Patent Protection for Second Medical Uses from Buhling... · 2017-01-20 · Patent Protection for Second Medical Uses vi Jochen Bühling Dr. jur., attorney-at-law, is a partner at

Patent Protection for Second Medical Uses

AIPPI Law Series

VOLUME 2

Series Editors

AIPPI

Introduction & Contents/Subjects

Books in this series are developed within the framework of the International Association for the Protection of Intellectual Property (AIPPI), a non-affiliated non-profit organization dedicated to the development and

improvement of legal regimes for the protection of intellectual property at both national and international levels.

Objective & Readership

The aim is to publish innovative work appealing to practitioners, other users of IP systems and academics.

The titles in this series are listed at the back of this volume.


Edited by

Jochen Bühling

Published by:Kluwer Law International B.V.PO Box 3162400 AH Alphen aan den RijnThe NetherlandsWebsite: www.wklawbusiness.com

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ISBN 978-90-411-8253-1

AIPPI Law Series ISBN 98-888-8020-8

© 2016 Kluwer Law International BV, The Netherlands

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Printed in the United Kingdom.

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List of Contributors

Dan Altman

Dan Altman is a partner in the Orange County California office of Knobbe Martens. He specializes in patent protection and related licensing issues for the biotechnology, pharmaceutical and chemical industries. During law school, Mr. Altman was an editor for the Berkeley Technology Law Journal. He completed an externship with the former chief judge of the U.S. District Court for the Central District of California, and was an adjunct professor for 11 years at the University of San Diego School of Law, where he initiated a course entitled “Biotechnology Law.”

Tal Band

Tal Band is a member of the Executive Board of S. Horowitz & Co. and Chair of the firm’s Intellectual Property Practice Group. Tal represents leading players in the pharmaceuticals and life sciences industry in complex litigation on all matters relating to patents, trademarks and copyright issues. Tal serves as President of the Israel Chapter of AIPPI (since 2004) and is a regular speaker in conferences and contributor to practitioner reference books on IP.

Nicolaj Bording

Nicolaj Bording is an attorney-at-law with the Danish law firm Kromann Reumert. His practice primarily focuses on Danish and international patent litigation, but his expertise also includes licence agreements, technology transfer and research coop-eration agreements, as well as trademark and other IP litigation. Nicolaj frequently gives lectures on patent related issues and has authored a number of articles within this area and is a co-author of The Unified Patent Court – the administration of justice at Europe’s new patent court.


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Jochen Bühling

Dr. jur., attorney-at-law, is a partner at the IP law firm Krieger Mes & Graf v. der Groeben specializing in patent and trademark matters with a strong focus on IP litigation. He advises national and international clients in all aspects of IP and has distinct experience, among others, in the field of pharmaceutical and biotechnological inventions, chemistry, medical engineering and electronics. He teaches IP law at the University of Münster (WWU) and publishes and lectures regularly about IP topics. In AIPPI, he held the office of Reporter General from 2006-2010.

Thierry Calame

Dr. iur., Attorney at Law, Partner at Lenz & Staehelin, Dipl. nat. sc. ETH (Chemistry). Thierry is an expert in intellectual property matters, with a particular emphasis in patent law and life sciences. He has over 20 years of experience as counsel in patent, trademark, copyright and unfair competition litigation as well as IP related arbitration. Thierry also sits as arbitrator in IP related arbitration and advises on licensing, the intellectual property aspects of a wide range of other transactions as well as pharmaceutical law, including regulatory and advertising issues.

An Chen

Mr. An Chen is a patent attorney and attorney at law at Wu, Feng & Zhang, who focuses his practice in chemical and pharmaceutical fields. He has over 13 years of extensive experience in the area of patent prosecution and client counseling concerning infringement, validity and FTO. He has a bachelor degree in organic synthesis and a master degree in chemical engineering and also obtained a LLM degree in intellectual property from a US law school.

Dan Davies

Daniel Davies practices litigation at Smart & Biggar. He represents clients in court proceedings involving patents, trademarks, copyrights and trade secrets. He also advises clients on intellectual property enforcement matters, and represents clients in trademark oppositions, trademark expungement proceedings, patent appeal board proceedings and domain name disputes. Daniel works with clients in a wide variety of fields, including high-tech, Internet, manufacturing, retail, pharmaceuticals, and oil and gas.

Maria Carmen de Souza Brito

Chemical engineer graduated from the State University of Rio de Janeiro. A patent specialist in the areas of chemistry. pharmaceutical, cosmetics, agribusiness, biotech-nology and traditional knowledge, amongst others. Partner at the Dannemann Siemsen firm where she started her career in 1988. President of the Brazilian Intellectual Property Association (ABPI) for the 2016-2017 term and member of International Association for the Protection of Intellectual Property (AIPPI), Inter-American


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Association of Intellectual Property (ASIPI) and Brazilian Association of Industrial Property Agents (ABAPI).

Amy Feng

Ms. Amy Feng has been practicing Patent law in the fields of Chemistry, Pharma-ceuticals and Biotech for over 20 years. She is the founding partner of Wu, Feng & Zhang. She is a Chinese attorney at law and a patent attorney. She has a master degree in Organic Chemistry and she got LLM from the John Marshall Law Scholl of the U.S.A. She is the co-chair of Biotech/Pharma committee of AIPPI and the vice director of the patent law committee of Beijing Lawyers Association.

Steven Garland

Steven Garland is a partner at Smart & Biggar. He has 25 years of experience in intellectual property litigation of all types and regularly acts on behalf of innovator pharmaceutical and biopharmaceutical companies in respect of patent related matters. He has also mediated intellectual property disputes. Steven is a Past President of the International Association for the Protection of Intellectual Property (AIPPI) Canadian Group, Past President of the Intellectual Property Institute of Canada, and an adjunct professor of patent law.

Penny Gilbert

Dr. Penny Gilbert is a founding Partner of Powell Gilbert LLP. She has an MA in Biochemistry and DPhil in Molecular Biology from Oxford University and is a solicitor advocate and qualified mediator. Penny specialises in patent litigation, particularly in the life sciences. She represents clients before the UK Patents Courts, including acting in the first patent case to be heard by the UK Supreme Court, and has acted in referrals on the SPC Regulation to the CJEU and to the EFTA Court. Penny is a member of AIPPI and is President of the European Patent Lawyers Association (EPLAW).

Bianca Manuela Gutierrez

IP Law Firm Gutierrez. Practising as a lawyer in the industrial and intellectual property field for over thirty years. Founder in 1997 of the Law Firm Gutierrez in Milan, specialized and currently operating in litigation and counsel work in patent, trade-mark, unfair competition, copyright and related contractual matters. Author of several publications in the field of intellectual and industrial property and competition. Among these, La Tutela del Diritto di Autore (first edition: 2000; second edition: 2008).

Seong-Ki Kim

Co-Chair of Lee & Ko IP. Areas of practice: Chemical/Bio/Pharmaceutical; IP litigation, license & transaction, prosecution outside Korea. Work experience: Lee & Ko IP: 2015-Present; AIPPI KOREA, President: 2011-Present; Ministry of Food and Drug Safety, Expert: 2014-Present; Organizing Committee for AIPPI Congress 2012 Seoul, Chairman: 2011-2013; Korean Intellectual Property Office, Patent Examiner:


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1985-1991; WIPO, EPO, USPTO, and JPO, Liaison Officer: 1981-1982. Awards: AIPPI Award of Merits (2013).

Gertjan Kuipers

Gertjan Kuipers is an attorney-at-law and partner at De Brauw Blackstone Westbroek. He studied law and physics at Utrecht University, and is a Fulbright alumnus of Franklin Pierce Law Center, Concord N.H. Gertjan advises and litigates for various international companies. He works mainly in cross-border projects, and has a vast experience in conducting and coordinating multi-jurisdictional litigation. His dual background in science and law serves him well in patent cases. Gertjan lectures on patent law at universities and to IP practitioners-in-training and is a country respondent for Bio Science Law Rèview.

Nicolai Lindgreen

Nicolai Lindgreen is an attorney-at-law and a partner of the Danish law firm Kromann Reumert. He has for many years predominantly been engaged with Danish and international patent litigation, but his practice also includes trademark and other IP litigation. He also advises on technology transfer, licensing, R&D and similar agreements. Nicolai is a frequent lecturer on patent-related topics and has authored a long list of articles, in particular within the patent area, and is a co-author of The Annotated Danish Patents Act and The Unified Patent Court – the administration of justice at Europe’s new patent court.

Lei Liu

Dr. Lei Liu’s practice at Smart & Biggar focusses on obtaining patent protection in Canada and around the world for pharmaceutical and biotechnology companies, universities, and research institutions. Lei has also been involved in numerous intellectual property transactional projects. Lei’s educational background is in the fields of biotechnology, biological science and chemistry. His doctoral studies focused on cardiovascular, obesity and atherosclerosis research.

Lamberto Liuzzo

IP Law Firm Liuzzo. Founder in 1990 of the Law Firm Liuzzo, specialized in the field of Intellectual Property Law. Former Professor of Intellectual Property Law at Lumsa University in Rome. Lecturer of Intellectual Property Law at “Qualifying Course for the legal professions” at Law faculty of Tor Vergata and Lumsa Universities of Rome. For many years Research Fellow at Max Planck Institute for Foreign and International Patent, Copyright and Competition Law – Munich, Germany. Author of numerous publications in Italian and international Industrial Law journals. Invited speaker at numerous national and international conferences in the field of Intellectual Property. Associated to: AIPPI, LES, LIDC, EPLAW, GRUR e UAE.


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Simon Tianle Luo

Mr. Simon Tianle Luo is a patent attorney and attorney at law at Wu, Feng & Zhang. He has been practicing Patent law in the fields of biotech and biopharmaceuticals for over 11 years. He has a bachelor degree in biological engineering from Beijing Institute of Technology and a master degree in biochemical engineering from the University of the Chinese Academy of Sciences. He did scientific research in Institute of Biophysics of the CAS before becoming a patent attorney.

Sarah Matheson

Sarah Matheson BA LLB is an attorney-at-law and a partner at Allens. She advises in contentious and non-contentious IP matters. She is an experienced patent litigator with a focus on acting for multinationals, and is also a registered Trade Marks Attor-ney. Sarah is the Reporter General of the International Association for the Protection of Intellectual Property (AIPPI), and a member of the Intellectual Property Society of Australia and New Zealand (IPSANZ), and the Licensing Executives Society of Australia and New Zealand (LESANZ).

Jürgen Meier

Dr. Meier is a European and German Patent Attorney, and a partner at Vossius & Partner, Munich. He has extensive experience representing clients before both national courts and the EPO in all phases of patent prosecution and litigation, including opposition, appeals, infringement actions and nullity suits. He primarily focuses on the fields of biotechnology, pharmaceuticals and medical uses. His legal expertise is supported by his technical background, having previously obtained a doctorate in molecular biology.

Shoichi Okuyama

Shoichi Okuyama is a registered Japanese Patent Attorney, Principal of Okuyama & Sasajima. He is the Vice-President of AIPPI Japan and a former President of the Japan Patent Attorneys Association. He holds a Ph.D. in chemistry from the University of Chicago and a bachelor’s degree in E.E. from Waseda University in Tokyo. He serves as an expert member of the Intellectual Property Strategy Headquarters organized by the Prime Minister of Japan since 2013.

Tim Powell

Tim Powell is a founding Partner of Powell Gilbert LLP. He is a solicitor advocate and has represented clients as an advocate in the UK and European Patent Offices the English Courts and the European Court of Justice. Tim specialises in multi-ju-risdictional litigation, particularly in the patents field where he has experience in coordinating litigation taking place simultaneously across Europe, North America and beyond. He also advises clients on healthcare regulatory issues. He is a member of the Intellectual Property Advisory Committee of the UK Bioindustry Association and a board member of IPLA.


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Justyna Rasiewicz

Attorney at law, Partner in LDS Łazewski Depo & Partners. Litigator with wide experience in intellectual property cases. Extensive experience in patent litigation, in particular pharmaceutical and biotech. Recommended by IP Star, Chambers and Partners, The Legal 500, The World’s Leading Trademark Professionals. Co-author of Commentary to the Law on Combating Unfair Competition (ed. 2011, 2016); of Commentary to the Industrial Property Law (ed. 2016); and International Design Protection a Global Handbook (2012).

Isabelle Romet

Isabelle Romet (1964) was admitted to the Bar in 1988. She is a partner with the French firm Véron & Associés that she co-founded, whose motto is 100 % patent litigation. She studied law at the Universities in Grenoble and Montpellier and at the Franklin Pierce Law center, USA. Like the other lawyers of the firm, she is active in all technical fields. However, she has developed a special expertise in life sciences and chemistry. Her experience in the field of pharmaceuticals goes with a focus on supplementary protection certificates. She extensively lectures on patent litigation including at Sciences Po Paris. She is a co-author of the book Saisie-Contrefaçon, published by French publisher Dalloz and edited by Pierre Véron (3rd edition, 2012).

Yoon Suk Shin

Yoon Suk Shin is a senior patent attorney at Lee International IP & Law Group with extensive experience of prosecuting patent applications before the Korean Intellectual Property Office in the fields of Chemistry, Biotechnology, Biochemistry and Pharmaceuticals. She has experience in handling patent litigation matters before the Korean Courts in the fields of pharmaceuticals and OLED materials. She has represented various clients in pharmaceutical regulatory matters with administrative bodies including the Patent-Marketing Approval Linkage System.

Hari Subramaniam

Hari Subramaniam is a leading IPR Attorney in practice for 35 years. He has been involved in over 40,000 cases including many landmark cases. He is a regular speaker at IPR fora worldwide including AIPPI, APAA, IPO, ABA and WIPO. He has authored several articles on IPR for leading international journals. He is a member of AIPPI Pharma and Biotech committees. Voted as “Leading Asia IPR Lawyer” by Asia Law for thirteen consecutive years and top tier Attorney by several magazines, he was featured in “50 IP Lawyers one must know in Asia and Oceania” in Asia Law.

Matthew Swinn

Matthew Swinn is a partner of King & Wood Mallesons, based in Melbourne. He is an intellectual property litigator recognised in particular for his patent litigation expertise in the manufacturing industries and life sciences sector, in which he also acts on other aspects of therapeutic goods regulation and marketing. Matt is a member


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of the Law Council of Australia’s Intellectual Property Committee and convenes its patents sub-committee.

Marta Sznajder

Attorney-at-law trainee, PhD candidate in the Department of Intellectual Property Law, Faculty of Law of Warsaw University, preparing doctoral dissertation concerning prior user rights in the industrial property law. Specializes in litigations in the field of patent law including pharmaceutical and biotech patents, as well as in the field of industrial design infringement and unfair competition. Author of the articles focused on patent infringement under the doctrine of equivalents and its application in Polish jurisprudence.

Dora Talvard

Dora Talvard (1986) has been a member of the Paris Bar since 2013. She is an associate at French patent law firm Véron & Associés, whose activity is entirely devoted to patent litigation. She obtained a Master 2 degree in intellectual property law at the Centre for International Intellectual Property Studies (CEIPI), University of Strasbourg, after a Master 1 degree in international law at University Paris I Panthéon-Sorbonne. Like the other lawyers of the firm, she is active in all technical fields, with a focus on pharmaceutical cases and supplementary protection certificates. She lectures about patent litigation in the Intellectual Property Master 2 at the University of Lyon III.

Javier Uhthoff-Orive

As a senior partner in the patent department at Uhthoff, Gomez Vega & Uhthoff, he has had substantial experience representing numerous clients, mostly in advising multinational companies, protecting different types of innovations. He has advised an extensive variety of industries of Europe, North America, Asia and Latin America. Javier Uhthoff-Orive has established a leading international reputation for IP matters.

Jonas Westerberg

Jonas Westerberg, Partner and Head of IP at Lindahl, has more than 20 years’ experience of patent litigation and currently spends 80 percent of his time on such matters. In addition he mainly represents clients in litigation concerning trade secrets and copyright, primarily in the context of disputes over right to technology. Most of the patent cases have concerned pharma patents (or SPCs). Jonas is a member of ICC Sweden’s IP group and since long on the boards of the Swedish AIPPI group and the European Patent Lawyers Association (EPLAW).

Yair Ziv

Yair Ziv is an associate in the Intellectual Property Practice Group of S. Horowitz & Co., where he assists in the representation of clients in the pharmaceuticals and life sciences industry on various IP issues.

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Table of Contents

List of Contributors v

Foreword lxiFelipe Claro

Introduction 1Dr. Jochen Bühling

European Patent Office 5Dr. Jürgen Meier

A. Availability of protection 5I. Legal framework 5

1. National statutory laws 51.1 Pharmaceuticals 131.2 Biologics 14

2. International treaties 152.1 TRIPS 152.2 FTAs 16

3. Availability through case law 164. Patent term extension/SPCs 16

II. Policy considerations 171. Health and social issues 172. Legal issues 17

B. Validity 18I. Allowable claim wording 18

1. Product claims 182. Method claims 183. Use claims 194. System claims 195. Dosage regimes 216. Patient groups 22

II. Novelty 23


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1. General definition of novelty and prior art 232. Definition of skilled person 233. Scope of disclosure 23

3.1 General rules 233.2 First medical use 243.3 New subject matter 243.4 New data 24

4. Requirements for second medical use 254.1 Distinction from first medical use 254.2 Sub-species of second medical use 254.3 Dosage regimes 254.4 Special patient groups 264.5 Special technical effect or mechanism leading to a truly

novel clinical/medical situation 275. Timing issues 28

5.1 Relevant time of development of second use 285.2 Role of new data 295.3 Use of old data 29

III. Inventive step/non-obviousness 291. Definition of inventive step/non-obviousness 292. Same scope of disclosure as for novelty? 303. Assessment of inventive step/non-obviousness 30

IV. Amendment of claims after grant 321. Admissibility of post-grant amendments in general 322. Procedural issues 32

2.1 Independent limitation proceedings 322.2 Opposition proceedings 32

3. Added matter 324. Sufficiency 325. Multiple indications 33

V. Change of patent category 331. General admissibility 332. Use claim as a category 343. From product to method claim 344. From method to product claim 345. System claims 346. Use claims 34

Germany 35Dr. Jochen Bühling



2. International treaties 372.1 TRIPS 37

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2.2 FTAs 373. Availability through case law 374. Patent term extension/SPCs 37




II. Novelty 401. General definition of novelty and prior art 402. Definition of skilled person 413. Scope of disclosure 41


4. Requirements for second medical use 424.1 Distinction from first medical use 424.2 Subspecies of first medical use 424.3 Dosage regimes 434.4 Special patient groups 43

5. Timing issues 435.1 Relevant time of development of second use 435.2 Role of new data 435.3 Use of old data 44

III. Non-obviousness 441. Definition of inventive step 442. Same scope of disclosure as for novelty? 443. Assessment of inventive step 44


2.1 Independent limitation proceedings 452.2 Opposition proceedings 462.3 Nullity actions 46


V. Change of patent category 471. General admissibility 472. Use claim as a category 47


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3. From product to method claim 474. From method to product claim 475. System claims 486. Use claims 48

C. Infringement and litigation 48I. Legal framework 48

1. National statutory laws 482. Case law 49

II. Claim construction 491. General rules 492. Specific issues for use claims 49

III. Scope of protection 501. Scope of the use 50

1.1 General definition of the term “use” 501.2 Manufacture of the pharmaceutical 501.3 Sale of the product 511.4 Offer for sale 511.5 Application to the patient 511.6 Combination products 51

2. Absolute product protection 522.1 Limitation through the term “use” 522.2 Off-label use 53

3. Dosage regimes 534. Patient groups 545. Extension under the doctrine of equivalents 54

IV. Infringing acts 551. Infringing person or entity 562. Direct infringement 56

2.1 Manufacture of the pharmaceutical 562.2 Offer for sale 582.3 Sale 582.4 Export 592.5 Import 592.6 Combination products 59

3. Indirect infringement 593.1 Objective acts 603.2 Subjective conditions 603.3 Export 603.4 Import 603.5 Combination products 61

4. Off-label use 614.1 General admissibility of off-label use 614.2 Liable persons 624.3 Objective requirements for infringement 624.4 Subjective requirements for infringement 64

5. Dosage regimes 646. Patient groups 64

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V. Remedies 641. Injunctions 642. Damages 653. Information 65

3.1 Names of manufacturer, distributors etc. 653.2 Names of customers 653.3 Information about infringing sales 653.4 Account of profits 66

4. Recall of products and destruction 665. Recovery of legal costs 66

VI. Exceptions from patent protection 661. Exhaustion of rights 662. Patient welfare 673. Others specific to second medical use claims 67

VII. Procedural issues 671. Preliminary injunction cases 67

1.1 Availability for second medical use claims 671.2 Specific requirements 68

2. Cases on the merits 683. Enforcement of judgments 68

VIII. Validity 691. Relevance for infringement cases 692. Specifics for second medical use claims 69

IX. Tactical considerations 691. Plaintiff 692. Defendant 69

Switzerland 71Dr. Thierry Calame



2. International treaties 733. Availability through case law 734. Patent term extension/SPCs 74


B. Validity 75I. Allowable claim wording 75II. Novelty 76


3.1 General rules 77


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3.2 First medical use 773.3 New subject matter 773.4 New data 78

4. Requirements for second medical use 784.1 Distinction from first medical use 784.2 Sub-species of second medical use 784.3 Dosage regimes 784.4 Special patient groups 78

5. Timing issues 795.1 Relevant time of development of second medical use 795.2 Role of new data 795.3 Use of old data 79





V. Change of patent category 82C. Infringement and litigation 83

I. Legal framework 831. National statutory laws 832. Case law 83






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4. Off-label use 934.1 General admissibility of off-label use 934.2 Liable persons 93


3.1 Names of manufacturer, distributors, etc. 953.2 Names of customers 953.3 Information about infringing sales 963.4 Account of profits 96


VI. Exceptions from patent protection 961. Exhaustion of rights 962. Patient welfare 973. Exception from infringement for medical doctors and pharmacists 97


1.1 Availability for second medical use claims 982. Cases on the merits 983. Enforcement of judgments 98

VIII. Tactical considerations 981. Plaintiff 982. Defendant 99

France 101Isabelle Romet, Dora Talvard


1. National statutory laws 1011.1 Pharmaceuticals 102


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1.2 Biologics 1022. International treaties 103

2.1 TRIPS 1032.2 FTAs 103

3. Availability through case law 1033.1 Second therapeutic use 1043.2 Dosage regimes 107

4. Patent term extension/SPCs 110II. Policy considerations 111

1. Health and social issues 1112. Legal issues 113



II. Novelty 1161. General definition of novelty and prior art 1162. Definition of the skilled person 1163. Scope of disclosure 116

3.1 General rules 1163.2 First medical use 1163.3 New subject-matter 1163.4 New data 116

4. Requirements for second medical use 1174.1 Distinction from first medical use 1174.2 Sub-species of first medical use 1174.3 Dosage regimes 1174.4 Special patient groups 117

5. Timing issues 118III. Inventive step/non-obviousness 118

1. Definition of inventive step/non-obviousness 1182. Same scope of disclosure as for novelty? 1183. Assessment of inventive step/non-obviousness 118





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2.1 Manufacture of the pharmaceutical 1272.2 Offer for sale 1272.3 Sale 1282.4 Export 1282.5 Import 1282.6 Use 1282.7 Holding 1292.8 Combination products 129





3.1 Names of manufacturers, distributors etc. 1353.2 Names of customers 135


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3.3 Information about infringing sales 1353.4 Account of profits 135







The Netherlands 141Gertjan Kuipers









3.1 General rules 1483.2 First medical use 148

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3.2 New subject matter 1483.4 New data 148

4. Requirements for second medical use 1484.1 Distinction from first medical use 1484.2 Sub-species of second medical use 1494.3 Dosage regimes 1494.4 Special patient groups 1494.5 Special technical effect or mechanism leading to a truly

novel clinical/medical situation 1495. Timing issues 149











1.1 General definition of the term “use” 1541.2 Manufacture of the pharmaceutical 1541.3 Sale of the product 1541.4 Offer for sale 1551.5 Application to the patient 155


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1.6 Combination products 1552. Absolute product protection 155

2.1 Limitation through the term “use” 1552.2 Off-label use 155













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Italy 167Lamberto Liuzzo, Bianca M. Gutierrez




II. Policy considerations 168B. Validity 168

I. Allowable claim wording 169II. Novelty 169



4. Requirements for second medical use 1705. Timing issues 170


IV. Amendment of claims 1711. Admissibility of amendments in general 1712. Procedural issues 172


3. Added matter 1724. Sufficiency 172


I. Legal framework 172


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1.1 General definition of the term “use” 1751.2 Manufacture of the pharmaceutical 1751.3 Sale of the product 1751.4. Offer for sale 1761.5 Application to the patient 1761.6 Combination products 176


3. Dosage regimes 1764. Extension under the doctrine of equivalents 176



3. Indirect infringement 1773.1 Objective acts 1773.2 Subjective conditions 1773.3 Export 1773.4 Import 177





VI. Exceptions from patent protection 1791. Exhaustion of rights 179

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2. Patient welfare 1793. Other issues specific to second medical use claims 179




VIII. Validity 180IX. Tactical considerations 180

1. Plaintiff 1802. Defendant 181

Sweden 183Jonas Westerberg



2. International treaties 1842.1 TRIPS 184











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V. Change of patent category 1911. General admissibility 1912. From method to product claim 191











4. Off-label use 1984.1 General admissibility of off-label use 198

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4.2 Liable persons 198V. Remedies 198

1. Injunctions 1982. Damages 1993. Information 200

3.1 Names of manufacturer, distributors, customers, sales etc. 2003.2 Account of profits 201








Denmark 207Nicolai Lindgreen, Nicolaj Bording









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3.3 New subject matter 2113.4 New data 211







V. Change of patent category 2141. General admissibility: product to use claims and vice versa 214








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VI. Exceptions from patent protection 2221. Exhaustion of rights 2222. Patient welfare 2233. Other issues specific to second medical use claims 223





Poland 227Justyna Rasiewicz, Marta Sznajder


1. National statutory laws 2281.1 Pharmaceuticals 229


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1.2 Biologics 2302. International treaties 230

2.1 TRIPS 2302.2 FTAs 230













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2.1 Non-medical use claims 2492.2 First medical use 2492.3 Second medical use 249








4. Off-label use case 256


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4.1 General admissibility of off-label use 2564.2 Liable persons 2574.3 Objective requirements for infringement 2574.4 Subjective requirements for infringement 257











United Kingdom 263Tim Powell, Dr. Penny Gilbert





B. Validity 268

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I. Allowable claim wording 268II. Novelty 269









V. Change of patent category 2761. General admissibility: product to use claims and vice versa 276







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1.6 Combination products 2792. Absolute product protection 279

2.1 Limitation through the term “use” 2792.2 Off-label use 279









VI. Exceptions from patent protection 2861. Exhaustion of rights 2862. Patient welfare 2873. Other issues specific to second medical use claims 287





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Israel 293Tal Band, Yair Ziv















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3. Indirect infringement 3103.1 Objective acts 3103.2 Subjective conditions 3103.3 Export 310

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3.4 Import 3113.5 Combination products 311




3.1 Names of manufacturer, distributors, etc. 3133.2 Names of customers 3133.3 Information about infringing sales 3143.4 Account of profits 314








United States of America 319Dan Altman




3. Availability through case law 326


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4. Patent term extension/SPCs 326II. Policy Considerations 327



1. Product claims 3292. Method claims 3293. Use claims 3304. System claims 3305. Dosage claims 3306. Patient groups 330

II. Novelty 3301. General definition of novelty and prior art 3302. Definition of skilled person 330

III. Allowable claim wording: patent eligible under 101 3321. Product claims 3322. Method claims 3333. Use claims 3344. System claims 3345. Dosage regimes 3346. Patient groups 335



II. Claim construction 3391. General rules 3392. Specific rules for use claims 339






2.1 Manufacture of the pharmaceutical 342

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2.2 Offer for sale 3432.3 Sale 3432.4 Export 3442.5 Import 3442.6 Combination products 345












D. Summary 355

Canada 357Steven Garland, Dan Davies, Dr. Lei Liu



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3. Availability through case law 3594. Patent term extension 362






4. Requirements for second medical use 3684.1 Distinction from first medical use 3684.2 Sub-species of first medical use 3684.3 Dosage regimes 368

5. Timing issues 369III. Inventive step/non-obviousness 370

1. Definition of inventive step/non-obviousness 3702. Same scope of disclosure as for novelty 3703. Assessment of inventive step/non-obviousness 370




V. Change of patent category 3731. General admissibility 373

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2. Use claim as a category 3733. From product to method claim 3734. From method to product claim 3745. System claims 3746. Use claims 374





1.1 General definition of the term “use” 3771.2 Manufacture of the pharmaceutical 3771.3 Sale of the product 3781.4 Offer for sale 3781.5 Application to the patent 3791.6 Combination products 379







5. Dosage regimes 383


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6. Patient groups 383V. Remedies 383

1. Injunctions 3832. Damages 3833. Information 384




VI. Procedural issues 3861. Preliminary injunction cases 386




IX. Pre-litigation strategic considerations 3881. Plaintiff 3882. Defendant 388

Australia 389Sarah Matheson, Matthew Swinn


1. National statutory laws 3892. Availability through case law 390

2.1 Pharmaceuticals 3912.2 Biologics 392


4. Patent term extension/SPCs 393II. Policy considerations 393



1. Product claims 3942. Method claims 395

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3. Use claims 3964. System claims 3965. Dosage regimes 3966. Patient groups 397












II. Claim construction 4101. General rules 410


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2. Specific issues “for use” claims 410III. Scope of protection 410

1. Scope of the use 4111.1 General definition of the term “use” 4111.2 Manufacture of the pharmaceutical 4111.3 Sale of the product 4111.4 Offer for sale 4121.5 Application to the patient 4121.6 Combination of products 412




2.1 Manufacture of the pharmaceutical 4142.2 Offer for sale 4142.3 Sale of the product 4152.4 Import 4152.5 Export 4152.6 Combination products 415

3. Indirect infringement 4163.1 Objective acts 4163.2 Subjective conditions 4173.3 Import 4173.4 Export 4183.5 Combination products 418




3.1 Account of profits 4213.2 Names of manufacturer, distributions etc., names of

customers and information about infringing sales 4214. Recall of products and destruction 4215. Recovery of legal costs 421

VI. Exceptions from patent protection 422

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1. Exhaustion of rights 4222. Patient welfare 422






Japan 427Dr. Shoichi Okuyama


1. Basics 4272. JPO Examination Guidelines 4273. International treaties 4284. Patent term extension 4295. Biologics 4296. Historical overview 429

II. Policy considerations 430B. Validity 431

I. Allowable claim wording 4311. Product claims 4312. Method claims 4323. Use claims 4324. System claims 4325. Dosage claims 4326. Disclosure requirements – enablement and support 433

II. Novelty 4341. General definition of novelty and prior art 4342. Grace period 4343. Definition of skilled person 4354. Scope of disclosure 435


5. Requirement for second medical use 4365.1 Distinction from first medical use 4365.2 Sub-species of first medical use 4365.3 Dosage regimes 436


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III. Inventive step 4371. Definition of inventive step 4372. Same scope of disclosure as for novelty? 4373. Assessment of inventive step 437





II. Claim construction 4401. General rules 4402. Specific issues for use claim 440

III. Scope of protection 4401. In general 440

1.1 Prescription 4411.2 Experimental use and testing of a patented drug by a

generics maker 4412. Absolute product protection 442

2.1 Off-label use 4423 Dosage regimes 4424. Doctrine of equivalents 442

IV. Infringing acts 4441. Direct infringement 4442. Indirect infringement 444

V. Remedies 4441. Injunctions 4442. Damages 4453. Availability of information – data exclusivity 446

VI. Exception from patent protection 4461. Patent exhaustion 4462. Experimental use and particular exemptions 447

VII. Procedural issues 4471. Preliminary injunction cases 4472. Cases on the merits 448

VIII. Validity 4481. Relevance to infringement cases 4482. Double track system 448

Republic of Korea 451Seong-Ki Kim, Yoon Suk Shin

A. Availability of protection 451

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I. Legal framework 4511. National statutory laws 451

1.1 Pharmaceuticals 4511.2 Biologics 452


3. Protection available through case law 4534. Patent term extension/SPCs 453


B. Validity 454I Allowable claim wording 454



3.1 General rules 4563.2 First medical use 4563.3 New subject composition matter 4563.4 New data 456

4. Requirements for second medical use 4564.1 Distinction from first medical use 4564.2 Sub-species of first medical use 4574.3 Dosage regimens 4574.4 Special patient groups 457






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V. Change of patent invention category 4621. General admissibility 4622. Use claim as a category 4623. From product to method claim 4624. From method to product claim 4625. System claims 4626. Use claims 462





1.1 General definition of the term “use” 4641.2 Manufacture of pharmaceuticals 4641.3 Sale of the product 4641.4 Offer for sale 4641.5 Application to the patient 4641.6 Combination products 465






4. Off-label use 468

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4.1 General admissibility of off-label use 4684.2 Liable persons 4694.3 Objective requirements for infringement 4694.4 Subjective requirements for infringement 469

5. Dosage regimens 4696. Patient groups 469



4. Recall and destruction of products 4715. Recovery of legal costs 471

VI. Exceptions from patent protection 4721. Exhaustion of rights 4722. Patient welfare 4723. Other exhaustion issues specific to second medical use claims 473






China 477Amy Feng, An Chen, Simon Tianle Luo


1. National statutory laws 4771.1 First medical use 4791.2 Second medical use 480


1. Product claims 4802. Method claims 4813. Use claims 4814. System claims 4825. Dosage regimes 482


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6. Patient groups 482II. Novelty 483







2.1 Independent limitation proceedings 4892.2 Opposition proceedings 489







2. Absolute product protection 4942.1 Limitation through the term “use” 494

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IV. Infringing acts 4941. Indirect infringement 494

1.1 Objective acts 4941.2 Subjective conditions 495

V. Remedies 4961. Injunctions 496

1.1 Permanent injunction 4961.2 Preliminary injunction 497

2. Damages 4973. Information 497

3.1 Disclosure of legal source 4973.2 Information about infringing sales and account of profits 497


VI. Exceptions from patent protection 4981. Exhaustion of rights 4982. Bolar exemption 4983. Compulsory license for public health purposes 4994. Non-granting of injunction based on national or public interest

considerations 499VII. Procedural issues 499

1. Preliminary injunction cases 4992. Cases on merits 500

2.1 Standing 5002.2 Venue 5002.3 Time 5002.4 Burden of proof 501

3. Enforcement of judgments 501VIII. Validity 501

1. Patent invalidity and stay of court proceedings 501

India 503Hari Subramaniam




3. Availability through case law 5084. Patent term extensions/SPCs 508

II Policy considerations 5081. Health and social issues 508


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2. Legal issues 509B. Validity 509

I Allowable claim wording 5091. Product claims 5092. Method claims 5093. Use claims 5104. System claims 5105. Dosage regimes 5106. Patient groups 511

II. Novelty 5111. General definition of novelty and prior art 5112. Definition of skilled person 5113. Scope of disclosures 511



III. Inventive step/non-obviousness 512IV. Amendment of claims after grant 513

1. Admissibility of post-grant amendments in general 5132. Procedural issues 5133. Added matter 5134. Sufficiency 5135. Multiple indications 513





III. Scope of protection 5151. Scope of the use 5152. Absolute product protection 5153. Dosage regimes 5154. Patient groups 5155. Extension under the doctrine of equivalents 515

IV. Infringing acts 516

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1. Infringing person or entity 5162. Direct infringement 5163. Indirect infringement 5164. Off-label use 5165. Dosage regimes 5166. Patient groups 516








Brazil 519Maria Carmen de Souza Brito







1. Product claims 5242. Method claims 5253. Use claims 525


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4. System claims 5265. Dosage regimes 5266. Patient groups 526













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VI. Exceptions from patent protection 540


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1. Exhaustion of rights 5402. Patient welfare 5403. Others specific to second medical use claims 541





IX. Tactical considerations 5421. Plaintiff 542

1.1 Requesting ex parte injunction before serving warning letter 5421.2 Priority to obtain preliminary injunction 5421.3 Obtaining discovery privately and early 5431.4 Suing on strong patents 5431.5 Reviewing the prosecution history of the patent 543

2. Defendant 5432.1 Monitoring of the courts 5432.2 Non-infringement declaratory court action 5442.3 Nullity action 544

Mexico 545Javier Uhthoff-Orive





4.1 Patent prosecution delays 5484.2 Marketing approval delays for pharmaceutical patents 548



1. Product claims 5502. Method claims 5503. Use claims 5504. System claims 551

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V. Change of patent category 5591. General admissibility 5592. Use claim as a category 559



2.1 Case law vs. “jurisprudencia” 560II. Claim construction 560

1. General rules 5602. Specific issues for use claims 561


1.1 General definition of the term “use” 5611.2 Manufacture of the pharmaceutical 561


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1.3 Sale and offer for sale of the product 5611.4 Application to the patient 5621.5 Combination products 562




2.1 Manufacture of the pharmaceutical 5642.2 Offer for sale 5642.3 Sale 5642.4 Import 5642.5 Export 564

3. Indirect infringement 5654. Off-label use 565

4.1 General admissibility of off-label use 565V. Remedies 565

1. Administrative and civil remedies are available as follows: 5652. Damages 565

2.1 Practical implications of such differences 5662.2 Mexican law provisions concerning quantification of

damages in patent matters 5662.3 Provisions set forth in the MLIP 5662.5 Other applicable legal bodies and provisions 5672.6 Restrictions concerning the concepts and application of

“damages and losses” 5673. Information 5674. Permanent injunction 5685. Recovery of legal costs 568





Resolution Question Q238 571

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Foreword

Felipe Claro

AIPPI, the International Association for the Protection of Intellectual Property, was founded in 1897 and is dedicated to the development, improvement, and legal protection of intellectual property. AIPPI is a non-affiliated, non-profit organization headquartered in Switzerland, having approximately 9,000 members representing over 100 countries. The members of AIPPI include lawyers, attorneys, and agents working across all fields of intellectual property in corporate and private practice throughout the world, as well as academics, judges, government officials and other persons interested in intellectual property. AIPPI is organized into 68 National and Regional Groups.

The objective of AIPPI is to improve and promote the protection of intellectual property at both national and international levels. It does this by studying and comparing existing and proposed laws and policies relating to intellectual property, and working with both government and non-government organisations for the development, expansion and improvement of international and regional treaties and agreements, and national laws.

As Series Editor, AIPPI is proud to continue working with Wolter Kluwer to produce the AIPPI Law Series, which introduces to a broader audience the substantial studies carried out by AIPPI’s members in preparation for the Resolutions adopted by its Executive Committee.

The present volume was inspired by AIPPI’s Resolution Q 238 – “Second medical use and other second indication claims” adopted at the AIPPI Congress in Toronto in 2014. The granting of patent protection for second medical uses encour-ages the development of solutions for unmet medical needs. Key to that incentive is the availability of enforceable patent rights of effective scope. This volume is a valuable tool for those working in or with the life sciences sector to navigate the key jurisdictional differences and challenges in protecting and enforcing second medical use claims.

AIPPI would particularly like to thank Jochen Bühling – Volume Editor, member of AIPPI and a past Reporter General. AIPPI is pleased to partner with him in an area which continues to see important legal developments. The chapter authors are also


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primarily AIPPI members. AIPPI sincerely thanks all contributors for their work on this timely and topical volume.

Felipe ClaroPresident of AIPPI

July 2016

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