A User’s Guide to Intellectual Property in Life Sciences 9781526511751, 9781526511782, 9781526511775

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A User’s Guide to Intellectual Property in Life Sciences

A User’s Guide to Intellectual Property in Life Sciences

Dr Paul England Simon Cohen Contributors: Dr Rose Hughes (Chapter 9) Louise Popple (Chapters 19 and 20) Debbie Heywood (Chapter 21)

BLOOMSBURY PROFESSIONAL Bloomsbury Publishing Plc 50 Bedford Square, London, WC1B 3DP, UK 1385 Broadway, New York, NY 10018, USA 29 Earlsfort Terrace, Dublin 2, Ireland BLOOMSBURY and the Diana logo are trademarks of Bloomsbury Publishing Plc © Simon Cohen and Paul England 2021 All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or any information storage or retrieval system, without prior permission in writing from the publishers. While every care has been taken to ensure the accuracy of this work, no responsibility for loss or damage occasioned to any person acting or refraining from action as a result of any statement in it can be accepted by the authors, editors or publishers. All UK Government legislation and other public sector information used in the work is Crown Copyright ©. All House of Lords and House of Commons information used in the work is Parliamentary Copyright ©. This information is reused under the terms of the Open Government Licence v3.0 (http://www.nationalarchives.gov.uk/doc/ open-government-licence/version/3) except where otherwise stated. All Eur-lex material used in the work is © European Union, http://eur-lex.europa.eu/, 1998–2021. British Library Cataloguing-in-Publication Data A catalogue record for this book is available from the British Library. ISBN:

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Preface

It has been a privilege to work as a lawyer in life sciences patent law for the last 30 years or so. It could hardly be more interesting; combining disciplines as diverse as law and science, and working with clients and businesses grappling with challenges affecting global healthcare. And none of it ever remains the same: the law changes and technology develops rapidly. It is not just the patent law of the 1977 Patents Act that has matured and adapted. The law has changed to account for the astonishing developments in the direction that the life sciences industry (or, more accurately, industries) has taken. Notably, during my career, we have seen the completion of the Human Genome Project, which started in 1990 with the goal of sequencing and identifying all base pairs in the human genome, with the aim of finding the genetic roots of disease and then ultimately developing treatments. The Project was declared complete in April 2003 and is the world’s largest collaborative biological project. Output from the Project itself gave rise to myriad legal and ethical issues and will continue to do so. As a result of the pace of technological change, new patent laws have been introduced (for example, the European Biotechnology Directive), as well as sui generis rights, such as supplementary protection certificates (SPCs) to compensate for any erosion in the patent monopoly caused by waiting for regulatory approval. SPCs have themselves spawned a whole new canon of life sciences case law, which we cover in some detail in this book. Businesses have developed accordingly. Once upon a time, patent battles in the life sciences arena were often ‘David and Goliath’ affairs, between so-called ‘branded’ pharmaceutical giants and fledgling generics. Witness, for example, the big battles that GSK fought in the early 2000s involving blockbusters Paroxetine and Seretide against several relatively small generic companies. All this has changed. Now, the generic companies are often global giants themselves, with their own research arms or group companies. And the ‘branded’ pharmaceutical companies are in the mix with the generic companies in the race to win market share in the massive and continually growing biosimilars market, which is seeing an increasing amount of patent litigation. v

Preface And let us not forget medical devices and diagnostics, which have come into their own in recent years by digital advances and where we are likely to see a lot more patent-related activity in the years to come. Against all this, the UK has one of the strongest life sciences industries in the world. This success has deep roots in academic and small business research. But it also extends through development, manufacturing, regulation and patient access. There was considerable UK pride that the UK regulator, the MHRA, was the first in the world to approve any Covid-19 vaccine. So British life sciences is a developing and exciting story, often front-page headlines during the recent Covid pandemic. Patent protection, other forms of intellectual property and regulatory exclusivity protection also have a vital role to play in supporting the life sciences industries; encouraging research, incentivising innovation and collaboration, and protecting against counterfeiting. For all the above reasons, when Ellie MacKenzie of Bloomsbury Professional first contacted us to write a book about intellectual property rights in the life sciences, my colleague Dr Paul England and I were keen to do it. Paul is our senior professional support lawyer looking after the whole life sciences area in Taylor Wessing. His knowledge, both legal and scientific, is superb, and so is his clear and concise writing. In particular, we all agreed that there was a need for an account of all the main rights relevant to the many types of business working in this sector; one that would be of use as a practical, go-to reference text for lawyers and patent attorneys advising in private practice and in-house, as well as commercial and technical people who do not have access to legal advice immediately, but are often on the front line. Paul and I hope that, together with the contributions from Debbie Heywood (Taylor Wessing – chapter on rights in personal data), Rose Hughes (AstraZeneca – chapter on the European Patent system) and Louise Popple (Taylor Wessing – chapters on trade marks, customs and related issues), we have achieved what we set out to do. Simon Cohen January 2021

vi

Contents

Page Preface v Table of Cases xv Table of Statutes xli Table of Statutory Instruments xlv Introduction 1 A decade of change 1 Common intellectual property issues in life sciences 5 Brexit 13 Notes on the text 14 Part I  Patents in the Life Sciences:Validity and Enforcement 15 Chapter 1  Requirements for a Valid Patent 1: Novelty 17 Life sciences context 17 General principles 17 Disclosure and enablement 20 Plausibility of the prior art 24 Prior art: made available to the public 25 Prior use 26 KEY ISSUE: Confidentiality and clinical trials 28 Prior art published on the internet 30 Prior art: what has been made available? 30 KEY ISSUE: Novelty and scope of claims 31 Implicit disclosure, inevitability and inherency 32 Selected compounds and parameters 33 KEY ISSUE: Numerical ranges 34 Increased purity and isolation 35 Purpose limited claims 36 Dosage regimes 36 KEY ISSUE: Claims to treating a sub-population 37 Priority 41 vii

Contents Chapter 2  Requirements for a Valid Patent 2: Inventive Step 47 Life sciences context 47 General principles 47 Factors when assessing inventive step 49 Secondary indicia 53 Bonus effects 55 Collocations 56 KEY CASE: 10 obviousness factors – Actavis v ICOS 56 KEY ISSUE: Plausibility obviousness 63 Selection inventions 67 The plausibility threshold – dasatanib T 488/16 68 Chapter 3  Requirements for a Valid Patent 3: Patentable Subject Matter and Exclusions 71 Life sciences context 71 Industrial applicability 71 KEY CASE: Sequence homology – Human Genome Sciences v Eli Lilly 74 Exclusions 77 KEY ISSUE: Computer programs and computer-implemented inventions 78 Discoveries and scientific theories 81 Mathematical methods and mental acts 82 Business methods 83 Presentations of information 85 Non-patentable subject matter and the Biotechnology Directive 87 Plant and animal varieties and essentially biological processes for their production 87 Microbiological processes 89 ‘Ordre public’ and morality 90 Stem cell-based inventions 92 KEY ISSUE: Methods of treatment and diagnostics 94 Treatment by surgery and therapeutic methods 96 Products used in therapy 98 Chapter 4  Requirements for a Valid Patent 4: Sufficiency 101 Life sciences context 101 General principles 102 KEY CASE: Classic insufficiency and principles of general application – Regeneron v Kymab 103 ‘Hybrid’ claims to a recombinant DNA molecule – Biogen v Medeva 108 A ‘pure’ product claim to escitalopram – Generics (UK) v Lundbeck 109 Consistency with principles in Regeneron v Kymab 109 viii

Contents Inventive improvements 110 Depositing cell lines 112 Reach-through claims 113 Plausibility threshold 114 KEY CASE: Pregabalin for treating pain – Warner-Lambert 114 Plausibility under Articles 56 and 83 of the EPC compared 119 Lack of clarity and uncertainty 122 KEY CASE: Ceric oxide catalyst – Anan Kasei v Neo Chemicals 122 Chapter 5  Patent Infringement 1: Scope of Protection of Claims 125 Life sciences context 125 General principles 125 KEY ISSUE: Doctrine of equivalents 128 KEY CASE: Dipotassium and disodium equivalent – Actavis v Eli Lilly 129 Applying the doctrine of equivalents to a mechanical patent 132 KEY ISSUE: Numerical ranges 136 Taking account of novelty – a Formstein objection? 138 Chapter 6  Patent Infringement 2: Acts of Infringement 141 Life sciences context 141 Direct infringement 141 KEY ISSUE: Offers to supply made before patent expiry 144 Process patents 146 Products made by an infringing process 147 KEY ISSUE: Second medical use claim infringement 148 KEY CASE: Pregabalin – Warner-Lambert 149 Infringement of DNA sequences 155 Indirect infringement 156 KEY CASE: Disposable canister for use in wound dressing treatment apparatus – KCI Licensing Inc v Smith & Nephew 160 Double territoriality 164 Second medical use claims and indirect infringement 165 Common design 166 Unjustified threats 167 Chapter 7  Patent Infringement 3: Defences 173 Life sciences context 173 The Bolar and experimental use exemptions 173 Original Experimental Use Exemption 175 Bolar exemption 177 KEY ISSUE: New Experimental Use Exemption 179 Exhaustion 180 The Gillette defence 182 ix

Contents KEY ISSUE: ‘Arrow declarations’ Prior use Crown use defence De minimis defence

184 188 190 190

Chapter 8  Patent Infringement 4: Remedies Life sciences context General provision of remedies KEY ISSUES: Preliminary injunctions Quia timet Preliminary injunction to appeal Final injunctions Damages, account of profits, or reasonable royalty? Other remedies Publication of judgment KEY ISSUES: Stays and tailored relief in life sciences cases Public interest defence

193 193 194 195 201 202 203 204 211 212 213 216

Part II  Patent Ownership, Dealings and Litigation

223

Chapter 9 The European Patent System and Obtaining a Patent 225 Introduction to the European Patent Organisation and European Patent Office 225 Drafting strategies for European life sciences patents 233 Prosecuting a patent application in the life sciences 239 Priority at the EPO 245 Chapter 10  Rights in a Patent Life sciences context Invention and ownership Effect on licensee of co-ownership and transfer

249 249 249 259

Chapter 11  Patent Dealings 261 Life sciences context 261 Patent assignment 261 Patent licence 262 Registration 268 Implied licence 269 Competition rules 270 Pay-for-delay 276 Compulsory licences and licences of right 277 Crown use 279 Security over patents 281 Insolvency 284 x

Contents Chapter 12  Patent Proceedings in the Courts of England and Wales 289 Life sciences context 289 Overview of procedure 290 Timing 291 Commencement and statements of case 292 Case management, security and admissions 294 Disclosure 296 Confidentiality 299 Privilege 300 Evidence 305 Post-trial issues 308 Shortening proceedings 312 Chapter 13  Amendment and Parallel Proceedings in the EPO and the English Courts Life sciences context Claim amendment Parallel EPO and English proceedings Post-trial amendment

317 317 317 324 328

Chapter 14 Terminating Patent Agreements and Points of Dispute 341 Life sciences context 341 Terminating a licence agreement for breach 341 The absence of termination provisions: common law rights 345 Getting termination right 349 KEY ISSUE: Royalty disputes 355 PART III  Other Rights Protecting Life Sciences Subject Matter 361 Chapter 15  Supplementary Protection Certificates 363 Life sciences context 363 Qualifying for an SPC 364 Fundamentals 366 Marketing authorisations 370 ‘Protected by a basic patent’ 373 Resolving what ‘identified / specified’ means 374 The meaning of product 379 Paediatric extensions 386 KEY ISSUE: The manufacturing waiver 387 Chapter 16  Data and Market Exclusivity Rights Life sciences context

391 391 xi

Contents The 8+2+1 regime New active substances and global marketing authorisations Orphan drugs

392 397 404

Chapter 17 Trade Secrets 413 Life sciences context 413 What is a trade secret? 413 The three elements of breach of confidence 416 Remedies 427 Chapter 18  Plants and Genetic Resources Life sciences context Plant breeders’ rights The Nagoya Protocol

431 431 432 436

Chapter 19 Trade Marks, Passing Off, Designs and Copyright 439 Overview 439 Naming of medicinal products 440 Trade marks 442 Passing off 486 Designs 487 Copyright 491 Chapter 20  Exhaustion of Rights, IP Offences and Customs Powers Application to life sciences Exhaustion of rights IP offences Customs powers and procedures Chapter 21  Personal Data – GDPR Rights and Obligations Life sciences context GDPR: General principles and features KEY ISSUE: Clinical trials and health research – selecting a lawful basis KEY ISSUE: Controller and processor roles in clinical research KEY ISSUE: Exemptions and derogations for scientific research Ongoing compliance

493 493 494 509 512 521 521 522 536 540 543 545

Coda Brexit 547 The impact of Brexit on EU-derived UK law 547 Does a deal make a difference? 548 Patents 548 Participation in the UPC and Unitary Patent 550 Supplementary protection certificates 550 xii

Contents Data and market exclusivity rights The authority of CJEU case law

552 553

Appendices 557 Appendix A  Patents Act 1977

559

Appendix B Trade Secrets (Enforcement, etc.) Regulations 2018

709

Appendix C  Intellectual Property (Enforcement, etc.) Regulations 2006

721

Appendix D  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

725

Appendix E  Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use

737

Appendix F  Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products

765

Appendix G  European Union (Withdrawal) Act 2018

777

Index 797

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Table of Cases

2nine Ltd v Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) (Case T-363/08) (24 March 2010).........................19.38 A ACK/NACK-transmission with different power levels / LG (Case T-512/07) (unpublished, 22 January 2010)..............................................................4.9 A-G v Blake [2001] 1 AC 268, [2000] 3 WLR 625, [2000] 4 All ER 385.....8.16 A-G v Guardian Newspapers Ltd (No 2) [1988] UKHL 6, [1990] 1 AC 109, [1988] 3 WLR 776..................................................................................1.14 AP-1 complex / SALK INSTITUTE (Case T 609/02) (unpublished, 27 October 2004)...................................................................................... 4.18, 9.14 AP Racing Ltd v Alcon Components Ltd [2014] EWCA Civ 40, [2014] 1 WLUK 654, [2014] RPC 27...................................................................13.8 AT & T Knowledge Ventures’ Application; AT & T Knowledge Ventures LP v Comptroller General of Patents Designs & Trade Marks [2009] EWHC 343 (Pat), [2009] 3 WLUK 31, [2009] Info TLR 69.......... 3.7, 3.9, 3.11 AXA Insurance UK plc v Financial Claims Solutions Ltd [2018] EWCA Civ 1330, [2018] 6 WLUK 282, [2019] RTR 1......................................8.19 Abbott Laboratories Ltd v Evysio Medical Devices ULC [2008] EWHC 800 (Ch), [2008] 4 WLUK 524, [2008] RPC 23....................................1.30 Abraxis Bioscience LLC v Comptroller of Patents [2017] EWHC 14 (Pat), [2017] 1 WLUK 109........................................................................ 15.28, 15.34 Acetals / NEW JAPAN CHEMICAL (Case T 1081/01) (unpublished, 27 September 2004).....................................................................................1.10 Actavis Group PTC EHF v Boehringer Ingelheim Pharma GmbH [2013] EWHC 2927 (Pat), [2013] 9 WLUK 485............................... 15.8, 15.18, 20.12 Actavis Group PTC EHF v ICOS Corpn [2016] EWHC 1955 (Pat), [2016] 8 WLUK 146; rev’sd [2017] EWCA Civ 1671, [2017] 11 WLUK 8, [2018] RPC 7; aff’d [2019] UKSC 15, [2020] 1 All ER 213, [2019] Bus LR 1318....................................................................... 1.30, 2.3, 2.10, 2.12, 2.13, 2.16, 6.4 Actavis Group PTC EHF v Sanofi (Case C-443/12) [2013] 12 WLUK 430, [2014] RPC 20 .................................................................................. 15.8, 15.18 Actavis UK Ltd v Eli Lilly & Co [2017] UKSC 48, [2018] 1 All ER 171, [2018] 2 All ER (Comm) 1 .................................................... 1.18, 5.2, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 5.10, 5.11 Actavis v Warner-Lambert see Warner-Lambert Co LLC v Actavis Group PTC EHF

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Table of Cases Actavis UK Ltd v Janssen Pharmaceutica NV [2008] EWHC 1422 (Pat), [2008] 6 WLUK 730, [2008] FSR 35.....................................................1.27 Actavis UK Ltd v Merck & Co Inc [2008] EWCA Civ 444, [2009] 1 WLR 1186, [2008] 1 All ER 196......................................................................1.25 Adidas Salomon & Adidas Benelux BV v Fitnessworld Trading Ltd (Case C-408/01) [2003] ECR U-12537............................................................19.40 Adrenaline / MEDCO RESEARCH (Case T 233/96) (unpublished, 4 May 2000).......................................................................................................1.26 Aerotel Ltd v Telco Holdings Ltd [2006] EWCA Civ 1371, [2007] 1 All ER 225, [2007] Bus LR 634........................................................ 3.6, 3.7, 3.10, 3.11, 3.12, 3.13 Aga Medical Corpn v Occlutech (UK) Ltd [2014] EWHC 2506 (Pat), [2014] 7 WLUK 830, [2015] RPC 12.....................................................1.14 AgrEvo / Tiazoles (Case T-939/92) [1996] EPOR 171...................................2.16 Akebia Therapeutics Inc v Fibrogen Inc [2020] EWHC 866 (Pat), [2020] 4 WLUK 194 ............................................................................. 2.3, 2.16, 4.8, 5.9, 6.11 Aktiengesellschaft fur Aluminium Schweissung v London Aluminium Co Ltd (No 2) (1923) 40 RPC 107...............................................................11.40 Alcon Inc v Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) (Case T-237/01) [2003] ECR II-00411.......... 19.17, 19.48, 19.54 Alpi Pietro E Figlio & C v John Wright & Sons (Veneers) Ltd [1971] 6 WLUK 91, [1971] FSR 510, [1972] RPC 125........................................6.33 American Cyanamid Co v Ethicon Ltd [1975] AC 396, [1975] 2 WLR 316, [1975] 1 All ER 504................................................................... 8.3, 8.4, 8.6, 8.7 Anan-Kasei Co Ltd v Neo Chemicals & Oxides Ltd (formerly Molycorp Chemicals & Oxides Ltd) [2019] EWCA Civ 1646, [2019] 10 WLUK 168, [2020] FSR 8...................................................................................4.20 Ancotel GmbH v Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) (Case T-408/09) [2011] ECR II-00151......19.48 Angle mirror / LUCHTENBERG (Case T-84/83) (unpublished, 29 September 1983).....................................................................................1.10 Ansul BV v Ajax Brandbeveiliging BV (Case C-40/01) [2003] ECR I-02439....................................................................................................19.56 Antaios Compania Naviera SA v Salen Rederierna AB (The Antaios) [1985] AC 191, [1984] 3 WLR 592, [1984] 3 All ER 229.................................14.7 Aortic graft for treating abdominal aortic aneurysms / BARONE (Case T-1407/08) (unpublished, 20 March 2013).............................................3.26 Appetite suppressant / DU PONT (Case T-144/83) [1986] EPO OJ 301...... 3.2, 3.28 Arcos Ltd v EA Ronaasen & Son [1933] AC 470, (1933) 45 Ll L Rep 33, [1933] 2 WLUK 3 ..................................................................................14.11 Ark Shipping Co LLC v Silverburn Shipping (IoM) Ltd [2019] EWCA Civ 1161, [2019] 2 Lloyd’s Rep 603, [2019] 7 WLUK 122..........................14.11 Armin Häupl v Lidl Stiftung & Co KG (Case C-246/05) [2007] ECR I-04673....................................................................................................19.60 Armour Pharmaceutical v Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) (Case T-483/04) (17 October 2006).......................................................................................................19.58

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Cases

Arnold v National Westminster Bank (No 1) [1991] 2 AC 93, [1991] 2 WLR 1177, [1991] 3 All ER 41...........................................13.18, 13.19, 13.21, 13.23 Arrow Generics Ltd v Merck & Co Inc [2007] EWHC 1900 (Pat), [2008] Bus LR 487, [2007] 7 WLUK 883...................................... 7.1, 7.14, 7.15, 7.16, 7.18, 7.19 Arsenal Football Club plc v Reed (Case C-206/01) [2003] Ch 454, [2003] 3 WLR 450, [2003] RPC 9........................................................................19.49 Asahi Kasei Kogyo KK’s Application, Re [1991] 5 WLUK 114, [1991] RPC 485........................................................................................ 1.6, 1.28, 1.30 Astex Therapeutics Ltd v Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) (Case T-48/06) [2008] ECR II-161, [2008] 9 WLUK 142, [2009] ETMR 3...................................................19.39 Astex Therapeutics Ltd v AstraZeneca AB [2018] EWCA Civ 2444, [2018] 11 WLUK 55...........................................................................................14.29 AstraZeneca AB v Comptroller General of Patents, Designs & Trade Marks (Case C-617/12) [2013] 11 WLUK 390, [2014] RPC 16.................... 15.5, 15.9 AstraZeneca AB v KRKA dd Novo Mesto [2014] EWHC 84 (Pat), [2014] 1 WLUK 565..............................................................................................8.3 Auchincloss v Agricultural & Veterinary Supplies [1998] 10 WLUK 557, [1999] RPC 397, (1999) 22 (1) IPD 22003.............................................7.3, 7.6 Audi AG v Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) (Case C-398/08P) [2010] ECR I-535........................19.15 August Storck KG v Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) (Case C-24/05P) (22 June 2006)........ 19.15, 19.16, 19.18 Authentication binding document with signature / VASCO (unpublished, 24 January 2018)..........................................................................................2.16 B B v Auckland District Law Society [2003] UKPC 38, [2003] 2 AC 736, [2003] 3 WLR 859..................................................................................12.29 BDP1 Phosphatase / MAX-PLANCK (Case T-870/04) (unpublished, 11 May 2005)...............................................................................................3.2, 3.4 Balabel v Air India [1988] Ch 317, [1988] 2 WLR 1036, [1988] 2 All ER 246..........................................................................................................12.21 Bayer Crop Science AG v Deutsches Patent- und Markenamt (Case C-11/13) (19 June 2014)....................................................................... 15.36, 15.37, 15.39 Beloit Technologies Inc v Valmet Paper Machinery Inc (No 2) [1995] 4 WLUK 308, [1995] RPC 705.................................................................1.3 Best Buy Co Inc v Worldwide Sales Corpn Espana SL [2011] EWCA Civ 618, [2011] Bus LR 1166, [2011] 5 WLUK 625....................................6.33 Best-Lock (Europe) Ltd v Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) (Case T-395/14) (16 June 2015)........ 19.18, 19.21 bet365 Group Ltd v European Union Intellectual Property Office (Case T-304/16) (14 December 2017)...............................................................19.18 Betts v Willmott (1870-71) LR 6 Ch App 239, [1871] 1 WLUK 115...... 7.11, 11.21, 20.15

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Tables

Table of Cases BioID AG (in liquidation) v Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) (Case C-37/03) [2002] ECR II‑5159.............................................................................................. 19.15, 19.16 Biogen Inc v Medeva plc [1994] 10 WLUK 291, [1995] FSR 4, [1995] RPC 25............................................................................................................1.30 Biogen Inc v Medeva plc [1996] 10 WLUK 486, [1997] RPC 1, (1997) 38 BMLR 149 ......................................................................... 4.1, 4.2, 4.6, 4.7, 4.8 Biogen Inc v Smithkline Beecham Biologicals SA (Case C-181/95) [1997] ECR I-357, [1997] 1 WLUK 277............................................................15.8 Blood separation systems / FENWAL (Case T-1075/06) (unpublished, 17 May 2011)...............................................................................................3.26 Boegli-Gravures SA v Darsail-ASP Ltd [2009] EWHC 2690 (Pat), [2009] 10 WLUK 754.........................................................................................6.29 Boehringer Ingelheim KG v Swingward Ltd (Case C-348/04) [2007] Bus LR 1100, [2007] ECR I-3391, [2007] 4 WLUK 459............... 20.7, 20.8, 20.11, 20.13 Bonzel v Intervention Ltd (No 3) [1991] 5 WLUK 50, [1991] RPC 553.......13.8 Break-stem blind river / AVDEL SYSTEMS (Case T-896/92) (unpublished, 28 April 1994).........................................................................................1.16 Bristol Myers Squibb Co v Baker Norton Pharmaceuticals Inc [2000] 5 WLUK 659, [2000] ENPR 230, [2001] RPC 1................................... 1.25, 1.26 Bristol Myers Squibb Co v Paranova A/S (Case C-427/93) [2003] Ch 75, [2002] 3 WLR 1746, [1996] ECR I-3457....................... 20.2, 20.7, 20.9, 20.10 British Coal Corpn v Dennis Rye Ltd (No 2) [1988] 1 WLR 1113, [1988] 3 All ER 816, [1988] 2 WLUK 259...........................................................12.29 Broccoli / PLANT BIOSCIENCE (Case G-2/07)......................................... 3.17, 9.5 Brugger v Medicaid Ltd (No 2) [1996] 6 WLUK 122, [1996] RPC 635.......2.16 Brüstle (Oliver) v Greenpeace eV (Case C-34/10) [2011] ECR I-9821, [2011] 10 WLUK 429, [2012] 1 CMLR 41............................................3.22 Bunge Corpn v Tradax Export SA [1981] 1 WLR 711, [1981] 2 All ER 540, [1981] 2 Lloyd’s Rep 1...........................................................................14.11 Buprenorphine patch / EURO-CELTIQUE (Case T-0259/15) (unpublished, 25 July 2017)...........................................................................................2.16 Buttes Gas & Oil Co v Hammer (No 3) [1981] QB 223, [1980] 3 WLR 668, [1980] 3 All ER 475................................................................................12.30 C C21 London Estates Ltd v Maurice Macneill Iona Ltd v Yaseen Noorkhan [2017] EWHC 998 (Ch), [2017] 5 WLUK 221......................................14.11 CDV Software Entertainment AG v Gamecock Media Europe Ltd [2009] EWHC 2965 (Ch), [2009] 11 WLUK 500....................................... 14.21, 14.25 Cadila Healthcare Ltd v Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) (Case T-288/08) (15 March 2012)..19.48 Cambridge Antibody Technology Ltd v Abbott Biotechnology Ltd [2004] EWHC 2974 (Pat), [2004] 12 WLUK 578, [2005] FSR 27............. 14.31, 14.33 Campbell v Mirror Group Newspapers [2004] UKHL 22, [2004] 2 AC 457, [2004] 2 WLR 1232............................................................................. 1.14, 17.4 Campina Melkunie BV v Benelux-Merkenbureau (Case C-265/00) [2004] ECR I-1699, [2004] 2 WLUK 269, [2005] 2 CMLR 9...........................19.16

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Cases

Canon Kabushiki Kaisha v Metro-Goldwyn Mayer Inc (Case C-39/97) [1998] ECR I-5507, [1998] 9 WLUK 285, [1999] 1 CMLR 77.............19.39 Cardiac pacing / TELECTRONICS (Case T-82/93) [1996] OJ EPO 274......3.26 Cassou’s Patent [1970] 7 WLUK 153, [1970] FSR 433, [1971] RPC 91.......11.37 Celanese Emulsions GmbH (Case T 0404/13) (28 July 2015).......................9.15 Celanese International Corpn v BP Chemicals [1998] 10 WLUK 439, [1999] RPC 203, (1999) 22 (1) IPD 22002.............................................8.16 Celgard LLC v Shenzhen Senior Technology Material Co Ltd [2020] EWHC 2072 (Ch), [2020] 7 WLUK 460, [2020] FSR 37......................17.15 Cellulase / NOVOZYME (Case T 1336/04) (unpublished, 9 March 2006)...1.24 Cellulose / WEYERSCHAEUSER (Case T 0727/95)....................................9.6 Celtech International Ltd v Dalkia Utilities Services plc [2004] EWHC 193 (Ch), [2004] 2 WLUK 275......................................................................14.5 Centrafarm BV v Sterling Drug Inc (Case 15-74) [1974] ECR 1147, [1974] 10 WLUK 135, [1974] 2 CMLR 480..................................................... 7.9, 20.1 Cephalon Inc v Orchid Europe Ltd [2010] EWHC 2945 (Pat), [2010] 11 WLUK 518..............................................................................................8.4 Chiron v Organon Teknika Ltd (No 10) [1994] 11 WLUK 376, [1995] FSR 325..........................................................................................................8.32 Chocoladefabriken Lindt & Sprüngli AG v Franz Hauswirth GmbH (Case C-529/07) [2010] Bus LR 443, [2009] ECR I-4893, [2009] 6 WLUK 265...19.31 Cie Commerciale Sucres et Denrees v C Czarnikow Ltd (The Naxos) [1990] 1 WLR 1337, [1990] 3 All ER 641, [1991] 1 Lloyd’s Rep 29................14.11 Cipia Ltd v Glaxo Group Ltd [2004] EWHC 477 (Pat), [2004] 3 WLUK 544, [2004] RPC 43............................................................................... 2.5, 2.10 Cleaning plaque / ICI (Case T-290/86) [1992] OJ EPO 414..........................3.28 Clinical Trials I see Klinische Versuche (Clinical Trials) I, Re (X ZR 99/92) Clinical Trials II see Klinische Versuche (Clinical Trials) II, Re (X ZE 68/94) Clipboard formats I / MICROSOFT (Case T-424/03) (unpublished, 23 February 2006)........................................................................................3.13 Club de Variedades Vegetales Protegidas v Adolfo Juan Martinez Sanchis (Case C-176/18) (19 December 2019)....................................................18.3 CNL-SUCAL NV v HAG GF AG [1990] (Case C-10/89) [1990] ECR I-3711, [1990] 10 WLUK 198, [1990] 3 CMLR 571.............................20.14 Coca-Cola Co v Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) (Case T-480/12) (11 December 2014)........19.41 Coco v AN Clark (Engineers) Ltd [1968] 7 WLUK 2, [1968] FSR 415, [1969] RPC 41........................................................................... 1.14, 17.4, 17.7, 17.15 Coflexip SA v Stolt Offshore MS Ltd (formerly Stolt Comex Seaway MS Ltd) (No 2) [2003] EWCA Civ 296, [2003] 3 WLUK 317, [2003] FSR 41............................................................................................................8.14 Coflexip SA v Stolt Offshore MS Ltd (No 2) [2004] EWCA Civ 213, [2004] 2 WLUK 715, [2004] FSR 34.......................................................... 13.21, 13.22 Collingwood Lighting Ltd v Aurora Ltd [2014] EWHC 228 (Pat), [2014] 2 WLUK 256..............................................................................................8.20 Compagnie des bateaux mouches v Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) (Case T-553/12) (21 May 2014).......................................................................................................19.18

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Tables

Table of Cases Computer program product / IBM (Case T-1137/97) [1999] EPO OH 609...3.13 Conor Medsystems Inc v Angiotech Pharmaceuticals Inc [2006] EWHC 260 (Pat), [2006] 2 WLUK 634, [2006] RPC 28; aff’d [2007] EWCA Civ 5; rev’sd [2008] UKHL 49, [2008] 4 All ER 621, [2008] 7 WLUK 255.......................................................................................  2.5, 2.6, 2.16, 2.21 Conte v European Union Intellectual Property Office (Cannabis Store Amsterdam) (Case T-683/18) (12 December 2019)......................... 19.25, 19.26 Contraceptive method / BRITISH TECHNOLOGY (Case T-74/93) [1995] EPO OJ 712.............................................................................................3.2 Contraceptive method / THE GENERAL HOSPITAL (Case T-820/92) [1995] OJ EPO 113.................................................................................3.28 Conversant Wireless Licensing SARL v Huawei Technologies Co Ltd [2019] EWHC 1687 (Pat), [2019] 7 WLUK 52......................................13.8 Copad v Christian Dior Couture, Vincent Gladel et Société Industrielle Lingerie (SIL) (Case C-59/08) [2009] Bus LR 1571, [2009] ECR I-3421, [2009] 4 WLUK 372..................................................................20.6 Copolymers / DUPONT (Case T 124/87) [1989] OJ EPO 491......................1.23 Corevalve Inc v Edwards Lifesciences AG [2009] EWHC 6 (Pat), [2009] 1 WLUK 51, [2009] FSR 8........................................................................7.3 Coty Prestige Lancaster Group GmbH v Simex Trading AG (Case C-127/09) [2010] 6 WLUK 26, [2010] ETMR 41, [2010] FSR 38.........................20.4 Couchman v Hill [1947] KB 544, [1947] 1 All ER 103, 63 TLR 81..............14.11 Coventry (t/a RDC Promotion) v Lawrence [2014] UKSC 13, [2014] AC 822, [2014] 2 WLR 433..........................................................................8.32 Credit Lyonnais v Export Credits Guarantee Department (EGCD) [1988] AC 1013..................................................................................................6.31 D Dasatinib / BRISTOL-MYERS SQUIB (Case T-0488/16) (unpublished, 1 February 2017).....................................................................................4.14 Dasatinib in the treatment of CML / BRISTOL (Case T-0950/13) (unpublished, 3 February 2017)..............................................................4.18 Decon Laboratories Ltd v Fred Baker Scientific [2000] 11 WLUK 347, [2001] ETMR 46, [2001] RPC 17...........................................................19.58 Délavage / CAYLA (Case T-165/96) (unpublished, 30 May 2000)................1.10 Design & Display Ltd v OOO Abbott see OOO Abbott v Design & Display Ltd Deutsche SiSi-Werke v Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) (Case C-173/04) [2006] ECR I-551, [2006] 1 WLUK 90, [2006] ETMR 41.................................. 19.13, 19.15 Diagnostic Agent / EHRINGER (Case T-99/85) [1987] OJ EPO 413............2.16 Diagnostic methods (Case G-1/04).................................................................3.25 Diastereomer / BAYER (Case T 12/81) [1981] OJ EPO 296.........................1.16 Diesel fuels / EXXON (Case T-409/91) [1993] OJ EPO 40...........................4.7 Diglycidverbindung (X ZR 69/10 GRUR 2012 45)........................................5.7 Disclaimer / SCRIPPS (Case G 2/10) [2012] OJ EPO 376....................... 13.8, 13.11 Disclaimer III / PRINCETON UNIVERSITY (Case G 1/16) [1998] OJ EPO supplementary publication 3 29 (18 December 2017)............................13.11 Dominion Corporate Trustees Ltd v Debenhams Properties Ltd [2010] EWHC 1193 (Ch), [2010] 5 WLUK 738, [2010] 23 EG 106 (CS)........14.6

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Cases

Dore (Susan Yvonne) v Leicestershire City Council [2010] EWHC 34 (Ch), [2010] 1 WLUK 220...............................................................................12.29 Dosage regime / ABBOTT RESPIRATORY (Case G 2/08) [2010] OJ EPO 456......................................................................................................... 1.25, 9.8 Douglas v Hello! Ltd (No 3); OBG v Allan Mainstream Properties Ltd [2007] UKHL 21, [2008] 1 AC 1, [2007] 2 WLR 920...........................17.4 Dr Reddy’s Laboratories (UK) v Eli Lilly & Co [2009] EWCA Civ 1362, [2009] 12 WLUK 609, [2010] RPC 9................................ 1.22, 1.23, 1.27, 2.27 Dr Reddy’s Laboratories (UK) Ltd v Warner-Lambert Co LLC [2012] EWHC 3715 (Pat), [2013] Bus LR 612, [2012] 12 WLUK 685............15.40 Drying Process / UNIVLEVER (Case T-913/01) (unpublished, 11 October 2004).......................................................................................................1.10 Duns Licensing Associates (Decision T-0154/05) (2006)..............................3.13 El Du Pont de Nemours & Co (Witsiepe’s) Application, Re [1982] 2 WLUK 204, [1982] FSR 303............................................................................ 1.22, 2.27 E E Mishan & Sons Inc (t/a Emson) v Hozelock Ltd [2019] EWHC 991 (Pat), [2019] 4 WLUK 336, [2019] RPC 17; aff’d [2020] EWCA Civ 871, [2020] 7 WLUK 64............................................................... 1.11, 1.18, 2.3, 2.9, 5.11 Easycare Inc v Bryan Lawrence & Co [1994] 12 WLUK 143, [1995] FSR 597..........................................................................................................6.33 Eden SARL v Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) (Case T-305/04).....................................................19.12 Edwards Lifesciences LLC v Boston Scientific Scimed Inc [2018] EWHC 664 (Pat), [2018] 3 WLUK 654, [2018] FSR 30................................. 8.13, 8.23 Edwards Lifesciences LLC v Boston Scientific Scimed Inc [2018] EWCA Civ 673, [2018] 3 WLUK 680, [2018] FSR 29.......................................8.30 Edwards Lifesciences AG v Cook Biotech Inc [2009] EWHC 1304 (Pat), [2009] 6 WLUK 330, [2009] FSR 27.....................................................1.32 Efomycine als Leistungsförderer / BAYER (Case T-773/89) (unpublished, 2 June 1992)...............................................................................................3.28 Elanco Products Ltd v Mandops (Agrochemical Specialists) Ltd [1980] FSR 46....................................................................................................19.69 El Corte Inglés v Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) (Case T-443/05) [2007] ECR II-2579, [2007] 7 WLUK 274, [2007] ETMR 81.................................................19.38 Electric Machine / BOSCH (Case T-1085/92) (unpublished, 10 November 1994).......................................................................................................1.10 Element & energy production device / ZACHARIAH (Case T-541/96) (unpublished, 7 March 2001)..................................................................3.2 Eli Lilly & Co v Genentech Inc [2020] EWHC 261 (Pat), [2020] 2 WLUK 185..............................................................................................7.16 Eli Lilly & Co v Genentech Inc [2019] EWHC 388 (Pat), [2019] 3 WLUK 4....15.11 Eli Lilly & Co v Human Genome Sciences Inc [2008] EWHC 1903 (Pat), [2008] 7 WLUK 978, [2008] RPC 29; aff’d [2010] EWCA Civ 33; rev’sd [2011] UKSC 51, [2012] 1 All ER 1154, [2011] 11 WLUK 62..... 3.2, 3.4, 3.10, 4.2, 4.11

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Tables

Table of Cases Eli Lilly & Co v Human Genome Sciences Inc [2014] EWHC 2404 (Pat), [2014] 7 WLUK 711, [2015] RPC 8................................................ 15.15, 15.20 Emanuel (Elizabeth Florence) v Continental Shelf 128 Ltd (Case C-259/04) [2006] ECR I-3089, [2006] 3 WLUK 789, [2006] ETMR 56................19.27 Eminence Property Developments Ltd v Heaney [2010] EWCA Civ 1168, [2011] 2 All ER (Comm) 223, [2010] 10 WLUK 503............................14.17 Emson v Hozelock see E Mishan & Sons Inc (t/a Emson) v Hozelock Ltd Enantiomer / HOECHST (Case T 296/87) [1990] OJ EPO 195.................. 1.21, 1.27 Estimating sales activity / DUNS LICENSING ASSOCIATES (Case T-154/04) [2008] OJ EPO 46..................................................................2.16 Ethinylestradiol & drospirenone for use as a contraceptive / BAYER (Case T-7/07) (unpublished, 7 July 2011).........................................................1.14 Eurim-Pharm Arzneimittel v Beiersdorf (Case C-71/94-C73/94)............. 20.9, 20.11 Eurocool Logistik GmbH & Co KG v Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) (Case T-34/00)......19.15 Evalve Inc v Edwards Lifesciences Ltd (unreported, 27 March 2019)...........12.47 Evalve Inc v Edwards Lifesciences Ltd [2019] EWHC 1158 (Pat), [2019] 5 WLUK 50, [2020] FSR 4.............................................................. 8.3, 8.11, 8.23 Evalve Inc v Edwards Lifesciences Ltd [2020] EWHC 513 (Pat), [2020] EWHC 514 (Pat) ........................................................................ 8.31, 8.32, 12.3 F F Hoffman-La Roche AG v Accord Healthcare OÜ (Case C-572/15) (2 November 2015).................................................................................15.5 F Hoffman La Roche & Co AG v Centrafarm Vertriebsgesellschaft Pharmazeutischer Erzeugnisse mbH (Case 102/77) [1978] ECR 1139, [1978] 5 WLUK 168, [1978] 3 CMLR 217....................................... 20.7, 20.10 Fabio Perini v LPC Group plc [2010] EWCA Civ 525, [2010] 5 WLUK 342..........................................................................................................6.31 Faccenda Chicken Ltd v Fowler [1987] Ch 117, [1986] 3 WLR 288, [1986] 1 All ER 617 ........................................................................... 17.2, 17.9, 17.10, 17.11 Fack Ju Göhte v Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) (Case T-69/17) (2 July 2019).....................19.25 Factor-9 / JOHN HOPKINS (Case T-1329/04) (unpublished, 28 June 2005)...................................................................................... 2.18, 2.20, 3.3, 3.4 Farmaitalia’s Application, Re (Case C-31/03)................................................15.28 Fish & Fish v Sea Shepherd [2015] UKSC 10, [2015] AC 1229, [2015] 2 WLR 694.................................................................................................6.31 Flexible Directional Indicator’s Application [1993] 5 WLUK 290, [1994] RPC 207..................................................................................................13.8 Foldable plastic bottle / DüRING (Case T-809/95) (unpublished, 29 April 1997).......................................................................................................1.10 Force India Formula One Team Ltd v Etihad Airways PJSC [2010] EWCA Civ 1051, [2010] 10 WLUK 100, [2011] ETMR 10.......................... 14.8, 14.20 Ford Motor Co v Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) (Case T-91/99) (30 March 2000)................19.18 Formica Ltd v Export Credits Guarantee Department (ECGD) [1995] 1 Lloyd’s Rep 692, [1994] 7 WLUK 142, [1994] CLC 1078....................12.30

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Table of Cases

Cases

Formstein (X ZR 28/85 GRUR 1986 803)..................................................... 5.7, 5.11 Forsgren (Arne) v Osterreichisches Patentamt (Case C-631/13) [2015] 1 WLUK 179, (2015) 143 BMLR 211................................................ 15.34, 15.38 Frederico Cortes del Valle Lopez v Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) (Case T-417/10) (9 March 2012).......................................................................................................19.25 Friction reducing additives / MOBIL IV (Case T-59/87) [1991] OJ EPO 561....1.19 Fuel oils / EXXON (Case T-409/91) [1994] OJ EPO 653..............................4.9 Führungsdrahtnavigation / BrainLAB (Case T-836/08) (unpublished, 12 May 2011)...............................................................................................3.26 Fujifilm Kyowa Kirin Biogenics Co Ltd v Abb Vie Biotechnology Ltd [2017] EWCA Civ 1, [2018] Bus LR 228, [2017] 1 WLUK 99......... 7.13, 7.14, 7.18 G GD Searle & Co Ltd v Celltech Ltd [1981] 3 WLUK 85, [1982] FSR 92.....17.10 Gale’s Patent Application [1990] 12 WLUK 171, [1991] RPC 305...............3.11 Garmin (Europe) Ltd v Koninklijke Phillips NV [2019] EWHC 107 (Ch), [2019] 1 WLUK 257...............................................................................5.6 Geddes (Anne) v Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) (Case T-173/03) [2004] ECR II-4165........19.16 Gedeon Richter plc v Bayer Schering Pharma AG [2011] EWHC 583 (Pat), [2011] 3 WLUK 528, [2011] Bus LR D153...........................................2.16 Gemstar-TV Guide International Inc v Virgin Media Ltd [2009] EWHC 3068 (Ch), [2009] 11 WLUK 646, [2009] Info TLR 227.......................3.13 Genentech / Arthritis patients with an inadequate response to a TNF-alpha inhibitor (Case T-734/12) (unreported, 17 May 2013)............................1.14 Genentech Inc v Hoechst GmbH (Case C-567/14) [2016] Bus LR 1016, [2016] 7 WLUK 154, [2016] 5 CMLR 9......................................... 11.12, 14.35 Genentech Inc’s Patent (Human Growth Hormone) [1988] 10 WLUK 278, [1989] RPC 147......................................................................................4.2 GENERAL MOTORS / Cellulose fibres (Case T 194/84) OJ EPO 1990 59.13.8 General Motors Corpn v Yplon SA (Case C-375/97) [1999] ECR I-5421, [1999] 9 WLUK 185, [1999] 3 CMLR 427............................................19.42 General Tire & Rubber Co v Firestone Tyre & Rubber Co Ltd (No 1) [1971] 7 WLUK 130, [1971] FSR 417, [1972] RPC 457...................................1.5 General Tire & Rubber Co Ltd v Firestone Tyre & Rubber Co Ltd (No 2) [1975] 1 WLR 819, [1975] 2 All ER 173, [1976] RPC 197.............. 8.14, 17.16 Generics (UK) Ltd v Competition & Markets Authority (Case C-307/18) [2020] Bus LR 1323, [2020] 1 WLUK 282, [2020] 4 CMLR 14...........11.35 Generics (UK) Ltd v H Lundbeck A/S [2007] EWHC 1040 (Pat), [2007] 5 WLUK 114, [2007] RPC 32; rev’sd [2008] EWCA Civ 311, [2008] 4 WLUK 266, [2008] RPC 19; aff’d [2009] UKHL 12, [2009] 2 All ER 955, [2009] Bus LR 828.......................................................... 1.21, 2.4, 4.2, 4.6, 4.7, 4.11 Generics (UK) Ltd v H Lundbeck A/S [2006] EWCA Civ 1261, [2006] 8 WLUK 23................................................................................................6.31 Generics (UK) Ltd (t/a Mylan) v Novartis AG [2012] EWCA Civ 1623, [2012] 12 WLUK 365.............................................................................2.16

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Tables

Table of Cases Generics (UK) Ltd v Synaptech Inc (Case C-427/09) [2011] 7 WLUK 825, [2012] 1 CMLR 4, [2011] ECR I-7099..................................................15.10 Generics UK Ltd (t/a Mylan) v Warner Lambert Co LLC [2015] EWHC 3370 (Pat), [2015] 11 WLUK 652, [2016] RPC 16......................... 13.24, 13.25 Generics (UK) Ltd (t/a Mylan) v Yeda Research & Development Co Ltd [2017] EWHC 2629 (Pat), [2017] 10 WLUK 635, [2018] RPC 2...... 5.10, 7.15, 7.16 Generics (UK) Ltd (t/a Mylan) v Yeda Research & Development Co Ltd & Teva Pharmaceutical Industries Ltd [2013] EWCA Civ 925, [2013] Bus LR 1329, [2013] 7 WLUK 907........................................................2.24 Georgetown University v Octrooicentrum Nederland (Case C-484/12) (12 December 2013) .....................................................................................15.8 Gerber Garment Technology Inc v Lectra Systems Ltd [1996] 12 WLUK 396, [1997] RPC 443, [1998] Masons CLR Rep 135.............................8.14 Ghazilian’s Trade Mark Application [2001] 11 WLUK 742, [2002] ETMR 57, [2002] RPC 33..................................................................................19.24 Gillette Safety Razor Co Ltd v Anglo-American Trading Co Ltd (1913) 30 RPC 465..................................................................................................7.13 Glaverbel v Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) (Case T-141/06) (12 September 2007)..................19.48 Glaxo Group Ltd v Genentech Inc [2008] EWCA Civ 23, [2008] Bus LR 888, [2008] 1 WLUK 583.................................................... 13.13, 13.14, 13.15, 13.16 GlaxoSmithKline Biologicals SA (GSK) v Comptroller-General of Patents, Designs & Trade Marks [2013] EWHC 619 (Pat), [2013] 3 WLUK 552, [2013] RPC 26...................................................15.32, 15.33, 15.34, 15.37 GlaxoSmithKline, Laboratorios Wellcome de Portugal & The Wellcome Foundation v Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) (Cases T-493/07, T-26/08 & T-27/08) (9 July 2010)................................................................................................19.58 GlaxoSmithKline UK Ltd (GSK) v Wyeth Holding LLC [2017] EWHC 91 (Pat), [2017] 1 WLUK 110.....................................................................8.16 Glaxo Wellcome UK Ltd v Sandoz Ltd [2019] EWHC 2545 (Ch), [2019] 10 WLUK 70................................................................................................19.61 Grimme Landmaschinenfabrik GmbH & Co KG v Scott (t/a Scotts Potato Machinery) [2010] EWCA Civ 1110, [2010] 10 WLUK 364, [2011] FSR 7......................................................................................................6.28 Grooved pulley / AUBECQ AUXI (Case T-478/91) (unpublished, 2 June 1993).......................................................................................................2.16 H H Lundbeck A/S v Norpharma SpA [2011] EWHC 907 (Pat), [2011] 4 WLUK 415, [2011] RPC 23...................................................................1.23 HTC Corpn v Gemalto SA [2013] EWHC 1876 (Pat), [2013] 7 WLUK 296, [2014] RPC 9 ...................................................................................... 1.15, 1.32 HTC Corpn v Nokia Corpn [2013] EWHC 3247 (Pat), [2013] 10 WLUK 968, [2014] RPC 19 ...............................................................................7.12 HTC Corpn v Nokia Corpn [2013] EWHC 3778 (Pat), [2014] Bus LR 217, [2013] 12 WLUK 25...............................................................................8.11

xxiv

Table of Cases

Cases

HTC Europe Co Ltd v Apple Inc [2013] EWCA Civ 451, [2013] 5 WLUK 113, [2013] Info TLR 161.......................................................................3.8, 3.9 HTC Europe Co Ltd v Apple Inc [2011] EWHC 2396 (Pat), [2011] 9 WLUK 375..........................................................................................................12.47 Haberman v Jackel International Ltd [1999] 1 WLUK 492, [1999] FSR 683, (1999) 22 (3) IPD 22024.........................................................................2.9 Hari due composition / KAO (Case T 2017/07) (unpublished, 26 November 2009).......................................................................................................13.10 Hallen Co v Brabantia (UK) Ltd (No 1) [1990] 10 WLUK 197, [1991] RPC 195....................................................................................................... 2.10, 2.16 Hallen Co v Brabantia (UK) Ltd (No 2) [1989] 5 WLUK 7, [1990] FSR 134....13.17 Hansson (Jørn) v Jungoflanzen Grünewald GmbH (Case C-481/14) (9 June 2016).......................................................................................................8.19 Harris’ Patent [1984] 6 WLUK 168, [1985] RPC 19.....................................10.5 Hauck GmbH & Co KG v Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) (Case C-205/13) [2014] Bus LR 1284, [2014] 9 WLUK 444, [2015] CEC 634.................................. 19.19, 19.22 Helena Rubenstein SNC & L’Oreal SA v Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) (Cases T-345/08 & T-357/08) (10 May 2012)........................................................................19.40 Hematopoietic receptor / ZYMOGENETICS (Case T-898/05) (unpublished, 7 July 2006)..................................................................................... 3.2, 3.4, 4.11 Henderson v All Around the World Recordings Ltd [2014] EWHC 3087 (IPEC), [2014] 10 WLUK 97..................................................................8.19 Henderson v Henderson [1843-60] All ER Rep 378, 67 ER 313, (1843) 3 Hare 100........................................................................................... 13.17, 13.25 Herbicides / ICI (Case T-206/83) [1987] OJ EPO 5.......................................4.9 Hewlett-Packard Development Co LP v Expansys UK Ltd [2005] EWHC 1495 (Ch), [2005] 7 WLUK 375, [2007] ECC 9....................................20.6 Hickman v Andrews [1977] 12 WLUK 98, [1983] RPC 147.........................7.13 Hightrade Traders Ltd, Re [1984] 1 WLUK 928, [1984] BCLC 151.............12.28 Hill v Evans (1862) 31 LJ (NS) 457, 45 ER 1195, (1862) 4 De GF & J 288.1.5 Hoechst / Enantionerism (Case T-296/87)......................................................1.21 Hoffman- La Roche v Centrafarm see F Hoffman La Roche & Co AG v Centrafarm Vertriebsgesellschaft Pharmazeutischer Erzeugnisse mbH (Case 102/77) Hogan Lovells International LLP v Bayer CropScience AG (Case C-229/09) [2010] ECR I-11335...............................................................................15.10 Hongkong Fir Shipping Co Ltd v Kawasaki Kisen Kaisha Ltd (The Hongkong Fir) [1962] 2 QB 26, [1962] 2 WLR 474, [1962] 1 All ER 474......................................................................................... 14.8, 14.12, 14.13 Hospira UK Ltd v Cubist Pharmaceuticals LLC [2016] EWHC 1285 (Pat), [2016] 6 WLUK 254, [2017] RPC 10.....................................................1.29 Hospira UK Ltd v Genentech Ltd [2014] EWHC 1094 (Pat), [2014] 4 WLUK 439........................................................................................... 1.30, 4.14 Hospira UK Ltd v Genentech Ltd [2015] EWHC 1796 (Pat), [2015] 6 WLUK 756, [2016] RPC 1.....................................................................1.14 Human Genome Sciences Inc v Eli Lilly & Co see Eli Lilly & Co v Human Genome Sciences Inc [2011] UKSC 51

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Tables

Table of Cases Hybrid plants / LUBRIZOL (Case T-320/87) [1990] EPO OJ 71..................3.16 Hydrogen-absorbing composition / PRYSMIAN (Case T-1464/05) (unpublished, 14 May 2009)...................................................................2.16 I IG Farbenindustrie’s Patents, Re (1930) 47 RPC 289....................................1.22 IHT International Heiztechnik v Ideal Standard GmbH (Case C-9/93) [1994] ECR I-2789, [1994] 6 WLUK 260, [1994] 3 CMLR 857...........20.14 IL-17 related polypeptide / Schering (Case T-1165/06) (19 July 2007).........3.4 IPCom GmbH & Co KG v HTC Europe Co Ltd [2013] EWCA Civ 1496, [2014] Bus LR 187, [2013] 11 WLUK 588..................................... 13.14, 13.15 IPCom GmbH & Co KG v HTC Europe Co Ltd [2013] EWHC 52 (Pat), [2013] 1 WLUK 436...............................................................................17.14 IPCom GmbH & Co KG v Vodafone Group plc [2020] EWHC 132 (Pat), [2020] Bus LR 514, [2020] 1 WLUK 215................................ 7.24, 11.40, 13.8 IPSEN / Pancreatic cells (Case T-0578/06) (unpublished, 29 June 2011)......4.18 Icescape Ltd v Ice-World International BV [2018] EWCA Civ 2219, [2018] 10 WLUK 187, [2019] FSR 5.................................................... 5.6, 5.7, 5.8, 5.9 Idenix Pharmaceuticals Inc v Gilead Sciences Inc [2016] EWCA Civ 1089, [2016] 11 WLUK 200................................................................... 2.25, 2.26, 4.2 Illumina Inc v Premaitha Health plc [2017] EWHC 2930 (Pat), [2017] 11 WLUK 484..............................................................................................3.10 Incyte Corpn v Szellemi Tulajdon Nemzeti Hivatala (Case C-492/16) [2017] 12 WLUK 545.........................................................................................15.7 Influenza vaccines / ABBOTT BIOLOGICALS (Case T-967/09) (unpublished, 4 November 2014)............................................................4.9 Ino Karelia v European Union Intellectual Property Office (Case T-878/16) (6 October 2017).....................................................................................19.16 Intel Corpn Inc v CPM United Kingdom Ltd (Case C-252/07) [2008] ECR I-8823................................................................................... 19.40, 19.43, 19.44, 19.49 Interleukin 1 / IMMUNEX CORPN (Case T 767/95) (unpublished, 5 September 2000).....................................................................................1.24 Internal registration of gas / air / CAMTECH (Case T-5/04) (unpublished, 17 January 2006).....................................................................................3.26 International Stem Cell Corpn v Comptroller General of Patents, Designs & Trade Marks (Case C-364/13) [2013] EWHC 807 (Ch).........................3.23 INVERMONT Trade Mark [1997] RPC 125..................................................19.60 Investors Compensation Scheme v West Bromwich Building Society (No 1) [1998] 1 WLR 896, [1998] 1 All ER 98, [1997] 6 WLUK 340..............14.22 Ion chamber / SCANDITRONIX (Case T-56/87) [1990] OJ EPO 188..........1.16 Irvine v Talksport Ltd (Damages) [2003] EWCA Civ 423, [2003] 2 All ER 881, [2003] 2 All ER (Comm) 141.........................................................19.61 Island Records Ltd v Tring International plc [1996] 1 WLR 1256, [1995] 3 All ER 444, [1995] 4 WLUK 189...........................................................12.41 J Jellification / EXXON (Case T-119/82) [1984] OJ EPO 217.........................2.16 John v MGN Ltd [1995] EWCA Civ 23, [1997] QB 586, [1996] 3 WLR 593....8.19

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Table of Cases

Cases

Johnson v Gore Wood & Co (No 1) [2002] 2 AC 1, [2001] 2 WLR 72.. 13.17, 13.25 Jushi v OCV Intellectual Capital LLC [2018] EWCA Civ 1416, [2018] 6 WLUK 344, [2019] RPC 1.................................................................. 1.23, 5.10 K KCI Licensing Inc v Smith & Nephew plc [2010] EWHC 1487 (Pat), [2010] 6 WLUK 529, [2010] FSR 31; rev’sd in part [2010] EWCA Civ 1260, [2010] 11 WLUK 480, [2011] FSR 8.................................................. 1.32, 6.26 Kelly (James Duncan) & Chiu (Kwok Wai) v GE Healthcare Ltd [2009] EWHC 181 (Pat), [2009] 2 WLUK 263, [2009] RPC 12.......................10.6 Kirin-Amgen v Hoechst Marion Roussel (No 2); Kirin-Amgen v Transkaryotic Therapies Inc (No 2) [2004] UKHL 46, [2005] 1 All ER 667, [2004] 10 WLUK 525.................................................................... 4.19, 5.4 Kirin-Amgen v Transkaryotic Therapies Inc (No 3); Kirin-Amgen Inc’s European Patent (No 148605) (Relief Pending Appeal) [2001] 9 WLUK 150, [2005] FSR 41, (2001) 24 (12) IPD 24080........................8.32 Klinische Versuche (Clinical Trials) II, Re (X ZE 68/94) [1998] 4 WLUK 261, [1998] RPC 423..............................................................................7.3 Klinische Versuche (Clinical Trials) I, Re (X ZR 99/92) [1995] 7 WLUK 120, [1997] RPC 623..............................................................................7.3 Koninklijke Philips Electronics NV v Remington Consumer Products Ltd (Case C-299/99) [2003] Ch 159, [2003] 2 WLR 294, [2002] ECR I-5475.................................................................................... 19.12, 19.15, 19.21 Koninklijke KPN Nederland NV v Benelux-Merkenbureau (Case C-363/99) [2006] Ch 1, [2005] 3 WLR 649, [2004] ECR I-1619..................... 19.11, 19.16 Koton Mağazacilik Tekstil Sanayi ve Ticaret v European Union Intellectual Property Office (Case C-104/18) (12 September 2019) ........................19.31 Kraft pulp preparation / METSO (Case T-410/99) (unpublished, 20 January 2003).......................................................................................................1.16 Kuddas v Chief Constable of Leicestershire [2001] UKHL 29, [2002] 2 AC 122, [2001] 2 WLR 1789........................................................................8.19 Kureha Corpn v Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) (Case T-487/08) [2010] ECR II-111... 19.55, 19.58 L L (a minor) (police investigation: privilege), Re [1997] AC 16, [1996] 2 WLR 395, [1996] 2 All ER 78................................................................12.26 L Schuler AG v Wickman Machine Tool Saks Ltd [1974] AC 235, [1973] 2 WLR 683, [1973] 2 All ER 39................................................................14.11 LIFFE Administration & Management v Pinkava [2006] EWHC 595 (Pat), [2006] 3 WLUK 700...............................................................................10.5 LTJ Diffusion SA v Sadas Vertbaudet SA (Case C-291/00) [2003] ECR I-2799, [2003] 3 WLUK 605, [2003] FSR 34.........................................19.35 La Mer Technology v Laboratoires Goemar SA [2004] EWHC 2960 (Ch), [2004] 12 WLUK 622, [2005] FSR 29...................................................19.56 Lancashire Fires Ltd v SA Lyons & Co Ltd [1996] 4 WLUK 288, [1997] IRLR 113, [1996] FSR 629................................................................ 17.9, 17.10 Lantana Ltd v The Comptroller General of Patents, Design & Trade Marks [2014] EWCA Civ 1463, [2014] 11 WLUK 343, [2015] RPC 16..........3.9

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Tables

Table of Cases Laserdisken v Kulturministeriet (Case C-479/04) [2006] ECR I-8089, [2006] 9 WLUK 140, [2007] 1 CMLR 6................................................20.15 Lego Juris / Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) (Case C-48/09P) [2010] ECR I-8403, [2010] 9 WLUK 242, [2010] ETMR 63................................................................19.19 Lenovo (Singapore) PTE Ltd v Comptroller General of Patents [2020] EWHC 1706 (Pat), [2020] 7 WLUK 136...............................................3.8, 3.9 Limiting feature / ADVANCED SEMICONDUCTOR DEVICES (Case G 1/93) [1994] OJ EPO 541.......................................................................13.7 Liqwd Inc v L’Oreal (UK) Ltd [2018] EWHC 1394 (Pat), [2018] 6 WLUK 165....................................................................................................... 1.11, 1.13 Livingstone v Rawyards Coal Co (1880) 5 App Cas 25, (1880) 7 R (HL) 1......... 8.6, 8.14 Lloyd Schuhfabrik Meyer v Klijsen Handel [1999] ECR I-3819, [1999] 6 WLUK 315, [1999] ETMR 690....................................................... 19.39, 19.48 Loeendersloot (t/a F Loendersloot Internationale Expeditie) v George Ballantine & Son Ltd [1997] ECR I-6227, [1997] 11 WLUK 180, [1998] 1 CMLR 1015..............................................................................20.7 Lombard North Central plc v Butterworth [1987] QB 527, [1987] 2 WLR 7, [1987] 1 All ER 267................................................................................14.11 London Taxi Corpn (t/a London Taxi Co) v Frazer-Nash Research Ltd [2017] EWCA Civ 1729, [2017] 11 WLUK 9, [2018] ETMR 7.... 19.18, 19.22, 19.23 Longevity Health Products Inc v Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) (Case T-161/10) [2011] 5 WLUK 643, [2012] ETMR 61................................................................19.38 L’Oreal SA v Bellure NV (Case C-487/07) [2010] Bus LR 303, [2009] ECR I-5185, [2009] 6 WLUK 482........................................................... 19.40, 19.44 L’Oreal SA v RN Ventures Ltd [2018] EWHC 173 (Pat), [2018] 2 WLUK 90, [2018] ECDR 14...............................................................................5.9 Lubrizol Corpn v Esso Petroleum Co Ltd (No 5) [1996] 11 WLUK 176, [1997] RPC 195; aff’d [1998] 4 WLUK 449, [1998] RPC 727, (1998) 21 (8) IPD 21081..........................................................7.20, 7.21, 10.15, 13.17 Lufthansa Technik AG v Astronics Advanced Electronic Systems [2020] EWHC 1968 (Pat), [2020] 7 WLUK 370...............................................6.31 Lundbeck v Commission (Case C-591/16P) (opinion 4 June 2020)..............11.35 M MMI Research Ltd v Cellxion Ltd [2009] EWHC 1533 (Pat), [2009] 7 WLUK 103, (2009) 32 (8) IPD 32059....................................................11.40 MPA Pharma v Rhone Poulenc Pharma (Case C-232/94) (11 July 1996)......20.7 Macrossan’s Patent Application (No 0314464.9) [2006] EWHC 705 (Pat), [2006] 4 WLUK 2, (2006) 29 (5) IPD 29043.........................................3.12 Mag Instrument Inc v Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) (Case C-136/02)..............................19.15 Maredelanto Cia Naviera SA v Bergbau-Handel GmbH (The Mihalis Angelos) [1971] 1 QB 164, [1970] 3 WLR 601, [1970] 3 All ER 125...14.11 Marek’s Disease Virus Vaccine / AMERICAN HOME PRODUCTS CORPN (Case T-1137/97) (unpublished, 14 October 2002)..................1.10

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Cases

Massachusetts Institute of Technology (MIT), proceedings brought by (Case C-431/04) [2006] ECR I-4089, [2006] 5 WLUK 86, [2006] RPC 34.......................................................................15.25, 15.28, 15.32, 15.34 Mastercigars Direct Ltd v Hunters & Frakau Ltd [2007] EWCA Civ 176, [2007] 3 WLUK 195, [2008] ECC 14.....................................................20.6 Maurice MacNeill Iona Ltd (t/a Century 21 UK) v C21 London Estates Ltd [2018] EWCA Civ 1823, [2018] 7 WLUK 179......................................14.11 Medimmune Ltd v Novartis Pharmaceuticals UK Ltd [2011] EWHC 1669 (Pat), [2011] 7 WLUK 92.......................................................................6.8 Meaning of Terms used in patent documents / NGK INSULATORS (Case T-1321/04) (unpublished, 20 January 2003)...........................................1.16 Medeva BV’s SPC Applications (Case C-322/10) [2011] ECR I-12051, [2011] 11 WLUK 709, [2012] RPC 25................................ 15.12, 15.13, 15.14, 15.15, 15.21 Menashe Business Mercantile Ltd v William Hill Organisation Ltd [2002] EWCA Civ 1702, [2003] 1 WLR 1462, [2003] 1 All ER 279................6.29 Mentor Corpn v Hollister Inc (No 2) [1992] 7 WLUK 465, [1993] RPC 7...1.6 Merck & Co Inc v Deutsches Patent- und Markenamt (Case C-125/10) [2011] ECR I-12987 ..............................................................................15.4 Merck & Co Inc v Primecrown Ltd [1995] 7 WLUK 210, [1996] 3 CMLR 724, [1995] FSR 909...............................................................................7.9 Merck Canada v Accord Healthcare Ltd (Case C-555/13) (13 February 2014).......................................................................................................15.5 Merck Canada v Sigma Pharmaceuticals plc (Form of Order) [2012] EWPCC 21, [2012] 5 WLUK 99, [2013] RPC 2....................................8.12 Merck Sharp & Dohme Corpn v Comptroller-General of Patents, Designs & Trade Marks (Case C-567/16) [2017] 12 WLUK 150, [2018] RPC 9....15.6 Merck Sharp & Dohme Ltd v Ono Pharmaceutical Co Ltd; Bristol Myers Squibb Co v Merck & Co Inc [2015] EWHC 2973 (Pat), [2015] 10 WLUK 598, [2016] RPC 10...................................................................1.9 Merck Sharp & Dohme Ltd v Shionogi & Co Ltd [2016] EWHC 2989 (Pat), [2016] 11 WLUK 667.............................................................................2.26 Merck Sharp & Dohme Ltd v Teva Pharma BV [2012] EWHC 627 (Pat), [2012] 3 WLUK 464, [2012] FSR 24.....................................................6.4, 8.9 Merrell Dow Pharmaceuticals Inc v HN Norton & Co Ltd [1995] 10 WLUK 330, [1996] RPC 76, (1997) 33 BMLR 201......................... 1.2, 1.5, 1.11, 1.18, 1.27, 5.11 Merrill Lynch’s Patent Application [1989] 4 WLUK 219, [1989] RPC 561..3.6 Method & apparatus for increasing the service life of aircraft multiple disc brakes / DUNLOP (Case T 95/9) (unpublished, 18 March 1999)..........1.19 Mexichem UK Ltd v Honeywell International Inc [2020] EWCA Civ 473, [2020] 3 WLUK 476 ..............................................................................7.19 MOBIL OIL / Friction reducing additives (Case G-2/88) [1990] OJ EPO (11 December 1989)............................................................................ 1.19, 1.26, 9.8 Monsanto Co v Stauffer Chemical Co [1985] 6 WLUK 105, [1985] RPC 515....7.3, 7.6 Monsanto Technology LLC v Cargill International SA [2006] EWHC 2864 (Pat), [2006] 11 WLUK 260, (2007) 30 (3) IPD 30018.........................6.9 Monsanto Technology LLC v Cefetra BV (Case C-428/08) [2011] Bus LR 1498, [2010] 7 WLUK 145, [2010] ECR I-6765....................................6.19

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Tables

Table of Cases Motor Oil Hellas (Corinth) Refineries SA v Shipping Corpn of India (The Kanchenjunga) [1990] 1 Lloyd’s Rep 391, [1990] 2 WLUK 229..........14.20 Mühlens v Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) (Case T-355/02) [2004] ECR II-791, [2004] 3 WLUK 60, [2004] ETMR 101................................................................19.37 Mundipharma / Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) v Atlanta Pharma (Case T-256/04) (13 February 2007)................................................................................. 19.37, 19.58 N Napp Pharmaceuticals Holdings Ltd v Dr Reddy’s Laboratories (UK) Ltd [2016] EWHC 1517 (Pat), [2016] 6 WLUK 675, [2017] RPC 4.......... 5.10, 6.4, 7.24 National Commercial Bank Jamaica Ltd v Olint Corpn Ltd [2009] UKPC 16, [2009] 1 WLR 1405, [2009] Bus LR 1110 National Power plc v United Gas Co Ltd [1998] All ER (D) 321............... 14.4, 14.5 Naxos, The see Cie Commerciale Sucres et Denrees v C Czarnikow Ltd (The Naxos) Nestec v Dualit Ltd [2013] EWHC 923 (Pat), [2013] 4 WLUK 469, [2013] RPC 32 ..................................................................................... 6.21, 6.23, 11.21 Neurim Pharmaceuticals (1991) Ltd v Generics (UK) Ltd (t/a Mylan) [2020] EWCA Civ 793, [2020] 6 WLUK 329........................... 8.3, 8.4, 8.5, 8.8 Neurim Pharmaceuticals (1991) Ltd v Comptroller-General of Patents (Case C-130/11) [2012] 7 WLUK 593, [2013] RPC 23...... 15.25, 15.26, 15.27, 15.28, 15.29, 15.31, 15.32, 15.34 Nikken Kosakusho Works v Pioneer Trading Co [2005] EWCA Civ 906, [2005] 6 WLUK 660, [2006] FSR 4................................................ 13.17, 13.24 Nokia Oyj (Nokia Corpn) v IPCom GmbH & Co KG [2012] EWCA Civ 567, [2012] 5 WLUK 341, [2013] RPC 5........................................ 13.10, 13.24 Nokia GmbH v IPCom GmbH & Co KG [2009] EWHC 3482 (Pat), [2010] 1 WLUK 254, [2010] Info TLR 1...........................................................2.11 Nokia GmbH v IPCom GmbH & Co KG (Permission to Amend) [2010] EWHC 789 (Pat), [2010] 3 WLUK 893.................................................13.17 Nomination di Antonio e Paolo Gensini SNC v Sebastian Brealey & Victoria Brealey (t/a JSC Jewellery) [2019] EWHC 599 (IPEC), [2019] 3 WLUK 214, [2019] ECC 15...................................................................20.7 Now Wireless v Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) (Case T-278/13) [2015] 1 WLUK 691, [2015] All ER (EC) 648..........................................................................19.58 Norbrook Laboratories (GB) Ltd v Adair [2008] EWHC 978 (QB), [2008] 5 WLUK 86, [2008] IRLR 878...............................................................17.8 Northern Territory of Australia v Collins [2008] HCA 49..............................6.23 Norton Healthcare v Beecham Group plc (unreported, 19 June 1997)...........2.5 Novartis AG v Comptroller-General of Patents, Designs & Trade Marks (Case C-207/03 & C-252/03) [2005] ECR I-3209, [2005] 4 WLUK 452, [2005] RPC 33................................................................................15.9 Novartis AG v European Union Intellectual Property Office (Case T-44/16) [2018] 1 WLUK 517........................................................................ 19.19, 19.48

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Cases

Novartis AG v Patent- och registeringsverket (Case C-354/19) (3 May 2019).......................................................................................................15.30 Novartis v European Commission (Cases C-629/15P & C-630/15P) (28 June 2017)................................................................................. 16.8, 16.9, 16.10 Novartis AG v Generics (UK) Ltd see Generics (UK) Ltd (t/a Mylan) v Novartis AG [2012] EWCA Civ 1623, [2012] 12 WLUK 365...............2.16 Novartis AG v Hospira Ltd [2013] EWHC 1285 (Pat), [2013] 5 WLUK 334..........................................................................................................8.10 O OOO Abbott v Design & Display Ltd [2016] EWCA Civ 98, [2016] 2 WLUK 645, [2016] FSR 27....................................................................8.17 OOO Abbott v Design & Display Ltd [2017] EWHC 932 (IPEC), [2017] 4 WLUK 451, [2017] FSR 43....................................................................8.16 Oberhauser v Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) (Case T-104/01) [2002] ECR II-4359, [2002] 10 WLUK 636, [2003] ETMR 58................................................................19.37 Obsessive-compulsive-disorder / PFIZER (Case T-158/96) (unpublished, 28 October 1998).........................................................................................4.18 Oceanbulk Shipping & Trading SA v TMT Asia Ltd [2010] EWCA Civ 79, [2010] 1 WLR 1803, [2010] 3 All ER 282.............................................12.31 Ocular Sciences Ltd v Aspect Vision Care (No 2) [1996] 11 WLUK 146, [1997] RPC 289, (1997) 20 (3) IPD 20022............................. 17.9, 17.10, 17.16 Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) v Erpo Mobelwerk GmbH (Case C-64/02P) [2004] ECR I-10031, [2004] 10 WLUK 529, [2005] ETMR 58.................................19.15 Okklusionsvorrichtung (X ZR 16/09 GRUR 2011 701).................................5.7 Omnipharm v Merial [2011] EWHC 3393 (Pat)............................................9.8 Onco-Mouse / HARVARD (Case T-19/90) [1990] EPO OJ 476................. 3.17, 3.20 Oneida Indian Nation’s Application No 0308259 [2007] EWHC 954 (Pat), [2007] 5 WLUK 37, [2007] LLR 393.....................................................3.12 Orifarm A/S v Paranova; Orifarm A/S v Merck Sharp & Dohme Corpn (formerly Merck & Co Inc) (Case C-400/09 & C-207/10) [2011] 7 WLUK 820, [2012] 1 CMLR 10, [2011] ETMR 59........................ 20.10, 20.11 Osete v European Union Intellectual Property Office (Cases T-427/16– T429/16) (29 June 2017).........................................................................19.60 Ottung v Klee & Weilbach (Case C-320/87) [1989] ECR 1177, [1989] 5 WLUK 125, [1990] 4 CMLR 915.................................................... 11.12, 14.36 Oxonica Energy v Neuftec Ltd [2009] EWCA Civ 668, [2009] 7 WLUK 235..........................................................................................................14.27 P PLG Research Ltd v Ardon International Ltd [1993] CLY 3041...................1.10 PLG Research Ltd v Ardon International Ltd [1994] 11 WLUK 215, [1995] FSR 116, [1995] RPC 287......................................................................2.4 Paclitaxel freisetzender Stent (14 W (Pat) 13/16 GRUR 2018 64).................15.10 Paki Logistics GmbH v Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) (Case T-526/09) [2011] ECR II‑346.......................................................................................................19.25

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Tables

Table of Cases Palettenbehälter II (X ZR 97/11; July 2012)...................................................6.3 Pall Corpn v Commercial Hydraulics (Bedford) Ltd [1989] 7 WLUK 307, [1990] FSR 329.......................................................................................1.13 Partial Priority / INFINEUM (Case G 1/15)...................................................1.31 Partial Priority / INFINEUM (Case T 0557b/13)...........................................1.31 Pavel v Sony Corpn (unreported, 13 January 1993).......................................6.23 Peak Holding AB v Axolin-Elinor AB (Case C-16/03) [2005] Ch 261, [2005] 2 WLR 650, [2004] ECR I-11313...............................................20.4 Pedestrian stimulation / CONNOR (22 February 2019).................................3.13 Penem derivatives / PFIZER (Case T 1048/92) (unpublished, 5 December 1994).......................................................................................................1.21 Pepper (Case G 3/19)......................................................................................9.2, 9.5 Perini (Fabio) v LPC / PCMC [2012] EWHC 1393 (Pat)...............................8.14 Peter Pan Manufacturing Corpn v Corsets Silhouette Ltd [1964] 1 WLR 96, [1963] 3 All ER 402, [1962] 11 WLUK 71............................................17.15 Pfizer / Obsessive-compulsive disorder (Case T-158/96) [1999] EPOR 285.1.14 Pfizer / Use of zipradisone for treating Tourette’s syndrome (Case T-715/03) (unreported, 16 January 2006)................................................................1.14 Pharmachemie / Glaxo (11/01662; 22 June 2012)..........................................6.4 Pharmacia Corpn v Merck & Co Inc [2001] EWCA Civ 1610, [2001] 12 WLUK 438, [2002] RPC 41...................................................................4.2, 5.3 Pharma Mar / Aplidine (Case T-385/07) (unreported, 5 October 2007).........1.14 Phones 4U Ltd (in administration) v EE Ltd [2018] EWHC 49 (Comm), [2018] 2 All ER (Comm) 315, [2018] Bus LR 574................................14.11 Pico Food GmbH v European Union Intellectual Property Office (Case T-623/11) (9 April 2014).........................................................................19.48 Pink Lady America LLC v Community Plant Variety Office (CPVO) (Case T-112/18) [2019] 9 WLUK 273..............................................................18.2 Pioneer Electronics Capital Inc v Warner Music Manufacturing Europe GmbH [1995] 1 WLUK 464, [1995] RPC 487.......................................6.9 Plant cells / PLANT GENETIC SYSTEMS (Case T-356/93) [1995] EPO OH 545........................................................................................ 3.16, 3.18, 3.20 Plasmid TR2030 / NORTH CAROLINA STATE UNIVERSITY (Case T-576/91) (18 May 1993)........................................................................1.10 Pneumatic Tyre Co Ltd v Puncture Proof Pneumatic Tyre Co Ltd (1899) 16 RPC 209................................................................................................. 8.8, 8.14 Polyether-based preparations / 3M (Case T 0260/14) (unpublished, 13 April 2017).......................................................................................................1.31 Polypeptide expression / GENENTECH (Case T-292/85) [1989] OJ EPO 275...4.9 Poulton v Adjustable Cover & Boiler Block Co [1908] 2 Ch 430, [1908] 7 WLUK 13......................................................................................... 13.20, 13.21 Pozzoli Spa v BDMO SA [2007] EWCA Civ 588, [2007] 6 WLUK 524, [2007] FSR 37 ................................................................................ 2.3, 2.7, 2.16 Pranahaus v Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) (Case T-226/07) [2008] ECR II-184......................19.16 Printers & Finishers Ltd v Holloway (No 2) [1965] 1 WLR 1, [1964] 3 All ER 731, [1964] 11 WLUK 13................................................... 17.2, 17.8, 17.11 Procter & Gamble Co v European Union Intellectual Property Office (Cases C-468/01P & C-472/01P) [2004] ECR I-5141.......................................19.15

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Cases

Public availability / HYDRO-QUEBEC (Case T-834/09) (unpublished, 2 February 2012).....................................................................................1.10 Q Quads for Kids v Colin Campbell [2006] EWHC 2482 (Ch), [2006] 10 WLUK 373, [2006] Info TLR 338..........................................................6.32 Questo, Trade Mark Revocation (O/127/99) (5 May 1999)............................19.60 R R v Johnstone (Robert Alexander) [2003] UKHL 27, [2003] 1 WLR 1736, [2003] FSR 42.........................................................................................20.18 R v M; R v C; R v T [2017] UKSC 58, [2017] 1 WLR 3006, [2018] 1 All ER 304....20.18 R Griggs Group Ltd v Evans (No 1) [2005] EWCA Civ 11, [2005] 1 WLUK 394, [2005] ECDR 30.............................................................................17.6 R (on the application of Jet2.com Ltd) v Civil Aviation Authority [2020] EWCA Civ 35, [2020] QB 1027, [2020] 2 WLR 1215..........................12.24 RBS (Rights Issue Litigation), Re [2016] EWHC 3161 (Ch), [2017] 1 WLR 1991, [2016] 12 WLUK 201...................................................................12.23 Racing Partnership Ltd v Sports Information Services Ltd [2020] EWCA Civ 1300, [2020] 10 WLUK 86, [2021] FSR 2.......................................17.5 Ranbaxy (UK) Ltd v AstraZeneca AB [2011] EWHC 1831 (Pat), [2011] 7 WLUK 472, [2011] FSR 45....................................................................6.8 Ratiopharm v Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) (Case T-48/07) [2008] ECR II-181........................19.16 Ray v Classic FM plc [1998] 3 WLUK 354, [1998] ECC 488, [1998] FSR 622..........................................................................................................17.6 Reckitt & Colman Products Ltd v Borden Inc (No 3) [1990] 1 WLR 491, [1990] 1 All ER 873, [1990] RPC 341....................................................19.61 Reckitt Benckiser UK v Home Pairfum Ltd [2004] EWHC 302 (Ch), [2004] 2 WLUK 324, [2005] ETMR 94.............................................................6.32 Regeneron Pharmaceuticals Inc v Genentech Inc [2012] EWHC 657 (Pat), [2012] 3 WLUK 721, (2012) 109 (25) LSG 19......................................1.14 Regeneron Pharmaceuticals Inc v Kymab Ltd [2016] EWHC 87 (Pat); rev’sd in part [2018] EWCA Civ 671; rev’sd [2020] UKSC 27, [2020] Bus LR 1394, [2020] 6 WLUK 303........................................ 4.3, 4.4, 4.9, 4.11, 5.1, 8.22, 8.23, 8.24 Regeneron Pharmaceuticals Inc v Kymab Ltd [2018] EWCA Civ 1186, [2018 ]5 WLUK 427, [2018] RPC 15.................................... 4.4, 4.5, 8.21, 8.24 Research Engineering & Manufacturing v Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) (Case T-558/14) (18 November 2015)...............................................................................19.16 Research in Motion UK Ltd v Inpro Licensing SARL [2005] EWHC 1292 (Pat).........................................................................................................12.47 Research in Motion UK Ltd v Visto Corpn [2008] EWHC 3025 (Pat), [2008] 12 WLUK 177, (2009) 32 (2) IPD 32012...................................12.47 Respiratory function of a mammal / AEROCRINE (Case T-0125/02)...........3.25 Rhone-Poulenc Rorer International Holdings Inc v Yeda Research & Development Co Ltd [2007] UKHL 43, [2008] 1 All ER 425, [2007] Bus LR 1796...................................................................................... 10.3, 10.13

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Tables

Table of Cases Rice (t/a Garden Guardian) v Great Yarmouth BC [2000] 6 WLUK 829, [2003] TCLR 1, (2001) 3 LGLR 4...................................14.6, 14.8, 14.9, 14.14 Richardson-Vick Inc’s Patent [1995] 5 WLUK 433, [1995] RPC 568...........13.8 Roche Products v Bolar Pharmaceuticals Co 733 F 2d 858 (Fed Cir)............7.2 Roche Products v Kent Pharmaceuticals Ltd [2006] EWCA Civ 1775, [2006] 12 WLUK 498, [2007] ECC 20...................................................20.6 Royalty Pharma Collection Trust v Deutsches Patent- und Markenamt (Case C-650/17) [2019] 9 WLUK 89......................................................... 15.22, 15.24 Rush & Tompkins Ltd v Greater London Council [1989] AC 1280, [1988] 3 WLR 939, [1988] 3 All ER 737..............................................................12.31 S SDL Hair Ltd v Next Row Ltd [2014] EWHC 2084 (IPEC)..........................8.14 Sabaf SpA v MFI Furniture Centres Ltd [2004] UKHL 45, [2004] 10 WLUK 329, [2005] RPC 10; rev’sd [2002] EWCA Civ 976, [2002] 7 WLUK 334, [2003] RPC 14................................................................ 2.12, 6.31 Sabel BV v Puma AG (Case C-251/95) [1997] ECR I-6191, [1997] 11 WLUK 183, [1998] 1 CMLR 445.................................................... 19.37, 19.39 Safe Skies LLC v European Union Intellectual Property Office (Case C-326/18)................................................................................................19.14 Saint Gobain Pam SA v Fusion Provida Ltd [2005] EWCA Civ 177, [2005] 2 WLUK 661, (2005) 28 (6) IPD 28043................................................ 2.5, 2.12 Saltman Engineering Co Ltd v Campbell Engineering Co Ltd [1963] 3 All ER 413 (Note), [1948] 1 WLUK 12, (1948) 65 RPC 203................... 17.4, 17.5 Samsung Electronics Co Lt v Apple Retail UK Ltd [2014] EWCA Civ 250, [2014] 3 WLUK 223, [2015] RPC 3.................................... 13.15, 13.16, 13.17, 13.24, 13.25 Samsung Electronics Co Ltd v Apple Retail UK Ltd, Apple Sales International [2013] EWHC 467 (Pat) [2013] EWHC 467 (Pat)............1.29 Samsung Electronics (UK) Ltd v Apple Inc [2012] EWHC 2049 (Pat), [2012] 7 WLUK 541...............................................................................8.22 Sandoz Ltd v GD Searle LLC [2018] EWCA Civ 49, [2018] 1 WLUK 390.... 15.22, 15.23, 15.24 Sandvik Intellectual Property AB v Kennametal UK Ltd, Kennametal Europe GmbH [2011] EWHC 3311 (Pat), [2011] 12 WLUK 524, [2012] RPC 23........................................................................................4.19 Sanofi-Aventis SA v Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) (Case T-146/06) (13 February 2008)..........19.38 Santen v Director of the French Patent Office (INPI) (Case C-673/18)............ 15.27, 15.28, 15.29, 15.31, 15.33, 15.35 Sat I SatellitenFensehen GmbH v European Union Intellectual Property Office (Case C-329/02) [2004] ECR I-8317.................................... 19.15, 19.48 Saturated dicarboxylic acids / COGNIS (Case T-1014/07) (unpublished, 2 July 2012)................................................................................................2.16 Scancom International A/S v RWH Enterprises Ltd [2003] All ER (D) 89....14.14 Schneidmesser I (GRUR 2002, 515)..................................................... 1.18, 5.7, 5.11 Schulin v Saatgut-Treuhandverwaltungs GmbH (Case C-305/00) [2003] ECR I-3525, [2003] 4 WLUK 291, [2005] 1 CMLR 17.........................18.3

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Cases

Schutz (UK) Ltd v Werit UK Ltd [2013] UKSC 16, [2013] 2 All ER 177, [2013] Bus LR 565...................................................................... 6.3, 6.22, 11.21 Schweppes SA / Red Paralela SL (Case C-291/16) [2017] 12 WLUK 531, [2018] ETMR 13 ....................................................................................20.14 Seager v Copydex Ltd (No 1) [1967] 1 WLR 923, [1967] 2 All ER 415 [1967] RPC 349................................................................................. 17.6, 17.15 Seattle Genetics Inc v Österreichisches Patentamt (Case C-471/14) [2015] 10 WLUK 122, (2016) 147 BMLR 77....................................................15.7 Sebago & Ancienne Maison Dubois et Fils SA v GB-Unic SA (Case C-173/98) (1 July 1999) .................................................................... 20.6, 20.15 Second medical indication (Case G-1/83) [1985] OJ EPO 60........................3.24 Second medical indication / EISAI (Case G-5/83) [1985] OJ EPO 64...... 3.24, 3.28, 3.29 Second medical indication / EISAI (Case G-6/83) [1985] OJ EPO 97..........3.24 Security Device & its Production Method / De La Rue (Case T-1285/15) (unpublished, 18 November 2019)..........................................................4.19 Serine protease inhibitors / AMGEN (Case T-420/96) (unpublished, 31 May 2001).......................................................................................................4.9 Serine protease / Bayer (Case T-1452/06) (10 May 2007).............................3.4 Serotonin receptor / ELI LILLY (Case T-241/95) [2001] OJ EPO 103..........4.18 Servier SAS, Servier Laboratories Ltd & Les Laboratoires Servier SA v Commission (Case C-201/19P) (28 February 2019)..............................11.35 Shanks v Unilever plc [2014] EWHC 1647 (Pat), [2014] 5 WLUK 883, [2014] RPC 29............................................ 10.6, 10.7, 10.8, 10.9, 10.10, 10.11 Sharpe & Dohme Inc v Boots Pure Drug Co Ltd (1927) 44 RPC 367...........1.17 Shelfer v City of London Electric Lighting Co (No 1) [1895] 1 Ch 287, [1894] 12 WLUK 96...............................................................................8.32 Shenzhen Senior Technology Material Co Ltd v Celgard LLC (Rev 1) [2020] EWCA Civ 1293, [2020] 10 WLUK 73, [2021] FSR 1........... 17.3, 17.4 Shield Mark BV v Kist (t/a Memex) (Case C-283/01) [2004] Ch 97, [2004] 2 WLR 1117, [2003] ECR I-14313.........................................................19.12 Shire Pharmaceuticals Ireland v EMA (Case T-80/16 & C-359/18)...............16.17 Sieckman (Ralf) v Deutsches Patent- und Markenamt (Case C-273/00) [2003] Ch 487, [2003] 3 WLR 424, [2002] ECR I-11737......................19.12 Silhouette International Schmied GmbH & Co KG v Hartiauer Handelsgesellschaft mbH (Case C-355/96) [1999] Ch 77, [1998] 3 WLR 1218, [1998] ECR I-4799..............................................................20.15 Simethicone Tablet / RIDER (Case T-2/83) [1984] OJ EPO 265...................2.16 Simvastatin (X ZR 76/05)...............................................................................6.4 Sky plc v Skykick UK Ltd (Case C-371/18) [2020] Bus LR 1550, [2020] 1 WLUK 242, [2020] ETMR 24......................................................... 19.11, 19.31 Smith & Nephew v ConvaTec Technologies Inc [2015] EWCA Civ 607, [2015] 6 WLUK 760, [2015] RPC 32.....................................................5.10 Smith & Nephew v ConvaTec Technologies Inc [2013] EWHC 3955 (Pat), [2013] 12 WLUK 438, [2014] RPC 22...................................................8.12 SmithKlineBeecham v Apotex Europe Ltd [2003] EWCA Civ 137, [2003] 2 WLUK 429, [2003] FSR 31.................................................................8.3 Société des produits Nestlé SA v Mondelez UK Holdings & Services Ltd (Cases C-84/17P & C-95/17P) (25 July 2018).......................................19.18

xxxv

Tables

Table of Cases Sofa Workshop Ltd v Sofaworks Ltd [2015] EWHC 1773 (IPEC), [2015] 6 WLUK 874, [2015] ECC 25...................................................................19.58 Spring Form Inc v Toy Brokers Ltd [2001] 7 WLUK 822, [2002] FSR 17, (2001) 24 (11) IPD 24073.......................................................................8.16 Stable bleaches / UNILEVER (Case T-226/85) [1988] OJ EPO 336.............4.9 State Trading Corpn of India Ltd v M Golodetz [1989] 2 Lloyd’s Rep 277, [1989] 6 WLUK 50 ................................................................................14.11 Stocznia Gdynia SA v Gearbulk Holdings Ltd [2009] EWCA Civ 75, [2010] QB 27, [2009] 3 WLR 677............................................................... 14.15, 14.16 Sudarshan Chemical Industries Ltd v Cariant Produkte (Deutschland) GmbH [2012] EWHC 1569 (Ch), [2012] 6 WLUK 156, (2012) 109 (27) LSG 18...6.34 Sumitomo Chemical Co Ltd v Deutsches Patent- und Markenamt (Case C-210/12) (17 October 2013)..................................................................15.10 Sunrider Corpn v Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) (Case C-416/04) (11 May 2006)................19.56 Superconductive thin film / SUMITOMO (Case T-348/94) (unpublished, 21 October 1998).........................................................................................1.10 Symbian Ltd v Comptroller General of Patents, Designs & Trademarks [2008] EWCA Civ 1066, [2009] Bus LR 607, [2009] RPC 1............... 3.6, 3.13 Symbian Ltd v Comptroller General of Patents (Case C-195/09) [2011] ECR I-7011, [2011] 7 WLUK 816, [2012] RPC 3.................................15.10 Synthon BV v Smithkline Beecham plc (No 2) [2005] UKHL 59, [2006] 1 All ER 685, [2005] 10 WLUK 591.......................................... 1.3, 1.7, 1.8, 1.23 T TGFalpha-HII / HUMAN GENOME SCIENCES (Case T-1450/07) (unpublished, 11 February 2009)............................................................3.2 TNF-alpha inhibitor (Case T 734/12) (unpublished, 17 May 2013)...............1.26 TNF / YEDA (Case T-0542/95)......................................................................9.9 TQ Delta LLC v ZyXel Communications Ltd [2019] EWHC 745 (Pat), [2019] 3 WLUK 483...............................................................................8.11 TQ Delta LLC v Zyxel Communications Ltd [2018] EWHC 1515 (Ch), [2018] Bus LR 1544, [2018] 6 WLUK 234............................................12.19 Takeda UK Ltd v F Hoffman-La Roche AG [2019] EWHC 1911 (Pat), [2019] Bus LR 2681, [2019] 7 WLUK 279............................................1.12 Tamglass Ltd Oy v Luoyang North Glass Technology Co Ltd [2006] EWHC 65 (Pat), [2006] 1 WLUK 544, [2006] FSR 32......................................6.7 Taurus-Film GmbH v Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) (Case T-135/99) [2001] ECR II379, [2001] 1 WLUK 731, [2001] ETMR 55.........................................19.16 T-cell growth factor / HOOPER (Case T-877/90) (unpublished, 28 July 1992).......................................................................................................1.10 Technetix v Teleste [2019] EWHC 126 (IPEC), [2019] 1 WLUK 363, [2019] FSR 19...................................................................................... 1.18, 5.11 Technograph Printed Circuits Ltd v Mills & Rockley (Electronics) Ltd [1971] 2 WLUK 122, [1971] FSR 188, [1972] RPC 346.......................2.16 Tegometall v Wupperman (Case T-458/05) [2007] ECR II-4721...................19.16 Tele2 International Card Co SA v Post Office Ltd [2009] EWCA Civ 9, [2009] 1 WLUK 319 ....................................................................... 14.18, 14.19

xxxvi

Table of Cases

Cases

Teva UK Ltd v Gilead Sciences Ltd (Case C-121/17)............................... 15.8, 15.16 Teva UK Ltd v Gilead Sciences Ltd [2017] EWHC 13 (Pat), [2017] 1 WLUK 130....................................................................................... 15.17, 15.23 Teva UK Ltd v Gilead Sciences Ltd [2018] EWHC 2416 (Pat), [2018] 9 WLUK 185..............................................................................................15.19 Teva UK Ltd v Gilead Sciences Ltd [2019] EWCA Civ 2272, [2019] 12 WLUK 276....................................................................................... 15.21, 15.22 Teva v European Medicines Agency (Case T-140/12)............................. 16.15, 16.19 Teva v European Medicines Agency (Case C-138/15P) [2016] 3 WLUK 125, [2016] 3 CMLR 8..................................................................... 16.16, 16.21 Teva UK Ltd v Leo Pharma A/S [2015] EWCA Civ 779, [2015] 7 WLUK 860, [2016] RPC 5 .................................................................................2.12 Teva UK Ltd v Chiesi Farmaceutici SpA [2020] EWHC 1311 (Pat), [2020] 6 WLUK 4, [2020] 5 CMLR 14..............................................................6.4, 8.9 Thaler v Comptroller-General of Patents, Designs & Trade Marks [2020] EWHC 2412 (Pat), [2020] Bus LR 2146, [2020] 9 WLUK 227............10.2 Therapeutic method / ELA MEDICAL (Case T-789/96) [2002] OJ EPO 364..........................................................................................................3.26 Thomas Marshall (Exports) Ltd v Guinle [1979] Ch 227, [1978] 3 WLR 116, [1978] 3 All ER 193........................................................................17.10 Thoratec Europe Ltd v AiS GmbH Aachen Innovative Solutions [2016] EWHC 2637 (Pat), [2016] 10 WLUK 671.............................................2.11 Three Rivers DC v Bank of England (No 5) [2003] EWCA Civ 474, [2003] QB 1556, [2003] 3 WLR 667..................................................................12.23 Three Rivers DC v Bank of England (No 6) [2004] UKHL 48, [2005] 1 AC 610, [2004] 3 WLR 1274................................................................. 12.21, 12.23 Tomatoes / STATE OF ISRAEL (Case G-1/08).............................................3.17 Tomatoes II (Case G2/12); Broccoli II (Case G-2/13) [2016] EPO OJ A28....... 3.17, 9.5 Tongyuan (USA) International Trading Group v Uni-Clan Ltd [2001] 1 WLUK 423..............................................................................................14.13 Trailfinders Ltd v Travel Counsellors Ltd [2020] EWHC 591 (IPEC), [2020] 3 WLUK 215, [2020] IRLR 448.............................................................17.3 Transgenic animals / HARVARD (Case T-315/03) [2005] EPO OJ 246..... 3.17, 3.20 Transgenic cotton plants / BAYER CROPSCIENCE (Case T-547/10) (unpublished, 13 July 2016)....................................................................3.16 Transgenic plant / NOVARTIS II (Case G-1/98) [2000] EPO OJ 111...........3.16 Treatment by surgery / MEDI-PHYSICS (Case G-1/07) [2011] OJ EPO 134............................................................................................. 3.24, 3.25, 3.26, 3.27, 9.8 Triazinylaminostilbene / CIBA (Case T 392/06) (unpublished, 22 October 2008).......................................................................................................1.24 Triazoles / AGREVO (Case T-939/92) [1996] OJ EPO 309, [1996] EPOR 171 ............................................................................................ 2.18, 2.19, 2.20, 2.21, 2.27, 3.2 U USA v Philip Morris Inc & British American Tobacco (Investments) Ltd [2001] 1 CLC 811...................................................................................12.28

xxxvii

Tables

Table of Cases Ultrahigh-molecular-weight0polyethylene / MITSUI (Case T-176/89) (unpublished, 27 June 1990)...................................................................2.16 Unilever plc v Chefaro Proprietaries Ltd (Discovery) [1993] 3 WLUK 188, [1994] FSR 135.......................................................................................6.31 Unilever plc v Ian Alexander Shanks see Shanks v Unilever plc Unilin Beheer BV v Berry Floor NV [2004] EWCA Civ 1021, [2004] 7 WLUK 909, [2005] FSR 6......................................................................1.29 Unilin Beheer BV v Berry Floor NV [2007] EWCA Civ 364, [2008] 1 All ER 156, [2007] FSR 25...........................................................................13.22 Union Carbide Corpn v BP Chemicals Ltd [1997] EWHC 373 (Pat)............6.6 United Wire Ltd v Screen Repair Services (Scotland) Ltd [2000] 4 All ER 353, [2000] 7 WLUK 605, [2001] RPC 24................................. 6.3, 6.22, 11.21 University of Queensland, CSL Ltd v Comptroller General of Parents, Designs & Trade Marks [2011] ECR I-12231........................................15.15 University of Southampton’s Applications, Re [2005] RPC 220....................1.3 Unwired Planet International Ltd v Huawei, Samsung & Google [2015] EWHC 3366 (Pat), [2016] Bus LR 435, [2015] 11 WLUK 575............1.29 Unwired Planet v Samsung & Huawei [2016] EWHC 576 (Pat), [2016] 3 WLUK 595..............................................................................................4.19 Use of embryos / WARF (Case G-2/06) [2009] EPO OJ 306.........................3.21 V Valensi v British Radio Corpn Ltd (No 1) [1972] 5 WLUK 82, [1972] FSR 273, [1973] RPC 337..............................................................................1.6 Van Doren + Q GmbH v Lifestyle sports + sportswear Handelsgesellschaft mbH, Michael Orth (Case C-244/00) [2003] ECR I-3051, [2003] 4 WLUK 235, [2003] 2 CMLR 6...............................................................20.6 Vector Corpn v Glatt Air Techniques Ltd [2007] EWCA Civ 805, [2007] 10 WLUK 504, [2008] RPC 10.............................................................. 13.8, 13.10 Vercoe v Rutland Fund Management Ltd [2010] EWHC 424 (Ch), [2010] 3 WLUK 187, [2010] Bus LR D141..........................................................17.15 Verein Radetzky-Orden v Bundesvereinigung Kameradschaft ‘Feldmarschall Radetzky’ (Case C-442/07) [2008] ECR I-9223, [2008] 12 WLUK 230, [2009] CEC 724..............................................................................19.56 Verfahren und Vorrichtung zur Bestimmung der Veränderung eines Objektes / BrainLAB (Case T-923/08) (unpublished, 2 August 2011)..................3.26 Vestergaard Frandsen A/S (now called MVF3 APS) v Bestnet Europe Ltd [2013] UKSC 31, [2013] 1 WLR 1556, [2013] 4 All ER 781............ 17.7, 17.8, 17.10, 17.12, 17.16 Vinylchlorid resins / SUMITOMO (Case T-14/83) [1984] OJ EPO 105........4.9 Virdis Pharmaceutical Ltd v European Union Intellectual Property Office (Case C-668/17) (3 July 2019)................................................................19.56 Virgin Atlantic Airways Ltd v Premium Aircraft Interiors Group Ltd [2009] EWCA Civ 1062, [2009] 10 WLUK 581, [2010] RPC 8.......................5.6 Virgin Atlantic Airways Ltd (respondent) v Zodiac Seats UK Ltd (formerly known as Contour Aerospace Ltd) [2013] UKSC 46, [2014] AC 160, [2013] 3 WLR 299 .............................................................. 13.14, 13.15, 13.16, 13.18, 13.19, 13.21, 13.23, 13.24

xxxviii

Table of Cases

Cases

Visual prosthesis / JOHNS HOPKINS UNIVERSITY (Case T-1798/08) (unpublished, 21 August 2012)...............................................................3.26 W WL Gore & Associates GmbH v Geox SpA [2008] EWCA Civ 622, [2008] 3 WLUK 467...........................................................................................12.47 Warner-Lambert Co LLC v Actavis Group PTC EHF [2015] EWHC 249 (Pat), [2015] 2 WLUK 217.....................................................................6.30 Warner-Lambert Co LLC v Generics (UK) Ltd (t/a Mylan) [2018] UKSC 56, [2019] 3 All ER 95, [2019] Bus LR 360....................... 2.26, 2.28, 3.4, 4.13, 4.15, 4.16, 4.18, 6.9, 6.17, 6.18 Washing Composition / UNILEVER (Case T 666/89) [1993] OJ EPO 495..1.23 Waugh v British Rlys Board [1980] AC 521, [1979] 3 WLR 150, [1979] 2 All ER 1169............................................................................................12.27 Wellcome Foundation Ltd v Paranova Pharmazeutika Handels GmbH (Case C-276/05) [2008] ECR I-10479, [2008] 12 WLUK 694, [2009] ETMR 20........................................................................................... 20.7, 20.12 Wheatley v Drillsafe Ltd [2000] 7 WLUK 96, [2001] RPC 7........................5.7 Williams v Nye (1890) 7 RPC 62...................................................................2.11 Windsurfing International Inc v Tabur Marine (Great Britain) Ltd [1984] 1 WLUK 1218, [1985] RPC 59......................................................... 2.3, 2.8, 2.16 Wm Wrigley Jr Co v Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) (Case C-191/01P) [2004] 1 WLR 1728, [2003] ECR I-12447, [2003] 10 WLUK 654..........................................19.16 Woodar Investment Development Ltd v Wimpey Construction UK Ltd [1980] 1 WLR 277, [1980] 1 All ER 571, [1980] 2 WLUK 157............14.17 X X / Same invention (Case G 2/98) OJ EPO 1998 509....................................13.8 X Technology Swiss v Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) (Case T-547/08) [2010] ECR II2409........................................................................................................19.48 Xanthines / DRACO (Case T 7/86) [1988] OJ EPO 381................................1.22 Y Yeda Research & Development Co Ltd v Rhone-Poulenc Rorer International Holdings Inc see Rhone-Poulenc Rorer International Holdings Inc v Yeda Research & Development Co Ltd Yissum Research & Development Co of the Hebrew University of Jerusalem v Comptroller-General of Patents (Case C-202/05) [2007] ECR I-2839..... 15.25, 15.28 You-Q BV v Office for Harmonisation in the Internal Market (Trade Marks & Designs) (OHIM) (Case T-369/10) (29 March 2012).........................19.45 Z ZTE (UK) Ltd v Telefonaktiebolaget LM Ericsson [2011] EWHC 2709 (Pat), [2011] 10 WLUK 476...................................................................12.47

xxxix

Tables

Table of Cases Zino Davidoff v A & G Imports Ltd; Levi Strauss v Tesco Stores, Costco Wholesale UK (Cases C-414/99 – C-416/99) [2002] Ch 109, [2002] 2 WLR 321, [2001] ECR I-8691 ...............................................................20.6 Zipher Ltd v Markem Systems Ltd [2008] EWHC 1379 (Pat), [2008] 6 WLUK 606, [2009] FSR 1......................................................................13.6

xl

Table of Statutes

Companies Act 2006................. 11.47 s 860(7)(i).............................. 11.44 Competition Act 1998............... 11.23 Consumer Protection Act 1987.20.21 Copyright, Designs and Patents Act 1988......................19.69, 20.22 s 1.......................................... 19.69 18(3).................................20.1, 20.3 107...................................... 20.17 111...................................... 20.29 182B.................................20.1, 20.3 198...................................... 20.17 Pt III (ss 213–264)................ 19.63 s 280...................................... 12.22 (3)................................. 12.22 (a)............................. 12.22 Data Protection Act 2018.....21.1, 21.10, 21.18, 21.25, 21.27 s 19........................................ 21.18 Sch 2 Pt 6 (paras 27, 28)............. 21.18 European Communities Act 1972.. C.1 European Union (Withdrawal) Act 2018................ 20.24, C.1, C.2, C.4, C.10 s 2(1)..............................C.2, C.4, C.9 3.......................................... C.7 (1)..................................... C.2 6......................................19.10, 20.3 (1)(a)................................. C.11 (b)................................. C.12 (2)..................................... C.12 (3)..................................... C.13 (4)(a), (ba)........................ C.13 (5A).................................. C.13 European Union (Withdrawal Agreement) Act 2020.......20.3, C.1 s 26.................................... C.10, C.13

Fraud Act 2006.......................... 20.17 s 2, 6, 7.................................. 20.17 Geneva Conventions Act 1957.. 19.28 Insolvency Act 1986.................. 11.47 Intellectual Property (Unjustified Threats) Act 2017.................................. 6.32 Patents Act 1949....................... 2.27 Patents Act 1977....................1.28, 2.27, 8.1, 8.32, 10.3, 10.6, 11.4, 11.36, 13.2, 13.16, C.3, C.4 s 1.......................................... 1.2 (a)...................................... 1.2 (2).............................1.2, 3.5, 3.10, 3.11 (a)................................. 3.10 (3)..................................... 1.2 2(1)..................................... 1.2 (2).......................1.2, 1.6, 1.11, 2.2 (3)...............................1.2, 1.4, 1.6, 1.10, 2.2 (4), (5)............................... 1.2 3.......................................... 2.2 4.......................................... 3.10 (1)..................................... 3.2, 3.4 5........................................1.28, 1.29 (2)..................................... 1.28 (a)...............................1.28, 1.30 (b)................................. 1.30 (2A).................................. 1.28 (a), (b)....................... 1.28 (2B), (2C)......................... 1.28 (3)..................................... 1.30 6.......................................... 1.28 7(2)..................................... 10.5 (a), (b).......................... 10.2

xli

Tables

Table of Statutes Patents Act 1977 – contd s 7(3)..................................... 10.2 (4)..................................... 10.2 8.......................................... 10.4 11(1)................................... 10.13 (2)................................... 10.15 (3)(b)............................... 10.15 (4), (5)............................. 10.15 12........................................ 10.4 13(1)................................... 10.2 19......................................13.2, 13.7 (1).................................13.3, 13.7 27......................................13.3, 13.5 (1)........................13.4, 13.6, 13.7 (2)–(5)............................. 13.4 (6).................................13.4, 13.6 30(6)................................... 11.2 33....................................11.2, 11.44 (1), (2).......................11.19, 11.49 36(1)................................... 10.3 (2)................................... 10.4 (3)................................... 10.4 37........................................ 10.4 39........................................ 10.5 (2)................................... 10.5 40........................ 10.6, 10.10, 10.11 (1)......................10.6, 10.8, 10.11 41...........................10.7, 10.8, 10.10 46........................................ 11.37 (2)................................... 11.37 (3)(d)............................... 11.37 47(1)................................... 11.37 (2)................................... 11.37 48–54.................................. 11.36 55...................... 11.38, 11.39, 11.40 (1)(a)...........................7.23, 11.38 (b)............................... 11.38 56, 57.................................. 11.38 57A..................................... 11.40 58........................................ 11.38 59..................................11.38, 11.39 60(1)................................... 6.2 (a)............................... 6.3 (b)........................6.5, 6.6, 6.24 (c).....................6.8, 6.12, 6.14, 6.16 (2).........................6.7, 6.20, 6.21, 6.22, 6.23, 6.24, 6.26, 6.28, 6.29, 6.30, 6.31

xlii

Patents Act 1977 – contd s 60(3).................................6.20, 6.23 (5)(b)............................... 7.2 (i)................................ 7.2, 7.4 (6D)........................7.2, 7.5, 8.25, 8.26 (6E)........................7.2, 8.25, 8.26 (6F)................................. 7.5 61........................................ 13.4 (1)...................................8.2, 8.13 (b)............................... 8.21 (2)................................... 8.13 62(7)................................... 8.20 64.............................7.20, 7.21, 7.22 (1)................................... 7.22 (2)................................... 7.22 67....................................11.4, 11.20 (1)................................... 10.14 68........................................ 11.2 70......................................6.33, 13.4 (2)................................... 6.33 70A..................................... 6.32 (2)................................ 6.34 (a), (b)..................... 6.34 (3)–(5).......................... 6.34 70B...................................6.32, 6.35 (1)(b)(i)........................ 6.35 (2)–(4).......................... 6.35 70C..................................... 6.32 (1), (3), (4)................... 6.36 70D...................................6.32, 6.36 70E, 70F............................. 6.32 71........................................ 13.4 72........................................ 13.4 (1)(c)........................1.6, 4.2, 4.10 (d)............................... 13.7 (e)............................... 13.7 73........................................ 13.7 74........................................ 13.4 75...........................13.3, 13.7, 13.25 (1)...............................13.5, 13.17 (2)–(4)............................. 13.5 (5).................................13.5, 13.6 76.............................13.3, 13.4, 13.7 (2)........................13.3, 13.7, 13.8 (3)........................13.7, 13.8, 13.9 (a), (b)........................ 13.7 76A..................................... 3.10 90........................................ 1.28

Table of Statutes Patents Act 1977 – contd s 130(7)................................. 1.2 Sch A2 para 2................................. 3.10 3(a)............................ 3.10 5................................. 3.10 Sch 2A..................................3.14, C.4 Patents Act 2004....................... 10.6 Plant Varieties Act 1997............ 18.1 s 4(2)–(4)............................... 18.2 6(1), (3), (4)........................ 18.3 7–9...................................... 18.3 11(1)................................... 18.3 13(2)................................... 18.5 14, 15.................................. 18.5 17........................................ 18.6 21........................................ 18.4 22(1)................................... 18.4 Proceeds of Crime Act 2002..... 20.17 Prosecution of Offences Act 1985 s 6(1)..................................... 20.20 Registered Designs Act 1949.... 19.63 s 1(2), (3)............................... 19.66 1B....................................... 19.66 (2), (3)............................ 19.66 1C....................................... 19.66 7....................................19.66, 19.67 7A(4)................................20.1, 20.3 11ZA................................... 19.66 33........................................ 20.17 35ZA................................... 20.17 Sale of Goods Act 1979 s 12(1), (5A).......................... 14.11 Senior Courts Act 1981............. 8.32 s 37........................................ 8.22 Trade Marks Act 1994..........19.9, 19.10, 20.1, 20.22 s 1(1)...............................19.12, 19.13 (b)................................. 19.12 3....................................19.12, 19.13 (1)...............................19.13, 19.18 (b)...........................19.13, 19.15 (c)...........................19.13, 19.16 (d)................................. 19.17 (2)..............................19.13, 19.19, 19.23 (3)..................................... 19.13 (a)................................. 19.24 (b)................................. 19.27

Statutes

Trade Marks Act 1994 – contd s 3(4)...............................19.13, 19.28 (4A), (4B)......................... 19.13 (4C), (4D)...................19.13, 19.29 (5)...............................19.13, 19.30 (6)...............................19.13, 19.31 4.......................................... 19.30 5....................................19.32, 19.49 (1)...............................19.35, 19.49 (b)................................. 19.36 (2)...............................19.36, 19.49 (3)...............................19.40, 19.49 (3A).................................. 19.40 (4)..................................... 19.46 (5)..................................... 19.32 (6)..................................... 19.47 5A....................................... 19.32 6....................................19.32, 19.33 (2)..................................... 19.33 6A....................................... 19.34 (1), (1A), (2), (4)............ 19.34 7.......................................... 19.32 9.......................................... 19.49 (3)(a), (b).......................... 19.49 10........................................ 19.49 (1)–(3)............................. 19.49 (3B)................................. 19.49 (6)................................... 19.49 11........................................ 20.18 (1)............................19.34, 19.50, 19.51 (1B)................................. 19.50 (2)(a)–(c)........................ 19.51 (3)................................... 19.51 11A..................................... 19.34 12...........................19.51, 20.2, 20.3 13....................................19.6, 19.51 34........................................ 19.11 39........................................ 19.11 40(3)................................... 19.6 42........................................ 19.6 43........................................ 19.6 46..................................19.54, 19.55 (1)................................... 19.55 (a)–(c)........................ 19.54 (2)................................... 19.59 (3)................................... 19.55 (4), (5)............................. 19.54 (6)................................... 19.54

xliii

Tables

Table of Statutes Trade Marks Act 1994 – contd s 47..................................19.34, 19.53 (1)................................... 19.53 (2A)................................ 19.51 (2B)................................. 19.34 (2G)..........................19.51, 19.53 (2H)................................ 19.53 (3)–(5)............................. 19.53 48........................................ 19.53 (1)................................... 19.51 89........................................ 20.29 92........................................ 20.18 (1)................................... 20.18 (a)–(c)........................ 20.18

xliv

Trade Marks Act 1994 – contd s 92(4), (5)............................. 20.18 (6)................................... 20.18 GERMANY Patent Act s 11........................................ 7.4 NETHERLANDS Patent Act art 53(1)................................. 6.4 UNITED STATES Hatch-Waxman Act................... 7.2

Table of Statutory Instruments

Animal Health, Invasive Alien Species, Plant Breeders’ Rights and Seeds (Amendment etc) (EU Exit) Regulations 2019, SI 2019/1220..................... 18.1 Civil Procedure Rules 1998, SI 1998/3132.................12.2, 12.15 Pt 3 (rr 3.1–3.21)................... 12.42 r 3.12..................................... 12.49 Pt 6 (rr 6.1–6.52)................... 12.5 PD 6A.................................... 12.5 PD 6B.................................... 12.5 r 7.2(1)................................... 12.5 7.4(1)................................... 12.6 7.5(1)................................... 12.5 15.4(1)................................. 12.9 PD 15.................................... 12.11 r 17.1(2)................................. 12.4 Pt 18 (rr 18.1, 18.2)............... 12.14 r 20.4..................................... 12.10 22.1(1)(a)............................ 12.4 (6)................................. 12.4 25.12................................... 12.13 25.13(2)............................... 12.13 31.2, 31.3............................ 12.15 31.6(b), (c).......................... 12.50 31.8..................................... 12.15 31.19................................... 12.18 31.22(2)............................... 12.19 32.18................................... 12.14 Pt 35 (rr 35.1–35.15)............. 12.32 PD 40A.................................. 12.41 r 44.2..................................... 12.42 (2)(a)............................ 12.42 (4)(b)............................ 12.42 44.3(2)................................. 12.42 44.4(2)................................. 12.42

Civil Procedure Rules 1998, SI 1998/3132 – contd PD 44.................................... 12.42 Pt 47 (rr 47.1–47.26)............. 12.42 PD 51U...........................12.15, 12.16, 12.17, 12.18, 12.19 r 52.3(2), (3).......................... 12.44 52.12(2)(a), (b)................... 12.44 52.13(2)............................... 12.45 PD 57AB.........................12.49, 12.50 Pt 63 (rr 63.1–63.28)........12.2, 12.18, 12.49 r 63.5..................................... 12.5 63.7(a)................................. 12.9 (c)................................. 12.11 63.8(1)................................. 12.11 (2)(b)............................ 12.11 63.14................................... 12.5 PD 63......................12.7, 12.8, 12.18, 12.34, 12.35 Competition (Amendment etc) (EU Exit) Regulations 2019, SI 2019/93............... 11.23 Consumer Protection from Unfair Trading Regulations 2008, SI 2008/1277............ 20.17 Copyright (Customs) Regulations 1989, SI 1989/1178......................... 20.29 Customs (Enforcement of Intellectual Property Rights) (Amendment) (EU Exit) Regulations 2019, SI 2019/514........................... 20.24 Designs and International Trade Marks (Amendment etc) (EU Exit) Regulations 2019, SI 2019/638............. 19.10

xlv

Tables

Table of Statutory Instruments European Union (Withdrawal) Act 2018 (Relevant Court) (Retained EU Case Law) Regulations 2020, SI 2020/1525...........19.10, 20.3, C.13 reg 5...................................... C.13 Human Medicines (Amendment etc) (EU Exit) Regulations 2019, SI 2019/775............19.2, C.9 Pt 4 (regs 45, 46)................... C.9 reg 58C.................................. C.9 64...................................15.1, C.8 Human Medicines (Amendment etc) (EU Exit) Regulations 2020, SI 2020/1488 reg 41.................................... C.9 Sch 2...................................... C.9 Human Medicines and Medical Devices (Amendment etc) (EU Exit) Regulations 2019, SI 2019/1385........... C.9 Human Medicines Regulations 2012, SI 2012/1916........16.1, 19.2, 19.4, 20.21, C.8, C.9 reg 58A.................................15.1, C.8 Intellectual Property (Amendment etc) (EU Exit) Regulations 2020, SI 2020/1050...........15.44, 19.10, C.7 reg 43.................................... 15.44 Intellectual Property (Enforcement etc) Regulations 2006, SI 2006/1028.......................... 8.1, C.4 reg 3...................................... 8.13 Intellectual Property (Exhaustion of Rights) (EU Exit) Regulations 2018 (draft)..... C.7 Intellectual Property (Exhaustion of Rights) (EU Exit) Regulations 2019, SI 2019/265........20.3, 20.15, C.7 Legislative Reform (Patents) Order 2014, SI 2014/1997.7.8 Nagoya Protocol (Compliance) (Amendment) (EU Exit) Regulations 2018, SI 2018/1393.....................18.1, 18.10

xlvi

Nagoya Protocol (Compliance) Regulations 2015, SI 2015/821........................... 18.1 Patents (Amendment) (EU Exit) Regulations 2019, SI 2019/801 Pt 8 (regs 51–69)..................15.1, C.7 reg 54, 60.............................. 15.1 Patents and Plant Variety Rights (Compulsory Licensing) Regulations 2002, SI 2002/247.......................11.36, 18.6 Patents and Trade Marks (World Trade Organisation) Regulations 1999, SI 1999/1899......................... 11.36 Patents Rules 2007, SI 2007/3291 r 5.......................................... 1.2 Plant Breeders’ Rights (Amendment etc) (EU Exit) Regulations 2019, SI 2019/204........................... 18.1 Plant Breeders’ Rights (Amendment) (EU Exit) Regulations 2020, SI 2020/769........................... 18.1 Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020, SI 2020/1471........... C.7 Trade Marks (Amendment etc) (EU Exit) Regulations 2019, SI 2019/269............. 19.10 Trade Marks (Customs) Regulations 1994, SI 1994/2625......................... 20.29 Trade Marks Regulations 2018, SI 2018/825....................... 19.9 Trade Marks Rules 2008, SI 2008/1797......................... 19.9 r 33........................................ 19.11 Trade Secrets (Enforcement etc) Regulations 2018, SI 2018/597...................17.3, 17.15 reg 2........................17.3, 17.5, 17.15, 17.16 (b).................................. 17.6 (c).................................. 17.6 3...................................... 17.3

Table of Statutory Instruments Trade Secrets (Enforcement etc) Regulations 2018, SI 2018/597 – contd reg 3(1)................................17.3, 17.7 (2)..............................17.3, 17.15 (b)............................. 17.11 (3).................................. 17.3

SIs

Trade Secrets (Enforcement etc) Regulations 2018, SI 2018/597 – contd reg 11(1)................................ 17.15 14(1)................................ 17.15 16–18.............................. 17.15

xlvii

Introduction

A DECADE OF CHANGE Diversification of the life sciences sector Just a decade ago, the Financial Crisis was still hitting hard and the life sciences sector, dominated by small-molecule pharmaceuticals, was being squeezed: on the one hand, it was finding it harder to identify small-molecule targets and match them with candidate drugs; on the other, it was meeting the challenge of generic competition to the ‘blockbuster’ drugs that had driven the market in the previous decade. As a result, some companies sought to diversify their businesses away from reliance on small-molecule drugs by developing biological products (which present new opportunities and greater difficulty for competitors to copy) and moving into medical devices. Furthermore, the divide between the originator companies and generics began to blur, as branded companies created their own lines of branded generic products and/or bought generic companies. Indeed, many generics themselves moved into products based on their own research and development, including the repurposing and reformulation of existing, off-patent drugs (termed ‘supergenerics’). Structural changes in businesses also took place, reflecting the need to fill pipelines whilst trying to share the risks associated with drug development – in particular, the acquisition of small research companies with one or two promising drug candidates, rather than conducting early-stage development in-house. Alternatively, divesting certain business operations, whilst retaining equity and intellectual property rights, allowed the creation of smaller, more focused, teams dedicated to particular product goals, and removed costs from the balance sheet. This diversification of the traditional, small-molecules industry at the large scale helped sustain the life sciences sector in a period of economic turmoil and throughout the decade. The advance of technology In the same period, a marriage between the understanding of molecular biology and in silico technologies has enabled medical innovation at an 1

Introduction

Introduction

unprecedented rate. This has also driven the development of new business sectors. Certainly, so far as patents filing activity and patent disputes in the Patents Court are litmus tests of where business interests in life sciences lie, small molecules, biotechnology and medical devices sectors are now equals. Add to this the coronavirus pandemic, which has led to hundreds of patent filings in 2020 for remote medical technologies, as the medtech industry adapts to provide solutions for socially distanced treatment of patients1. Artificial intelligence (AI), in particular, has been the focus of attention for a number of years. The impact of this already appears clear. Take, for example, the announcement in April 2019 that AstraZeneca and BenevolentAI were forming a long-term collaboration to use AI (here a combination of sophisticated algorithms and machine learning) for the discovery and development of treatments for chronic kidney disease and idiopathic pulmonary fibrosis. And then, in September 2019, BenevolentAI teamed up again, this time with Novartis’s precision medicine team, to investigate further their existing oncology pipeline. All these diseases are complex and the underlying disease biology is not clearly understood. Research requires the interrogation of vast datasets. Both collaborations are therefore intended to combine known biomedical, genomic, clinical and molecular data, which has been extracted and contextualised using BenevolentAI’s proprietary ‘knowledge graph’, with a target identification platform. This uses relation inference models to help predict potential non-obvious disease targets. Potential drug-like molecules are then generated with optimised treatment properties, for synthesis. In other words, computational techniques are being used to identify biological features, or ‘biomarkers’, that suggest certain drugs can be used for particular indications and/or subsets of patients within a particular disease group, and to work out what those drugs are. The use of AI in combination with large datasets therefore promises to drive new and more targeted treatments. It is a trend that is not going to be reversed. Indeed, BenevolentAI claim that 90% of the world’s data was produced in the last two years alone. Right on trend, NHS England also has plans to use the wealth of data that it has accumulated over 70 years, once depersonalised, to identify groups of people who are vulnerable to health risks and to predict which individuals are likely to benefit from healthcare interventions. The NHS also expects this data to be beneficial to companies within the life sciences sphere, as it makes it available to industry with the aim of driving research and innovation. Then there is what is claimed to be the world’s largest genome sequencing project. Announced on 12  September 2019, a consortium of UK  Research and Innovation (a UK government agency), The Wellcome Trust, and four pharmaceutical companies (Amgen, AstraZeneca, GSK 1

2

‘Coronavirus sparks surge in medtech patents’, Michael Cogley, Telegraph, 26 July 2020.

A decade of change

Introduction

and Johnson & Johnson) has funded the genome-sequencing of 500,000 individuals at UK Biobank in Manchester. There is clearly a lot of work and risk that lies between identification of a drug target and bringing a new treatment to market. But the ambition is that data will boost the possibility of finding the root causes of disease in specific, and smaller, groups rather than addressing merely the symptoms of whole populations. It is also expected that the in silico methods offered by BenevolentAI and others will increasingly replace the costly and timeconsuming traditional ‘wet-lab’ techniques for drug discovery. What are the implications for intellectual property? The power of new technology will accelerate issues that are already stretching the patent case law. As techniques such as that of BenevolentAI make it easier to find new uses for old drugs, for example, presently unresolved questions will arise more often about where the novelty in patent claims to such uses can be found. It is also unclear how they can be enforced, an issue that the courts have not yet satisfactorily been able to resolve, even for second medical use claims. The supplementary protection certificate (SPC) regime further illustrates the challenges that existing rights face. The present SPC system works for a product consisting of a novel and single active ingredient that is covered by a patent and a first marketing authorisation. That model worked for the medicines sector when the original SPC legislation was introduced in 19932, but it was not designed to adapt. Nowhere is this clearer than the debacle over the protection of second medical uses of active ingredients. In the 2012 case, Neurim, the CJEU allowed SPC protection for this form of innovation for the first time, on the teleological grounds that the EU  Regulation governing SPCs was designed to protect investment in pharmaceutical research. It appeared a puzzling decision at the time, because it was not supported by the wording of the Regulation or the previous case law. Manufacturers nonetheless made investment decisions on the basis of it, and generic companies modified their launch plans, only for the CJEU to make a U-turn on the issue eight years later, effectively invalidating this whole class of SPCs in the process. Personalised drug treatments also provide an example of how sui generis rights might be added to the statute book to deal with some challenges. In this case, personalised drug treatments can, in the right circumstances, receive structural support and encouragement from regulators in orphan

2

Council Regulation (EEC) No 1768/92 which came into force on 2 January 1993, now replaced by Regulation (EC) No 469/2009 of 6 May 2009 (the ‘SPC Regulation’).

3

Introduction

Introduction

drug legislation. Such orphans also receive market exclusivity protection for 10 years under EU law. Other intellectual property rights also have a role to play. This is evident from the way in which trade marks have been the focus of parallel importation disputes over the years. The branding and design of the drugs themselves, their packaging, and/or their delivery methods are also important in their own right as means to distinguish the products of innovators from their rivals, build brand loyalty and even provide market exclusivity. Digital technology is at play here too, in particular the popularity of appbased methods of tracking individual patient data using devices worn on the body. Computer-implemented inventions lie on the very edge of what may be patented here, and in many cases developers will have to rely on trade secrets and copyright to protect the algorithms and code that underlie these. The continuing role of patents Despite being stretched to their limits in some respects, patents will nonetheless remain central to intellectual property protection in the life sciences. The life sciences are, of course, intrinsically technical and it is products and processes of this nature that patents are designed to protect. A commercially successful, patented technology can corner the market – excluding competition for the same technology. And, although patents cannot guarantee that an innovation will be commercially successful, they do ensure, if properly managed, that the rewards of a successful invention flow to the patent owner. As the filing of remote treatment patents hints, industries in the biosciences sector are amongst those with the highest levels of patenting. As has been pointed out many times3, the market value placed on medicines is a reflection of not simply the cost of raw materials and manufacture, but also the scientific challenges and material costs of their development. These include the pre-clinical developments and clinical trial costs of successful drugs and also those for drug candidates that never make it to market. The price of medicines reflects these costs. By contrast, when the exclusivity afforded by patent protection is lost, competitors whose costs are limited largely to raw materials and manufacture can offer the same drug at a small percentage of the price. Patents are therefore important to secure the willingness of investors to put large sums of money towards innovations for the future4: ‘… some commentators question the value of intellectual property rights (IPRs) such as pharmaceutical patents because they increase the prices of recent

3

See, for example, Mari Lundeby-Grepstad and David Tordrup (LSE), and Tinas Craig and David Taylor (UCL School of Pharmacy), ‘Patients’ needs, medicines innovation and the global public’s interests’, January 2014, UCL School of Pharmacy. 4 Ibid.

4

Common intellectual property issues in life sciences

Introduction

therapeutic developments. But without intellectual property rights private investment in high risk biomedical research would be very unlikely to take place. This would almost certainly have negative ‘knock on’ effects on public funding for fundamental research.’

In Chiron v Organon No 105 Aldous J expands upon the same point: ‘A patent system, for what the Statute of Monopolies called new manufacturers, has been adopted by nearly every country in the world, because it is generally accepted that the opportunity of acquiring monopoly rights in an invention stimulates technical progress in at least four ways. First it encourages research and invention; secondly, it induces an inventor to disclose his discoveries instead of keeping them a secret; thirdly, it offers a reward for the expense of developing inventions to the state at which they are commercially practical and, fourthly, it provides an inducement to invest capital in new lines of production which might not appear profitable if many competing producers embarked on them simultaneously. Those are particularly relevant to the development of medicinal products. It is inherent in any patent system that a patentee will acquire a monopoly giving to him a right to restrict competition and also enabling him to put up or at least maintain prices. That affects the public and is contrary to the public interest, but it is the recognised price that has been accepted to be necessary to secure the advantages to which I have referred. Ever since the Statute of Monopolies certain safeguards have been recognised to be necessary to protect the interests of the public against abuse by a patentee of his monopoly rights. Such safeguards, as are considered necessary to safeguard the public, are now contained in the Patents Act 1977.’

There is a fifth point that might be added to Aldous J’s four. Innovation is not necessarily a matter of coming up with new technology out of thin air, but also recombining technologies that already exist. Patents enable this because they provide the commercial security of having a registered property right in technology that allows relatively easy collaboration with others. This is why it has been possible for the COVID-19 crisis to drive a list of research and development companies, large and small, into collaboration on drug discovery and the repurposing of existing drugs. The role of patent rights in life sciences research remains a fact of life and will continue to do so. COMMON INTELLECTUAL PROPERTY ISSUES IN LIFE SCIENCES In this book we examine in detail how intellectual property rights apply in the life sciences. A broad outline of the chapters is as follows:

5

[1995] FSR 325. See also Kirin-Amgen v TKT (No 3) [2005] FSR 41.

5

Introduction

Introduction Obtaining patents Companies should always have a feel for the relative strengths of their patents, particularly those that are most strategically important. Most patents, when they have passed through prosecution in the EPO (see Chapter 9), will remain without challenge until they expire. Others, if they no longer have any commercial use, may be allowed to lapse. The validity of some patents, however – those that play a particularly important role between the patentee and one or more competitors – may be challenged in the English courts. It is in these circumstances that validity really comes under scrutiny. The starting point when assessing patent validity is usually to examine whether the patent is new over the state of the art. This concept, although apparently simple on its face, can give rise to difficult technical issues of law as well as having practical impacts. The most obvious example of a practical implication is the importance that novelty places on maintaining confidentiality of the subject matter to be patented before it is filed. This is an issue that may need managing all the way from the laboratory and the academic conference circuit up to and including, in some cases, clinical trials. As regards legal technicality, and as noted above, there is a trend in pharmaceuticals and biotechnology to seek novelty in the application of known drugs – from new indications, to new dosage regimes, to use in sub-populations of existing patient groups – which is challenging our legal understanding of where novelty of an invention can reside (see Chapter 1). Of all the patentability requirements for a life sciences invention, the most commonly encountered in practice, when the validity of patents is disputed, is inventive step. Inventive step demands that the subject matter of the patent adds more to the state of the art than just a new technical contribution; that contribution must not be something that is obvious to a person skilled in the art. The issue arises frequently in the context of generic companies who seek to ‘clear the way’ of secondary patents protecting a brand product, which block access to the market after protection for the original active ingredient in that product has expired. Such patents may protect new dosage regimes, formulations, combinations, modifications and selections, amongst other subject matter. As a consequence, much of the case law on inventive step deals with challenges to patents of this kind. This dynamic is seen not only for traditional, small-molecule pharmaceuticals, but for biosimilar products too. Issues also arise between patent owners when seeking competitive advantage in areas of technology where they have overlapping commercial interests. The biotechnology and medical devices sector is prominent in this regard, because the complexity of the products in question (and often the processes for making them) lends itself to large portfolios of patents covering different aspects of the technology in question, some of which may overlap (see Chapter 2).

6

Common intellectual property issues in life sciences

Introduction

For diverse reasons, certain forms of subject matter are not patentable. Most fundamentally, a patent must disclose matter that is capable of industrial application. In particular, there is a risk in the biotechnology field – given the relative ease in finding information on genes and proteins that has been enabled by in silico techniques – of filing a patent before the technical application of that information has been adequately established. As mentioned above, a further key issue is being driven by advances in digital communications technology. This is the application in the medical devices sector of algorithms to monitor, diagnose and enable treatment using devices in or attached to the body, working with remote medical professionals or personal handheld devices. This development is placing issues about the patentability of computer-implemented inventions, mathematical methods, mental acts and the presentation of information front and centre in this field. Special considerations and exclusions also apply to certain forms of life sciences subject matter that is technical but nonetheless may not be patented for reasons of public policy. This includes plant and animal varieties, certain stem cell technology, diagnostic methods, treatments by surgery and therapeutic methods (see Chapter 3). Sufficiency is an area of patent law where many issues tend to lead back to the public policy on why patents are justified. That policy is often referred to as the ‘patent bargain’ and it requires the patent applicant, in exchange for the period of exclusivity provided by their patent, to disclose sufficient information to the public that their invention can be made to work for the wider benefit of society. Many of the broader principles on governing sufficiency have developed in case law concerning pharmaceuticals but, largely due to their technical complexity, biotechnological inventions have featured in authorities at the highest level for over two decades already. Most recently, the Regeneron v Kymab transgenic mouse case has illustrated how the patent bargain has to often be re-assessed and re-stated for new forms of technology. The competitive nature of the innovator pharmaceuticals and therapeutic biologicals industry in many areas of disease also means that drug companies want to file patent applications as early as possible, in order to avoid being beaten to obtaining exclusivity protection by their rivals. This raises a tension between the commercial pressure to file patent applications as soon as possible and the public policy of providing enough information that the invention works to justify the exclusivity that the patent brings – the applicant’s dilemma: how much information must be made available in the patent so that the patent application can be filed as soon as possible, without the risk of failing to disclose enough information to satisfy the patent bargain? This dilemma has given rise in a very short period of time to the issue of plausibility which, although it is most easily associated with sufficiency in UK patent law, has become pervasive as a common threshold of patentability underlying a number of other requirements (see Chapter 4). 7

Introduction

Introduction Enforcing patents Whether applying for a patent or seeking to enforce one, it is key to know what the patent claims protect (see Chapter 5). In particular, when investing in products, it is vital to know that the patent covers the product so that third parties can be prevented from manufacture and marketing. This is also important when assessing ‘freedom to operate’ in respect of present and future business activities. If patents are too broad, furthermore, then the difficulty may arise that the claims cover prior art technology and risk invalidation, or that they are not sufficiently supported by the disclosure of the patent. Conversely, if the claims are too narrow, then competitors may develop their own products or processes which compete commercially but do not infringe and cannot, therefore, be injuncted. The way in which the scope of protection of a patent claim is determined has changed radically in the UK in the last few years to include products and processes that are not covered by the language of the claim, but are equivalent to embodiments that are – the ‘doctrine of equivalents’. This new doctrine was introduced by the Supreme Court in a case concerning different salts of a small-molecule drug, pemetrexed. It nonetheless has implications for patents covering all technologies, including biotechnology and medical devices, and is now the staple approach for owners of such patents when assessing whether their patent claims are infringed by a third party or whether they risk infringing another’s patents. To demonstrate infringement, once it has been shown that a third party product or process falls within the scope of protection of a patent, it is necessary to determine whether there has been an infringing act in respect of that product or process (see Chapter  6). There are two classes of infringing act: directly infringing acts and indirectly infringing acts. The most common form of direct patent infringement encountered in the life sciences in practice is the import or manufacture of a product. There is no single factual scenario, however, and infringing acts may range from the launch ‘at risk’ of a drug in the expectation of a large short-term return at first-mover price, followed by revocation of the underlying patent later, to strategic disputes between competitor medical device manufacturers. As regards indirect infringement, due to the contributory nature of the act giving rise to liability under this head, it tends to arise in the medical devices field, where patented products are assembled from multiple components. Indeed, the leading case in this area concerns wound dressing treatment apparatus. By far the biggest issue raised in recent times is the question of how to determine infringement of second medical use patents. The recent Supreme Court decision concerning pregabalin only deals with a part of this question and, with a trend for companies to leverage existing compounds in other ways such as using claims limited to sub-populations, the difficulty of

8

Common intellectual property issues in life sciences

Introduction

policing how known compounds are used for new purposes is becoming more complex. There are a number of defences potentially available against liability for patent infringement, depending on the circumstances of the case (see Chapter  7). These derive from statute and case law. Most of these are common to all forms of subject matter, although there are two forms of experimental use defence, one of which lends itself broadly to life sciences subject matter and another that applies specifically to medicines (as defined). In the former case, the exemption is to experiments conducted for the purpose of discovering something new about the subject matter of the invention. The leading cases under this exemption concern agricultural products and medical devices. The latter exemption is relatively new to statute, and is designed to protect from infringement work done in or for the purposes of a ‘medicinal product assessment’. This exemption covers and expands on the protection offered by the narrower ‘Bolar exemption’, which applies only to studies necessary to obtain a generic abridged marketing authorisation. An important defence has developed in case law in recent years in the context of the market entry of biosimilar products, but has also been raised in small-molecule generic pharmaceutical cases. This is the ‘Arrow declaration’, which effectively provides a shield for a specific third party product against any number of divisional applications and other patents that are, or may be, granted in the future. The traditional forms of relief available in the UK, including damages, injunction and delivery up, arise in patent cases concerning all forms of subject matter (see Chapter 8). It is in the life sciences, however, that the courts of England and Wales have shown particular flexibility in tailoring the relief awarded at the end of a patent dispute to fit the particular practical and commercial context of the case at hand. In these cases, a final injunction has either never been sought or the court has stayed it in order to avoid serious reputational harm and disruption to patient treatments. Certain exemptions and qualifications to the injunctions have also been applied. Special considerations often apply to preliminary injunctions – normally a rarity in patent disputes – in generic launch cases. These recognise that the downward ‘price spiral’ caused by generic competition may cause irrecoverable damage for which only a preliminary injunction to hold the status quo until a decision on the merits of the case is the appropriate remedy. Exploiting patent rights There is more to holding patent rights than the exclusive right that they afford the holder to exploit an invention themselves (see Chapters 10 and 11). Indeed, it has been observed that the true work of innovation is not necessarily coming up with an innovation, but recombining technologies and expertise that already exist. It is now commonplace, for instance, to 9

Introduction

Introduction have close partnerships between academic and small, private laboratories and industry product development: the former do not have the infrastructure and know-how to take products to the large-scale, clinical trials and market; and the latter would like to complement their product pipelines without bearing all the high risks and costs of the initial research. These relationships require the careful managing of the technology being used – who is entitled to do what, with what technology, and who owns the technology used or created? This is achieved using collaboration agreements which, at their heart, license patent rights. The COVID-19 crisis and the threat of antibiotic resistance, amongst other global health challenges, have also shifted attention to wider collaborations between innovators. Whilst there are, no doubt, altruistic and reputational drivers at play in these, there will also be issues at stake about the patent protection on products that results – in particular, ownership, licences and rewards. More recently, the courts have also handled successful claims for employee inventor compensation and Crown use, rights that were previously thought to be vanishingly rarely applicable. Disputes relating to patents The purpose of a patent is to provide the owner with the exclusive right to practise the invention protected by the patent claims. Subject to the right of the owner to license others to practise the invention, no other party is permitted to do so. This right is of little value, however, if the owner is not prepared to enforce their rights against infringers in the courts (see Chapter 12). In generics cases, if a third party wishes to access the market with their own product, but this is blocked by patent protection, they are encouraged by the courts to ‘clear the way’ of those patents before launch, rather than launching ‘at risk’. This means that the third party must bring a claim for revocation of those patents in the courts, under one or more grounds of invalidity. In other cases, revocation may form the substance of a defence to a claim of patent infringement. These scenarios are played out regularly in the courts, particularly in the fields of generic and biosimilar product launches. Strategic litigation between patent holders, large and small, of biotechnology and medical device products is also common. Indeed, disputes concerning life sciences subject matter are the mainstay of actions in the patents area. As a result, these cases are handled by the Patents Court, a specialist court of the High Court of Justice of England and Wales. This court, as well as the Court of Appeal and the Supreme Court, has a number of judges with specialist patents and other intellectual property expertise, as well as scientific qualifications. Smaller intellectual property actions are heard in the Intellectual Property Enterprise Court (IPEC). Of those actions that reach trial in the Patents Court, many last several days and involve a rigorous adversarial process by which arguments and

10

Common intellectual property issues in life sciences

Introduction

expert evidence are tested in cross-examination. Judgments are closely reasoned and very detailed. As such, decisions on patent matters in the English courts are often regarded in other jurisdictions, although they are not binding on them. Most patents relating to life sciences subject matter that are in force in the UK are EP(UK) European patents that were filed and prosecuted in the EPO. Furthermore, despite the national character that European patents take upon grant, it is still possible for them to be revoked or amended centrally at the EPO in the opposition and appeal procedures, which together can take several years. Additionally, as well as amendment at the national level, there is a power of central amendment outside of opposition, appeal and national proceedings (see Chapter 13). Importantly, opposition and appeal in the EPO can run concurrently with a UK action, creating a dynamic system in which amendment and revocation may have an impact on English proceedings both before and after trial. This situation often arises in the life sciences, particularly in the generics industry, where the long, but relatively inexpensive, approach of opposing newly granted patents is begun pending more focused commercial decisions about challenging particular patents nationally. A number of cases have addressed the details of how this relationship should be managed between the courts and the EPO when such parallel proceedings are on foot. Terminating patent agreements and points of dispute Negotiating a good patent licence is challenging: securing the terms wanted commercially and then drafting the agreement to accurately reflect the deal agreed and to govern it. In the life sciences, where the success of a partnership could make or break a business, making sure the terms of a licence are clear and effective is especially important. The issues that can lead to a dispute have been highlighted by a number of cases in the English courts (see Chapter  14). These typically arise from imprecise and ambiguous drafting, in particular in royalty clauses – royalty sharing provisions, and the timing and period of payments – and the scope of rights licensed. The issue of when it is possible to terminate an agreement for breach is paramount. Other exclusivity rights Supplementary protection certificates (SPCs) (see Chapter 15) are rights designed specifically to extend the exclusivity afforded to particular medicinal products and plant protection products, based on an underlying patent. The purpose of SPCs is to remedy the problem that the term of patent monopoly for many medicinal products is largely eroded as the patentee or their licensee awaits the grant of a marketing authorisation. This could result in a proprietor having little or no patent term left by the time they are 11

Introduction

Introduction able to reach the market with the related product. The SPC system seeks to address this problem by providing for up to five years’ further monopoly protection for specific patented products, as defined. The highly regulated nature of the pharmaceutical sector makes compliance a significant cost, in particular generating the data needed to support the marketing authorisation necessary to bring a product to market. In regulating the pharmaceutical industry, legislators therefore have to balance a number of competing interests. First, they aim to offer rewards for the research and development that produces innovative new treatments, while also allowing generic competition that will bring down the overall cost of medicines. They must also ensure that sufficient preclinical and clinical data are produced by pharmaceutical companies to demonstrate that drugs are safe and effective, whilst avoiding unnecessary testing in humans. Patents and supplementary protection certificates are two forms of exclusivity protection intended to protect the investment in development of a medicine. But how can investment in the collecting of clinical data also be protected and encouraged? The answer is to use various forms of data exclusivity and market exclusivity rights (see Chapter  16). These rights are additional to, and independent of, any granted patent exclusivity right covering a medicinal product. Their effect, however, is often also to provide a de facto monopoly for the medicinal products concerned. Data and market exclusivity compensate the innovator company for the investment that it has put into developing a new medicinal product, and in particular in generating the data required to obtain its marketing authorisation. Trade secrets is a species of the law of confidential information that has particular relevance to the life sciences (see Chapter  17). Broadly speaking, it is a tool for protecting confidential material, usually of a high degree of confidentiality, that will be a vitally important part of a life science company’s intellectual property assets. It is typically relied upon to protect subject matter and information which either cannot be protected by patent rights, because the information does not readily take the form of discrete inventions or because the various patentability requirements are not met, or which the holder does not want disclosed to the public domain. Plant breeders’ rights (or plant variety rights) protect new varieties of plants, including genetically modified varieties. They are relevant to the life sciences industry as a source of materials in the manufacture of pharmaceuticals, and as functional foods. The Nagoya Protocol aims to prevent the commercial development of non-human biological compounds or genetic sequences by a technologically advanced country or organisation without obtaining consent from, or providing fair compensation to, the peoples or nations in whose territory the materials were discovered. It also intends to ensure the participation of the countries of origin and/ or indigenous or local communities in the benefits of the use of genetic resources (see Chapter 18).

12

Brexit

Introduction

As well as rights in unregistered trade marks, designs and copyright, it is possible to register company names, trading names, product/service names, brand names, logos and potentially also colours and shapes (amongst other things) as trade marks. Certain types of design may also be registered. Life sciences companies should consider applying to register key rights at an early stage of planning, well in advance of launch (see Chapter 19). The offences in the Trade Marks Act 1994 (ie counterfeiting) are also of particular relevance to the pharmaceutical sector. A recent report6 estimated that the total value of counterfeit pharmaceuticals traded worldwide is up to €4.03 billion, representing up to 3.3% of world trade. Lifestyle drugs and painkillers ranked as the most counterfeited pharmaceutical products. As well as the economic impacts, there are suggestions of links to IP crime and organised crime as well as possible threats to public health7. Since the trade mark offences are typically most relevant to the life sciences sector, these are the focus of Chapter 20. The principle of exhaustion of rights is also particularly relevant to the pharmaceutical industry, since there is scope for parallel importers8 to exploit price differentials for pharmaceuticals and medical devices across EEA Member States. These price differentials exist due to factors such as government price controls and exchange rate differences (see Chapter 20). Rights in personal data – GDPR The EU’s General Data Protection Regulation (GDPR) came into effect on 25 May 2018. It overhauled EU data protection law, bringing in enhanced rights forvindividuals and new obligations on controllers and processors, as well as significant penalties for non-compliance. There are a number of aspects of the GDPR which are particularly challenging for life sciences businesses. They often rely on processing personal data, and, in particular, special category personal data (previously known as ‘sensitive data’), whether for research, clinical trials, pharmacovigilance, or to programme machine learning in the operation of medical devices (see Chapter 21). BREXIT The UK left the institutions of the EU at 11pm on 31 January 2020. On this date, the European Union (Withdrawal) Act 2018 (2018 Act) repealed the European Communities Act 1972, by which EU law ultimately took effect 6 7 8

‘Trade in Counterfeit Pharmaceutical Products’, EU Intellectual Property Office and the Organisation for Economic Co-operation and Development. See para 20.16. Parallel trade is generally trade in goods outside of the trade mark proprietor’s authorised distribution networks. The goods in question are often referred to as ‘parallel imports’ or ‘grey’ market goods to distinguish them from counterfeit goods.

13

Introduction

Introduction in the UK. At the very same time, however, the similarly titled European Union (Withdrawal Agreement) Act 2020 (2020 Act) implemented in UK law the Withdrawal Agreement agreed between the UK and EU, containing provisions to ‘save’ much EU law (including that relevant to intellectual property in the life sciences) so that it continued to apply in the UK until the end of the transition period, or Implementation Period as it is called in the legislation (which ended at 11pm on 31 December 2020). Saved EU law governing life sciences exclusivity rights – in particular, data and market exclusivity, supplementary protection certificates and orphan drug protection, but also other rights discussed in this book – was then transferred to the UK statute book, with adaptations so that it works in the domestic context (see Coda on Brexit). Paul England and Simon Cohen November 2020 NOTES ON THE TEXT The titles of legislative instruments which have been abbreviated are defined by their full title once at the beginning of each chapter in which they are referred to. The abbreviation is then used. On the basis that their substantive terms will be transferred to UK law at the end of the Implementation Period on 31 December 2020, but all the legislation that is required to achieve this is not made or in force at the time of writing, references are mostly made to EU Regulations and Directives. Where relevant, chapters are headed with ‘A note on Brexit’ which provides an outline of the UK legislation that will either copy or refer to EU law. The Coda to this book – on Brexit – also summarises how EU law will be implemented in UK law at the end of the Implementation Period. To avoid repeated reference to their later elevation, the judges quoted in this book are given the honorifics they would have had at the time of making the cited decision only. For example, ‘Birss J’ is used rather than ‘Birss J (as he then was)’. The authors would like to acknowledge the following for the input of their expertise on this project: Alice Anderson, Verena Bertram, Alison Dennis, Nina Goodyear, Anja Lunze, James Marshall, Colin McCall, Josie Miller, Justyna Ostrowska, Matthew Royle, Michael Washbrook and Edward Vickers.

14

Part I

Patents in the Life Sciences: Validity and Enforcement

15

Chapter 1 Requirements for a Valid Patent 1: Novelty

LIFE SCIENCES CONTEXT 1.1 The strong validity of a patent is fundamental to its commercial and strategic value and it needs to be able to withstand a potential revocation action. The starting point, when establishing that an application or granted patent that claims life sciences subject matter is valid, is whether it is new over the state of the art. This concept, although simple on its face, can give rise to both highly technical issues of law as well as having immediate practical impacts. The most obvious example of the latter is the need that novelty places on maintaining confidentiality of the patented subject matter before the filing, or earliest priority, date. This is an issue that may need managing all the way from the lab and the academic conference circuit up to and including, in some cases, clinical trials. As regards the former, there is now a well-established trend in pharmaceuticals and biotechnology to seek novelty in narrowing forms of application of known drugs – from new indications, to new dosage regimes, to use in sub-populations of existing patient groups. This is challenging our technical understanding of where novelty of an invention can reside.

GENERAL PRINCIPLES 1.2

Section 1 of the Patents Act 1977 begins with the words:

‘A patent may be granted only for an invention in respect of which the following conditions are satisfied, …’

The first of these conditions, listed under this section, is: ‘(a) the invention is new;’

17

1.2

Requirements for a Valid Patent 1: Novelty Further to section 2(1)1 of the Patents Act 1977, the invention is new (or, more often in patent terminology, ‘novel’; a patent that lacks novelty is ‘anticipated’) if it has no prior existence in the state of the art: ‘(1) An invention shall be taken to be new if it does not form part of the state of the art;’

The ‘state of the art’ is itself defined in section 2(2)2: ‘(2) The state of the art in the case of an invention shall be taken to comprise all matter3 (whether a product, a process, information about either, or anything else) which has at any time before the priority date of that invention been made available to the public (whether in the United Kingdom or elsewhere) by written or oral description, by use or in any other way;’

In summary, to satisfy the novelty condition of section 1(a), the invention claimed by a patent must not have been previously disclosed to the public, in any way, anywhere in the world, before the date at which the application for the patent is first filed (its priority date). The state of the art does not include documents of the same date as the filing or priority of the patent application in issue4. Further to section 2(3)5, a patent application that was filed before the priority date of the patent being assessed for novelty will form part of the state of the art even if it is published on or after the priority date of the patent being assessed. The subject matter in the published application must, however, be the same as the application filed: ‘(3) The state of the art in the case of an invention to which an application for a patent or a patent relates shall be taken also to comprise matter contained in an application for another patent which was published on or after the priority date of that invention, if the following conditions are satisfied, that is to say– (a) that matter was contained in the application for that other patent both as filed and as published; and (b) the priority date of that matter is earlier than that of the invention.’6

There are limited exceptions, set out in section 2(4)7, by which a disclosure of an invention within six months before the priority date of a patent is disregarded from the state of the art. These are found in subparagraphs (a) and (b), which apply in circumstances where the invention was obtained unlawfully or in breach of confidence from certain persons, including the inventor: 1 See European Patent Convention (EPC), Article 54(1). 2 See EPC, Article 54(2). See also Patents Act 1977, s 2(5). 3 See Merrell Dow Pharmaceuticals Inc v HN Norton & Co Ltd [1996] RPC 76: ‘matter’ is information, and it is information that must be made available. 4 T 123/82 Use of reactive, organic fillers/BAYER (unpublished) (30 August 1985). 5 See EPC, Article 54(3) in conjunction with EPC, Article 88(4). 6 Section 1(1)–(3) should be read in conformity with EPC, Article 52 (see Patents Act 1977, s 130(7)). 7 See EPC, Article 55(1)(a).

18

General principles

1.2

‘(4) For the purposes of this section the disclosure of matter constituting an invention shall be disregarded in the case of a patent or an application for a patent if occurring later than the beginning of the period of six months immediately preceding the date of filing the application for the patent and either– (a) the disclosure was due to, or made in consequence of, the matter having been obtained unlawfully or in breach of confidence by any person– (i) from the inventor8 or from any other person to whom the matter was made available in confidence by the inventor or who obtained it from the inventor because he or the inventor believed that he was entitled to obtain it; or (ii) from any other person to whom the matter was made available in confidence by any person mentioned in sub-paragraph (i) above or in this sub-paragraph or who obtained it from any person so mentioned because he or the person from whom he obtained it believed that he was entitled to obtain it; (b) the disclosure was made in breach of confidence by any person who obtained the matter in confidence from the inventor or from any other person to whom it was made available, or who obtained it, from the inventor; or (c) the disclosure was due to, or made in consequence of the inventor displaying the invention at an international exhibition and the applicant states, on filing the application, that the invention has been so displayed and also, within the prescribed period, files written evidence in support of the statement complying with any prescribed conditions.’

Subparagraph (c) applies in specific cases resulting from the inventor displaying the invention at an international exhibition, provided this is stated upon application for the patent and written evidence is filed in support of the statement complying with any prescribed conditions9. Aside from these exceptions, the state of the art is taken to consist of all knowledge that is available to the public anywhere10 in the world (it is ‘absolute’). For this purpose, a disclosure of information only needs to be made to a single person who is not under a duty to keep it confidential in order for it to be made available to the public and form part of the state of the art (see para 1.10). When assessing the novelty of a patented invention it is necessary to identify the prior art document that most closely embodies the subject matter of the patented invention being assessed (this may also be a use or, in limited circumstances, a combination of documents; see para 1.17). The comparison between the prior art and the patented invention, for the purpose of section 2(1), must be objective and based on the subject matter that a skilled person or team can derive directly and unambiguously, using their common general knowledge, from the prior art document. 8

Note that, under s 2(5), references to the inventor include references to any proprietor of the invention for the time being. 9 See Patents Rules 2007, SI 2007/3291, r 5. 10 See the wording of EPC, Article 54(2).

19

1.3

Requirements for a Valid Patent 1: Novelty DISCLOSURE AND ENABLEMENT Distinct concepts 1.3 According to case law, the information derived from the prior art must satisfy two distinct requirements if it is to anticipate the invention: enablement; and disclosure. This is stated at the highest level by the House of Lords in Synthon BV v Smithkline Beecham plc11: 1. the prior art must disclose subject matter which, if performed, would necessarily result in an infringement of the patent; and 2. the ordinary skilled person must be able to perform the invention which satisfies the requirement of disclosure. In respect of the second, enablement, requirement, the skilled person is entitled to make trial and error experiments to get the disclosed invention to work. The disclosure requirement is strict: the prior publication must contain clear and unmistakeable directions to do what the patentee claims to have invented. A  signpost, however clear, upon the road to the patentee’s invention will not suffice. The prior inventor must be clearly shown to have planted his flag at the precise destination before the patentee. The Synthon v Smithkline case is discussed further in the following section. KEY CASE: Paroxetine crystals – Synthon v Smithkline Beecham The facts of Synthon v Smithkline 1.4 The case concerns paroxetine, a compound used to treat depression and related disorders. This was, for a number of years, marketed in the form of its hydrochloride hemihydrate salt under the name ‘Paxil’ or ‘Seroxat’. It was discovered, in about 1997 by both Synthon BV and Smithkline Beecham plc, that a different paroxetine salt, paroxetine methanesulfonate (‘PMS’), is more stable, less hygroscopic and a more soluble alternative to the hydrochloride hemihydrate salt. Synthon filed a patent application for PMS but, before it was published, Smithkline made its own filing by which it obtained priority for a UK patent application, which was later granted. During the course of prosecuting the patent application, PMS was identified in the prior art as one of many suitable paroxetine salts and, as a result, Smithkline limited its claim to a particular form of crystalline PMS, defined in claim 1, and dependent claims by reference to its IR and XRD peaks. No other form of crystal was claimed, even though it was possible that PMS could be polymorphic. The IR peaks disclosed in the Smithkline patent were different to those disclosed 11 [2005] UKHL 59 (20 October 2005). See also University of Southampton’s Applications [2005]  RPC  220, 236 and Beloit Technologies Inc v Valmet Paper Machinery Inc [1995] RPC 705.

20

Disclosure and enablement

1.5

in the Synthon PMS application such that a skilled person would think that the Synthon and Smithkline documents identified different polymorphs. Synthon brought revocation proceedings, claiming that the crystalline form of PMS described in claim 1 of Smithkline’s patent was not novel. They relied for this on section 2(3) of the Patents Act 1977, claiming that the invention in claim 1 had been disclosed by their own patent application. In his leading judgment in the House of Lords in this case, Lord Hoffmann separates out the concepts of disclosure and enablement. Disclosure 1.5 The concept of disclosure, Lord Hoffmann says, is explained in two judgments of unquestionable authority. The first is Lord Westbury LC in Hill v Evans12: ‘I apprehend the principle is correctly thus expressed: the antecedent statement must be such that a person of ordinary knowledge of the subject would at once perceive, understand and be able practically to apply the discovery without the necessity of making further experiments and gaining further information before the invention can be made useful. If something remains to be ascertained which is necessary for the useful application of the discovery, that affords sufficient room for another valid patent.’

The second authoritative statement comes from the Court of Appeal (Sachs, Buckley and Orr LJJ) in General Tire and Rubber Co v Firestone Tyre and Rubber Co Ltd13: ‘To determine whether a patentee’s claim has been anticipated by an earlier publication it is necessary to compare the earlier publication with the patentee’s claim … If the earlier publication … discloses the same device as the device which the patentee by his claim … asserts that he has invented, the patentee’s claim has been anticipated, but not otherwise. … When the prior inventor’s publication and the patentee’s claim have respectively been construed by the court in the light of all properly admissible evidence as to technical matters, the meaning of words and expressions used in the art and so forth, the question whether the patentee’s claim is new … falls to be decided as a question of fact. If the prior inventor’s publication contains a clear description of, or clear instructions to do or make, something that would infringe the patentee’s claim if carried out after the grant of the patentee’s patent, the patentee’s claim will have been shown to lack the necessary novelty … The prior inventor, however, and the patentee may have approached the same device from different starting points and may for this reason, or it may be for other reasons, have so described their devices that it cannot be immediately discerned from a reading of the language which they have respectively used that they have discovered in truth the same device; but if carrying out the directions contained in

12 (1862) 31 LJ(NS) 457, 463. 13 [1972] RPC 457, 485–486.

21

1.6

Requirements for a Valid Patent 1: Novelty the prior inventor’s publication will inevitably result in something being made or done which, if the patentee’s claim were valid, would constitute an infringement of the patentee’s claim, this circumstance demonstrates that the patentee’s claim has in fact been anticipated. If, on the other hand, the prior publication contains a direction which is capable of being carried out in a manner which would infringe the patentee’s claim, but would be at least as likely to be carried out in a way which would not do so, the patentee’s claim will not have been anticipated, although it may fail on the ground of obviousness. To anticipate the patentee’s claim the prior publication must contain clear and unmistakeable directions to do what the patentee claims to have invented … A signpost, however clear, upon the road to the patentee’s invention will not suffice. The prior inventor must be clearly shown to have planted his flag at the precise destination before the patentee.’

Summarising the principles set out in these passages, Lord Hoffmann says that the matter relied upon as prior art must disclose subject matter which, if performed, would necessarily result in an infringement of the patent. This may be because the prior art discloses the same invention, in which case there will be no question that performance of the earlier invention would infringe, and usually it will be apparent to someone who is aware of both the prior art and the patent that it will do so. Whether or not it would be apparent to anyone at the time, however, when subject-matter described in the prior disclosure is capable of being performed and is such that, if performed, it must result in the patent being infringed, the disclosure condition is satisfied: ‘The flag has been planted, even though the author or maker of the prior art was not aware that he was doing so’. The House of Lords uses the case of Merrell Dow Pharmaceuticals Inc v H  N  Norton & Co Ltd14 to illustrate this principle. In Merrell Dow, the prior art disclosed the ingestion of terfenadine by hay-fever sufferers. This necessarily entailed the making of the patented acid metabolite in their livers and was therefore an anticipation of that patent. It did not matter that no one was aware that it was being made or even that it existed. It must also be not merely a possible or even likely consequence of performing the invention disclosed by the prior disclosure – it must be necessarily entailed. Otherwise, the flag has not been planted on the patented invention. It is this requirement, that performance of an invention disclosed in the prior art must necessarily infringe the patent, which distinguishes novelty from obviousness (see, however, the discussion of purpose limited claims in Chapter 3). Enablement 1.6 Enablement requires that the skilled person can perform the invention that has satisfied the requirement of disclosure15. For the degree of 14 [1996] RPC 76. 15 Asahi Kasei Kogyo KK’s Application [1991] RPC 485.

22

Disclosure and enablement

1.8

knowledge, skill and perseverance that the skilled person is assumed to have in this respect, Lord Hoffmann refers to the example of Valensi v British Radio Corporation16 in which Buckley LJ said: ‘The hypothetical addressee is not a person of exceptional skill and knowledge, that he is not to be expected to exercise any invention nor any prolonged research, inquiry or experiment. He must, however, be prepared to display a reasonable degree of skill and common knowledge of the art in making trials and to correct obvious errors in the specification if a means of correcting them can readily be found.’17

The judge also referred to sufficiency under section 72(1)(c) of the Patents Act 1977: ‘the specification of the patent does not disclose the invention clearly enough and completely enough for it to be performed by a person skilled in the art’ (see Chapter  4). In Lord Hoffmann’s opinion, the authorities on insufficiency in section 72(1)(c) are equally applicable to enablement for the purposes of novelty in section 2(2) and (3)18. The role of the skilled person for disclosure and enablement 1.7 The role of the person skilled in the art is different in relation to disclosure and enablement. For the purpose of disclosure, when the matter relied upon as prior art consists of a written description, the skilled person is taken to be trying to understand what the author of the description meant. Their common general knowledge forms the background to this exercise in construction (see Chapter 5). When the meaning of the prior disclosure and the patent have been determined, the skilled person must address whether the invention which the prior art discloses works – ‘the disclosure is either of an invention which, if performed, would infringe the patent, or it is not’19. The Synthon decision on the facts 1.8 On the facts of Synthon, the House of Lords held that there was no doubt that the Synthon application disclosed the existence of PMS crystals of 98% purity and that they could be made. Their existence and their advantages for pharmaceutical use were clearly disclosed in the application. On the basis of the first instance judge’s finding of monomorphism, a PMS

16 [1973] RPC 337, 377. 17 See also Mentor Corporation v Hollister Incorporated [1993] RPC 7. 18 Lord Hoffmann noted that there may be differences in the application of this test in sufficiency and anticipation cases – for example, because, in the sufficiency context, the skilled person has the goal of attempting to perform a claimed invention; in the anticipation context, the prior art may have disclosed the subject matter of the invention but not identified it as such. 19 Synthon [2005] UKHL 59 (20 October 2005).

23

1.9

Requirements for a Valid Patent 1: Novelty crystal of 98% purity must necessarily have all the characteristics of the crystals claimed in the Smithkline patent, including the IR and XRD spectra. It did not matter that the Synthon application attributed to PMS crystals an IR spectrum that was wrong. Because the crystals in question were monomorphic, the IR spectrum was a superfluous part of the description. It may be that the skilled person, having successfully made what the application describes, namely PMS crystals of 98% purity, would be puzzled, perhaps even disconcerted, to find that their IR spectrum turned out to be different from what they had been led to believe. But they would have made the crystals and they would necessarily infringe the Smithkline patent. Once it had been decided that the disclosure in the application was crystalline PMS and that the IR spectrum was superfluous and irrelevant, the question of enablement was whether the skilled person would have been able to make crystalline PMS. If they could, they would necessarily have made the product claimed in the patent. In this case, there was no dispute that the disclosure enabled the skilled person to make PMS. The issue was whether they would have been able to get it to crystallise. The first instance judge had found on the evidence that the skilled person would have tried some other solvent from the range mentioned in the application or forming part of their common general knowledge and would have been able to make PMS crystals within a reasonable time and the House of Lords was reluctant to interfere with that finding. PLAUSIBILITY OF THE PRIOR ART 1.9 Joined cases Merck Sharp & Dohme and Bristol Myers Squibb20 concerned a patent relating to the use of anti-PD-1 antibodies for the treatment of cancer. In their attack on novelty, Merck argued that the patent lacked novelty over prior art disclosing the idea of an anti-PD-1 agent to treat diseases including cancer. Ono responded that plausibility was an aspect of the law of novelty and that the prior art in this case lacked plausibility. Birss J agreed that plausibility is an aspect of enablement: ‘there is no distinct requirement for plausibility in the law of novelty, over and above disclosure and enablement, but in a proper case plausibility is an aspect of enablement. In order to amount to an enabling disclosure of a medical use claim and thereby deprive the claim of novelty, the prior art has to make the therapeutic effect plausible.’

20 Merck Sharp & Dohme Limited v Ono Pharmaceutical Co Limited & anor; Bristol Myers Squibb Company & Ors v Merck & Co Inc & Anor [2015] EWHC 2973 (Pat) (22 October 2015).

24

Prior art: made available to the public

1.10

in this case, the judge held that the prior art was not plausible. In particular, it would have been understood at the priority date that such agents have both an inhibitory effect and a co-stimulatory effect on the PD-1 receptor. Therefore, while the content might be sufficiently broad to render plausible the idea of using an agent which acts on the PD-1 pathway in medicine generally, it was not specific enough for cancer, to render plausible the use of that agent in the treatment of cancer. PRIOR ART: MADE AVAILABLE TO THE PUBLIC General principles 1.10 In the UK, information must be made available to the public if it is to form part of the state of the art. It does not matter where, how or in what language the information was made available to the public. The correct test is set out by Aldous LJ in PLG Research Ltd v Ardon International Ltd21: ‘Thus to form part of the state of the art, the information given by the use must have been made available to at least one member of the public who was free in law and equity to use it.’

The words ‘free in law and equity’ are normally understood to mean that it is possible to gain access to the information without any obligation of confidence (see para 1.14). The exception is prior filed patent applications, under section 2(3) of the Patents Act 1977, which are not published. A disclosure made under conditions of confidentiality will not form part of the state of the art. Confidentiality may be by contractual obligation, such as in a non-disclosure agreement or a licence22, or further to special forms of relationship, such as those of an employer and employee23 (see Chapter 17). Made available to the public in the European Patent Office Much of the case law in this area comes from the Technical Boards of Appeal (TBA) of the European Patent Office (EPO). For example, the matter does not have to be supplied to a person skilled in the art in order that it is made available to the public24, nor does it matter if no-one has actually accessed the information25. Furthermore, 21 [1993] CLY 3041. 22 For example, T  576/91 Plasmid pTR2030/NORTH CAROLINA STATE UNIVERSITY (unpublished) (18 May 1993). 23 Special relationship between donor and recipient, T  1081/01 Acetals/NEW JAPAN CHEMICAL (unpublished) (27 September 2004); employees of the company T 1085/92 Electric machine/BOSCH (unpublished) (10  November 1994); commercial interrelationship T 913/01 Drying process/UNILEVER (unpublished) (11 October 2004). 24 For example, see T 809/95 Foldable plastic bottle/ Düring (unpublished) (29 April 1997). 25 See T 84/83 Angle mirror/Luchtenberg (unpublished) (29 September 1983)

25

1.11

Requirements for a Valid Patent 1: Novelty information made available to only a limited circle of individuals26 or a small segment of society27 is made available to the public. Disclosure may be in any form, written or oral (for example, by way of oral lecture28), although evidence may be needed to demonstrate that a published account of a presentation at a public conference some years earlier is the same as that given orally29,30. The date at which a document was made available to the public may be evidenced by a date stamping31, but this depends on the practice of the particular body concerned32 (see para 1.15).

PRIOR USE Necessary information 1.11 Further to section 2(2), anticipation may be by a single prior use of the invention in public. Prior use of an invention can take the form of making, offering, marketing or otherwise exploiting a product or process before the priority date of the relevant patent. To be part of the state of the art: ‘the invention must have been made available to the public. An invention is a piece of information. Making matter available to the public within the meaning of section 2(2) therefore requires the communication of information. The use of a product makes the invention part of the state of the art only so far as that use makes available the necessary information.’33

For example, Liqwd Inc v L’Oreal (UK) Ltd34 concerned a patent to a method for bleaching hair comprising use of the active component maleic acid, which is commercially sold in the form of a product called Olaplex No.1 Bond Multiplier. This had been distributed to colourists in the United States before the priority date of the patent. It was common ground that, if a skilled person who had such a sample of Olaplex No.1 Bond Multiplier and analysed it, they would find that it contained the active component in 26 See, for example, T 877/90 T-cell growth factor/HOOPER (unpublished) (28 July 1992). 27 See T 165/96 Délavage/CAYLA (unpublished) (30 May 2000). 28 T 877/90 T-cell growth factor/HOOPER (unpublished) (28 July 1992). 29 T 348/94 Superconductive thin film/SUMITOMO (unpublished) (21 October 1998). 30 (unpublished) (19 September 2017). 31 T 834/09 Public availability/HYDRO-QUEBEC (unpublished) (2 February 2012). 32 In  T  1137/97 Marek’s Disease Virus Vaccine/AMERICAN HOME PRODUCTS CORPORATION (unpublished) (14 October 2002). 33 Merrell Dow Pharmaceuticals Inc v HN Norton & Co Ltd [1995] UKHL 14 (26 October 1995). See also E Mishan & Sons, Inc (t/a Emson) v Hozelock Ltd & Ors [2019] EWHC 991 (Pat) (17 April 2019), in the context of obviousness (the point was not addressed in the appeal of the case). 34 [2018] EWHC 1394 (Pat) (11 June 2018).

26

Prior use

1.13

appreciable amounts. The information acquired would, if the person was free to obtain and use it, make the invention available to that person. Reproducibility 1.12 Anticipation by prior use requires that the necessary information makes it possible for the person skilled in the art, without undue burden, to analyse the prior used composition sufficiently in order to be able to reproduce it for themselves. In Takeda v Roche35, which concerned an action to revoke Roche’s patent titled ‘glycosylated antibodies’, the question was raised whether, as Roche argued, every feature of the embodiment disclosed in the prior art must be reproducible – or are only those features that are claimed by the patent under attack? The answer in this case was the latter, unless the unreproducible unclaimed features of the prior art make it impossible to reproduce at all. Terms of supply preventing availability to the public 1.13 Whether or not giving someone a sample of product makes its contents available to the public depends on the terms on which the sample is provided (see also paras 1.2 and 1.10). In  Pall Corp v Commercial Hydraulics36, six samples of a microporous nylon membrane were supplied to Motorola, a potential customer, for use in public tests in the presence of trade rivals. It was held that the samples supplied to Motorola were experimental and secret, and that the testing did not reveal any information about the nature of the product to the public. Accordingly, although the tests were in public, they did not make available to the public the information necessary to reveal the invention. Liqwd Inc v L’Oreal37 also turned on the terms under which the Olaplex No.1 Bond Multiplier product had been supplied to the US before the priority date of the patent. Olaplex argued that the chemical composition of the product could only be identified by a process of chemical analysis, requiring that the recipients were free as a matter of law and equity both to send the composition away for analysis and then make use of the information obtained, including its public disclosure. However, on the evidence, it was found that colourists who had taken samples for use before the priority date and tested them in the presence of members of the public were subject to material restrictions on their use, preventing any such information being made available to the public.

35 [2019] EWHC 1991 (Pat). 36 [1990] FSR 329 (25 July 1989). 37 [2018] EWHC 1394 (Pat) (11 June 2018).

27

1.14

Requirements for a Valid Patent 1: Novelty KEY ISSUE: CONFIDENTIALITY AND CLINICAL TRIALS 1.14 In order to deprive a claim of novelty, prior disclosure in a clinical trial must contain material from which one could directly and unambiguously deduce the claimed therapeutic effect38. In Hospira UK Limited v Genetech Inc39, Hospira argued that a piece of prior art called Baselga 97, which describes a Phase III trial of trastuzumab in combinations with paclitaxel and other agents, but does not disclose any results from that trial, disclosed the invention of claim 1 of Genentech’s patent which was a Swiss-form claim to the use of trastuzumab in combination with a taxane for the treatment of HER2-positive breast cancer. Whilst it was accepted that Baselga 97 did not disclose the results of the Phase III trial and the clinical benefit claimed in the patent, it was contended that it contained other information from which the clinical benefit could be directly and unambiguously derived. In this regard, Hospira relied upon the whole disclosure of Baselga 97, but in particular upon three passages: • •

•

The reported finding that ‘65.2% of [metastatic breast cancer] patients with HER2-positive tumors responded’ to taxanes. The description of the Phase II trial of trastuzumab as a single agent, particularly the statement that toxicity was minimal and the conclusion that trastuzumab ‘is clinically active in patients who have metastatic breast cancers that overexpress HER2 and have received extensive prior therapy’. The statement that ‘treatment with paclitaxel plus [MoAb] 4D5 resulted in major antitumor activity, with 93% growth inhibition’ in xenograft tests, compared with 35% inhibition when either of the agents (paclitaxel or MoAb 4D5) were used alone.

Arnold J  did not consider these passages to enable the clinical benefit claimed in the patent to be directly and unambiguously derived. In particular, they did not disclose that the combination of trastuzumab and paclitaxel had increased efficacy in human beings compared to paclitaxel; and, whilst the xenograft results might give the skilled person some expectation that the Phase III trials would be successful, they did not show that those trials would be successful. Hospira’s alternative argument was that Baselga 97 fully and accurately disclosed the design of the Phase III trial. All that was missing was the results, which were shown in the patent. Therefore, the inevitable result of following the directions in Baselga 97 was the carrying out of the process claimed. The judge did not accept this either, because of the mental element in the claim (see para 1.25): one cannot intend to administer the combination 38 Regeneron Pharmaceuticals Inc v Genentech Inc [2012] EWHC 657 (Pat). 39 [2015] EWHC 1796 (Pat).

28

KEY ISSUE: Confidentiality and clinical trials

1.14

of trastuzumab and a taxane to achieve increased efficacy in the treatment of breast cancer compared to the taxane alone, unless one knows that that clinical benefit will be obtained. In Aga Medical Corporation v Occlutech (UK) Limited40, Aga’s patent relating to an occluding device was held to be anticipated because the patentee had provided the patented device to a hospital for the purpose of conducting clinical trials, without any express confidentiality restrictions and without the doctors being given any impression that the devices were confidential. As a result, in the trial of the matter it was examined whether the circumstances of the clinical trials implied an obligation of confidence41. It was held that the clinical trial, in itself, did not give rise to a presumption of confidentiality. Confidentiality and clinical trials in the EPO The case law of the Boards of Appeal of the EPO has, like the UK, established that a prior disclosure of the existence of a clinical trial does not anticipate a claim which includes a specified therapeutic effect revealed by the (undisclosed) results of that clinical trial unless the therapeutic effect can be derived directly and unambiguously from the prior disclosure42. Anticipation may be held, however, where control has effectively been lost over the drug that is the subject of the trial. Ethinylestradiol and drospirenone for use as a contraceptive/BAYER T 7/0743 concerns whether claimed contraceptive drugs had become publicly available by prior use in clinical trials that took place before the priority date. In the trials, a large number of patients participating in the trials had been informed of the ingredients and had not signed a confidentiality agreement. Furthermore, they were given tablets to take home with them for use over a longer period of time, and not all of the unused study drugs were returned. It was found that the respondent had effectively lost control of the drugs and they were held to have been made available to the public. The patentee had argued that, according to established TBA case law, any persons involved in clinical trials are implicitly bound to confidentiality. However, the case was 40 [2014] EWHC 2506 (Pat) (22 July 2014). 41 See Attorney General v Guardian Newspapers Ltd (No 2) [1988] UKHL 6 (13 October 1988); Campbell v Mirror Group Newspapers [2004] UKHL 22 (6 May 2004); Coco v AN Clark (Engineers) Ltd [1969] RPC 41 (1 July 1968). 42 See, for example, T  158/96 Pfizer/Obsessive-compulsive disorder [1999]  EPOR  285; T  715/03 Pfizer/Use of ziprasidone for treating Tourette’s syndrome (unreported, 16  January 2006); T  385/07 Pharma Mar/Aplidine (unreported, 5  October 2007); T  734/12 Genentech/Arthritis patients with an inadequate response to a TNF-alpha inhibitor (unreported, 17 May 2013). 43 (unpublished) (7 July 2011).

29

1.15

Requirements for a Valid Patent 1: Novelty distinguished from previous authorities in which devices had been implanted in a small number of patients without confidentiality restrictions. In those cases, the patients were not in a position to pass the prototypes on or even inspect them themselves.

PRIOR ART PUBLISHED ON THE INTERNET 1.15 There are no restrictions on the geographical origin or age of the prior art44. However, the ubiquity of electronic sources of information now available, and the nature of the internet as a source that is constantly updated, requires special attention. In particular, the date and content of internet publications may not be possible to take at face value. Further investigation may be needed to prove publication date and the exact content that was published at that date. For this purpose, some services, such as the Wayback Machine45, claim to provide authentic reproductions of internet pages as they appeared at a certain date. For prior art purposes, these are intended to provide an electronic equivalent to a photocopy of an archived research article taken from a library. Such services have been used uncritically in English proceedings46. PRIOR ART: WHAT HAS BEEN MADE AVAILABLE? General considerations 1.16 A  prior art document must be read by the skilled person as on its date of publication – except under section 2(3) of the Patents Act 1977, in which case it must be read as at its date of filing or, if applicable, an earlier priority date. Many of the general rules by which prior art documents must be approached are established by TBA case law. The disclosure of a prior art document must be read as a whole47 – cherry-picking of some information, without regard to the rest of the document and the context of the whole, is not permitted. As regards prior published patents, the teaching is not confined to the detailed information given in the examples, but includes information in the claims and description that enable a person skilled in the art to carry out the invention48. Such a patent may also serve as its own 44 Guidelines for Examination GIV, 1, November 2015 edition. 45 https://archive.org/web/. 46 For example, HTC Corporation v Gemalto SA [2013] EWHC 1876 (Pat) (10 July 2013). The EPO also specifically mentions the Wayback Machine as an internet archiving system which may be used to provide evidence to establish or confirm a publication date: EPO notice [2009] OJ EPO 8-9, 456. 47 T 56/87 Ion chamber/Scanditronix [1990] OJ EPO 188 (20 September 1988). 48 T 12/81 Diastereomer/BAYER [1982] OJ EPO 296 (9 February 1982).

30

KEY ISSUE: Novelty and scope of claims

1.18

dictionary but, otherwise, words used should be given their normal meaning in the art49 according to the meaning that the skilled person would attribute to them using their common general knowledge50. If the prior art document contains drawings, these must show the structure of a feature clearly and it must be possible to derive its technical function51. The rule against mosaicing 1.17 To destroy novelty, the claimed subject matter of a patent must be obtained directly and unambiguously from the matter disclosed in the prior art, explicitly or implicitly. This normally requires comparison between the single, closest piece of prior art to the subject matter of the patent. Combining the features of more than one piece of prior art, ‘mosaicing’, is not permitted, per Tomlin J: ‘It is not open to you to take a packet of prior documents and … putting a puzzle together produce what you say is a disclosure in the nature of a combination of the various elements which have been contained in the prior documents. I think it is necessary to point to a clear and specific disclosure of something which is said to be like the patentee’s invention.’

It is permitted to combine documents only if one document refers to the other such that ‘anyone reading one is referred by cross-reference to the others’52. KEY ISSUE: NOVELTY AND SCOPE OF CLAIMS 1.18 In Actavis v Eli Lilly53 the UK  Supreme Court held that direct infringement cannot be determined solely by whether a product or process falls within the language of the claim. Instead, the issue of whether variants falling outside the language of the claim may still infringe must be taken into account as a second step – a doctrine of equivalents test (see Chapter 5). Does the doctrine of equivalents apply to patent claims in the context of determining novelty or other validity objections? This matters in the UK, because an infringing embodiment that post-dates the patent would necessarily anticipate the patent if it were of an earlier date – the ‘Merrell Dow principle’54 (see above and Chapter 3). The application of the doctrine

49 Eg T  1321/04 Meaning of terms used in patent documents/NGK INSULATORS (unpublished) (28 February 2005). 50 T 410/99 Kraft pulp preparation/METSO (unpublished) (20 January 2003). 51 T 896/92 Break-stem blind rivet/ Avdel Systems (unpublished) (28 April 1994). 52 Sharpe & Dohme Inc v Boots Pure Drug Co Ltd (1927) 44 RPC, 367. 53 [2017] UKSC 48. 54 [1996] RPC 76.

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1.19

Requirements for a Valid Patent 1: Novelty of equivalents to infringement has now cast doubt on this relationship. Is it correct that a product – which would not anticipate a patent if it was prior art – can now nonetheless infringe if it post-dates that patent? The first suggestion that there may be a solution to this question came in a decision of the Intellectual Property and Enterprise Court in Technetix v Teleste55, where HHJ Hacon considered that a Formstein-type objection, as found in German law, may have a role in English cases, because it reflects the Merrell Dow principle. In this case, the judge held the patent invalid and did not have to make a ruling on the point. Later, Mr Justice Nugee in Emson v Hozelock56 found that a patent for an expandable hose assembly would be infringed on the doctrine of equivalents. In his decision, Nugee J again discusses Formstein – although, because the patent was held invalid, his decision again did not turn on the issue. The Formstein objection, to which the judges in both cases refer, is a feature of the approach to the doctrine of equivalents in Germany57. If a variant is found to be equivalent using the three-step approach to the doctrine of equivalents in Germany (see Chapter 5), the Formstein objection is then employed as a fourth step. This asks: ‘Does the variant, having regard to the state of the art, lack novelty or is the variant obvious to a person skilled in the art?’. HHJ Hacon in Technetix interprets this objection like this: ‘One way of reconciling the Merrell Dow principle with the doctrine of equivalents would be to say that if an accused product or process is an equivalent and for that reason is nominally within the scope of the claim, but the equivalent would have lacked novelty or inventive step over the prior art at the priority date, then it is deemed to fall outside the scope of the claim, thus providing a defence to infringement.’

The Formstein objection is not therefore concerned with the interpretation of the claims of the patented invention for the purpose of novelty assessment, but it limits the scope of the claim for purposes of infringement if the doctrine of equivalents would otherwise include non-novel or non-inventive subject matter. It remains to be seen whether the Formstein issue will gain further traction in the English cases. IMPLICIT DISCLOSURE, INEVITABILITY AND INHERENCY 1.19 A disclosure is implicit if it is immediately apparent to the skilled person that it allows nothing else to form part of the subject matter disclosed58. The EPO case law makes a distinction between a feature that 55 56 57 58

32

[2019] EWHC 126 (IPEC) (29 January 2019). [2019] EWHC 991 (Pat) (17 April 2019). As exemplified by Schneidmesser I (GRUR 2002, 515). T 95/9 7 Method and apparatus for increasing the service life of aircraft multiple disc brakes/DUNLOP (unpublished) (18 March 1999).

Selected compounds and parameters

1.21

is implicit in the prior art and a feature that is inherent. The latter may not be made available to the public59. This is illustrated by the MOBIL OIL / Friction reducing additives G 2/8860 case. The MOBIL case concerned a patent for the inherent, but previously unknown, friction-reducing properties of an additive to engine oil. The use of the additive before the priority date of the patent was for the reduction of rust. It would also have had the inherent result of reducing friction in an engine, although this would not have been evident. The Enlarged Board of Appeal (EBA) allowed the patent on the basis that the hidden or secret friction-reducing properties, not previously having been made available to the public, did not anticipate the claims of the patent. The Board stated, at paragraph 10.3: ‘If that technical feature has not been previously made available to the public … then the claimed invention is novel, even though such technical effect may have inherently taken place in the course of carrying out what has previously been made available to the public.’

The full implications of this case are yet to be worked out in the English cases (see para 1.26). SELECTED COMPOUNDS AND PARAMETERS Selection inventions 1.20 There are a number of areas in which a patent claims a selection of content that can also be found within the more general disclosure of a prior art document. Is a general disclosure of subject matter capable of anticipating the selected subject matter? Such ‘selection inventions’ require special consideration. Racemates and enantiomers 1.21 The issue of whether an enantiomer isolated from a known racemate is capable of novelty was settled in Generics (UK) Ltd v H  Lundbeck A/ S61. This case concerned claims to the SSRI escitalopram, the S enantiomer of citalopram. Here, the Court of Appeal brought English law into line with TBA authority on the novelty of claims to enantiomers when made available to the public for the first time in isolated form62. According to TBA case law, without individualised disclosure and enablement to separate its

59 T 59/87 Friction reducing additives/MOBIL IV [1991] OJ EPO 561 (14 August 1990). 60 G 2/88 93, 469 [1990] OJ EPO (11 December 1989). 61 [2007] EWHC 1040 (Pat); [2008] EWCA Civ 311; and [2009] UKHL 12. 62 EPO Technical Board of Appeal decision in Hoechst /Enantiomerism (T-296/87).

33

1.22

Requirements for a Valid Patent 1: Novelty enantiomers, a prior art description of a racemate does not disclose, and therefore cannot anticipate, a claim to those isolated enantiomers63. Markush formulae 1.22 In the Dr Reddy’s case concerning olanzapine64, the Court of Appeal had to decide whether Eli Lilly’s patent claiming olanzapine was valid over a prior art specification claiming a novel class of thienobenzodiazepines. This class of compounds was disclosed in the prior art by means of a Markush formula estimated to cover some 1019 compounds. The Markush formula in the prior art covered olanzapine, but it was not identified specifically. Therefore, the question arose whether the disclosure of olanzapine generically could be an anticipation of the Eli Lilly patent to olanzapine alone. Until Dr Reddy’s, the leading English cases on selection inventions had been decided under rules on selection patents pre-dating the introduction into English law of the European Patent Convention (EPC)65. In Dr Reddy’s the Court of Appeal again adjusted the English approach to selection inventions to bring it into line with the individualised description approach of the TBA66. KEY ISSUE: NUMERICAL RANGES 1.23 Numerical ranges in the EPO In cases of overlapping ranges of physical parameters between a claim and a prior art disclosure, the TBA draws a distinction between subject matter that is ‘hidden’ (which is not available for novelty purposes67) and matter that has been made available, by asking if a skilled person would find it difficult to carry out the prior art teaching in the range of overlap68. In particular, the TBA will consider whether a person skilled in the art would, in the light of all the technical facts at their disposal, ‘seriously contemplate’ applying the technical teaching of the prior art document in the range 63 T 296/87 Enantiomer/HOECHST [1990] OJ EPO 195 (30 August 1988) and T 1048/92 Penem derivatives/PFIZER (unpublished) (5 December 1994). 64 Dr Reddy’s Laboratories (UK) v Eli Lilly & Co [2009] EWCA Civ 1362 (18 December 2009). 65 See Du Pont’s Patent 1982] FSR 303 (18 February 1982) and IG Farbenindustrie’s Patents (1930) 47 RPC 289. 66 See, for example, T 7/86 Xanthines/DRACO [1988] OJ EPO 381 (16 September 1987). 67 T 666/89 Washing Composition/UNILEVER [1993] OJ EPO 495 (10 September 1991). 68 T 124/87 Copolymers/DUPONT [1989] OJ EPO 491 (9 August 1988).

34

Increased purity and isolation

1.24

of overlap. If the information in the prior art document, combined with common general knowledge, is sufficient to enable the skilled person to practise the technical teaching, and if it can reasonably be assumed that they would do so, the claim will lack novelty. The English court is aligned with the TBA as regards the treatment of novelty in cases of overlapping ranges. These are regarded as being no different from novelty in other circumstances69. The court does not, however, consider that a lack of novelty would follow where a skilled person would ‘seriously contemplate’ moving from a broad range to a narrow range in the absence of disclosure of the narrower range. Instead, where no specific individual value is disclosed, the court considers there to be no clear direction to use a value within the narrower range. Consequently, a person carrying out the disclosure of the prior range will not inevitably fall within the claim of the later patent70. In Jushi v OCV Intellectual Capital71 a claimed glass strand comprised 12 listed constituents, each present in prescribed percentages by weight. The patent described the advantage of glass strands with constituents within the claimed range, together with examples. Jushi argued lack of novelty over a single US patent, on the basis that the ranges of the glass fibre constituents described in it either overlapped or fell within the ranges claimed. In particular, Jushi argued that the prior art disclosed a compositional space in which the skilled person would understand that any combination of individual values could be chosen. The Court of Appeal disagreed and applied the approach taken in Markush formulae cases that a broad generic disclosure in the prior art does not anticipate a selection from within that disclosure72. INCREASED PURITY AND ISOLATION 1.24 According to TBA case law, prior disclosure of an impure small molecule compound would normally be expected to anticipate a later claim of the compound in greater purity, as a matter of enablement, provided that no undue effort is required to perform the purification73. By contrast, a claim to an isolated enzyme, sufficiently pure to be sequenced, has been held novel

69 H Lundbeck AS v Norpharma SPA & Ors [2011] EWHC 907 (Pat) (14 April 2011). 70 The conventional approach to novelty expounded in Synthon BV v SmithKline Beecham Plc (No 2) [2005] UKHL 59 (20 October 2005) and Dr Reddy’s Laboratories (UK) Ltd v Eli Lilly & Co Ltd [2009] EWCA Civ 1362 (18 December 2009). 71 [2018] EWCA Civ 1416 (19 June 2018). 72 Dr Reddy’s Laboratories (UK) Ltd v Eli Lilly & Co Ltd [2009]  EWCA  Civ 1362 (18 December 2009). 73 T 392/06 Triazinylaminostilbene/CIBA (unpublished) (22 October 2008).

35

1.25

Requirements for a Valid Patent 1: Novelty where such purification had not proved possible in the prior art74. A prior art nucleic acid sequence that was not indexed or annotated, was uncharacterised and without any identification of possible structural features did not disclose the claimed sequence SEQ ID NO 5 as an isolated nucleic acid sequence, even though that nucleic acid sequence was comprised within it75. PURPOSE LIMITED CLAIMS 1.25 It is EPO practice that a substance may be patented for a medicinal use, even if it is a known product and it is known for an alternative use outside medicine76. Such claims are typically drafted in the form of a pharmaceutical compound X  for use as a medicament: ‘X  for use as a medicament’. A substance that is already known to have been used for such a ‘first medical use’ may again be patentable under Article 54(5) of the EPC for second and subsequent uses, provided that the use is novel and inventive. However, the form in which the claim to such a use is drafted is significant. In particular, a patent claim in the form ‘Use of substance or composition X  for the treatment of disease Y…’ is excluded from patentability by Article 53(c) of the EPC as a method for treatment. In order to avoid this problem, particular forms of claim drafting have developed to avoid both novelty and method of treatment objections. For patents with a filing or earliest priority date before 29  January 2011, the (‘Swiss-form’) process claim was used: ‘Use of a substance or composition X  for the manufacture of a medicament for therapeutic application Y’. Such claims are still acceptable and, because of the patent term, widely in circulation. However, further to a Notice from the EPO on 20 September 201077, for patent claims filed after 29 January 2011, the form used must be that of a product claim: ‘Substance X for use in the treatment of disease Y’. The English courts largely follow the principles established by the case law of the EPO as regards first, second and subsequent medical use claims. In the context of infringement, these forms of claim have provided a particular challenge (see Chapter 6). DOSAGE REGIMES 1.25a A further form of claim, common in the pharmaceuticals field, is the dosage regime claim: the drug and the indication claimed are not novel, but 74 T 1336/04 Cellulase/NOVOZYME (unpublished) (9 March 2006) and T 767/95 Interleukin 1/IMMUNEX CORPORATION (unpublished) (5 September 2000). 75 (unpublished) (15 September 2016). 76 Guidelines for examination at the European Patent Office: Part G – Chapter VI-4, 7.1. 77 [2010] OJ EPO 514 (20 September 2010).

36

KEY ISSUE: Claims to treating a sub-population

1.26

the dosing regime or form of administration of the drug for that use is new. It was not until Actavis UK Ltd v Merck & Co Inc78 that the courts of England & Wales followed the EPO in holding that the novelty of such claims can reside in the dosage regime or manner of application of a medicament79. On the facts, Actavis sought revocation of Merck’s patent claiming in Swissform the use of finasteride for the treatment of male pattern baldness at a daily dose of 0.05 to 1mg. The attack was based on an earlier patent that describes the use of finasteride (5mg daily) as a prostate enlargement treatment, but which also mentions using finasteride as an anti-baldness treatment. The Court of Appeal held that novelty can lie in a new dosage regime (or other form of administration) of a known substance for a known indication. In particular, Actavis v Merck clarified that new dosage regimes and other methods of administration of a drug are not per se excluded from patentability as methods of treatment80. The court also outlined the policy reasons why the method of treatment exception should be construed restrictively: ‘Research into new and better dosage regimes is clearly desirable – and there is simply no policy reason why, if a novel non-obvious regime is invented, there should not be an appropriate patent reward. Such a reward cannot extend to covering the actual treatment but a Swiss form claim which specifies the new, inventive, regime is entirely in accordance with policy.’

As a Swiss-form claim in this case, the court noted that it was, in essence, to the use of finasteride for the preparation of a medicament of the specified dosages. As such, it was directed at the manufacturer and would not affect doctors. In other cases, however, patentability will depend on how exactly the claim is drafted and whether it would cover doctors who make a clinical choice as to the dosage to be administered. KEY ISSUE: CLAIMS TO TREATING A SUB-POPULATION ‘Personalised medicine claims’ 1.26 In second medical use claims, novelty lies in the new indication; and, in dosage regime claims, the novelty lies in a new administration. In each case, the claim is novel because it is to do something that has not been done before. There is another form of claim, however, for treating subpopulations; what is sometimes termed a ‘personalised medicine claim’.

78 [2008] EWCA Civ 444 (21 May 2008). 79 EPC, Article 54(5). Also, see G 2/08 Dosage regime/ABBOTT RESPIRATORY [2010] OJ EPO 456 (19 February 2010). 80 The claim in Actavis was directed at the manufacturer, unlike cases in which the claim would cover doctors making a clinical choice as to the dosage to be administered. See Bristol Myers Squibb Co v Baker Norton Pharmaceuticals Inc [2011] RPC 1 (23 May 2000).

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1.26

Requirements for a Valid Patent 1: Novelty A  personalised medicine in this context is one that is not effective against the whole of a group symptomatic of a disease, but rather those subpopulations within it that share a particular predictive biomarker, there being a causal link between the action of the biomarker and the action of the drug. In other words, when taken by the whole group with the disease, not all of whom have the biomarker, a conventional drug may appear ineffective, or even cause adverse effects – the unwanted effects in people who do not have the biomarker can mask the true potential of the drug in those who do. Once those with the predictive biomarker to which the drug responds are identified, a drug that appears unpromising in the disease group as a whole, or even responsible for adverse events, can be demonstrated to have enhanced efficacy. An example is the drug gefitinib. Gefitinib originally failed to show significant benefits in an overall population of patients with lung cancer in a Phase III clinical study. As a consequence, the drug was not given European approval. It was later discovered, however, that a sub-population of about 10–15% of lung cancer patients having tumours with a mutation in the epidermal growth factor receptor for tyrosine kinase (EGFR-TK) responded particularly well to the drug. This is because gefitinib inhibits the EGFR-TK activity that promotes the growth of certain lung cancer cells. Subsequently, gefitinib was granted marketing authorisation for the treatment of adults with locally advanced or metastatic non-small cell lung cancer who present positive for mutations of EGFR-TK. The question arises whether use in a sub-population is inherently disclosed by the prior use in the wider disease population, defeating novelty. Personalised medicine claims in the EPO For a time, the case law of the EPO appeared to regard inherency as a problem for the novelty of personalised medicine claims: the treatment or diagnosis of the same condition with the same compound was only novel if it is applied to a new group of subjects distinguished by a ‘physiological or pathological status’81 that does not overlap with the group previously treated. In more recent cases, however, claims to treatment of defined sub-populations by the same compound for the same disease have been held novel by the TBA, regardless of overlap. For example, in TNF-alpha inhibitor T  734/1282, a claim to the treatment of autoimmune disease in patients with ‘an inadequate response to a TNF-alpha inhibitor’ using rituximab (an antiTNF-alpha antibody) was held to be novel. The physiological or pathological feature – the predictive biomarker – shared by the sub-

81 T 233/96 Adrenaline/MEDCO RESEARCH (unpublished) (4 May 2000). 82 T 734/12 TNF-alpha inhibitor (unpublished) (17 May 2013).

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KEY ISSUE: Claims to treating a sub-population

1.27

population, which distinguished it from the wider population, was increased Th17 cell numbers and IL-17 expression levels, which responded to rituximab. The claim was held novel, despite the treatment of rheumatoid arthritis patients by rituximab being known before the priority date. Why that result? It is necessary to go back and look at the reasoning of the decisions in MOBIL OIL/Friction reducing additives G 2/88 to understand83. The MOBIL case concerns a patent for the inherent, but previously unknown, friction-reducing properties of an additive to engine oil. The use of the additive before the priority date of the patent was for reduction of rust, but it would have also had the unknown, but inherent, effect of reducing friction in an engine at the same time. The EBA allowed the patent on the basis that the hidden or secret friction-reducing properties, not previously having been made available to the public, did not anticipate the claims of the patent. The Board said this: ‘If that technical feature has not been previously made available to the public … then the claimed invention is novel, even though such technical effect may have inherently taken place in the course of carrying out what has previously been made available to the public.’

This means that both the TNF-alpha inhibitor and MOBIL decisions go further than cases finding validity for patents claiming second medical indications and dosage regimes, because they hold that there is novelty essentially for ‘mere discoveries about old uses’84.

Where is the novelty in personalised medicine claims? 1.27 To date, there has been no decision of the English courts on personalised medicine claims, as such. The UK House of Lords referred in Merrell Dow85, to the Enlarged Board of Appeal G 2/88 MOBIL decision, in which its principles were accepted, obiter. In particular, Lord Hoffmann agreed broadly that secret or hidden properties would not anticipate unless disclosed. There is another context in which the English courts have clearly not found inherent disclosure a bar to novelty. This is in selection invention

83 MOBIL OIL/Friction reducing additives G 2/88 93, 469 [1990] OJ EPO (11 December 1989). 84 See Jacob J in Patents Court, Bristol Myers Squibb v Baker Norton [1999] RPC 253, at 65 (20 August 1998). 85 Merrell Dow Pharmaceuticals Inc v HN Norton & Co Ltd [1996] RPC 76 (26 October 1995).

39

1.27

Requirements for a Valid Patent 1: Novelty patents and, in particular, the Patents Court and the Court of Appeal in Dr Reddy’s v Eli Lilly86, in which the court relied on a strand of EPO case law, specifically Hoechst Enantiomers87, for authority that a compound is not anticipated when it is one of an earlier class of disclosed compounds, unless it is disclosed by ‘individualised description’. But, Floyd J  (who is now Lord Justice Floyd) in Actavis UK  Ltd v Janssen88 seems to have doubts about MOBIL: ‘If MOBIL is correctly decided, then unadvertised technical effects which underlie new uses of known materials are an exception to the rule about inevitable results.’89

A further consideration arises from the Actavis v Janssen case, which is the objection that novelty cannot lie in a new explanation of the mechanism of an old use. In that case, Actavis sought revocation of Janssen’s European patent concerning the stereochemistry of an important blood pressurelowering drug, nebivolol. The relevant part of claim 1 of the patent was: ‘use for the manufacture of a medicament for potentiating the effects of blood pressure reducing agents having adrenergic and/or vasodilating activity … of a compound of the formula (I).’ (bold added)

The question was whether this claim, in particular the feature of potentiating activity, was inherently anticipated by the use in the prior art of a compound falling within the claim for the same purpose, but without the disclosure of that potentiating activity. Floyd J concluded that: ‘In my judgement, merely explaining the mechanism which underlies a use already described in the prior art cannot, without more, give rise to novelty. In MOBIL, the technical effects which underlay the new and old uses were different and distinct … It is not the case that every discovery about the mode of action of a drug can be translated into a new purpose and claimed as such.’90

The difference between claiming an old use of a drug for a sub-population with a newly disclosed biomarker, on the one hand, and a claim to a new explanation for the mechanism of an old use, on the other, may not always be clear. Therefore, as with all patents, the precise drafting of personal medicine claims is critical (see Table1.1). The crucial difference between the two kinds of claim would appear to be that the latter provides a new technical contribution by disclosing a physiological or pathological characteristic that may be targeted to produce improved treatment. The former merely provides information on the causal relationship that makes it work. 86 Dr Reddy’s Laboratories (UK) Limited v Eli Lilly and Company Limited [2009] EWCA Civ 1362 (18 December 2009). 87 T 296/87 Enantiomer/C [1990] OJ EPO195 (30 August 1988). 88 Patents Court, Actavis UK Ltd v Janssen Pharmaceutica NV EWHC 1422 (Pat) (30 June 2008). 89 At para 90. 90 At para 99.

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Priority

1.28

Table 1.1  Technical contribution in forms of purpose-limited claim Claim type

Genericised form of claim

Technical contribution

Non-medical MOBIL-type claim

Use of X for purpose Y

New discovery of an effect of old use

Actavis v Janssentype claim

X potentiating the effects of Y having activity Z

None: merely a new explanation of the mechanism of an old use

Second medical use

X for use in treating Y

A new indication

Personalised medicine

X for use in treating Y in an individual characterised by Z

A pathological or physiological characteristic linked to improved treatment

PRIORITY Claiming priority 1.28 The right of priority is described in the CIPA Guide to the Patents Acts91 as: ‘… one of the cornerstones of the Paris Convention, originally signed in 1883. Its basic purpose is to safeguard, for a limited period, the interests of the patent applicant in his attempt to obtain international protection for his invention, thereby alleviating the negative consequences of the principle of territoriality in patent law.’

An applicant may fix a priority date for their invention in contracting state A, on the basis of an earlier filing of an application in another contracting state B (the ‘priority document’), provided that the filing in A occurs within a limited period of the filing in B. This time period is 12 months (see below). This is important because (as explained in para 1.2 above and Chapter 2) the priority date is the date at which the patentability of the subject matter of a patent is judged against the prior art. This is made clear in section 6 of the Patents Act 1977: ‘(1) It is hereby declared for the avoidance of doubt that where an application (the application in suit) is made for a patent and a declaration is made in accordance with section 5(2) [see below] in or in connection with that application specifying an earlier relevant application, the application in suit and any patent granted in pursuance of it shall not be invalidated by reason only of relevant intervening acts. ]2) … “relevant intervening acts” means acts done in relation to matter disclosed in an earlier relevant application between the dates of the earlier relevant

91 9th Edition, section 5.31.

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1.28

Requirements for a Valid Patent 1: Novelty application and the application in suit, as for example, filing another application for the invention for which the earlier relevant application was made, making information available to the public about that invention or that matter or working that invention, …’

The right to priority is provided in section 5 of the Patents Act 1977: ‘(1) For the purposes of this Act the priority date of an invention to which an application for a patent relates and also of any matter (whether or not the same as the invention) contained in any such application is, except as provided by the following provisions of this Act, the date of filing the application. (2) If in or in connection with an application for a patent (the application in suit) a declaration is made, whether by the applicant or any predecessor in title of his, complying with the relevant requirements of rules and specifying one or more earlier relevant applications for the purposes of this section made by the applicant or a predecessor in title of his and the application in suit has a date of filing during the period allowed under subsection (2A)(a) or (b) below, then– (a) if an invention to which the application in suit relates92 is supported by matter disclosed in the earlier relevant application or applications, the priority date of that invention shall instead of being the date of filing the application in suit be the date of filing the relevant application in which that matter was disclosed, or, if it was disclosed in more than one relevant application, the earliest of them; (b) the priority date of any matter contained in the application in suit which was also disclosed in the earlier relevant application or applications shall be the date of filing the relevant application in which that matter was disclosed or, if it was disclosed in more than one relevant application, the earliest of them.’

The period referred to in section 5(2) is the period of 12 months immediately following the date of filing of the earlier specified relevant application or, if there is more than one, of the earliest of them93. A ‘relevant application’ is defined as any of the following applications which has a date of filing: 1. an application for a patent under the 1977 Act; 2. an application in or for a country (other than the United Kingdom) which is a member of the World Trade Organisation, which includes, for example: Australia, Canada, China, Israel, Japan, New Zealand, 92 As to the difference between section 5(2)(a) (‘an invention to which an application relates’) and section 5(2)(b) (‘matter contained in the application in suit’), see Re Asahi Kasei Kogyo KK’s Application [1991] RPC 485. 93 Patents Act 1977, s 5(2A)(a). Further to s 5(2A)(b), the comptroller may give permission under subsection (2B) for a late declaration to be made under subsection (2). In that case, the period during which the application must be filed commences immediately after the end of the period allowed under s 5(2A)(a) and ends at the end of the prescribed period (see also s 5(2B) and (2C)).

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Priority

1.29

South Africa, Switzerland and the United States; provided that there is a national filing adequate to establish the date on which it was filed in the country concerned; or 3. an application in or for a convention country94 (which includes European and international applications). The meaning of ‘supported by the matter disclosed’ ‘Same invention’ 1.29 Article  87(1) of the EPC, which is the equivalent provision to section 5 of the Patents Act 1977, refers to priority being derivable from an earlier application in respect of the ‘same invention’. The meaning of ‘same invention’ is explained, by the Enlarged Board of Appeal in G 2/98 Condition required for priority claim, to mean that a patent application may only take priority from an earlier application if its subject matter is directly and unambiguously derived from the content of that earlier application95. In the English courts, in Unilin Beheer BV v Berry Floor NV96, Jacob LJ elaborates on what this means: ‘… priority is a question about technical disclosure, explicit or implicit. Is there enough in the priority document to give the skilled man essentially the same information as forms the subject of the claim and enables him to work the invention in accordance with that claim?’

The nature of the invention is important in this respect and there is no formulaic approach. The judge explains this by examining a hypothetical example provided by counsel for the appellants: a priority document which discloses features A, B and C, but in which the later patent claims only two of these features: ‘… there were three features, A+B+C … They are disclosed in combination – hence, [counsel] says, a claim to one without the other two cannot have priority. I would reject that submission…. The fact of the matter is that when features A+B+C are disclosed, a lot must turn on what they actually are. Some inventions consist of a combination of features – the invention consists in the very idea of putting them together. In other cases that is simply not so – the features are independent one from the other. Whether, given a disclosure of A+B+C, there is also a disclosure of A or B or C independently depends on substance, not a formula. The ultimate question is simply whether the skilled man can derive the subject-matter of the claim from the priority document as a whole.’

94 See Patents Act 1977, s 90. 95 [2001] OJ EPO 413 (31 May 2001). 96 [2004] EWCA Civ 1021.

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1.30

Requirements for a Valid Patent 1: Novelty In Samsung Electronics97, Floyd J  took from the above that the subject matter of a claim is not the same thing as the scope of the monopoly that it claims and that the task for the court is as follows: (a) to read and understand, through the eyes of the skilled person, the disclosure of the priority document as a whole; (b) to determine the subject matter of the relevant claim; and (c) to decide whether, as a matter of substance not of form, the subject matter of the claim can be derived directly and unambiguously from the disclosure of the priority document. This means that the test for establishing priority should not be confused with the test for assessing novelty – it is not a question of asking whether the features of the claim are present in the priority document. Taking up the example from Unilin Beheer, Floyd J  went on to say that the Court of Appeal recognised in that case that the disclosure of A+B+C  may, in some circumstances, not provide priority for a claim to A or B alone or to A+B. By contrast, the judge said, the disclosure of A+B+C will normally deprive a claim to A, B or A+B of novelty. The additional presence of other features in the disclosure would not matter. Applying the infringement test, A+B+C will still infringe, whether the claim is to A, B or A+B. When testing for priority, one must therefore guard against simply asking whether the features called for by the claim are present in the priority document: ‘The test for claiming priority in respect of the same invention has more substance, and is less formal, than that’98. An assessment of whether the priority document discloses the ‘same invention’ should not go to the other extreme: it is not synonymous with asking if the ‘key concept’ or ‘the same crux of the invention’ is disclosed in the priority document99. See also para 1.31. Enablement 1.30 As regards enablement, under section 5(2)(a) of the Patents Act 1977 the priority document must be sufficient. In other words, it must enable the person skilled in the art to do what it discloses in respect of the later claim100 (see Chapter 4). For this purpose, the priority document must be taken as a whole and it is not sufficient that it may be an obvious development of what 97 Samsung Electronics Co Limited v Apple Retail UK Limited, Apple Sales International [2013] EWHC 467 (Pat) (7 March 2013). 98 See also Unwired Planet v Huawei, Samsung and Google [2015] EWHC 3366 (Pat). 99 Hospira UK Ltd v Cubist Pharmaceuticals LLC [2016] EWHC 1285 (Pat). 100 Once the priority document had been identified, however, the burden is on a challenger to the claimed priority date to show that it is insufficient (see the Court of Appeal in Biogen Inc v Medeva Plc [1995] RPC 25 (27 October 1994).

44

Priority

1.32

is disclosed101. The priority document must also meet the lower standard of plausibility102: ‘In the context of an invention which includes the achievement of a therapeutic effect as one of its features, absolute proof is not required but the patentee must show that the therapeutic effect is plausible … It seems to me that this logic applies just as much to priority as it does to sufficiency of disclosure.’

Section 5(2)(a) should be contrasted with section 5(2)(b), under which an earlier priority date has been held based on a formula identified in the priority document, even though the priority document did not disclose a method of manufacturing the compound103. The difference between the two subsections appears to lie in the fact that the lack of an enabling disclosure of the formula means that it cannot be novelty-destroying under section 2(3) against a claim to the compound with a later priority date. Partial priority 1.31 The Enlarged Board of Appeal in G  2/08 stated that the claiming of partial priority is permitted if ‘it gives rise to the claiming of a limited number of clearly defined alternatives’. The application of this test is straightforward in cases of clearly defined alternatives – for example, where ‘A or B salt’ is claimed in the later document. Here, if the priority document refers only to ‘A salt’, priority to this may be claimed, but priority to the ‘B salt’ cannot be claimed. In cases where alternatives are claimed in a generic ‘OR’ claim, such as a Markush formula or a continuous range of numerical values, Partial Priority/INFINEUM  G  1/15 held that entitlement to partial priority may not be refused for a generic ‘OR’ claim encompassing alternative subject matter, provided that the alternative subject matter had been disclosed for the first time directly, or at least implicitly, unambiguously and in an enabling manner in the priority document104 (see also para 1.29). Assignment of priority 1.32 The applicant claiming priority must be the successor in title to the person who filed the earlier application at the time the subsequent

101 See also Abbott Laboratories Ltd v Evysio Medical Devices ULC [2008] EWHC 800 (Ch) (21 April 2008). 102 Hospira UK  Limited v Genentech Inc [2014]  EWHC  1094 (Pat) (10  April 2014) and Actavis Group PTC EHF v ICOS Corp [2017] EWCA Civ 1671. 103 Re Asahi Kasei Kogyo KK’s Application [1991] RPC 485. 104 See also T  0557b/13 Partial Priority/INFINEUM (unpublished) (17  July 2015) and T 0260/14 Polyether-based preparations/3M (unpublished) (13 April 2017).

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1.32

Requirements for a Valid Patent 1: Novelty application is filed. A  succession in title later than the filing date of the subsequent application is not sufficient. In HTC  Corporation v Gemalto SA105, three parties filed the priority application, none of whom was the subsequent applicant. It was held that, in order to claim priority to the earlier application, the subsequent applicant must be the successor in title to all of the priority applicants106, such that they have acquired the entire beneficial interest in the invention by that date107.

105 [2013] EWHC 1876 (Pat) (10 July 2013). 106 Edwards Lifesciences AG v Cook Biotech Inc [2009] EWHC 1304 (Pat) (12 June 2009). 107 KCI Licensing Inc & Ors v Smith & Nephew Plc & Ors [2010] EWHC 1487 (Pat) (23 June 2010).

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Chapter 2 Requirements for a Valid Patent 2: Inventive Step

LIFE SCIENCES CONTEXT 2.1 Of the patentability requirements for a life sciences invention, the most commonly encountered in practice, particularly when the validity of a patent is challenged, is inventive step. It is also a key way for a party to gauge the strength of its own patents. The issue arises particularly in the context of generic companies that are seeking to ‘clear the way’ of secondary patents protecting a brand product, which may block access to the market after protection for the original active ingredient in that product has expired. Such patents may protect new dosage regimes, formulations, combinations, modifications and selections, amongst other subject matter. As a consequence, much of the case law on inventive step deals with challenges to patents of this kind. This is a dynamic seen not only for traditional, small-molecule pharmaceuticals, but also for biosimilar products. Conflicting patent rights also arise between patent owners when seeking competitive advantage in areas of technology where they have overlapping commercial interests. The biotechnology and medical devices sector is prominent in this regard, because the complexity of the products in question (and often the processes for making them) lends itself to large portfolios of patents covering different aspects of the technology in question. GENERAL PRINCIPLES The approach to inventive step in the UK 2.2 Section 1(1) of the Patents Act 1977 immediately follows the novelty requirement of sub-paragraph (a) (see Chapter 1) with the further condition in sub-paragraph (b)1 that the invention:

1

This should be read in conformity with EPC, Article 52(1).

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2.3

Requirements for a Valid Patent 2: Inventive Step ‘… involves an inventive step;’

The meaning of ‘inventive step’ is defined in section 3 of the Patents Act 19772: ‘An invention shall be taken to involve an inventive step if it is not obvious to a person skilled in the art, having regard to any matter which forms part of the state of the art by virtue only of section 2(2) above (and disregarding section 2(3) above).’

The statutory question that must be asked when deciding whether an invention actually involves an inventive step is, therefore, ‘Is the invention obvious to a person skilled in the art?’. Consequently, a lack of inventive step is also referred to as ‘obviousness’. Like novelty, the invention claimed is compared with the state of the art as defined by section 2(2) at the priority date. Rather than merely addressing whether the invention adds new subject matter to the art, however, an inventive step requires the subject matter to be qualitatively non-obvious to a skilled person. As explored in this chapter, this question can be addressed in a number of ways but, as recently affirmed by the Supreme Court (see para 2.12), the issue must always return to this statutory question. Preparing to ask whether an invention is obvious 2.3 Although its use is not mandatory3, the English courts have for many years applied a structured, four-step approach to the section 3 statutory question. This approach was established in Windsurfing International Inc v Tabur Marine (Great Britain) Ltd4, as later modified by Pozzoli Spa v BDMO SA & Anor5. As an approach, Windsurfing/Pozzoli is not a substitute for the statutory question. Indeed, the statutory question is asked at step (4), in paraphrased form: (1) (a) Identify the notional ‘person skilled in the art’; and (b) identify the relevant common general knowledge of that person. (2) Identify the inventive concept of the claim in question or, if that cannot readily be done, construe it. (3) Identify what, if any, differences exist between the matter cited as forming part of the ‘state of the art’ and the inventive concept of the claim or the claim as construed. (4) Viewed without any knowledge of the alleged invention as claimed, do those differences constitute steps which would have been obvious to the person skilled in the art or do they require a degree of invention? 2 3 4 5

48

See also EPC, Article 56. Actavis Group PTC EHF & Ors v ICOS Corporation & Anor [2019] UKSC 15 (27 March 2019). [1985] RPC 59 (31 January 1984). [2007] EWCA Civ 588 (22 June 2007), at para 23.

Factors when assessing inventive step

2.4

The Windsurfing/Pozzoli approach is intended to provide a consistent way for the court to equip itself with the relevant perspective (that of the skilled person) and knowledge (the skilled person’s common general knowledge6 together with the state of the art), before identifying what subject matter is to be addressed for obviousness. As emphasised by step (4), the subject matter to be addressed is the difference between the closest piece of prior art and the inventive concept of the claim in question; it is these differences that must be assessed for inventive step. Note that step (4) nonetheless requires any knowledge of the claimed invention to be discarded. This is important to safeguard the principle that any assessment of obviousness must always exclude hindsight. It is then answering the question, at step (4), that the UK courts have emphasised a number of times that replacing the statutory test with paraphrases or sub-tests does not assist. That warning has culminated in the recent Supreme Court decision in ICOS (see para 2.12). Nonetheless, it has been the habit for the use of sub-tests to persist. The most prevalent of these is to ask whether the invention was ‘obvious-to-try’ with an expectation of success (see para 2.5). As stated above, the correct approach is to identify the state of the art (which, in practical terms, means the parties identifying the closest piece or pieces of prior art7) and identify whether there is an inventive step in the differences between this prior art and the inventive concept claimed. The teaching of more than one prior art document may not be combined for this purpose (‘mosaiced’), unless it is obvious for the skilled person to do so8. FACTORS WHEN ASSESSING INVENTIVE STEP Sub-tests 2.4 The structured approach is important, not least because it is designed to prevent hindsight when assessing inventive step. The English courts have, however, emphasised that the really important question is that laid down in the statute itself9. The court has also emphasised that it is important, when answering this question, to take a multi-factorial approach to obviousness depending on the evidence before it, including expectation of success10: 6

For a recent discussion, see Akebia Therapeutics Inc v Fibrogen, Inc [2020] EWHC 866 (Pat) (20 April 2020). 7 This is a less stringent approach than that used in the EPO under the problem-and-solution approach, which may give rise to different results; see E Mishan & Sons, Inc v Hozelock Ltd & Ors [2020] EWCA Civ 871 (8 July 2020). 8 For a discussion of when a skilled person may follow documents incorporated, see Akebia Therapeutics Inc v Fibrogen, Inc [2020] EWHC 866 (Pat) (20 April 2020). 9 For example, PLG  Research Limited & Anor v Arnold International Limited & Ors [1995] FSR 116 (16 November 1994). 10 Generics (UK) Limited & Ors v H Lundbeck A/S [2007] EWHC 1040 (Pat) (4 May 2007), per Kitchin J at para 74.

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2.5

Requirements for a Valid Patent 2: Inventive Step ‘The question of obviousness must be considered on the facts of each case. The court must consider the weight to be attached to any particular factor in the light of all the relevant circumstances. These may include such matters as the motive to find a solution to the problem the patent addresses, the number and extent of the possible avenues of research, the effort involved in pursuing them and the expectation of success.’

Nonetheless, sub-tests continue to be used to assist the court when determining what is, and what is not, obvious. These include the ‘workshop variations’ approach, which is designed to prevent the patenting of anything which is merely an obvious extension or workshop variation of what is already known at the priority date. The court will also be interested in whether there is a ‘lion in the path’. The most prevalent of these sub-tests is to ask whether the invention was ‘obvious-to-try’ in the expectation of some success. Obvious-to-try 2.5

Aldous LJ states, in Cipla Limited & Others v Glaxo Group Limited11:

‘In my judgment, evidence that the skilled person will be led to try something because there is a reasonable expectation that it will produce a useful result establishes one possible route to a possible finding of obviousness. But if it is obvious to try that thing for other reasons, there need be no superadded requirement that there should also be some expectation of success. This was made clear in the decision of the Court of Appeal in Norton Healthcare v Beecham Group plc CA 19 June 1997 (unrep) where Aldous LJ said: “When deciding whether a claimed invention is obvious, it is often necessary to decide whether a particular avenue of research leading to the invention was obvious. In such circumstances the extent of the different avenues of research and the perceived chances of any one of them providing a successful result can be relevant to the decision whether the invention claimed was obvious. Whether the subject matter was obvious may depend upon whether it was obvious to try in the circumstances of that particular case and in those circumstances it will be necessary to take into account the expectation of achieving a good result. But that does not mean that in every case the decision whether a claimed invention was obvious can be determined by deciding whether there was a reasonable expectation that a person might get a good result from trying a particular avenue of research”.’

Pumfrey J employed a similar approach at first instance on the facts in Conor Medsystems Inc v Angiotech Pharmaceuticals Inc (‘Conor Medsystems’)12. As early as Saint Gobain PAM SA  v Fusion Provida Limited13, however, 11 [2004] RPC 43, at para 42. 12 [2006] RPC 28. 13 [2005] EWCA Civ 177.

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Factors when assessing inventive step

2.6

Jacob LJ was pointing out that removing motivation from the assessment of obviousness in this way would lead to a situation where few inventions would be patentable and the only research that would be worthwhile (because of the prospect of protection) would be into areas totally devoid of prospect. Jacob LJ preferred to say that ‘the “obvious-to-try” test really only works where it is more-or-less self-evident that what is being tested ought to work’14. Not long afterwards, Lord Hoffmann, giving the leading judgment in Conor Medsystems (which had reached the House of Lords), emphatically rejected the approach of Pumfrey J  (and Aldous LJ). Lord Hoffmann said, in the context of the taxol coated stents which were claimed, but without evidence that they would work in the patent15: ‘It is hard to see how the notion that something is worth trying or might have some effect can be described as an invention in respect of which anyone would be entitled to a monopoly. It is therefore perhaps not surprising that the test for obviousness which Pumfrey J devised for such an “invention” was whether it was obvious to try it without any expectation of success. This oxymoronic concept has, so far as I know, no precedent in the law of patents.’

Instead, Lord Hoffmann said that he understood the English cases, and in particular Jacob LJ, to be saying that ‘obvious-to-try’ was useful only in a case in which there was a ‘fair expectation of success’. Criticism of obvious-to-try 2.6 Recent cases have illustrated how an over-emphasis of the obviousto-try test has led to a lack of perspective on the question of inventive step (see para  2.12). There have been other criticisms of obvious-to-try as an approach to obviousness when taken in isolation. It has also been suggested that obvious-to-try, as an approach focused on the motivations of the skilled person, has limitations. Lord Walker said this in the Conor Medsystems case16: ‘On its face, this produces an unworkable or irrational test. If the reward for finding a solution to a problem and securing a monopoly for that solution is very high, then it may well be worthwhile for large players to examine all potential avenues to see if one gives the right result, even though the prospects of any one of them succeeding are much less than 50/50. What makes something worth trying is the outcome of a simple risk to reward calculation. Yet, if the reward is very large, the avenues worth trying will be expanded accordingly. So, the more commercially attractive the solution and the more pressing the public clamour for

14 [2005] EWCA Civ 177, at para 35. 15 [2008] UKHL 49, at para 28. 16 Reflecting Sir Hugh Laddie’s comments in: ‘Patents – what’s invention got to do with it?’ (in Intellectual property in the new millennium: essays in honour of William R Cornish (2004), p 93).

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2.7

Requirements for a Valid Patent 2: Inventive Step it, the harder it will be to avoid an obviousness attack. In those circumstances a solution which is quite low down a list of alternatives, all of which are more or less worth trying, will fail for obviousness; …’

In other words, the more the potential reward and the public demand, the more the motivation and the more likely the invention is to be obvious. The traditional obvious-to-try analysis, Lord Walker appears to suggest, is rooted in a lower-tech age than one in which technological development is increasingly fast and intensive17: ‘During the last forty years the volume of high-tech research has increased enormously, especially in the fields of pharmaceuticals and biotechnology. The resources committed to research are enormous, because the potential rewards in world-wide markets are so great. Competition is fierce. In this climate “obvious to try” has tended to take on a life of its own as an important weapon in the armoury of those challenging the validity of a patent.’

In other words, if relied on too much, the obvious-to-try test will too readily favour patent revocation as the pace of technological development speeds up. Other sub-tests and paraphrases for inventive step ‘Lion in the path’ 2.7 The English courts will also consider whether the prior art pointed the skilled person in a different direction, or whether there was a direct prejudice that was overcome by the teaching of the patent – a so-called ‘lion in the path’. Indeed, finding a prejudice in the art that the patent has gone against and overcome is often a successful way to demonstrate an inventive step in the UK courts. It is not enough, however, to simply patent an old idea thought not to work without contributing to the art an explanation of how or why it works, in the words of Lord Justice Jacob18: ‘Patentability is justified because the prior idea which was thought not to work must, as a piece of prior art, be taken as it would be understood by the person skilled in the art. He will read it with the prejudice of such a person. So, that which forms part of the state of the art really consists of two things in combination, the idea and the prejudice that it would not work or be impractical. A patentee who contributes something new by showing that, contrary to the mistaken prejudice, the idea will work or is practical has shown something new. He has shown that an apparent “lion in the path” is merely a paper tiger. Then his contribution is novel and non-obvious and he deserves his patent.

17 Conor Medsystems Incorporated v Angiotech Pharmaceuticals Incorporated & Ors [2008] UKHL 49 (9 July 2008). 18 Pozzoli Spa v BDMO SA & Anor [2007] EWCA Civ 588 (22 June 2007), at 27–28. 

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Secondary indicia

2.9

Where, however, the patentee merely patents an old idea thought not to work or to be practical and does not explain how or why, contrary to the prejudice, that it does work or is practical, things are different. Then his patent contributes nothing to human knowledge. The lion remains at least apparent (it may even be real) and the patent cannot be justified.’

The prejudice that the judge describes must be commonly shared by those engaged in the art, rather than merely held by some, and it may take the form of a ‘mindset’ within the industry concerned with the subject matter of the patent. It must also be a technical prejudice rather than a commercial one. It may also be relevant if the prior art arises from a technical field unrelated to the subject matter of the patent19. ‘Workshop variations’ 2.8 There is also the ‘workshop variations’ approach. Here, the courts have observed that the doctrine of obviousness is intended to ensure that the public is not prevented from doing anything which is merely an obvious extension or workshop variation of what is already known at the priority date. If the patentee has come up with a solution to a problem which is no more than an obvious extension or workshop variation of the prior art, it cannot have a monopoly for that solution, whether or not the skilled man would be likely to have known of the prior art in question. In these circumstances, the notional addressee is likely to want to use materials readily at hand to make essentially the same thing as is disclosed in the prior art. This is sufficient motivation and the use of those materials is, accordingly, obvious20. SECONDARY INDICIA 2.9 There is the possibility that evidence of other factors, called secondary evidence or secondary indicia, may also be considered on matters such as long-felt-want and commercial success. These factors, although admissible in the English courts, are not concerned with the objective technical analysis of the inventive step and are therefore of limited value by comparison with the primary evidence. They may, however, help to confirm a judge in their decision that a patent is already obvious. In Haberman v Jackel21, Mr Justice Laddie explains that commercial success is only relevant if it provides an insight into the thinking of the 19 E Mishan & Sons, Inc v Hozelock Ltd & Ors [2020] EWCA Civ 871 (8 July 2020). 20 Windsurfing International Inc v Tabur Marine (Great Britain) Ltd [1985] RPC 59. 21 Haberman v Jackel International Ltd [1999] 1 WLUK 492 (15 January 1999). See also E Mishan & Sons, Inc v Hozelock Ltd & Ors [2020] EWCA Civ 871 (8 July 2020).

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2.9

Requirements for a Valid Patent 2: Inventive Step skilled person when considering that prior art, and he lists factors to be taken into consideration when determining this: ‘(a) What was the problem which the patented development addressed? Although sometimes a development may be the obvious solution to another problem, that is not frequently the case. (b) How long had that problem existed? (c) How significant was the problem seen to be? A problem which was viewed in the trade as trivial might not have generated much in the way of efforts to find a solution. So an extended period during which no solution was proposed (or proposed as a commercial proposition) would throw little light on whether, technically, it was obvious. Such an extended period of inactivity may demonstrate no more than that those in the trade did not believe that finding a solution was commercially worth the effort. The fact, if it be one, that they had miscalculated the commercial benefits to be achieved by the solution says little about its technical obviousness and it is only the latter which counts. On the other hand evidence which suggests that those in the art were aware of the problem and had been trying to find a solution will assist the patentee. (d) How widely known was the problem and how many were likely to be seeking a solution? Where the problem was widely known to many in the relevant art, the greater the prospect of it being solved quickly. (e) What prior art would have been likely to be known to all or most of those who would have been expected to be involved in finding a solution? A development may be obvious over a piece of esoteric prior art of which most in the trade would have been ignorant. If that is so, commercial success over other, less relevant, prior art will have much reduced significance. (f) What other solutions were put forward in the period leading up to the publication of the patentee’s development? This overlaps with other factors. For example, it illustrates that others in the art were aware of the problem and were seeking a solution. But it is also of relevance in that it may indicate that the patentee’s development was not what would have occurred to the relevant workers. This factor must be treated with care. As has been said on more than one occasion, there may be more than one obvious route round a technical problem. The existence of alternatives does not prevent each or them from being obvious. On the other hand where the patentee’s development would have been expected to be at the forefront of solutions to be found yet it was not and other, more expensive or complex or less satisfactory, solutions were employed instead, then this may suggest that the ex post facto assessment that the solution was at the forefront of possibilities is wrong. (g) To what extent were there factors which would have held back the exploitation of the solution even if it was technically obvious? For example, it may be that the materials or equipment necessary to exploit the solution were only available belatedly or their cost was so high as to act as a commercial deterrent. On the other hand if the necessary materials and apparatus were readily available at reasonable cost, a lengthy period during which the solution was not proposed is a factor which is consistent with lack of obviousness.

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Bonus effects

2.10

(h) How well has the patentee’s development been received? Once the product or process was put into commercial operation, to what extent was it a commercial success. In looking at this, it is legitimate to have regard not only to the success indicated by exploitation by the patentee and his licensees but also to the commercial success achieved by infringers. Furthermore, the number of infringers may reflect on some of the other factors set out above. For example, if there are a large number of infringers it may be some indication of the number of members of the trade who were likely to be looking for alternative or improved products (see (iv) above). (i) To what extent can it be shown that the whole or much of the commercial success is due to the technical merits of the development, i.e. because it solves the problem? Success which is largely attributable to other factors, such as the commercial power of the patentee or his license, extensive advertising focusing on features which have nothing to do with the development, branding or other technical features of the product or process, says nothing about the value of the intention.’

The judge suggests that this list is not exhaustive, but that it represents factors which, taken together, may point towards or away from inventiveness. BONUS EFFECTS 2.10 A further issue often arises when answering the statutory question. This has to do with bonus effects, or the ‘golden bonus’. The English court may be assisted by evidence that the benefits of the invention were unexpected, but an inventive step cannot be founded on a beneficial technical effect if the invention is obvious for other reasons (see Actavis v ICOS above). The classic case is Hallen Co & Anor v Brabantia (UK) Ltd, which concerned the advantageous effect of adding PTFE to selfpulling cork screws22. Per Slade LJ: ‘True it is that, as the Judge found, it was not obvious that coating a self-puller with PTFE would have the dramatic effect that it did in extracting the cork, and indeed that probably without the intervention of the patent in suit such a corkscrew would not have been marketed for many years. However, as he rightly appreciated, there were in law irrelevant considerations. The dramatic improvement in extraction was for the Plaintiffs a golden bonus; but it is common ground that an added benefit, however great, will not found a valid patent if the claimed invention is obvious for another purpose.’

An unexpected synergistic effect arising from the combination of two or more elements will similarly not constitute an inventive step if making the combination was otherwise obvious to those skilled in the art23. 22 [1991] RPC 195, page 213. 23 See, for example, Cipla Ltd & Ors v Glaxo Group Ltd [2004] EWHC 477 (Pat) (19 March 2004).

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Requirements for a Valid Patent 2: Inventive Step COLLOCATIONS 2.11 Attention should be paid to whether the features in a patent claim are a combination or a collocation. The latter is merely a juxtaposition of features with independent function, rather than features that interact to produce a new technical contribution24. Such collocations should be interpreted as independent inventions, per Lord Hoffmann25: ‘Two inventions do not become one invention because they are included in the same hardware. A  compact motor car may contain many inventions, each operating independently of each other but all designed to contribute to the overall goal of having a compact car. That does not make the car a single invention. … The EPO  Guidelines say that “the invention claimed must normally be considered as a whole”. But equally, one must not try to consider as a whole what are in fact two separate inventions. What the Guidelines do is to state the principle upon which you decide whether you are dealing with a single invention or not. If the two integers interact upon each other, if there is synergy between them, they constitute a single invention having a combined effect and one applies section 3 to the idea of combining them. If each integer “performs its own proper function independently of any of the others”, then each is for the purposes of section 3 a separate invention and it has to be applied to each one separately.’

KEY CASE: 10 OBVIOUSNESS FACTORS – ACTAVIS V ICOS Well worth investigating – the Calcipotriol case 2.12 In Teva v Leo Pharma the Court of Appeal, overturning the first instance decision, held to be inventive Leo’s patent for an ointment consisting of two active ingredients, calcipotriol (a vitamin D analogue) and betamethasone (a corticosteroid), together with a base and a commercially available solvent called Arlamol E. The common general knowledge at the priority date was that calcipotriol and betamethasone could not be used together, because they are both active in different pH ranges. It was thought that the answer to this problem was to use a non-aqueous solvent. However, it was not established that any non-aqueous non-toxic solvent would produce a stable ointment. Instead, the skilled person would have to undergo a research project. The judge at first instance had found that the use of non-aqueous solvents was obvious, because it would be ‘wellworth investigating’. But the Court of Appeal commented that this is not 24 The classic case is the ‘sausage machine’ in Williams v Nye (1890) 7 RPC 62 CA. Of the modern cases, see Nokia GmbH  v IPCom GmbH & Co KG  [2009]  EWHC  3482 (Pat) (18  January 2010) and Thoratec Europe Ltd v Ais GmbH  Aachen Innovative Solutions [2016] EWHC 2637 (Pat) (28 October 2016). 25 Sabaf SpA v MFI Furniture Centres Ltd [2004] UKHL 45 (14 October 2004).

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the same as saying that any particular such solvent had a fair expectation of success26: ‘The Judge said that “there was a sufficient prospect of a positive result in the tests with this compound to make it worth testing”. But that is to say no more than that there was a sufficient prospect of success with any non-aqueous solvent. On this analysis all such solvents were worth testing. Yet the evidence had shown that the “apparent pH” problem was real and that one could not say that just because a solvent was non-aqueous it would work. In effect the Judge was saying that the idea of including this solvent as part of a research project amounted to obviousness. The “obvious to try” standard requires a higher expectation of success than that. Otherwise, as I observed in St Gobain at [35]: “Mere possible inclusion of something within a research programme on the basis you will find out more and something might turn up is not enough. If it were otherwise there would be few inventions which were patentable. The only research which would be worthwhile (because of the prospect of protection) would be in areas totally devoid of prospect”.’

In other words, the ‘obvious to try’ test does not work if it is applied to every course of research that is worth trying, particularly if there is one or more other reasons why that research would not be tried. Teva v Leo Pharma is a rare case in which a first instance decision that a patent is obvious was overturned by the Court of Appeal. Not long afterwards, however, Teva v Leo Pharma was followed by another case in which the issue on which the decision turned was the application of the obvious-to-try sub-test. This time, the fact pattern was almost the inverse of that in Teva v Leo Pharma, and the first instance judge held the patent inventive, but the Court of Appeal held it obvious. This is Actavis Group PTC EHF & Ors v ICOS Corporation & Anor27. Expectation of success – the Tadalafil case 2.13 Actavis v ICOS illustrates that the obvious-to-try test must be kept in context as one approach to the statutory question; and, in particular, that, although an expectation of success may indicate obviousness, the reverse is not necessarily true – an invention may be obvious for other reasons, even if it was not expected to work. First instance 2.14 Actavis sought the revocation of ICOS’s patent relating to the use of tadalafil in a 1 to 5mg dosage form, on a number of grounds including obviousness. The prior art disclosed use of tadalafil for erectile dysfunction in doses ranging from 0.5 to 800mg, daily, together with its activity data. An example of the patent specifically concerned the use of a 50mg tablet of 26 [2015] EWCA Civ 779 (28 July 2015), at paras 31–32. 27 [2017] EWCA Civ 1671 (1 November 2017).

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Requirements for a Valid Patent 2: Inventive Step tadalafil. The patentee argued that this was a case to be considered as one of obvious-to-try and that there was no fair prospect of success that a 5mg dose of tadalafil would work. At first instance, the allegation of obviousness failed. The judge held that, starting with the prior art, the skilled team would not have a reasonable expectation that a dose of 5mg per day would provide a useful treatment for erectile dysfunction, nor any expectation at all that this would produce a clinically relevant effect but with minimal side effects. They would discover during routine trials, however, that this dose was both effective and had reduced side effects, and this would be a surprise. In other words, they would not have a reasonable expectation that the drug at this dose would be a useful treatment for erectile dysfunction and it would not be obvious. Court of Appeal 2.15 The Court of Appeal held that the first instance judge had lost sight of the fact that, on his own findings, the invention lay at the end of the familiar path through the routine pre-clinical and clinical trials process. The Phase I studies would produce results which would lead the skilled team to design and undertake the Phase IIa ‘go no-go’ study of a single 50mg dose of tadalafil in a relatively small group of patients. They would embark on that study with a reasonable expectation that the drug would be safe, tolerable and effective at that dose. Turning to the Phase IIb studies, the first instance judge had concluded that the first dose ranging study would be of on demand dosing using 25, 50 and 100mg of the drug. The judge had also concluded that it was not inevitable that the skilled team would investigate lower doses after discovering the therapeutic plateau because they had found a dose (at least 10mg) which was safe, tolerable and effective and thus had secured the prime objective of the programme; but he had held that it was ‘very likely’ that they would. In the course of these studies, it was very likely that they would arrive at the claimed invention by testing a dose of 5mg tadalafil per day, finding it safe and efficacious. The 5mg dose would thus be arrived at by routine and, therefore, the fact that the skilled team would not have a fair expectation of its success, or that they would be surprised by the efficacy of 5mg, was irrelevant. In other words, an expectation of success is not required if the invention is obvious for another reason – in this case, carrying out routine testing. The Supreme Court’s 10 factors 2.16 The Supreme Court28 unanimously dismissed an appeal from the Court of Appeal decision, upholding its decision that the patent is invalid for

28 Actavis Group PTC EHF & Ors v ICOS Corporation & Anor [2019] UKSC 15 (27 March 2019).

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2.16

lack of inventive step. In doing so, the Court emphasised that the assessment of inventive step was multi-factorial, and it set out ten factors that should be taken into consideration on the facts of the case, only the first of which is the obvious-to-try test, as follows in edited form: i. First, consider whether at the priority date something was obvious to try, in other words whether it was obvious to undertake a specific piece of research which had a reasonable or fair prospect of success29: in many cases the consideration that there is a likelihood of success which is sufficient to warrant an actual trial is an important pointer to obviousness. However, there is no requirement that it is manifest that a test ought to work30; that would impose a straightjacket which would preclude a finding of obviousness in a case where the results of an entirely routine test are unpredictable. Conversely, some experiments which are undertaken without any particular expectation as to result are obvious. The relevance of the ‘obvious to try’ consideration and its weight when balanced against other relevant considerations depend on the particular facts of the case. ii. Secondly, the routine nature of the research and any established practice of following such research through to a particular point may be a relevant consideration which is weighed against the consideration that the claimed process or product was not obvious to try at the outset of a research programme. Again, it is only one of several factors to be weighed in the assessment and it has no primacy and certainly no paramount status as a consideration31. iii. Thirdly, the burden and cost of the research programme is relevant. But the weight to be attached to this factor will vary depending on the particular circumstances. The cost and effort involved in bringing a drug to market through pre-clinical and clinical trials are notorious32. But the effort involved in research is only one of several factors which may be relevant to the statutory question of obviousness. iv. Fourthly, the necessity for and the nature of the value judgments which the skilled team would have in the course of a testing programme are relevant considerations. v. Fifthly, the existence of alternative or multiple paths of research will often be an indicator that the invention contained in the claim or claims was not obvious. If the notional skilled person is faced with only one avenue of research, a ‘one way street’, it is more likely that the result of his or her research is obvious than if he or she were faced with a

29 Conor Medsystems Inc v Angiotech Pharmaceuticals Inc [2008] UKHL 49. 30 Novartis AG v Generics (UK) Ltd [2012] EWCA Civ 1623. 31 See Akebia Therapeutics Inc v Fibrogen, Inc [2020] EWHC 866 (Pat) (20 April 2020). 32 Sir Hugh Laddie, ‘Patents – what’s invention got to do with it?’ (in Intellectual property in the new millennium: essays in honour of William R Cornish (2004), p 91 et seq).

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Requirements for a Valid Patent 2: Inventive Step multiplicity of different avenues. But it is necessary to bear in mind the possibility that more than one avenue of research may be obvious33. vi. Sixthly, the motive of the skilled person is a relevant consideration. The notional skilled person is not assumed to undertake technical trials for the sake of doing so but rather because he or she has some end in mind. It is not sufficient that a skilled person could undertake a particular trial; one may wish to ask whether in the circumstances he or she would be motivated to do so. The absence of a motive to take the allegedly inventive step makes an argument of obviousness more difficult34. vii. Seventhly, the fact that the results of research which the inventor actually carried out are unexpected or surprising is a relevant consideration as it may point to an inventive step, at least in so far as it suggests that a test was not obvious to try or otherwise the absence of a known target of the research which would make it less likely that the skilled person would conduct a test. viii. Eighthly, the courts have repeatedly emphasised that one must not use hindsight, which includes knowledge of the invention, in addressing the statutory question of obviousness. Where the pattern of the research programme which the notional skilled person would undertake can clearly be foreseen, it may be legitimate to take a step by step analysis35. But, the obvious danger of a step by step analysis is that the combination of steps by which the inventor arrived at his invention is ascertained by hindsight knowledge of a successful invention36, but this concern would have no bearing in a case in which the steps which the notional skilled person would take can readily be ascertained without the taint of hindsight. ix. Ninthly, it is necessary to consider whether a feature of a claimed invention is an added benefit in a context in which the claimed innovation is obvious for another purpose37. x. A tenth consideration is the nature of the invention. In this case a dosage regime patent. The Supreme Court held that a target of the skilled team, from the outset, would be to ascertain the appropriate dose, which would usually be the lowest effective dose. The pre-clinical and clinical tests involved familiar and routine procedures and normally progressed to the discovery of the dose-response relationship in Phase IIb. In this case the trial judge’s findings of what would have been the sequence of the tests, which did not depend upon hindsight, included the finding, which the evidence clearly justified,

33 34 35 36 37

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Brugger v Medic-Aid Ltd (No 2) [1996] RPC 635. AgrEvo/Tiazoles (T-939/92) [1996] EPOR 171. Gedeon Richter plc v Bayer Schering Pharma AG [2011] EWHC 583 (Pat). Technograph Printed Circuits Ltd v Mills & Rockley (Electronics) Ltd [1972] RPC 346. Hallen & Co v Brabantia (UK) Ltd [1991] RPC 195.

KEY CASE: 10 obviousness factors – Actavis v ICOS

2.16

that the team, having found a therapeutic plateau, would be very likely to test lower doses and so come upon the dosage regime which is the subject matter of the patent. The patent was consequently invalid for obviousness. The ICOS case is something of a cautionary tale about the importance of keeping sight of the statutory test for inventive step: ‘is the invention obvious?’. The Supreme Court said that even the well-established Windsurfing/Pozzoli approach to addressing the statutory question must not be applied too mechanistically. Instead, it must be treated cautiously and in context, together with the other factors where present. Inventive step in the EPO The statutory question for inventive step in Article  56 of the EPC applies in the EPO  Boards of Appeal as it does in the UK. The Boards do not use the Windsurfing/Pozzoli approach to determining this question, but instead the ‘problem-and-solution approach’. This is set out in the Guidelines for Examination in the EPO38: ‘Problem-and-solution approach In order to assess inventive step in an objective and predictable manner, the so-called “problem-and-solution approach” is applied. In the problem-and-solution approach, there are three main stages: (1) determining the “closest prior art”, (2) establishing the “objective technical problem” to be solved, and (3) considering whether or not the claimed invention, starting from the closest prior art and the objective technical problem, would have been obvious to the skilled person.’

The EPO problem-and-solution approach requires that the single closest piece of prior art is identified in Step (1). It is the single closest piece of prior art that is relevant39. This is the piece of prior art that is the most promising starting point for arriving at the invention. It may be common general knowledge40 or public prior use41. The closest piece of prior art may not be combined with other prior art documents unless it is obvious for the skilled person to do so 42.

38 Guidelines for Examination in the EPO, Part G, Patentability, Chapter VII, 2-3, November 2018. 39 Exceptionally, this may be two documents in combination with each other (T  176/89 Ultrahigh-molecular-weight polyethylene/MITSUI (unpublished) (27 June 1990)). For a comparison to the UK, see E Mishan & Sons, Inc v Hozelock Ltd & Ors [2020] EWCA Civ 871 (8 July 2020). 40 T  2101/12 Authentication binding document with signature/VASCO (unpublished) (24 January 2018). 41 T 1464/05 Hydrogen-absorbing composition/PRYSMIAN (unpublished) (14 May 2009). 42 See T 1014/07 Saturated dicarboxylic acids/COGNIS (unpublished) (2 July 2012).

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Requirements for a Valid Patent 2: Inventive Step Step (2) is then designed to establish, in an objective way, the technical problem to be solved. The description of a patent must ‘disclose the invention, as claimed, in such terms that the technical problem (even if not expressly stated as such) and its solution can be understood, and state any advantageous effect of the invention with reference to the background art’43. The objective technical problem has to be established objectively by examining the patent description, the prior art and the technical44 (as opposed to non-technical) distinguishing features between the two45. The resulting technical problem may not be the same as that identified by the patent alone. As in the UK, eliminating hindsight is critical and so the problem identified must not contain any pointers to the solution46. Much like Windsurfing/Pozzoli in the UK, the problem-andsolution is a structured approach to the statutory question – is the claimed invention obvious to a person skilled in the art? – and not a means to answer that question in itself. In the problem-and-solution approach, this statutory question is actually asked at Step (3). The EPO addresses this using the ‘could-would’ approach47: ‘Could-would approach In the third stage the question to be answered is whether there is any teaching in the prior art as a whole that would (not simply could, but would) have prompted the skilled person, faced with the objective technical problem, to modify or adapt the closest prior art while taking account of that teaching, thereby arriving at something falling within the terms of the claims, and thus achieving what the invention achieves.’

The question is not whether the skilled person could have arrived at the invention claimed in the patent by using their common general knowledge to make the adaptations or modifications to the closest prior art that it discloses, but whether they would have done so. This is a question about motivation, and examines whether there are factors that would motivate the skilled person in the hope of solving the objective technical problem or in the expectation of some improvement or advantage48. As in the UK, however, care needs to be taken to avoid substituting this approach entirely for the simple test in Article 56. In particular,

43 EPC, Rule 42(1)(c). 44 T 154/04 Estimating sales activity/DUNS LICENSING ASSOCIATES [2008] OJ EPO 46 (15 November 2006). 45 See Guidelines for Examination in the EPO, Part G, Chapter VII, 5.2. 46 See T 99/85 Diagnostic Agent/BOEHRINGER [1987] OJ EPO 413 (23 October 1986). 47 Guidelines for Examination in the EPO, Part G, Patentability, Chapter VII-5, November 2018. 48 See, for example, T 2/83 Simethicone Tablet/RIDER [1984] OJ EPO 265 (15 March 1984).

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KEY ISSUE: Plausibility obviousness

2.19

the Board has noted that a reasonable expectation of success is not appropriate when the implementation and the testing of an approach suggested by the prior art does not involve any particular technical difficulties. Here, the skilled person would prefer to verify a potential solution than abandon a project because success is not certain49. Secondary indicia are also relevant in the EPO but, as in the UK, they are only persuasive in finely balanced cases. These include commercial success, provided that it is corroborated by long-felt want or need and that it is due to the technical features of the invention rather than other factors such as marketing or market monopoly50. Overcoming a technical prejudice by the invention is also considered to be a secondary indicator51. An unexpected technical effect may count in favour of inventive step, if derived from the subject matter claimed, but there must not be other reasons why the invention is obvious.

KEY ISSUE: PLAUSIBILITY OBVIOUSNESS 2.17 Plausibility obviousness is now established as a form of obviousness attack, which can be run alongside, and is complementary to, classic obviousness. Technical contribution and plausibility 2.18 In basing its approach to Article 56 on the solution to the objective technical problem (see the shaded box in para 2.16), the EPO has contributed a further approach to obviousness, which has been adopted by the UK courts in recent years. This approach asks whether there is any technical solution, and therefore technical contribution, at all, by asking whether the claimed contribution is plausible. EPO authority on plausible technical contribution is rooted in two authorities in particular: Triazoles/AGREVO and Factor-9/ John Hopkins. Origins of plausibility in EPO life sciences cases Triazoles/AGREVO 2.19 Although the word ‘plausibility’ is not actually used in the case, it has its origins in the EPO Technical Boards of Appeal decision Triazoles/ 49 T 0259/15 Buprenorphine patch/EURO-CELTIQUE (unpublished) (25 July 2017). 50 T 478/91 Grooved pulley/ AUBECQ AUXI (unpublished) (2 June 1993). 51 See T 119/82 Jellification/EXXON [1984] OJ EPO 217 (12 December 1983).

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2.20

Requirements for a Valid Patent 2: Inventive Step AGREVO T 939/9252. This case concerned a per se product claim for a class of triazole sulphonamide compounds useful as herbicides. On appeal, the patent was held sufficient by the TBA because it had been established that all of these compounds could be made. The TBA also held that the patent was invalid for obviousness. It did so, first, on the finding that there was nothing inventive in making the compounds. This meant that, if there was to be any invention at all, it would have to reside in the finding that the compounds had herbicidal properties. The problem for the patentee, however, was that the description contained nothing to justify its assertion that all of the compounds claimed were, in fact, herbicidal. The TBA held that there must be a technical effect (in this case, herbicidal properties) and this must not be ‘inherently unlikely’ in substantially all of the compounds. Instead, it should be ‘reasonably predictable’, ‘fairly assumed’ or ‘credible’. The technical problem of the prior art – identified for the purpose of the problem-solution approach – had not been solved and, if it had not been solved, there could be no technical contribution and no invention under Article 56 of the EPC. Factor-9/Johns Hopkins 2.20 A  decade later, in the Factor-9/Johns Hopkins T  1329/0453 case, the threshold for demonstrating a technical contribution was reiterated and expressed in different terms. Johns Hopkins concerned the validity of a per se claim to growth differentiating factor (GDF-9), in particular polynucleotides encoding polypeptides having GDF-9 activity. The technical problem addressed by the patent application was the identification of a further member of the TGF-β superfamily, a group of polypeptide factors that regulate differentiation processes during embryogenesis. In the patent application, functions of members of the TGF-β superfamily were attributed to GDF-9 on the basis of amino acid sequence homology with the superfamily, but without any technical evidence of equivalent function. The decision for the TBA in Johns Hopkins was how much weight could be given to these speculations when assessing inventive step according to the approach of AgrEvo. The TBA concluded that the application did not sufficiently identify this factor as a member of this family; there was not enough evidence in the application to make at least plausible that a solution was found to the problem that was purportedly solved. In short, the requirement in AgrEvo for the patent specification to provide a ‘reasonably predictable’, ‘fairly assumed’ or ‘credible’ basis for

52 T 939/92 Triazoles/AGREVO [1996] OJ EPO 309 (12 September 1995). 53 T 1329/04 Factor-9/JOHNS HOPKINS (unpublished) (28 June 2005).

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2.23

the technical contribution in a class of compounds was, in Johns Hopkins, expressed as the need for the technical contribution of the invention to be ‘at least plausible’. Plausibility in the UK – the taxol stent case Facts 2.21 The first time AgrEvo was applied at appeal level in English law was in the House of Lords in Conor Medsystems v Angiotech54. The patent in suit in Conor Medsystems claimed the use of a stent coated in an anti-angiogenic factor, in particular taxol, for treating or preventing recurrent restenosis – that is, the growth of tissue and associated blood vessels by angiogenesis, in and around the structure of the stent. To solve the restenosis problem, Angiotech claimed the use of a stent covered in an anti-angiogenic factor, in particular taxol. Taxol was one of a number of known drugs at the priority date of the patent that could prevent cell division and thus restenosis. Importantly, the patent did not contain any experimental results to show that the stent coated with taxol would actually work to treat restenosis. Conor sought revocation of the patent on the basis that it was obvious in the light of prior art that disclosed a drug-eluting stent for local delivery of ‘anti-replicate’ drugs that might reduce restenosis. First instance and appeal 2.22 At first instance, Pumfrey J revoked the patent as obvious. Given the lack of evidence in the patent that taxol would work, both Pumfrey J and the Court of Appeal said that the correct obviousness question to ask is whether it is obvious that taxol might work in the stent, not that it would work. House of Lords 2.23 On appeal to the House of Lords, the argument was put along the same lines: because the patent did not show that taxol would actually work in reducing restenosis, it was nothing more than an idea that taxol might work. And ideas, as such, cannot form the basis of an invention. The Lords agreed that a patent must not be granted for an idea which is mere speculation, unsupported by any disclosure in the specification. However, that was not the case here: the patent did contain support for a claim to a taxol-coated stent to treat or prevent restenosis, even if there was no actual evidence of it having done so.

54 Conor Medsystems Inc v Angiotech Pharmaceuticals Inc & Ors [2008] UKHL 49 (9 July 2008).

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Requirements for a Valid Patent 2: Inventive Step Angiotech were therefore entitled to have the obviousness of the patent addressed on the assumption that taxol would work, provided that it was plausible. Subsequent applications of plausibility to pharmaceutical cases 2.24 The English Court of Appeal has summarised the role of plausibility in an obviousness assessment, as follows55: ‘i) Article  56 of the EPC is in part based on the underlying principle that the scope of the patent monopoly must be justified by the patentee’s contribution to the art; ii) If the alleged contribution is a technical effect which is not common to substantially everything covered by a claim, it cannot be used to formulate the question for the purposes of judging obviousness; iii) In such circumstances the claim must either be restricted to the subject matter which makes good the technical contribution, or a different technical solution common to the whole claim must be found; iv) A  selection from the prior art which is purely arbitrary and cannot be justified by some useful technical property is likely to be held to be obvious because it does not make a real technical advance; v) A  technical effect which is not rendered plausible by the patent specification may not be taken into account in assessing inventive step; vi) Later evidence may be adduced to support a technical effect made plausible by the specification; vii) Provided the technical effect is made plausible, no further proof of the existence of the effect is to be demanded of the specification before judging obviousness by reference to the technical effect propounded.’

The principle that a claimed invention will be obvious if it does not disclose a plausible technical contribution has been applied in a number of English cases, although plausibility is still more usually encountered in insufficiency cases (see Chapter 4). Idenix Pharmaceuticals v Gilead – nucleoside prodrugs 2.25 Idenix Pharmaceuticals v Gilead56 concerned a patent claiming a class of modified nucleoside prodrugs and their use for treating flaviridae infections, in particular hepatitis C  virus (HCV). Gilead had a marketing authorisation for sofosbuvir (which is an HCV treatment). Idenix claimed that Gilead was infringing by keeping and disposing of sofosbuvir. Gilead

55 Generics (UK) Limited t/a Mylan v Yeda Research and Development Co Ltd and Teva Pharmaceutical Industries Ltd [2013] EWCA Civ 925 (29 July 2013), at para 49. 56 Idenix Pharmaceuticals Inc v Gilead Sciences Inc & Ors [2016]  EWCA  Civ 1089 (8 November 2016).

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Selection inventions

2.27

successfully counterclaimed at first instance that the patent should be revoked for lack of novelty over an earlier patent application, that it lacked inventive step because it made no technical contribution, and also that it was insufficient and contained added matter. Upholding the first instance decision, the Court of Appeal re-stated the principle that, when assessing obviousness in the Patents Court, the claimed technical contribution of the invention must be plausible in light of the teaching of the specification and the common general knowledge. In this case, a mere assertion in the patent that ‘nucleosides of this invention may inhibit flaviridae polymerase activity’ and that ‘nucleosides can be screened for their ability to inhibit …’ did not provide either the evidence or the rationale needed for the judge to hold the patent plausible for the purpose of inventive step. Merck v Shionogi 2.26 Idenix was quickly followed by Merck v Shionogi57, in which the patent was held obvious purely on the basis that it did not disclose a plausible technical contribution. In this case, the patent claimed a class of compounds (described by a Markush formula covering some 1039 compounds) for use as integrase inhibitors for preventing or treating viral disease. Mr Justice Arnold found at first instance that the specification did not even make it plausible that substantially all of the compounds covered by the Markush formula possessed integrase inhibitory activity in a biochemical assay; much less that they possessed actual antiviral activity – the specification did not report any antiviral data, toxicity data or validation work for even a single compound. The lack of plausibility finding meant that the teaching of the patent could not be performed across the whole scope of the claim and must be obvious. At the same time, and for the same reason, it was also held to be insufficient, demonstrating that plausibility is a common threshold to patentability under more than one head of validity. Indeed, it is under the statutory head of insufficiency, in the later Warner-Lambert case, that the English courts have addressed plausibility in most detail (see Chapter 4). SELECTION INVENTIONS 2.27 In Dr Reddy’s v Eli Lilly58, the Court of Appeal had to decide whether Eli Lilly’s patent claiming the single compound olanzapine, and claims to 57 Merck Sharp and Dohme Ltd v Shionogi & Co Ltd [2016] EWHC 2989 (Pat) (25 November 2016). 58 Dr Reddy’s Laboratories (UK) Ltd v Eli Lilly & Company Ltd [2009] EWCA Civ 1362 (18 December 2009).

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Requirements for a Valid Patent 2: Inventive Step its use as an anti-psychotic, were valid over a prior art specification claiming a novel class of thieno-benzo-diazepines. This class of compounds was disclosed in the prior art by means of a Markush formula. Substituting all of the options for R1, R2, Q and T given in the specification of the prior art document, the Markush formula was estimated to cover some 1019 compounds. These compounds included olanzapine, but it was nowhere identified specifically in the earlier patent. As a result, the question arose whether the disclosure of olanzapine generically, in the Markush formula, could be an anticipation of the Eli Lilly patent to olanzapine alone. Until Dr Reddy’s, the leading English case on selection inventions had been Du Pont’s Patent, decided by the House of Lords under the rules on ‘selection patents’ formulated under the Patents Act 1949. Since then, however, both the Patents Act 1977 had come into force and the EPO had introduced a different approach to selection patents. Consequently, in Dr  Reddy’s, the Court of Appeal thought it time to adjust the English approach accordingly. This new approach is described by Jacob LJ as follows: ‘So I think the better approach is to see what the EPO Boards do when a patented product or class of products falls within a greater class. They deploy the objection of obviousness where the patentee has in truth made no real technical advance. The EPO jurisprudence is founded firmly around a fundamental question: has the patentee made a novel non-obvious technical advance and provided sufficient justification for it to be credible? That is the basis of all the reasoning of AgrEvo. A “selection” (by which I mean the later claimed compound or sub-class) which makes a real technical advance in the art is patentable.’

In order to be non-obvious, a selection of compounds must not be arbitrary (it must also be novel, see Chapter  1). It must instead be justified by a hitherto unknown ‘technical advance’. That advance must also be ‘credible’ across the selected compounds, in keeping with the authority of AgrEvo. Selection inventions are, in this way, linked to the plausibility issue. THE PLAUSIBILITY THRESHOLD – DASATINIB T 488/16 2.28 The requirement for a plausible technical contribution has also continued to feature in the TBA cases. In particular, the dasatinib case (T  488/16) brings the thinking in the TBA up-to-date. This is one of two dasatinib cases dealing with plausibility, but the other case (T 0950/13) does so in the context of sufficiency (see Chapter 4), illustrating the interconnection between inventive step and sufficiency at the plausibility level. In T 488/16, the TBA found that the application contained no verifiable data. There was also no established structure-activity relationship making it plausible for dasatinib to act as a Protein tyrosine kinase (PTK) inhibitor and therefore make it suitable in the treatment of associated PTK disorders, in particular cancer. As a result, the TBA held that a mere verbal statement that the compounds had been found active did not render it credible that 68

The plausibility threshold – dasatinib T 488/16

2.28

the invention solved the technical problem that the application purported to solve – a PTK inhibitor, in particular dasatinib, to treat disorders or associated diseases. Without resolving a technical problem, Article 56 could not be met. The patentee submitted that there should be a presumption that a granted patent solves the technical problem that it purports to solve. But the TBA disagreed, holding that, even if the burden was on the opponents to raise substantiated doubts, they had discharged this by pointing to the lack of plausibility based on the application as filed. The TBA stated: ‘it is not always required to include experimental data or results in an application … It is however a conditio sine qua non that it is shown that the technical problem underlying the invention was at least plausibly solved at the filing date. If, as in the present case, the nature of the invention is such that it relies on a technical effect, which is neither self-evident nor predictable or based on a conclusive theoretical concept, at least some technical evidence is required to show that a technical problem has indeed been solved. In the board’s judgement, it is not acceptable to draw up a generic formula, which covers millions of compounds, vaguely indicate an ‘activity’ against PTKs and leave it to the imagination of the skilled reader or to future investigations to establish which compound inhibits which kinase and is therefore suitable to treat the respective diseases associated therewith.’

These issues, in particular the alternative basis of plausibility either in evidence or as a concept, are explored in greater detail in the UK case of Warner-Lambert, relating to pregabalin. This case also addresses whether there is actually any difference between the plausibility threshold in the EPO and in the UK courts (see Chapter 4).

69

Chapter 3 Requirements for a Valid Patent 3: Patentable Subject Matter and Exclusions

LIFE SCIENCES CONTEXT 3.1 Certain forms of subject matter are not patentable. Most fundamentally, a patent cannot protect a mere idea, it must disclose matter that is capable of ‘industrial application’. In the biotechnology field, given the way in which information on genes and proteins can be gathered using in silico techniques, there is a risk of filing a patent before it has been adequately established what the technical application of that information is. A  further key issue being driven by advances in computer technology applies in the medical devices sector. Here, algorithms are being applied to mediate the communication of information between devices in or on the body and handheld devices or medical centres. This is placing issues about the patentability of computer-implemented inventions, mathematical methods, mental acts and the presentation of information front and centre in this field. Special considerations and exclusions also apply to certain forms of life sciences subject matter that are technical but nonetheless may not be patented for reasons of public policy. These include plant and animal varieties, certain stem cell technology, forms of diagnostic method, treatments by surgery and therapeutic methods. INDUSTRIAL APPLICABILITY General principles 3.2 1

Section 4(1) of the Patents Act 19771 provides that: Framed as to have, as nearly as practicable, the same effects as Article 57 of the EPC.

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3.2

Requirements for a Valid Patent 3: Patentable Subject Matter ‘an invention shall be taken to be capable of industrial application if it can be made or used in any kind of industry, including agriculture.’

Industrial applicability is generally regarded as a low-threshold step to patentability. It is also construed widely and seldom, therefore, arises as an issue in practice. The low nature of the threshold has been reinforced more recently by its apparent identity with plausibility in the Supreme Court decision of Human Genome Sciences Inc v Eli Lilly & Company2 (‘HGS’), which has led to a renewed focus on the subject (see para 3.6). Case law from the EPO has been an important source of guidance in the UK on industrial applicability. Industrial applicability in the EPO and the UK is also closely associated with plausibility and the role of plausibility in sufficiency (see also Chapter 4). Before addressing the HGS authority, it is therefore necessary to look at the roots of plausibility in the EPO case law. Industrial applicability in the EPO Industrial application must be derivable from the patent application together with the common general knowledge, and it is a concept that the Boards of Appeal construe broadly3. It includes subject matter of immediate concrete benefit4, as well as applications carried out for ‘financial (commercial) gain’5 and ‘profitable use’,6 meaning the possibility of practical use in industry7: ‘“profitable use” should be understood more in the sense of “immediate concrete benefit”. This conveys, in the words “concrete benefit”, the need to disclose in definite technical terms the purpose of the invention and how it can be used in industrial practice to solve a given technical problem, this being the actual benefit or advantage of exploiting the invention. The essence of the requirement is that there must be at least a prospect of a real as opposed to a purely theoretical possibility of exploitation. Further, the use of the word “immediate” conveys the need for this to be derivable directly from the description, if it is not already obvious from the nature of the invention or from the background art. It should not be left to the skilled reader to find out how to exploit the invention by carrying out a research programme.’

2

Human Genome Sciences Inc v Eli Lilly & Company [2011]  UKSC  51 (2  November 2011). 3 T 74/93 Contraceptive method/BRITISH TECHNOLOGY [1995] EPO OJ 712 (9 November 1994). 4 T 898/05 Hematopoietic receptor/ZYMOGENETICS (unpublished) (7 July 2006). 5 T 144/83 Appetite suppressant/DU PONT [1986] EPO OJ 301 (27 March 1986). 6 T 870/04 BDP1 Phosphatase/MAX-PLANCK (unpublished) (11 May 2005). 7 T 898/05 Hematopoietic receptor/ZYMOGENETICS (unpublished) (7 July 2006).

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Industrial applicability

3.2

Subject matter is not industrially applicable if it contravenes the laws of physics8 or is purely for private and personal purposes9. Findings of research can be a particular issue in the field of biotechnology, where discovery can outpace the characterisation of function10: ‘where a substance, naturally occurring in the human body, is identified, and possibly also structurally characterised and made available through some method, but either its function is not known or it is complex and incompletely understood, and no disease or condition has yet been identified as being attributable to an excess or deficiency of the substance, and no other practical use is suggested for the substance, then industrial applicability cannot be acknowledged. Even though research results may be a scientific achievement of considerable merit, they are not necessarily an invention which can be applied industrially.’

Mere speculative indications of applications to be found by future research do not qualify11: ‘Accordingly, a product whose structure is given (e.g. a nucleic acid sequence) but whose function is undetermined or obscure or only vaguely indicated might not fulfil the above criteria, in spite of the fact that the structure of the product per se can be reproduced. If a patent is granted therefor, it might prevent further research in that area, and/or give the patentee unjustified control over others who are actively investigating in that area and who might eventually find actual ways to exploit it. On the other hand, a product which is definitely described and plausibly shown to be usable, e.g. to cure a rare or orphan disease, might be considered to have a profitable use or concrete benefit, irrespective of whether it is actually intended for the pursuit of any trade at all. Thus, although no particular economic profit might be expected in the development of such products, nevertheless there is no doubt that it might be considered to display immediate concrete benefits.’

Subject matter will be industrially applicable if it makes plausible the identity of the claimed compound, and the compound putative functions are disclosed12. Experimental evidence is not necessary, provided that reasonable assumptions can be made about the known functions of other family members of a compound or biological agent as well as, for example, by taking into account its distribution in the body. These must relate to the function being attributed to the molecule.

8 T  541/96 Element and energy production device/ZACHARIAH (unpublished) (7  March 2001). 9 Contraceptive method/BRITISH TECHNOLOGY [1995] EPO OJ 712 (9 November 1994). 10 T 870/04 BDP1 Phosphatase/MAX-PLANCK (unpublished) (11 May 2005). 11 T 898/05 Hematopoietic receptor/ZYMOGENETICS (unpublished) (7 July 2006). 12 T 1450/07 TGFalpha-HII/Human Genome Sciences (unpublished) (11 February 2009).

73

3.3

Requirements for a Valid Patent 3: Patentable Subject Matter Plausibility and industrial applicability 3.3 The requirement to provide a plausible technical contribution has its origins in the EPO  Technical Boards of Appeal decisions Triazoles/ AGREVO13 and Factor-9/Johns Hopkins14 (see paras 2.19 and 2.20). Although not a statutory ground of objection to validity on its own, plausibility has now become established as a base-line or ‘threshold test’ to patent validity underlying a number of the statutory objections and aligning particularly with industrial applicability. Indeed, the industrial application requirement serves essentially the same policy considerations as plausibility. This is particularly visible in the context of second medical use claims, where Birss J has rationalised plausibility as providing a balance between: at one extreme, a demand that the patent specification must contain the results of a clinical trial in order to prove efficacy, since the claims contain this element as a feature; and, at the other extreme, the argument that, if all that the patent contains is a mere proposal, it has not made a contribution to the art (that is, it is merely theoretical). The problem that the first extreme poses is this: although the existence of a patent (or patent application) may encourage investment in a clinical trial that might not otherwise take place, a rule which demanded clinical results could cause real difficulties. The problem posed by the other extreme is that it would be a recipe for abuse if all that was required in order to obtain a patent in the field in question was a mere proposal, without any basis, to use drug A to treat disease B. KEY CASE: SEQUENCE HOMOLOGY – HUMAN GENOME SCIENCES V ELI LILLY 3.4 The HGS15 case is a particularly significant application of plausibility in the context of biotechnological inventions, as Lord Hope explains, because it concerns the right point in a long research process at which it is best to file a patent: ‘The bioscience industry is particularly dependent, however, on funding for long term research and development. It is commonplace for those who need money for these activities to have to look to other organisations to provide it. The tests that must be applied are necessarily very rigorous, and it may require many years of investment before a product can be declared safe for use in the promotion of health in humans. The gap between the point of initial research and the point where the discovery is ready to be developed by the pharmaceutical industry can be

13 AgrEvo/Tiazoles (T-939/92) [1996] EPOR 171. 14 T 1329/04 Factor-9/JOHNS HOPKINS (unpublished) (28 June 2005). 15 Human Genome Sciences Inc v Eli Lilly & Company [2011]  UKSC  51 (2  November 2011).

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KEY CASE: Sequence homology – Human Genome Sciences v Eli Lilly

3.4

very wide. Various steps along this uncertain road can be identified in the present case. First, there is the inventive step itself. In this case it revealed the existence of Neutrokine-α, a previously unknown member of the TNF ligand superfamily. The characteristics of the newly discovered protein had then to be examined and analysed. In this case the task was to determine whether the Neutrokine-α molecule had characteristics that offered the prospect of influencing biological mechanisms in the same way as other members of the superfamily. If that could be achieved, there would then have to follow a large amount of research and development before the molecule could be deployed therapeutically. The question that this case raises is how far along that road the process must go before the invention can be held to be susceptible of industrial application and patented.’

The case concerned a patent disclosing the amino acid and coding nucleotide sequence for a polypeptide called Neutrokine-α (a member of the tumour necrosis factor (TNF) superligand family). HGS’s scientists had determined the nucleotide sequence for the gene coding for Neutrokine-α and its amino acid sequence using a bioinformatics technique. The use of this technique meant, however, that there was no experimental evidence of activity. Instead, only presumptions could be made about Neutrokine-α activity, based on shared sequence homology with other members of the same superfamily. The identity of any receptor was also unknown, as was any disease which the polypeptide might treat. As a result, Eli Lilly claimed that the patent was invalid because it did not disclose an invention capable of industrial application. At issue in the case was the industrial applicability requirements of section 4(1) of the Patents Act 1977, as well as the requirement in Article 5 of the Biotechnology Directive that the industrial application of a gene sequence be disclosed in the patent application. Given the dearth of English authorities on the issue, the case reached the Supreme Court, which reviewed the TBA authorities16; amongst them, Johns Hopkins: ‘… on 28  June 2005, the Board decided T  1329/04 Factor-9 / Johns Hopkins, in which it again upheld the ED’s refusal of a patent application. At T 1329/04, para  4, the Board embarked on its familiar problem/solution approach, and described “the problem to be solved … as isolating a further member of the TGF-β superfamily”, whose established members it described as “[having] influence on a wide variety of differentiation processes such as adipogenesis, myogenesis etc”. The Board went on to say that the patent’s claimed solution was the nucleotide sequence encoding for the claimed polypeptide, and described the issue as being “[w]hether or not the problem … has been plausibly solved”.’

Lord Neuberger summarised the TBA’s approach to Article 57 in relation to biological material, and set out a number of points of general principle and

16 In particular: T  0898/05 Hematopoietic receptor/ZymoGenetics; T  0870/04 BDP1 Phosphatase/ Max-Planck; T  1165/06  IL-17 related polypeptide/Schering, decided 19 July 2007; T 1452/06 Serine protease/Bayer (10 May 2007).

75

3.4

Requirements for a Valid Patent 3: Patentable Subject Matter points relevant to particular types of protein claims, a number of which are summarised above: ‘The general principles are: (i) The patent must disclose “a practical application” and “some profitable use” for the claimed substance, so that the ensuing monopoly “can be expected [to lead to] some … commercial benefit” …; (ii) A “concrete benefit”, namely the invention’s “use … in industrial practice” must be “derivable directly from the description”, coupled with common general knowledge …; (iii) A merely “speculative” use will not suffice, so “a vague and speculative indication of possible objectives that might or might not be achievable” will not do …; (iv) The patent and common general knowledge must enable the skilled person “to reproduce” or “exploit” the claimed invention without “undue burden”, or having to carry out “a research programme” …; Where a patent discloses a new protein and its encoding gene: (v) The patent, when taken with common general knowledge, must demonstrate “a real as opposed to a purely theoretical possibility of exploitation” … ; (vi) Merely identifying the structure of a protein, without attributing to it a “clear role”, or “suggest[ing]” any “practical use” for it, or suggesting “a vague and speculative indication of possible objectives that might be achieved”, is not enough …; (vii) The absence of any experimental or wet lab evidence of activity of the claimed protein is not fatal …; (viii) A  “plausible” or “reasonably credible” claimed use or an “educated guess”, can suffice …; (ix) Such plausibility can be assisted by being confirmed by “later evidence”, although later evidence on its own will not do …; (x) The requirements of a plausible and specific possibility of exploitation can be at the biochemical, the cellular or the biological level …; Where the protein is said to be a family or superfamily member: (xi) If all known members have a “role in the proliferation, differentiation and/or activation of immune cells” or “function in controlling physiology, development and differentiation of mammalian cells”, assigning a similar role to the protein may suffice …; (xii) So “the problem to be solved” in such a case can be “isolating a further member of the [family]” …; (xiii) If the disclosure is “important to the pharmaceutical industry”, the disclosure of the sequences of the protein and its gene may suffice, even though its role has not “been clearly defined” …; (xiv) The position may be different if there is evidence, either in the patent or elsewhere, which calls the claimed role or membership of the family into question …; (xv) The position may also be different if the known members have different activities, although they need not always be “precisely interchangeable in terms of their biological action”, and it may be acceptable if “most” of them have a common role …’

76

Exclusions

3.5

In the light of these principles, the disclosure of the existence and structure of Neutrokine-α and its gene sequence, and its membership of the TNF ligand superfamily were sufficient, taking into account the common general knowledge, to satisfy the requirements of Article 57. It is also important to read the Supreme Court HGS decision alongside the Supreme Court decision in Warner-Lambert, where the issue of plausibility arose again, but in the context of sufficiency (see Chapter 4). The Warner-Lambert decision dealt with the requirements of what is, it is submitted, the same threshold of patentability, albeit relating to a second medical use claim. EXCLUSIONS The exclusions in outline 3.5

Section 1(2) of the Patents Act 1977 states:

‘(2) It is hereby declared that the following (among other things) are not inventions for the purposes of this Act, that is to say, anything which consists of– (a) a discovery, scientific theory or mathematical method; (b) a literary, dramatic, musical or artistic work or any other aesthetic creation whatsoever; (c) a scheme, rule or method for performing a mental act, playing a game or doing business, or a program for a computer; (d) the presentation of information; but the foregoing provision shall prevent anything from being treated as an invention for the purposes of this Act only to the extent that a patent or application for a patent relates to that thing as such.’

In the context of the life sciences, the most obvious significance of the section 1(2) exclusions is in relation to discoveries and scientific theories. The approach that is now taken by the English courts to all the exclusions, however, was developed in the context of programs for computers. Indeed, with the pervasive application of digital technology to drug discovery and medical devices, computer-implemented inventions are a good starting point for examining the practical application of the exclusions, even though they are not first in the section 1(2) list. That is the approach taken in this chapter. When considering what is and what is not excluded from patent protection, it is essential to refer to the final paragraph of section 1(2). This provides that subject matter that does not consist purely of one or more non-patentable categories – as such – may be patentable (provided it satisfies all other conditions under the Act). It is the need to determine the boundaries between excluded and non-excluded subject matter that gives rise to most case law in this area. Some inventions may also contain a mixture of more than one category of excluded subject matter, together with non-excluded elements. For example, it is in the nature of computer-implemented inventions that they often comprise both business methods and computer programs. 77

3.6

Requirements for a Valid Patent 3: Patentable Subject Matter KEY ISSUE: COMPUTER PROGRAMS AND COMPUTERIMPLEMENTED INVENTIONS Finding a technical contribution or effect: Aerotel and Macrossan 3.6 Computer-implemented inventions typically combine a computer program element (excluded subject matter) with operating hardware or a system of hardware (non-excluded subject matter) or, as the European Patent Office defines it17: ‘… an invention that works by using a computer, a computer network or other programmable apparatus. To qualify, the invention also needs to have one or more features which are realised wholly or partly by means of a computer program.’

In England and Wales, the initial approach to whether a computerimplemented invention qualifies for patent protection is set out in the joint appeal cases Aerotel and Macrossan18. The judgment in this case provides a four-step test: 1. properly construe the patent claim; 2. identify the actual contribution – what has the inventor really added to human knowledge? 3. ask whether it (the contribution) falls solely within the excluded subject matter (for example, a method of doing business or computer software); and 4. if still necessary, ask whether the contribution is actually technical in nature. The Court of Appeal’s expanded upon these steps as follows19: ‘No-one could quarrel with the first step – construction. You first have to decide what the monopoly is before going on to the question of whether it is excluded. Any test must involve this first step. The second step – identify the contribution – is said to be more problematical. How do you assess the contribution? Mr Birss submits the test is workable – it is an exercise in judgment probably involving the problem said to be solved, how the invention works, what its advantages are. What has the inventor really added to human knowledge perhaps best sums up the exercise. The formulation involves looking at substance not form – which is surely what the legislator intended. Mr Birss added the words “or alleged contribution” in his formulation of the second step. That will do at the application stage – where the Office must generally perforce accept what the inventor says is his contribution. It cannot actually be conclusive, however. If an inventor claims a computer when programmed with his new program, it will not assist him if he alleges wrongly that he has invented the computer itself, even if he specifies all the detailed elements of a computer in his 17 Guidelines for Examination in the EPO, Index for Computer-Implemented Inventions, November 2018. 18 Aerotel Ltd v Telco Holdings Ltd & Ors [2006] EWCA Civ 1371 (27 October 2006). 19 The court viewed this structured approach as consistent with earlier Court of Appeal case law, in particular Merrill Lynch’s Application [1989] RPC 561.

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KEY ISSUE:Computer programs and computer-implemented inventions

3.7

claim. In the end the test must be what contribution has actually been made, not what the inventor says he has made. The third step – is the contribution solely of excluded matter? – is merely an expression of the “as such” qualification of Art.52(3). During the course of argument Mr Birss accepted a re-formulation of the third step: Ask whether the contribution thus identified consists of excluded subject matter as such? We think either formulation will do – they mean the same thing. The fourth step – check whether the contribution is “technical” – may not be necessary because the third step should have covered that. It is a necessary check however if one is to follow Merrill Lynch as we must.’

In effect, the Aerotel test takes the invention and removes non-novel subject matter (typically, standard hardware elements), and then asks whether what is left is of a technical nature – a technical contribution or effect. This is emphasised by the Court of Appeal judgment in Symbian Ltd v Comptroller General of Patents20, where the Aerotel test is again applied and the court underlines that the broad principles developed in earlier case law, in particular the mere fact that the patent application concerns a computer program, are not determinative. Instead, the four-step test is addressed essentially to whether the invention reveals a ‘technical contribution’ to the state of the art; an innovative technical element, whether or not part of the immediate hardware associated with the computer program, may avoid the exclusion. The Court of Appeal also emphasises in Symbian that it is difficult to formulate a precise test and that each case must be determined by reference to its particular facts and features. ‘Signposts’ to a technical contribution 3.7 In the later case of AT&T  Knowledge Ventures’ Application21 the Patents Court builds on Aerotel, by setting out a number of ‘signposts’ to assist in identifying a technical contribution: 1. does the claimed technical effect have a technical effect on a process which is carried on outside the computer? 2. does the claimed technical effect operate at the level of the architecture of the computer; that is to say, is the effect produced irrespective of the data being processed or the applications being run? 3. does the claimed technical effect result in the computer being made to operate in a new way? 4. does the program make a computer a better computer, in the sense of running more efficiently and effectively as a computer? 5. is the perceived problem overcome by the claimed invention as opposed to being merely circumvented? 20 Symbian Ltd v Comptroller General of Patents [2009] RPC 1 (8 October 2008). 21 [2009] EWHC 343 (Pat) (3 March 2009).

79

3.8

Requirements for a Valid Patent 3: Patentable Subject Matter A positive answer to any of these questions will tend to suggest a technical contribution. It is not, however, an exhaustive list that can be regarded as providing an answer in every case. Examples of cases with and without technical contribution Multi-touch function 3.8 The signposts were endorsed by the Court of Appeal, in HTC Europe Co Ltd v Apple Inc22, albeit with a modified signpost 4 (included above). HTC  Europe concerned a computer device with touch-sensitive screens capable of responding to more than one touch at a time and illustrated an example of an invention that provided a technical contribution or effect beyond the computer program and was not excluded as such. The system software enabled the multi-touch function by changing the basic internal operation of the device, causing it to operate in a new and improved way, dividing up the screen of the device into views and configuring them as single-touch or multi-touch23. Transferring data between computers 3.9 HTC  Europe may be compared with the decision in Lantana24, which also followed the signposts and came to a different conclusion. The case related to a method of extracting and transferring data between two computers. The method operates when both computers are linked up to the internet and one makes a request to the other for a file, with the local computer having a list of the documents on the other computer. The user of the local computer sends an email message to the other, which automatically responds by sending a message to the local computer with the file attached. In the example given by the court, a solicitor who had gone to South America and wished to use a precedent for a joint venture agreement, which he had on his desk computer in his London office, could use this software to get the file for use at his location abroad. Lantana argued that this method saves the need for continuous connection to the desk computer in London and the risks of being hacked while so connected or losing the connection; what the court called ‘the problem of vulnerable connectivity’. The issue for the Court of Appeal was to identify the contribution made by the invention and whether it constituted purely excluded matter. To do so, the features of the invention had to be disaggregated to determine whether 22 [2013] EWCA Civ 451 (3 May 2013). 23 See also Lenovo (Singapore) Pte Ltd v Comptroller General of Patents [2020] EWHC 1706 (Pat) (9 July 2020). 24 Lantana Ltd v The Comptroller General of Patents, Design and Trade Marks [2014] EWCA Civ 1463 (13 November 2014).

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Discoveries and scientific theories

3.10

they fell within or without excluded matter. Following the signposts in AT&T Knowledge Ventures, the Hearing Officer at the UKIPO concluded that the contribution was excluded as a program for a computer as such. This was upheld by the Patents Court on appeal, where Birss J summarised the position in this way: ‘In substance the claim relates to computer software running on conventional computers connected by a conventional network. The task the software performs moves data from one computer to another using a conventional technique for carrying out that task, i.e. email. The context in which this arises is that accessing remote computers via continuous connections can be problematic but this is not a technical solution to those problems, it avoids them, but does so using a conventional technique. The claim has been found to be novel and inventive by the examiner and in that sense it makes a contribution of some kind to the art, but the applicant has been unable to identify anything which this claim can fairly be said to contribute which has a technical character. In my judgment this claim is to unpatentable subject matter.’

This decision was, in turn, upheld by the Court of Appeal, which added that, just because the claimed invention circumvented the problem of vulnerable connectivity by novel and inventive processing, this did not mean that the invention escaped the exclusion from patentability of computer programs as such. As a matter of practical reality, the invention contributed nothing to the state of the art, over and above the fact that it related to a program for a computer25. DISCOVERIES AND SCIENTIFIC THEORIES 3.10 The Aerotel test is usually seen in the context of computerimplemented inventions and business methods, but it applies to the excluded subject matter discussed in section 1(2) of the Patents Act 1977 generally. In Illumina Inc v Premaitha Health Plc26 the test was applied in the context of the exclusion for discoveries as such, in section 1(2)(a). Illumina concerns three interwoven claims that were heard together in respect of five patents, all of which concerned non-invasive prenatal diagnosis – genetic testing on a foetus that requires only sampling of the mother’s blood, or other non-invasively collected analyte. The defendants submitted that the contribution was simply the discovery that certain foetal nucleic acids that are paternally inherited and not possessed by the mother are detectable in maternal serum or plasma samples; a contribution that is a mere discovery and is not technical.

25 But compare with Lenovo (Singapore) Pte Ltd v Comptroller General of Patents [2020] EWHC 1706 (Pat) (9 July 2020). 26 [2017] EWHC 2930 (Pat) (21 November 2017).

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3.11

Requirements for a Valid Patent 3: Patentable Subject Matter In his judgment, Henry Carr J referred to the application of the Aerotel four-step test but, having already found the relevant claims invalid, he merely made an obiter summary of his view that the disputed subject matter was not a discovery as such: the claims were not directed to information about the natural world, but rather to a practical process, namely a ‘detection method’ which uses information about the natural world. Claim 1, in particular, was directed to the detection of foetal DNA in a sample of plasma or serum: such samples do not exist in the natural world and must be artificially created; the claimed method of detection was also an artificial process which does not exist in the natural world. The claim was a practical process of implementing a discovery, for practical applications – the actual contribution did not fall solely within the excluded subject matter; it was technical in nature. Technical character may also be derived by the isolation from its natural environment of biological material, or from its production by a technical process. This is made clear by Article 3(ii) of the Biotechnology Directive27. As regards the human body, Article 5 of the same Directive28 provides that the human body and the ‘simple discovery of one of its elements, including the sequence or partial sequence of a gene’ are not patentable, reflecting the broader provision in Section 1(2) of the Patents Act 1977. Importantly, Article  529 again goes on to provide that, once isolated from the human body or otherwise produced by a technical process, an element from the human body including a full or partial gene sequence may constitute a patentable invention, even if the structure of that element is identical to that of a natural element. In Article  5, however, it is stated explicitly that the industrial application for the gene sequence must be disclosed in the patent application as filed30. MATHEMATICAL METHODS AND MENTAL ACTS 3.11 Mathematical methods and mental acts, as such, are excluded subject matter and, in practice, may overlap with computer programs and each other as the subject matter of an invention31. Again, however, they may form patentable subject matter if a technical effect or contribution is produced.

27 28 29 30

Implemented in the Patents Act 1977 by s 76A and Sch A2, para 2. See Patents Act 1977, Sch A2, para 3(a). Patents Act 1977, Sch A2, para 5. Note that, in the UK  Supreme Court judgment in HGS, this requirement was treated as having no impact on Patents Act 1977, s 4: the industrial applicability of the coding nucleotide sequence for Neutrokine-α was addressed under the latter provision (see para 3.2 onwards). 31 For example, see T 471/05 Optical system/ Koninklijke Philips Electronics (unpublished) (6 February 2007).

82

Business methods

3.12

In Gale’s Patent Application32, Mr Gale discovered how a computer could be controlled in order to calculate the square root of a number in a manner which overcomes the prior art need for a division stage. He put the instructions necessary to do this into a ROM device and claimed the ROM and the instructions. The ROM would be installed in a computer so that, when a program running in the computer required a square root to be evaluated, the ROM would be given temporary control of the computer to evaluate the square root to be performed. It was held by the Court of Appeal that instructions to be used in a computer were not patentable. The physical form of the instructions in a disc or ROM was no more than an established type of artefact in which the instructions were embedded. Per Aldous LJ: ‘In the present case Mr. Gale claims to have discovered an algorithm. Clearly that, as such, is not patentable. It is an intellectual discovery which, for good measure, falls squarely within one of the items, mathematical method, listed in section 1(2). But the nature of this discovery is such that it has a practical application, in that it enables instruction to be written for conventional computers in a way which will, so it is claimed, expedite one of the calculations frequently made with the aid of a computer. In my view the application of Mr. Gale’s mathematical formulae for the purpose of writing computer instruction is sufficient to dispose of the contention that he is claiming a mathematical method as such. That still leaves the difficulty that those instructions when written, and without more, are not patentable, because they constitute a computer program. Is there something more? In the end I have come to the conclusion that there is not. The attraction of Mr. Gale’s case lies in the simple approach that, as claimed, he has found an improved means of carrying out an everyday function of computers. To that extent, and in that respect, his program makes a more efficient use of a computer’s resources. A computer, including a pocket calculator with a square root function, will be a better computer when programmed with Mr. Gale’s instructions. So it may. But the instructions do not embody a technical process which exists outside the computer.’

Gale’s Patent Application pre-dates the Aerotel four-step test and the AT&T signposts. It is submitted that this would be the approach now applied, but that the result would be the same: there is no technical contribution and a patent cannot therefore subsist. BUSINESS METHODS 3.12 Inventions that consist of subject matter that is a business method as such are excluded from patent protection. Methods of doing business subject matter often overlaps with computer programs as such. The facts of the Macrossan part of the joint appeal in Aerotel33 are illustrative. 32 [1991] RPC 305. 33 Aerotel Ltd v Telco Holdings Ltd & Ors [2006] EWCA Civ 1371 (27 October 2006).

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3.12

Requirements for a Valid Patent 3: Patentable Subject Matter The Macrossan application claimed a patent for an automated method of acquiring the documents necessary to incorporate a company. It involved a user sitting at a computer and communicating with a remote server, answering questions. By means of posing questions to a user in a number of stages, enough information could be gleaned from the user’s answers to produce the required documents. Questions posed in the second and subsequent stages were then determined from previous answers provided and the user’s answers stored in a database structure. This process would be repeated until the user had provided enough information to allow the documents legally required to create the corporate entity to be generated. A  number of document templates would also be stored and the data processor configured to merge at least one of these templates with the user’s answers to generate the required legal documents. The documents could then be sent to the user in an electronic form for the user to print out and submit, mailed to the user, or submitted to the appropriate registration authority on behalf of the user. The Court of Appeal considered the patent to be both for a method of doing business as such and for a computer program as such. Addressing the exclusion for a method of doing business, the court applied the fourstep test: ‘Step 1 of the structured approach (construe the claim) causes no difficulty. Step 2 calls for an assessment of the inventor’s contribution. That again poses little difficulty. Mr Macrossan does not suggest he has invented any new kind of hardware. What he has thought of is an interactive system which will do the job which otherwise would have been done by a solicitor or company formation agent. Questions are asked, the answers incorporated in the draft, and depending on some particular answers, further questions are asked and the answers incorporated. That is his contribution. Step 3 – is that contribution solely excluded matter? That depends on the meaning of “a scheme rule or method of doing business as such”. The hearing officer held that the claim was indeed just for that. She said: “To my mind, the production of legally compliant documents is just the sort of activity that falls within the business method exclusion. It is something that solicitors are paid to do. Thus, I find the present invention to fall potentially within the ‘business method’ exclusion”. The final step is to ask whether there is anything technical about the contribution – there obviously is none beyond the mere fact of the running of a computer program.’

In Oneida Indian Nation’s Application No.030825934 the claimed invention was designed to facilitate gaming from an off-site location. Whereas, in the prior art, a wager was placed followed by the generation and display of results by the apparatus in one sequence of operations, in the claimed 34 [2007] EWHC 954 (Pat) (2 May 2007).

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Presentations of information

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invention, apparatus pre-generated and stored the results following the wager but the player had to make a separate request to display the results. The separate request could be made on- or off-site and could be time shifted from the time of the wager (for example, to comply with local gaming laws). The Patents Court held that the invention was merely a way of putting a new business method into effect and lay wholly within the excluded field of a business method as such. PRESENTATIONS OF INFORMATION 3.13 Following the four-step test in Aerotel, the core issue to be resolved when addressing presentations of information is again whether the manner in which that information is generated or presented reveals a technical contribution avoiding excluded subject matter as such; ‘what achieves patentability is some real world technical achievement outside the information itself’35. Examples may be technical effects arising from a manner of presentation if they enable the user to continue to interact with a machine or to perform a technical task, or ways that enable more efficient or precise operation of a technical task. In Gemstar-TV  Guide International Inc & Ors v Virgin Media Ltd & Anor36, the technical effect relied on by Gemstar for its electronic program guides was a better interface, or at least a different interface. The court considered this to be an abstract concept, which did not in terms describe some physical activity or effect. The effect was still part of the computer program and not an external effect. Many computers running a program are likely to have a display output, the court said, and, if that were enough to be a technical effect, every program in such a computer would be likely to fall outside the exclusion, which is unlikely to have been the intention of the draftsman of the Act. A different display to that shown before does not go far enough to amount to a technical effect. The exclusions in the EPO At the time of the Court of Appeal judgment in Symbian Ltd v Comptroller General of Patents the court noted that recent decisions by the TBA had the effect that any program on a carrier (by that reason alone) would have a technical character and so was potentially patentable, subject to novelty and obviousness. This

35 For example, see Gemstar-TV  Guide International Inc v Virgin Media Ltd [2009] EWHC 3068 (Ch). 36 [2009] EWHC 3068 (Ch) (26 November 2009).

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Requirements for a Valid Patent 3: Patentable Subject Matter appeared to suggest that the EPO was taking a broader, more patentfriendly, approach than that taken by the Aerotel four-step test in English law. Nonetheless, Neuberger LJ took the conciliatory view that discrepancies, even in approach or principle, were occasionally inevitable. As a result of a clash with the English courts37 on the correct approach, then President of the EPO, Alison Brimelow, referred a number of questions to the supreme EPO decision-making body, the Enlarged Board of Appeal (EBA). These related to the scope of the exclusion of computer programs, as such, given the apparent divergence of opinion on it in national patent courts and offices and within the EPO itself. Unfortunately, this opportunity to clear the matter up and provide some definitive guidance across Europe was declined as inadmissible by the EBA in May 2010, in its opinion G  3/0838. The EBA would not resolve conflicts with decisions of national courts. G 3/08 in fact endorses the approach taken in Computer program product/IBM T 1173/9739: patentability requires a computer program, when running on a computer or loaded into a computer, to bring about a technical effect which goes beyond the ‘normal’ physical interactions between the program (software) and the computer (hardware) on which it is run, such as the electrical currents involved. Instead, a ‘further technical effect’ is required, derived from the execution of the program40. As G 3/08 acknowledges, some TBA case law diverges from IBM, such as the requirement that the program is on a computer-readable medium41. In T  0489/1442, which concerns a mathematical model and algorithm for simulating the movement of individual pedestrians through an environment, questions have again been referred to the EBA under Article 52(2) and (3) of the EPC. Despite the interaction between the English courts and the EPO on the issue of these exclusions, it remains difficult to identify practical examples where the outcome would be different in either forum43.

37 Decision T 0154/05 Duns Licensing Associates (2006). 38 G 3/08 Programs for Computers (12 May 2010). 39 [1999] EPO OJ 609 (1 July 1998). 40 T  1173/97 Computer program product/International Business Machines Corporation [1999] EPO OJ 609 (1 July 1998) also saw the end of the so-called ‘contribution approach’ to the exclusion under Article 52(2) and (3) of the EPC. 41 For example, see T 424/03 Clipboard formats I/MICROSOFT (unpublished) (23 February 2006). 42 Pedestrian simulation/CONNOR (22 February 2019). 43 The decision in G 1/19 on computer simulated inventions is awaited at the time of writing.

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Plant and animal varieties and essentially biological processes

3.16

NON-PATENTABLE SUBJECT MATTER AND THE BIOTECHNOLOGY DIRECTIVE 3.14 Additional and specific rules and exceptions apply to biotechnological subject matter. These are provided in the Biotechnology Directive, which is implemented in UK law in Schedule 2A to the Patents Act 1977 (see Coda on Brexit). Article 3 of the Biotechnology Directive provides that: ‘(i) the ordinary test of patentability shall apply to products that consist of or contain biological material or a process by means of which biological material is produced, processed or used;’

In other words, further to Article  3(i), biotechnological inventions do not represent a special category as regards the usual requirements of novelty and inventive-step. PLANT AND ANIMAL VARIETIES AND ESSENTIALLY BIOLOGICAL PROCESSES FOR THEIR PRODUCTION 3.15 Article  4(1) of the Biotechnology Directive44 states that plant and animal varieties and essentially biological processes for the production of plants or animals are not patentable45, per se. Plant and animal varieties 3.16 Plant or animal varieties are exceptions to patent protection under the first half of Article 53(b) of the EPC. ‘Plant variety’ is defined in Rule 26(4) of the EPC as: ‘any plant grouping within a single botanical taxon of the lowest known rank, which grouping, irrespective of whether the conditions for the grant of a plant variety right are fully met, can be: (a) defined by the expression of the characteristics that results from a given genotype or combination of genotypes, (b) distinguished from any other plant grouping by the expression of at least one of the said characteristics, and  (c) considered as a unit with regard to its suitability for being propagated unchanged.’

The term does not include hybrid seeds and plants46, plant cells47 or transgenic plants48. In the TBA decisions, which form most of the case law 44 See also Article 53(b) and Rule 28(2) of the EPC. 45 See also Article 53(b) of the EPC 2000. 46 T 320/87 Hybrid plants/LUBRIZOL [1990] EPO OJ 71 (10 November 1988). 47 T 356/93 Plant cells/ PLANT GENETIC SYSTEMS [1995] EPO OJ 545 (21 February 1995). 48 T 547/10 Transgenic cotton plants/BAYER CROPSCIENCE (unpublished) (13 July 2016).

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Requirements for a Valid Patent 3: Patentable Subject Matter in this area, a distinction is made between claims substantially to specific plant varieties, and claims to teaching that does not individually claim plant varieties but can be embodied in or embrace plant varieties. The former are not patentable, whereas the latter are49. Single animal varieties, species or races are excepted from protection. By virtue of the second sentence of Article 53(b) of the EPC, patents to animals and plants produced by microbiological process50 may be patented, if there is no conflict with Article 53(a) of the EPC. Essentially biological processes and their products 3.17 Essentially biological processes for the production of plants or animals are an exception to patent protection under the first half of Article 53(b) of the EPC. Under Rule 26(5) of the EPC, ‘A process for the production of plants or animals is essentially biological if it consists entirely of natural phenomena such as crossing or selection’. Therefore, essentially biological processes do not include genetic manipulation or the production of transgenic animals through chromosomal incorporation51. In the EBA cases of Broccoli/PLANT BIOSCIENCE  G  2/07 and Tomatoes/STATE OF ISRAEL G 1/0852, a non-microbiological process for the production of plants which contains or consists of the steps of sexually crossing the whole genomes of plants and of subsequently selecting plants was held to be an essentially biological process. The inclusion of a step of a technical nature, which serves to enable or assist the performance of the steps of sexually crossing the whole genomes of plants or of subsequently selecting plants, does not enable the process to escape exclusion. The exclusion will not apply, however, if the step of a technical nature itself introduces a trait into the genome or modifies a trait in the genome of the plant produced, which is not the result of the mixing of the genes of the plants chosen for sexual crossing. In Notice 2016/C 411/03, on 3 November 2016, the European Commission adopted the position that animals and plants derived from essentially biological processes should not be patentable under Article  53(b) of the EPC53. Previously, there had been differing views between the EPO and the EU on this issue. The EU considered that both processes and products were not patentable and the EBA had held that the resultant animal or plants of an essentially biological process could be patented, even though the process could

49 G 1/98 Transgenic plant/NOVARTIS II [2000] EPO OJ 111 (20 December 1999). 50 See definition in Rule 26(6) of the EPC. 51 T 315/03 Transgenic animals/HARVARD [2005] EPO OJ 246 (6 July 2004), and T 19/90 Onco-Mouse/HARVARD [1990] EPO OJ 476 (3 October 1990). 52 [2012] EPO OJ 130 and 206 (9 December 2010). 53 Article 4(1) of the Biotechnology Directive.

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Microbiological processes

3.18

not54. Further to the Commission Notice, the EPO published its own notice on 29 June 2017 stating that, for patent applications filed on or after 1 July 2017, it would exclude applications for plants and animals exclusively obtained by an essentially biological breeding process from patentability. The EPO said in its notice that, while the Biotechnology Directive excludes essentially biological processes from patentability, it does not provide for a clear exclusion for plants or animals obtained from such processes. The Commission Notice clarified, the EPO explained, that the European legislator’s intention was to exclude not only these processes but also the products obtained by them. Rule 28 of the EPC was subsequently amended by the addition of paragraph (2)55 to make clear that the exclusion applies to plants or animals exclusively obtained by means of an essentially biological process. Subsequently, however, in T 1063/18, the Board has held that Rule 28(2) of the EPC is incompatible with Article 53(b) of the EPC and the amendment is void. The Board saw no reason to deviate from the interpretation of the EBA and that the provisions of Article  53(b) of the EPC would prevail. The case was referred to the EBA in G  3/19, which held ‘that new Rule 28(2)  EPC allowed and indeed called for a dynamic interpretation of Article  53(b) EPC’ and that plants and animal products produced by essentially biological processes are not patentable. MICROBIOLOGICAL PROCESSES 3.18 Further to the second half of Article 53(b) of the EPC, the exception does not apply to microbiological processes or their products. The term ‘micro-organism’ refers to all unicellular organisms with dimensions beneath the limits of vision which can be propagated and manipulated in a laboratory. It includes plasmids, viruses, bacteria, yeasts, fungi, algae and protozoa, as well as animal (including human) and plant cells. A microbiological process is defined by Rule 26(6) of the EPC as meaning ‘any process involving or performed upon or resulting in microbiological material’. The exception covers products that are made or modified using micro-organisms, as well as the new micro-organisms that result from those processes56. Merely including a microbiological step in a larger technical process does not, however, render it a microbiological process, or the resulting product a product of a microbiological process57. 54 Joined cases Tomatoes II G 2/12 (a method for breeding tomatoes having reduced water content, and the product of the method) and Broccoli II G 2/13 (a method for selective increase of the anticarcinogenic glucosinolates in brassica species) [2016] EPO OJ A28 (25 March 2015). 55 [2017] EPO OJ A56. 56 T 356/93 Plant cells/PLANT GENETIC SYSTEMS [1995] EPO OJ 545 (21 February 1995). 57 T  356/93 Plant cells/PLANT GENETIC SYSTEMS  [1995]  EPO OJ  545 (21  February 1995).

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Requirements for a Valid Patent 3: Patentable Subject Matter ‘ORDRE PUBLIC’ AND MORALITY The relationship between Article 6(1) of the Biotechnology Directive, and Article 53(a) and Rule 28(1)(d) of the EPC 3.19 Article 6 of the Biotechnology Directive includes ethical exclusions for (amongst other subject matter) human cloning and the use of human embryos for industrial or commercial purposes: ‘1. Inventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality; however, exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation. 2. On the basis of paragraph 1, the following, in particular, shall be considered unpatentable: (a) processes for cloning human beings; (b) processes for modifying the germ line genetic identity of human beings; (c) uses of human embryos for industrial or commercial purposes; (d) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.’

Article 6(1) is transposed into Article 53(a) of the EPC by Rule 28 of the EPC, and the exclusions are in exactly the same terms: ‘(1) Under Article 53(a), European patents shall not be granted in respect of biotechnological inventions which, in particular, concern the following: (a) processes for cloning human beings;  (b) processes for modifying the germ line genetic identity of human beings;  (c) uses of human embryos for industrial or commercial purposes;  (d) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.’

It should be noted, however, that Article 53(a) of the EPC is broader than Article 6(1) of the Biotechnology Directive (see below), and therefore an invention may be excluded under the former and not the latter. Article 6(2) of the Biotechnology Directive is transposed into Article 53(b) of the EPC by Rule 28(2) of the EPC: ‘(2) Under Article  53(b), European patents shall not be granted in respect of plants or animals exclusively obtained by means of an essentially biological process.’

The goal of the Biotechnology Directive is thus to harmonise the patentability rules so as to strike a balance between the promotion of the European biotech industry and respect for ethical rules, and provide clarity as to what is and what is not patentable. The Biotechnology Directive should therefore be read together with Article 53 of the EPC, which in full provides: 90

‘Ordre public’ and morality

3.20

‘European patents shall not be granted in respect of: (a) inventions the commercial exploitation of which would be contrary to ‘ordre public’ or morality; such exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States; (b) plant or animal varieties or essentially biological processes for the production of plants or animals; this provision shall not apply to microbiological processes or the products thereof;  (c) methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods.’

The Biotechnology Directive and Article  53 of the EPC have proved particularly important when addressing the patentability of plant and animal varieties, DNA sequences, stem cells, methods of treatment and diagnostics. Modifying the genetic identity of animals 3.20 Processes for modifying the genetic identity of animals, and also animals resulting from such processes, which are likely to cause them suffering without any substantial medical benefit to man or animal, are not patentable under Rule 28(1)(d) of the EPC58. The Technical Board of Appeal case Transgenic animals/HARVARD T 315/0359 provides three factors for determining whether a patent is excluded on this ground: 1. animal suffering; 2. medical benefit; and 3. the necessary correspondence between the two as regards the animals in question. But Rule 28(1)(d) of the EPC is an objection within Article 53(a) of the EPC and so, if the facts of a case do not fall within Rule 28(1)(d), Article 53(a) must still be considered. The Technical Board of Appeal case Onco-Mouse/HARVARD T 19/9060 sets out the approach to be taken under Article 53(a). This differs from Transgenic animals in particular by allowing matters other than animal suffering and medical benefit to be taken into account. It balances the suffering of animals against usefulness to mankind, rather than against medical benefit to man or animal – requiring ‘a careful weighing up of the suffering of animals and possible risks to the environment on the one hand, and the invention’s usefulness to mankind on the other’, which is sufficiently broad to encompass contemporary views on social order, accepted risk and accepted standards

58 And see predecessor provision, Rule 23d of the EPC 1973. 59 [2005] EPO OJ 246 (6 July 2004). 60 [1990] EPO OJ 476 (3 October 1990).

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3.21

Requirements for a Valid Patent 3: Patentable Subject Matter of behaviour in European culture. This approach balances possible risks to the environment against usefulness to mankind, and so it is a test for use in ‘ordre public’ cases and morality cases generally under Article 6(1)(a) of the Biotechnology Directive61. The exclusion of inventions the exploitation of which would be contrary to ‘ordre public’ or morality has been defined by the Technical Board of Appeal as ‘not in conformity with the conventionally accepted standards of conduct pertaining to this culture’62. However, there is no single definition of ‘morality’ accepted as standard in European culture, whether based on economic or religious views, opinion poll evidence or other sources63, but it will include the protection of public security and the safety of individuals64. STEM CELL-BASED INVENTIONS Destruction of human embryos 3.21 The patentability of stem cells has been the subject of decision making in both the TBA and the CJEU under Article 6(2)(c) of the Biotechnology Directive65, which states: ‘On the basis of paragraph  1, the following, in particular, shall be considered unpatentable: … (c) uses of human embryos for industrial or commercial purposes …66.’

The EBA decision in Use of embryos/WARF G 2/0667 addresses inventions which can only be obtained by the destruction of human embryos. In WARF, the EBA decided that Article 6(2)(c)68 is intended to bar patents for inventions that necessitate the destruction of an embryo at their filing date. Therefore, although it did not state the source of its hESCs, WARF’s invention was unpatentable on the basis that ‘a claimed new and inventive product must first be made before it can be used’. It was irrelevant to the Board that, after the filing date of the WARF patent, cultured cell lines had become available that made the use of the invention possible without requiring any further destruction of an embryo. The decision does not prevent the patenting of inventions using already existing, deposited hESC cell lines, and is not concerned with the patentability of stem cells generally. 61 T 315/03 Transgenic animals/HARVARD [2005] EPO OJ 246 (6 July 2004). 62 T  356/93 Plant cells/PLANT GENETIC SYSTEMS  [1995]  EPO OJ  545 (21  February 1995). 63 T 315/03 Transgenic animals/HARVARD [2005] EPO OJ 246 (6 July 2004). 64 T  356/93 Plant cells/PLANT GENETIC SYSTEMS  [1995]  EPO OJ  545 (21  February 1995). 65 See also Article 53(a) and Rule 28(1)(c) of the EPC. 66 See also Rule 28(1)(c) of the EPC. 67 [2009] EPO OJ 306 (25 November 2008). 68 And Rule 28(1)(c) of the EPC.

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Stem cell-based inventions

3.22

The meaning of ‘human embryo’ – Oliver Brüstle v Greenpeace 3.22 The WARF decision was then superseded by the CJEU ruling in Oliver Brüstle v Greenpeace69, which concerned a patent claiming isolated, purified neural precursor cells, processes for their production from hESCs, and their use for the treatment of neural defects. Initially, the German Federal Patent Court held the patent to be invalid under the German law implementing Article 6(2)(c) of the Biotechnology Directive due to the invention’s use of precursor cells from hESCs. The German court referred questions to the CJEU for a preliminary ruling on the meaning of the term ‘human embryos’ in Article  6(2)(c) and whether it covers all stages of the development of human life, beginning with fertilisation, or whether attainment of a certain developmental stage is necessary. The CJEU ruled that the Biotechnology Directive is intended to exclude ‘any possibility of patentability where respect for human dignity could be affected’. Therefore, ‘the concept of “human embryo” … must be understood in a wide sense’ and, consequently, a ‘human embryo’ should be understood to include a fertilised egg. The court also held that the words ‘industrial or commercial purposes’ in Article 6(2) (c) include the purposes of scientific research, except where inventions for therapeutic or diagnostic purposes ‘are applied to the embryo and are useful to it’70. However, the CJEU said that it was for the national courts to decide ‘in light of scientific developments’ whether stem cells obtained from blastocysts are capable of developing into a human being, and therefore whether or not they fall within the definition of ‘human embryo’. Consistent with the WARF decision, the CJEU applied the exclusion where the technical teaching of a patent ‘requires the prior destruction of human embryos or their use as base material, whatever the stage at which that takes place’, regardless of whether or not use of the human embryo is referred to in the patent. It goes further than this, however, by adding that it is also irrelevant that: ‘destruction may occur at a stage long before the implementation of the invention, as in the case of the production of embryonic stem cells from a lineage of stem cells, the mere production of which implied the destruction of human embryos …’

In other words, the use of lines of hESCs that originated with the destruction of an embryo are excluded from patentability.

69 C-34/10 Oliver Brüstle v Greenpeace eV [2011] I-09821 (18 October 2011). 70 See Recital 42 of the Biotechnology Directive.

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3.23

Requirements for a Valid Patent 3: Patentable Subject Matter Parthenogenetically activated oocytes 3.23 The later CJEU ruling in International Stem Cell Corporation71 again concerns the patentability of stem cells, this time on questions referred by the English Patents Court72. The CJEU had to decide whether stem cells obtained from parthenogenetically stimulated human ova are excluded from patentability as ‘human embryos’. This form of stem cell uses parthenogenetic activation of oocytes, and therefore does not involve the destruction of a fertilised ovum capable of developing into a human being. Earlier, in Brüstle, the CJEU had appeared to say that ‘human embryo’ would include non-fertilised human ova whose division and further development had been stimulated by parthenogenesis. ISCC argued that this was based on an incorrect understanding of the science. As a result, based on its reasoning that, in order to be a human embryo, it is necessary to be ‘capable of commencing the process of development of a human being which leads to a human being’, the CJEU ruled in ISCC that parthenogenetically derived stem cells were not ‘human embryos’ within the meaning of the Biotechnology Directive: ‘… in order to be classified as a “human embryo”, a non-fertilised human ovum must necessarily have the inherent capacity of developing into a human being. Consequently, the mere fact that a parthenogenetically-activated human ovum commences a process of development is not sufficient for it to be regarded as a “human embryo”.’

The court added that, in the light of current scientific knowledge, these particular cells did not have the inherent capacity of developing into a human being. However, as in Brüstle, the CJEU repeated that such factual matters are for national courts to determine. KEY ISSUE: METHODS OF TREATMENT AND DIAGNOSTICS 3.24 As a matter of policy – to protect clinicians and veterinarians from the threat of enforcement – methods for treatment by surgery or therapy and diagnostic methods are excluded from patentability in Article 53(c) of the EPC73. The leading case law on this exclusion comes from the EPO Boards, who interpret it narrowly, rather than the UK courts. Consequently, this case law presents the best guide to this area of patent law. 71 Case C-364/13 International Stem Cell Corporation v Comptroller General of Patents, Designs and Trade Marks (18 December 2014). 72 International Stem Cell Corporation v Comptroller General of Patents [2013] EWHC 807 (Ch) (17 April 2013). 73 See G  1/83 Second medical indication/BAYER  [1985]  OJ EPO  60 (5  December 1984), G  5/83 Second medical indication/EISAI  [1985]  OJ EPO  64, and G  6/83 [1985]  OJ EPO 97 (decided under Article 52(4) of the EPC 1973), and reiterated in G 1/07 Treatment by surgery/MEDI-PHYSICS [2011] OJ EPO 134 (15 February 2010).

94

KEY ISSUE: Methods of treatment and diagnostics

3.25

Diagnostic patents 3.25 ‘Diagnostic methods practised on the human or animal body’ are excluded from patent protection further to Article 53(c). The exclusion is based on policy considerations that are the same as those for the exclusion for treatment by surgery, explained by the Enlarged Board of Appeal in Treatment by surgery/MEDI-PHYSICS G 1/07: ‘… the real reason for excluding the defined methods from patentability were socio-ethical considerations and considerations of public health. Excluding methods for treatment of the human or animal body by surgery or therapy and diagnostic methods from patentability by way of the legal fiction that they were not to be regarded as inventions susceptible of industrial application was only the legislative mechanism by which this was achieved. Medical and veterinary practitioners should be free to use their skills and knowledge of the best available treatments to achieve the utmost benefit for their patients uninhibited by any worry that some treatment might be covered by a patent.’

Also, like the exclusion for treatment by surgery, the exclusion must be interpreted narrowly, as held in Diagnostic methods G 1/04. The effect of Diagnostic methods is summarised in the EPO’s Guidelines for Examination as follows74: ‘To determine whether a claim is directed to a diagnostic method within the meaning of Art. 53(c), it must first be established whether all of the necessary phases are included in the claim (G 1/04). The claim must include method steps relating to all of the following phases: (i) the examination phase, involving the collection of data, (ii) the comparison of these data with standard values, (iii) the finding of any significant deviation, i.e. a symptom, during the comparison, (iv) the attribution of the deviation to a particular clinical picture, i.e. the deductive medical or veterinary decision phase (diagnosis75 for curative purposes stricto sensu).’ (bold provided in the Guidelines)

The technical method steps in phases (i) to (iii) must each be performed on a human or animal body – an interaction with the human or animal body takes place. If all of the requirements set out in Diagnostic methods G 1/04 are met, the claim is subject to the bar in Article 53(c) of the EPC. This means that, with appropriate drafting of patent claims, the exclusion may be avoided – for example, a method for merely obtaining information from a human or animal body will not be excluded from patentability under Article  53(c). Products, such as substances or compositions for use in a 74 Part G, II-28, November 2018. 75 This includes a negative finding that a particular condition can be ruled out (G  1/04, para 5.1). However, the diagnosis does not require identification of the underlying disease, but it must be sufficient to decide upon a therapeutic action (see Respiratory function of a mammal/AEROCRINE T 0125/02).

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3.26

Requirements for a Valid Patent 3: Patentable Subject Matter diagnostic method, may also be patented76, as may companion diagnostic apparatus. The exclusion as a diagnostic method, or exclusion as a surgical method, does not depend on the identity of the person performing a particular step, whether it be a veterinarian, physician, technical support person, automated system or otherwise.

TREATMENT BY SURGERY AND THERAPEUTIC METHODS Treatment by surgery: general considerations 3.26 As a general approach, the exclusion from patentability of surgical methods should not be applied broadly, unless the interests of protecting public health, and the need to allow the medical profession the freedom to provide treatments that they judge necessary, require it. The EBA does not define ‘treatment by surgery’, and its meaning may be expected to change with time and convention. However, it is not as broad as ‘“any physical intervention” on the human body’, and some level of medical expertise and health risk77 should be involved in the method. At the same time, it is not to be limited to only therapeutic surgery78 or invasive methods79. Methods which do not themselves cover surgical steps, but necessarily imply that such steps must take place, have fallen on either side of the line defined by the exclusion80, but the Board has consistently rejected arguments that devices functionally defined in relation to the body of a patient are surgical method claims in disguise81. Methods for the operation of a device that have no functional link to an effect produced on the body have also been held to fall outside the exclusion82.

76 Article 54(4) of the EPC. 77 See T 663/02 (unpublished) (17 March 2011) with T 1075/06 Blood separation systems/ FENWAL (unpublished) (17 May 2011). 78 G 1/07 Treatment by surgery/MEDI-PHYSICS [2011] OJ EPO 134 (15 February 2010). 79 T 5/04 Internal registration of gas/air/CAMTECH (unpublished) (17 January 2006). 80 See T  836/08 Führungsdrahtnavigation/ BrainLAB (unpublished) (12  May 2011) and T  923/08 Verfahren und Vorrichtung zur Bestimmung der Veränderung eines Objektes/ BrainLAB (unpublished) (2 August 2011). 81 See, for example, T  1798/08 Visual prosthesis/JOHNS HOPKINS UNIVERSITY (unpublished) (21 August 2012) and T 1407/08 Aortic graft for treating abdominal aortic aneurysms/ BARONE (unpublished) (20 March 2013). 82 See, for example, T  789/96 Therapeutic method/ELA MEDICAL  [2002]  OJ EPO  364 (23  August 2001). See also T  82/93 Cardiac pacing/Telectronics [1996]  OJ EPO  274 (15 May 1995).

96

Treatment by surgery and therapeutic methods

3.28

Imaging method – Treatment by surgery/MEDI-PHYSICS G 1/07 3.27 The leading authority on treatment by surgery or therapy has also come from the EBA in Treatment by surgery/MEDI-PHYSICS  G  1/07. MEDI-PHYSICS concerns a patent claiming an imaging method, which comprises or encompasses a physical intervention step of injecting a contrast agent into the human heart, and deals with whether this subject matter must be excluded from patent protection pursuant to Article  53(c) of the EPC. The EBA held that the exclusion applies if a claimed method comprises or encompasses at least one feature defining a physical activity or action that constitutes a method step for treatment of a human or animal body by surgery or therapy. The claimed imaging method was an invasive step representing a substantial physical intervention on the body, requiring professional medical expertise to be carried out and which entailed a substantial health risk even when carried out with the required professional care and expertise. It was thus excluded from patentability. However, the exclusion could be avoided, according to the Board, by disclaiming the embodiment in which the contrast agent is injected into the heart of a human or animal body. Therapeutic methods 3.28 Therapeutic methods will similarly be excluded from patent protection if the claim includes at least one feature that defines a physical activity or action constituting a method step for treatment of the human or animal body by therapy. Unlike surgery, ‘therapy’ is defined: it is the treatment of a disease in general or a curative treatment in the narrow sense, as well as the alleviation of the symptoms of pain and suffering83. This definition includes prophylactic treatment84. The Boards of Appeal do, however, make a distinction between therapy, on the one hand, and performance improvement85 and cosmetic treatments86 on the other. Much depends upon the wording of the claim in question. For example, if the claimed invention is not directed solely to non-excluded subject matter, such as a cosmetic effect, but is also necessarily defining a treatment of the human body by therapy as well, such a claim is excluded from patentability87.

83 T 144/83 Appetite suppressant/DU PONT [1986] EPO OJ 301 (27 March 1986). 84 G 5/83 Second medical indication/EISAI [1985] OJ EPO 64 and T 820/92 Contraceptive method/The General Hospital [1995] OJ EPO 113 (11 January 1994). 85 T 774/89 Efomycine als Leistungsförderer/BAYER (unpublished) (2 June 1992). 86 T 144/83 Appetite suppressant/DU PONT [1986] EPO OJ 301 (27 March 1986). 87 T 290/86 Cleaning plaque/ICI [1992] OJ EPO 414 (13 November 1990). Compare, for example, T 1635/09 and T 469/94.

97

3.29

Requirements for a Valid Patent 3: Patentable Subject Matter PRODUCTS USED IN THERAPY 3.29 The exclusion of Article 53(c) of the EPC does not apply to products for use in methods of treatment. Pharmaceutical products may therefore be patented for more than one use. In fact, Article 54(4) of the EPC states that, even though a product may be part of the state of the art, this ‘shall not exclude the patentability of any substance or composition … for use in a method referred to in Article 53(c) EPC, provided that its use for any such method is not comprised in the state of the art’. Complications have, however, arisen when drafting such claims. This is because, if the patent is drafted using a product claim, it is susceptible to a novelty attack based on the pre-existence of the drug. Alternatively, if it is drafted in the form of a process claim to a treatment, the claim is likely to fall foul of the bar on patenting methods of treatment in the EPC88 (see Table 3.1). This dilemma has given rise to two forms of claim for a second medical use: 1. ‘Swiss-form’ claims: prior to 13  December 2007 (under the old EPC 1973), the dilemma was addressed by the case law of the Boards holding that second89 or subsequent therapeutic applications of a product are patentable, provided that the new treatment indication is novel. The form in which the EBA required such claims to be drafted was the ‘Swiss form’: ‘Use of compound X  for the manufacture of a medicament for treating disease Y’90. The element of manufacture in such claims was intended to avoid their interpretation as a method of treatment claim that could touch on the activities of doctors. 2. ‘EPC 2000’ claims: for all claims dating from 13 December 2007 and after, the EPC 2000 provided for the use of the claim form ‘X for use in treating Y’91. These claims permit the use of a product X in a method of treatment Y, which treatment in and of itself would be unpatentable as a method of treatment. It is the purpose limitation of this form of claim that makes it novel over the pre-existence of the drug itself. It was the intention of the EPC  2000 claim form to be equivalent to the Swiss-form claim. However, it has subsequently been held by the TBA that the Swiss-form claim is a purpose-limited process claim, because it requires the manufacture of a medicament, whereas the EPC 2000 claim is a purpose-limited product claim, in which there is no such manufacturing requirement92. 88 Now in Article 53(c) of the EPC 2000. 89 Compare with ‘first medical use’ claims in the general form, eg ‘X for use as a medicament’. 90 Second medical indication/EISAI G 5/83; extending the notional novelty provided to first medical use claims by Article 54(5) of the EPC 1973 to subsequent novel uses. 91 Article 54(5) of the EPC 2000 and Kos Life Science, G 2/08. 92 Board of Regents, The University of Texas System, T 1780/12.

98

Article 54(5)

First medical use claims

Second medical use claims

EPC 1973

Article 52(4)

Claims

Methods of treatment

Eisai G 5/83.

[The novelty provisions] 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 Art 52(4), provided that its use for any method referred to in that paragraph is not comprised in the state of the art.

Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body shall not be regarded as inventions which are susceptible of industrial application; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods.

Table 3.1  Applicable Articles in EPC 1973 and EPC 2000 EPC 2000

Article 54(5)

Article 54(4)

Article 53(c)

[The Novelty provisions] shall also not exclude the patentability of any substance or composition referred to in para 4 for any specific use in a method referred to in Art 53(c), provided that such use is not comprised in the state of the art.

[The novelty provisions] 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 Art 53(c), provided that its use for any such method is not comprised in the state of the art.

European patents shall not be granted in respect of: methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods.

Products used in therapy 3.29

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Chapter 4 Requirements for a Valid Patent 4: Sufficiency

LIFE SCIENCES CONTEXT 4.1 The ground of validity called ‘sufficiency’ is founded on the public policy referred to as the ‘patent bargain’. This requires the patent applicant, in exchange for the period of exclusivity provided by their patent, to disclose sufficient information to the public that their invention can be made to work for the wider benefit of society. Many of the broader principles of sufficiency have developed in case law concerning pharmaceuticals but, largely due to their technical complexity, biotechnological inventions have featured in authorities at the highest level for decades already. Most recently, the Regeneron v Kymab transgenic mouse case has illustrated how the patent bargain principle often has to be re-assessed and re-stated for new forms of technology. The competitive nature of the pharmaceuticals and biologicals industry, in many areas of disease, also means that drug companies want to file patent applications as early as possible, in order to avoid being beaten to exclusivity by their rivals, or simply to avoid the publication of prior art that will destroy the novelty of their invention. This raises a tension between the commercial pressure to file patent applications as soon as possible and the public policy of providing enough information that the invention works to justify the exclusivity that a patent brings – the applicant’s dilemma: how much information must be made available in the patent so that the patent application can be filed as soon as possible, without the risk of failing to disclose enough information to satisfy the patent bargain? This dilemma has given rise, in a very short period of time, to the issue of plausibility which, although it is most readily associated with sufficiency in UK patent law, has become pervasive as a common threshold of patentability underlying a number of other requirements. 101

4.2

Requirements for a Valid Patent 4: Sufficiency GENERAL PRINCIPLES 4.2 The sufficiency requirement is codified in UK law in section 72(1) (c)1 of the Patents Act 1977, which enables the court or the comptroller to revoke a patent because: ‘the specification of the patent does not disclose the invention clearly enough and completely enough for it to be performed by a person skilled in the art.’

This insufficiency objection is concerned with enablement of the full extent of the monopoly claimed2. Like enablement in the context of novelty, the skilled person is entitled to make trial and error, routine changes in order to get the disclosed invention to work. The disclosure of how to perform one embodiment of the invention will be sufficient to support other embodiments in the claim if it discloses a general principle of application which will work in respect of all those embodiments across the claim. The fact that a few marginal instances cannot be made to work will not be enough to attack the sufficiency of a claim3, but insufficiency will result if it can be shown that a substantial proportion of the claimed embodiments cannot be made to work by the skilled person using their common general knowledge and routine trial and error (‘classic insufficiency’)4. The basic principles are summarised by Kitchin J  in Eli Lilly & Co v Human Genome Sciences Inc5: ‘The specification must disclose the invention clearly and completely enough for it to be performed by a person skilled in the art. The key elements of this requirement which bear on the present case are these: (i) the first step is to identify the invention and that is to be done by reading and construing the claims; (ii) in the case of a product claim that means making or otherwise obtaining the product; (iii) in the case of a process claim, it means working the process; (iv) sufficiency of the disclosure must be assessed on the basis of the specification as a whole including the description and the claims; (v) the disclosure is aimed at the skilled person who may use his common general knowledge to supplement the information contained in the specification; (vi) the specification must be sufficient to allow the invention to be performed over the whole scope of the claim; (vii) the specification must be sufficient to allow the invention to be so performed without undue burden [see Chapter 1].

1 2 3 4 5

102

Implementing Article 83 of the EPC. Biogen Inc v Medeva Plc [1996] UKHL 18 (31 October 1996), at 48. Genentech Inc’s Patent [1989] RPC 147 (1 April 1989). For example, see PharmaciaCorp v Merck & Co Inc [2002] RPC 41 (1 January 2002). [2008]  EWHC  1903 (Pat). Approved on appeal and in Idenix Pharmaceuticals Inc v Gilead Sciences Inc [2016] EWCA Civ 1089.

KEY CASE: Classic insufficiency and principles of general application

4.3

…

The extent of the disclosure necessary to make the patent sufficient depends on the nature of the invention, the scope of the claims and the art in which the invention is made …’

The English law of insufficiency has particularly developed in the circumstances giving rise to the Biogen (see para 4.6) and Lundbeck (see para 4.7) cases, as well as in the area of plausibility (see para 4.12). KEY CASE: CLASSIC INSUFFICIENCY AND PRINCIPLES OF GENERAL APPLICATION – REGENERON V KYMAB What the case was about 4.3 In Regeneron Pharmaceuticals Inc v Kymab Ltd6, the Supreme Court, by a majority, held two patents invalid for insufficiency. The patents were owned by Regeneron and covered transgenic mice technology. The press release for the Supreme Court decision at the time stated the need to rebalance patent law: ‘[the Court of Appeal’s] analysis watered down the sufficiency requirement which is a bedrock of patent law, tilting the balance of patent law in favour of patentees and against the public’. This was not, however, because the Supreme Court was changing the law, but because the Court of Appeal had mis-applied a key principle concerning sufficiency. The decision was really directed at clarifying existing principle, albeit in the context of a class claim in a new area of technology. The case concerned the following Regeneron patents, each with substantially the same disclosure:  •

EP1360287 (specifically process claim 1, and product claims 5 and 6): claimed methods of modifying the antibody variable regions of a mouse cell by replacement of the mouse antibody variable genes with the equivalent human genes (a human antibody light chain – variable (V) and joining (J) – or heavy chain – V, Diversity (D) and J – variable region), whilst retaining the mouse constant regions; creating a ‘reverse chimeric locus’.

The method described in the patent used, in particular, large targeting vectors (LTVECs) for use in eukaryotic cells in combination with a particular assay, the modification of allele (MOA). The use of LTVECs was made possible by the MOA assay which detects unmodified alleles, so that a cell in which one allele had been modified could be distinguished from a cell in which neither had been modified.

6 [2020] UKSC 27.

103

4.4

Requirements for a Valid Patent 4: Sufficiency •

a divisional of the above, EP2264163 (specifically, claim 1): claimed the range of transgenic mice that result from the above methods, containing the reverse chimeric locus.

The genes for these variable regions undergo rearrangement during the B-cell maturation process in the mouse, as well as a process of somatic hypermutation that introduces potentially dozens of mutations in the variable region, and thus the potential for specificity. The hybrid antibodies produced by these techniques are not, however, the final therapeutic product, because they contain mouse constant regions which would be liable to induce the human anti-mouse antibody (HAMA) response. They can, however, be engineered to produce fully human antibodies in a subsequent step, by replacing the mouse constant regions with human constant regions. Importantly, in this case, by virtue of the reverse chimeric locus, the mice produced using the above techniques are not immunologically sick. This was a significant inventive advance compared to the techniques of the prior art, and an important element in the decisions of the Court of Appeal and the Supreme Court. A  number of issues had been in dispute in both the Patents Court and the Court of Appeal, including infringement of the patents by Kymab’s KymouseTM technology (which, as a result of the Supreme Court holding the patents invalid, does not infringe them (see Chapter 8)). The only issue before the Supreme Court, however, was whether the patents were invalid for lack of sufficiency. The focus of the Supreme Court decision was on claim 1 of the ‘163 patent but, if this were invalid for sufficiency, so too would be the other relevant claims. Without undue burden and without invention – the Regeneron v Kymab decisions on sufficiency at first and second instance 4.4 At first instance, Mr Justice Henry Carr7 had held that the method of the ‘287 patent was not capable of being performed at the priority date without undue burden and without invention, and was therefore insufficient. As a result, the judge also held that the product claims in issue, which relied on the method and were considerably wider in scope, must necessarily also be insufficient. A specific aspect of Carr J’s findings, focusing on claim 1 of ‘287 and the relevant Example 3, was that they required techniques in which mouse DNA sequences would be replaced with equivalent human sequences of a size too large (replacement of 100 kb of mouse sequence by 200-300 kb

7

104

Regeneron Pharmaceuticals Inc v Kymab Ltd & Anor [2016] EWHC 87 (Pat) (1 February 2016).

KEY CASE: Classic insufficiency and principles of general application

4.4

of human sequence, or replacement of 150 kb of mouse sequence by 75 kb of human sequence). This was not possible at the priority date using the LTVEC method described. The alternative technique of Example 3, using recombinase-mediated cassette exchange (RMCE), would not have worked either. The Court of Appeal8 agreed with the trial judge that Example 3 would not have worked at the priority date, but it overturned the judge on insufficiency, on the principle that the common general knowledge of the skilled person or team can be used to make the invention work if it does not require undue effort, even if this means that the teaching of the patent is not followed precisely. In this case, expert evidence from the trial, which the judge had not considered in this context, suggested that a skilled person would have considered it obvious to use other techniques (which were common general knowledge at the priority date of the patents) to shorten the inserts to a manageable size. These included the use of a genetically engineered construct which includes the V, D and J segments, but in which non-essential DNA sequences (such as introns) have been removed – the ‘minigene’ approach. These techniques, according to the Court of Appeal, provided the necessary support for the claim, even though they could produce only a hybrid gene structure with a small sub-set of the 125 human V segments in the variable region, and an unspecified number of human D and J segments. Transplantation of the whole of the human variable region into a hybrid gene structure, as taught by the patent, would not be possible (indeed, this has only since been achieved with the benefit of further inventive processes not forming part of the disclosure of the patents or the prior art). There was, however, another issue concerning sufficiency. Only a very small range of the mice claimed could be made, even allowing for the common general knowledge techniques, and none at all containing the entire human variable region. The product claims nonetheless claimed all mice containing a reverse chimeric locus. The claims therefore covered many mice that could not be made at all at the priority date. The Court of Appeal held that this fact did not render these claims invalid, because there was a ‘principle of general application’ disclosed by the patent that did cover all of the claims: the inventive concept that using a reverse chimeric locus prevents the mice being immunologically sick. This principle would apply to all mice that could be made under the claim or made in the future and, as such, the claim was sufficient across its breadth. As a consequence, the Court of Appeal held the patents to be sufficient and valid9. 8

Regeneron Pharmaceuticals Inc v Kymab Ltd & Anor [2018] EWCA Civ 1186 (23 May 2018). 9 A  decision that the court noted to be consistent with the Board of Appeal decision upholding the validity of the ‘287 patent in T 2220/14 (9 November 2015).

105

4.5

Requirements for a Valid Patent 4: Sufficiency Principle of general application – the reasoning of the Supreme Court 4.5 The Supreme Court, led by Lord Briggs, identified the reasoning of the Court of Appeal when coming to its decision as follows: ‘The patent bargain requires that the reward given to the patentee should be commensurate with the contribution which the invention makes to the art. An invention which consists of a new generally applicable principle may contribute to the art by its use, not only in products which can currently be made, but equally in products which will only be capable of being made in the future, after further inventive research and development. To limit the patentee strictly to a monopoly over the products which can immediately be made would be to deprive the patentee of any reward for the public benefit which will be derived from the use of that same invention in future types of product. In a fast-moving field, where new products quickly outperform their predecessors so as to render them obsolete, the reward of a monopoly limited to those immediately capable of being made would be short-lived and illusory. Accordingly the invention should be regarded as sufficiently enabled across the range if it can be seen that it will in due course benefit all products in the range, provided that, as at the priority date, the teaching in the patent enables at least one type to be made immediately. Since the Reverse Chimeric Locus would be likely to deal with murine immunological sickness in mice whose genomes were fitted with “all or any” amount of the human variable segments, up to and including the whole of the human variable region, its invention was one of those principles of general application which should be regarded as enabled across the whole range contemplated by Claim 1. A  monopoly over the making and exploitation of the whole range would correspond with the contribution made by the Reverse Chimeric Locus to the art.’

It was this second part of the Court of Appeal’s reasoning – that the lack of immunological sickness of all the mice claimed was a principle of general application supporting the claim across its breadth – with which the Supreme Court disagreed, and as a result held the patents invalid for insufficiency. Lord Briggs reviewed the authorities in the UK and the EPO and summarised the law in eight points of principle: ‘i) The requirement of sufficiency imposed by article 83 of the EPC exists to ensure that the extent of the monopoly conferred by the patent corresponds with the extent of the contribution which it makes to the art. ii) In the case of a product claim, the contribution to the art is the ability of the skilled person to make the product itself, rather than (if different) the invention. iii) Patentees are free to choose how widely to frame the range of products for which they claim protection. But they need to ensure that they make no broader claim than is enabled by their disclosure. iv) The disclosure required of the patentee is such as will, coupled with the common general knowledge existing as at the priority date, be sufficient to enable the skilled person to make substantially all the types or embodiments of products within the scope of the claim. That is what, in the context of a product claim, enablement means.

106

KEY CASE: Classic insufficiency and principles of general application

4.5

v) A  claim which seeks to protect products which cannot be made by the skilled person using the disclosure in the patent will, subject to de minimis or wholly irrelevant exceptions, be bound to exceed the contribution to the art made by the patent, measured as it must be at the priority date. vi) This does not mean that the patentee has to demonstrate in the disclosure that every embodiment within the scope of the claim has been tried, tested and proved to have been enabled to be made. Patentees may rely, if they can, upon a principle of general application if it would appear reasonably likely to enable the whole range of products within the scope of the claim to be made. But they take the risk, if challenged, that the supposed general principle will be proved at trial not in fact to enable a significant, relevant, part of the claimed range to be made, as at the priority date. vii) Nor will a claim which in substance passes the sufficiency test be defeated by dividing the product claim into a range denominated by some wholly irrelevant factor, such as the length of a mouse’s tail. The requirement to show enablement across the whole scope of the claim applies only across a relevant range. Put broadly, the range will be relevant if it is denominated by reference to a variable which significantly affects the value or utility of the product in achieving the purpose for which it is to be made. viii) Enablement across the scope of a product claim is not established merely by showing that all products within the relevant range will, if and when they can be made, deliver the same general benefit intended to be generated by the invention, regardless how valuable and ground-breaking that invention may prove to be.’

In particular, the court reiterated that the requirement of sufficiency imposed by Article 83 of the European Patent Convention (EPC) exists to ensure that the extent of the monopoly conferred by the patent corresponds with the extent of the contribution which it makes to the art. The contribution to the art of the claims in this case is transgenic mice containing the reverse chimeric locus. It is not the inventive concept that the mice produced are not immunologically sick. The latter is just an idea which, if it cannot be made, is not a technical contribution to the art at all. Per Lord Briggs: ‘In the case of a product claim, the contribution to the art is the product which is enabled to be made by the disclosure, not the invention itself. Patents are about products and processes, not pure ideas. Secondly, I do not accept their conclusion that an invention may be “enabled” in relation to a particular type of product falling within the scope of the claim even if it does not permit the skilled person to make it. They thought it was enough that the benefits which the invention unlocked (in terms of preventing murine immunological sickness) would in due course be realised over the whole range, if and when all embodiments within the range could be made. In practical terms they upheld a monopoly over that part of the range of products answering the broad description in Claim 1 which was likely to be of most benefit to medical genetic engineering, at a time when the disclosure in the patent only enabled the skilled person to make products over a very small part of the range, and at the least beneficial end of the range denominated by the amount of the human variable region gene locus incorporated in the hybrid gene structure.’

107

4.6

Requirements for a Valid Patent 4: Sufficiency Patents are for products and processes and here the technical contribution – the transgenic mouse with the reverse chimeric locus ‘product’ – was far from being enabled across the claim. As if to emphasise the public policy of limiting patent protection to the contribution that it makes, Lord Briggs addressed what the Court of Appeal decision would have meant if it had been upheld: ‘It is now known that the type of mouse fitted with a Reverse Chimeric Locus which actually does serve as the gold standard in the art has the whole of the human variable region gene locus as part of its hybrid antibody gene structure. Yet the Court of Appeal would have upheld a monopoly for its manufacture and exploitation when the disclosure in the patent, coupled with the common general knowledge, would not have enabled a skilled person to make such a mouse at all. The ability of both the appellant and the respondent to make such a mouse now depends upon further (and different) inventions separately made by each of them some years after the priority date.’

In short, the Supreme Court reiterated in Regeneron v Kymab, in the context of a class claim to transgenic mice, that a patent cannot claim products that it has not enabled to be made. ‘HYBRID’ CLAIMS TO A RECOMBINANT DNA MOLECULE – BIOGEN V MEDEVA 4.6 The patent at issue in Biogen Inc v Medeva Plc 10 claimed any recombinant DNA molecule expressing the genes of any hepatitis B virus (HBV) antigen in any host cell. The claimed molecules were therefore identified partly by the way in which they had been made – that is, recombinantly. The claim was therefore generalised to any method that would produce a recombinant DNA molecule achieving the necessary expression. The method disclosed for making the DNA molecule actually used a standard pBR322 plasmid and large fragments from Dane particle DNA. Large Dane particles were used because the inventor did not have the necessary coding sequences. Conventional means of expressing the DNA were then used in a conventional bacterial host. The inventive concept of the patent was the idea of trying to express unsequenced eukaryotic DNA in a prokaryotic host. The defendant, by contrast, had used a more sophisticated technique for producing their molecules that had been enabled when the HBV genome was sequenced a few months later than the priority date of the patent. This was to use restriction enzymes based on knowledge of the HBV genome and mammalian host cells. The claim to recombinant DNA molecules was held by the House of Lords to be insufficient to sustain a claim to the defendant’s method of producing HBV antigens. 10 [1997] RPC 1 (31 October 1996).

108

A ‘pure’ product claim to escitalopram – Generics (UK) v Lundbeck

4.8

For a time, it was thought that the Biogen ruling meant that a patent on a product would be invalid for insufficiency if the process described for making that product was only one of a number of possible methods11. The House of Lords revisited this subject, however, in Generics (UK) Limited and others v H Lundbeck A/S 12. A ‘PURE’ PRODUCT CLAIM TO ESCITALOPRAM – GENERICS (UK) V LUNDBECK 4.7 This case differs from Biogen because it concerned a product claim – the (+) enantiomer compound called escitalopram. It was held that the claim to escitalopram was not insufficient merely because the patent did not disclose all possible methods by which that product could be made. The House of Lords explained that Biogen concerned a claim to a product with process elements (a ‘hybrid’ claim), which contrasts with the ‘pure’ product claim in Lundbeck. Such pure product claims are sufficient if there is at least one method by which they can be made. In coming to this decision, the House of Lords drew a distinction between the invention – that is, the method for making the enantiomer, in this case – and the technical contribution – that is, the enantiomer product claimed. It did not matter that escitalopram was known to be a desirable target at the priority date (a ‘known desideratum’) and that the only invention of the patent was therefore the process of making the enantiomer; what was claimed – that is, the product – was enabled. By contrast, the technical contribution in Biogen was claimed to be a recombinant DNA molecule. The use of the word ‘recombinant’ implied the methods capable of making it. This claim was not enabled across its breadth – the recombinant DNA molecule could be (and was) obtained using other recombinant methods that were not disclosed in the patent13. CONSISTENCY WITH PRINCIPLES IN REGENERON V KYMAB 4.8 How does the reasoning of the Supreme Court in Regeneron v Kymab compare with the reasoning of the same court on insufficiency in Lundbeck?

11 See Kitchin J  at first instance in Generics (UK) Limited and others v H  Lundbeck A/S [2007] RPC 32 (4 May 2007). 12 Generics (UK) Limited and others v H Lundbeck A/S [2009] UKHL 12 (25 February 2009). 13 In the TBA, there is no distinction made between a Biogen-type claim and a Lundbecktype claim. What is important is enablement – if the claim includes embodiments that are not enabled by the description, the patent will be insufficient. See, for example, T 409/91 Diesel fuels/EXXON [1993] OJ EPO 40 (18 March 1993).

109

4.9

Requirements for a Valid Patent 4: Sufficiency In Lundbeck, only one product was claimed by the patent – the escitalopram enantiomer. This product was the technical contribution to the art, even though it was not the invention, and was sufficient because the patent taught how to make it (the method of making the product was the invention of the patent). In Regeneron v Kymab, the technical contribution is again a product, but here it is claimed as a mouse able to produce a broad class of antibodies, many of which are not enabled. There was no principle of general application across the claim for making all of the products claimed. Both cases make a distinction between the inventive concept and the technical contribution. In Regeneron v Kymab, however, the distinction between the two is more subtle than in Lundbeck. In Regeneron v Kymab, the inventive concept (which the Court of Appeal, and Lady Black in the minority in the Supreme Court, incorrectly considered to be the principle of general application) was the idea of using a reverse chimeric locus to prevent the mice from being immunologically sick. As a mere idea, this could not amount to a technical contribution, and it could not enable all of the products of the claim to be made. As regards the Biogen decision, it is important to remember, as the Supreme Court states, that the technical contribution of a patent must lie in a product and/or process. The patent in Biogen was a hybrid product and process claim – recombinant DNA molecules – and so the technical contribution was in both. Like the claims in Regeneron v Kymab, it was also a class claim. But in the Biogen case it was the process element of the technical contribution that was not enabled – the claim covered the whole class of recombinant techniques, but enabled only one of them14. INVENTIVE IMPROVEMENTS 4.9 One question raised by the Regeneron v Kymab decision is whether it allows future products (or processes) to fall within a claim – often referred to as ‘inventive improvements’ or ‘inventive infringement’. The answer to this would seem to depend on a number of factors, not least the specific nature and drafting of the claim and the level of generality of its features in a particular case. To take a hypothetical and very simple example: a claim to a bicycle drafted simply to claim a vehicle with two spoked wheels, a seat, handle bars and driven by a person using pedals. If this patent were filed in the 1870s and the only embodiment of the claimed bicycle disclosed was a Penny Farthing, would it be sufficient? The answer is ‘yes’ because, within the terms of the claim, each of the features is supported by the Penny Farthing. 14 See also the analysis in Akebia Therapeutics Inc v Fibrogen Inc [2020] EWHC 866 (Pat) (20 April 2020).

110

Inventive improvements

4.9

To quibble that it does not disclose how to make a bicycle with fewer spokes or a bicycle with suspension is to divide the product claim into a range denominated by some wholly irrelevant factor – ‘the length of a mouse’s tail’, as Lord Briggs put it in Regeneron v Kymab. Supposing again that, unlike real patents, the patent had an unlimited term. Moving forward in the history of bicycle design, would the patent be infringed by a BMX or mountain bike? The answer must again be ‘yes’, because both of those types of bike have the features claimed. This example demonstrates that inventive improvements may be covered by a claim. And, although the technology is a far cry from transgenic mice, this approach is not affected by any point of principle adopted in the Regeneron v Kymab ruling. Insufficiency in the EPO As in the UK, the issue of sufficiency, under Article 83 of the EPC, is concerned with the ability of the skilled person to reproduce the invention defined by the patent claims, using their common general knowledge without any undue burden or invention. A  reasonable amount of trial and error is permissible in an unexplored field or where there are many technical difficulties. The subject matter claimed by a European patent must be clearly identified at the date of filing, and it is assessed on the basis of the specification as a whole15 (later additions to the specification to address gaps will fall foul of the added-matter objection (see Chapter 13, although insufficiency may be overcome by narrowing the claims16). Regardless of whether they are essential, all features of all embodiments falling within the claims must be supported by the disclosed subject matter17. Again, like the UK, the skilled person’s common general knowledge may be used to supplement any missing information in the specification or recognise and rectify any errors18. The skilled person for the purpose of assessing sufficiency is the same as for assessing inventive step19 (see Chapter  1). An invention may also be sufficiently disclosed if the necessary information to reproduce it is contained in another document unambiguously identified and available to the public by the publication date of the patent20.

15 T 14/83 Vinylchlorid resins/SUMITOMO [1984] OJ EPO 105 (7 June 1983). 16 T  512/07  ACK/NACK-transmission with different power levels/LG (unpublished) (22 January 2010). 17 T 226/85 Stable bleaches/UNILEVER [1988] OJ EPO 336 (17 March 1987). 18 T 206/83 Herbicides/ICI [1987] OJ EPO 5 (26 March 1986). 19 T 967/09 Influenza vaccines/ABBOTT BIOLOGICALS (unpublished) (4 November 2014). 20 T 429/96 Serine protease inhibitors/AMGEN (unpublished) (31 May 2001).

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Requirements for a Valid Patent 4: Sufficiency At least one method of enabling the person skilled in the art to carry out the invention must be clearly indicated in the patent21. Such a method must allow the person skilled in the art to perform the invention in the whole range that is claimed22. As in the UK, if the claimed invention is to a class of embodiments, the disclosed method must have general application across that class so that all embodiments of the class are enabled. In such cases, it is not necessary to prove the application of the invention in every individual instance. So, for example, in the case of a claim to a ‘Markush formula’, the specification must identify the technical characteristics of the whole class of compounds claimed and a method of manufacture that applies across the claimed class. As regards claims containing combinations of parameter ranges, it is only necessary that each value within the claimed ranges can be achieved individually – Article 83 of the EPC does not require that each and every permutation of parameters within the claimed ranges can be achieved23.

DEPOSITING CELL LINES 4.10 ‘Biological material’ – that is, ‘Any material containing genetic information and capable of reproducing itself or being reproduced in a biological system’24 referred to in a patent that is not otherwise available to the public as a readily available product (for example, baker’s yeast), or a standard preserved strain – must be deposited in a sample with a recognised depositary institution25 if the patent is to satisfy the sufficiency requirements of section 72(1)(c) of the Patents Act 1977. Such deposits must be on the terms laid down in the Budapest Treaty26 not later than the date of filing of the patent application27: • The application as filed must give such relevant information as is available to the applicant on the characteristics of the biological material. • The depositary institution and the accession number of the deposited biological material must also be stated in the application28.

21 T 292/85 Polypeptide expression/GENENTECH I [1989] OJ EPO 275 (27 January 1988). 22 T 409/91 Fuel oils/EXXON [1994] OJ EPO 653 (18 March 1993). 23 (unpublished) 19 April 2016. 24 Rule 26(3) of the EPC. 25 See Rule 33(6) of the EPC. 26 Budapest Treaty on the International Recognition of the Deposit of Micro-organisms for the Purposes of Patent Procedure of 28 April 1977. 27 Rule 31(1)(a) of the EPC. 28 Rule 31(1)(b) and (c) of the EPC.

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For biological material that has been deposited by a person other than the applicant, the name and address of the depositor must be stated in the application. A  document must also be submitted to the EPO providing evidence that the depositor has authorised the applicant to refer to the deposited biological material in the application and has given his unreserved and irrevocable consent to the deposited material being made available to the public29.

Deposited biological material must be available upon request to any person from the date of publication of the European patent application, and to any person having the right to inspect the files30 prior to that date. Subject to Rule 32 of the EPC, availability is effected by the issue of a sample of the biological material to the person making the request31. REACH-THROUGH CLAIMS 4.11 In English law, it is generally thought that a patent must not extend (‘reach-through’) to claim the results of applying the technical contribution that it makes to the art. A particular example would be a patent claiming a research method, which also claims any functionally defined compounds that would be found as a result of using that method. Although there is no clear authority on the point, in Human Genome Sciences Inc v Eli Lilly and Company32 a claim including the features ‘An isolated nucleic acid molecule comprising a polynucleotide sequence encoding a Neutrokine-α polypeptide …’ was not insufficient. In this case, the reference to a ‘Neutrokine-α polypeptide’ was held simply to be a reference to the polypeptide, and did not incorporate any claim to its activities – it was without any specific functional feature requiring sufficient disclosure. The claim merely had to meet the threshold of a non-specific industrial application. The Supreme Court refers, however, to T 0898/0533, in which it is said that the skilled reader should not be left to find out how to exploit the invention by carrying out a research programme. This case identifies both the need to indicate how to exploit the invention (industrial applicability) and the need to provide a sufficient disclosure of the claimed invention (sufficiency), which reflect the basic principle of the patent system that exclusive rights can only be granted in exchange for a full disclosure of the invention. 29 30 31 32 33

Rules 31(1)(c) and 33 of the EPC. See Article 128(2) of the EPC. Subject to Rule 32 of the EPC. [2011] UKSC 51 (2 November 2011). Hematopoietic receptor/ZYMOGENETICS (unpublished) (7 July 2006).

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Requirements for a Valid Patent 4: Sufficiency Clearer examples of offending claims are found in the EPO’s TBA case law. For example, in T  0544/12, a claim to organometallic iridium compounds having the functional property of phosphorescence at certain temperatures was held to be insufficient. There were an almost infinite number of organometallic compounds potentially covered, but not all of them would be phosphorescent and fall within the claim. The skilled person would not be able to use their common general knowledge, without undue burden, at the priority date of the patent to identify the phosphorescent compounds out of the alternatives covered by the claim. The subject of reach-through claims is, it is submitted, reducible to the division of inventive concept and technical contribution, as outlined in Lundbeck and Regeneron v Kymab. Applying the analysis of the latter case, a reach-through claim, although it may claim compounds that can be derived using an inventive method, does not actually make them. It has made no technical contribution and cannot be sufficient. Indeed, the claim in Regeneron v Kymab is arguably a form of reach-through claim: it is claiming an invention to a reverse chimeric locus mouse with human VDJ regions that can produce antibodies of various types, but these have not yet been found or made – the mouse is essentially a research tool.

PLAUSIBILITY THRESHOLD 4.12 As stated at the beginning of this chapter, patents raise a conundrum: to what extent should it be demonstrated in the patent at the time of filing that the claimed invention works? To deal with this issue, the TBA and the UK, in particular, have developed the requirement of plausibility: to be patentable, claims must make a technical contribution which is at least plausible. This has been described by the UK courts as a base-line or ‘threshold test’ of patentability. Depending on the context, falling below the plausibility threshold will render the patent invalid as obvious (Chapter  2), lacking industrial applicability (Chapter 3), or insufficient (Chapter 4).

KEY CASE: PREGABALIN FOR TREATING PAIN – WARNERLAMBERT 4.13 In recent years, UK patent law has taken a lead from the case law of the EPO in developing a non-statutory threshold step to validity that underlies all the statutory requirements. This is to first ask whether the patent discloses a plausible technical contribution. But what fulfils the mark of plausibility; how low or high is the threshold? This question has real implications for the amount of information that must be provided in a patent 114

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4.14

application, particularly in the pharmaceuticals and biologics fields, and therefore the optimum time for filing. This plausibility threshold was the subject of the recent UK Supreme Court case, Warner-Lambert Company LLC v Generics (UK) Ltd (t/a Mylan) & Anor34. The plausibility threshold 4.14 The policy behind the plausibility threshold has been explained by the UK judges in the particular context of second medical use claims, where efficacy as a particular therapy is claimed. They reason that plausibility provides a balance between, on the one hand, a demand that the patent specification must contain the results of a clinical trial in order to prove efficacy; and, on the other hand, the argument that, if all that the patent contains is a mere proposal, it has not made a contribution to the art (thus failing the patent bargain). The problem with the first proposition is this: although the existence of a patent (or application) may facilitate investment in a clinical trial that might not otherwise take place, this means that the patent has to be applied for before the results are known; a rule which demands clinical results first risks the publication of such results destroying the novelty of the invention. The problem with the second proposition is that it would be a recipe for abuse if all that is required to obtain a patent is a proposal, without any basis, to use drug A to treat disease B35: ‘Patent law seeks to address these factors balancing the requirements for sufficiency of disclosure against the rules of novelty and inventive step. But the conventional sufficiency test of asking whether the claimed invention works, does not help. The treatment does work but what if the patent does not say so? For these reasons the idea of “plausibility” as part of the law of sufficiency of disclosure has been developed both in the EPO … and the UK … The term “plausibility” has been coined to characterise what it is that a patent specification must provide in order to be sufficient, short of full clinical proof of efficacy.’

This rationale is not limited to second medical use cases, but also per se claims to a product. According to the case law of the Boards of Appeal of the EPO, a chemical compound is not patentable merely because it potentially enriches chemistry. In such cases, just as in second medical use claims, some indication of the technical effect or contribution of the claimed invention is needed. This must manifest itself in a valuable property in the widest sense, as an effect or an increase in the potency of an effect. That effect must be plausible36.

34 [2018] UKSC 56 (14 November 2018). 35 Hospira UK Ltd v Genentech Inc [2014] EWHC 1094 (Pat) (10 April 2014). 36 T 0488/16 Dasatinib/BRISTOL-MYERS SQUIB (unpublished) (1 February 2017).

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Requirements for a Valid Patent 4: Sufficiency Facts and decision 4.15 Aside from the infringement case in Warner-Lambert (see further Chapter 6), which was based on the launch of generic pregabalin by Actavis in February 2015, Actavis, together with Mylan, claimed the revocation of the following Warner-Lambert patent claims: ‘1. Use of (S)-3-(aminomethyl)-5-methylhexanoic acid [pregabalin] or a pharmaceutically acceptable salt thereof for the preparation of a pharmaceutical composition for treating pain. … 3. Use according to Claim 1 wherein the pain is neuropathic pain.’

At first instance, Arnold J  held that none of the claims of the patent was obvious, but that claims 1 and 3, as well as other claims, were invalid on the ground of insufficiency, specifically because the claims were not plausible across their scope. The Court of Appeal upheld the first instance decision. That decision was then appealed to the Supreme Court, including a challenge to the test being used for insufficiency, based on lack of plausibility. On the issue of plausibility, Lord Sumption (giving the leading judgment for the whole court) upheld the lower courts’ decisions that the patent did not plausibly support the treatment of central neuropathic pain. He also led the majority in overturning the Court of Appeal by holding that the patent did not plausibly support any kind of neuropathic pain. The claims alleged to be infringed were therefore invalid due to insufficiency. Guidelines for demonstrating plausibility 4.16 In Warner-Lambert the Supreme Court explained what plausibility requires in the context of patent claims to the second medical use of pregabalin for treating pain. Before the case reached the Supreme Court, the Court of Appeal had thought that the threshold was not only low, but that the test could be satisfied by a ‘prediction … based on the slimmest of evidence’. Lord Sumption in the Supreme Court disagreed with this, stating that, whilst the test is relatively undemanding, it cannot be deprived of all meaning, or reduced to little more than a test of good faith. In Lord Sumption’s view, the Court of Appeal’s approach would be unlikely to serve even the limited purpose of barring speculative or ‘armchair claims’. With the support of the majority of the Supreme Court, Lord Sumption instead set out seven guidelines relevant to deciding plausibility in this case (see Table 4.1).

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Table 4.1  The seven guidelines in Warner-Lambert 1.

The proposition that a product is efficacious for the treatment of a given condition must be plausible.

2.

It is not made plausible by a bare assertion to that effect, and the disclosure of a mere possibility that it will work is no better than a bare assertion.

3.

The claimed therapeutic effect may well be rendered plausible by a specification showing that something was worth trying for a reason – reasonable scientific grounds are disclosed for expecting that it might well work.

4.

Although the patent need not prove the assertion that the product works for the claimed purpose, there must be something that causes the skilled person to think there is a reasonable prospect that the assertion will prove to be true.

5.

That reasonable prospect must be based on ‘a direct effect on a metabolic mechanism specifically involved in the disease, this mechanism being either known from the prior art or demonstrated in the patent per se’.

6.

The effect on the disease process need not necessarily be demonstrated by experimental data. It can be demonstrated by a priori reasoning.

7.

Sufficiency is a characteristic of the disclosure, although the disclosure may be supplemented or explained by the common general knowledge of the skilled person.

In the view of the minority of judges (Lords Mance and Hodge), Lord Sumption had put the test of plausibility too high. Lord Mance expressed concern that there was a real risk that the test described by Lord Sumption would amount to, or be understood as, requiring a prima facie case to be established on the material contained in the specification. This, in His Lordship’s view, was not supported by the EPO authorities to which the Supreme Court was referred in the case. The authorities, Lord Mance said, certainly rejected speculative or wide-ranging unsubstantiated claims, but they also accepted as sufficient a tailored claim which appeared scientifically possible, even though it could not be said to be even prima facie established, without for example testing or assays according to the state of the art. In Lord Mance’s judgement, following the EPO authorities should mean that only if a person skilled in the art would have significant doubts about the workability of the invention would it fail for insufficiency of disclosure. Similarly, Lord Hodge appeared to differ from Lord Sumption by stating that a patent did not need to disclose experimental evidence of plausibility unless there was an allegation, supported by sufficient evidence, that the invention did not work. In other words, the minority in the Supreme Court said that the EPO case law only required plausibility to be demonstrated if the therapeutic effect in a second medical use patent was inherently implausible. Lord Sumption, for the majority, said that, if this were correct, it would mean that, if nothing was known either for or against the claimed therapeutic 117

4.17

Requirements for a Valid Patent 4: Sufficiency effect, no disclosure need be made in support of it. This, he said, would be an odd result and contrary to the policy considerations of plausibility. Instead, the majority adopted a positive requirement for the patent to show plausibility – there must be something that causes the skilled person to think that there is a reasonable prospect that the assertion will prove to be true, in the sense that plausibility must be based on some predictive data, or a priori reasoning. Applying the principles to the facts 4.17 Lord Sumption reviewed the findings of the judge at first instance about the empirical data disclosed in the patent supporting the WarnerLambert patent claims. This consisted of references to a number of pre‑clinical animal models used to test drugs for various kinds of pain (see Table 4.2). In the unanimous view of the Supreme Court, it followed from these that the experimental data in the specification was predictive of efficacy against inflammatory pain. There was, however, no experimental data or a priori reasoning to make it plausible that pregabalin was effective for the treatment of central neuropathic pain. Furthermore, the skilled person would not have considered that there was any reasonable basis for thinking that an anticonvulsant like pregabalin, known to be effective for the treatment of epilepsy, would for that reason alone be effective for treating central neuropathic pain. Table 4.2  The data supporting the patent claims Test result

Meaning

The rat paw formalin test

This test models inflammatory pain. The patent records that the test results showed pregabalin to be effective in treating inflammatory pain. There is no statement in the patent that it is effective to treat neuropathic pain.

The carrageenin test

This also models inflammatory pain. The patent specification records that test results showed pregabalin to be effective in treating this pain.

The post-operative pain model

This tests for pain responses following surgery. Like the other tests, nothing in the literature suggests that this model could be used to predict efficacy for neuropathic pain.

The Bennett model and the Kim and Chung model

The patent specification refers to these as two well-known models for peripheral neuropathy, but no data is presented from either model.

The Supreme Court also examined whether it was plausible, on the basis of the patent, that pregabalin was effective against any neuropathic pain (peripheral or central). 118

Plausibility under Articles 56 and 83 of the EPC compared

4.18

Lord Sumption noted that neither the specification nor the common general knowledge supplied any reason for supposing this. In particular, there was nothing to suggest, even as a hypothesis, that Warner-Lambert were right when arguing that pregabalin worked to treat peripheral neuropathic pain by blocking central sensitisation. There was also simply an absence of any evidence that Pregabalin acted on central sensitisation at all. In the majority view, it was not enough to justify a monopoly that it is ‘possible’ a priori that a drug which is effective for inflammatory pain would also be effective for neuropathic pain, without any reason to suppose that the possibility had some scientific basis or that it was more than speculative. As Lord Sumption put it: ‘Everything is possible that is not impossible, but “not impossible” is very far from being an acceptable test for sufficiency. Plausibility may be easy to demonstrate, but it calls for more than that’. PLAUSIBILITY UNDER ARTICLES 56 AND 83 OF THE EPC COMPARED 4.18 In the dasatinib cases (see Chapter 2 and ‘Plausibility in the EPO’ below), plausibility of the per se claims was dealt with under the requirement of inventive step (Article 56) and the second medical use case as a matter of insufficiency (Article 83). This is because, once the claimed therapeutic application of the latter has been demonstrated to be plausible, as a threshold step, it is then necessary to show that the therapeutic use actually works as a matter of sufficiency. This sufficiency step is not required for the former per se claim, merely that the compound claimed can be made (that there is a technical contribution for the purpose of assessing inventive step using the problem-and-solution approach of the EPO). The difference between these two forms of claim is not therefore the plausibility analysis, but the further requirement of sufficiency. In this respect, the English court agrees that the plausibility tests for Articles 56 and 83 are the same37: ‘the claimed therapeutic effect may well be rendered plausible by a specification showing that something was worth trying for a reason, ie not just because there was an abstract possibility that it would work but because reasonable scientific grounds were disclosed for expecting that it might well work. The disclosure of those grounds marks the difference between a speculation and a contribution to the art. This is in substance what the Technical Board of Appeal has held in the context of article 56, … In my opinion, there is no reason to apply a lower standard of plausibility when the sufficiency of disclosure arises in the context of EPC article 83 … In both contexts, the test has the same purpose.’

37 [2018] UKSC 56 (14 November 2018), para 37.

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Requirements for a Valid Patent 4: Sufficiency Plausibility in the EPO As discussed in Chapter 2, the origins of plausibility lie in the EPO’s approach to inventive step. However, plausibility also appears as a threshold step in the context of insufficiency when assessing purposelimited medicinal use claims. This was established by T 609/02 AP-1 complex/SALK INSTITUTE38, in which the Board stated that, under Article 83 of the EPC, the application must disclose the suitability of the product for the claimed therapeutic application claimed, unless already known to the skilled person at the priority date. In the case of purpose-limited medicinal use patents, the Board recognised that a patent application must be made before definitive evidence of therapeutic effect is available from clinical trials: ‘… for a sufficient disclosure of a therapeutic application, it is not always necessary that results of applying the claimed composition in clinical trials, or at least to animals are reported. Yet, this does not mean that a simple verbal statement in a patent specification that compound X  may be used to treat disease Y is enough to ensure sufficiency of disclosure in relation to a claim to a pharmaceutical. It is required that the patent provides some information in the form of, for example, experimental tests, to the avail that the claimed compound has a direct effect on a metabolic mechanism specifically involved in the disease, this mechanism being either known from the prior art or demonstrated in the patent per se. Showing a pharmaceutical effect in vitro may be sufficient if for the skilled person this observed effect directly and unambiguously reflects such a therapeutic application (T 241/95 Serotonin receptor/ELI LILLY [2001] OJ EPO 103 (14 June 2000)) or, … if there is a “clear and accepted established relationship” between the shown physiological activities and the disease (T  158/96 Obsessive-compulsivedisorder/PFIZER (unpublished) (28 October 1998)).’

As in the UK, the mere assertion or speculation that a compound is suitable for a particular indication is not enough for the invention to be plausible. SALK is clear that in vitro tests may be enough, as may the results of experiments that demonstrate that the claimed compound has a direct effect on a metabolic mechanism specifically involved in the disease. Like the UK, plausibility may also be demonstrated by the patent without such evidence, if there is no substantiated doubt about the theoretical case made for the efficacy of the invention39. The two dasatinib decisions from the EPO (Dasatinib/BRISTOLMYERS SQUIB T 0488/16, unpublished, 1 February 2017 (discussed in Chapter 2) and Dasatinib in the treatment of CML/BRISTOL T 0950/1340) 38 (unpublished) (27 October 2004). 39 This was the case in T 0578/06 IPSEN/Pancreatic cells (unpublished) (29 June 2011). 40 Dasatinib in the treatment of chronic myelogenous leukemia/BRISTOL (unpublished) (3 February 2017).

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illustrate how, despite similar facts to each other, the EPO  Boards of Appeal have applied plausibility as an inventive step consideration when addressing per se claims, and as a sufficiency consideration when applied to purpose-limited medicinal claims. It was the second medical use claim to dasatinib (T 0950/13) in which plausibility was applied to Article 83. Specifically, T  0950/13 concerned claims to dasatinib in the manufacture of a medicament for, and for use in, the oral treatment of cancer, wherein the cancer is chronic myelogenous leukaemia (CML). Although the application as filed claimed a generic group of compounds for this purpose, the only compound identified in the description as preferred was dasatinib. In the absence of experimental evidence for dasatinib’s BRC-ABL PTK activity, the Board accepted the applicant’s argument that it would be part of the skilled person’s common general knowledge that they could test dasatinib for BRC-ABL PTK inhibition. The common general knowledge of the skilled person was that BRC-ABL PTK inhibition is as an effective way to treat CML, and Imatinib, an analogue of dasatinib, is a PTK inhibitor and has been used successfully in the treatment of CML. Furthermore, there was evidence in the patent itself of inhibitory activity of other PTKs by dasatinib. The functional equivalence of dasatinib to imatinib as a BRC-ABL PTK inhibitor in the application satisfied the TBA that it was suitable in the treatment of CML. Furthermore, there was no a priori reason why the skilled person would regard this concept as incredible or implausible. Consequently, there would seem to be little to distinguish the approach taken by the TBA to plausibility and that set out by the Supreme Court in Warner-Lambert: both require that plausibility is based on some predictive data, or a priori reasoning. In T 0950/13, the TBA re-states the principle in SALK that, for a second medical use patent claim to be sufficient, under Article 83, it must be possible to show that the content of the patent as filed, together with the common general knowledge at that date, enable the skilled person to prepare the claimed compound, and that the claimed treatment can be achieved in a reliable and reproducible manner. This requires that either the applicant must provide suitable evidence for the claimed therapeutic effect, or it must be derivable from the prior art or common general knowledge. The TBA agreed with the applicant in T  0950/13 that it was not always necessary to disclose experimental results to demonstrate sufficiency, if the application discloses at least a plausible technical concept for which there are no substantial doubts that it can be put into practice.

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Requirements for a Valid Patent 4: Sufficiency LACK OF CLARITY AND UNCERTAINTY The difference between lack of clarity and uncertainty 4.19 Lack of clarity or indefinite scope (sometimes referred to as a ‘fuzzy boundary’) is not a statutory ground on which validity can be challenged after grant in the English courts. Furthermore, the court will usually try to determine what the skilled person would understand the patentee intended to mean by the words used. There is a distinction to be drawn between lack of clarity and uncertainty. The latter is a ground for insufficiency. The factual circumstances in which a truly uncertain claim has been identified so far in the English courts are ones which depend on carrying out a technical test to find out if a product or process is within the claim or not. If the skilled person is unable to determine whether they are carrying out the right test, the claim is truly uncertain and will be insufficient (although the principle is not limited to cases where a technical test can be applied)41. A claim is not rendered uncertain, however, simply because it is difficult to judge what is covered at the edge of the claim. If the scope of a claim is at least clear enough to work out that a defendant has infringed it, an argument that the claim is insufficient for uncertainty is likely to be met with scepticism by the court42.

KEY CASE: CERIC OXIDE CATALYST – ANAN KASEI V NEO CHEMICALS 4.20 In Anan Kasei & Anor v Neo Chemicals and Oxides & Ors43, Anan Kasei claimed infringement of a patent relating to ceric oxide or ceria, which is an oxide of the element cerium, and is a catalyst known for use in a variety of applications. In particular, the patent was concerned with use as a catalyst for purifying vehicle exhaust gases. The defendant denied infringement and counterclaimed for revocation of the patent on the grounds of lack of novelty, obviousness and insufficiency. The appeal was concerned solely with the judge’s rejection of the insufficiency ground.

41 See for example, Kirin-Amgen v Hoechst Marion Roussel [2004] UKHL 46 (21 October 2004) and Sandvik Intellectual Property AB  v Kennametal UK  Limited, Kennametal Europe GmbH [2011] EWHC 3311 (Pat) (15 December 2011). 42 Unwired Planet v Samsung and Huawei [2016] EWHC 576 (Pat) (22 March 2016). For a recent example in the EPO, see T 1285/15 Security Device and its Production Method/De La Rue (unpublished) (18 November 2019). 43 [2019] EWCA Civ 1646.

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4.23

‘Uncertainty’ not ‘ambiguity’ 4.21 The patentee had limited its claim by the words ‘consisting essentially of’ a particular oxide. The Court of Appeal rejected the insufficiency of the claim (upholding the decision at first instance) on the first argument, which said that the words were capable of more than one meaning. In the past, this has been referred to as ‘ambiguity’, but the Court of Appeal re-named it ‘uncertainty’, thinking this more accurately described the nature of the objection. ‘Consisting essentially of ’ 4.22 Specifically, the appeal dealt with whether the words ‘consisting essentially of’ gave rise to such uncertainty as to lead to invalidity of the patent. The patentee also limited its claim by reference to a desirable physical characteristic for such an oxide, namely high specific surface area, and specified that it remained the same after being subjected to a high temperature heating test. The Court of Appeal noted that the words ‘consisting essentially of’ in a claim are something of a hybrid of ‘consisting of’ (which means that nothing else is present) and ‘comprising of’ (which means that other ingredients may be included). The words do not restrict the claim to the specified ingredient alone, and might be said to give rise to some uncertainty, in the absence of further guidance, as to what they mean. The skilled person would regard the claims as meaning that, apart from the mandatory ingredient, no other ingredients are present which materially affect the essential characteristics of the product. Sufficiency attack Facts 4.23 Neo’s invalidity attack was that the words ‘consisting essentially of’ rendered the claim invalid for insufficiency, because they were uncertain. In particular, where the alleged infringing ceric oxide contained an ingredient other than ceric oxide, the skilled person would be required to perform a test to determine whether the presence of the extra ingredient had a material effect on the essential characteristics of the product (‘the materiality test’). The materiality test which the skilled person would need to perform would be to compare the allegedly infringing sample with a control which, whilst otherwise identical, did not have the added ingredient. The requirement for a comparator, Neo said, gave rise to difficulty for the skilled person, because the method by which solid ceric oxides are made will always involve a final heating step; the added ingredient will be baked in and it will not be possible to remove it (by analogy, like taking an ingredient out of a cake after it is cooked). So, the skilled person would 123

4.24

Requirements for a Valid Patent 4: Sufficiency not be able to obtain the control sample which they need for the materiality test. Neo said that it was no answer to suggest that the skilled person could obtain a comparator by manufacturing one from scratch, because a person in possession of the alleged infringing sample must be able to tell from the product alone whether it infringes, and will not necessarily know the process by which it was made, which may be secret. Even if the skilled person could obtain access to the process, the argument continued, that would not be enough. The skilled person would not know whether it was the presence of the added ingredient in the final product which was affecting the properties, or whether the added ingredient had affected the process (for example, by altering the way in which precipitation occurred). The claim required a focus on the effect of the added ingredient in the product, teased apart from process effects. Court of Appeal 4.24 The court held that Neo’s insufficiency attack failed: •

First, this was not a case where there was any argument about the criterion which one needs to apply, and possibly test for, once the argument about the construction of the claim was resolved, as it had been. It was simply whether the added ingredient had a material effect on the essential characteristics of the product. • Secondly, Neo’s case, insofar as it depended on a purchaser not having access to process details in order to make a comparator, was based on a false premise. The test for sufficiency was whether the specification of the patent disclosed the invention clearly enough and completely enough for it to be performed by a person skilled in the art. The test was not whether a purchaser of the product lacking the relevant skill in the art could determine whether it infringed. There were many situations countenanced by patent law (product by process claims being one example) where a purchaser would not be able to test for infringement without access to process details. • Thirdly, and most fundamentally, the suggestion that determining whether a product was inside or outside the claim would impose an undue burden on the skilled person was not made out on the evidence. The judge did not make any detailed findings on the nature of the task which would face the skilled person in deciding whether specific products fell within the ‘consisting essentially of’ wording. The suggestion that the skilled person would think that they were being required to create a comparator with the added ingredient removed from the baked composition was rejected. The skilled person would not think that they were being asked to perform the impossible. A lack of clarity can result in insufficiency if the lack of clarity affects the patent as a whole, to the extent that the skilled person, using the common general knowledge, cannot carry out the invention. 124

Chapter 5 Patent Infringement 1: Scope of Protection of Claims

LIFE SCIENCES CONTEXT 5.1 Whether applying for a patent or seeking to enforce one, it is important to know what the patent claims protect. When seeking ‘freedom to operate’, it is also vital to know what third party patents protect. If patent claims are too broad, the difficulty may arise that the claims cover prior art technology and they risk invalidation, or that they or not sufficiently supported by the disclosure of the patent. Conversely, if the claims are too narrow, competitors may develop their own products or processes which compete commercially but do not infringe. The way in which the scope of protection of a patent claim is determined has changed radically in the UK in the last few years to include products and processes that are not covered by the language of the claim, but are equivalent to embodiments that are – the ‘doctrine of equivalents’. This doctrine was introduced by the Supreme Court in a case concerning different salts of a small-molecule drug, pemetrexed. It nonetheless has implications for patents covering all technologies, including biotechnology and medical devices, and is now the staple approach for owners of patents when assessing whether their patent claims are infringed by a third party or whether they risk infringing another’s patents.

GENERAL PRINCIPLES Article 69 of the EPC and the Protocol 5.2 Article  69(1) of the European Patent Convention (EPC) governs the scope of the protection conferred by European patent claims and their interpretation: 125

5.2

Patent Infringement 1: Scope of Protection of Claims ‘(1) The extent of the protection conferred by a European patent or a European patent application shall be determined by the claims. Nevertheless, the description and drawings shall be used to interpret the claims.’

Accordingly, the claims of a patent are central to determining the scope of its protection. The information disclosed by the description and drawings in the patent specification are used to interpret the language used in the claims. Article 69 of the EPC is further elaborated by the Protocol on Interpretation of Article 69 of the EPC (‘the Protocol’). Article 1 of the Protocol states: ‘Article  69 should not be interpreted in the sense that the extent of the protection conferred by a European Patent is to be understood as that defined by the strict, literal meaning of the wording used in the claims, the description and drawings being employed only for the purpose of resolving an ambiguity found in the claims. Neither should it be interpreted in the sense that the claims serve only as a guideline and that the actual protection conferred may extend to what, from a consideration of the description and drawings by a person skilled in the art, the patentee has contemplated. On the contrary, it is to be interpreted as defining a position between these extremes which combines a fair protection for the patentee with a reasonable degree of certainty for third parties.’

The purpose of the Protocol, as it says, is to direct claim interpretation to a balance between the need for a reasonable degree of certainty for third parties, so that they can practise their activities without risk of infringement, and a fair protection for the patentee for the invention that they have contributed. This middle way is found between two extremes: 1. The literal approach in which the words used in the patent are either restricted to their contextual meaning (as interpreted by the patent and surrounding circumstances); or, acontextual (‘the meanings assigned to the words by a dictionary and to the syntax by a grammar’1). This approach provides the reasonable degree of certainty to third parties that the Protocol refers to, but it also risks an injustice to the patentee if something that they thought they had claimed is excluded by a strict and unforgiving construction of the language of the claim. 2. The wording of the claims is only taken as a guideline, which aims to identify the ‘inventive concept’ of the patent. This provides ample protection for the patentee, but it leaves third parties in doubt as to the activities that may infringe. The literal approach is likely to exclude immaterial variants, known as ‘equivalents’ – a (small) variation of a product or process, which uses the patented inventive concept, but without literally infringing the language of the patent claim (that is, the product or process lies outside the claim, strictly construed).

1

126

H Laddie, ‘Kirin Amgen – the end of equivalents in England?’ IIC 2009 40(1) 3–38.

General principles

5.3

To expressly address equivalents, the Protocol was revised to add Article 2 in the EPC 20002: ‘… for the purpose of determining the extent of protection conferred by a European patent, due account shall be taken of any element which is equivalent to an element specified in the claims.’

In the UK, as a result of the Supreme Court decision in Actavis UK Limited v Eli Lilly and Company3, a structured approach to giving ‘due account’ to equivalents is now part of the law (see para 5.4). Pre-doctrine of equivalence: tautomers – Pharmacia Corp v Merck 5.3 Even before the recent introduction of a doctrine of equivalents into UK law, Pharmacia Corp v Merck & Co Inc4 demonstrated that, whereas interpretation of a patent claim was limited to the purposive approach (see para 5.6), the court was able to examine the pluralistic behaviour of a product to find that it can fall within a claim. In Pharmacia v Merck, the patent in suit claimed a class of compounds using the following Markush formula:

Importantly, X  could be a hydroxy group, but not a keto group. The active ingredient of the allegedly infringing product, Vioxx, was 4-(4-methylsulphonylphenyl)- 3-phenyl-5H-furan-2-one (known as MK-966). This is represented in the following formula:

2 By the Munich Amendment Act to the European Patent Convention, 29 November 2000. 3 [2017] UKSC 48 (12 July 2017). 4 [2001] EWCA Civ 1610.

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5.4

Patent Infringement 1: Scope of Protection of Claims Both parties accepted that a compound of the formula of MK-966 would not literally infringe the claim, because it contains a keto substitution rather than a hydroxy substitution. The evidence showed, however, that in aqueous solution MK-966 undergoes tautomerisation in equilibrium between keto and hydroxy substituted tautomers (called the furanone and the hydroxyfuran, respectively):

As a result, the court had to decide whether MK-966 infringed the claim because the compound covered by the claim would be understood as a tautomer of the furanone. The Court of Appeal held that the skilled reader would know, from their common general knowledge, that the furanone would tautomerise in aqueous solution into the hydroxyfuran, that the two compounds would be inseparable in solution, and therefore that the reference to one would include the other. As a result, the furanone would fall within the claim. A  factor in the decision, which illustrates the importance of the patent specification as a whole in interpreting the claims, was that the court took into account the statement in the patent that the compounds of the claimed class are said to be active in the body. Thus, in order to give fair protection to the patentee, the court held, it is reasonable to take into account the existence of the compound in the body, and it is the composite of both forms that have effect. Under the doctrine of equivalents now established in UK law, a second analysis is possible. This would focus not on the pluralistic behaviour of MK-966, but instead the hydroxy compound claimed in the patent would likely be considered equivalent to the ketone. KEY ISSUE: DOCTRINE OF EQUIVALENTS 5.4 At the time of the introduction of Article  2 to the Protocol (see para 5.2), a ‘doctrine of equivalents’ was not considered a part of UK law. Instead, the House of Lords held that Article 69 of the EPC ‘shuts the door 128

KEY CASE: Dipotassium and disodium equivalent – Actavis v Eli Lilly

5.6

on any doctrine which extends protection outside the claims’5; the scope of protection of a patent claim was considered to be firmly limited by the claim language, with equivalence merely providing context6. The law changed course in this respect with the Actavis UK Limited v Eli Lilly and Company7 decision of the Supreme Court in July 2017. KEY CASE: DIPOTASSIUM AND DISODIUM EQUIVALENT – ACTAVIS V ELI LILLY 5.5 Actavis v Eli Lilly concerned a patent claiming a combination of pemetrexed disodium with vitamin B12 for the prevention of the growth of tumours. Actavis sought declarations of non-infringement of the patent in respect of its proposed marketing of pemetrexed diacid, pemetrexed dipotassium and pemetrexed ditromethamine products. The case centred on the meaning of the words ‘pemetrexed disodium’ and, in particular, whether these words should be interpreted to cover pemetrexed dipotassium, pemetrexed diacid or pemetrexed ditromethamine. The UK Supreme Court held that direct infringement cannot be determined solely on the basis of the language of the claim. Instead, equivalents to the claimed embodiments must also be considered as a second step. The court must ask: 1. does the variant infringe any of the claims as a matter of normal interpretation of the language used by the claims; and, if not, 2. does the variant nonetheless infringe because it varies from the invention in a way or ways which is or are immaterial? If the answer to either issue is ‘yes’, there is infringement. Step 1: the purposive approach 5.6 Under Step 1, the existing approach of purposive construction is preserved – what would the person skilled in the art have understood the patentee to be using the language of the claims to mean8? The most recent guidance on the interpretation of the language of the claims for this purpose is given by the Court of Appeal in Virgin Atlantic Airways Ltd v Premium Aircraft Interiors Group Ltd 9:

5 6 7 8 9

Kirin-Amgen Inc v Hoechst Marion Roussel Ltd [2004] UKHL 46 (21 October 2004). Per Lord Hoffmann, Ibid, at para 49. [2017] UKSC 48 (12 July 2017). Icescape Ltd v Ice-World International BV & Ors [2018] EWCA Civ 2219 (10 October 2018). [2009] EWCA Civ 1062 (22 October 2009).

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5.6

Patent Infringement 1: Scope of Protection of Claims ‘(i) The first overarching principle is that contained in Article  69 of the European Patent Convention. (ii) Article 69 says that the extent of protection is determined by the claims. It goes on to say that the description and drawings shall be used to interpret the claims. In short the claims are to be construed in context. (iii) It follows that the claims are to be construed purposively – the inventor’s purpose being ascertained from the description and drawings. (iv) It further follows that the claims must not be construed as if they stood alone – the drawings and description only being used to resolve any ambiguity. Purpose is vital to the construction of claims. (v) When ascertaining the inventor’s purpose, it must be remembered that he may have several purposes depending on the level of generality of his invention. Typically, for instance, an inventor may have one, generally more than one, specific embodiment as well as a generalised concept. But there is no presumption that the patentee necessarily intended the widest possible meaning consistent with his purpose be given to the words that he used: purpose and meaning are different. (vi) Thus purpose is not the be-all and end-all. One is still at the end of the day concerned with the meaning of the language used. Hence the other extreme of the Protocol – a mere guideline – is also ruled out by Article 69 itself. It is the terms of the claims which delineate the patentee’s territory. (vii) It follows that if the patentee has included what is obviously a deliberate limitation in his claims, it must have a meaning. One cannot disregard obviously intentional elements. It also follows that where a patentee has used a word or phrase which, acontextually, might have a particular meaning (narrow or wide) it does not necessarily have that meaning in context. It further follows that there is no general “doctrine of equivalents”. (viii) On the other hand purposive construction can lead to the conclusion that a technically trivial or minor difference between an element of a claim and the corresponding element of the alleged infringement nonetheless falls within the meaning of the element when read purposively. This is not because there is a doctrine of equivalents: it is because that is the fair way to read the claim in context. (ix) Finally purposive construction leads one to eschew the kind of meticulous verbal analysis which lawyers are too often tempted by their training to indulge.’

The guidance in Virgin Atlantic predates the authority of Actavis v Eli Lilly, and to some extent, for example in point (viii), they overlap. Virgin Atlantic remains good law for construing the language of claims purposively10, except for the third paragraph of point (vii), which is now overridden by Step 2 of Actavis v Eli Lilly. Step 2 squarely raises the possibility of infringing equivalents, but limits their inclusion within the claim to those variants which are immaterial to the invention. As such, in the view of the Supreme 10 Garmin (Europe) Limited v Koninklijke Philips NV [2019] EWHC 107 (Ch) (29 January 2019).

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KEY CASE: Dipotassium and disodium equivalent – Actavis v Eli Lilly

5.7

Court, Step 2 now complies with Article 2 of the Protocol. In the view of the Supreme Court, this two-step approach also brings into balance the competing interests of the patentee and third parties, as required by the Protocol. Step 2: determining immaterial variants 5.7 Further to introducing Step 2, the Supreme Court in Actavis v Eli Lilly then provided guidance on how an immaterial variant that is equivalent to a feature of the claim is to be identified. It did so by adopting a set of already existing tests called the Protocol/Improver Questions11 and adapting them to produce a new set of three questions – ‘Actavis Questions’: ‘1. Notwithstanding that it is not within the literal meaning of the relevant claim(s) of the patent, does the variant achieve substantially the same result in substantially the same way as the invention, ie  the inventive concept revealed by the patent? 2. Would it be obvious to the person skilled in the art, reading the patent at the priority date, but knowing that the variant achieves substantially the same result as the invention, that it does so in substantially the same way as the invention? 3. Would such a reader of the patent have concluded that the patentee nonetheless intended that strict compliance with the literal meaning of the relevant claim(s) of the patent was an essential requirement of the invention?’

In order to demonstrate that a variant infringes a claim on the basis of the doctrine of equivalents under the Actavis Questions, a patentee must show that the answer to the first two of these Questions is ‘yes’, and that the answer to the third Question is ‘no’. The Supreme Court suggested in Eli Lilly v Actavis that these Questions mean that a variant is more likely to be immaterial if it is not a variant of part of the inventive concept claimed. On the facts of the Actavis case, the sodium cation was not judged part of the inventive concept, which is instead the administration of the pemetrexed anion together with vitamin B12. The Supreme Court’s observation about variants that are part of the inventive concept was amplified in the Court of Appeal decision in Icescape Ltd v Ice-World International BV & Ors 12. The doctrine of equivalents in Germany The claims are the decisive basis on which claims are construed in Germany, as it is in the UK. The claims must also include equivalents, further to Article 2 of the Protocol. Whether a variant is equivalent in Germany is determined according to the approach exemplified by the 11 See Wheatley & Anor v Drillsafe Ltd & Ors [2000] EWCA Civ 209 (5 July 2000). 12 [2018] EWCA Civ 2219 (10 October 2018).

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5.8

Patent Infringement 1: Scope of Protection of Claims Schneidmesser I13 case. This requires a positive answer to be given to each of the following three steps (sometimes referred to as the ‘Schneidmesser Questions’): ‘1. Does the modified embodiment solve the problem underlying the invention with means that have objectively the same technical effect / advantage? 2. Was the person skilled in the art, using his specialist knowledge, able to find the variant at the priority date as having the same effect? 3. Are the considerations which the skilled person takes into account for the variant in the light of the meaning of the invention close enough to the considerations taken into account for the literal solution protected by the claims, such that the skilled person will consider the variant as a solution which is equal/equivalent to the literal one?’

The third step, in particular, has been the subject of a number of decisions in the German Supreme Court14. For those rare cases in which a positive answer to the first three questions extends the scope of protection to a variant which is obvious or lacks novelty with regard to the prior art, a fourth question (the ‘Formstein15 objection’) is applied – this must be answered in the negative in order to guard against over-extending the scope of the claim: ‘4. Does the variant, having regard to the state of the art, lack novelty or is the variant obvious to a person skilled in the art?’

The use of this defence is limited and difficult to apply. This is because, due to the bifurcated nature of proceedings in Germany, the defendant must use prior art that is specific to the variant in question and does not raise issues about the validity of the claimed subject matter. If the prior art is relevant for the claimed subject matter and not only for the variant, the defence can only be raised in nullity proceedings (see para 5.11).

APPLYING THE DOCTRINE OF EQUIVALENTS TO A MECHANICAL PATENT The inventive core of the patent 5.8 Icescape is not a life sciences-related case, but it is the first example of the Court of Appeal applying the Actavis Questions and demonstrates how the new doctrine of equivalents has quickly been integrated into UK law. 13 Schneidmesser X ZR 168/00 GRUR 2002, 515. 14 Okklusionsvorrichtung X  ZR  16/09  GRUR  2011 701(10  May 2011); Diglycidverbindung X ZR 69/10; GRUR 2012 45 (13 September 2011); Pemetrexed X ZR 29/15 (14 June 2016). 15 BGH Formstein X ZR 28/85 GRUR 1986 803 (29 April 1986).

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Applying the doctrine of equivalents to a mechanical patent

5.8

The invention of the patent in Icescape addresses the problems raised when installing and dismantling conventional ice-rink coolant systems, in particular the laborious, relatively time-consuming and expensive nature of the task and the tendency for leakage to occur. The patent provides a cooling member for an ice rink which can be installed and dismantled rapidly, and which allows the rink to be made with different surface areas. This cooling system uses a feed manifold and a discharge manifold, a number of longitudinal pipes connected to the manifold at one end and via a connector at a second end, so that a fluid path is formed from the feed manifold to the discharge manifold via the longitudinal pipes. Importantly, the various pipes of the invention are connected in a fluidtight manner using flexible joint members, which allow the connected pipe sections to fold relative to each other and be easily transported. The feed and discharge manifolds are described in the patent to ‘extend in the extension of one another in the transverse direction’ and are ‘provided with a coupling member (47, 48) to make a fluid-tight connection between the respective feed and discharge manifolds of the first and the second element’. This means that the manifold pipes described by the patent are connected in series (see Figure 5.1). Figure 5.1  The cooling system claimed in Icescape

It is the series connection claimed by the patent that Icescape argued was not present in its ice rink cooling system. Although Icescape used foldable

133

5.8

Patent Infringement 1: Scope of Protection of Claims joints between the pipes, by contrast to the patent the feed and discharge manifolds of its system were configured in parallel, as shown in Figure 5.2: Figure 5.2  The defendant’s cooling system in Icescape

The Court of Appeal agreed that, on a purposive reading, in light of the teaching of the specification and the common general knowledge, the two manifolds of the invention connect together in series and this was not the same as the parallel configuration of the manifolds in the Icescape system. The court then considered the Actavis Questions: Question 1: Does the Icescape system achieve the same result in substantially the same way as the patented invention? The court considered what it referred to as the patent’s inventive core, which was the provision of a joint member. It was the joint member that formed a fluid tight and flexible connection between the rigid pipe sections and which allowed the connected pipe sections to fold relative to one another for transportation. It was this feature, in the court’s judgement, that made the patented system different from the conventional systems in the common general knowledge. By contrast, organising connection in series was simply a common general knowledge way of implementing that invention. It was true that Icescape’s parallel rather than series connection between the manifolds may confer certain advantages as well as disadvantages, but this had nothing to do with the inventive core of the patent. As regards the inventive core, the Icescape system achieved the same result in substantially the same way as the patent: it provided a cooling member which could be installed rapidly and was reliable in operation, with which it was possible to proceed rapidly to the ice-forming stage, and with which a mobile ice rink could be made with a large number of different surface areas. The first Actavis Question was answered in the affirmative. 134

Applying the doctrine of equivalents to a mechanical patent

5.9

Question 2: Would it be obvious to the person skilled in the art, reading the patent and knowing that the variant achieves substantially the same result as the invention, that it does so in substantially the same way as the invention? The court answered this question in the affirmative – the variant would achieve the same result in precisely the same way. Question 3: Would the skilled reader of the patent conclude that the patentee nonetheless intended that strict compliance with the literal meaning of the claim and, in particular, features D  and E, would be an essential requirement of the invention? In the court’s judgement, the fact that the language of the claim did not cover the Icescape system did not justify holding that Question 3 was not satisfied. It must also be considered whether the connection in series claimed by the patent was an essential part of the invention. To examine this, the court again had regard to the inventive core of the patent and found that the coupling of the elements together, or whether the fluid flows through them in series or in parallel, had nothing to do with the inventive core of the patent and answered this question ‘no’. The prosecution file 5.9 In Actavis v Eli Lilly, the UK Supreme Court also had to examine whether the prosecution file could be relied upon as a source for interpretation of a patent claim. Much like the lower courts, the Supreme Court was sceptical about reliance on the prosecution file, but it set out two situations in which it may be appropriate to use its contents: 1. when the point at issue is truly unclear if one confines oneself to the specification and claims of the patent, and the contents of the file unambiguously resolve the point, or 2. when it would be contrary to the public interest for the contents of the file to be ignored. This situation would be exemplified by a case in which the patentee has made it clear to the EPO that they are not seeking to contend that the patent, if granted, would extend its scope to the sort of variant which it is now claimed that it infringes. These two scenarios are relatively narrow: either the file definitively resolves the interpretation of a truly unclear claim when the granted patent does not; or there is an express statement in the prosecution file that the patent would not be asserted against the type of variant against which it is now being asserted. Icescape provides an example of a case which fell short of the requirements. The contents of the prosecution file did not unambiguously 135

5.10

Patent Infringement 1: Scope of Protection of Claims resolve the relevant point on the scope of protection conferred by claim 1 of the patent, and it would not be contrary to the public interest for the contents of the file to be ignored. Indeed, the Court of Appeal in Icescape commented that the case provided a very good illustration of why it is generally so unprofitable to explore the prosecution history16. In L’Oréal Société Anonyme & Anor v RN  Ventures Limited17 the defendant again sought to rely on the prosecution history of the patent. In this case, to support inventive step, the patentee had limited claim 1 of its patents to the ‘tension/compression embodiment’ rather than the ‘shear’ embodiment. The judge, Henry Carr J, did not consider that either of the two circumstances contemplated in Actavis v Eli Lilly applied to allow the prosecution file to be relied upon for claim interpretation; the points at issue were not truly unclear in the light of the specification and claims of the patent, and the file did not unambiguously resolve anything. The judge also did not consider that it was contrary to the public interest for the contents of the file to be ignored, and added that: ‘It should be emphasised that reference to the prosecution history is the exception, and not the rule … Parties should think carefully in future before incurring additional costs in arguing about the prosecution history.’

The Patents Court has nonetheless applied the prosecution history for the first time as a factor against applying the doctrine of equivalents in Akebia v Fibrogen18. The facts of this case fell into the public interest category, because the patentee had made it clear to the EPO in prosecution that they would not seek to assert their patent, which claimed certain heterocyclic carboxamides of formula I, over prior art compounds which they subsequently did indeed assert it against in the proceedings at hand. KEY ISSUE: NUMERICAL RANGES 5.10 Smith & Nephew v ConvaTec Technologies Inc19 illustrates one approach that the Court of Appeal has taken to the interpretation of numerical ranges in patent claims. The patent at issue related to a process for silverisation of gel-forming fibres in wound dressings and claimed a binding agent present ‘in a concentration of between 1% and 25%’. Smith & Nephew had developed a process using binding agent in a concentration of no more than 0.77%. The patent specification identified a series of different concentration ranges for one component, some quoted to one decimal place and some to zero (whole numbers). It also identified ranges of binding 16 17 18 19

136

But see Akebia Therapeutics Inc v Fibrogen Inc [2020] EWHC 866 (Pat) (20 April 2020). [2018] EWHC 173 (Pat) (5 February 2018). Akebia Therapeutics Inc v Fibrogen Inc [2020] EWHC 866 (Pat) (20 April 2020). [2015] EWCA Civ 607 (24 June 2015).

KEY ISSUE: Numerical ranges

5.10

agents, specifying the ranges at various degrees of precision of zero, one and two decimal places. As a result, there were three possible and competing constructions of the lower limit of the claim 1 requirement of ‘between 1% and 25%’ of binding agent. These were: • • •

a lower limit of exactly 1% (an ‘exact values’ approach); a lower limit of 0.5% (on the basis that the number ‘1’ is stated as a whole number / to zero decimal places and, using the number rounding convention, the number ‘1’ covers values ≥ 0.5 and < 1.5); a lower limit of 0.95% (on the basis that the number ‘1’ in the claim is stated to one significant figure and, using the significant figures convention, the number ‘1’ covers values ≥ 0.95 and < 1.5).

The first instance judge preferred the significant figures convention, finding there was no infringement because 0.77 falls outside the range with a lower limit starting at 0.95. This was then rejected by the Court of Appeal, which instead applied the number rounding convention to find that 0.77 fell within a range having a lower limit of 0.5. As a result, the claim was held to be infringed. In Napp Pharmaceuticals Holdings Limited v Dr Reddy’s Laboratories (UK) Limited20, the whole numbers approach used in Smith & Nephew v ConvaTec was again adopted. In this case, a claim to use 10% buprenorphine was held to be expressed in terms of whole numbers and, applying conventional rounding, extended to ≥9.5 to