A Practitioner’s Guide to European Patent Law: For National Practice and the Unified Patent Court 9781509928606, 9781509928637, 9781509928613

Written by a team of lawyers with long-standing experience in patent litigation in Europe, this book is a comprehensive

300 122 5MB

English Pages [551] Year 2019

Table of contents :
Explanatory Note and Acknowledgements
Contents
Abbreviations
Table of Cases
Table of EU and International Material
Table of National Materials
Introduction
I. Towards a Common Standard of Patent Law
II. The Purpose of this Book
III. Outline of Chapters
1. The Skilled Person and their Common General Knowledge
I. The Skilled Person or Team
II. Common General Knowledge
III. Towards Common Ground in the UPC
2. Scope of Protection of Patent Claims
I. Statutory Basis
II. General Principles of National Law on the Doctrine of Equivalents
III. The Role of the Prosecution File
IV. Numerical Ranges
V. Case Comparison - The Pemetrexed Decisions
VI. Towards Common Ground in the UPC
3. Direct Infringement
I. Statutory Basis
II. Issues Relating to Article 25(a) CPC 1989
III. Products Made by an Infringing Process (Article 24(c) CPC 1989)
IV. Second Medical Use Claim Infringement
V. Infringement of DNA Sequences
VI. Towards Common Ground for the UPC
4. Indirect Infringement
I. Statutory Basis
II. Means Relating to an Essential Element of the Invention
III. Staple Commercial Products
IV. Knowledge
V. Double Territoriality
VI. Indirect Infringement of Second Medical Use Claims
VII. Common Design
VIII. Towards Common Ground in the UPC
5. Defences
I. The Diverse Sources of Defence to Infringement
II. The Experimental Use Exemption
III. The Bolar Exemption
IV. Exhaustion
V. Invalidity of Claims Asserted
VI. FRAND Licence Objection
VII. Prior Use
VIII. Innocent Infringement as a Defence to Damages
IX. Towards Common Ground in the UPC
6. Remedies
I. Statutory Basis
II. Preliminary Injunctions
III. Final Injunction
IV. Stays of Injunction and Tailored Orders
V. Springboard Relief
VI. Award of Damages and Lost Profits
VII. Recall, Removing from the Channels of Commerce and Destruction
VIII. Publication of Judgment
IX. Towards Common Ground in the UPC
7. Patentability and Industrial Application
I. Statutory Basis
II. Industrial Application
III. Excluded Subject-matter
IV. Exceptions to Patentability
V. Methods of Treatment and Diagnostics - Article 53(c) EPC
VI. Towards Common Ground in the UPC
8. Novelty
I. Statutory Basis
II. General Principles of EPO and National Case Law
III. Interpreting Patent Claims and the Prior Art for Novelty Purposes
IV. Made Available to the Public
V. Novelty Over General Disclosures in the Art
VI. Priority
VII. First, Second and Subsequent Medical Uses
VIII. Other Forms of Purpose-limited Claims
IX. Claim Amendment
X. Towards a Common Approach for the UPC
9. Inventive Step
I. Statutory Basis
II. The Approach of the EPO Boards
III. The Approaches of the National Courts
IV. Criticism of Problem-and-Solution
V. Criticism of Motivation-based Tests
VI. An Alternative Basis for Assessing Inventive Step
VII. Mixed Technical and Non-technical Features
VIII. Combinations of Prior Art Features
IX. Secondary Indicia
X. Case Comparison
XI. Towards Common Ground for the UPC
10. Sufficiency
I. Statutory Basis
II. General Approaches of EPO and National Law
III. Biogen Insufficiency and Lundbeck-type Cases
IV. Functionally Defined, "Reach-through" Claims
V. Biological Deposits
VI. Plausibility in the Context of Insufficiency
VII. Lack of Clarity
VIII. Towards Common Ground in the UPC
11. Plausibility
I. Is There a Statutory Basis?
II. Origins of Plausibility in the EPO
III. Inventive Step
IV. Insufficiency
V. Industrial Applicability
VI. The Novelty Context
VII. Post-dated Evidence
VIII. The Plausibility Threshold
IX. Further Questions
X. Towards Common Ground for the UPC
12. Supplementary Protection Certificates
I. Statutory Basis
II. Conditions for Grant
III. Protected by a Basic Patent in Force
IV. Marketing Authorisations in the SPC Context
V. Term
VI. Medicinal Products for Paediatric Use68
VII. Reform
VIII. Towards Common Ground for the UPC
13. Patent Ownership, Dealings and Employee Inventors
I. Introduction
II. Ownership
III. Inventor Compensation
IV. Rights of Co-owners
V. Patent Dealings
VI. Effect of Transfer of Ownership on Licensee
VII. Compulsory Licences and Licences of Right
VIII. Patent Ownership, Dealings and Employee Inventors in the UPC
14. Cross-border Actions in Europe
I. The Brussels Regulation
II. Cross-border Validity Actions
III. Cross-border Infringement Actions
IV. Cross-border Declarations of Non-infringement
V. Common Ground for the UPC
15. The Impact of Brexit
I. Background
II. The Brexit Options
III. Brexit and Patents
IV. Brexit and Supplementary Protection Certificates
Appendices
Appendix A: Extracts of EPC 2000
Appendix B: Extracts of the Community Patent Convention 1989
Appendix C: The SPC Regulation
Appendix D: The Biotechnology Directive
Appendix E: The Enforcement Directive
Appendix F: The Unitary Patent Regulation
Appendix G: Extracts of the Unified Patent Court Agreement
Appendix H: Consolidated Version of the Paediatric Regulation1
Index

Recommend Papers

A Practitioner’s Guide to European Patent Law: For National Practice and the Unified Patent Court 9781509947645, 9781509947676, 9781509947669

This new edition is a comprehensive and practical guide to European patent law – a ‘ius commune’. The book highlights th

228 45 8MB Read more

European Patent Law: The Unified Patent Court and the European Patent Convention 9783110781687, 9783110774016

This book provides a comprehensive overview of European Patent Law. It presents a critical analysis of the European pate

105 79 2MB Read more

European Patent Law: The Unified Patent Court and the European Patent Convention 9783110781687, 9783110774016

This book provides a comprehensive overview of European Patent Law. It presents a critical analysis of the European pate

110 54 2MB Read more

A Practitioner’s Guide to the Unified Patent Court and Unitary Patent 9781849467827, 9781509904204, 9781509904211

A Practitioner’s Guide to the Unified Patent Court and Unitary Patent provides practical and detailed advice on all aspe

148 40 5MB Read more

Rethinking Patent Law 9780674064966

Scientific and technological innovations are forcing patent law into the spotlight and revealing its many glaring inadeq

134 28 1MB Read more

The New European Patent 9781782259695, 9781849468336, 9781782259671

On 17 December 2012, following a complex negotiation which lasted 12 years, the European Parliament adopted Regulations

188 82 1MB Read more

Strategic patent planning for software companies: a look at current patent and licensing strategies

This report discusses the current status of international patent protection with regard to computer-implemented inventio

351 71 804KB Read more

Fragmentation and the European Patent System 9781509939312, 9781509939343, 9781509939336

This book provides an in-depth study on current perceptions of, and responses to, fragmentation in the European patent s

169 97 4MB Read more

Rethinking patent law 9780674064683, 0674064682, 9780674064966, 0674064968

Scientific and technological innovations are forcing patent law into the spotlight and revealing its many glaring inadeq

355 69 1MB Read more

How to Make Patent Drawings: A Patent It Yourself Companion [5 ed.] 9781413306538, 1413306535

Patent drafters charge $75 to $100 per sheet to prepare drawings -- but you can draw them yourself! How to Make Patent D

411 22 5MB Read more

A Practitioner’s Guide to European Patent Law: For National Practice and the Unified Patent Court
9781509928606, 9781509928637, 9781509928613

Author / Uploaded
Paul England

0 0 0
Like this paper and download? You can publish your own PDF file online for free in a few minutes! Sign Up

File loading please wait...

Citation preview

A PRACTITIONER’S GUIDE TO EUROPEAN PATENT LAW: FOR NATIONAL PRACTICE AND THE UNIFIED PATENT COURT Written by a team of lawyers with long-standing experience in patent litigation in Europe, this book is a comprehensive and practical guide to European patent law, highlighting the areas of consistency and difference between the most influential European patent law jurisdictions: the European Patent Office (EPO), England & Wales, France, Germany and the Netherlands. It is frequently the case that the decisions and approaches of these courts are cited by European patent lawyers of all jurisdictions when submitting arguments in their own national courts. The book is therefore intended to provide a guide to patent lawyers acting in the national European courts today. The book also looks to the future, by addressing all the areas of patent law for which the proposed Unified Patent Court (UPC) will need to establish a common approach. Uniquely, the book addresses European patent law by subject matter area, assessing the key national and EPO approaches together rather than in nation-by-nation chapters; and provides an outline in each chapter of the common ground between the national approaches, as a guide for the possible application of European patent law in the UPC.

ii

A Practitioner’s Guide to European Patent Law For National Practice and the Unified Patent Court

Paul England

Solicitor (Taylor Wessing, London)

With contributions by:

Sara Burghart

Lead IP Litigation Counsel (Sandoz, Munich)

Judith Krens

Partner, Advocaat (Taylor Wessing, Amsterdam)

François Pochart

Partner, European Patent Attorney (August Debouzy, Paris)

HART PUBLISHING Bloomsbury Publishing Plc Kemp House, Chawley Park, Cumnor Hill, Oxford, OX2 9PH, UK HART PUBLISHING, the Hart/Stag logo, BLOOMSBURY and the Diana logo are trademarks of Bloomsbury Publishing Plc First published in Great Britain 2019 Copyright © Paul England, 2019 Paul England has asserted his right under the Copyright, Designs and Patents Act 1988 to be identified as Author of this work. 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/, 1998–2019. A catalogue record for this book is available from the British Library. Library of Congress Cataloging-in-Publication data Names: England, Paul, 1971- author. Title: A practitioner’s guide to European patent law : for national practice and the Unified Patent Court / Paul England. Description: Oxford ; New York : Hart 2019. | Includes bibliographical references and index. Identifiers: LCCN 2019030701 (print) | LCCN 2019030702 (ebook) | ISBN 9781509928606 (hardback) | ISBN 9781509928620 (Epub) Subjects: LCSH: Patent laws and legislation—Europe. | European Patent Convention (2000 November 29) | Unified Patent Court. | Patent laws and legislation—Great Britain. | International and municipal law—Great Britain. Classification: LCC KJC2725 .E54 2019 (print) | LCC KJC2725 (ebook) | DDC 346.404/86—dc23 LC record available at https://lccn.loc.gov/2019030701 LC ebook record available at https://lccn.loc.gov/2019030702 ISBN: HB: 978-1-50992-860-6 ePDF: 978-1-50992-861-3 ePub: 978-1-50992-862-0 Typeset by Compuscript Ltd, Shannon

To find out more about our authors and books visit www.hartpublishing.co.uk. Here you will find extracts, author information, details of forthcoming events and the option to sign up for our newsletters.

EXPLANATORY NOTE AND ACKNOWLEDGEMENTS This book has its origins in a series of articles, written for the Journal of Intellectual Property and Practice and the BioScience Law Review between 2014 and 2018. These articles sketched out areas of common ground in substantive patent law between England and Wales, France, Germany and the Netherlands. At the time that exercise was started, the UPC and Unitary Patent project appeared relatively close to completion and provided a particular motivation for examining the features of national approaches that could pave the way ahead for the new court. Since that time, the UPC project has stalled, first by the Brexit decision and then by a constitutional complaint filed in Germany. By the time this foreword is being read it should be known whether that project is close to coming into force or whether it has been indefinitely shelved. In the meantime, however, it has become clear in day-to-day practice at Taylor Wessing, and from kind correspondence further afield, that there is enthusiasm for an approach to substantive European patent law that compares the principal jurisdictions in a subjectby-subject manner. This comes from in-house lawyers who have to deal with patent litigation in Europe, lawyers practising in the national courts and patent attorneys prosecuting patents in the EPO. As the Introduction explains, the national European courts do not exist in a vacuum; there is an interest in learning from and aligning with, where possible, the approaches to substantive law in other jurisdictions. All those involved with European patents therefore need to take something of a borderless approach to the subject of substantive law. This book is intended to serve this approach. To emphasise, this book is concerned with substantive law and not the national procedures of the European courts dealing with patent matters. Likewise, although it briefly explores in each chapter the application of substantive law in the UPC, it does not discuss the, as yet, draft procedures of the UPC. There are, however, some areas in which the line between substantive law and procedure is difficult to draw and a judgement has been made on what to include and what to exclude. Remedies is one example. As a result, some readers may wonder why preliminary injunctions are included but not, for example, search and seizure. The latter will have to wait for another book. Furthermore, there is no doubt justification for including other jurisdictions in addition to England and Wales, France, Germany and the Netherlands, but these will have to wait for another time. Where reference is made to England & Wales in this book, it is to reflect the fact that most patent cases in the UK are decided by the Patents Court and the Court of Appeal. These jurisdictions do not extend to Scotland and Northern Ireland although, as a matter of fact, most substantive English patent case law is followed across the UK. By contrast, the Patents Act 1977 itself and decisions of the Supreme Court do

vi Explanatory Note and Acknowledgements apply across the whole of the UK. Reference to the UK is, therefore, largely restricted to discussion of the Act and Supreme Court decisions, or where the broader context demands it. Special thanks is due to the contributors to this book – Sara Burghart (Sandoz), Judith Krens (Taylor Wessing) and François Pochart (August Debouzy) – for their expertise and patience, and also to the partners of the Taylor Wessing Patents Group for their patronage of this project, in particular Nigel Stoate and Simon Cohen who lead the UK and European practices. This book has also borrowed liberally from notes and articles by a large number of colleagues and former colleagues across the Taylor Wessing European patent practices. These include the following: Malcolm Bates, Eelco Bergsma, Verena Bertram, Misja Boeken, Britta Bröker, Christoph de Coster, Amanda Ebbutt, Manja Epping, Michael Henley, Gisbert Hohagen, Christoph Höhne, Matthias Hülsewig, Dietrich Kamlah, Anja Lunze, Saufung Ma, Wim Maas, James Marshall, Colin McCall, Josie Miller, Andrew Payne, Jan Phillip Rektorschek, Matthew Royle, Carreen Shannon, Talitha Shkopiak, Christopher Thornham, Edward Vickers, Michael Washbrook, Tim Worden, Julius Zacharias. Paul England Taylor Wessing March 2019

CONTENTS Explanatory Note and Acknowledgements��v Abbreviations��xxi Table of Cases��xxv Table of EU and International Material �� lxi Table of National Materials�� lxxiii Introduction�� 1 I. Towards a Common Standard of Patent Law�� 1 A. International Trade; National Law�� 1 B. Harmonisation in Europe�� 2 i. International Treaties�� 2 ii. European Union Law and the CJEU�� 3 iii. EPO Case Law�� 3 iv. Differences in Application Remain�� 4 C. The Proposed Solution – The UPC�� 5 II. The Purpose of this Book�� 6 III. Outline of Chapters�� 6 1. The Skilled Person and their Common General Knowledge�� 8 I. The Skilled Person or Team�� 8 A. Basic Role�� 8 B. Definitions�� 9 C. Area and Level of Expertise�� 10 D. Hindsight Risk�� 11 E. Different Expertise for Sufficiency and Inventive Step�� 11 F. Documents Addressed�� 13 II. Common General Knowledge�� 13 A. Basic Principles�� 13 B. Literature Searches and Databases�� 14 i. Secondary Common General Knowledge�� 14 ii. The TBA Approach to Databases�� 16 C. Local Common General Knowledge�� 17 III. Towards Common Ground in the UPC�� 17 A. The Skilled Person�� 17 B. Common General Knowledge�� 18

viii Contents 2. Scope of Protection of Patent Claims�� 20 I. Statutory Basis�� 20 II. General Principles of National Law on the Doctrine of Equivalents�� 21 A. England and Wales�� 21 i. The Introduction of a Doctrine of Equivalents�� 21 ii. Determining Immaterial Variants�� 23 iii. The Inventive Core of the Patent�� 24 a. Actavis Question 1�� 25 b. Actavis Question 2�� 26 c. Actavis Question 3�� 26 B. France�� 26 C. Germany�� 28 D. The Netherlands�� 30 i. The ‘Essence of the Invention’ to the ‘Inventive Concept Behind the Wording of the Claims’�� 30 ii. Essence of the Invention is a ‘Viewpoint’�� 31 iii. The Dutch Approach Confirmed in AstraZeneca/ Resolution��32 III. The Role of the Prosecution File�� 34 IV. Numerical Ranges�� 35 A. England and Wales�� 35 B. France�� 37 C. Germany�� 38 V. Case Comparison – The Pemetrexed Decisions�� 38 A. The Case in England and Wales�� 38 B. The Case in Germany�� 39 C. The Case in the Netherlands�� 41 VI. Towards Common Ground in the UPC�� 43 3. Direct Infringement�� 46 I. Statutory Basis�� 46 II. Issues Relating to Article 25(a) CPC 1989�� 46 A. Pre-expiry Offers�� 47 B. Repair and Manufacture�� 49 III. Products Made by an Infringing Process (Article 24(c) CPC 1989)�� 51 IV. Second Medical Use Claim Infringement�� 53 A. Swiss-form and EPC 2000 Claims�� 53 B. ‘Skinny Labelling’�� 53 C. England and Wales�� 54 i. Prescribing and Dispensing Practice�� 54 ii. The Pregabalin Case – Warner-Lambert v Mylan & Actavis��55 a. Foreseeability Test�� 55 b. Subjective Intention Test�� 56 c. ‘Outward Presentation’ Test�� 57 d. Conclusions and Implications from Warner-Lambert��58 iii. Infringement of EPC 2000 Claims (Article 24(a) CPC 1989)�� 58

Contents ix D. France�� 58 E. Germany�� 59 F. The Netherlands�� 61 V. Infringement of DNA Sequences�� 62 VI. Towards Common Ground for the UPC�� 63 A. Offers as Acts of Direct Infringement�� 63 B. Repair�� 63 C. Products of Processes�� 64 D. Second Medical Use�� 64 4. Indirect Infringement�� 65 I. Statutory Basis�� 65 II. Means Relating to an Essential Element of the Invention�� 65 III. Staple Commercial Products�� 68 IV. Knowledge�� 69 A. Actual and Constructive Knowledge�� 69 B. Timing of the Intention and Infringement by the Supplied Party�� 70 V. Double Territoriality�� 71 VI. Indirect Infringement of Second Medical Use Claims�� 72 A. England and Wales�� 72 B. France�� 73 C. Germany�� 74 D. The Netherlands�� 75 VII. Common Design�� 76 VIII. Towards Common Ground in the UPC�� 78 A. Acts of Indirect Infringement Applicable to European Patents�� 78 i. Essential Element of the Invention�� 78 ii. Means Suitable�� 79 iii. Knowledge�� 79 iv. Double-territoriality�� 79 v. Indirect Infringement Applied to Second Medical Use Patents�� 80 5. Defences�� 81 I. The Diverse Sources of Defence to Infringement�� 81 II. The Experimental Use Exemption�� 82 A. General Principles of National Law�� 82 i. England and Wales�� 82 ii. France�� 83 iii. Germany�� 84 iv. The Netherlands�� 84 III. The Bolar Exemption�� 85 A. General Principles of National Law�� 85 i. England and Wales�� 85 ii. France�� 86 iii. Germany�� 86 iv. The Netherlands�� 87

x Contents

IV.

V.

VI.

VII.

VIII. IX.

B. Third Party Supply�� 87 C. Reform to Bolar�� 88 Exhaustion�� 88 A. Placing on the Market Outside the EEA: Exhaustion or Implied Licence?�� 89 B. Exhaustion of Method Claims�� 90 C. Spare Parts or Impermissible Making?�� 90 D. The ‘Specific Mechanism’�� 91 Invalidity of Claims Asserted�� 91 A. General Considerations�� 91 B. The Gillette Defence�� 92 i. English ‘Arrow Declaration’�� 93 ii. Dutch ‘Gillette Declaration’�� 96 iii. France�� 97 FRAND Licence Objection�� 98 A. General Principles of National Law��100 i. England and Wales��100 ii. France��102 iii. Germany��102 iv. The Netherlands��103 Prior Use��104 A. England and Wales��104 B. France��104 C. Germany��105 D. The Netherlands��106 Innocent Infringement as a Defence to Damages��107 Towards Common Ground in the UPC��108 A. Limitations on Infringement in the UPC Agreement��108 B. Guidance from the National Courts��109 C. Principles of Exhaustion��110 D. Experimental Use and Bolar Exemptions��111 E. FRAND Defence��112

6. Remedies��113 I. Statutory Basis��113 II. Preliminary Injunctions��114 A. England and Wales��114 B. France��115 C. Germany��116 D. The Netherlands��117 III. Final Injunction��118 IV. Stays of Injunction and Tailored Orders��120 V. Springboard Relief��122 VI. Award of Damages and Lost Profits��123 A. Grounds of Recovery��123 B. Calculation of Damages��126

Contents xi C. Innocent Infringement��127 D. Punitive Damages and Moral Prejudice��127 VII. Recall, Removing from the Channels of Commerce and Destruction��128 VIII. Publication of Judgment��129 IX. Towards Common Ground in the UPC��130 A. Preliminary Injunctions��130 B. Final Injunctions��132 C. Damages��132 D. Seizure and Delivery-up��133 E. Publication��134 7. Patentability and Industrial Application��135 I. Statutory Basis��135 II. Industrial Application��135 A. The Boards of the EPO��135 B. England and Wales��137 C. France��137 D. Germany��138 E. The Netherlands��138 III. Excluded Subject-matter��138 A. Business Methods��139 B. Discoveries and Scientific Theories��139 C. Mathematical Methods and Mental Acts��140 D. Presentations of Information��141 i. The Cognitive Content of the Information Presented – ‘What’ is Presented��141 ii. The Manner in Which the Information is Presented – ‘How’ the Information is Presented��142 E. Computer Programs and Computer Implemented Inventions��143 i. The Boards of Appeal of the EPO��144 ii. England and Wales��145 iii. France��146 iv. Germany��147 v. The Netherlands��148 IV. Exceptions to Patentability��148 A. Overview of the Biotechnology Directive��148 B. Isolated Biological Material (Including DNA Sequences) – Articles 3(ii) and 5 Biotechnology Directive��150 C. ‘Ordre Public’ and Morality – Article 6(1) Biotechnology Directive, and Article 53(a) and Rule 28(1)(d) EPC��151 D. Human Cloning and the Use of Human Embryos (Including Stem Cells) – Article 6(2)(c) Biotechnology Directive, Article 53(a) and Rule 28(1)(c) EPC��151 i. Brüstle v Greenpeace��152 ii. International Stem Cell Corporation��153

xii Contents E. Plant and Animal Varieties – Article 53(b)EPC (Rule 28(2)) and Article 4(1) Biotechnology Directive��154 i. Plant and Animal Varieties��154 ii. Essentially Biological Processes��154 a. Essentially Biological Processes��154 b. Products of Essentially Biological Processes��155 F. Microbiological Processes��156 V. Methods of Treatment and Diagnostics – Article 53(c) EPC��156 A. Treatment by Surgery��156 B. Therapeutic Methods��157 C. Products Used in Therapy��158 D. Diagnostic Patents��160 VI. Towards Common Ground in the UPC��162 A. Industrial Applicability��162 B. Excluded Subject-matter��162 C. Exceptions to Patentability��163 8. Novelty��164 I. Statutory Basis��164 II. General Principles of EPO and National Case Law��164 A. The Boards of the EPO��164 B. England and Wales��165 C. France��166 D. Germany��166 E. The Netherlands��167 III. Interpreting Patent Claims and the Prior Art for Novelty Purposes��167 A. The Role of Article 69 and the Protocol��167 i. Claim Interpretation��167 ii. Prior Art Interpretation��168 B. The Teaching of the Prior Art��169 i. The Content of the Prior Art��169 ii. Inevitability and Inherency��169 iii. Plausibility and the Prior Art��171 IV. Made Available to the Public��171 A. General Principles��171 B. Prior Use��172 C. The Public��174 D. Bar of Confidentiality��175 i. Circumstances Giving Rise to Confidentiality��175 ii. Clinical Trials��176 iii. Standard of Proof��177 E. Prior Art Published on the Internet��177 V. Novelty Over General Disclosures in the Art��178 A. Selection Inventions in General��178 B. Increased Purity and Isolation��179 C. Markush Formulae��179 D. Numerical Ranges��181

Contents xiii VI. Priority��183 A. Claiming Priority��183 B. Assignment of Priority��184 C. Partial Priority��185 D. Application of Plausibility to Priority��186 VII. First, Second and Subsequent Medical Uses��187 VIII. Other Forms of Purpose-limited Claims��188 A. Dosage Regimes��188 B. Personalised Medicines��190 i. The EPO Approach��190 ii. The MOBIL OIL Case��191 IX. Claim Amendment��194 A. Allowable Amendments��194 B. Subject-matter Extending Beyond the Content of the Application as Filed (Added Matter) (Article 123(2))��194 i. General Principles��194 ii. Subsequently Filed Items��195 iii. Documents Cross-referred to in the Filed Application��195 iv. Disclaimers��195 C. Extending the Protection Conferred by a Granted Patent (Article 123(3))��196 i. General Principles��196 ii. Intermediate Generalisations��197 X. Towards a Common Approach for the UPC��198 A. The Application of the EPC in the UPC��198 B. Areas of Consistency in EPO and National Case Law on Novelty��198 C. Application of the Protocol for the Purpose of Novelty?��199 9. Inventive Step��200 I. Statutory Basis��200 II. The Approach of the EPO Boards��200 A. EPO Problem-and-Solution Approach��200 i. Overview��200 ii. Could-would��201 iii. Identifying the Closest Prior Art��203 iv. The Objective Technical Problem��203 v. Secondary Indicia��204 B. Technical Contribution and Plausibility��204 i. AgrEvo��205 ii. Johns Hopkins��205 III. The Approaches of the National Courts��206 A. England and Wales��206 i. ‘Obvious-to-try’��206 a. The Level of Expectation of Success��206 b. Obvious-to-try is One of a Number of Factors – Actavis v ICOS��207 ii. First Instance��208

xiv Contents

IV.

V. VI.

VII.

VIII. IX. X.

XI.

iii. Court of Appeal��208 iv. Supreme Court��208 v. Technical Contribution and Plausibility��210 vi. Other Sub-tests��211 B. France��212 C. Germany��213 D. The Netherlands��213 Criticism of Problem-and-Solution��214 A. Hindsight��214 B. Perceiving that there is a Problem��215 C. The 5¼ Inch Plate Paradox��215 Criticism of Motivation-based Tests��216 An Alternative Basis for Assessing Inventive Step��217 A. The ‘Workshop Variations’ Approach��217 i. The Windsurfing Example��217 ii. A Solution to the 5¼ Inch Plate Problem��218 B. Workshop Variations in the EPO and Other Countries��218 Mixed Technical and Non-technical Features��219 A. The Approach of the EPO Boards��219 i. ‘Technical Leakage Fallacy’��220 ii. ‘Broken Technical Chain Fallacy’��220 iii. ‘Non-technical Prejudice Fallacy’��220 B. Computer-implemented Simulation of a Technical System��221 C. Outside the EPO��222 Combinations of Prior Art Features��223 Secondary Indicia��223 A. Technical Prejudice as a Secondary Indication��225 B. Bonus Effects��226 Case Comparison��227 A. The Case in England and Wales��227 B. The Case in Germany��228 C. The Case in the Netherlands��229 Towards Common Ground for the UPC��229 A. The Application of the EPC in the UPC��229 B. Different Structures, Similar Principles��230 C. Scope for Flexibility��230 D. No One-size-fits-all��231

10. Sufficiency��232 I. Statutory Basis��232 II. General Approaches of EPO and National Law��232 A. The Boards of the EPO��232 i. General Outline��232 ii. Undue Burden��233 iii. Performing Invention Across the Claimed Range��233 iv. Characterisation by Distinctive Parameters��234

Contents xv

III. IV. V. VI.

VII.

VIII.

B. England and Wales��235 C. France��235 D. Germany��236 E. The Netherlands��236 Biogen Insufficiency and Lundbeck-type Cases��237 Functionally Defined, ‘Reach-through’ Claims��238 Biological Deposits��240 Plausibility in the Context of Insufficiency��241 A. The Warner-Lambert Decision��242 i. Guidelines��242 ii. Application to the Facts��243 iii. Plausibility is One Element of Sufficiency��244 iv. Cross-appeal��245 B. The UK v EPO Approaches to the Threshold��245 C. Second Medical Use Claims versus Per Se Claims��246 Lack of Clarity��247 A. Statutory Basis��247 B. Lack of Clarity Attack Hidden Behind Insufficiency��247 C. Lack of Clarity Contributing to Insufficiency��248 D. Lack of Clarity versus Ambiguity��248 Towards Common Ground in the UPC��250 A. The Application of the EPC in the UPC��250 B. Common Principles��251 C. Differences��251 D. Plausibility of Technical Contribution��251

11. Plausibility��252 I. Is There a Statutory Basis?��252 II. Origins of Plausibility in the EPO��253 III. Inventive Step��254 A. First Application in the UK – Mere Speculation versus Plausibility��254 B. Plausibility in Light of the Teaching of the Specification and the Common General Knowledge��255 C. Obvious and Insufficient for Lack of Plausibility Alone��255 D. Vaguely Indicating an ‘Activity’ for Millions of Compounds Not Enough��256 E. Selection Inventions��256 IV. Insufficiency��258 A. Plausible Experimental Results or Technical Concept��258 B. Further Second Medical Use Cases��259 V. Industrial Applicability��261 VI. The Novelty Context��261 A. Priority Document��261 B. Prior Art��262 VII. Post-dated Evidence��262

xvi Contents VIII. The Plausibility Threshold��264 A. The Warner-Lambert Pregabalin Case��264 i. Facts and Decision��264 ii. Guidelines for Demonstrating Plausibility��265 iii. Applying the Principles to the Facts��266 B. Is There a Difference in Approach to the Threshold between the EPO and the UK?��267 i. Not Plausible: Claim to Dasatinib (T 0488/16)��268 ii. Plausible: Claim to Dasatinib Second Medical Use (T 0950/13)��269 C. Conclusions��270 IX. Further Questions��270 A. Are Per Se and Second Medical Use Claims Treated the Same Way?��270 B. Is the Plausibility Test the Same When Examined Under Article 56 and Article 83?��271 X. Towards Common Ground for the UPC��271 A. Technical Contribution��271 B. Plausibility as a Threshold Step��273 C. Plausibility as a Positive Requirement��273 12. Supplementary Protection Certificates��275 I. Statutory Basis��275 II. Conditions for Grant��276 A. What is an ‘Active Ingredient’?��276 i. Strict Approach��276 ii. Teleological Approach – Second Indications��277 iii. Adjuvants��278 B. Re-formulation��278 i. ‘Safeners’��279 ii. Conjugated Components��280 III. Protected by a Basic Patent in Force��283 A. The Medeva Ruling��283 i. Article 3(b) SPC Regulation – The SPC Must Mirror the Marketing Authorisation��283 ii. Article 3(a) SPC Regulation – The SPC Must Mirror the Product Identified in the Basic Patent��283 iii. ‘Identified’ by a Basic Patent in Force?��284 B. Functional Claims��284 i. Eli Lilly v Human Genome Sciences��284 ii. Sitagliptin��285 iii. Clarification in Gilead Sciences?��286 C. Claims to a Combination��286 i. The Gilead/Truvada Case��286 ii. The CJEU Ruling on Truvada��287

Contents xvii iii. Referral of Truvada Back to the Patents Court��288 iv. The Truvada Case in Germany and France��289 D. Markush Formulae��289 E. Protection in the Context of Multiple SPCs��290 i. Georgetown University v Octrooicentrum Nederland��290 ii. Actavis Group v Sanofi��291 iii. Actavis v Boehringer Ingelheim��291 IV. Marketing Authorisations in the SPC Context��293 A. Non-EU Compliant First Marketing Authorisation��293 B. Equivalent Authorisations��293 C. SPC Based on Third Party Marketing Authorisation��295 V. Term��295 A. Negative or Zero Term��295 B. EU Accession Countries��296 C. ‘End of Procedure Notice’��296 D. ‘Date of Notification’��297 VI. Medicinal Products for Paediatric Use��298 A. Purpose and Scope��298 B. Application of the Specific Mechanism��299 VII. Reform��300 A. Creation of a European SPC Title – A ‘Unitary SPC’��300 B. Introduction of an SPC Manufacturing Waiver��301 i. Current Status��302 ii. Stockpiling and Safeguards��302 iii. Transitional Arrangements��303 VIII. Towards Common Ground for the UPC��304 13. Patent Ownership, Dealings and Employee Inventors��305 I. Introduction��305 II. Ownership��306 A. Basic Principles in National Law��306 B. Employee Inventors��307 C. Contractor Inventors��308 D. Co-contributors��309 III. Inventor Compensation��310 IV. Rights of Co-owners��312 V. Patent Dealings��314 A. Patent Assignment��314 B. Patent Licence��315 VI. Effect of Transfer of Ownership on Licensee��317 A. A Licensee’s Rights if a Third Party Becomes a Co-owner of the Licensed Patent��317 i. Existence of the Licence��317 ii. The Right of the Licensee to Bring Infringement Proceedings��318

xviii Contents B. A Licensee’s Rights if a Third Party Becomes a Sole Owner of the Licensed Patent��319 VII. Compulsory Licences and Licences of Right��321 A. England and Wales��321 B. France��322 C. Germany��323 D. The Netherlands��324 VIII. Patent Ownership, Dealings and Employee Inventors in the UPC��325 A. The Law Applicable to Unitary Patents as Objects of Property��325 B. What are ‘Objects of Property’?��326 i. Recordal of Assignments, Licences and Other Encumbrances��326 ii. Entitlement and Co-ownership��327 iii. Patent Agreements��327 iv. Rights to Employee’s Invention and Compensation��327 C. Rights to Employee’s Invention and Compensation��327 D. Patent Licences and Other Agreements��328 i. The Law Applicable to Patent Agreement Disputes��328 ii. Patent Licences Raised in Defence��328 iii. Licences of Right��328 iv. Compulsory Licences��328 E. Right Based on Prior Use of the Invention��329 i. Personal Possession��329 a. Unitary Patents��329 b. European Patents��329 14. Cross-border Actions in Europe��330 I. The Brussels Regulation��330 II. Cross-border Validity Actions��331 A. GAT v LuK��331 III. Cross-border Infringement Actions��333 A. CJEU Authority��333 i. Roche v Primus��333 ii. Preliminary Injunctions – Solvay v Honeywell��334 iii. Single Defendant Cross-border Infringement Actions��335 B. The Dutch Approach to Cross-border Infringement Actions��336 C. The German Approach to Cross-border Infringement Actions��337 D. The English Approach to Cross-border Infringement Actions��338 IV. Cross-border Declarations of Non-infringement��340 A. ‘Torpedo’ Actions��340 B. Cross-border Declarations of Non-infringement Under English Law��341 C. Deciding the Terms of a Global FRAND Licence��342 V. Common Ground for the UPC��344

Contents xix 15. The Impact of Brexit��348 I. Background��348 II. The Brexit Options��348 A. The Withdrawal Agreement and Transition Period��348 B. A ‘Managed No-deal’��349 i. Directives and Regulations��350 C. Guidance on a ‘Managed No-deal’ Brexit��350 III. Brexit and Patents��350 A. Patent Exhaustion��351 B. Cross-border Disputes��351 C. Participation in the UPC and Unitary Patent��351 IV. Brexit and Supplementary Protection Certificates��353 A. Replacing the SPC Regulation��353 B. Paediatric Extensions to SPCs��354 C. Brexit and the Role of the CJEU and its Case Law��354 Appendices��356 Appendix A: Extracts of EPC 2000��356 Convention on the Grant of European Patents (European Patent Convention)��356 Protocol on the Interpretation of Article 69 EPC��363 Appendix B: Extracts of the Community Patent Convention 1989��364 Appendix C: The SPC Regulation��367 Appendix D: The Biotechnology Directive��378 Appendix E: The Enforcement Directive��390 Appendix F: The Unitary Patent Regulation��405 Appendix G: Extracts of the Unified Patent Court Agreement��418 Appendix H: Consolidated Version of the Paediatric Regulation��429 Index��455

xx

ABBREVIATIONS API

Active pharmaceutical ingredient

BGH

Bundesgerichtshof (German Federal Court of Justice)

Biotechnology Directive

Directive 98/44/EC of 6 July 1998 on the legal protection of biotechnological inventions

Board

A board of appeal of the EPO

Bolar Exemption

The exemption to patent infringement under Article 10(6) Medicines Directive (also referred to as the ‘Regulatory Review Defence’)

BpatG

Bundespatentgericht (German Federal Patent Court)

Brussels Regulation

Regulation (EU) No 1215/2012 of the European Parliament and of the Council of 12 December 2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (recast)

CEPS

The French Economic Committee of Health Care Products (Comité économique des produits de santé)

CIIs

Computer implemented inventions

CJEU

Court of Justice of the European Union

Contracting Member State

A Member State that signed the UPC Agreement on 19 February 2013

CPC 1973

Community Patent Convention 1973

CPC 1989

Community Patent Convention 1989

EBA

Enlarged Board of Appeal of the EPO

EBP

Essentially biological process

EEA

European Economic Area

EMA

European Medicines Agency

Enforcement Directive Directive 2004/48/EC of the European Parliament and of the Council of 29 April 2004 on the Enforcement of Intellectual Property Rights

xxii Abbreviations EPC

European Patent Convention

EPO

European Patent Office

ETSI

European Telecommunications Standards Institute

EU

European Union

FRAND

Fair Reasonable and non-discriminatory

Gerichtshof Den Haag Court of Appeal of the Hague Hoge Raad

Dutch Supreme Court

INN

International non-proprietary name

INPI

French National Institute of Industrial Property (Institut National de la Propriété Industrielle)

IPC

The French Intellectual Property Code (Code de la propriété intellectuelle)

LG

Landesgerichte (German district court)

MA

Marketing authorisation

Medicines Directive

Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (as amended)

Member State

A Member State of the European Union

MHRA

Medicines & Healthcare products Regulatory Agency

OLG

Oberlandesgericht (German district appeal or higher court)

Paediatric Regulation

Regulation (EC) 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use (as amended)

Plant Products SPC Regulation

Regulation (EU) 1610/96 of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products

Protocol

Protocol on Interpretation of Article 69 of the EPC

Rechtbank Den Haag

District Court of the Hague

Rules of Procedure

Rules of Procedure of the Unified Patent Court (18th draft of 19 October 2015, as amended on 30 June 2016)

SEP

Standard essential patent

SmPC

Summary of Product Characteristics

SPC

Supplementary protection certificate

Abbreviations xxiii SPC Regulation

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

TGI Paris

Tribunal de Grande Instance de Paris (Paris court of first instance)

Translation Regulation Regulation (EU) No 1260 / 2012 of 17 December 2012 implementing enhanced cooperation in the area of the creation of unitary patent protection with regard to the applicable translation arrangements New Exemption

The experimental use exemption introduced to the UK Patents Act 1977 by Legislative Reform (Patents) Order 2014 No 1997

Participating Member State

A Member State that signed the UP Regulation on 17 December 2012

PIP

Paediatric Investigation Plan

PIL

Patient information leaflet

UK

United Kingdom of Great Britain and Northern Ireland

UKIPO

UK Intellectual Property Office

TBA

Technical boards of appeal of the EPO

TRIPS

Trade-Related Aspects of Intellectual Property Rights

Unitary Patent

European patent with unitary effect

UP Regulation

Regulation (EU) No 1257/2012 of 17 December 2012 implementing enhanced cooperation in the area of the creation of unitary patent protection

UPC

Unified Patent Court

UPC Agreement

Agreement on a Unified Patent Court 19 February 2013

WTO

World Trade Organization

xxiv

TABLE OF CASES References are to page number A method of functional analysis/GEORGES T 953/94 (unpublished) (15 July 1996)��140 A pneumatic tire/GOODYEAR T 221/91 (unpublished) (8 December 1992)��175 ABB AB/Siemens Aktiengesellschaft ALSTOM Power AG T 0473/13 (11 May 2016) (unpublished)��177 Abbott/Evysio (14 January 2009), TGI Paris, France�� 10 Abgestuftes Getriebe GRUR 2002, 801, 803, BGH��317 Abraxis Bioscience LLC v Comptroller General of Patents [2017] EWHC 14 (Pat) (13 January 2017), Pat Ct��278, 279 Abraxis Bioscience LLC v Comptroller General of Patents, Case C-443/17, EU:C:2018:1020 (13 December 2018), Ad-Gen’s Opinion��279 Abraxis Bioscience LLC v Comptroller General of Patents, Case C-443/17, EU:C:2019:238 (21 March 2019), CJEU��279 Absorbent article/UNICHARM T 2096/12 (unpublished) (23 February 2017)��247 Accord v AstraZeneca 200.108.411-01 (10 June 2014), Hague Ct of Appeal, Netherlands��229 Accord Healthcare, SLU & Sandoz Farmaceutica, SA v AstraZeneca AB 74/2014 (20 May 2016), Spain.��229 Acetals/NEW JAPAN CHEMICAL T 1081/01 (unpublished) (27 September 2004)��174 Acieries de Bonpertuis SAS v D 16/06011 (30 March 2017), TGI Paris��311 ACK/NACK-transmission with different power levels/LG T 512/07 (unpublished) (22 January 2010)��233 Actavis v MSD 07/16296 (28 September 2010), TGI Paris��190 Actavis Group HF v Eli Lilly & Co Joined with Medef EHF v Eli Lilly and Co [2012] EWHC 3316 (Pat) (27 November 2012)��341, 342 Actavis Group HF v Eli Lilly & Co [2013] EWCA Civ 517, [2013] RPC 37 (21 May 2013)��341 Actavis Group PTC EHF v Eli Lilly & Co [2015] EWHC 3294 (Pat), [2016] RPC 12 (16 November 2015)��187, 262 Actavis Group PTC EHF v ICOS Corp [2016] EWHC 1955 (Pat) (10 August 2016)�� 47, 48, 208 Actavis Group PTC EHF v ICOS Corp [2017] EWCA Civ 1671, [2018] RPC 7 (1 November 2017)�� 206, 207, 208

xxvi Table of Cases Actavis Group PTC EHF v ICOS Corp [2019] UKSC 15, [2019] Bus LR 1318 (27 March 2019)�� 4, 5, 208, 209, 210, 226, 231 Actavis Group PTC EHF v Warner-Lambert Co LLC. See Generics (UK) Ltd (t/a Mylan) v Warner-Lambert Co LLC Actavis Group PTC EHF and Actavis UK Ltd v Boehringer Ingelheim Pharma GmbH & Co KG Case C-577/13 ECLI:EU:C:2015:165 (12 March 2015), CJEU��286, 288, 291, 292 Actavis Group PTC EHF and Actavis UK Ltd v Sanofi Case C-443/12 ECLI:EU:C:2013:833 (12 December 2013), CJEU�� 286, 288, 289, 291, 292 Actavis UK Ltd v Eli Lilly & Co [2017] UKSC 48, [2017] RPC 21, [2017] Bus LR 1731 (12 July 2017)�� 4, 21, 22, 23, 24, 25, 26, 29, 30, 34, 36, 38, 39, 42 Actavis UK Ltd v Janssen Pharmaceutica NV [2008] EWHC 1422 (Pat) [2008] FSR 35 (30 June 2008), Pat Ct��192, 193 Actavis UK Ltd v Merck & Co Inc [2008] EWCA Civ 444, [2008] RPC 26 (21 May 2008), CA�� 188, 189, 192 Actavis UK Ltd v Novartis AG [2010] EWCA Civ 82, [2010] FSR 18 (17 February 2010)��214, 215 Administrative agreement G7/88 [1991] OJ EPO 137 (16 November 1990)��357 Administrative agreement G8/88 1991] OJ EPO 137 (16 November 1990)��357 Administrative agreement/Medtronic G5/88 [1991] OJ EPO 137 (16 November 1990)��357 Admissibility of Disclaimer G1/03, G2/03 [2004] EPOR 33 (8 April 2004)��358, 359, 360, 361, 362 Adrenaline/MEDCO RESEARCH T 233/96 (unpublished) (4 May 2000)��191 Adsorbent for LDL/KANEGAFUCHI T 0936/96 (unpublished) (11 June 1999)��226 Aerocrine v Medisoft A/11/3039 (28 June 2012), Liège Commercial Court��222 Aerotel Ltd v Telco Holdings Ltd; Macrossan's Patent Application [2006] EWCA Civ 1371, [2007] RPC 7 (27 October 2006)��140, 143, 145, 163 AGA v Occlutech 11/00304 (25 May 2012)�� 31 AGA v Occlutech C-09-407582-HA ZA 11-2682 (4 March 2015), Rechtbank Den Haag��177 Aga Medical Corp v Occlutech (UK) Ltd [2014] EWHC 2506, [2015] RPC 12 (22 July 2014), Pat Ct��176, 177 AGFA Graphics v Fujifilm C/09/494257/KG ZA 15-1216 (27 November 2015), Rechtbank Den Haag��337 Agilent/Waters (14 January 2009), TGI Paris��127 Agrevo/Tiazoles T-939/92 [1996] EPOR 171, [1996] OJ EPO 309��209, 210 Agrosol SA v Sodifag Sarl, 4e ch; PIBD 2005, n° 819, III, p.685 (7 October 2005), Cour d’Appel Paris�� 83 Air filled microballoons/BRACCOT 270/97 (unpublished) (20 December 1999)��170

Table of Cases xxvii Aktiebolaget Hassle v Astra France SA INPI: B20000011 (19 January 2000), Cour d’Appel Paris�� 72 Aktiebolaget Hassle v Lek DD Ljubljana PIBD 2001 723-III-329 (30 January 2001), Cour de Cassation�� 47 Alexander & Co v Henry & Co (1895) 12 RPC 360 (14 August 1895), ChD��127 Alkermes/Ethypharm 21 December 2012, TGI Paris�� 59 Allergan v Orifarm C/09/534204/KG ZA 17-771 (15 September 2017), Rechtbank Den Haag�� 91 Alpha-interferon II/BIOGEN T 0500/91 (unpublished) (21 October 1992)�� 9 Alsapan SAS v Classen Industries GmbH 14/03974 (8 September 2016), TGI Paris��249 American Cyanamid Co v Ethicon Ltd [1975] AC 396 (5 February 1975), HL��114 Amorphous Lercanidipine Hydrochloride/RECORDATI T 1085/13 (unpublished) (9 November 2018)��179, 182 Analogs/AMGEN T 1208/97 (unpublished) (3 November 2000)��167, 168 Anan Kasei Co, Ltd & Rhodia Operations SAS v Molycorp Chemicals & Oxides (Europe) Ltd [2016] EWHC 1722 (Pat), [2017] FSR 13 (14 July 2016), Pat Ct��339 Angle mirror/LUCHTENBERG (unpublished) (29 September 1983)��174 Anki v Stadlbauer 2608/2015 (5 February 2018), Tribunale di Roma��341 Anne D; Sarl AD v Hermes Sellier SA 12/16589 (12 February 2014), Cour d’Appel Paris��212 Anonymous v Inventor 86-19166 (21 June 1988), Cour de Cassation��308 Antioxydant/TELECOMMUNICATIONS T 173/83 [1987] OJ EPO 465 (1 July 1985)��172 Anywayup Cup Case. See Haberman v Jackel International Aortic graft for treating abdominal aortic aneurysms/BARONE T 1407/08 (unpublished) (20 March 2013)��157 AP-I complex/SALK INSTITUTE FOR BIOLOGICAL STUDIES T 609/02 (unpublished) (27 October 2004)��258, 263, 264, 267, 270 Appetite suppressant/DU PONT T 144/83 [1986] OJ EPO 301 (27 March 1986)��158 Apple v Samsung 200.096.074-01 (20 May 2014), Gerechtshof Den Haag��337 Apotex v Wellcome Foundation Ltd PIBD 2001 726 III 429 (15 September 2000), Cour d’Appel, Paris�� 73 Apparatus for hair removal/IMPROVER T 754/89 (unpublished) (24 April 1991)��224 Appetite suppressant/DU PONT T 144/83 [1986] OJ EPO 301 (27 March 1986)��136 Arcelormittal v Voestalpine 09/23852 (21 March 2012), Cour d’Appel de Paris��236 Archos SA v Koninklijke Philips NV C/09/505587/HA ZA 16-206 (8 February 2017), Rechtbank Den Haag��103 Arne Forsgren v Österreichisches Patentamt Case C 631/13 ECLI:EU:C:2015:13 (15 January 2015), CJEU.��280 Arrow Generics Ltd v Merck & Co Inc [2007] EWHC 1900 (Pat), [2007] FSR 39 (31 July 2007), Pat Ct��81, 92, 93, 94, 95, 96, 110

xxviii Table of Cases ARS v Organon 15390 NJ 1995 33 (17 June 1994), Hoge Raad�� 85 ARS v Organon 15706 NJ 1997 41 (23 June 1995), Hoger Raad�� 85 Aryloxybenzaldehydes/SHELL T 20/81 [1982] OJ EPO 217 (10 February 1982)��204 Arzneimittelgebrauchsmuster X ZB 7/03 GRUR 2006 135 (5 October 2005), BGH��189 Astellas Pharma Inc v Polpharma SA Pharmaceutical Works 4a O 282/10 (26 July 2012), LG Dusseldorf�� 87 Astellas Pharma Inc v Polpharma SA Pharmaceutical Works I-2 U 68/12 (5 December 2013), OLG Dusseldorf��87, 88 AstraZeneca/Resolution NJB 2018/1195 (8 June 2018), Hoge Raad, Netherlands��32, 35 AstraZeneca AB v Comptroller General of Patents, Designs and Trade Marks Case C-617/12 (14 November 2013 ECLI:EU:C:2013:761; rectification 17 January 2014 ECLI:EU:C:2014:28)��293, 296 Astrazeneca AB v Hexal AG [2013] EWCA Civ 454 (30 April 2013), CA�� 227, 228, 229 AstraZeneca AB v Sandoz NV 2014/KR/232 (3 November 2015), Belgium��229 AT&T Knowledge Ventures LP’s Patent Application [2009] EWHC 343 (Pat), [2009] FSR 19 (3 March 2009), Pat Ct��146 Attorney General v Guardian Newspapers Ltd (No 2) [1988] UKHL 6, [1990] 1 AC 109 (13 October 1988)��176 Auchincloss v Agricultural & Veterinary Supplies Ltd [1999] RPC 397, CA��82, 83 Auction method/HITACHI T 258/03 [2004] OJ EPO 575 (21 April 2004)��144 Audiosignalcodierung X ZR 69/13 GRUR 2015, 467 (3 February 2015), BGH�� 72 Auslegung des Art 55(1) G2/99 [2001] OJ EPO 83(12 July 2000)�� 359, 360, 362 Austausch der Anmeldungsunterlagen G2/95 [1996] OJ EPO 555 (14 May 1996)��361, 362 Austrian Oberster Gerichtshof Obp /2/13 (8 May 2013)��172 Austrian Patent Office Board of Appeal Decision B 1/2011 (22 November 2012)��177 Austrian Supreme Patent and Trademark Chamber Op 1/12 (27 June 2012)��201 Austrian Supreme Patent and Trademark Chamber Op 3/13 (27 November 2013)��222 Authentication binding document with signature/VASCO T 2101/12 (unpublished) (24 January 2018)��203, 221 Availability to the public G1/92 [1993] OJ EPO 27 (18 December 1992)��173, 359 Aventis Inc v Apothecon BV & Ratiopharm BV, 299702/KG ZA 07-1439 IEF 8683 (16 March 2010), Gerchtshof Den Haag��117, 180 Aventis v Hospira, Intas, Teva 10/56899, 10/56902, 10/56889 (19 August 2010), TGI Paris�� 48 Avery Dennison v Gemalto 17/14906 (9 January 2019), Cour de Cassation��249, 250 B v Sarl R Santé 15/12226 (21 April 2017), Paris Cour d’Appel��314 B2M Industries v Acome 06-17915 (20 November 2007), Cour de Cassation�� 27 Balipro Sarl v Vinmer SA 11/05096 (6 June 2013), TGI Paris��105 Balipro c Vinmer 13/17363 (17 April 2015), Cour d’Appel Paris��105 Barcelona Commercial Court no 5, AJM B 75/2017, 12 September 2017��140 Basf v Bayer 13625 of (14 December 2016), Tribunale di Milano��341

Table of Cases xxix Basic Holdings v Ruby Decor C/09/504274/KG ZA 16-100 (4 May 2016), Rechtbank Den Haag,��337 Batch mixer/M TEC T 234/91 (unpublished) (25 June 1993)��224 BAUER/Non-refund of further search fees G1/11 [2015] EPOR 21 (19 March 2014)��357 Bayer CropScience AG v Deutsches Pantent- und Markenamt (6 December 2012), BGH��279 Bayer CropScience AG v Deutsches Pantent- und Markenamt Case C-11/13 ECLI:EU:C:2014:2010 (19 June 2014), CJEU��279, 280 Bayer/Sandoz 5 NJ 2016/496 (February 2016), Hoge Raad, Netherlands�� 32 BDP1 Phosphatase/MAX-PLANCK T 870/04 (unpublished) (11 May 2005)��136 Belgische Vereniging van Auteurs, Componisten en Uitgevers CVBA (SABAM) v Netlog NV Case C-360/10 [2012] ECR I-0000 (16 February 2012), CJEU��118 Berichtigung nach Regel 88, Satz 2 EPÜ G3/89 [1993] OJ EPO 117 (19 November 1992) ��362 Betts v Willmott (1870–71) LR 6 Ch App 239, Lord Chancellor�� 89 Biegevorrichtung X ZR 32/99 GRUR 2002 231 (13 November 2001), BGH��106 Bimetallic catalyst/INTEVEP T1465/05 (unpublished) (18 March 2009)��175 Binocular telescope/SWAROVSKI OPTIK T 0267/03 (unpublished) (28 September 2005)��171 Biogen v Celltrion C/09/531270/KG ZA 17-519 (12 May 2017), PI judge Rechtbank Den Haag��117 Biogen Inc v Medeva Plc [1996] UKHL 18, [1997] RPC 1 (31 October 1996)��235, 237, 238, 251 BL Macchine Automatische v Windmoeller KG 19550 GRUR Int 2005 264 (19 December 2003), Corte Suprema di Cassazione, Italy��340 Blood separation systems/FENWAL T 1075/06 (unpublished) (17 May 2011)��157 Bodenseitige Vereinzelungseinrichtung GRUR 2004, 1023 (7 September 2004), BGH, Germany�� 9 Bodenwaschanlage X ZR 137/99 GRUR 2001 223 (14 November 2000), BGH�� 90 Boegli Gravures c. Darsail 11-18440 (20 November 2012), Cour de Cassation�� 11 Boegli-Gravures SA v Darsail-Asp Ltd [2009] EWHC 2690 (Pat) (29 October 2009)�� 71 Boehringer v Kirin Amgen 15623 NJ 1995/103 (21 April 1995)�� 85 Boehringer v Kirin-Amgen NJ 1996, 462 (21 April 1995), Hoge Raad��120 Boehringer v Teva 324094/KG ZA 12-319 (15 August 2012), Rechtbank Utrecht�� 52 Boehringer Mannheim v Kirin Amgen IEPT 20000127 (27 January 2000), Gerechtshof Den Haag��237 Boehringer Mannheim/ Kirin Amgen ECLI:NL:GHSGR:2000:AM2907 (27 January 2000), Gerechtshof Den Haag��238 Bolton v Reckitt Benckiser, 14/04698 (18 December 2015), TGI Paris��181 Bon v SARL Theirart 15/09231 (12 January 2017), TGI Paris��316 Bornemann/Houttuin 02/3036 (2 July 2003), Rechtbank Den Haag��224

xxx Table of Cases Boston Scientific v Edwards Lifesciences C/09/548434/KG ZA 18-176 (15 May 2018), Rechtbank Den Haag��337 Bottle dispenser/VITLAB T 252/06 (unpublished) (6 May 2008)��224 Bourjois and Geka 03-16.532 and 03-18.818 (22 March 2005), Cour de Cassation��249 Brain stimulation/CLEVELAND T 1802/13 (unpublished) (10 November 2016)��141, 142 Break-stem blind rivet/AVDEL SYSTEMS T 896/92 (unpublished) (28 April 1994)��169 Bristol-Myers Squibb v Baker Norton [1999] RPC 253 (20 August 1998), Pat Ct��191 Bristol Myers Squibb Co v Baker Norton Pharmaceuticals Inc [2001] RPC 1 (23 May 2000)��188 British Acoustic Films Ltd v Nettlefold Productions (1936) 53 RPC 221��14, 15 Broccoli/PLANT BIOSCIENCE G2/07; Tomatoes/STATE OF ISRAEL G1/08 [2012] OJ EPO 130 and 206 (9 December 2010)��155, 358 Brugger v Medic-Aid Ltd (No 2) [1996] RPC 635 (12 June 1996), Pat Ct��207, 209 Bugnot v X 00-15495 (26 February 2002), Cour de Cassation��316 Buhler AG v FP Spomax SA [2008] EWHC 823 (Ch), [2008] FSR 27 (21 April 2008)��225 Buprenorphine patch/EURO-CELTIQUE T 0259/15 (unpublished) (25 July 2017)��202, 203 C Van Der Lely v PJ Zweegers en Zonen 91-13931 (23 March 1993), Cour de Cassation�� 97 C v SA Spie Batignolles 02/01353 (5 January 2006), TGI Paris��311 C10-Alkoxylate/BASF T 1948/10 (unpublished) (26 June 2014)��248 Campbell v Mirror Group Newspapers [2004] UKHL 22, [2004] 2 AC 457 (6 May 2004), HL��176 Cancer treatment/BOARD OF REGENTS, THE UNIVERSITY OF TEXAS SYSTEM, T1780/12 (unpublished) (30 January 2014)��53, 159 Cardiac pacing/TELECTRONICS T 82/93 [1996] OJ EPO 274 (15 May 1995)��157 Carl Freudenberg v Stadsing SH2017.T-14-14S, So- og Handelsretten��201 Carrera & Texas c Muller 16-28.322 and 17-14.673 (23 January 2019), Cour de Cassation��126 Carrier substrate for electronic components/SCHOTT T 51/10 (unpublished) (24 March 2015)��170 Carvediol II X ZR 236/01 A GRUR 2007 404 (19 December 2006), BGH��189 Case 133R 15/18f (23 April 2018), Vienna Ct of Appeals.�� 43 Case A-19-17 (8 December 2017), Danish Maritime and Commercial High Court.�� 42 Case 00/13122 (28 May 2002), TGI Paris��316 Case 04/09812 (14 September 2005), Cour d’Appel, Paris��319 Case 05/09022 (1 July 2008), TGI Paris��212 Case 06/0061 (12 February 2008), TGI Paris��212 Case 13-25.082 (23 June 2015), Cour de Cassation, France��217 Catnic Components Ltd v Hill & Smith Ltd [1982] RPC 183, [1981] FSR 60, (27 November 1980) HL�� 29, 39, 168

Table of Cases xxxi Cavitron Inc, 91-19915 (4 January 1994), Cour de Cassation��315 Cellulase/NOVOZYME T 1336/04 (unpublished) (9 March 2006)��179 Centrafarm BV v Sterling Drug Inc Case 15-74 [1974] ECR 1147, ECJ��88, 111 Cephalon Inc v Orchid Europe Ltd [2010] EWHC 2945 (Pat) (19 November 2010), Pat Ct��114 Cerebral ischemia/EHRENREICH 293/07 (unpublished) (24 July 2008)��203 Checkpoint simulation/ACCENTURE T 531/09 (unpublished) (3 May 2012).��145 Chimeric gene/BAYER (T 890/02) [2005] OJ EPO 497 (T 890/02) (14 October 2004)��8, 16, 17 Chimeric genes in plant cells/MONSANTO T 387/94 (unpublished) (7 March 1997)��202 Chronic Hepatitis C 4a O 145/12 (14 March 2013), OLG Dusseldorf�� 60 Ciba-Geigy v Ote Optics NJ 1995/391 (13 January 1995) Hoge Raad, Netherlands��31, 43 Cipla Ltd v Glaxo Group Ltd [2004] EWHC 477 (Pat), [2004] RPC 43 (19 March 2004)�� 225, 226, 227 Circuit simulation I/INFINEON TECHNOLOGIES T 1227/05 [2007] OJ EPO 574 (13 December 2006)�� 144, 145, 222 Cistus Incanus 2 U 54/11 (31 January 2013), OLG�� 60 Classification method/COMPTEL T 1784/06 (unpublished) (21 September 2012)��221 Cleaning apparatus for conveyor belt/FIVES-CAIL BABCOCK T 32/81 OJ 1982, 225 (5 March 1982)�� 10 Cleaning plaque/ICI T 290/86 [1992] OJ EPO 414 (13 November 1990)��158 Clipboard formats I/MICROSOFT T 424/03 (unpublished) (23 February 2006)��144, 145 Closing a heat exchange tube/ ABB REAKTOR T 1072/92 (unpublished) (28 June 1994)��224 Coated tablets/JOHNSON & JOHNSON T 0282/12 (unpublished) (9 November 2017)��186 Coaxial Connector/AMP T 260/85 [1989] OJ EPO 105 (9 December 1987)��195 Coco v AN Clark (Engineers) Ltd [1969] RPC 41 (1 July 1968), ChD��176 Coflexip SA v Stolt Offshore MS Ltd [2003] EWCA Civ 296, [2003] FSR 41 (13 March 2003)��127 Coin Controls Ltd v Suzo International (UK) Ltd [1999] Ch 33 (26 March 1997), Pat Ct��338, 339 Collagen casing/DEVRO T 2453/09 (unpublished) (5 October 2011)��225 Collagenase I, BGH��189 Collingwood Lighting Ltd v Aurora Ltd [2014] EWHC 228 (Pat) (10 February 2014), Pat Ct��107 Colloidal binder/PAROC T 230/07 (unpublished) (5 May 2010)��182 Combustion engine/LUCAS 0426/88 [1992] OJ EPO 427 (9 November 1990)�� 17 Composite prelaminated tapes/3M T 37/98 (unpublished) (17 May 2001)��175 Composition and wipe/KIMBERLY-CLARK T 2070/13 (unpublished) (12 April 2018)��234

xxxii Table of Cases Composition Contraceptive/BAYER SCHERING T 1635/09 [2011] OJ EPO 542 (27 October 2010)��158 Computer program product/INTERNATIONAL BUSINESS MACHINES CORPORATION T 1173/97 [1999] OJ EPO 609 (1 July 1998)�� 144, 163, 221 Computer-related invention/VICOM T 208/84 [1987] OJ EPO 14 (15 July 1986)�� 139, 140, 144 COMVIK/Hitachi T 641/00 [2003] OJ EPO 352 (26 September 2002)��144 Concept microfibre c DME 12/11633 (31 March 1989), France��105 Condition required for priority claim G2/98 [2001] OJ EPO 413 (31 May 2001)�� 183, 359, 360, 361, 362, 362 Conor Medsystems Inc v Angiotech Pharmaceuticals Inc [2006] EWHC 260 (Pat), [2006] RPC 28 (24 February 2006)��254 Conor Medsystems Inc v Angiotech Pharmaceuticals Inc [2007] EWCA 5, [2007] RPC 20 (16 January 2007)��254 Conor Medsystems Inc v Angiotech Pharmaceuticals Inc [2008] UKHL 49, [2008] RPC 28 (9 July 2008)��206, 209, 210, 211, 216, 254, 255 Contraceptive method/BRITISH TECHNOLOGY T 74/93 [1995] OJ EPO 712 (9 November 1994)��135, 136 Contraceptive method/THE GENERAL HOSPITAL T 820/92 [1995] OJ EPO 113 (11 January 1994)��158 Controlling pension benefits system/PBS PARTNERSHIP T 931/95 [2001] OJ EPO 441(8 September 2000)��139 Copolymers/DUPONT T 124/87 [1989] OJ EPO 491 (9 August 1988)��179, 182 Core/Miral v Axxom/Castorama/Browaeys Brame 12/07634 (26 April 2013), Cour d’Appel de Paris��223 CoreValve Inc v Edwards Lifesciences AG [2009] EWHC 6 (Pat), [2009] FSR 8 (9 January 2009), Pat Ct�� 82 Correction of decision to grant G8/95 [1996] OJ EPO 481 (16 April 1996)��357 Corte Suprema di Cassazione, No 22495 (16 October 2006), Italy�� 72 Corte Suprema di Cassazione (Cass Civ SS UU 05.07.2017, no 16601, Italy��127 Cour d’Appel Paris 88.18686 (31 May 1990).�� 28 Cour d’Appel, Paris, (20 May 2005)��249 Cour d’Appel, Paris, 11/03663 (21 December 2012)��309 Cour d’Appel, Paris, 13/15831 (3 April 2015)��249 Cour d’Appel, Paris, 15/12176 (28 November 2017)�� 27 Cour d’Appel, Paris, 17/01202 (4 December 2018)�� 27 Cour d’Appel, Paris, 17/06356 (16 October 2018)�� 27 Cour d’Appel, Paris, Pole 5 Chamber 1 docket No 10-19186 (12 December 2012), confirmed on this point by the Cour de Cassation, commercial court, docket No 13-15862 (17 March 2015)��176 Cour de Cassation 91-20417 (26 October 1993)�� 27 Cour de Cassation 94-13790 (16 January 1996)�� 27 Cour de Cassation, 94-15283 (12 March 1996)��166 Cour de Cassation 02-18650 (31 March 2004)�� 27 Cour de Cassation 10-30907 (2 November 2011)�� 27

Table of Cases xxxiii Cour de Cassation, 11-27686 (14 May 2013)��166 Cour de Cassation 16-20644 (27 June 2018)�� 27 Cour de Cassation, 16-28322 (23 January 2019)�� 27 Cour de Cassation, commercial chamber, 20 November 2007, 06-17915�� 27 Cour de Cassation, commercial chamber, 26 February 2008, 05-21452�� 27 Credit Lyonnais v EGCD [1988] AC 1013, CA�� 77 Crypthographie a cles publiques/FRANCE TELECOM T 27/97 (unpublished) (30 May 2000)��140 Custodiol I X ZB 12/00 GRUR 2002 523, BGH�� 28 Custodiol II X ZR 73/01 GRUR 2002 527, BGH�� 28 Dasatinib/BRISTOL-MYERS SQUIB T 0488/16 (unpublished) (1 February 2017)�� 253, 256, 259, 262, 268, 269, 270 Dasatinib in the treatment of chronic myelogenous leukemia/BRISTOL T 0950/13 (unpublished) (3 February 2017)��241, 242, 259, 263, 268, 269, 270, 271 Data selection system/BRITISH TELECOMMUNICATIONS T 1143/06 (unpublished) (1 April 2009)��141, 142 Data structure product/KONINKLIJKE PHILIPS ELECTRONICS T 1194/97 [2000] OJ EPO 525 (15 March 2000)��141 Datenträger X ZB 4/92 GRUR 1995 113 (6 October 1994), BGH��236 Decision of the Administrative Council of 29 June 2017 amending Rules 27 and 28 of the implementing Regulations to the European Patent Convention (CA/D 6/17) [2017] OJ EPO A56��155 Deckenheizung X ZR 153/03 GRUR 2006 839 (13 June 2006), BGH�� 69, 70, 71, 74 Delavage/CAYLA T 165/96 (unpublished) (30 May 2000)��174 Deodorant detergent/UNILEVER T 585/92 [1996] OJ EPO 129 (9 February 1995)��172 Depagne v Sogexi 03/06651(24 February 2005), Cour d’Appel, Lyon�� 98 Depagne v Sogexi P.05-14707 (3 April 2007), Cour de Cassation�� 98 Dermaconcept JMC v Laboratoire Bioderma SAS 15/00069 (7 July 2017), TGI Paris��158 Desmopressin X ZR 131/09 GRUR 2012, 895 (12 June 2012), BGH��105, 106 Dexmedetomidin 2 U 30/17 (1 March 2018), OLG Dusseldorf; confirming LG Dusseldorf GRUR 2017 1107 (5 May 2017).�� 60 Dexmedetomidine 34R113/16m (11 May 2017), Vienna Oberlandesgerichte��193 DHL Express France SAS v Chronopost SA Case C-235/09 [2011] ECR I-2801 (12 April 2011), CJEU��118 Diagnostic Agent/BOEHRINGER T 99/85 [1987] OJ EPO 413 (23 October 1986)��204 Diagnostic methods G1/04 [2006] OJ EPO 334 (16 December 2005).�� 156, 157, 161, 357, 358, 360, 361 Diastereomer/BAYER 12/81 [1982] OJ EPO 296 (9 February 1982)��165, 169, 170, 178 Diesel fuels/EXXON T 409/91 [1993] OJ EPO 40 (18 March 1993)��238 Digester/BELOIT T 37/96 (unpublished) (7 February 2000)��171 Diglycidverbindung X ZR 69/10 GRUR 2012 45 (13 September 2011), BGH��30, 40 Dipeptidyl-Peptidase-Inhibitoren X ZB 8/12 (11 September 2013), BGH��239, 285

xxxiv Table of Cases Disclaimer/SCRIPPS G 2/10 [2012] OJ EPO 376 (30 August 2011)��194, 196, 361, 362 Disclaimer III/PRINCETON UNIVERSITY G1/16 [2018] EPOR 11, [1998] OJ EPO supplementary publication 3 29 (18 December 2017)��196 Dispensing of restricted goods/BLUEPOINT T 578/12 (unpublished) (8 June 2017)��169 Divisonal/ASTROPOWER G1/05 [2007] EPOR 46 (28 June 2007)��362 Document scoring/Google T 0817/16 (unpublished) (10 January 2019)��220 Document summary/ARIZAN CORPORATION T 0483/11 (unpublished) (13 October 2015)��221 Dosage regime/ABBOTT RESPIRATORY G2/08 (Kos Life Science) [2010] EPOR 26, OJ EPO 456 (19 February 2010)�� 53, 159, 185, 188, 358, 359 Doxycycline 12045 (Pfizer v Pharmon) (10 June 1983), Hoge Raad�� 52 Dr Reddy’s Laboratories (UK) Ltd v Eli Lilly & Co Ltd [2009] EWCA Civ 1362, [2010] RPC 9 (18 December 2009)�� 180, 183, 192, 256, 257, 258 Dr Reddy’s Laboratories (UK) Ltd v Warner-Lambert Co LLC [2012] EWHC 3715 (Pat), [2013] RPC 31 (20 December 2012), Pat Ct��298, 299 Dreizler v Remeha NJ 1995, 392 (13 January 1995), Hoge Raad, Netherlands�� 32 Dry granulated product/AJINOMOTO T 1543/12 (unpublished) (19 April 2016)��234, 235 Drying process/UNILEVER T 913/01 (unpublished) (11 October 2004)��174 DSM v Novozymes C/09/515238/KG ZA 16-906 (6 January 2017), Rechtbank Den Haag��337 Du Pont’s Patent [1982] FSR 303 (18 February 1982), HL��180, 257 Duns Licensing Associates/Estimantig sales activity T 0154/04 ECLI:EP:BA:2006:T015404.20061115 (15 November 2006)��163 Duphar v Gist-Brocades, Rechtsbank Den Haag [1987] BIE 1988/28, Netherlands�� 9 Dyson Appliances Ltd v Hoover Ltd [2001] EWCA Civ 1440, [2002] RPC 22 (4 October 2001)��225 E-Mail via SMS X ZR 58/10 GRUR 2012 261 (22 November 2011), BGH��216 Ebrahim Simhaee PIBD 802 III 102 (5 November 2004), TGI Paris�� 71 Edwards Lifesciences LLC v Boston Scientific Scimed Inc [2018] EWCA Civ 673, [2018] FSR 29 (28 March 2018)��120, 121 Edwards Lifesciences AG v Cook Biotech Inc [2009] EWHC 1304 (Pat), [2009] FSR 27 (12 June 2009), Pat Ct��185 Efomycine als Leistungsforderer/BAYER T 774/89 (unpublished) (2 June 1992)��158 Einstein-Bohr end/ZAGYANSKY T 1538/05 (unpublished) (28 August 2006)��139 Eisei G 5/83 Second medical indication/EISAI [1985] OJ EPO 64 (5 December 1984)�� 53 Electric machine/BOSCH T 1085/92 (unpublished) (10 November 1994)��174 Electrical device containing a halogenated dielectric fluid/OCCIDENTAL T 131/87 (unpublished) (7 September 1989)��272 Elektrische Steckverbindung X ZB 15/93 GRUR 95 330 (17 January 1995), BGH��169 Elektronische Funktionseinheit X ZR 4/00 GRUR 2004 133 (14 October 2003), BGH��184

Table of Cases xxxv Element and energy production device/ZACHARIAH T 541/96 (unpublished) (7 March 2001)��136 Element for a solar heat reflector/RIOGLASS T 0523/14 (unpublished) (17 February 2017)��177 Eli Lilly v Fresenius, Teva C/09/538525/KG ZA 17-1159 and C/09/537158/KG ZA 17-1072 (24 October 2017), Rechtbank Den Haag��117 Eli Lilly v Sandoz C/09/526079/KG ZA 17-129 (1 March 2017), PI judge Rechtbank Den Haag��117 Eli Lilly v Teva Sante,12/07203 (12 March 2014), Cour d’Appel, Paris��219 Eli Lilly and Co v Genentech Inc [2019] EWHC 388 (Pat), (1 March 2019), Pat Ct��295 Eli Lilly and Co v Genentech Inc [2019] EWHC 389 (Pat), (1 March 2019), Pat Ct��295 Eli Lilly & Co v Human Genome Sciences Inc [2014] EWHC 2404 (Pat), [2015] RPC 8 (18 July 2014), Pat Ct��284, 285 Eli Lilly v Human Genome Sciences (HGS) Case C-493/12 [2014] RPC 21 (12 December 2013), CJEU��284, 285, 286, 287, 289, 290, 292 Eli Lilly & Co v Janssen Alzheimer Immunotherapy [2013] EWHC 1737 (Pat), [2014] RPC 1 (25 June 2013), Pat Ct��263, 264 Eli Lilly & Co, Eli Lilly Italia Spa v Fresenius Oncology PLC and Fresenius Kabi Srl 45209/2017 (15 October 2018), Ct of Milan, business division�� 42 Eli Lilly/Fresenius Kabi C/09/537158/KG ZA 17-1072 (24 October 2017), Rechtbank Den Haag�� 41 Eli Lilly/Teva C/09/538525/KG ZA 17-1159 (24 October 2017)�� 41 Eli Lilly & Co/Ratiopharm GmbH. 200.069.117/01 (27 September 2011), Gerechtshof Den Haag��258 Enantiomer/C T 296/87 [1990] OJ EPO 195 (30 August 1988)�� 179, 192, 193 Enantiomer/HOECST T 296/87 [1990] OJ EPO 195 (30 August 1988)��179 Entitlement to priority 0577/11 (unpublished) (14 April 2016)��184, 185 Entsperrbild 2 Ni 59/11 and 2 Ni 64/11 (4 April 2013), BpatG��222 Entsperrbild X ZR 110/13 (16 February 2016), BGH��222 Ericsson v TMT, docket No 12/14922 (29 November 2013), TGI Paris��102 Escitalopram GRUR 2010, 123 (9 September 2009), BGH, Germany�� 10 Estimating sales activity/DUNS LICENSING ASSOCIATES 154/04 [2008] OJ EPO 46 (15 November 2006)��219 Etablissement Barre v Technique Equipment Medical, SARL 15/23689 (29 September 2017), Cour d’Appel, Paris��166 Etablissement D’Hospitalisation, 16-00062 (19 February 2016), Cour d’Appel, Paris��166 Etching metal services/SCHMID T 229/85 [1987] OJ EPO 237 (27 October 1986) ��204, 215 Ethinylestradiol and drospirenone for use as a contraceptive/BAYER T 7/07 (unpublished) (7 July 2011)��176 Ethypharm SA v/ Merck Sharp & Dohme Corp 16/01225 (28 January 2018), TGI��247

xxxvi Table of Cases European Pallet Association v PHZ C/09/506432/HA ZA 16-253 (31 August 2016), Rechtbank Den Haag.�� 90 Evalve Inc v Edwards Lifesciences Ltd [2019] EWHC 1158 (Pat) (3 May 2019), Pat Ct��114 Event Detector/RAYCHEM T 689/90 [1993] OJ EPO 616 (21 January 1992)��195 Examination of clarity objections G3/14 [2015] EPOR 29 (24 March 2015)��361, 362 Expression in yeast/ GENENTECH T 0455/91 [1995] OJ EPO 684 (20 June 1994)�� 9 Expression in yeast/ GENENTECH T 0455/91 [1996] EPOR 85 (20 June 1994)��215, 218 F Hoffmann-La Roche AG v Accord Healthcare OÜ Case C-572/15 ECLI:EU:C:2016:739 (5 October 2016), CJEU��296 F v C 11/11185 (13 May 2016), TGI Paris��310 Fabio Perini v LPC/PCMC [2012] EWHC 1393 (Pat) (4 April 2012)��127 Fabio Perini v LPC Group PLC [2010] EWCA Civ 525 (14 May 2010).�� 77 Factor VIII formulation/BIOVITRUM T 847/07 (unpublished) (13 January 2010)��203 Factor-9/JOHNS HOPKINS T 1329/04 [2006] EPOR 8 (28 June 2005)��204, 205, 226, 231, 242, 253, 254, 255, 261, 273 Fahrzeugnavigationssystem X ZR 27/12 (23 April 2013), BGH.��142 Fahrzeugscheibe X ZR 49/12 GRUR 2013 712 (16 April 2013), BGH��185 Farbversorgungssystem X ZR 139/10 GRUR 2014 647 (11 March 2014), BGH��213 Farmitalia Carlo Erba SRL’s SPC Application C -392/97 [1999] ECR I-05553 (16 September 1999), ECJ��284 Faurecia Sieges D’Automobile SAS v Lear Corp Seating France SAS 12/17582 (8 January 2016), TGI Paris, confirmed by Cour d’Appel de Paris16/04223 (6 February 2018)��166 Fettsäuren X ZR 40/12 GRUR 2014 54 (24 September 2013), BGH��189 Filler mass/ N.I.INDUSTRIES T 560/89 [1992] OJ EPO 725 (24 April 1991)�� 10 Filterwerk Mann and Hummel (6 March 2002), TGI Paris�� 72 Finasteride. See Teva v Merck 15-19.726 Flügelradzähler X ZR 48/03 GRUR 2004 758 (4 May 2004), BGH��49, 66, 67 Foil container closing apparatus/EKCO T 517/90 (unpublished) (13 May 1992)��170 Foldable plastic bottle/DURING T 809/95 (unpublished) (29 April 1997)��174, 175 Folien Fischer AG v Ritrama SpA Case C-133/11 ECLI:EU:C:2012:664, (25 October 2012), CJEU��340 Formalities Officers Powers G1/02 [2003] EPOR 49 (23 January 2003)��357 Formstein X ZR 28/85 GRUR 1986, 803 (29 April 1986), BGH��28, 29, 44, 168, 199 Forsgren v Osterreichisches Patentamt (C-631/13) EU:C:2015:13, (2015) 143 BMLR 211, (15 January 2015), ECJ (8th Chamber)��279 Fort Dodge Animal Health Ltd v Akzo Nobel NV [1998] FSR 222 (27 October 1997), CA��339

Table of Cases xxxvii Fort Vale v Pelican B9 6289 (18 June 2008), Rechtbank Den Haag�� 97 Fort Vale v Pelican IEF 6298 (18 June 2008), Rechtbank Den Haag��337 Fresenius c Amgen 19/50489 (14 February 2018) TGI Paris��105 Fresenius Kabi Nederland BV v Eli Lilly & Company 200.228.753/01 (8 May 2018) Gerechtshof Den Haag�� 33 Fresenius v Eli Lilly 200.228.753/01 (8 May 2018), Gerechtshof Den Haag�� 41 Friction reducing additive/MOBIL G 2/88 [1990] OJ EPO 93, 469 (11 December 1989)��258, 359, 360, 362 Friction reducing additives/MOBIL IV T 59/87 [1991] OJ EPO 561 (14 August 1990)��170 Fuel injector valve/Nissan T 167/84 [1987] OJ EPO 369 (20 January 1987)��168 Fuel oils/EXXON T 409/91 [1994] OJ EPO 653 (18 March 1993)��233, 237, 271, 272 Fuhrungsdrahtnavigation/BrainLAB T 836/08 (unpublished) (12 May 2011)��157 Fujifilm Kyowa Kirin Biologics Co Ltd v Abbvie Biotechnology Ltd [2016] EWHC 3383 (Ch), [2017] RPC 8 (29 December 2016)�� 94 Fujifilm Kyowa Kirin Biologics Co Ltd v AbbVie Biotechnology Ltd [2017] EWHC 395 (Pat), [2018] RPC 1 (3 March 2017)��93, 94 Fujifilm Kyowa Kirin Biologics Co Ltd v Abbvie Biotechnology Ltd [2017] EWCA Civ 1, [2017] RPC 9 (12 January 2017)��93, 94, 96 Fullplastverfahren KZR 14/78 GRUR 1980 38 (24 September 1979), BGH�� 90 Funkuhr II X ZR 53/04 GRUR 2007, 313 (30 January 2007), BGH�� 72 Galactic c Jungbunzlauer 12/06951 (3 April 2014), TGI Paris��105 Galicier v ACM Caruelle 03-14167 (14 June 2005), Cour de Cassation��315 Garmin (Europe) Ltd v Koninklijke Philips NV [2019] EWHC 107 (Ch) (29 January 2019), Pat Ct��23, 143 GAT v LuK Case C-4/03 [2006] ECR I-06509 (13 July 2006), ECJ�� 331, 332, 333, 334, 336, 337, 339, 341, 344, 345 GD Searle LLC & Janssen v Sandoz 18/60334 (11 January 2019), TGI Paris��129 Gedeon Richter plc v Bayer Schering Pharma AG [2011] EWHC 583 (Pat), [2011] Bus LR D153 (17 March 2011)��210 Gegensprechanlage X ZB 3/00 (20 November 2001), BGH��250 Gemstar-TV Guide International Inc v Virgin Media Ltd [2009] EWHC 3068 (Ch), [2010] RPC 10, (26 November 2009), Pat Ct��143 Gene coding for interleukin-2 polypeptide/AJINOMOTO T 128/92 (unpublished) (30 November 1994)��174 Genentech Inc’s Patent [1989] RPC 147 (1 April 1989), CA��235 General Hospital Corp and Société Zeltiq Aesthetics Inc v Société Clinipro, 11-18480 (25 May 2013), TGI Paris��193 General technical knowledge/BOEING T 195/84 [1986] OJ EPO 121 (10 October 1985)��11, 13 General Tire & Rubber Co Ltd v Firestone Tyre & Rubber Co Ltd (No 1) [1972] RPC 457, [1971] FSR 417 (28 July 1971), CA��14, 165 Generics (UK) Ltd v Daiichi Pharmaceutical Co Ltd [2008] EWHC 2413 (Pat), [2009] RPC 4 (15 October 2008)��198 Generics (UK) Ltd v H Lundbeck A/S [2006] EWCA Civ 1261 (2 August 2006)��7, 77

xxxviii Table of Cases Generics (UK) Ltd v H Lundbeck A/S [2007] EWHC 1040 (Pat), [2007] RPC 32 (4 May 2007)��211, 237 Generics (UK) Ltd v H Lundbeck A/S [2009] UKHL 12, [2009] RPC 13 (25 February 2009)�� 235, 237, 238, 251, 272, 273 Generics (UK) Ltd v Synaptech Inc Case C-427/09 [2011] ECR I-07099 (28 July 2011), CJEU��294 Generics (UK) Ltd (t/a Mylan) v Yeda Research and Development Co Ltd, Teva Pharmaceutical Industries Ltd [2013] EWCA Civ 925, [2014] RPC 4 (29 July 2013)�� 211, 263, 264 Generics (UK) Ltd (t/a Mylan) v Yeda Research & Development Co Ltd [2017] EWHC 2629 (Pat), [2018] RPC 2 (26 October 2017)��36, 94, 95 Generics (UK) Ltd (t/a Mylan) v Warner-Lambert Co LLC; sub nom Warner-Lambert Co LLC v Generics (UK) Ltd (t/a Mylan); Actavis Group PTC EHF v Warner-Lambert Co LLC [2015] EWHC 2548 (Pat), [2016] RPC 3 (10 September 2015), Pat Ct�� 17, 260, 265 Generics (UK) Ltd (t/a Mylan) v Warner-Lambert Co LLC [2016] EWCA Civ 1006, [2017] RPC 1 (13 October 2016)��242, 243, 244, 245, 246, 260, 265, 273, 274 Georgetown University v Octrooicentrum Nederland Case C-484/12 [2013] WLR (D) 487 (12 December 2013), CJEU�� 290, 291, 292 Geotechnics/Meeuwissen 02/1067 (16 April 2003), Rechtbank Den Haag��214 Gerber Garment Technology Inc v Lectra Systems Ltd [1997] RPC 443 (18 December 1996), CA��126 German Graphics Graphische Maschinen Case C-292/08 [2009] ECR I-8421 (10 September 2009), ECJ 330 Geschaftspolitik C-539/03 GRUR 2007 47 (13 July 2006), EuGH��338 Gesellschaft fur Antriebstechnik mBH & Co KG (GAT) v Lamellen und Kupplungsbau Beteiligungs KG (LuK), Dusseldorf Regional Court��332 Gilead Sciences and others v Mylan SAS 17/57112 (5 September 2017), TGI Paris��289 Gillette Safety Razor Co Ltd v Anglo American Trading Co Ltd (1913) 30 RPC 465, (3 September 1913), HL�� 29, 44, 81, 92, 93, 94, 96, 97, 109, 110, 199, 337 Giulini Chemie GmbH v Lambiotte Freres PIBD 1991, 493 III 76 (18 October 1990), Cour de Cassation, France�� 10 Glaxo Group Ltd v Vectura Ltd [2018] EWHC 3414 (Pat), (13 December 2018), Pat Ct�� 95 GlaxoSmithKline Biologicals SA v Comptroller-General of Patents [2013] EWHC 619 (Pat), [2013] RPC 26 (21 March 2013)��278 Glaxosmithkline Biologicals SA v Comptroller General of Patents, Designs and Trade Marks Case C-210/13, [2014] RPC 17 (14 November 2013), CJEU�� 278, 279, 280 GlaxoSmithKline UK Ltd (GSK) v Wyeth Holdings LLC [2017] EWHC 91 (Pat) (13 January 2017)��125

Table of Cases xxxix Glaxosmithkline UK Ltd v Wyeth Holdings LLC [2016] EWHC 1045 (Ch), (12 May 2016), Pat Ct�� 15 Glide-shoe arrangement for a variable-crown roll/VALMET T 92/92 (unpublished) (21 September 1993)��204 Glu-Gln (Celtrix/Correction of Errors) G11/91 [1993] EPOR 245 (19 November 1992) ��362 Go Sport v Time Sport International 11-10924 (31 January 2012), Cour de Cassation��184 Grimme v Steenvoorden (20 April 2010), Rechtbank Den Haag�� 71 Grimme Landmaschinenfabrik GmbH & Co KG v Scott (t/a Scotts Potato Machinery) [2010] EWCA Civ 1110, [2011] FSR 7 (15 October 2010)��4, 6, 69, 70 Grooved pully/AUBECQ AUXI T 478/91 (unpublished) (2 June 1993)��224 Groupe Vicard SA v Tonnellerie Ludonnaise SA 10-30907 (2 November 2011), Cour de Cassation��212 GUI layout/SAP T 1741/08 (unpublished) (2 August 2012)��141 Gummielastische Masse II X ZR 152/03 GRUR 2005 663 (22 March 2005), BGH��313 H Lundbeck A/S v Norpharma SPA [2011] EWHC 907 (Pat), [2011] RPC 23 (14 April 2011), Pat Ct��182, 183 H2O2/EVONIK T 608/12 (unpublished) (21 October 2014)��248 Haberman v Jackel International [1999] FSR 683 (15 January 1999), Pat Ct��215 Hair dye composition/KAO T 2017/07 (unpublished) (26 November 2009)��197 Hallen & Co v Brabantia (UK) Ltd [1991] RPC 195 (17 October 1990), CA�� 210, 226, 227 Halliburton Energy Services Inc’s Patent Applications [2011] EWHC 2508 (Pat), [2012] RPC 12 (5 October 2011), Pat Ct��163 Harnkatheterset I-2 U 126/09 (29 April 2010), OLG Dusseldorf��116 Haubenstretchautomat X ZR 173/02 GRUR 2007 679 (9 January 2007), BGH�� 69 Hearing aid/BOSCH T 109/82, [1984] OJ EPO 1984, 473 (15 May 1984)��224 Heated fuel line/PACCAR T 213/87 (unpublished) (8 July 1990)��218 Heating apparatus/THORN EMI T 110/92 (unpublished) (12 October 1994)��224 Hematopoietic receptor/ZYMOGENETICS T 898/05 (unpublished) (7 July 2006)��135, 136, 240, 261 Henderson v All Around the World Recordings Ltd [2014] EWHC 3087 (IPEC) (3 October 2014)��128 Henkel v Diversey [2001] BIE 2002/37, Rechtsbank Den Haag, Netherlands�� 9 Henkel/Diversey II BIE 2004, 8 (6 March 2002), Rechtbank Den Haag�� 71 Hepatitis A virus G2/93 [1995] OJ EPO 275 (21 December 1994)��360 Herbicides/ICI T 206/83 [1987] OJ EPO 5 26 March 1986��233 Hewlett-Packard v Digital Revolution 200.185.688/01 (23 May 2017) Gerichtshof Den Haag�� 90 Hewlett Packard GmbH v Agilent Technologies Deutschland GmbH 08/00882 (27 January 2010) Cour d’Appel, Paris�� 34 Hickman v Andrews [1983] RPC 147 (13 December 1977), CA�� 93

xl Table of Cases High density absorbent structures/PROCTOR & GAMBLE T 1054/92 (unpublished) (20 June 1996)��175 Highland Industries/Request for Reimbursement of appeal fee G3/03 [2005] EPOR 25 (28 January 2005)��357 HILTI 00-11857 (4 June 2002), Cour de Cassation��236 Hoechst Celanese Corp v BP Chemicals Ltd [1997] EWHC 370 (Pat), [1997] FSR 547 (6 February 1997), Pat Ct��217 Hoechst Marion Roussel v X 98-11.900 (21 November 2000), Cour de Cassation��311 Hogan Lovells International LLP v Bayer CropScience AG C-229/09 [2010] ECR I-11335 (11 November 2010), CJEU��294 Hospira UK Ltd v Genentech Inc [2014] EWHC 1094 (Pat) (10 April 2014), Pat Ct��184, 187, 252, 253, 262 Hot strip or heavy plate/THYSSEN STAHL T 153/88 (unpublished) (9 January 1991)��171 HTC Corp v Gemalto SA [2013] EWHC 1876, [2014] RPC 9 (10 July 2013), Pat Ct��178, 185 HTC Corp v Nokia Corp [2013] EWCA Civ 1759, [2014] RPC 31 (12 December 2013).��120 HTC Corp v Nokia Corp [2013] EWHC 3247 (Pat), [2014] RPC 19 (30 October 2013), Pat Ct�� 89 HTC Corp v Nokia Corp [2013] EWHC 3778 (Pat), [2014] RPC 30 (3 December 2013), Pat Ct��119 HTC Corp v Yozmot 33 Ltd [2010] EWHC 786 (Pat) (20 April 2010), Pat Ct��143 HTC Europe Co Ltd v Apple Inc [2013] EWCA Civ 451, [2013] RPC 30 (3 May 2013)��146 Huawei Technologies Co Ltd v Conversant Wireless Licensing SARL [2019] EWCA Civ 38 (30 January 2019)��343, 344 Huawei Technologies Co Ltd v ZTE Corp ZTE Deutschland GmbH Case C-170/13 ECLI:EU:C:2015:477 (16 July 2015), CJEU�� 99, 100, 101, 102, 103, 112 Huawei Technologies Co Ltd v ZTE Corp ZTE Deutschland GmbH Case C-170/13, Att-Gen’s opinion ECLI:EU:C:2014:2391 (20 November 2014)��103 Human Genome Sciences Inc v Eli Lilly & Co [2011] UKSC 51, [2012] RPC 6 (2 November 2011)��137, 150, 240, 261 Hupkens v Van Ginneken NJ 1995 136 (27 May 1994), Hoge Raad��312 Hutchison/Gomma Barre Thomas (10 March 2009), TGI Paris��212 Hybrid plants/LUBRIZOL T 320/87 [1990] OJ EPO 71 (10 November 1988)��154 Hydrofinishing/EXXON T 1014/92 (unpublished) (10 January 1995)��224 Hydrogen-absorbing composition/PRYSMIAN T 1464/05 (unpublished) (14 May 2009)��9, 203 Hydropyridin X ZB 4/83 GRUR 1983 729 (20 September 1983), BGH��188 I-15 U 135/14, LG Dusseldorf��119 I-15 U 65/15, LG Dusseldorf��119 Ian Alexander Shanks v Unilever Plc [2014] EWHC 1647 (Pat), [2014] RPC 29 (23 May 2014), Pat Ct��310

Table of Cases xli Icescape Ltd v Ice-World International BV [2018] EWCA Civ 2219, [2019] FSR 5 (10 October 2018)�� 22, 24, 25, 26, 34 ICI v Medicopharma 14795 NJ 1993/81 (18 December 1992), Hoge Raad�� 85 ICI/Medicopharma 14795 NJ 1993 735 (18 December 1992), Hoge Raad�� 85 ICOS v Teva, Sandoz, Mylan C-09-543070-KG ZA 17-1462 (5 December 2017), PI judge Rechtbank Den Haag��117 Idenix Pharmaceuticals Inc v Gilead Sciences Inc [2016] EWCA Civ 1089 (8 November 2016)��255 IG Farbenindustrie’s Patents (1930) 47 RPC 289 (2 July 1930), HL��180, 257 Ili Lilly/Fresenius Kabi C/09/541424/HA ZA 17-1097 (19 June 2019) Rechtbank Den Haag ��33, 41 Illumina Inc v Premaitha Health Plc [2017] EWHC 2930 (Pat) (21 November 2017), Pat Ct��140, 145 Image display device X ZR 41/11 GRUR 2014 251 (15 October 2013), BGH��176 Image rotating system having an arbitrary angle/MITSUBISHI T 190/94 (unpublished) (26 October 1995)��144 Immune-compromised patient/GLAXOSMITHKLINE T 1118/12 (unpublished) (1 March 2016)��170 Impact detection apparatus/BOARD OF TRUSTEES OPERATING MICHIGAN STATE UNIVERSITY T 955/90 (unpublished) (21 November 1991)�� 10 Impag v Hasbro NJ 2001, 602 (29 June 200), Hoge Raad��117 Implant for ligament reconstruction/MAYR (T 1117/14) (unpublished) (29 September 2015)�� 8 Improved gasket of elastomer material/GIAT T 1008/96 (unpublished) (25 June 2003)��184 Improved process for preparing polyarylates/AMOCO CORPORATION T 424/86 (unpublished) (11 August 1988)��169 Improver Corp v Remington Consumer Products Ltd [1990] FSR 181, (16 May 1989), Pat Ct�� 29 Inadmissible referral G3/95 [1996] OJ EPO 169 (27 November 1995)��358 Incyte Corp v Szellemi Tulajdon Nemzeti Hivatala Case C-492/16 ECLI:EU:C:2017:995 (20 December 2017), CJEU��297, 298 Industrias Alimentarias de Navarra, SA v Mivisa Envases, SA 263/2017 (3 May 2017), Spanish Supreme Court�� 69 INFINEUM G1/15 [2017] EPOR 14, [2017] OJ EPO Supplementary Publication 44 (29 November 2016)��186 Influenza vaccines/ABBOTT BIOLOGICALS T 967/09 (unpublished) (4 November 2014)��11, 233 Information management/NEC T 1054/05 (unpublished) (28 May 2008)��223 Inkrustierungsinhibitoren X ZR 40/95 GRUR 00 591 (7 December 1999), BGH��182 Inspection machine/KRONES T 779/02 (unpublished) (24 November 2004)��225 Institut Pasteur v Chiron Healthcare S 09-15668 (23 November 2010), Cour de Cassation�� 27 Interleukin 1/IMMUNEX CORPORATION T 767/95 (unpublished) (5 September 2000)��179

xlii Table of Cases Internal registration of gas/air/CAMTECH T 5/04 (unpublished) (17 January 2006)��157 International Stem Cell Corp v Comptroller General of Patents [2013] EWHC 807 (Ch), [2014] RPC 2 (17 April 2013), Pat Ct��153 International Stem Cell Corp v Comptroller General of Patents, Designs and Trade Marks Case C-364/13, [2015] RPC 19 (18 December 2014), CJEU��153 Internet citations/KONAMI T 1134/06 (unpublished) (16 January 2007)��177 Ion chamber/SCANDITRONIX T 56/87 [1990] OJ EPO 188 (20 September 1988)��169 Ionenanalyse, GRUR 1988, 896, BGH�� 28 Iontophoretic delivery device /ALZA CORPORATION T 26/98 (unpublished) (30 April 2002)�� 10 IPSEN/Pancreatic cells T 0578/06 (unpublished, 29 June 2011)��268 Isentress 3 LiQ 1/16 GRUR 2017 373 (31 August 2016), BpatG��323 Italian Corte Suprema di Cassazione No 5406 (12 June 1996)�� 69 Italian Supreme Court, No 22495 (16 October 2006)�� 72 JALON/Luminescent Security Fibres T 422/93 [1997] OJ EPO 24 (21 September 1995)�� 12 James Duncan Kelly, Kwok Wai Chiu v GE Healthcare Ltd [2009] EWHC 181 (Pat), [2009] RPC 12 (11 February 2009), Pat Ct��310 Jellification/EXXON T 119/82 [1984] OJ EPO 217 (12 December 1983)��225 Jørn Hansson v Jungpflanzen Grünewald GmbH Case C-481/14 ECLI:EU:C:2016:419 (9 June 2016), CJEU.��124, 127 JP Morgan Chase Bank NA v Berliner Verkehrbetriebe (BVG) Anstalt des Őfftenlichen Rechts [2010] EWCA Civ 390, [2012] QB 176 (28 April 2010)��339 Jushi Group Co Ltd v OCV Intellectual Capital LLC [2018] EWCA Civ 1416 (19 June 2018)��36, 183 Kaufler c Armor inox 05/14964 (20 September 2006), TGI Paris��105 KCI Licensing Inc v Smith & Nephew Plc [2010] EWHC 1487 (Pat), [2010] FSR 31 (23 June 2010) Pat Ct��16, 185 KCI Licensing Inc v Smith & Nephew Plc [2010] EWCA Civ 1260, [2011] FSR 8 (18 November 2010)�� 70 Kirin-Amgen Inc v Hoechst Marion Roussel Ltd [2004] UKHL 46, [2005] RPC 9 (21 October 2004)�� 21, 22, 249, 272 Kleiderbügel 128, 220, 223, BGH��317 Kleiderbügel X ZR 56/93 GRUR 1995 338 (20 December 1994), BGH��129 Klinische Versuche I X ZR 99/92 GRUR 1996 109 (11 July 1995), BGH�� 82, 84, 112 Klinische Versuche II X ZR 68/94 (17 April 1997), BGH�� 82, 84, 112 Koninklijke Philips NV v Asustek Computers Inc C/09/512839/HA ZA 16-712 (22 March 2017), Rechtbank Den Haag��103 Koninklijke Philips NV v Asustek Computers Inc C/09/515192/HA ZA 16-864 (27 September 2017), Rechtbank Den Haag��103 Koninklijke Philips NV v Wiko SAS C/09/508681/HA ZA 16-411 (18 October 2017), Rechtbank Den Haag��103 Kraft pulp preparation/METSO T 410/99 (unpublished) (20 January 2003)��169 Kunststoffrohrteil X ZR 43/01 GRUR 2002 511 (12 March 2002), BGH��28, 38

Table of Cases xliii L Steinhardt v Sté ISD environnement PIBD 2002, 742 III 217 (19 November 2001), Cour d’Appel de Paris, France��10, 18 L’Oreal Société Anonyme v Rn Ventures Ltd [2018] EWHC 173 (Pat), [2018] FSR 20 (5 February 2018).�� 34 L v Air Industrie Systemes 96/11140 (11 March 2003), TGI Paris��311 Lantana v Comptroller General of Patents [2013] EWHC 2673 (Pat), [2013] Info TLR 231 (4 September 2013), Pat Ct; [2014] EWCA Civ 1463, [2015] RPC 16 (13 November 2014), CA��146 Large-scale vehicle for passenger transport/SIEMENS T 1410/14 (unpublished) (14 October 2015)��173 Laufkranz X ZR 45/05 GRUR 2006 837 (3 May 2006), BGH�� 49 Lely/Delaval C06/054HR (7 September 2007) Hoge Raad, Netherlands�� 31 Leo Pharma v Sandoz 13/03763 (3 October 2014), Hoge Raad��214 LG Philips LCD Co Ltd v Tatung (UK) Ltd [2006] EWCA Civ 1774, [2007] RPC 21 (20 December 2006)��198 Lighting device and lighting method/CREE T 0378/12 (unpublished) (8 December 2016)��181 Lighting device/VDO ADOLF SCHINDLING T 324/94 (unpublished) (7 May 1996)��218 Limiting feature G1/93 [1994] OJ EPO 541 (2 February 1994).�� 194, 197, 362 Linco v Meijn (17 November 2010), Rechtbank Den Haag�� 97 Lincoln v Interlas NJ 1992/404 (24 November 1989), Hoge Raad��336 Liquid supplying system/CANON T 1811/13 (unpublished) (8 November 2016)��248 Liqwd Inc v L’Oreal (UK) Ltd [2018] EWHC 1394 (Pat) (11 June 2018), Pat Ct.�� 22, 168, 173, 175 Logikverifikation X ZB 11/98 GRUR 2000 498 (13 December 1999), BGH��147 Looijengoed v Dronrijp BIE 2010 19 (20 August 2010), Netherlands Patent Office.��148 L’Oreal SA v eBay International AG Case C-324/09 [2011] ECR I-6011 (12 July 2011), CJEU��118, 132 Low-emission emulsion paints/CLARIANT T 0231/97 (unpublished) (21 March 2000)��226 Lubrizol Corp v Esso Petroleum Co Ltd [1992] RPC 281 (1 November 1991), Pat Ct��104 Lubrizol Corp v Esso Petroleum Co Ltd [1997] RPC 195 (13 November 1996), Pat Ct��104 Lubrizol Corp v Esso Petroleum Co Ltd [1998] RPC 727 (30 April 1998), CA��104, 319 Lucasfilm Ltd v Ainsworth [2011] UKSC 39, [2011] FSR 41 (27 July 2011), SC��342 Luftheizgerät X ZR 176/98 GRUR 2001 228 (10 October 2000), BGH��67, 69 Luminescent security fibres/JALON 422/93 [1997] OJ EPO 25 (21 September 1995)�� 11 Lundbeck v Tiefenbacher 12/00888 (7 January 2013), Hoge Raad��214 Lundbeck SA/Sandoz BV 424154 – KG ZA 12-787 (14 August 2012), Rechtbank Den Haag��238

xliv Table of Cases Manoir Industries v Nexter Systems SA 10/10211 (12 October 2012), Cour d’Appel, Paris��309 Marek’s Disease Virus Vaccine/AMERICAN HOME PRODUCTS CORPORATION T 1137/97 (unpublished) (14 October 2002)��172 Marker/BEATTIE 603/89 603/89 [1992] OJ EPO 230 (3 July 1990).��140 MBI/Shimano, Berichten IE 2014/7–8173 (8 October 2014), Rechtbank Den Haag��31, 32 Mass selective ejection/FINNIGAN T 677/91 (unpublished) (3 November 1992)��170 Massachusetts Institute of Technology (MIT) Case C-431/04 [2006] ECR I-4089 (4 May 2006), ECJ��276, 277, 278, 279, 281 Meaning of terms used in patent documents/NGK INSULATORS T 1321/04 (unpublished) (28 February 2005)��169 Means for regulating plant growth/BAYER G 6/88 [1990] OJ EPO 114 (11 December 1989)�� 258, 359, 360 Medeva BV’s SPC Applications; sub nom Medeva BV v Comptroller General of Patents, Designs and Trade Marks v Case C-322/10 [2011] ECR I-12051, [2012] RPC 25 (24 November 2011), CJEU��283, 284, 292, 304 Medimmune Ltd v Novartis Pharmaceuticals UK Ltd [2011] EWHC 1669 (Pat) (05 July 2011)�� 52 Medinol v Abbott 13/00522 (4 April 2014)�� 31 Meijn Food Processing Technology v Tieleman Food Equipment et al KG RK 08-0517 (1 April 2008), Rechtbank Den Haag��117 Memory device/NATIONAL INSTITUTE OF ADVANCED INDUSTRIAL SCIENCE AND TECHNOLOGY T 2001/12 (unpublished) (29 January 2015)��233 Menashe Business Mercantile Ltd v William Hill Organization Ltd [2002] EWCA Civ 1702, [2003] RPC 31 (28 November 2002)�� 72 Merck v Ratiofarm (13 February 2008), Rechtbank Den Haag�� 93 Merck v Shionogi. See Isentress 3 LiQ (BPatG); Raltegravir (BGH) Merck v Stephar Case 187/80 [1981] ECR 2063, [1981] 3 CMLR 463, (14 July 1981), ECJ��111 Merck & Co v Primecrown Ltd Joined Cases C-267/95 and C-268/95 [1997] FSR 237, (5 December 1996), ECJ��88, 110 Merck Canada Inc v Accord Healthcare Ltd and Others Case C-555/13 ECLI:EU:C:2014:92 (13 February 2014)��296 Merck Canada Inc v Sigma Pharmaceuticals plc (No 2) [2013] EWPCC 21, [2013] RPC 2 (3 May 2012), Pat Cty Ct; upheld [2013] EWCA Civ 326, [2013] RPC 35 (18 April 2013)��132 Merck Sharp & Dohme Corp v Deutsches Patent und Markenamt Case C-125/10 [2011] ECR I-12987 (8 December 2011), CJEU��295, 296 Merck Sharp & Dohme Corp v Comptroller-General of Patents, Designs and Trade Marks [2016] EWHC 1896 (Pat), [2017] RPC 2 (29 July 20106)��297 Merck Sharp & Dohme Corp (‘MSD’) v Comptroller-General of Patents, Designs and Trade Marks Case C-567/16 [2018] RPC 9 (7 December 2017), CJEU��296, 297

Table of Cases xlv Merck Sharp & Dohme Corp v Teva Pharma 15/04934 (3 November 2017), Hoge Raad�� 66 Merck Sharp Dohme Corp v Teva Pharma BV [2012] EWHC 627 (Pat), [2012] FSR 24 (15 March 2012)�� 48, 114, 115 Merck Sharp & Dohme Ltd v Ono Pharmaceutical Co Ltd; Bristol Myers Squibb Co v Merck & Co Inc [2015] EWHC 2973 (Pat), [2016] RPC 10 (22 October 1015), Pat Ct��171, 262 Merck Sharp And Dohme Ltd v Shionogi & Co Ltd [2016] EWHC 2989 (Pat) (25 November 2016)��255 Merck/Teva 10/23603 (30 January 2015), Cour d’Appel Paris��236 Merrell Dow Pharmaceuticals Inc v HN Norton & Co Ltd [1995] UKHL 14, [1996] RPC 76, (26 October 1995), HL��3, 44, 173, 192, 199 Metal-containing transaction card and method of making the same/AMERICAN EXPRESS TRAVEL RELATED SERVICES COMPANY INC T 519/12 (unpublished) (17 March 2017)�� 13 Metal refining/BASF T 24/81 [1983] OJ EPO 133 (13 October 1982)��202, 225 Method and apparatus for a mail processing system T 0986/96 (unpublished) (10 August 2000)�� 10 Method and apparatus for increasing the service life of aircraft multiple disc brakes/DUNLOP T 95/97 (unpublished) (18 March 1999)��170 Method for creating dictation macros/NUANCE T 526/12 (unpublished) (31 August 2015)��171 Method for fabricating a dental appliance/ALIGN TECHNOLOGY INC T 0015/15 (unpublished) (16 March 2017)�� 10 Method for magnetic resonance imaging/PRINCE T 663/02 (unpublished) (17 March 2011)��157 Method of producing a piston through casting/TOYOTA JIDOSHA KABUSHIKI KAISHA T 0151/05 (unpublished) (22 November 2007)�� 14 Method of supplementing animals with carotenoids by drinking water/ZHEJIANG MEDICINE CO T 1000/12 (unpublished) (17 December 2013)�� 14 Methods and systems for effecting payment card transactions/EUROPEAN TAX FREE SHOPPING LIMITED T 384/07 (unpublished) (8 September 2009)��139 Meyn/Stork NJ 1989/506 (27 January 1989) Hoge Raad, Netherlands�� 31 miR-1/MAX-PLANCK-GESELLSCHAFT T 1285/13 (unpublished) (20 October 2016)��136 Missing publication number/GENERAL ELECTRIC T 737/90 (unpublished) (9 September 1993)��195, 233 MOBIL OIL/Friction reducing additives G2/88 93, 469 [1990] OJ EPO 93, [1990] EPOR 73 (11 December 1989).�� 191, 192, 193 Mobile Sanitary Solutions BV v TWT Verhuur, BV 200.222.873/01 (28 May 2019), Gerechtshof Den Haag��214 Modifying plant cells/ MYCOGEN PLANT SCIENCE 694/92 [1997] OJ EPO 408 (8 May 1996)�� 11 Monsanto Co v Stauffer Chemical Co [1985] RPC 515, (11 June 1985), CA��82, 83

xlvi Table of Cases Monsanto Technology v Cefetra (Case C-428/08) [2010] ECR I-06765 (6 July 2010), CJEU�� 62 Monsanto Technology LLC v Cargill International SA [2006] EWHC 2864 (Pat), (2007) 30(3) IPD 30018 (13 November 2006)�� 52 MP2-Geräten 6 U 34/12 GRUR 2014, 59 (8 May 2013), OLG Karlsruhe�� 72 MPEG2-Standard VIII I-2 U 124/08 (28 January 2010), OLG Dusseldorf��51, 90 MPEG2 Videosignalcodierung X ZR 33/10 (21 August 2012), BGH�� 66 Mr L v Publicis Groupe & RATP 10/21790 (28 June 2013), Cour d’Appel de Paris��147 Mr Y v Company Y 98-11580 (24 October 2000), Cour de Cassation��127 MSD v Teva 200.082.008/02 (14 July 2015), Gerechtshof Den Haag�� 62 MSD v Teva 15/04934 (3 November 2017) (Ribavirin Case), Hoge Raad�� 61, 62, 76, 80, 188 Multilayer polyurethane protective films T 2068/15 (unpublished) (25 January 2017)��175 Mundipharma-Grunenthal/Mylan cases (21 July 2008, 20 October 2009 and 27 September 2012), France�� 59 Mundipharma Laboratories GmbH v Medochemie Ltd 2008/01373 (21 July 2008), TGI Lyon��115 Mylan v Astrazeneca,15/05880 (1 July 2016), TGI Paris��263 Mylan v Lilli and Icos 16/05073 (5 April 2018), TGI Paris��190 Mylan SAS; Generics (UK) Ltd v Warner-Lambert Co LLC 14/14370 (8 July 2016), TGI Paris��246 Napp v Asta Medica [1999] FSR 370 (23 October 1998), Patents Ct�� 77 Napp Pharmaceuticals Holdings Ltd v Dr Reddy’s Laboratories (UK) Ltd [2016] EWHC 1517 (Pat), [2017] RPC 4 (28 June 2016)��36, 48 National prior right/MOBIL T550/88 [1992] OJ EPO 117 (27 March 1990)��165 Navcom v Philips [2000] BIE 2001/3 (26 April 2000), Rechtbank��236 Nestec SA v Dualit Ltd [2013] EWHC 923 (Pat), [2013] RPC 32 (22 April 2013), Pat Ct.�� 66, 67, 186 Neurim Pharmaceuticals (1991) Ltd v Comptroller-General of Patents [2010] EWHC 976 (Pat), [2010] RPC 22, (6 May 2010), Pat Ct��277 Neurim Pharmaceuticals (1991) Ltd v Comptroller-General of Patents Case C-130/11 [2012] ECR I-0000, [2013] RPC 23 (19 July 2012), CJEU��277, 278, 281, 282, 294 Newell Rubbermaid v Vermop 200.094.832-01 + 200.094.837-01 + 200.072.139-01 (25 February 2014), Gerechtshof Den Haag��197 Nikon Corp v ASML Holding C/09/537395/HA ZA 17-848 (18 July 2018), Rechtbank Den Haag��103 Nikon v ASML (1 August 2018), Rechtbank Den Haag��336 NJOZ 2009, 1458 – ‘Unterlassungsanspruche einer Patentverwertungsgesellschaft’, LG Mannheim��119 Notlaschenverbinder I-2 U 72/11 (4 April 2013), OLG Dusseldorf��313 Novartis v EG LABO 11/52706 (5 April 2011), TGI Paris�� 48 Novartis v Mylan and Qualimed 11/12942 (21 March 2012), Cour d’Appel, France��115, 116

Table of Cases xlvii Novartis v Sun 200.150.713/01 (27 January 2015), Gerechtshof Den Haag.�� 61 Novartis v Teva C/09/500844/KG ZA 15-1829 (30 March 2016), Rechtbank Den Haag��337 Novartis AG v Generics (UK) Ltd [2012] EWCA Civ 1623 (12 December 2012)��209 Novartis AG v Hospira UK Ltd [2013] EWHC 1285 (Pat) (14 May 2013)��115 Novartis AG v Hospira UK Ltd [2013] EWCA Civ 583, [2014] RPC 3 (22 May 2013)��115 Novartis AG v Mylan, 11/12942 (21 March 2012), Cour d’Appel Paris��181 Novartis AG v Sun Pharmaceutical Industries (Europe) BV C/09/460540/KG ZA 14-1 (27 January 2015), Gerechtshof Den Haag��75, 76, 80 Novartis AG v Comptroller General of Patents, Designs and Trade Marks C-207/03; Millenium Pharmaceuticals C- 252/03, Joined Cases [2005] ECR I-03209 (21 April 2005), ECJ��293 NovogenResearch/Care for Women 105.004.393/01 (3 July 2008), Gerechtshof Den Haag��214 Novozymes v DSM [2010] B9 884 (17 February 2010), Rechtbank Den Haag�� 237, 238, 239 Oberster Gerichtshof 4 Ob 17/15a (22 September 2015), Austria��201 Obsessive-compulsive-disorder/PFIZER T 158/96 (unpublished) (28 October 1998)�� 258, 259, 268 Occhio v Malvern RG A/09/663 (21 February 2013, Tribunal de Commerce Mons, Belgium��248, 249 Okklusionsvorrichtung X ZR 16/09 GRUR 2011 701(10 May 2011), BGH��30, 40 Olanzapin X ZR 89/07 GRUR 2009 382 (16 December 2008), BGH��180, 213 Oliver Brüstle v Greenpeace eV C-34/10 [2011] ECR I-09821 (18 October 2011), CJEU�� 152, 153, 161 Omnipharm Ltd v Merial [2011] EWHC 3393 (Pat) (21 December 2011), Pat Ct��252 On-demand instantiation/RAYTHEON T 1742/12 (unpublished) (22 June 2016)��203 Onco-Mouse/HARVARD T 19/90 [1990] OJ EPO 476 (3 October 1990).��151, 154 Ono v MSD 16/51152 (15 March 2016), TGI Paris�� 86 Opinion 1/92 [1992] ECR I-02821 (10 April 1992)��352 Opinion 1/00 [2002] ECR I-03493 (18 April 2002).��352 Opinion of the Court (Full Court), Opinion 1/09, ECLI:EU:C:2011:123, (8 March 2011)�� 351, 352, 353 Optical sensor devie /CNOGA T 623/13 (unpublished) (1 December 2016)��247 Optical system/KONINKLIJKE PHILIPS ELECTRONICS T 471/05 (unpublished) (6 February 2007)��140 Oral Decision of 5 December 2018 T 1063/18, TBA; G3/19 referral pending, EBA��155, 156 Orange Book, Germany��103 Orange/Freebox 14/05735 (18 June 2015), TGI Paris��147 Order of the case management judge, 3rd chamber 1st section, docket No 16/1596 (7 June 2018), France��116

xlviii Table of Cases Order of the case management judge, 3rd chamber 2nd section, docket No 17/15019 (6 July 2018), France��116 Preliminary injunction order, 3rd chamber 4th section, docket No 18/60334 (11 January 2019), France��116 Organic light emitting devices/PRINCETON UNIVERSITY T 0544/12 (unpublished) 22 November 2013��239 Oriented grained Y-Ba-Cu-O superconductors/UNIVERSITY OF HOUSTON T 517/98 (unpublished) (17 January 2002)��234 Orion-Novartis v Eurogenerics A/15/0430 (9 May 2017), Tribunal de Commerce of Brussels��201 Outer membrane protein immunogen Neisseria/GLAXOSMITHKLINE T 1581/12 (unpublished) (15 September 2016)��179 Paclitaxel freisetzender Stent 14 W (pat) 13/16 GRUR 2018, 64 (18 July 2017), BPat G��294, 295 Palettenbehälter II X ZR 97/11 (July 2012), BGH�� 49 Pall Corp v Commercial Hydraulics [1990] FSR 329 (25 July 1989), Pat Ct��173, 174 Pall Corp v Commercial Hydraulics (Bedford) Ltd [1989] RPC 703 (7 November 1988), CA��175 Palmaz’s European Patents [1999] RPC 47 (26 June 1998), Pat Ct��198 Paris Cour d’Appel 2000/15216 (10 October 2003)��314 Partial Priority/INFINEUM T 0557/13 (unpublished) (17 July 2015)��186 Partial Priority/INFINEUM T 0557b/13 (unpublished) (17 July 2015)��186 Particulate detergent composition/ UNILEVER T606/89 (unpublished) (18 September 1990)��201, 203 Paul Robert v Administrator of CF Gomma Barre, T12-14.803 (13 November 2013), Cour de Cassation��236 Pedestrian simulation/CONNOR T 0489/14 (22 February 2019).�� 145, 221, 222 Pemetrexed X ZR 29/15 GRUR 2016 921 (14 June 2016), BGH�� 30, 35, 40, 75, 80 Pemetrexeddinatrium 4b O 114/12 U (3 April 2014), LG Dusseldorf��39, 40 Pemetrexeddinatrium I-2 U 16/14 (5 March 2015), OLG Dusseldorf�� 40 Pencil sharpener T 176/84 [1986] OJ EPO 50 (22 November 1985)�� 10 Penem derivatives/PFIZER T 1048/92 (unpublished) (5 December 1994)��179 Perception of Fatigue/MIT T 469/94 (unpublished) (1 July 1997)��158 Pfizer v F Hoffmann La-Roche [2019] EWHC 1520 (Pat) (20 June 2019), Pat Ct�� 96 Pfizer v Sintex 86-19.521 (13 December 1988), Cour de Cassation�� 53 Pfizer Ireland Pharmaceuticals, Operations Support Group v Orifarm GmbH Case C-681/16, ECLI:EU:C:2018:484 (21 June 2018)��299, 300 Pfizer Ltd v Biogaran, Sanofi et al. 16/57469 (2 December 2016), TGI Paris��316 Pfizer Ltd/Chemo Iberica AC 2002/235 (12 June 2001), Barcelona CA�� 66 Pharmaceutical Price Index 4Ob54/12p (12 June 2012), Oberster Gerichtshof, Austria�� 47 Pharmachemie/Glaxo 11/01662 (22 June 2012), Hoge Raad�� 47 Pharmacia Corp v Merck & Co Inc [2001] EWCA Civ 1610, [2002] RPC 41 (14 December 2001), CA��235

Table of Cases xlix Pharmacia Italia SpA v Deutsches Patentamt Case C-31/03 [2004] ECR I-10001, [2005] RPC 27 (19 October 2004), ECJ��281 Philips v Tasseron IEF 12127, NJ 1930/1217, NJ 1930/1219 (20 June 1930), Hoge Raad, Netherlands��30, 106 Philips/SK Kasseten, Netherlands��103 Phosphorodithioates/LUBRIZOL T68/93 (unpublished) (24 January 1995)��169 Photocatalytic concrete/ITALCEMENTI SPA T 1513/11 (unpublished) (25 July 2016)��173 Photovoltaic module/KANEKA CORPORATION T 1829/06 (unpublished) (10 November 2009)��174 PIBD 1997, 644-III-633 (17 September 1997), Cour d’Appel Paris��176 Pioneer Electronics Capital Inc v Warner Music Manufacturing Europe GmbH [1995] RPC 487 (27 July 1995), Patents Ct�� 52 Pipettensystem X ZR 38/06 GRUR 2007 769 (27 February 2007), BGH��49, 66, 67 Plant cells/PLANT GENETIC SYSTEMS T 356/93 [1995] OJ EPO 545 (21 February 1995)�� 151, 154, 156 Plant for transmitting electric power/ABB T 473/13 (unpublished) (11 May 2016)��175 Plasmid pTR2030/NORTH CAROLINA STATE UNIVERSITY T 576/91 (unpublished) (18 May 1993)��174 Plasterboard production/BAYER T 602/91 (unpublished) (13 September 1994)��175 Plastus Kreativ AB v Minnesota Mining & Manufacturing Co [1995] RPC 438, (9 December 1994), Pat Ct��341 PLG Research Ltd v Ardon International Ltd [1995] RPC 287, [1995] FSR 116 (16 November 1994), CA��206, 217 Plymouth v Samex 02-21585 (28 April 2004), Cour de Cassation��319 Polycarbonate resin composition/GE PLASTICS T 62/05 (unpublished) (14 November 2006)��184 Polyether-based preparations/3M T 0260/14 (unpublished) (13 April 2017)��186 Polyethylene terephthalate resin-coated metal plate/ TOYO KOHAN T 0593/09 (unpublished) (20 December 2011)��247 Polyferon X ZR 26/92 GRUR 1996 190 (5 December 1995), BGH��323 Polymer Composition X ZR 134/11 (12 December 2012), BGH�� 14 Polymerisationsbeschleuniger Ia ZR 152/63 GRUR 1965 138 (5 November 1964), BGH��236 Polymerschaum X ZR 117/11GRUR 2012 1124 (17 July 2012), BGH��184 Polypeptide expression/GENENTECH I T 292/85 [1989] OJ EPO 275 (27 January 1988)��233, 235 Polyurethane coating materials T 742/89 (unpublished) (2 November 1992).��272 Portal system/ACCENTURE T 528/07 (unpublished) (27 April 2010)��141 Potez c Airflam Ann. PI 1966.54 (7 November 1966) Cour d’Appel Paris,��105 Power supply unit/TELEMECHANIQUE T 482/89 [1992] OJ EPO 646 (11 December 1990)��174 Pozzoli Spa v BDMO SA [2007] EWCA Civ 588, [2007] FSR 37 (22 June 2007), CA��206, 210, 225, 230 Pregabalin 327 0 67/12 (2 April 2015), LG Hamburg��74, 75

l Table of Cases Presentation of operating instructions/GAMBRO T 336/14 (unpublished) (2 September 2015)��141 Prior use/PACKARD INSTRUMENT T 952/92 [1995] OJ EPO 755 (17 August 1994)��173 Priority interval G3/93 [1995] OJ EPO 18 (16 August 1994)�� 359, 361, 362 Process and catalyst for polyolefin density and molecular weight control/EXXONMOBIL T 314/99 (unpublished) (21 June 2001)��172 Process for dosing an additive into a fuel/ INNOSPEC LIMITED T 1989/08 (unpublished) (21 July 2010)��225 Process for manufacturing a composite workpiece/ARCELORMITTAL T 146/13 (unpublished) (30 January 2015)��171 Process for preparing polycarbonates/GENERAL ELECTRIC COMPANY T 0786/00 (unpublished) (19 December 2001)�� 13 Process for the production of pre-foamed particles/JAPAN STYRENE T 444/88 (unpublished) (9 May 1990)��171 Productores de Musica de Espana (Promusicae) v Telefonica de Espana SAU Case C-275/06 [2008] ECR I-271 (29 January 2008), ECJ��118 Programs for Computers/Referral by the President of the EPO G3/08 [2011] OJ EPO 10 (16 October 2009)�� 144, 219, 358 Propylene-ethylene copolymers/BASELL T 0089/13 (unpublished) (3 May 2016)��247 Prudential Assurance Co Ltd v Prudential Insurance Co of America [2003] EWCA Civ 327, [2004] FSR 25 (12 March 2003)��339 Public availability/HYDRO-QUEBEC T 834/09 (unpublished) (2 February 2012)��172 Pyrazolopyrimidinones for the treatment of impotence/PFIZER LIMITED T 1212/01 (unpublished) (3 February 2005)��224 Quantum v DMS C/09/526366/KG ZA 17-154 (13 June 2017), Rechtbank Den Haag�� 35 Quetiapine X ZR 41/13 (13 January 2015), Fed Ct of Justice, Germany��229 Radial tyre/SUMITOMO T 676/94 (unpublished) (6 February 1996)�� 16 Railroad line bed/INDUSTRIA PREFABRICATI T 0605/91 (unpublished) (20 July 1993)��224 Raloxifene Case. See Eli Lilly v Teva Sante Raltegravir X ZB 2/17 GRUR 2017 1017 (11 July 2017), BGH��323, 324 Ranbaxy (UK) Ltd v AstraZeneca AB [2011] EWHC 1831 (Pat), [2011] FSR 45 (15 July 2011)�� 52 RDPI 1998 86 (16 January 1998), Cour d’Appel, Paris��176 Reach-through claim T 1063/06 [2009] OJ EPO 516 (3 February 2009)��239 Reaction injection moulded polyurethane elastomers/TEXACO T 279/89 (unpublished) (3 July 1991)��181 Reactivity of exhaust products/ETHYL CORPORATION T717/98 (unpublished) (4 November 2002)��167 Realchemie Nederland Case C-406/09 [2011] ECR I-9773 (18 October 2011), ECJ.��330 Redox Catalyst/ AIR PRODUCTS T171/84 [1986] OJ EPO 95 (24 October 1985)�� 16

Table of Cases li Reduced-viscocity concentrated protein formulations/GENENTECH T 99/13 (unpublished) (14 January 2016)��195 Referral by the President of the EPO. See Programs for Computers Reformatio in peius/3M G01/99 [2001] EPOR 50 (3 April 2001)��362 Regeneron Pharmaceuticals Inc v Kymab Ltd & Novo Nordisk A/S [2018] EWCA Civ 671, [2018] RPC 14 (28 March 2018).��121, 122 Regeneron Pharmaceuticals Inc and Bayer Pharma AG v Genentech Inc [2012] EWHC 657 (Pat), (2012) 109(25) LSG 19 (22 March 2012)��259 Regeneron Pharmaceuticals Inc and Bayer Pharma AG v Genentech Inc [2013] EWCA Civ 93, [2013] RPC 28 (21 February 2013)�� 242, 259, 260, 263, 264 Relative dimensions in drawings/KIRCHNER T 2052/14 (unpublished) (24 June 2016)��169 Respiratory function of a mammal/AEROCRINE T 0125/02 (unpublished) (23May 2006)��161 Ribavirin 4a 0 12/03 GRUR-RR 2004 193 (24 February 2004), LG Dusseldorf��60, 74 Richter v HRA Pharma and Mylan 15/16651 (2 March 2018), Cour d’Appel, Paris��190 Richter Gedeon Vegyeszeti Gyar RT v Generics (UK) Ltd (t/a Mylan) [2016] EWCA Civ 410 (26 April 2016)�� 16 Rider/Simethicone T 2/83 [1984] OJ EPO 265 (15 March 1984)��202, 223 Riluzol 4b O 135/12 (19 October 2012), OLG Dusseldorf.��116 Roche v Primus II C02/228HR en C02/280HR (30 November 2007), Hoge Raad��336 Roche Nederland v Frederick Primus & Milton Goldenberg Case C-539/03 ECLI:EU:C:2005:749, (8 December 2005), Ad-Gen’s Opinion��334 Roche Nederland v Frederick Primus & Milton Goldenberg Case C-539/03 [2006] ECR I-06535 (13 July 2006), ECJ�� 333, 334, 335, 339, 344, 345 Rockwater Ltd v Technip France SA [2004] EWCA Civ 381, [2004] RPC 46 (1 April 2004)�� 8 Rockwool/Isover C06/021HR (15 February 2008), Hoge Raad��214, 223 Routenplanung X ZR 3/12 (18 December 2012), BGH��223 Rubber composition/BRIDGESTONE T 1994/12 (unpublished) (19 April 2016)��232 S (Alain) v Bosch Systemes de Freinage (Sté) (12 September 2003) Cour d’Appel, Paris��308 SA FN Herstal v Heckler & Koch GmbH (28 April 2017), Tribunal de Commerce Francophone de Bruxelles��223 SA Multy Pack v Société Sacchettificio Lima 03/12470 (5 November 2004), TGI Paris�� 67 SA Pellenc v SA Extrussion de Basse Normandie Exbanor 16/23925 (9 February 2018), Cour d’Appel, Paris��123 SA Publi Embal v Société Coprima, 06/05136 (3 December 2018), Cour d’Appel Rennes�� 67 Sabaf Spa v MFI Furniture Centres [2002] EWCA Civ 976, [2003] RPC 14 (11 July 2002)�� 77

lii Table of Cases Saint Gobain v Knauf 09-13464 (9 December 2001), TGI Paris�� 37 Saint Gobain v Knauf 12/06678 (16 May 2014), Cour d’Appel, Paris �� 37 Saint-Gobain PAM SA v Fusion Provida Ltd [2005] EWCA Civ 177, (2005) 28(6) IPD 28043, (25 February 2005), CA��207 Sample holder for secondary ion mass spectrometry/SIEMANS T 551/89 (unpublished) (20 March 1990)��226 Samsung Electronics (UK) Ltd v Apple Inc [2012] EWHC 2049 (Pat) (18 July 2012), Pat Ct��130 Samsung Electronics (UK) Ltd v Apple Inc [2012] EWCA Civ 1339, [2013] FSR 9 (18 October 2012)��130 Sandoz v Eli Lilly 10/17727 (13 January 2012) Cour d’Appel de Paris�� 14 Sandoz Ltd v GD Searle LLC [2017] EWHC 987 (Pat), [2019] ECC 3 (3 May 2017), Pat Ct�� 285, 289, 290 Sandoz Ltd v GD Searle LLC [2018] EWCA Civ 49 (25 January 2018)��290 Sandvik Intellectual Property AB v Kennametal UK Ltd, Kennametal Europe GMBH [2011] EWHC 3311 (Pat), [2012] RPC 23 (15 December 2011)��249 Sanofi v Amgen 3 LiQ 1/18 (6 and 7 September 2018), BPatG��324 Sanofi v Amgen, X ZB 2/19 (4 June 2019), BGH��324 Santen v Director of the French Patent Office Case C-673/18 (pending), CJEU��277 Sara Lee v Integro, Dutch Supreme Ct�� 66 Sarl Filtech v Société Rupofil 00/04626 (19 September 2002), Cour d’Appel, Lyon�� 67 SAS Sandoz v Eli Lilly and Company 10/17727 (13 January 2012), Cour d’Appel Paris��212 SAS Santed v INPI 17/19934 (9 October 2018), Cour d’Appel��278 SAS Techip France v SA ITP 10-27413 (13 December 2011), Cour de Cassation�� 11 Satellite broadcast recording/SONY T 55/01 (unpublished) (11 February 2003)��171 Saturated dicarboxylic acids/COGNIS T 1014/07 (unpublished) (2 July 2012)��223 SBM v Bluewater 259706/HA ZA 06-544 (11 April 2007) Rechtbank Den Haag�� 72 SCA Tissue France SAS v Industrie Cartarie Tronchetti Iberica SL 84/2018 (26 March 2018), Barcelona Commercial Court No 1��13, 200 Scarlet Extended SA v Société Belge des Auteurs, Composituers et Editeurs (SABAM) Case C-70/10 [2011] ECR I-11959 (24 November 2011), CJEU��118 Schering-Plough Ltd v Norbrook Laboratories Ltd [2005] EWHC 2532 (Ch), [2006] FSR 18 (18 November 2005), Pat Ct��226 Schindler v Otis 1143 of (27 January 2014), Tribunale di Milano��341 Schlumberger Holdings Ltd v Electromagnetic Geoservices AS [2010] EWCA Civ 819, [2010] RPC 33 (28 July 2010)�� 11 Schlusselpaarberechnung/GIESECKE & DEVRIENT T 1326/06 (unpublished) (30 November 2010)��140 Schmierfettzusammernsetzung X ZR 168/96 GRUR 2000 296 (30 September 1999), BGH��180 Schneider/Cordis, BIE 2007/13 (8 June 2005), Rechtbank Den Haag��106 Schneidmesser II X ZR 135/01 GRUR 2002 519 (12 March 2002), BGH��28, 38, 40 Schneidmesser l X ZR 168/00 GRUR 2002, 515, BGH ��28, 29, 40 Schutz (UK) Ltd v Werit (UK) Ltd [2013] UKSC 16, [2013] RPC 16 (13 March 2013)��4, 50

Table of Cases liii Science Union, Servier v Corbiere et Bellon (27 November 1984) (Dioriven Case), Cour d’Appel, Paris, 4e ch�� 83 Scope of Article 55(1) EPC G3/98 [2001] OJ EPO 62 (12 July 2000)�� 359, 360, 362 Searle v Sandoz C/09/561999/KG ZA 18-1112 (1 November 2018) PI judge Rechtbank Den Haag��117 Seattle Genetics Inc v Osterreichisches Patentamt Case C-471/14, ECLI:EU:C:2015:659 (6 October 2015), CJEU��297, 298 Second medical indication/BAYER G1/83 [1985] OJ EPO 60 (5 December 1984)��156 Second medical indication/EISAI G5/83 [1985] OJ EPO 64 [1979–85] EPOR B241 (5 December 1984)��156, 158, 159, 160 Second medical indication/EISAI G 6/83 [1985] OJ EPO 67 (5 December 1984)��156 Secure buffering/BROADCOM CORPORATION T 1030/06 (unpublished) (17 December 2008)�� 9 Securing access to a digital resource/BOUYGUES T 286/10 (unpublished) (21 May 2014)��178 Selecting psychotropic medications/MAYO FOUNDATION 0758/12 (unpublished) (4 July 2017)��140, 141 Sepracor Inc v Hoechst Marion Roussel Ltd [1999] FSR 746 (29 January 1999), Pat Ct��342 Serine protease inhibitors/AMGEN T 429/96 (unpublished) (31 May 2001)��233 Serotonin receptor/ELI LILLY T 241/95 [2001] OJ EPO 103 (14 June 2000)�� 259, 267, 268 Setting accelerator/SIKA T 897/07 (unpublished) (3 May 2011)��174 Shear/GREHAL T 305/87 [1991] OJ EPO 429 (1 September 1989)��165 Shopping with mobile device/NOKIA T 1670/07 (unpublished) (11 July 2013)��220 Signal vision c Axo 14 258/86 (3 July 2014), CFI Paris��105 Silver catalyst/SD T 0764/14 (unpublished) (11 November 2015)��247 Simethicone Tablet/RIDER T 2/83 [1984] OJ EPO 265 (15 March 1984)��202, 223 Simethicone Tablet/RIDER T 37/85 [1988] OJ EPO 86 (15 March 1984)��223 Simvastatin X ZR 76/05 (5 December 2006), BGH�� 47 Sisvel v Haier I-15 U 65/15 (30 March 2017), OLG Dusseldorf��102 Sitagliptin III,14W (pat) 12/17 (17 October 2017), BpatG��285 Smith & Nephew v Convatec Technologies Inc [2013] EWHC 3955 (Pat), [2014] RPC 22 (12 December 2013), Pat Ct��122, 132 Smith & Nephew v ConvaTech Technologies Inc [2015] EWCA Civ 607, [2015] RPC 32 (24 June 2015).�� 35, 36, 122 Smithkline Beecham Plc v Apotex Europe Ltd [2003] EWCA Civ 137, [2003] FSR 31 (14 February 2003)��47, 114 Société Apotex France and Société Apotex Inc v Wellcome Foundation Ltd, PIBD 2001 III 429 (15 September 2000), Cour d’Appel, Paris��188 Société Clinipro v General Hospital Corp and Société Zeltiq Aesthetics Inc, 13-13050 (12 January 2016), Paris Court of Appeal��193 Société EVINERUDE 10/14406 (3 July 2014), TGI Paris��140 Société Guy La Roche v 4 Every Ware Stocklots BV ECLI:NL:RBDHA:2016: 10887 (14 September 2016), Rechtbank den Haag�� 89

liv Table of Cases Société Instrumentation Laboratory Spa 05/07419 (21 November 2006), TGI Paris��314 Société KONE 2007/20589 (5 June 2009), Cour d’Appel de Paris��147 Société Robotswim, Sarl v Société Auchan France 16/20760 (3 July 2018), Cour d’Appel, Paris��123 Société ZA v Société FG, 14/13942 (8 December 2016), TGI Paris ��123 Software structure/TRILOGY T 1755/10 (unpublished) (6 November 2014)��221 Solvay SA v Honeywell Fluorine Products Europe BV and Others Case C-616/10 ECLI:EU:C:2012:445 (12 July 2012), CJEU��118, 332, 334, 335, 338, 344, 345 Solvay SA v Honeywell Fluorine Products Europe BV 342164/HA ZA 09-2275 (22 December 2010), Rechtbank Den Haag��118, 335 Sortenschutzrechts, Hohe der Verletzervergutung, I-15 U 21/14 (16 October 2014), OLG Dusseldorf��124 Space-filling miniature antennas/FRACTUS T 667/08 (unpublished) (20 April 2012)��195 Spannschraube X ZR 85/96 GRUR 1999 909 (2 March 1999), BGH��250 Spiliada Maritime Corp v Cansulex Ltd [1986] UKHL 10, [1987] AC 460 (19 November 1986), HL��341 Spiro compounds/CIBA GEIGY T 181/82 [1984] OJ EPO 401 (28 February 1984)��223 Sprachanalyseeinrichtung X ZB 15/98 GRUR 2000 1007 (11 May 2000), BGH��147 Stable bleaches/UNILEVER T 226/85 [1988] OJ EPO 336 (17 March 1987)��233 Starsight v Numericable, docket No 10/08326 (7 June 2013), GI Paris.��142, 143 Starting compounds/MERCK OJ [1991] EPO 177, T 0051/87 (8 December 1988)�� 13 Sté EFSA v Gerard CECCHI PIBD 1995 III, 320 (14 April 1995), Cour d’Appel Paris��212 Sté Robert Bosch GmbH v SA ets Guillet PIBD 1996, 602 III 34 (17 October 1995), Cour de Cassation, France��9, 10 Stoβwellen-Lithotripter XZR 115/96 GRUR 1999, 145 (12 May 1998), BGH, Germany��10, 226 Stowarzyszenie ‘Olawska Telewizja Kablowa’ v Stowarzyszenie Filmowcow Polskich C-367/15 ECLI:EU:C:2017:36 (25 January 2017), CJEU��124 Streaming to a game console/MICROSOFT T 2172/13 (unpublished) (7 September 2016)��220 Streit um Truvada 7 O 11152/17 (17 August 2017), LG München��289 Styrene-based resin composition/IDEMITSU T 0172/99 (unpublished) (7 March 2002)��234 Suche fehlerhafter Zeichenketten X ZB 16/00 GRUR 2002 143 (17 October 2001), BGH��147 Sumitomo Chemical Co Ltd v Deutsches Patent und Markenamt C-210/12 ECLI:EU:C:2013:665 (17 October 2013), CJEU��294 Sun v Novartis C/09/469148/HA ZA 14-770 (5 April 2017), Gerechtshof Den Haag�� 76 Superconductive thin film/SUMITOMO T 348/94 (unpublished) (21 October 1998)��171

Table of Cases lv Swiss Pharma/Biogen C/09/513693/HA ZA 16-773 (12 July 2017), Rechtbank Den Haag��214 Symbian Ltd v Comptroller General of Patents [2008] EWCA Civ 1066, [2009] RPC 1 (8 October 2008).��145 Synthex v Debiopharm [1998] BIE 1999/13 (4 February 1998), Rechtbank Den Haag��237 Synthon v Yeda Research & Development C/09/521009 /HA ZA 16-1231 (6 September 2017), Rechtbank Den Haag��96, 97 Synthon BV v Merz Pharma GmbH & Co KG Case C-195/09 [2011] ECR I-07011 (28 July 2011), CJEU��294 Synthon BV v Smithkline Beecham plc [2005] UKHL 59, [2006] RPC 10 (20 October 2005), HL��165, 183 Synthon BV v Teva Pharmaceutical Industries Ltd [2017] EWCA Civ 148 (21 March 2017), CA��194 System for surveillance/TELEFONAKTIEBOLAGET LM ERICSSON T 149/07 (unpublished) (20 November 2009)�� 13 T-cell growth factor/HOOPER T 877/90 (unpublished) (28 July 1992)��171, 174 Tape drive and printing apparatus/VIDEOJET T 1727/12 (unpublished) (1 February 2016)��238 Taste of Nature Holding BV v Cresco Handels-BV 416501 and 418860 (8 May 2013), Rechtbank Den Haag��155 Taxol X ZR 168/97 GRUR 2001 813 (3 May 2001), BGH��236 Technetix BV v Teleste Ltd [2019] EWHC 126 (IPEC), [2019] FSR 19 (29 January 2019), Patents Ct��44, 199 Techniques for evaluating urinary stress incontinence/PNEUMOFLEX T369/12 (unpublished) (25 May 2016)��215 Technogenia 01/0035 and 01.0036 (29 June 2004), TGI Paris�� 37 Technogenia 04.16096 (10 January 2007), Cour d’Appel, Paris�� 37 Technograph Printed Circuits Ltd v Mills & Rockley (Electronics) Ltd [1972] RPC 346 (24 February 1971), HL��8, 210 Telomerase peptides/GEMVAX T 903/05 (unpublished) (30 August 2007)��186, 187, 261, 262 Tetra/Meyn 96/1213 (30 September 1999), Gerechtshof Den Haag��224 Teva v Merck 15-19.726 (6 December 2017) (Finasteride), Cour de Cassation��246, 247 Teva Nederland BV v Eli Lilly & Company 200.228.774/01 (8 May 2018) Gerechtshof Den Haag,�� 33 Teva UK Ltd v Astrazeneca AB [2012] EWHC 655 (Pat), (2012) 109(25) LSG 19 (22 March 2012)��227, 228 Teva UK Ltd v Astrazeneca AB [2014] EWHC 2873 (Pat), (2015) 142 BMLR 94 (2 September 2014), Pat Ct�� 15 Teva UK Ltd v Gilead Sciences Inc [2017] EWHC 13 (Pat) (13 January 2017)��286 Teva UK Ltd v Gilead Sciences Inc [2018] EWHC 2416 (Pat) (18 September 2018)��288, 289 Teva UK Ltd v Gilead Sciences Inc C-121/17 ECLI:EU:C:2018:278 (25 July 2018), Ad-Gen’s Opinion��287, 288

lvi Table of Cases Teva UK Ltd v Gilead Sciences Inc C-121/17 ECLI:EU:C:2018:585 (25 July 2018), CJEU�� 285, 286, 287, 288, 289, 292 Teva UK Ltd v Leo Pharma A/S [2015] EWCA Civ 779, [2016] RPC 5 (28 July 2015).��207 Teva UK Ltd v Merck & Co Inc [2009] EWHC 2952 (Pat), [2010] FSR 17 (20 November 2009)�� 17 Teva/Icos C/09/532013/HA ZA 17-488 (14 March 2018), Rechtbank Den Haag��214 TGFalpha-HII/HUMAN GENOME SCIENCES T 1450/07 (unpublished) (11 February 2009)��136 TGI Paris 4702/84 (25 April 1984, confirmed 11 May 1987), Paris Cour d’Appel��314 TGI Paris 15/06627 (5 October 2017)��249 The General Hospital Corp and Palomar Medical Technologies Inc v Asclepion Laser Technologies GmbH 14508 (10 June 2013), Corte Suprema di Cassazione, Italy�� 340, 341, 345 The Home Store I ZR 33/05 GRUR 2008 254 (13 September 2007), BGH��337 Therapeutic method/ELA MEDICAL T 789/96 [2002] OJ EPO 364 (23 August 2001)��157 Thickness of magnetic layers/TOSHIBA T 26/85 [1990] OJ EPO 22 (20 September 1988)��182 Thiochloroformates/HOECHST T 198/84 [1985] OJ EPO 209 (28 February 1985)�� 179, 181, 182 3M/Avery 253070/HA ZA 05-3435 (25 April 2007), Rechtbank Den Haag��227 Thur & Uretek v Temsol 17/00427 (24 May 2018), TGI Paris�� 48 Time limit for appeal/BEHR T 389/86 [1988] OJ EPO 87 (31 March 1987)��204, 223 Tissue France v Global Hygiene P. 15-29.378 (8 June 2017), Cour de Cassation�� 67 TNF-alpha inhibitor T 734/12 (unpublished) (17 May 2013).��191 TNO v Ter Meulen NJ 2003 210 (1 March 2002), Hoge Raad��312 Tomatoes II G 2/12 and Broccoli II G 2/13 [2016] OJ EPO A28 (25 March 2015)��155 Tough composition for food applications/BOREALIS T 1833/14 (unpublished) (7 December 2017)��173 Toulouse Court of Appeal, 2nd Chamber, docket No 09/00799 (26 January 2011)��176 TQ Delta LLC v ZyXEL Communications Ltd [2019] EWHC 745 (Pat) (18 March 2019), Pat Ct��101, 120 TQ Delta, LLC v ZyXEL Communications Ltd [2019] EWHC 562 (Ch) (11 March 2019), ChD (Pat Ct)��101 Transdermal therapeutic system/ LTS LOHMANN T 2306/12 (unpublished) (12 July 2016)��247 Transformed coding/ORANGE T 2517/11 (unpublished) (12 October 2016)��203 Transformer with high-temperature superconductor for locomotives/ALSTOM T 1173/00 [2004] OJ EPO 16 (5 June 2003)��238 Transgenic animals/HARVARD T 315/03 [2005] OJ EPO 246 (6 July 2004)��151, 154 Transgenic cotton plants/BAYER CRO PSCIENCE T 547/10 (unpublished) (13 July 2016)��154

Table of Cases lvii Transgenic plant/NOVARTIS II EPO G1/98 [2000] OJ EPO 111 (20 December 1999)�� 154, 358, 359 Treatment by surgery/MEDI-PHYSICS G 1/07 [2011] OJ EPO 134, [2010] EPOR 25 (15 February 2010)��156, 157, 160, 358 Triazinylaminostilbene/CIBA T 392/06 (unpublished) (22 October 2008)��179 Triazoles/AGREVO T 939/92 [1996] EPOR 171 (12 September 1995)��253, 254, 255, 258, 271, 272, 273 Triazoles/AGREVO T 939/92 [1996] OJ EPO 309 (12 September 1995)�� 13, 205, 231, 242 Tribunal Supremo de Espana 263/2017 (3 May 2017), Spain�� 129, 200, 201 Trommeleinheit Case X ZR 57/16, BGH�� 49 Trommeleinheit X ZR 55/16 GRUR 2018 170 (24 October 2017), BGH��49, 90 Truvada-Schutzzertifikat 4 Ni 12/17 (15 May 2018), BPatG��289 Two identities/COMVIK T 641/00 [2003] OJ EPO 352 (26 September 2002)�� 219, 220, 221 Ultrahigh-molecularweight polyethylene/MITSUI T 176/89 (unpublished) (27 June 1990)��203 Undeliverable mail/PITNEY BOWES T 388/04 [2007] OJ EPO 16 (22 March 2006)��139 Unilever Plc v Chefaro Proprietaries Ltd [1994] FSR 135 (11 March 1993), CA�� 77 Unilever Plc v Ian Alexander Shanks [2010] EWCA Civ 1283, [2011] RPC 12 (25 November 2010)��311 Union & Laboratories Servier v AJC Pharma (25 January 2002), TGI Paris�� 83 United Wire Ltd v Screen Repair Services (Scotland) Ltd [2000] UKHL 42, [2001] RPC 24 (20th July, 2000).��50, 67 University of Queensland, CSL Ltd v Comptroller General of Patents, Designs and Trade Marks Case C-630/10 [2011] ECR I-12231 (25 November 2011), CJEU��284, 292 Unwired Planet v Huawei, I-2 U 31/16 (6 June 2019), OLG Dusseldorf��102 Unwired Planet International Ltd v Huawei Technologies Co Ltd and Samsung Electronics Co Ltd [2016] EWHC 576 (Pat) (22 March 2016)��249 Unwired Planet International Ltd v Huawei Technologies Co Ltd [2017] EWHC 711 (Pat), [2019] 4 CMLR 7 (5 April 2017), Pat Ct��100, 101 Unwired Planet International Ltd v Huawei Technologies Co Ltd [2018] EWCA Civ 2344, [2018] RPC 20 (23 October 2018)�� 98, 99, 101, 342, 343, 344 UPC Telekabel Wien GmbH v Constantin Film Verleih GmbH Case C-314/12 ECLI:EU:C:2014:192, (26 November 2013), CJEU��118 Urinalventil II 4A_131/2016 (3 October 2016) Fed Sup Ct of Switzerland��21, 42 Use of embryos/WARF G 2/06 [2009] OJ EPO 306, [2009] EPOR 15, (25 November 2008)��152, 153, 162, 358 Use of reactive, organic fillers/BAYER T 123/82 (unpublished) (30 August 1985)��165 UV-unempfindliche Druckplatte X ZR 3/10 GRUR 2012 1133 (14 August 2012), BGH��184

lviii Table of Cases Vaccines/GENENTECH T 187/93 (unpublished) (5 March 1997)��202 Vacuum carbo-nitriding method/KOYO THERMAL SYSTEMS T 428/13 (unpublished) (19 September 2017)��171, 172 Valorem c Urba Waste 12/05288 (2 May 2014) TGI Paris��105 Van Bentum/Kool NJ 2002/530 (29 March 2002) Hoge Raad, Netherlands�� 31 Van Diepen/Pronk 298589/HA ZA 07-3506 (2 July 2008), Rechtbank Den Haag��223 Verfahren und Vorrichtung zur Bestimmung der Veranderung eines Objektes/BrainLAB T 923/08 (unpublished) (2 August 2011)��157 Verfahren zum Herstellen von Gipsbauteilen/ KOSSATZ T 397/87 (unpublished) (31 January 1989)�� 11 Verfahren zum Vorabspeichern von Computernetzwerk-Information 17 W (pat) 1/02, GRUR 2003, 323 (17 October 2002) BpatG��178 Vermehrungsgut/CIBA GEIGY T 49/83 [1984] OJ EPO 112 (26 July 1983)��154 Vernichtungsanspruch I ZR 242/94 GRUR 1997 899 (10 April 1997), BGH��129 Vetrotech v Interver 07/12696 (25 March 2009), TGI Paris�� 37 Vetrotech v Interver 09-24271 (29 June 2004), Cour d’Appel de Paris�� 37 Vetrotech v Interver 11-26.361 (12 February 2013), Cour de Cassation�� 37 Video game/KONAMI T 928/03 (unpublished) (2 June 2006)��142 Videosignal-Codierung I 4b O 508/05 (30 November 2006), LG Dusseldorf�� 51 Vinylchlorid resins/SUMITOMO T 14/83 [1984] OJ EPO 105 (7 June 1983)��232, 236 Virbac v Merial 13/00455 (13 February 2014), TGI Paris��236, 248 Virgin Atlantic Airways Ltd v Premium Aircraft Interiors Group Ltd [2009] EWCA Civ 1062, [2010] RPC 8 (22 October 2009).��22, 23 Vision Sciences Inc v Xmed Srl 13/14830 (10 July 2015), TGI Paris, confirmed on the assessment of the novelty by Cour d’Appel de Paris, Vision Sciences Inc v Xmed Srl 15/16413 (16 February 2018)��166 Visual prosthesis/JOHNS HOPKINS UNIVERSITY T 1798/08 (unpublished) (21 August 2012)��157 Vorrichtung zum Verbinden von Bauteilen, X ZR 108/16 (31 July 2018), BGH��184 Vringo Infrastructure Inc v ZTE (UK) Ltd [2013] EWHC 1591 (Pat) (6 June 2013), Pat Ct��101 VSY v ZEISS C/09/513279/HA ZA 16-741 (7 June 2017), Rechtbank Den Haag��337 Wall element/VEREINIGTE METALLWERKE T 169/83 [1985] OJ EPO 193 (25 March 1985)��232 Warenregal 166/97 (29 February 2000), BGH�� 14 Warner Lambert and Pfizer v Sandoz, Mylan, Teva, Sanofi, Biogaran (2 December 2016), (Pregabalin Case) TGI Paris��59, 73 Warner-Lambert Co LLC v Laboratoires Cinfa SA (unreported) (5 July 2016), Barcelona CA�� 55 Warner-Lambert/Ranbaxy 07/272 (28 February 2008), Gerechtshof Den Haag��224

Table of Cases lix Warners Lambert Co LLC v Mylan & Actavis [2018] UKSC 56, [2018] RPC 21, [2019] Bus LR 360 (14 November 2018), SC�� 54, 55, 56, 57, 58, 137, 242, 243, 244, 245, 246, 260, 261, 265, 266, 267, 271, 273, 274 Warner-Lambert Co LLC v Actavis Group PTC EHF [2015] EWHC 249 (Pat), (6 February 2015)��73, 76, 80 Warner-Lambert Co LLC v Actavis Group PTC EHF [2015] EWHC 2548 (Pat); sub nom Generics (UK) Ltd t/a Mylan) v Warner-Lambert Company LLC [2016] RPC 3 (10 September 2015)�� 17, 260, 265 Warner-Lambert Co LLC v Generics (UK) Ltd (t/a Mylan). See Generics (UK) Ltd (t/a Mylan) v Warner-Lambert Co LLC Washing Composition/UNILEVER T 666/89 [1993] OJ EPO 495 (10 September 1991)��170, 178, 182, 183 Waters v Hewlett-Packard GmbH and Agilent technologies 97/20725 (14 January 2009), TGI Paris��123 Waters v Hewlett-Packard GmbH and Agilent technologies 09/02423 (5 October 2011), Cour d’Appel��123 Webseitenanzeige X ZR 121/09 GRUR 2011,15 (24 February 2011), BGH��148 Wellcome Foundation v Parexel International and Flamel (27 January 1999), Cour d’Appel, Paris�� 83 Wellcome Foundation v Parexel International and Flamel (20 February 2001), TGI Paris�� 83 Wheatley v Drillsafe Ltd [2000] EWCA Civ 209, [2001] RPC 7 (5 July 2000).�� 23 Wind energy system/WOBBEN T 0064/13 (unpublished) (17 May 2017)��177 Windsurfing International Inc v Tabur Marine (Great Britain) Ltd [1985] RPC 59, (31 January 1984), CA�� 168, 206, 210, 217, 218, 230 X v Nouvelle Eurocable 93-12212 (7 February 1995), Cour de Cassation��319 X v Y 04-19482 (25 April 2006), Cour de Cassation; confirmed 11/03021 (29 May 2013), Paris Court of Appeal��308 X v Y 08-70138 (2 June 2010), Cour de Cassation��308 Xaga v SELARL Debois-Herbaut 13/11351 (18 November 2016), TGI Paris��147 Xanthines/DRACO T 7/86 [1988] OJ EPO 381 (16 September 1987)��179 Y v Dexcel and X 99-11183 (18 December 2001), Cour de Cassation��314 Y v Télécom Design and Info Networks Systems 16-13262 (31 January 2018), Cour de Cassation��311 Yeda Research & Development Co Ltd v Rhone-Poulenc Rorer International Holdings Inc [2007] UKHL 43, [2008] RPC 1 (24 October 2007)��309, 317 Yissum Research and Development Co of the Hebrew University of Jerusalem v Comptroller-General of Patents Case C-202/05 [2007] ECR-I-2839 (17 April 2007), ECJ.�� 276, 277, 282 Ziehmaschinenzugeinheit II X ZR 49/09 GRUR 2010 992 (29 June 2010), BGH��224 Zuid-Chemie BV v Philippo’s Mineralenfabriek NV/SA2 Case C-189/08 [2009] ECR I-6917 (16 July 2009), ECJ��330

lx Table of Cases Zuständigkeit der Juristischen Beschwerdekammer G2/90 [1992] OJ EPO 10 (4 August 1991)��357 Zwangsmischer 7 O 22100/10 (24 November 2011), LG Munchen��130 Case Law of the Boards of Appeal of the European Patent Office 2.2, 12��139 2.8.1.�� 13 I C 2.44��165 I C 3.2.1-3.2.2��171

TABLE OF EU AND INTERNATIONAL MATERIAL References are to page number. References in italics are to materials set out in appendices. Act of Accession 2003��299 Annex IV, Chap 2�� 91 Act of Accession 2005��299 Act of Accession 2012��299 Agreement on a Unified Patent Court OJ 2013/C 175/01 (UPC Agreement)��80, 109, 110, 111, 325, 347, 351, 352, 353, 418 preamble��418–9 Art 1��346, 420 Arts 2, 3��420 Art 8��421 Art 18��422 Art 20��422 Art 21��346, 422 Art 24��422 Art 24(1)�� 43, 162, 198, 229, 230, 250, 422 Art 24(1)(a), (b)��422 Art 24(1)(c)�� 43, 162, 198, 229, 250, 422 Art 24(1)(d)��422 Art 24(1)(e)�� 63, 78, 109, 422 Art 25��63, 78, 423 Art 25(a)–(c)��63, 423 Art 26��63, 78, 79, 80, 132, 423 Art 26(1)–(3)��78, 423 Art 27�� 63, 108, 109, 424 Art 27(a)–(c)�� 78, 108, 424 Art 27(d)��78, 108, 111, 112, 424 Art 27(e)�� 78, 108, 424 Art 27(f)��108, 424 Art 27(g)–(i)��109, 424 Art 27(j)��109, 425 Art 27(k), (l)�� 108, 109, 425

lxii Table of EU and International Material Art 28�� 110, 326, 329, 425 Art 29��110, 425 Art 30��425 Art 32(1)(a)��328, 426 Art 32(1)(b)–(f)��426 Art 32(1)(g)��329, 426 Art 32(1)(h), (i)��426 Art 34��132 Art 62��131, 426 Art 63(1)��132, 427 Art 63(2)��427 Art 64��133, 427 Art 64(1)–(3)��427 Art 64(4)��133, 427 Art 65(1)��427 Art 65(2)–(5)��428 Art 68��133, 428 Art 80��134 Art 82��428 Art 83��346 Art 83(3)��346 Art 89(1)��346 Annex I Art 38(2)��304 Agreement on the European Economic Area, OJ L 001, 03/01/1994 P. 0003–0036 (1 January 1994)��88, 322 Agreement relating to Community Patents (Community Patent Convention 1989) 89/695/EEC [1989] OJ L 401/1, 30 December 1989��2, 46, 63, 81, 109, 364 Preamble ��365–6 Art 24(a)�� 58 Art 24(c)�� 51, 52, 53, 55, 64 Art 25�� 46, 65, 81, 366 Art 25(a)�� 46, 47, 49, 366 Art 25(b), (c)��46, 366 Art 26��65, 69, 70, 71, 72, 74, 78, 79, 80, 81, 366 Art 26(1)��65, 366 Art 26(2)��65, 68, 366 Art 26(3)��366 Art 27��108, 366 Art 28�� 81 Art 37�� 81 Brussels Convention��330 Art 6(1)��333 Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure of 28 April 1977��240

Table of EU and International Material lxiii Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use [2016] OJ L32/1��303 CO M(90) 101 final-SYN 225, 25��294 COM(2017) 712 final (29 November 2017) Communication issued by the European Commission�� 99 Communication from the Commission to the Institutions on Guidance on certain aspects of Directive 2004/48/EC of the European Parliament and of the Council on the enforcement of intellectual property rights (‘Guidance Communication’).��113, 119, 124, 128 COM(2015) 550 final Communication ‘Upgrading the Single Market: more opportunities for people and business’, 28 October 2015��301 section 3.3��301 section 3.3.3��302 Convention for the European Patent for the Common Market (Community Patent Convention 1973) 76/76 EEC [1976] OJ L17/1, 26 January 1976�� 2, 5 Art 76��110 Convention on International Civil Aviation of 7 December 1944 ‘Chicago Convention’, Document 7300/9 Art 27��109 Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products [1966] OJ L22/369��294 Directive 93/42/EEC of 14 June 1993 concerning medical devices [1993] OJ L169/1��294, 295 Annex I, section 7.4�� 14 Directive 98/44/EC of 6 July 1998 on the legal protection of biotechnological inventions – Biotechnology Directive [1998] OJ L 213/13�� 3, 62, 135, 138, 139, 148, 150, 151, 152, 155, 161, 163, 261, 350, 378–89 Recitals (1)–(4)��378 Recitals (5)–(13)��379 Recitals (14), (15)��380 Recital (16)�� 152, 161, 380 Recitals (17)–(41)��380–82 Recital (42)�� 152, 161, 382 Recitals (43)–(56)��382–4 Arts 1, 2��384 Art 3��148, 385 Art 3(i)��148, 385 Art 3(ii)�� 148, 150, 385 Art 4��385 Art 4(1)�� 149, 154, 155, 385 Art 4(2), (3)��385 Art 5�� 149, 150, 385

lxiv Table of EU and International Material Art 6��149, 385 Art 6(1)��149, 150, 151, 154 Art 6(1)(a)��151 Art 6(2)��150 Art 6(2)(a), (b)��149, 385 Art 6(2)(c)��149, 151, 152, 161, 385 Art 6(2)(d)��149, 385 Arts 7, 8��386 Art 9��62, 386 Art 10��108, 386 Art 11��386 Art 12��387 Art 13��149, 387 Art 14��149, 388 Art 15–17��389 Directive 2001/82/EC of 6 November 2001 on the Community code relating to veterinary medicinal products [2001] OJ L311/1�� 108, 276, 293 Art 13(1)-(5)��85, 87 Art 13(6)��108, 111 Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use – Medicines Directive [2001] OJ L 311/67��85, 87, 108, 276, 293, 294, 295, 350 Art 10�� 54 Art 10(1)–(4)��85, 87 Art 10(6)�� 81, 85, 108, 111 Art 11��54, 59 Directive 2004/48/EC of the European Parliament and of the Council of 29 April 2004 on the enforcement of intellectual property rights (Enforcement Directive) [2004] OJ L 195/16��113, 114, 118, 123, 124, 125, 128, 129, 130, 132, 134, 390–405 Recital (1)��390 Recitals (2)–(6)��391 Recital (7)��113, 391 Recitals (8), (9)��391 Recitals (10)–(16)��392 Recitals (17)–(23)��393 Recitals (24), (25)��394 Recital (26)�� 125, 127, 394 Recital (27)��130, 394 Recitals (28), (29)��394 Recitals (30)–(32)��395 Art 1��395 Art 2(1), (2)��395 Art 2(3)��396

Table of EU and International Material lxv Art 3(1)��396 Art 3(2)�� 118, 119, 396 Art 4��396 Arts 5–7��397 Art 8��398 Art 9��399 Art 10��129, 401 Art 10(1)–(3)��128, 401 Art 11��119, 401 Art 11(1), (2)��118 Art 11(3)��132 Art 12��118, 401 Art 13�� 124, 133, 402 Art 13(1)��123, 402 Art 13(1)(a)�� 123, 124, 128, 402 Art 13(1)(b)�� 124, 128, 402 Art 13(2)�� 107, 124, 402 Art 14��402 Art 15��129, 402 Arts 16–18��403 Arts 19–22��404 Directive 2009/24/EC of the European Parliament and of the Council of 23 April 2009 on the legal protection of computer programs [2009] OJ L 111/16 Arts 5, 6��108, 109 Guidelines for Examination in the EPO��18, 201 Part G Patentability G II-28, November 2018��161 G II, 3.7 November 2018��141 G-IV-1, November 2015 edition��165 G-IV-1, November 2018��164 G-VII, 1, November 2018�� 9 G-VI-3, November 2015 edition��165 G-VI-4, 7.1��187 G-VII-2–3, November 2018��201 G-VII-4, November 2018��201 G-VII-5, November 2018�� 202, 214, 215 G-VII-5.1��203 G-VII-5.2��204 G-VII-6, November 2018��202 G-VII-10.2��226 Index for Computer-Implemented Inventions, November 2018��143 EPO Notice [2009] OJ EPO 8–9, 456��177, 178 EPO Notice [2010] OJ EPO 514 (20 September 2010)��187 EPO Notice concerning the filing of sequence listings [2013] OJ EPO 542 (10 October 2013)��195

lxvi Table of EU and International Material EPO Notice of 29 June 2017��155 EC Treaty Art 28��110 Art 30��110 European Patent Convention of 5 October 1973��53, 159 Art 23d��151 Art 52(4)��156, 159 Art 54(5)�� 53, 159, 160 Art 83��248 EPC European Patent Convention of 5 October 1973 as revised by the Act revising Article 63 EPC of 17 December 1991 and the Act revising the EPC of 29 November 2000�� 2, 3, 4, 5, 8, 12, 26, 31, 53, 55, 58, 75, 76, 148, 149, 156, 158, 166, 188, 257, 334, 356 Arts 1–4��356–7 Art 6(1)��150, 325 Arts 21, 22��357–8 Arts 52–57��196, 358 Art 52��147, 358 Art 52(1)�� 135, 138, 358 Art 52(2)�� 135, 138, 139, 143, 144, 145, 147, 148, 162, 222, 358 Art 52(2)(a)�� 138, 139, 148, 358 Art 52(2)(b)��138, 358 Art 52(2)(c)�� 139, 142, 144, 358 Art 52(2)(d)��139, 358 Art 52(3)��139, 143, 144, 145, 147, 222, 358 Art 52(4)��160 Art 53�� 135, 150, 358 Art 53(a)��149, 150, 151, 154, 358 Art 53(b)��150, 154, 155, 156, 358 Art 53(c)�� 150, 156, 157, 158, 159, 160, 161, 162, 187, 358 Art 54�� 164, 167, 178, 198, 273, 359 Art 54(1)��164, 359 Art 54(2)��164, 172, 178, 196, 359 Art 54(3)��164, 165, 171, 196, 359 Art 54(4)��76, 158, 160, 161, 164, 188, 196, 359 Art 54(5)�� 53, 75, 159, 160, 164, 187, 189, 359 Art 55(1)��359 Art 55(1)(a)��172, 359 Art 55(1)(b)��359

Table of EU and International Material lxvii Art 56��18, 29, 145, 200, 202, 204, 206, 211, 212, 213, 222, 230, 231, 256, 258, 263, 269, 271, 272, 273, 359 Art 57�� 135, 136, 137, 138, 150, 162, 240, 261, 273, 360 Art 64(3)��168 Art 68��360 Art 69��20, 21, 22, 26, 31, 41, 43, 76, 167, 168, 285, 286, 288, 360 Art 69(1)��20, 43, 167, 197, 360 Art 69(2)��43, 360 Art 71��326 Art 73��326 Art 74��326 Art 78(1)(b)��195 Art 83�� 232, 233, 234, 235, 236, 238, 239, 240, 241, 247, 251, 258, 259, 267, 269, 270, 271, 272, 360 Art 84��196, 211, 237, 247, 248, 255, 272, 361 Art 87��361 Art 87(1)��186, 361 Art 87(2)–(5)��361 Arts 88, 89.....................................................................................................................��362 Art 100(b)��232 Art 123��362 Art 123(1)��362 Art 123(2)�� 194, 195, 196, 362 Art 123(3)�� 194, 196, 362 Art 128(2)��241 Art 138��232, 236, 247, 248, 362 Art 142��352 Art 164��327 Art 169��363 Implementing Regulations to the Convention on the Grant of European Patents of 5 October 1973 r 22��326 r 26(1)��161 r 26(3)��240 r 26(4)–(6)��154 r 28��149, 155 r 28(1)(a), (b)��149 r 28(1)(c)��150, 151 r 28(1)(d)�� 150, 151, 154 r 28(c)��152 r 28(2)��155, 156 r 29(1)–(3)��149

lxviii Table of EU and International Material r 31(1)(a), (b)��240 r 31(1)(c)��240, 241 r 32��241 r 33��241 r 33(6)��240 r 42(1)(c)��203 r 42(1)(f)��136 r 56(3)��195 r 58��195 r 85��326 Munich Amendment Act to the European Patent Convention, 29 November 2000�� 21 Note from the Presidency to the Council (Doc. 10630/11) – ‘Non-paper of the Commission Services’��351 Notice 2016/C 411/03, relating to the Biotechnology Directive 3 November 2016, European Commission��155 Paris Convention 1883�� 2 Patent Cooperation Treaty��184 Proposal for a Regulation amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products – outcome of proceedings (20 February 2019)��302 Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) No 1215/2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters��346 Protocol on Interpretation of Article 69 of the EPC of 5 October 1973 as revised by the Act revising the EPC of 29 November 2000�� 20, 21, 31, 33, 43, 167, 168, 197, 199, 285, 286, 288, 363 Art 1��20, 76, 364 Art 2�� 21, 22, 28, 364 Art 53(b)��149 Protocol on Jurisdiction and the Recognition of Decisions in Respect of the Right to the Grant of a European Patent (Protocol on Recognition) of 5 October 1973�� 305, 327, 328 Arts 2–5��327 Art 6��305, 327 Regulation 2100/94 of 27 July 1994 on Community plant variety rights [1994] OJ L227/1 Art 14��109 Regulation (EC) 44/2001 of 22 December 2000 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters [2001] OJ L12/1��330 Regulation (EC) 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 [2006] OJ L378/1��3, 298, 299, 354, 429–53

Table of EU and International Material lxix Art 1��429 Arts 2, 3��430 Art 4, 5��431 Art 6��432 Arts 7–10��433 Arts 11–13��434 Arts 14–16��435 Arts 17–20��436 Arts 21–23��437 Arts 24, 25��438 Arts 26, 27��439 Arts 28–30��440 Arts 31, 32��441 Arts 33, 34��442 Arts 35, 36��443 Arts 37–39��444 Arts 40–42��445 Arts 43–45��446 Arts 46, 47��447 Arts 48–50��448 Arts 51, 52��449 Art 53��451 Arts 54, 55��452 Arts 56, 57��453 Commission Statement ��453 Regulation (EC) 864/2007 of the European Parliament and of the Council of 11 July 2007 on the law applicable to non-contractual obligations (‘Rome II’) [2007] OJ L199/40��351 Regulation (EC) 593/2008 of the European Parliament and of the Council of 17 June 2008 on the law applicable to contractual obligations (‘Rome I’) [2008] OJ L 177/6��351 Art 3��328 Regulation 469/2009 of 6 May 2009 concerning the supplementary protection certificate for medicinal products and replacing Regulation 1768/1992 (SPC Regulation) [2009] OJ L152/1��3, 275, 276, 278, 279, 280, 288, 290, 294, 295, 296, 297, 299, 302, 303, 304, 350, 353, 354, 367 Recitals (1)–(11)��368 Art 1��369 Art 1(b)�� 276, 277, 278, 279, 280, 281, 282 Art 2�� 293, 294, 295, 369 Art 3�� 276, 369–70 Art 3(a)�� 276, 279, 280, 283, 284, 285, 286, 287, 288, 289, 290, 291 Art 3(b)��276, 279, 283, 293, 297 Art 3(c)��276, 291 Art 3(d)�� 276, 277, 279

lxx Table of EU and International Material Arts 4–7��370 Art 8��371 Art 9��372 Art 10��372–3 Art 10(3)��297 Arts 11, 12��373 Art 13��373–4 Art 13(1)��293 Arts 14–16��374 Art 17��375 Art 18��298, 375 Art 19��281, 375 Art 20��375–7 Arts 21–23��377 Regulation (EU) 1901/2006 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products (Plant Products SPC Regulation) [1996] OJ L198/30�� 3, 275, 279, 354 Regulation (EU) 1215/2012 of the European Parliament and of the Council of 12 December 2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (recast) (Brussels Regulation) [2012] OJ L351/1��7, 330, 331, 332, 333, 340, 344, 346, 347 Recital (15)��331 Art 4(1)�� 330, 331, 336, 340, 341, 345 Art 6(1)��341 Art 7(2)�� 330, 331, 337, 340, 341, 344, 345 Art 8(1)��331, 333, 334, 335, 336, 337, 338, 344, 345 Art 21��347 Art 22��347 Art 22(4)��336 Art 23��347 Art 24��331 Art 24(4)�� 97, 331, 332, 334, 335, 336, 338, 339, 341, 342, 344, 346 Art 27�� 331, 338, 339 Arts 29, 30��340 Art 35��331, 335 Art 71a(1)��346 Regulation (EU) 1257/2012 of 17 December 2012 implementing enhanced cooperation in the area of the creation of unitary patent protection (UP Regulation) [2012] OJ L361/1�� 43, 110,111, 112, 325, 326, 351, 352, 405–17 Recitals (1), (2)��405 Recitals (3)–(6)��406

Table of EU and International Material lxxi Recital (7)��329, 406 Recitals (8), (9)��407 Recital (10)��328, 407 Recitals (11)–(15)��407 Recitals (16)–(21)��408 Recitals (22)–(27)��409 Arts 1–3��410 Arts 4, 5��411 Art 6��110, 411 Art 7�� 305, 325, 326, 327, 328, 329, 412 Art 7(1)–(4)��325, 412 Art 8(1)��412 Art 8(2)��328, 412 Art 9��413 Arts 10–12��414 Art 13��415 Arts 14–17��416 Art 18��417 Regulation (EU) 542/2014 amending the Brussels Regulation as regards the rules to be applied with respect to the Unified Patent Court and the Benelux Court of Justice [2014] OJ L163/1��346 Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products [2019] OJ L153/1��302 Art 5(5)��303 Art 5(8), (9)��303 Annex 1��303 Rules of Procedure of the Unified Patent Court, 18th draft (15 March 2017) rr 205 et seq��131 SWD(2017) 431 – IPR Enforcement Directive Evaluation post RSCC��113 TEU (Lisbon Treaty)��348 Art 50��348 Art 50(2)��348 TFEU Art 102��99, 102 Withdrawal Agreement 2 T F50 (2018) 55 – Commission to EU27, 14 November 2018��348, 349 Art 56��354 Art 86(2)��355 Art 89(1)��355 Art 90��355 Art 127��349 WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement�� 2, 113, 321

lxxii

TABLE OF NATIONAL MATERIALS References are to page number FRANCE Code of Civil Enforcement Procedures Arts 132-1–132-4��120 Code of Civil Procedure Art 521��122 Art 524��121 Art 526��121 Art 1101��314 Art 1582��314 Intellectual Property Code Art L.611-(1)��166 Art L.611-6��306 Art L.611-7�� 307, 308, 311 Art L.611-8��306, 309 Art L.611-9��306 Art L.611-10��147 Art L.611-10(2)(c)��146 Art L.611-11(5)��188 Art 611-14��8, 212 Art L.611-15��137 Art L.611-16��158, 190 Art 612–5�� 8 Art L.612-6��249 Art L.612-7��184 Art L.612-7(5)��166 Art L.612-10��306 Art L.613-2�� 26 Art L.613-3 b�� 72 Art L.613-3 c)�� 52 Art L.613-4��67, 72, 73 Art L.613-4(2)�� 69 Art L.613-5��83, 249 Art L.613-5(d)�� 86

lxxiv Table of National Materials Art L.613-6��50, 89 Art L.613-7��104 Art L.613-8��306, 314, 315, 316 Art L.613-9��314, 316 Art L.613-11 et seq��322 Art L.613-12��322 Art L.613-13��322 Art L.613-14��322 Art L.613-15��323 Art L.613-15-1��322 Art L.613-16��323 Art L.613-17��323 Art L.613-18��323 Art L.613-19��323 Art L.613-19-1��323 Art L.613-29��312, 318 Art L.613-29 a)–d)��313 Art L.615-2��318 Art L.615-3��115 Art L.615-5-1�� 53 Art L.615-7��126 Art R.611-1��307 Art R.611-14-1��312 Art R.612-5��235 Art R.612-6��235 Art R.612-12��137, 235 Public Health Code Art R.5121-102�� 48 Art L 5125.23�� 59 GERMANY Civil Code s 137 1st sentence��315 s 398ff��315 s 413��315 s 741 et seq��310, 313 s 743(2)��313 s 745(1)��313 s 745(1) 2��313 s 747��316 Civil Procedure Act ss 916–945��116 Employee Invention Act s 6��308 s 42��308

Table of National Materials lxxv Patent Act 1981 s 1��147 s 1(3)��148 s 1a(3)��138 s 3(1)��166 s 3(3)��188 s 3(4)��189 s 4��8, 213 s 5��138 s 9��106 s 10��74, 106 s 10(2)�� 68 s 11(2)�� 84 s 11(2b)�� 86 s 12��105 s 14�� 8 s 15(2)��315, 316 s 21(1.2)��250 s 21 no 4��194 s 24��323 s 30(4)��316 s 34(4)��236, 250 s 38��194 s 85��323 s 140a)��129 Patent Code Section 3, para 4�� 75 Rules of the Patent and Trademark Office s 10(2)��138 NETHERLANDS Civil Code Art 3:303�� 97 Art 3:175��313 Art 6:162�� 52 Art 6(e)��337 Patent Act 1995�� 107, 138, 148 Art 2(2)(c)��148 Art 2(3)��148 Art 4��167 Art 4(2)��167 Art 4(6)�� 76 Art 6��213 Art 7(1)��138 Art 8��306

lxxvi Table of National Materials Art 11��306 Art 12(1)��308 Art 12(5)��308 Art 12(6)��312 Art 13��310 Art 14(1), (2)��307 Art 25��236 Art 53��52, 107 Art 53(1)�� 47 Art 53(3)�� 84 Art 53(4)�� 87 Art 53(6)��106 Art 53(a)�� 50 Art 53(a)(b)�� 61 Art 55��106, 107 Art 57��120, 324 Art 58��120, 324 Art 58(6)��324 Art 58a(1)-(3)��324 Art 64��315 Art 65(1)��315 Art 65(3)��315 Art 66��310, 313 Art 66(2)��313 Art 70(6)��317 Art 70(7)��129 Art 70(12)��130 Art 73�� 52 Art 73(1)��75, 76 Art 73(2)�� 68 Art 75(1)(b)��236 Art 78(4)��318 SPAIN Patents Act (in force 1 April 2017)��129 SWITZERLAND Patents Act��298 Patents Ordinance��298

Table of National Materials lxxvii UNITED KINGDOM Draft Patents (Amendment) (EU Exit) Regulations 2018��354 European Union (Withdrawal) Act 2018��349, 350, 353, 354, 355 s 6(1), (2)��355 Legislative Reform (Patents) Order 2014, SI 2014/1997�� 82 Patents Act 1977�� v, vi, 82, 111, 112, 192, 257, 307, 310, 350 s 2(2)��192 s 2(3)��186 s 3��206 s 7(2)(a), (b)��306 s 7(3)��309 s 7(4)��306 s 11��319 s 11(1)��317 s 11(2)��319 s 11(3)(b)��319 s 11(4), (5)��319 s 13(1)��306 s 14(5)(c)��211, 255 s 30(6)��314 s 33��314 s 36(1)��309 s 36(2)(a)��312 s 36(3)(a), (b)��312 s 39(10)��307 s 40��310 s 46��322 ss 48–59��329 s 48��321 s 49��321 s 60�� 82 s 60(1)(a)�� 58 s 60(1)(c)�� 52, 55, 56, 57 s 60(2)��72, 73 s 60(3)�� 68 s 60(5)(i)�� 85 s 60(6D)–(6E)��121 s 61(1)(b)��129 s 62(7)��107 s 64 ��104 s 64(1)��104

lxxviii Table of National Materials s 64(2)��104 s 67��316 s 67(1)��318 s 68��314 s 72(1)(c)��235 Senior Courts Act 1981 s 37��130

Introduction I. Towards a Common Standard of Patent Law A. International Trade; National Law International trade is nothing new. English, Dutch, Spanish and Portuguese trading companies were competing (often accompanied by military force) for business in products as varied as silk, saltpetre and tea, around the coasts of the Indian Ocean from the beginning of the seventeenth century. For a period of some 300 years before this, the Hanseatic League of trading cities, centred in the Free City of Lübeck, ran a trading network of fur, wax and timber along the North and Baltic Sea coasts, from London to Novgorod. In the end, the closure of Novgorod in 1494, by Ivan III of Russia, and expulsion from London in 1597, by Queen Elizabeth I, marked a century of decline for the League. Meanwhile, the long success of the League in northern Europe was mirrored in the south by the Republic of Venice, which dominated trade with Africa and Asia in the Mediterranean. It goes without saying that the mercantile networks of Rome and the civilisations of the Ancient Near East long predate all of this. Nearly 900 years after the beginnings of Lübeck and Venice, however, the World Trade Organization (WTO), free trade areas, instant digital communication and fast and frequent international travel, make it trite to observe that business now operates in a global marketplace more efficiently and extensively than at any time in history. However, such global trade is far from seamless: the continuing success (and popularity) of the nation state means that invisible barriers persist. For economists this typically means tariffs, but for lawyers it first and foremost means contending with differences of national law. In particular, where there is trade in new and innovative products there are patents and patent law. Indeed, it is no coincidence that the first recognisable patent rights are thought to have emerged from the trading powers of fifteenth century Venice and Elizabethan England. The connection between trade and innovation is recognised by the WTO: The idea of trade, and what makes trade valuable for societies, has evolved beyond simply shipping goods across borders. Innovation, creativity and branding represent a large amount of the value that changes hands in international trade today. How to enhance this value and how to facilitate the flow of knowledge-rich goods and services across borders have become integral considerations in development and trade policy.1

1 www.wto.org/english/thewto_e/whatis_e/tif_e/agrm7_e.htm.

2 Introduction Patent rights are national in scope – their protection ends at the borders of the country in which they are registered. Even if patents are registered in every country necessary to cover the commercially important markets in which a product is sold or a process used, differences in national patent laws or their interpretation by national courts may be encountered. These can prove significant: the difference between an infringement in one country and not in another; or, the invalidity of a patent in one country and not in another. Preparing to contend with the differences in national patent regimes, either as a patent owner or a competing third party, can require the services of patent attorneys and patent lawyers in every country of commercial significance; a large cost in time and money. How then can these differences be mitigated so as to allow businesses to operate more smoothly and cost effectively across borders?

B. Harmonisation in Europe i. International Treaties The first step is international harmonisation. Truly international rules on intellectual property date back to the 1880s,2 but it was not until the WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, negotiated during the 1986–94 Uruguay Round, that global minimum standards for obtaining and enforcing patents were set out for the first time. Even before TRIPS was negotiated, the issue had been a decades long concern for the European countries (including, but not limited to, the European Union Member States). Although the European countries maintain their own national courts and legislatures, pan-European treaty instruments have provided a basis for the harmonisation of national patent validity and infringement law rules. These first took shape with the introduction of the European Patent Convention (EPC), which came into force on 7 October 1977.3 The EPC provided, amongst other matters, for the central grant by the European Patent Office (EPO) of European patents protecting national territories. The latter rules were provided by the Convention for the European Patent for the Common Market,4 often referred to as the Community Patent Convention 1973 (CPC 1973), which was signed on 15 December 1975 by the nine Member States at that time. The CPC 1973 was never fully ratified and it was not until fourteen years later that another attempt to revive it was made in the form of the Agreement relating to Community Patents,5 more commonly referred to as the Community Patent Convention 1989 (CPC 1989). Much like its predecessor, although this Agreement was signed, it was never fully ratified and did not come into force,6 but it remains the basis for the acts of infringement in many European countries.

2 The Paris Convention 1883. 3 For the first participating countries, Belgium, France, Luxembourg, the Netherlands, Switzerland, the United Kingdom and (former) West Germany. 4 76/76 EEC Official Journal, L17/1, 26 January 1976. 5 89/695/EEC Official Journal, L 401, 15 December 1989. 6 The Agreement was signed by 12 states but only seven ratified.

Towards a Common Standard of Patent Law 3

ii. European Union Law and the CJEU The EU itself has also provided harmonising and directly effective legislation of a narrower scope: supplementary protection certificates (SPCs), the regulatory review defence (usually referred to as the ‘Bolar Exemption’) and the B iotechnology Directive, amongst others. Questions on the interpretation of these matters are referrable to the Court of Justice of the European Union (CJEU) for preliminary rulings. The experience of national courts is that the instrument most likely to give rise to referrals is Regulation 469/2009 of 6 May 2009 concerning the supplementary protection certificate for medicinal products (the ‘SPC Regulation’). However, other European Union instruments relevant to patent matters include: Regulation (EC) 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use (the ‘Paediatric Regulation’); Regulation (EU) 1610/96 of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products (the ‘Plant Products SPC Regulation’); and, Directive 98/44/EC of 6 July 1998 on the legal protection of biotechnological inventions (the ‘Biotechnology Directive’).

iii. EPO Case Law European patents take effect as a bundle of national rights upon grant, but it is still possible for them to be revoked centrally at the EPO, using the opposition procedure. An opposition must be initiated within nine months of grant of the patent or the right to oppose the patent in the EPO is permanently lost. The opposition will typically end with an oral hearing, followed by a decision of the Opposition Division that the patent in issue is invalid, valid, or partially valid and must be amended. The Opposition D ivision decision may then be appealed to the Technical Boards of Appeal (TBA) or even the Enlarged Board of Appeal (EBA). A final decision of the TBA that a patent is invalid or valid only in amended form will result in the patent being revoked or amended, respectively, in all the national offices in which it is registered. The EPO thus has a direct impact on the national registers. Moreover, in the process of their decision making, the TBA and EBA have built up a significant body of case law, which has varying degrees of influence in the national courts. Take, for example, their impact on the courts of the United Kingdom: These decisions are not strictly binding upon courts in the United Kingdom but they are of great persuasive authority; first, because they are decisions of expert courts (the Boards of Appeal and Enlarged Board of Appeal of the EPO) involved daily in the administration of the EPC and secondly, because it would be highly undesirable for the provisions of the EPC to be construed differently in the EPO from the way they are interpreted in the national courts of a Contracting State.7

7 Lord Hoffmann in Merrell Dow Pharmaceuticals Inc v HN Norton & Co Ltd [1995] UKHL 14 (26 October 1995).

4 Introduction And: It is also well established in the jurisprudence of courts in the United Kingdom that our courts, although not bound to do so, should normally follow the settled jurisprudence of the EPO (especially decisions of its Enlarged Board of Appeal) on the interpretation of the European Patent Convention in the interests of uniformity, especially when the question is one of principle.8

iv. Differences in Application Remain Have these instruments succeeded in harmonising patent law across the European countries? The answer, in practice, is that whilst the signatories of the EPC (and within that group, the EU Member States) share very similar substantive laws at the statutory level, it is still not unusual for different national courts to come to different decisions when presented with cases arising from the same or similar facts. This is despite the fact that, although they are not obliged to do so,9 European judges of the higher instance courts frequently take notice of each others’ judgments. Where it is possible to do so, they will be consistent with the decisions of each other. Jacob LJ put it like this in the Court of Appeal in Grimme Maschinenfabrik GmbH & Co KG v Derek Scott (t/a Scotts Potato Machinery): Broadly we think the principle in our courts – and indeed that in the courts of other member states – should be to try to follow the reasoning of an important decision in another country. Only if the court of one state is convinced that the reasoning of a court in another member state is erroneous should it depart from a point that has been authoritatively decided there. Increasingly that has become the practice in a number of countries, particularly in the important patent countries of France, Germany, Holland and England and Wales. Nowadays we refer to each other’s decisions with a frequency which would have been hardly imaginable even twenty years ago. And we do try to be consistent where possible.10

A recent and notable case in which one court has acknowledged the approach taken by its foreign counterparts and adjusted its course to bring it into closer alignment with them, is the UK Supreme Court in Actavis UK Ltd v Eli Lilly & Co (see Chapter 2).11 Equally, there are cases in which the national courts have gone their own way, as they are entitled to do: The court heard submissions about the judgments of the courts of other countries which are signatories of the EPC on parallel revocation proceedings against the 181 patent. The claimants founded principally on the judgments in the Netherlands and Germany, in which in each case the national court revoked the patent on the ground of obviousness. We were also referred to judgments from other jurisdictions concerning the same patent, including Belgium and Portugal, which upheld the obviousness challenge, and Denmark, Poland and 8 Lord Hodge in Actavis Group PTC EHF & Ors v ICOS Corporation & Anor [2019] UKSC 15 (27 March 2019). 9 The Supreme Court in Schutz (UK) Limited v Werit (UK) Limited [2013] UKSC 16 paragraph 40. 10 Grimme Maschinenfabrik GmbH & Co KG v Derek Scott (t/a Scotts Potato Machinery) [2010] EWCA Civ 1110. 11 Actavis UK Ltd v Eli Lilly & Co [2017] UKSC 48 (12 July 2017).

Towards a Common Standard of Patent Law 5 the Czech Republic, which reached a different view. I do not find the judgments particularly helpful. While consistency of approach between the domestic courts of the signatory states to the EPC on matters of principle is desirable, we are not bound by the judgments of other national courts and it is possible that national courts applying the same law may come to different conclusions for various reasons…12

C. The Proposed Solution – The UPC The reason decisions continue to differ are complex. There are, however, three particular difficulties faced when trying to achieve consistency of decision-making between national courts. First, procedural differences in the national European systems can present foreign judges with different evidence by which to assess the facts. Second, there are differences in the implementation of international instruments in national law; and, third, there are differences in the way the national courts interpret those laws. The proposed answer to resolving these sources of inconsistency is the Unified Patent Court (UPC) and European patent having unitary effect (Unitary Patent) system. The idea of a single, pan-European patent protecting all territories in what was then the European Economic Community, dates to the CPC 1973. However, the emergence of the UPC and Unitary Patent, in its current state of preparation, has taken a further 45 years and is (at the time of writing) still not in force. The rules governing the constitution of judicial panels in the UPC are designed to achieve convergence in the approach to procedural rules, convergence of the substantive law applied and, as a result, consistency in judicial decision making. The rules by which judges are assigned to the panels of the local, regional and central divisions of the UPC Court of First Instance and the Court of Appeal are designed to achieve consistency of quality in decision making and in the application of substantive and procedural law. They do so by providing for a mix of national legal experience. The expertise of existing national patent judges is particularly important to the UPC. Those contracting Member States that have an average number of less than 50 patent cases per year over a consecutive period of three years will have only one local judge per panel of three in a local division. The remaining seats on the panel will be occupied by judges foreign to the division but allocated from the international pool of judges, recruited from across the contracting states to the UPC. This allows more experienced judges to be in the majority where most needed. These judges can be expected to share their expertise with judges from countries where patent cases are rare or who had no experience of patent matters prior to sitting in the UPC. In reviewing the law applied in first instance decisions, the Court of Appeal and, exceptionally, the Full Court, are thus expected to establish a body of case law that provides an increasingly uniform approach to patent law in the UPC over time.

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

6 Introduction

II. The Purpose of this Book Pending the arrival of the UPC, an account is needed of the areas of consistency and difference between the key European patent law jurisdictions of England and Wales, France, Germany and the Netherlands across all the areas of patent law over which the UPC will need to establish a common approach. It is also often the case that the decisions and approaches of other courts are important for European patent lawyers of all jurisdictions when submitting arguments in national courts. Therefore, and with the spirit of cooperation in mind that is outlined in Grimme Maschinenfabrik, this book is also intended to provide a guide to patent lawyers acting in the national European courts now: when looking outside their immediate jurisdiction to find out how other courts approach a particular issue, will they find that the approach to an issue by their national court is outside the mainstream, does another court provide a better solution to a particular problem, or do the other major courts supply a ready-made approach for circumstances that are new at home? To assist, the book presents the key issues of patent law by theme, assessing the national approaches together, rather than in nation-by-nation chapters. By taking a pan-European view of patent law, the book is also intended to outline the relevant issues ready for the development of patent law in the future UPC. For this purpose, each chapter provides a high-level summary of common ground between the national approaches.

III. Outline of Chapters The chapters cover the following substantive issues. Chapter 1 explains the identity of the skilled person or team, the fictional construct through whose eyes European patents are assessed, as well as the common general knowledge that is attributed to this person or team. In particular, the area and level of expertise of the skilled person or team is addressed and the scope of the information that is contained within the common general knowledge. Chapter 2 examines the key question of the scope of protection of patent claims, which must be determined through the eyes of the skilled person or team before infringement can be assessed. For this purpose, the general principles of national law in England and Wales, France, Germany and the Netherlands are examined, together with a comparison of the substantive decisions in the seminal, parallel national cases concerning generic pemetrexed products. The role of the prosecution file and the construction of numerical ranges is also discussed. Chapter 3 addresses acts of direct patent infringement in Europe, focusing on offers, repair and products of processes. The infringement of second medical use claims is also examined, with reference to the parallel national decisions concerning pregabalin. Chapter 4 then discusses the approach of the English, French, German and Dutch courts to the component aspects of indirect infringement – means relating to an essential element of the invention, staple commercial products, knowledge and double territoriality. Chapter 5 explores the principal forms of defence to infringement available in Europe, including the experimental use exemption, the ‘Bolar Exemption’, exhaustion,

Outline of Chapters 7 forms of validity defence and the FRAND defence. Chapter 6 then covers the substantive aspects of remedies, including preliminary injunctions, final injunctions, damages and account of profits. Chapter 7 begins the examination of patentability in Europe with industrial applicability, the exceptions to patentability, excluded subject matter and methods of treatment and diagnostics. The discussion is broadened to include case law of the Boards of Appeal of the EPO in addition to the national decisions of England and Wales, France, Germany and the Netherlands. Chapter 8 follows with the subject of novelty, covering the basic principles of EPO Boards and national case law, the interpretation of patent claims and prior art for novelty purposes, the teaching of the prior art, availability to the public and an examination of selection inventions and overlapping ranges. The issues of priority and first, second and subsequent medical uses are also discussed, as well as amendment. The inventive step requirement is discussed in Chapter 9. The problem-and-solution approach of the EPO and comparative approaches in the national law of England and Wales, France, Germany and the Netherlands are covered, including discussion of motivation-based tests and the ‘workshop variations’ approach. The issue of p lausibility as it relates to inventive step is also examined. The chapter also covers the specific issues of mixed technical and non-technical features, combinations and secondary indicia and other factors. Claim sufficiency is covered in Chapter 10, including discussion of the general principles of EPO and national law, Lundbeck-type cases and functionally defined claims. Lack of clarity is also discussed. Plausibility, which has become an issue applicable to inventive step and sufficiency assessment, amongst other areas, in the EPO and England and Wales especially, is given a chapter of its own (Chapter 11). The area of SPCs, which has been the focus of a large number of CJEU rulings in recent years is explored in Chapter 12, with a particular focus on the vexed questions of what is a product and how a product must be specified. Extensions of SPCs for m edicinal products for paediatric use are discussed as well as recent proposals for reform of the SPC system. Patent ownership and dealings are the subject of Chapter 13, together with rights of licensees and the issue of inventor compensation. Chapter 14 on cross-border actions in Europe, looks at the substantive application of the Brussels Regulation to cross-border validity and infringement in CJEU case law, and the application of these rules. Finally, Chapter 15 looks at the implications of Brexit for patents and related rights in the UK.

1 The Skilled Person and their Common General Knowledge I. The Skilled Person or Team A. Basic Role Making a decision about infringement and validity requires the court, often with the assistance of a party- or court-appointed expert, to address the claims of a disputed patent and the prior art.1 The court must not make this assessment, however, on the basis of its own, subjective, technical knowledge or indeed that of any expert witness. Instead, these matters must be addressed as if ‘standing in the shoes’ of an objective and notional figure that the EPC calls the ‘man skilled in the art’ or, the ‘skilled person’.2 This is particularly important, as regards experts, because the skilled person is usually of lesser experience and knowledge than the expert who has been called to give evidence. In particular, the skilled person is not inventive: … a skilled technician who is well acquainted with workshop technique and who has carefully read the relevant literature. He is supposed to have an unlimited capacity to assimilate the contents of, it may be, scores of specifications but to be incapable of a scintilla of invention.3

More pithily, it has been said ‘this man if real, could be very boring – a nerd’.4 This chapter discusses the characteristics of this fictional legal character. The chapter also examines the nature of the common general knowledge possessed by the skilled person, which may be applied to supplement the information contained within a patent or patent application5 and the prior art.6

1 Note that, in France, the skilled person is referred to by the IPC only in relation to inventive step (Art 611-14) and sufficiency (Art 612-5). 2 ‘Fachmann’ in Germany (s 4 Patent Act 1981 and relevant to scope of protection in s 14 Patent Act); ‘homme du metier’ in France (Arts L611-14 and L612-5 IPC). 3 House of Lords, Technograph Printed Circuits Ltd v Mills & Rockley (Electronics) Ltd [1972] RPC 346 (24 February 1971). 4 Court of Appeal, Rockwater Ltd v Technip France SA & Anor [2004] EWCA Civ 381 (01 April 2004). 5 T 1117/14 Implant for ligament reconstruction/MAYR (unpublished) (29 September 2015). 6 T 890/02 Chimeric gene/BAYER [2005] EPO OJ 497 (14 October 2004).

The Skilled Person or Team 9

B. Definitions Various descriptions of the skilled person can be found in the national courts: in France the skilled person is regarded as unimaginative and has a ‘normal knowledge’ of the technical field at issue;7 in Germany it is an uninventive practitioner with average knowledge, skills and experience in the relevant technical field;8 in the Netherlands, the skilled person or ‘average skilled worker’ is again a fictional character9 of the law who will address matters of validity and scope of claim,10 but who is uninventive and will not suggest solutions that go against prejudices in the art. Like in the national courts, descriptions of the skilled person or team in the case law of the TBA vary in their precise terms. However, the Guidelines for Examination11 offer the following, general definition of the person skilled in the art: [He] should be presumed to be an experienced practitioner who has average knowledge and abilities and is aware of what was common general knowledge in the relevant art concerned at a particular time (average skilled person). He should also be presumed to have had access to everything in the state of the art, in particular the documents cited in the search report, and to have had at his disposal the normal means and capacity for routine work and experimentation.

Note that the skilled person has average knowledge and abilities. In other words, the skilled person, or team, again does not have any inventive ability. The skilled person is also taken to know all the prior art relevant to their area of technology,12 whether by disclosure in any form or by use (see Chapter 8). They are also possessed with the common general knowledge and the ability to make a teaching work by routine work and experimentation,13 provided it does not entail undue burden (see Chapter 10). In the field of biotechnology, the skilled person has been described as someone operating at a practical level, and that the technical development which might normally be expected of them does not include solving technical problems through scientific research.14 Furthermore, again in this field, the skilled person has been characterised as cautious and conservative in their approach to the prior art:15 the skilled person in this field is well aware of the fact that even a small structural change in a product (eg a vector, a protein, a DNA sequence) or in a procedure (eg a purification process) can produce dramatic functional changes. Therefore, the said expert would constantly be conditioned by the prior art and, before taking action, would carefully ponder any possible modification, change or adjustment against the background of the existing knowledge. Under these circumstances, in the Board’s view, the skilled person would adopt a conservative attitude. However, this must not be seen in the sense of being reluctant or opposed to modify or adjust a known product or process, but rather in the sense of being cautious. For example,

7 Cour

de Cassation in Sté Robert Bosch GmbH v SA ets Guillet PIBD 1996, 602, III, 34 (17 October 1995). Bodenseitige Vereinzelungseinrichtung GRUR 2004, 1023 (7 September 2004). 9 Rechtsbank Den Haag, Henkel v Diversey [2001] BIE 2002/37. 10 Rechtsbank Den Haag, Duphar v Gist-Brocades [1987] BIE 1988/28. 11 Guidelines G‑VII, 1, November 2018. 12 T 1464/05 Hydrogen-absorbing composition/PRYSMIAN (unpublished) (14 May 2009). 13 T 1030/06 Secure buffering/BROADCOM CORPORATION (unpublished) (17 December 2008). 14 T 0500/91 Alpha-interferon II/BIOGEN (unpublished) (21 October 1992). 15 T 0455/91 Expression in yeast/ GENENTECH [1995] OJ EPO 684 (20 June 1994). 8 BGH

10 Skilled Person and Common General Knowledge the skilled person in question would neither go against an established prejudice nor try to enter into ‘sacrosanct’ or unpredictable areas nor take incalculable risks. However, within the normal design procedures, the said expert would readily seek appropriate, manifest changes, modifications or adjustments which involve little trouble or work and no risks or only calculable risks, especially for the sake of obtaining a more handy or convenient product or of simplifying a procedure. In particular, the skilled person working in one field (e.g. expression in yeast) would regard a means conveniently adopted in a neighbouring field (e.g. the bacterial art) as being readily usable also in that field, if this transfer of technical knowledge involves nothing out of the ordinary.

The knowledge of a skilled team of persons with different areas of expertise can be taken into account in appropriate circumstances.16 For example, where one person is qualified to deal with one part of the solution to the problem, while another is qualified to deal with another part of the problem in a different technical field (see Area and Level of Expertise, subsection C below).

C. Area and Level of Expertise Defining the correct area of technical knowledge to be addressed by the skilled person may be difficult in cases where technical fields meet.17 The skilled person may be taken to have knowledge of associated technical fields,18 or to ask for advice from such people.19 Where a new technology is about to spread into a traditional field, it is common practice to group people from both technical fields into a development team.20 The following principles have been summarised in Iontophoretic delivery device/ALZA CORPORATION T 26/9821 to address such situations: –– If the problem prompts the person skilled in the art to seek its solution in another technical field, then the specialist in that field is the person qualified to solve the problem.22 –– The person skilled in the art can be expected to look for suggestions in neighbouring fields if the same or similar problems arise in such fields.23 –– The skilled person may be expected to look for suggestions in a general technical field if he or she is aware of such fields.24 16 T 0986/96 Method and apparatus for a mail processing system (unpublished) (10 August 2000); in Germany see, for example, BGH Escitalopram GRUR 2010, 123 (9 September 2009); in France see, for example, TGI Paris Abbott/Evysio (14 January 2009), although see the decision of the Cour de Cassation Sté Robert Bosch GmbH v SA ets Guillet PIBD 1996, 602 III 34 (17 October 1995) which holds that the skilled person must solve the problem according to the invention using their own knowledge. 17 See, for example, Cour de Cassation, Giulini Chemie GmbH v Lambiotte Frères PIBD 1991, 493 III 76 (18 October 1990). 18 Cour d’Appel de Paris L Steinhardt and Ors v Ste ISD environnement & Ors PIBD 2002, 742 III 217 (19 November 2001). 19 BGH Stoβwellen-Lithotripter GRUR 1999, 145 (12 May 1998). 20 T 0015/15 Method for fabricating a dental appliance/ALIGN TECHNOLOGY INC (unpublished) (16 March 2017). 21 T 26/98 Iontophoretic delivery device /ALZA CORPORATION (unpublished) (30 April 2002). 22 See also T 32/81 Cleaning apparatus for conveyor belt/FIVES-CAIL BABCOCK OJ 1982, 225 (5 March 1982). 23 See T 176/84 Pencil sharpener [1986] OJ EPO 50 (22 November 1985). 24 See also T 560/89 Filler mass/ N.I.INDUSTRIES OJ 1992, 725 (24 April 1991) and T 955/90 Impact detection apparatus/BOARD OF TRUSTEES OPERATING MICHIGAN STATE UNIVERSITY (unpublished)

The Skilled Person or Team 11 –– In advanced technical fields the competent ‘skilled person’ could be taken to mean a team of experts from the relevant technical branches. –– Solutions of general technical problems in non-specific (general) fields are considered to be part of the general technical knowledge.25

D. Hindsight Risk Caution needs to be exercised when examining inventive step using the ‘problemand-solution’ approach in order to avoid the inclusion of hindsight by the choice of skilled person (see Chapter 9): the technical problem must be formulated so as not to anticipate the solution, so the starting point for defining the appropriate skilled person in this context is the technical problem to be solved on the basis of what the closest prior art discloses – the skilled person must not represent the technical field to which the proposed solution belongs if this is different to the one considered when formulating the technical problem. Furthermore, the skilled person’s knowledge does not include the different technical field of the proposed solution, if the closest prior art gives no indication that this is where the solution is to be found.26 In other jurisdictions where a problem-and-solution approach is taken to addressing inventive step, such as the Netherlands and, to an extent, France,27 the skilled person’s technical knowledge is defined by the field of the technical problem underlying the patent rather than the solution, so far as these are different.

E. Different Expertise for Sufficiency and Inventive Step For the purpose of evaluating inventive step the skilled person has the prior art only, but for the purpose of evaluating sufficiency of disclosure they have knowledge of the prior art and of the invention as disclosed.28 In most cases, however, the skilled person is the same, whatever their purpose in construing the subject-matter of a claim.29 By contrast, in the Schlumberger decision of the English Court of Appeal,30 it was held that the expertise of the skilled team for the purpose of determining claim construction and sufficiency may differ from that used to determine obviousness. This case concerned a patent for a method of marine controlled source electromagnetic (CSEM) surveying on an under-sea layer to find out whether it contains hydrocarbon reserves.

(21 November 1991); a skilled person trying to solve a non-trivial problem may be led to the claimed process by simple examples from everyday life not related to the problem in question (T 397/87 Verfahren zum Herstellen von Gipsbauteilen/ KOSSATZ (unpublished) (31 January 1989). 25 T 195/84 General technical knowledge/BOEING [1986] OJ EPO 121 (10 October 1985). 26 T 422/93 Luminescent security fibres/JALON [1997] OJ EPO 25. 27 Cour de Cassation, SAS Techip France v SA ITP 10-27413 (13 December 2011); Cour de Cassation, Boegli Gravures c.Darsail 11-18440 (20 November 2012). 28 T 694/92 Modifying plant cells/ MYCOGEN PLANT SCIENCE [1997] OJ EPO 408 (8 May 1996). 29 T 967/09 Influenza vaccines/ABBOTT BIOLOGICALS (unpublished) (4 November 2014). 30 Court of Appeal, Schlumberger Holdings Ltd v Electromagnetic Geoservices AS [2010] EWCA Civ 819 (28 July 2010).

12 Skilled Person and Common General Knowledge The method used the fact that hydrocarbon has high resistivity (low c onductivity) whilst water or brine is the opposite (low resistivity, high conductivity). Prior to the invention of the patent, it was necessary to drill an exploratory well in order to confirm a potential hydrocarbon-containing under-sea layer once it had been found by seismic methods. The kind of scientist who would be actively engaged by oil and gas exploration companies to find hydrocarbon reserves is an exploration geophysicist. Such an individual would know that seismics can identify a potential hydrocarbon containing layer, but not whether it contains hydrocarbon reserves or merely brine or water. An exploration geophysicist would have merely a vague knowledge of CSEM and no apparent use for it. To perform the method of the patent, the skills of a CSEM expert would be needed, otherwise the patent would fail to give enough instructions on how to perform the method. Similarly, to determine the scope of the claims, a skilled team including both exploration and CSEM geophysicists would be needed. Did this mean, by law, that the prior art must also be viewed through the eyes of a skilled person or team with both exploration geophysics and CSEM skills? If so, the invention would be prima facie obvious. The Court of Appeal stated that there is not a different construction given to the phrase ‘person skilled in the art’ in the different Articles of the EPC. It also acknowledged that in nearly all cases the skilled team would on the facts be the same for all purposes of obviousness, novelty, construction and sufficiency. For both claim construction and sufficiency, however, the person skilled in the art already has the patent in hand to tell them how to perform the invention and what the monopoly claimed is – these are not available when considering obviousness, and the relevant art may be different if the invention of the patent itself is art-changing. The correct approach in this case was therefore to start with the real problem faced by exploration geophysicists and ask whether the notional exploration geophysicist who read the cited prior art would see that the answer was to use CSEM; or, if not that, at least that CSEM had a sufficient prospect of being useful that it was worth asking a CSEM expert. The Schlumberger case takes support from JALON/Luminescent Security Fibres T422/93.31 In this case, the patent was for a process for the production of security fibres containing luminescent rare earth chelates. Using the problem-and-solution approach to obviousness, the closest prior art was identified as the idea of incorporating chelates in a mass and then extruding in a spinning process. The patentee said its method, which involved using a dyeing process, was better than the prior art because it was useful for small quantities of fibre. The opposition division relied on the view that the skilled person was a dyeing expert who would see immediately that dyeing could be used to incorporate chelates. The Board, however, considered that the idea of introducing a rare earth chelate by a dyeing process clearly formed part of the solution to the technical problem to be solved. The expert in dyeing could not therefore be the skilled person because the very fact of choosing to introduce rare earth chelates by a dyeing process is the essential feature of the solution proposed. The dyeing expert would, however, be necessary to make the invention work. The implication of the reasoning in Jalon was therefore that the person skilled in the art for obviousness is not necessarily the same person skilled in the art for performing the invention once it is made.

31 T422/93

JALON/Luminescent Security Fibres [1997] EPO OJ 24 (21 September 1995).

Common General Knowledge 13

F. Documents Addressed A number of courts32 have emphasised that the skilled person, whilst knowledgeable, is very forgetful of material that is outside their common general knowledge – unless a piece of prior art is part of the common general knowledge, the skilled person is treated as only ever aware of one piece of prior art at any one time. The rule exists to prevent prior art being combined – ‘mosaiced’ – when addressing obviousness, unless to combine more than one piece of prior art is itself obvious.

II. Common General Knowledge A. Basic Principles The state of the art may reside in the common general knowledge of the person skilled in the art or the skilled team. A working definition of common general knowledge is provided by the Case Law of the Boards of Appeal: … common general knowledge is to be found in basic handbooks, monographs, encyclopaedias, textbooks and reference books. It is knowledge that an experienced person in the field in question is expected to have, or at least to be aware of, to the extent that he knows he could look it up in a book if he needed it.33

The common general knowledge is not, however, limited to documented information. It may also be too new to be recorded in textbooks34 and composed of several sources, such that it does not depend on the publication of any one document on a particular date.35 Instead, it may be simply a part of the unwritten ‘mental furniture’ of the skilled person36 and inferred from a number of sources.37 Such information must be unambiguous and directly and straightforwardly usable without further investigation being required.38 Solutions of general problems are viewed as forming part of the general technical knowledge attributed to the skilled person qualified in the specific technical field.39

32 For example, England and Wales and The Netherlands. For Germany, see Schulte Patentgesetz mit Europäischem Patentübereinkommen 10th edn (Cologne, Carl Heymanns, 2017) s 4 para 17 with further references. Similarly, in Spain, the Supreme Court has held that prior art documents may not be combined unless that specific combination is directed by the prior art or it would have been obvious to the skilled person (Accord & Sandoz v Astrazeneca 334/2016 (20 May 2016)); see also, Barcelona Commercial Court No 1 SCA Tissue France SAS v Industrie Cartarie Tronchetti Ibérica SL 84/2018 (26 March 2018). 33 Case Law of the Boards of Appeal of the European Patent Office, 2.8.1. 34 T 0051/87 Starting compounds/MERCK OJ [1991] EPO 177 (8 December 1988). 35 T 0786/00 Process for preparing polycarbonates/GENERAL ELECTRIC COMPANY (unpublished) (19 December 2001). 36 T 939/92 Triazole/AGREVO [1996] OJ EPO 309. 37 T 0786/00 Process for preparing polycarbonates/GENERAL ELECTRIC COMPANY (unpublished) (19 December 2001). 38 See T 149/07 System for surveillance/TELEFONAKTIEBOLAGET LM ERICSSON (unpublished) (20 November 2009). 39 T 195/84 General technical knowledge/BOEING [1986] OJ EPO 121 (10 October 1985). For example, in respect of technical standards, see T 519/12 Metal-containing transaction card and method of making the same/ AMERICAN EXPRESS TRAVEL RELATED SERVICES COMPANY INC (unpublished) (17 March 2017).

14 Skilled Person and Common General Knowledge Common general knowledge does not, however, ordinarily include patents and s cientific papers,40 unless these establish consistently that particular technical subject matter was generally known in the art at a particular date.41 The above approach is reflected in the statement describing common general knowledge in the English court by Luxmoore, J in British Acoustic Films: In my judgment it is not sufficient to prove common general knowledge that a particular disclosure is made in an article, or series of articles, in a scientific journal, no matter how wide the circulation of that journal may be, in the absence of any evidence that the disclosure is accepted generally by those who are engaged in the art to which the disclosure relates. A piece of particular knowledge as disclosed in a scientific paper does not become common general knowledge merely because it is widely read, and still less because it is widely circulated. Such a piece of knowledge only becomes general knowledge when it is generally known and accepted without question by the bulk of those who are engaged in the particular art; in other words, when it becomes part of their common stock of knowledge relating to the art.42

It has been commented, however, that ‘accepted without question’ in the above passage may be putting it too highly and that ‘generally regarded as a good basis for further action’ is preferable.43 In Germany, a skilled person may make use of the knowledge and skills they have acquired from their training and experience, in order to understand the prior art, what may be deduced from it and to apply it to find uninventive solutions to problems that arise in the relevant technical field.44 This knowledge is referred to as ‘general knowledge’. Similarly, in France, when assessing whether a skilled person would be unable to carry out the teaching of a patent without using inventive effort, they are entitled to rely on their own scientific and technical knowledge.45 In the Netherlands, the skilled person is also possessed of common general knowledge in the technical field of the invention at issue and may use it, for example, in order to reproduce the teaching of the prior art. However, the knowledge the skilled person would have is less clearly defined than in Germany and the UK.

B. Literature Searches and Databases i. Secondary Common General Knowledge It has been debated whether a second category of information, related to the common general knowledge, has developed in the English courts. This has been referred to as

40 For example, see T 1000/12 Method of supplementing animals with carotenoids by drinking water/ ZHEJIANG MEDICINE CO (unpublished) (17 December 2013). 41 T 0151/05 Method of producing a piston through casting / TOYOTA JIDOSHA KABUSHIKI KAISHA (unpublished) (22 November 2007). 42 Luxmoore J in British Acoustic Films & Ors v Nettlefold Productions (1936) 53 RPC 221. 43 Court of Appeal, General Tire v Firestone Tire & Rubber [1972] RPC 457 (28 July 1971). 44 BGH Warenregal 166/97 (29 February 2000); BGH Polymer Composition X ZR 134/11 (12 December 2012). 45 Cour d’Appel de Paris Sandoz v Eli Lilly 10/17727 (13 January 2012).

Common General Knowledge 15 ‘secondary common general knowledge’, per Sales J in Teva UK Ltd & Anor v A strazeneca AB,46 and consists of documents that the skilled person would quickly identify in a literature search: I was also taken to a range of journal articles which were not in leading journals in the field of respiratory medicine, and would not have been likely to have been read by the notional skilled person in the ordinary course of keeping himself up to date. On the other hand, these materials would have been quickly identified by any person conducting a literature search and review into the use of formoterol and ICS in relation to the treatment of asthma. I refer to these articles as the ‘secondary articles’. A question arises whether these materials should be taken into account in assessing the CGK of the notional skilled person. In my view, they should be.47

In the same case, the judge suggests that common general knowledge includes not just information directly in the mind of the notional skilled person and such information as they would be able to locate by reference to well-known textbooks, but also databases: This guidance needs to be adapted and kept appropriately up to date for the procedures for dissemination of scientific knowledge in the age of the internet and digital databases of journal articles. Searches of such databases are part and parcel of the routine sharing of information in the scientific community and are an ordinary research technique. In my view, if there is a sufficient basis (as here) in the background CGK relating to a particular issue to make it obvious to the unimaginative and uninventive skilled person that there is likely to be – not merely a speculative possibility that there may be – relevant published material bearing directly on that issue which would be identified by such a search, the relevant CGK will include material that would readily be identified by such a search.

This approach would open the scope of the common general knowledge to a potentially large number of documents. So while Carr J in Glaxosmithkline UK Ltd v Wyeth Holdings LLC48 voices approval of the above passage, he qualifies it sufficiently to bring it back into line with the definition of Luxmoore J in British Acoustic Films: [Sales J] does not mean that all material available on-line constitutes common general knowledge. Rather it indicates that material which the skilled addressee knows to be available on-line and which is generally accepted as a good basis for further action (such as material which might be found off-line in a textbook or a key journal article) may constitute common general knowledge.49

To be common general knowledge, therefore, the information must be widely read and widely accepted, rather than merely distributed widely by a database. Comparatively, this is a narrower approach to databases than that taken by the TBA (see The TBA Approach to Databases, subsection C below). In addition, the English Court of Appeal has tended to disagree with the idea that information the skilled person knows they can look up as a

46 Patents

Court, Teva UK Ltd & Anor v Astrazeneca AB [2014] EWHC 2873 (2 September 2014). para 58. 48 Patents Court, Glaxosmithkline UK Ltd v Wyeth Holdings LLC [2016] EWHC 1045 (Ch) (12 May 2016). 49 ibid, para 30. 47 ibid,

16 Skilled Person and Common General Knowledge matter of routine is part of the common general knowledge. Instead, the court considers this to be part of the question of obviousness: Mr Silverleaf sought to characterise the sort of information which a person skilled in the art would know he could look up as a ‘species of or extension of … common general knowledge.’ But that is not correct – as Arnold J made clear. It will be taken into account for an obviousness assessment not because it is in the notional head of the notional person but because it would be obvious to such a person to look it up.50

The correct approach to such information is instead that set out in KCI Licensing Inc & Ors v Smith & Nephew Plc & Ors: … even if information is neither disclosed by a specific item of prior art nor common general knowledge, it may nevertheless be taken into account as part of a case of obviousness if it is proved that the skilled person faced with the problem to which the patent is addressed would acquire that information as a matter of routine. For example, if the problem is how to formulate a particular pharmaceutical substance for administration to patients, then it may be shown that the skilled formulator would as a matter of routine start by ascertaining certain physical and chemical properties of that substance (e.g. its aqueous solubility) from the literature or by routine testing. If so, it is legitimate to take that information into account when assessing the obviousness of a particular formulation. But that is because it is obvious for the skilled person to obtain the information, not because it is common general knowledge.51

In summary, if a skilled person knows where to find a document it may be common general knowledge if what is found reflects what is widely read and accepted as a good basis for further action. Aside from these documents, matter that is sought as a matter of routine, such as a literature search, is instead only to be taken into account when assessing obviousness.

ii. The TBA Approach to Databases The TBA has stated that when identifying common general knowledge it would take undue effort for the skilled person to search literature covering most of the state of the art.52 As regards databases, however, the TBA criteria are seemingly broad enough to catch most resources. In Chimeric gene/BAYER T 890/02,53 the Board concluded that whilst they are not encyclopaedias and handbooks in a strict sense, databases: (a) which are known to the skilled person as an adequate source for obtaining the required information; (b) from which this information may be retrieved without undue burden; and (c) which provide it in a straightforward and unambiguous manner without any need for supplementary searches, do represent the common general knowledge of the skilled

50 Court of Appeal, Richter Gedeon Vegyeszeti Gyar RT v Generics (UK) Ltd (t/a Mylan) [2016] EWCA Civ 410 (26 April 2016). 51 Patents Court, KCI Licensing Inc & Ors v Smith & Nephew Plc & Ors [2010] EWHC 1487 (Pat) (23 June 2010). 52 See T171/84 Redox Catalyst/ AIR PRODUCTS [1986] OJ EPO 95 (24 October 1985) and T676/94 Radial tyre/SUMITOMO (unpublished) (6 February 1996). 53 T 890/02 Chimeric gene/BAYER [2005] OJ EPO 497 (14 October 2004).

Towards Common Ground in the UPC 17 person. Similarly, under German law, the common general knowledge also comprises knowledge that the skilled person can easily obtain from accessible resources such as basic handbooks and textbooks and databases.54

C. Local Common General Knowledge As in Germany, the TBA does not make a distinction between the common general knowledge known by the skilled person in one geographical area and that known in another. For example, it is the view of the TBA that the language of publication alone cannot be decisive for the admissibility of a technical book representing the common general knowledge of the skilled person. Otherwise, there would be a prejudicial differentiation between skilled persons’ knowledge according to their nationality.55 The English Patents Court has taken a different view, stating that when applying the common general knowledge to a UK patent, it must ‘at minimum’ be shown to be common general knowledge in the UK: … The reason for this is that, whether one is concerned with the validity of a European Patent (UK), or a UK patent, one is concerned with a right in respect of the UK. It is true that the prior art may have been published anywhere in the world, but I do not think that alters the need for the skilled team to consider that art as if they were located in the UK. I do not think it matters that a fact was common general knowledge in (say) China, if it was not common general knowledge here. The position may be different if all the persons skilled in a particular art in the UK are acquainted with the position in China, but no point of that kind arises here.56

III. Towards Common Ground in the UPC The skilled person and the common general knowledge are nowhere mentioned in the UPC Agreement. It is clear, however, from the discussions of determination of scope of protection of claim and validity in the following chapters, that these concepts will be required when assessing these issues in the UPC. The detail of these concepts as they apply in the UPC is to be worked out in practice, but the following characteristics can be summarised from the national courts and the EPO.

A. The Skilled Person The Boards and the national courts all share the concept of the skilled person, or team, although there are differences in terminology. There is no shared definition, although 54 ibid. 55 T 0426/88 Combustion engine/LUCAS [1992] OJ EPO 427 (9 November 1990). 56 Patents Court, Warner-Lambert Company LLC v Actavis Group PTC EHF & Ors [2015] EWHC 2548 (Pat) (10 September 2015); See also, Patents Court, Teva UK Ltd v Merck & Co Inc [2009] EWHC 2952 (Pat) (20 November 2009).

18 Skilled Person and Common General Knowledge the most universal attempt at such a definition can be found in the Guidelines for Examination – the person skilled in the art: should be presumed to be an experienced practitioner who has average knowledge and abilities and is aware of what was common general knowledge in the relevant art concerned at a particular time (average skilled person). He should also be presumed to have had access to everything in the state of the art, in particular the documents cited in the search report, and to have had at his disposal the normal means and capacity for routine work and experimentation.

Whether the skilled person is thought of as a ‘nerd’, unimaginative, average or otherwise, however, the important connecting characteristic across these jurisdictions must be that the skilled person is uninventive. Indeed, they are cautious and conservative. This is of course crucial when it comes to questions of whether the skilled person or team would think an invention obvious for the purpose of Article 56 EPC. Despite the skilled person’s lack of invention, they do know the prior art relevant to any particular invention, albeit that they can only contemplate one piece at a time, unless it is obvious to combine them or they are directed by the prior art in question to do so – ‘mosaicing’ is generally not permitted. The skilled person possesses a faultless common general knowledge relevant to their technical field and is able to bring this to bear on a disputed patent in order to understand its teaching and its claims. Where the skilled person’s knowledge does not match the full extent of subject matter of a patent, it can be complemented by other skilled people in the team. The TBA has set out principles by which a skilled person may be taken to have knowledge of associated technical fields,57 or to ask for advice from such people. Care needs to be taken that the skilled person or team is selected according to the technical problem to be solved rather than the solution proposed by the invention, where these differ. Consideration should also be given to whether the area of technical knowledge of the skilled person is different when assessing obviousness and sufficiency.

B. Common General Knowledge The common general knowledge attributed to the skilled person or team at the priority date of a patent again differs slightly in terminology and identity in the national courts and the EPO. The Boards again provide a useful starting point: … common general knowledge is to be found in basic handbooks, monographs, encyclopaedias, textbooks and reference books. It is knowledge that an experienced person in the field in question is expected to have, or at least to be aware of, to the extent that he knows he could look it up in a book if he needed it.

This definition should be read broadly; the common general knowledge is not limited to information that is specifically documented – it may be the unwritten ‘mental furniture’ of the skilled person. Indeed, the common general knowledge does not usually include patents and scientific papers, unless these show that the subject matter was generally 57 Cour d’Appel de Paris, L Steinhardt and Ors v Ste ISD environnement & Ors PIBD 2002,742 III, 217 (19 November 2001).

Towards Common Ground in the UPC 19 known in the art at the relevant date; and, that it was generally accepted or regarded as a good basis for further action. In the UK, the courts have considered whether there is a second category of common general knowledge, which consists of documents that the skilled person would quickly identify in a literature search. This idea reflects in particular the availability of digital databases. Latterly, the UK courts seem to have adopted the more restrictive, and traditional view, that documents found in this way must nonetheless be widely read and widely accepted, rather than merely distributed widely, if they are to conform with common general knowledge – what and what are not routine steps for the skilled person to take is a matter of obviousness. The point may be contentious: the TBA appears to accept that the contents of databases are common general knowledge, providing the database is known to the skilled person as an adequate source of the required information, it can be retrieved without undue burden and it is retrievable in a straightforward and unambiguous manner.

2 Scope of Protection of Patent Claims I. Statutory Basis Article 69(1) EPC governs the scope of the protection conferred by European patent claims and their interpretation. The scope of protection is determined by the claims. The description and drawings are used to interpret the claims. Article 69 must itself be understood according to 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 Protocol requires that a middle-way is found between the two extreme approaches that it describes. One extreme adopts a literal approach in which the words used in the patent are either: restricted to their meaning, as interpreted by the patent and surrounding circumstances (contextual); or, alternatively, ‘the meanings assigned to the words by a dictionary and to the syntax by a grammar’ (acontextual).1 According to this approach, the words used by the patent draftsman are intended to mark out the claims of the patent precisely. 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 they thought they had claimed is excluded by a strict and unforgiving construction of the language of the claim. The other extreme is liberal: the wording of the claims is only taken as a guideline, to be read together with the specification and drawings. It aims to identify the ‘inventive concept’ that the patent protects. This approach will provide ample protection for the patentee, but it leaves third parties in doubt as to the activities that may infringe. The difficulty in applying the Protocol is finding the middle way between these two approaches: ‘Like the hippopotamus, the median position is difficult to define but the hope is that the man skilled in the art will recognise it when he sees it.’2

1 H

Laddie, ‘Kirin Amgen – the End of Equivalents in England?’ (2009) 40(1) IIC 3–38. at 30.

2 ibid

General Principles of National Law on the Doctrine of Equivalents 21 A particular concern with the literal approach is that it is likely to exclude immaterial variants, otherwise referred to as ‘equivalents’. An equivalent is generally understood to be a small variation of a product or process, which uses the patented inventive concept, but without literally infringing the language of the patent claim – the product or process lies outside the claim, strictly construed. To expressly address equivalents, the Protocol was revised to add Article 2 in the EPC 2000: ‘…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.’3 How ‘due account’ is given to equivalents in a clear and structured way goes to the central issue of how the scope of protection of patent claims should be determined. The approaches of England and Wales, France, Germany and the Netherlands to this important question are examined in this chapter.

II. General Principles of National Law on the Doctrine of Equivalents4 A. England and Wales i. The Introduction of a Doctrine of Equivalents The specific mention of equivalents in Article 2 of the Protocol in EPC 2000 was a source of interest in the UK, because at the time it was introduced a ‘doctrine of equivalents’ was not considered a part of the law. Shortly before Article 2 came into force, but aware that it was coming, the House of Lords had held that Article 69 EPC ‘shuts the door on any doctrine which extends protection outside the claims’.5 Thus, any determination of scope of protection was considered to be limited by the claim language, with equivalents merely providing context.6 With the Actavis UK Limited v Eli Lilly 3 By the Munich Amendment Act to the European Patent Convention, 29 November 2000. 4 See also the Federal Supreme Court of Switzerland Urinalventil II 4A_131/2016 (3 October 2016), for the three-step function, accessibility and equal value test applied to the determination of equivalents in Switzerland: ‘does the replacing feature objectively have the same technical function as the replaced feature?; starting from the teaching of the patent, is it evident for the skilled person that the replacing feature has the same technical effect as the replaced feature? Considering the claim language in light of the description, would the skilled person have taken the replacing feature into account as being an equivalent solution?’ As regards the approach likely to be taken by the Spanish courts to the doctrine of equivalents, see Paragraph 97 of the Supreme Court in Actavis v Eli Lilly: ‘So far as Spanish law is concerned, it is common ground that the Spanish courts have followed the United Kingdom approach, which leads to the difficult question whether one should assume that they would follow this decision in modifying the Improver questions and in particular the second question. I incline to the view that judicial comity would tend to suggest that the Spanish courts would follow this court in modifying the Improver questions, not least because this appears to render the UK courts and therefore the Spanish courts more consistent with the German and Dutch courts, and no more inconsistent with the French and Italian courts.’ 5 House of Lords, Kirin-Amgen Inc v Hoechst Marion Roussel Ltd [2004] UKHL 46 (21 October 2004). 6 Per Lord Hoffmann, ibid, at para 49: ‘Although Article 69 prevents equivalence from extending protection outside the claims, there is no reason why it cannot be an important part of the background of facts known to the skilled man which would affect what he understood the claims to mean. That is no more than common sense. It is also expressly provided by the new Article 2 added to the Protocol by the Munich Act revising the EPC …’

22 Scope of Protection of Patent Claims and Company7 decision of the Supreme Court, this approach has changed. Actavis v Eli Lilly concerns European patent EP 1 313 508, claiming a combination of p emetrexed disodium with vitamin B12 for the prevention of the growth of tumours. Actavis sought declarations that its proposed pemetrexed diacid, pemetrexed dipotassium and pemetrexed ditromethamine products would not infringe this patent. The focus of the case was on the limitation of the language ‘pemetrexed disodium’ – does the scope of the claim nonetheless extend to pemetrexed dipotassium, pemetrexed diacid or pemetrexed ditromethamine? Overturning the lower court decisions, the UK Supreme Court held that there is direct infringement of the pemetrexed disodium claims by these alternatives (see also Case Comparison, section IV below). In doing so, the court states that direct infringement cannot be determined solely by whether a product or process falls within the language of the claim. Instead, equivalents must be taken into account as a second step. The court must therefore ask: (i) does the variant infringe any of the claims as a matter of normal interpretation of the language used by the claims;8 and, if not, (ii) 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. This approach, the court says, complies with Article 2 of the Protocol, because issue (ii) squarely raises the possibility of infringing equivalents, but limits their inclusion within the claim to those variants which are immaterial to the invention. It is also apparent that the Supreme Court believes this two-step approach balances the competing interests of the patentee with the need for clarity for third parties. As regards step (i), the correct approach remains that of purposive construction – what would the person skilled in the art have understood the patentee to be using the language of the claims to mean?9 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: (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;

7 Supreme Court, Actavis UK Limited v Eli Lilly and Company [2017] UKSC 48 (12 July 2017). 8 Patents Court, Liqwd Inc & Anor v L’Oréal (UK) Ltd & Anor [2018] EWHC 1394 (Pat) (11 June 2018). Birss J notes, obiter, that the other judges of the English Patents Court have all expressed the view that the first step of the approach to construction in Actavis is purposive rather than literal. However, that approach, as set out by the House of Lords in Kirin Amgen, was already supposed to take account of equivalents. So, the judge sees scope for debate about whether the new first step approach is precisely the same as every nuance of the process of the determination of claim scope prior to Actavis. However, this seems to have been clarified by the Court of Appeal in Icescape Ltd v Ice-World International BV & Ors [2018] EWCA Civ 2219 (10 October 2018) (see below). 9 Court of Appeal, Icescape Ltd v Ice-World International BV & Ors [2018] EWCA Civ 2219 (10 October 2018).

General Principles of National Law on the Doctrine of Equivalents 23 (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; (viii) 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; (ix) it further follows that there is no general ‘doctrine of equivalents’; (x) 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; (xi) finally purposive construction leads one to eschew the kind of meticulous verbal analysis which lawyers are too often tempted by their training to indulge.10

The Guidance in Virgin Atlantic predates the authority of Actavis v Eli Lilly, and to some extent, for example in point (x), they overlap. However, with the exception of point (ix), specifically, Virgin Atlantic remains good law for construing the language of claims purposively.11

ii. Determining Immaterial Variants Further to introducing the second step (ii), Actavis v Eli Lilly provides guidance on how to identify an immaterial variant equivalent to a feature of the claim. The Supreme Court does so by adopting, in amended form, a set of already existing tests – the ‘Protocol/Improver Questions’.12 These three amended questions – ‘Actavis Questions’ – are as follows: 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? 10 Court of Appeal, Virgin Atlantic Airways Ltd v Premium Aircraft Interiors Group Ltd [2009] EWCA Civ 1062 (22 October 2009). 11 Patents Court, Garmin (Europe) Limited v Koninklijke Philips NV [2019] EWHC 107 (Ch) (29 January 2019). 12 See Court of Appeal, Wheatley & Anor v Drillsafe Ltd & Ors [2000] EWCA Civ 209 (5 July 2000).

24 Scope of Protection of Patent Claims 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 establish infringement in a case where there is no infringement on the purposive construction, a patentee would have to show that the answer to the first two questions is ‘yes’ and that the answer to the third question is ‘no’. The Supreme Court suggests in Eli Lilly v Actavis 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. This observation becomes a touchstone of the Court of Appeal decision in Icescape Ltd v Ice-World International BV & Ors,13 which applies Actavis to hold that, had it not been invalid, the patent in question would have been infringed using the doctrine of equivalents, but not on a purposive construction.

iii. The Inventive Core of the Patent In Icescape, the problem addressed by the patented invention was that the installation and dismantling of conventional ice-rink coolant systems requires all of the various components to be assembled and then disassembled; a laborious, relatively time consuming and expensive process. Leakage could also occur as a result of the need to assemble all of the different components, causing delay. The invention of the patent addressed this problem by providing 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. The claimed cooling system comprised 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, as shown in Figure 2.1. The various pipes of the invention are connected to one another in a fluid-tight manner via flexible joint members. It is these flexible joint members that allow the connected pipe sections to fold relative to each other for the purposes of transportation. In particular, 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’. In other words, the manifold pipes are connected in series in the patent. It was this feature, in particular, in integers D and E of claim 1 of the patent, that Icescape argued was not present in its ice-rink cooling system. Although there were foldable joints between the pipes in the Icescape system, by contrast to the patent the feed and discharge manifolds of Icescape’s system were configured in parallel, as shown in Figure 2.2.

13 Court of Appeal, Icescape Ltd v Ice-World International BV & Ors [2018] EWCA Civ 2219 (10 October 2018).

General Principles of National Law on the Doctrine of Equivalents 25 Figure 2.1 The cooling system claimed in Icescape Flexible joint 71 member

72

Longitudinal pipes

40

Feed manifold

53

43 1

68

47

65

51 66

68'

54

69'

Connector

63 51

67

48

45

Discharge manifold

60

50 61

56

Fluid-tight coupling members, connecting manifolds in series

50

69 69'

68'

54 44 53 55

70

46

42

63' 67

Figure 2.2 The defendant’s cooling system in Icescape BD

Feed manifolds in parallel

BF

F1 D1

F2 D2

F2

P D2

F3 D3

F2 D2

F3

D3

D3 c

E2

F2

Discharge manifolds in parallel

c

c

E1

F3

x

F3

F1

E3 P

c

x D3

D2

D1

The Court of Appeal agreed that on a purposive reading of the two integers D and E, in light of the teaching of the specification and the common general knowledge, the two manifolds of the invention connect together in series so that the fluid does not leak as it flows between them from one to the other. This was not the same as the parallel configuration of the manifolds in the Icescape system. The court then turned to what it called the ‘Actavis Questions’: a. Actavis Question 1 Does the icescape system achieve the same result in substantially the same way as the patented invention?

26 Scope of Protection of Patent Claims On this question, the court had regard to the problem underlying the invention and the patent’s inventive core. The inventive core of the patent was the provision of a joint member. This forms a connection between the rigid pipe sections which are fluid-tight and flexible and allows the connected pipe sections to fold relative to one another for the purposes of transportation. In the court’s judgment it was this feature which made the patented system different from the conventional systems in the common general knowledge. By contrast, integers D and E were simply common general knowledge ways of implementing that invention. Focusing on the inventive core, the court was satisfied that the variant achieved the same result in substantially the same way as the invention. It satisfied the aims of the patent: to provide a cooling member which can be installed rapidly and is reliable in operation; with which it is possible to proceed rapidly to the ice-forming stage; and, with which a mobile ice-rink can be made with a large number of different surface areas. Whilst it was true that the Icescape system had a parallel rather than a series connection between the manifolds and that this may confer certain advantages as well as disadvantages, this had nothing to do with the inventive core of the patent. The first Actavis Question was answered in the affirmative. b. Actavis 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. Indeed, the court thought the variant would achieve the same result in precisely the same way. c. Actavis 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, is an essential requirement of the invention? The court stated that the fact that the language of the claim does not cover the Icescape system is not enough to justify holding that it does not satisfy this question. It must also be considered whether integers D and E are an essential part of the invention. Here, the court had regard again to the inventive core of the patent. Because the inventive core of the patent had nothing to do with the coupling of the elements together or whether the fluid flows through them in series or in parallel, the court answered this question ‘no’.

B. France Article 69 EPC, as amended by EPC 2000, is codified in French law.14 The doctrine of equivalents is not codified but has been widely adopted and understood by the French courts to mean that the scope of protection of claims includes variants that have the same function and achieve the same result as those embodiments within the express

14 Art

L.613-2 Intellectual Property Code.

General Principles of National Law on the Doctrine of Equivalents 27 language of the claim. For the doctrine to apply in France, the court must first assess whether the function of that means is new,15 meaning not in the state of the art at the day of filing or priority.16 If the means is already known to the art, the scope of protection is limited to the means presented in the claim. An example is the claim to detect HIV with a particular DNA fragment probe, using a specific means of DNA/RNA hybridization.17 The function of this specific means was known to the art at the priority date. It followed that the claim could not be interpreted as protecting other methods of hybridization that are not claimed but achieve the same function. Case law applies the doctrine of equivalents regularly, even more so given claims that are drafted with reference to the function performed by the means claimed. It has also been pointed out many times that any means performing the same function for the same technical result are considered equivalent and covered by the claim.18 The three qualifying criteria for equivalence have recently been re-stated by the Supreme Court:19 –– the novelty of the function claimed in the patent; –– the means, even with different forms, perform the same function; –– in order to obtain the same result. If new, therefore, two means are equivalent when, even with a different form, they have the same function and achieve the same result.20 The identity of the function of the means is the key element of the doctrine of equivalents. Indeed, differences between the infringing product and the claimed product do not matter if those differences relate to an element which performs the same first technical function as the one of the invention.21 If the patent covers the means only considering its form but not considering its f unction, the means cannot be infringed. Once the means have the same function, equivalent means must produce results of the same nature. The third condition is, however, unclear as regards degree or quality. Recently, on one hand the Court of Appeal22 has followed the Supreme Court by considering that the result has to be identical but, on the other hand, it has allowed for the result to be similar,23 of the same nature or degree24 and even imperfect due to a lack of know-how.25 Consequently, it

15 Cour de Cassation, commercial chamber, 20 November 2007, 06-17915 and Cour de Cassation, commercial chamber, 26 February 2008, 05-21452. 16 Jérôme Passa, Droit de la propriété industrielle, Tome 2 (Paris, LGDJ, 2013) 523 and Paul Mathely, Le nouveau droit français des brevets d’invention, Tome 1 (Paris, Librairie du Journal des notaires et des avocats, 1991) 118; Cour d’Appel, Paris, 28 November 2017, 15/12176. 17 Cour de Cassation Institut Pasteur v Chiron Healthcare S 09-15668 (23 November 2010); compare Cour de Cassation B2M Industries v Acome 06-17915 (20 November 2007), in which a means was found to be equivalent to a novel integer because it performed the same function and produced the same result as that claimed in the patent. 18 Cour de Cassation 91-20417 (26 October 1993); Cour de Cassation 94-13790 (16 January 1996); Cour de Cassation 02-18650 (31 March 2004); Cour de Cassation 10-30907 (2 November 2011). 19 Cour de Cassation 16-20644 (27 June 2018). 20 Mathely, n 16, 417. 21 Passa, n 16, 523. 22 Cour d’Appel, Paris, 17/01202 (4 December 2018). 23 Cour d’Appel, Paris, 15/12176 (28 November 2017). 24 Cour d’Appel, Paris, 17/06356 (16 October 2018). 25 Cour de Cassation, 16-28322 (23 January 2019).

28 Scope of Protection of Patent Claims appears that in order to assess infringement by equivalents, one should concentrate on the sole means which has a different form in the product in question in relation to the patented invention. Then, it is necessary to compare the function – the primary technical effect26 – of this sole means to the function of the means of the patent. It is only in the event of a reproduction of the function of the means of the patent by a means of the product, that the results of these two means will be examined. The Supreme Court only controls the characterization of the equivalence of the means. Indeed, the judge does not have to consider whether the replacement of the means was obvious to the skilled person in the art, nor to examine the patentee’s intention when drafting the claims, or in the context of the examination.27

C. Germany The principles developed by the German Supreme Court place the claims as the decisive basis for determining claim construction – the extent of protection must align with the claims.28 However, because claims must include equivalents, further to Article 2 of the Protocol, it is not possible to provide the optimum of certainty for third parties in the way that would be provided by literal attention to claims. For this purpose it must be determined whether: the objective person skilled in the art using their expert knowledge, on the basis of considerations linked to the meaning of the claims – that is to the invention described therein – is able to arrive at the modified embodiment as having the same effect for the purposes of solving the problem underlying the invention.29 Whether the variant is equivalent in Germany is determined according to the approach exemplified by Schneidmesser I.30 This requires a positive answer to be given to each of the following three steps (sometimes referred to as the ‘Schneidmesser Questions’):31 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

26 Mathely, n 16, 118. 27 J. Azéma and J.-C. Galloux, Droit de la propriété industrielle, 7th edn, (Paris, Dalloz – Precis, 2012) 444 and Cour d’Appel de Paris 88.18686 (31 May 1990). 28 P Meier-Beck, ‘The Scope of Protection – the Test for Determining Equivalence’ (2005) 36(3) ‫ۥ‬ICC 339–44. 29 BGH Formstein X ZR 28/85 GRUR 1986, 803 (29 April 1986); BGH Ionenanalyse, GRUR 1988, 896. 30 Indeed, the decision Schneidmesser l X ZR 168/00 GRUR 2002, 515 is only one of a series of BGH decisions that were delivered on 12 March 2002 that identically phrased the questions. The decisions are Kunststoffrohrteil X ZR 43/01 GRUR 2002 511; Schneidmesser II X ZR 135/01 GRUR 2002 519; Custodiol I X ZB 12/00 GRUR 2002 523 and Custodiol II X ZR 73/01 GRUR 2002 527. Schneidmesser I is usually regarded as the lead decision. 31 See for example P Meier-Beck, ‘Aktuelle Fragen der Schutzbereichsbestimmung im deutschen undeuropäischen Patentrecht’ (2003) GRUR 907 and K Grabinski ‘“Schneidmesser” versus “Amgen” Zum Sinn oder Unsinn patentrechtlicher Äquivalenz (2006) GRUR 716.

General Principles of National Law on the Doctrine of Equivalents 29 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?32 As regards step 1, the more broadly the advantages/effects of the invention can be defined, the broader the scope of protection. These effects must be determined by interpreting the patent. Furthermore, it is not only the intended overall effect of the invention that must – at least essentially – be achieved, but also the effects of every single feature of the claim. The effects of the features may be more specific, but they must also be achieved by the variant to a practically relevant extent. 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 ‘Formstein33 objection’, a relation to the Gillette defence in England and Wales and the Netherlands) 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. It has been noted that the Schneidmesser Questions resemble the UK Protocol/ Improver Questions,34 as they were formulated before Actavis, in particular as regards the similarity of the second step to the second Protocol/Improver Question: at least if we understand the word ‘obvious’ in the Improver test as we understand it in Art.56 EPC, i.e. meaning that no inventive step is needed. For, just like applying Art.56, we have to exclude those cases where an inventive step is necessary to find the modified means as having the same effect.35

While the German courts do apply their inventive step test for the second step, this now appears to be a point of difference to the second question in the UK Actavis approach (see subsection A, England and Wales). However, like the UK, the German courts assess this step at the priority date, but agree that infringement by equivalents is not limited to foreseeable variants only. As regards the third step, the German Supreme Court has 32 Schneidmesser I as translated into English by P Meyer in F Van Helsen et al, Europe’s Courts Converge on Non-literal Infringement Managing Intellectual Property, Life Sciences Focus, Supplement, 2005; Meier-Beck, ibid, at 343 offers a different translation: ‘Are the considerations that the person skilled in the art had to apply oriented to the technical teaching of the patent claim in such a way that the person skilled in the art took the variant into account as being an equivalent solution?’ ' 33 BGH Formstein X ZR 28/85 GRUR 1986 803 (29 April 1986). 34 The reason for the similarities is that, in formulating this approach, the German court was to some extent influenced by the English cases of Catnic Components Ltd v Hill & Smith Ltd [1981] FSR 60 (27 November 1980) and Improver Corporation v Remington Consumer Products Ltd [1990] FSR 181 (12 August 1988), and was consciously making a step towards an approach concerned as much with claim language as pure inventive concept. 35 Meier-Beck, n 28,342 and 343.

30 Scope of Protection of Patent Claims recently explained this in terms very similar to those used in the third Actavis Question: whether the person skilled in the art understands that strict compliance with the wording of the claim is an essential requirement of the claimed invention.36 As in the UK, this is a very fact specific question and is often the step on which the decision turns. The German courts have placed limitations on the doctrine of equivalents. The Supreme Court in Okklusionsvorrichtung,37 and in Diglycidverbindung,38 strengthened the applicant’s responsibility to clearly formulate their patent claims and defined tighter requirements for patent infringement under the doctrine of equivalents. In particular, the Supreme Court has pointed out that: in cases of contradiction between the claim language and the patent description, in particular in the case of a specific selection by the claim language for only one embodiment out of several embodiments described in the patent specification, the person skilled in the art will consider this selection when assessing equivalence under Schneidmesser Question 3 – embodiments not selected in the claim language do not fall within the scope of protection of the patent and there is no infringement under the doctrine of equivalents. In its Pemetrexed39 decision the Supreme Court has subsequently limited the application of this rule (see also section V, Case Comparison). According to the Supreme Court, a selection decision – which excludes patent infringement under the doctrine of equivalents – can only be assumed if the selection was made to distinguish the invention from prior art. The specifically disclosed but not claimed embodiment is disclaimed. However, this rule does not generally apply in cases where the specification points to other possible, but not specifically disclosed, embodiments without claiming them. In these cases a conscious decision of the patentee to select an embodiment can only be assumed on the basis of the circumstances, for example if the claimed embodiments have specific advantages that distinguish them from other possible, but not claimed embodiments. Pemetrexed therefore presents a wider doctrine of equivalents than the more limited scope it was thought to have on the basis of Okklusionsvorrichtung.

D. The Netherlands i. The ‘Essence of the Invention’ to the ‘Inventive Concept Behind the Wording of the Claims’ Historically, in the Netherlands, the approach followed to determining the scope of claims was the Supreme Court decision in Philips v Tasseron.40 Here, the Court held that the scope of protection of a patent must be based on the ‘essence of the invention’ (‘het wezen van de uitvinding’). This approach allowed the scope of protection of a claim to be broader than the wording of the claim itself. The effect was to make it difficult for third parties to rely on the wording of the claims to know whether they were working within

36 BGH,

Pemetrexed X ZR 29/15 GRUR 2016 921 (14 June 2016). Okklusionsvorrichtung X ZR 16/09 GRUR 2011 701(10 May 2011). 38 BGH, Diglycidverbindung X ZR 69/10 GRUR 2012 45 (13 September 2011). 39 ibid. 40 Hoge Raad, Philips v Tasseron NJ 1930/1217 (20 June 1930). 37 BGH,

General Principles of National Law on the Doctrine of Equivalents 31 their scope of protection and therefore infringing. Despite the introduction of the EPC and Article 69 and the Protocol, the Dutch courts remained reluctant to move away from placing the essence of the invention at the heart of their method of assessing the scope of protection.41 This changed to only a limited extent in Ciba-Geigy v Oté Optics,42 in which the Supreme Court changed its emphasis from the essence of the invention to the ‘inventive concept behind the wording of the claims’ (‘de achter de woorden van de conclusies liggende uitvindingsgedachte’). There were four factors which the Supreme Court, in Ciba-Geigy vs Oté Optics, ruled must be used to assess the scope of protection: 1. 2. 3. 4.

in interpreting the terms of the claims, the court is to determine the essence of the invention; in other words, consider the inventive concept behind the wording of the claims; this interpretation then needs to be corrected to give a reasonable degree of certainty for third parties, which may sometimes justify a restricted, literal interpretation of the wording of the claims; the skilled person may – with restraint – use the prosecution history file for the purpose of claim interpretation; and all other circumstances of the case are to be taken into account, including the possible breakthrough nature of the invention (justifying a broader scope). When considering factors 2 and 3, poor drafting of the patent may be construed to be to the patentee’s disadvantage.43

ii. Essence of the Invention is a ‘Viewpoint’ This continues to be the approach of the Supreme Court, although it has more recently clarified that the essence of the invention is a ‘viewpoint’ rather than the ‘starting point’ by which scope of claims must be determined.44 However, the decision in Medinol demonstrates that this viewpoint may nonetheless be the dominant factor in an assessment. The essence of the invention in the Medinol case was the solution to the problem that out-of-phase stents shorten when expanded, which was not perceived as a problem for in-phase stents at the priority date. Therefore, the Supreme Court held, the in-phase variant could not be included within the scope of the claim. The District Court of the Hague has since explained the Supreme Court’s reasoning in Medinol as follows: [T]he scope of protection of a European patent is established on the basis of the skilled person’s perspective on the first [priority/filing] date in view of … aforementioned principles (also named the contextual interpretation). Equivalents already known at that moment will be involved in this interpretation. The question to be answered thereafter, whether a product or method should be considered infringing, takes, in principle, place on the basis of the scope of protection on the first date, as established by the contextual interpretation. The possibility of additional protection by equivalence will be limited, as equivalents known to the skilled person have already been involved in the contextual interpretation on the first date.

41 Hoge Raad, Meyn/Stork NJ 1989/506 (27 January 1989). 42 Hoge Raad, Ciba-Geigy v Oté Optics NJ 1995/391 (13 January 1995). 43 The approach is clarified by the Hoge Raad in Van Bentum/Kool NJ 2002/530 (29 March 2002) to say that the skilled person can only assume that the patentee has surrendered a part of the patent protection if there is a ‘proper ground’ to do so. 44 Hoge Raad Lely/Delaval C06/054HR (7 September 2007); AGA v Occlutech 11/00304 (25 May 2012); Medinol v Abbott 13/00522 (4 April 2014).

32 Scope of Protection of Patent Claims Such a possibility only seems to exist in case of equivalents which were not foreseeable at the first date, which can then be involved in the infringement question and, if appropriate, brought within the scope of protection.45

In practice, however, the lower courts have tended towards an approach that distinguishes literal infringement from non-literal infringement by equivalents. To assess non-literal infringement the courts often use: the ‘function-way/means-result’ test46 – does the non-literal variant fulfil the same function as the patented one, by using similar means, leading to a similar result, which is in essence the first Protocol/Improver question; or, the insubstantial differences test (more easily applied to chemical and biochemical cases), which assesses whether the differences between the allegedly infringing article or process and the claim are material? In applying these tests the court takes care that any protection outside the literal wording of the claims does not go outside the invention (and as such the approach remains in line with the Supreme Court). However, concerns about providing certainty for third parties have persisted and it has become rarer to see cases in which infringement is held on the basis of equivalence. Most recently, in his advice to the Supreme Court in the Bayer/Sandoz case (see subsection iii below, The Dutch Approach Confirmed in AstraZeneca/Resolution) Advocate-General Van Peursem states that by applying these tests it will always be necessary to establish the meaning of the claims in light of the description and the drawings as understood by the skilled person using his knowledge of the prior art. The Dutch courts also apply a ‘disclosed but not claimed is disclaimed’ rule, which has the practical impact that if the application discloses a certain product or feature as a possible variant it should also be claimed.

iii. The Dutch Approach Confirmed in AstraZeneca/Resolution In the Netherlands the latest Supreme Court judgment is in the case of AstraZeneca/ Resolution,47 but this judgment mainly reiterates the rules established in Bayer/Sandoz.48 Bayer is the holder of two European patents for a method of preparation of drospirenone, the active ingredient in Bayer’s contraceptive pill sold under the brand name Yasmin. Sandoz offered for sale a generic version of Yasmin, EE/DRSP Sandoz. Bayer initiated preliminary injunction proceedings which Sandoz defended by raising an invalidity defence. The invalidity defence was dismissed by the preliminary injunction judge and the patents were found valid and infringed, and an injunction was granted. Sandoz then developed a workaround, which instead of using metal salt ruthenium as a catalyst as claimed in the first patent, used an organic compound named TEMPO. Furthermore, Sandoz did not separate water by adding pTSA as claimed in the second patent, but with the weak base pyridine with water. Bayer again sued Sandoz for infringement in preliminary injunction proceedings, on the basis that the workaround method is equivalent to the claimed method. The preliminary injunction judge dismissed this claim. The Court of Appeal agreed, ruling that the skilled person would assume Bayer had knowingly chosen to claim the ruthenium salt and therefore that the scope of protection does not

45 Rechtbank

Den Haag, MBI/Shimano, Berichten IE 2014 / 7 – 8 173 (8 October 2014). Raad, Dreizler v Remeha NJ 1995, 392 (13 January 1995). Raad, AstraZeneca/Resolution NJB 2018/1195 (8 June 2018). 48 Hoge Raad, Bayer/Sandoz 5 NJ 2016/496 (February 2016). 46 Hoge 47 Hoge

General Principles of National Law on the Doctrine of Equivalents 33 extend to use of the variant TEMPO. With respect to the second patent the Court of Appeal decided that the skilled person would understand the patent to be limited to only the use of the specific acid pTSA, which would exclude from the scope of protection the use of other products such as pyridine with water. The case was appealed to the Supreme Court to rule on whether the Court of Appeal applied the law correctly. Advocate-General Van Peursem advised the Supreme Court to again dismiss the claim. In doing so, the Advocate-General reiterates that the Supreme Court must apply a ‘contextual interpretation of the claims’ in which the ‘idea behind the invention’ is a view point as is the literal meaning of the claims. However, these two viewpoints are the two ‘extremes’ referred to by the Protocol which should be avoided. One should seek a balance between the honest protection for the patentee as well as a reasonable degree of legal certainty for third parties. The description and the drawings are an important source to establish the ‘idea behind the invention’. All prior art (referred to in the description or not) could be of importance since the perspective of the skilled person (with their knowledge of the prior art) is key to applying a ‘contextual interpretation of the claims’. Bayer argued that the Court of Appeal had been wrong to rule that the skilled person would assume the claim to the ruthenium salt to have been knowingly chosen, limiting the scope of protection. Instead it submitted that an equivalent can only be excluded if there is a reasonable ground to assume that the patentee had knowingly renounced protection for it. The Supreme Court did not agree, and held that the Court of Appeal had been correct to take into account the skilled person’s perspective on a number of factors: the contents of the patent, the prior art, the objectives of the claimed method, the additional advantages of this method, the knowledge of existence of the involved products, the nature of and the relationship between those products, the degree and the way in which these products would lead to the result. In essence, the Supreme Court rules that the question to be answered is whether, in the perspective of the skilled person, the claims, read in light of the description and drawings, leave room for equivalents, taking into account on the one hand a reasonable protection for the patentee and on the other hand the legal certainty for third parties. The will or the intent of the applicant to renounce such protection does not play a decisive role. There is a normal ‘purposive claim construction’ and there is the question of protection for equivalents beyond the meaning of the claims. But, as Advocate-General Van Peursem puts it in his advisory opinion, ‘double counting’ should be avoided. If equivalents are already taken into account while interpreting the meaning of the claims from the perspective of the skilled person, there seems to be little room to also protect equivalent embodiments beyond that meaning. This approach was further confirmed in the appeal of the Dutch pemetrexed cases. Here, the Court of Appeal of the Hague confirmed the judgments in first instance of the District Court: a renouncement of protection could only be inferred from a conscious choice of the patentee based on technical reasons and could not be based on the mere mentioning of a specific type of salt.49 49 Gerechtshof Den Haag, Fresenius Kabi Nederland BV v Eli Lilly & Company 200.228.753/01 (8 May 2018) and Teva Nederland BV v Eli Lilly & Company 200.228.774/01 (8 May 2018). Since this book went to proof the District Court in The Hague in proceedings on the merits (Rechtbank Den Haag, Ili Lilly / Fresenius Kabi C/09/541424 / HA ZA 17-1097 (19 June 2019) ruled that there was no infringement by equivalence inter alia because during prosecution the patent was consciously limited to the disodium salt of pemetrexed. The legal certainty for third parties in these circumstances does not justify a broader scope of protection and infringement by equivalence.

34 Scope of Protection of Patent Claims

III. The Role of the Prosecution File In Actavis v Eli Lilly, the UK Supreme Court is sceptical about reliance on the prosecution file, but it sets out two situations in which it may be appropriate to use its contents: • 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 • 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 infringes. These two sets of circumstances are relatively narrow: the granted patent does not itself resolve the issue, and the file does; or there has been an express statement that the patent would not be asserted against the type of variant at issue. In Icescape, the Court of Appeal considered a letter written by the examining division during the prosecution, but found that the evidence it provided fell well below the threshold set by the Supreme Court in Actavis. The contents of the file did not unambiguously 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. In the court’s view, the circumstances were a very good illustration of why it is generally so unprofitable to explore the prosecution history. In L’Oréal Société Anonyme & Anor v Rn Ventures Limited50 the defendant sought to rely on the prosecution history of the patent, where the patentee had limited claim 1 of its patents to the ‘tension/compression embodiment’ rather than the ‘shear’ embodiment, in order to support inventive step. However, Carr J did not consider either of the two circumstances in which the prosecution history may be used in claim construction contemplated in Actavis v Eli Lilly to apply in this case. This was because the points at issue were not truly unclear in the light of the specification and claims of the patent and nor did the file unambiguously resolve any issue. It was also not contrary to the public interest for the contents of the file to be ignored. In particular, L’Oréal was under no duty to correct any misunderstanding about the scope of the claims on the part of the examiner. The judge 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.’ In the French approach to the scope of protection of claims, the prosecution file will form part of the general factual context by which scope is determined. It has an additional significance for claims that were narrowed during prosecution, especially when the claims were narrowed in order to secure the grant of the disputed patent. In these cases, a non-ambiguous claim with narrow scope cannot through interpretation be given a general scope, in particular when the patentee has been forced, in order to distinguish the invention from the prior art, to limit the scope of the claim in the context of the granting process.51 50 Patents Court, L’Oréal Société Anonyme & Anor v Rn Ventures Limited [2018] EWHC 173 (Pat) (5 February 2018). 51 Cour d’Appel, Paris, Hewlett Packard GmbH v Agilent Technologies Deutschland GmbH 08/00882 (27 January 2010).

Numerical Ranges 35 In Germany, it is not generally permitted to use the prosecution file as a means to construe the scope of protection of claims. However, while refusing to make a definitive statement in this regard, the Supreme Court52 has opened up the possibility that variants that were initially disclosed but later on excluded from the claim and the specification during prosecution, in order to distinguish the claimed invention from the prior art, might be disclaimed. Otherwise, that is, if the variants that were initially disclosed were later excluded due to formal requirements (such as inadmissible extension) the scope of protection is not limited to the disclosed variant. In the Netherlands, the Supreme Court has held that the patentee can only rely on the prosecution file if the claims are unclear. However, an alleged infringer is not so limited if they wish to rely on the prosecution file in order to argue that the patentee is estopped from asserting infringement by equivalence (for example, because the patentee limited the claims during prosecution or interpreted the claims in a limiting manner to secure the patent).53 In fact, an alleged infringer can even rely on the prosecution file of a different patent of the same patent family.54

IV. Numerical Ranges A. England and Wales In Smith & Nephew v ConvaTech Technologies Inc,55 ConvaTech’s patent related to a process for silverisation of gel-forming fibres in wound dressings. Claim 1 (as amended in the UK) required a binding agent present ‘in a concentration of between 1% and 25%’. Smith & Nephew had developed a process at a concentration of no more than 0.77 per cent. The patent identified a series of different concentration ranges for one component, some quoted to one decimal place and some to zero (whole numbers). Identified ranges of binding agents relevant to the claimed invention were also identified, specifying the ranges at various degrees of precision of zero, one and two decimal places. There were three competing constructions of the lower limit of the claim 1 requirement of ‘between 1% and 25%’ of binding agent, namely: (a) a lower limit of exactly 1 per cent (an ‘exact values’ approach); (b) a lower limit of 0.5 per cent (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); (c) a lower limit of 0.95 per cent (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). At trial, the Judge adopted the significant figures convention, leading to a finding of no infringement (0.77 falling outside the range with a lower limit starting at 0.95).

52 BGH,

Pemetrexed X ZR 29/15 GRUR 2016 921 (14 June 2016). in Hoge Raad, Resolution v AstraZeneca NJB 2018/1195 (8 June 2018), para 3.4.3. 54 Rechtbank Den Haag, Quantum v DMS C/09/526366 / KG ZA 17-154 (13 June 2017), para. 4.3.3. 55 Court of Appeal, Smith & Nephew v ConvaTech Technologies Inc [2015] EWCA Civ 607 (24 June 2015). 53 Confirmed

36 Scope of Protection of Patent Claims The Court of Appeal rejected that approach and applied the number rounding convention, leading to a finding of infringement (0.77 falling within the range with a lower limit starting at 0.5). Kitchin LJ noted that ordinarily the purpose of expressing numbers to a particular degree of precision is to convey to the reader the degree of accuracy with which a measurement or calculation has been made, but the purpose of numerical ranges in a claim is different: to convey the range of permissible concentrations and the accuracy with which those concentrations need to be determined. In that context, it is the precision with which the number is written that is important. In Napp Pharmaceuticals Holidings Limited v Dr Reddy’s Laboratories (UK) Limited,56 the whole numbers approach from Smith & Nephew v Convatec was adopted. In this case, a claim to use 10 per cent buprenorphine would be understood to be expressed in terms of whole numbers, and applying conventional rounding extends to ≥9.5 to