be granted (decision of 20 October 2010 of the Federal Administrative Court, No. B-1019/2010, “Exenatide”, published in sic! 2011, p. 249 et seqq. [Annex A7.II.]). Several SPCs can be granted for one product if the applications are based upon different patents belonging to various proprietors. However, the earlier application(s) must still be pending at the time of the filing of the application (Art. 140 c Para. 3 PatA). Because of lit. a of Art. 140 f Para. 1 PatA (time limit for filing the application), the Institute waits for the time limit of 6 months to expire before granting an SPC. However, it is possible that a patent is granted to the patentee only after the first MA. If the patentee files an application for an SPC within six months of the grant of the patent (Art. 140 f Para. 1 lit. b PatA), an SPC can be granted to said patentee even if an SPC has already been granted to one or more patentees for the same product [Page 110 of the Guidelines of the Institute] at the time of the application (decision of the Federal Administrative Court of 13 September 2010, BVGE 2010/48, “Etanercept”, published in sic! 2010, p. 113 et seqq. [Annex A7.III.]). Notwithstanding the foregoing, the following applies: If an SPC has been granted for an active ingredient A, another SPC can be granted for a combination of active ingredients containing A, because the latter constitutes another product. The same applies if the order is reversed, and also if the basic patent is the same. 13.3 Technical Examination If one of the requirements for the grant of the SPC is not fulfilled, the Institute issues a technical objection, in which the applicant is informed about the relevant fault (e. g. the missing connection to the basic patent or the fact that the MA is not the first one). At the same time, the applicant gets the possibility to substantiate why the abovementioned requirements, contrary to the opinion of the Institute, are to be considered fulfilled. In case of objections with regard to the MA, the following must be noted: – If a MA of the competent authority is missing, the applicant will be requested to file such a MA according to Art. 127 b Para. 1 lit. b PatO. – If the filed MA is not the first one, the applicant will be requested to file the first MA subsequently. However, an SPC can only be granted if the first MA was issued at least five years after the filing date of the patent (Art. 140 e Para. 1 PatA). If said requirement is not met by the first MA (filed subsequently), this circumstance is to 240

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be indicated in the objection if need be in order to avoid unnecessary inconveniences by the applicant. The time limit for objections shall be 3 months. In the event that the time limit is not met or that the reasons given are insufficient, the Institute will decide upon the further course of action, i. e. usually upon the rejection or the dismissal of the application. However, the applicant must always have had the possibility to make a statement. In exceptional cases, a second objection with a shorter time limit (2 months) is possible. In analogy to the substantive examination of patent applications, the time limits for the objections can be extended as well (see Art. 12 Para. 2 PatO). Minor modifications can be settled with the applicant by telephone; a memorandum is mandatory in such cases. An appeal against a rejection or a dismissal can be lodged with the Federal Administrative Court within the time limit of one month. An instruction concerning the right to appeal is to be indicated in every one of these orders. These orders are established by the legal department patents & designs. If during the substantive examination, changes occur with regard to the already published application for the SPC, such changes (e. g. corrected designation of the product or modified first MA) are to be indicated to the administration so that they can be included into the publication of the grant. Furthermore, the internal database (BAGIS) is to be updated with these changes.

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