Compulsory Patent Licensing and Access to Medicines: A Silver Bullet Approach to Public Health? (Palgrave Studies in Public Health Policy Research)

Dr. Van Anh Le has written an important and timely new book focusing on the ability of countries to provide essential medicines to their populations even when these medicines are patented. Martin J. Adelman, Theodore and James Pedas Family Professor of Intellectual Property and Technology Law, George Washington University Law School. The work of Van Anh Le is a timely and much needed one. It provides an updated and useful analysis of current global intellectual property flexibilities and case studies from several developing countries including India and Brazil. It also provides policy recommendations which many developing counties could consider while designing their national intellectual property protection regimes. A must have in any library. Mohammed El Said, Professor in International Trade and Intellectual Property Law, School of Law and Social Science, University of Central Lancashire. This timely monograph focuses on India and Brazils use of compulsory licensing, one of the most significant and controversial TRIPS flexibilities. This is a topical work at this critical time when the COVID-19 has stirred up the debate about compulsory licensing and access to medicines. A closer look into the historical use of compulsory licences in certain countries can offer some takeaways for the current situation. The author studies historical developments and political conditions of the patent system and compulsory licensing from the earliest stage to the modern arena, with a great emphasis on TRIPS. After conducting a cross-national study of India and Brazil, the book moves on to evaluate the different philosophies on compulsory licensing of multilateral organizations such as the EU, the WIPO, the WTO, and NGOs. This important book will strongly appeal to intellectual property students, academics, policymakers, and lawyers practicing in the area. It will also be of interest to academics working in the areas of international law, development, and public health as well as state actors and others with relevant concerns working in multilateral organizations. Van Anh Le is Departmental Lecturer in Intellectual Property Law at the University of Oxford, UK Contents 6 Abbreviations 10 List of Figures 11 1 An Introduction to the Debate on Patents and Access to Medicines 12 1.1 The Access to Medicines Debate: From TRIPS to COVID-19 12 1.2 Overview of Key Subject Matters 15 1.2.1 Patent vs. Compulsory Licensing: The Beast and Beauty 15 1.2.2 Country Case Studies: India and Brazil 18 1.2.3 Multilateral Organisations 19 1.3 The Structure of This Book 20 References 24 2 International Patent Law and the Pharmaceutical Industry 26 2.1 Introduction 26 2.2 The International Patent System Prior to TRIPS 27 2.2.1 Early History 27 2.2.2 Towards an Internationalised Patent System: The Creation of the Paris Convention 29 2.2.3 From Paris to GATT 31 2.3 The TRIPS Agreement 34 2.3.1 The Contextualisation of the TRIPS Agreement Within the Uruguay Round 34 2.3.2 The US’s Strategy Leading Up to the Uruguay Round 35 2.4 The Writing of TRIPS 37 2.4.1 September 1986–April 1989 37 2.4.2 April 1989–1990 39 2.4.3 1991–1994 41 2.5 TRIPS Implications on Medicine Patents 41 2.5.1 Parallel Importation 41 2.5.2 Patentable Subject Matter 43 2.5.3 Term of Protection 44 2.5.4 Transitional Arrangement and Marketing Exclusive Rights 44 2.6 The Pharmaceutical Industry—One of a Kind 47 2.6.1 Medicine—A Dual Personality 47 2.6.2 New Medicine: From Genesis to Commercialisation 48 2.6.3 Pharmaceutical Innovation 49 2.6.4 Generics and Market Entry 52 2.6.5 The Importance of Patents in the Pharmaceutical Industry 53 2.7 Conclusions 54 References 58 3 The Development of Compulsory Licensing in International Patent Laws 62 3.1 Introduction 62 3.2 Historical Development of Compulsory Licensing 63 3.2.1 Prior to TRIPS 63 3.2.2 During the Negotiations of TRIPS 66 3.3 An Examination of Article 31 of TRIPS 68 3.4 Possible Grounds to Grant a Compulsory Licence 73 3.5 The Effects of Compulsory Licensing on the Pharmaceutical Industry 78 3.6 The Doha Declaration—Has the Balance Between Patents and Public Health Been Achieved? 79 3.6.1 The Path to Doha 79 3.6.2 The Content of the Doha Declaration, Its Legal Status, and Effects 80 3.6.3 A Snapshot of Article 31bis 82 3.7 Conclusions 83 References 87 4 The Indian Case Study of Compulsory Licensing 91 4.1 Introduction 91 4.2 India’s Patent Law and the Pharmaceutical Industry 92 4.2.1 Pre-TRIPS 93 4.2.2 The TRIPS Scenario 95 4.2.3 The Indian Pharmaceutical Industry—A Sunrise Sector 97 4.3 Compulsory Licensing Under the Indian Patents Act 98 4.3.1 Section 84 98 4.3.2 Section 92 100 4.4 Compulsory Licensing Applications Under Section 84 101 4.4.1 Natco v. Bayer 102 4.4.2 BDR v. Bristol Myers Squibb (BMS) 110 4.4.3 Lee Pharma v. AstraZeneca (AZ) 114 4.5 Compulsory Licensing Applications Under Section 92 116 4.6 Conclusions 117 References 121 5 The Brazilian Case Study of Compulsory Licensing 123 5.1 Introduction 123 5.2 Brazil’s Patent Law, the Right to Health and the Pharmaceutical Industry 125 5.2.1 A Brazilian Perspective on Patent Law 125 5.2.2 The Right to Health 128 5.2.3 Brazil’s Pharmaceutical Capacity 129 5.3 Compulsory Licensing Under the Brazilian Patents Act 131 5.3.1 Article 68 131 5.3.2 Article 71 135 5.4 Compulsory Licensing Applications of Article 71 136 5.4.1 2001: Efavirenz and Nelfinaviz 137 5.4.2 2003: Kaletra, Efavirenz, and Nelfinavir 138 5.4.3 2005: The “Kaletra Deal” 138 5.4.4 2007: The Compulsory Licence for Efavirenz 141 5.5 An Evaluation of Brazil’s Compulsory Licensing Strategy 144 5.5.1 Reasons Behind the Country’s Use 145 5.5.2 Factors Making Brazil’s Compulsory Licensing Strategy Successful 145 5.5.3 Brazil’s Further Development of Compulsory Licensing 146 5.6 Conclusions 147 References 150 6 Access to Medicines and Multilateral Organisations 154 6.1 Introduction 154 6.2 Compulsory Licensing in the EU 155 6.3 The WIPO 161 6.4 The WHO 165 6.5 The NGOs 170 6.6 Conclusions 174 References 180 7 Conclusions 182 7.1 Patents and Access to Medicines: A Complex and Multifaceted Problem 182 7.2 Major Findings and Recommendations 187 7.2.1 Major Findings 187 7.2.2 Recommendations to Be Drawn from the Collective Experience of the Country Case Studies 189 Index 191 "This book focuses on the ability of countries to provide essential medicines to their populations even when these medicines are patented. It provides an analysis of current global intellectual property flexibilities and case studies from several developing countries including India and Brazil. It also provides policy recommendations which many developing counties could consider while designing their national intellectual property protection regimes. This monograph focuses on India and Brazil's use of compulsory licensing, one of the most significant and controversial TRIPS flexibilities. The author studies historical developments and political conditions of the patent system and compulsory licensing from the earliest stage to the modern arena, with a great emphasis on TRIPS. After conducting a cross-national study of India and Brazil, the book moves on to evaluate the different philosophies on compulsory licensing of multilateral organizations such as the EU, the WIPO, the WTO, and NGOs"--Publisher's description