Table of Contents
List of abbreviations / 9 Introduction
1. The genesis and importance of the impact of intellectual property protection at the World Trade Organization on access to medicinal products / 11
2. Objectives, methodological assumptions, and book structure / 20 Chapter One
Standards for the protection of medicinal products in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) / 23
1. Genesis of the TRIPS Agreement / 23 1.1. Antecedents / 23
1.2. The General Agreement on Tariffs and Trade (GATT) / 26 1.3. The Uruguay Round of the GATT / 33
2. General characteristics of the TRIPS Agreement / 38
2.1. The nature of the TRIPS Agreement and its relationship with other international agreements / 38
2.2. Principles of intellectual property protection / 41 3. Patent protection / 43
3.1. Subject matter of patent protection / 43 3.1.1. Rationale for patentability / 43 3.1.2. Prohibition of discrimination / 46 3.2. Scope of patent rights / 48
3.2.1. Rights to a product / 49 3.2.2. Rights to a process / 50 3.3. Time period of protection / 50
3.3.1. Minimum period of patent protection / 50 3.3.2. Protection of existing subjects of rights / 52
Table of Contents
6
4. Protection of undisclosed information / 56
5. Trademark protection in the context of border control measures / 60 6. Summary / 66
Chapter Two
Measures for increasing access to medicinal products as part of the World Trade Organization system of intellectual property protection / 69
1. Introductory remarks / 69
2. Flexibilities – concept and attempt at classification / 70
3. The importance of the interpretation and implementation of the TRIPS Agreement / 73
3.1. General comments / 73
3.2. Problems of developing countries – Declaration on the TRIPS Agreement and Public Health / 79
3.2.1. Antecedents / 79 3.2.2. Declaration text / 85 3.2.3. Assessment attempt / 92 4. Exclusion from patentability / 94 5. Fair use of others’ inventions / 95
5.1. General comments / 95
5.2. The Canada – Patent Protection of Pharmaceutical Products (DS114) dispute / 96
5.2.1. Dispute background / 97 5.2.2. Dispute parties’ positions / 99 5.2.3. Report of the Panel / 103 5.2.4. Concluding remarks / 108 6. Compulsory licensing / 109
6.1. General comments / 109
6.2. Reasons and conditions for issuing compulsory licenses / 112 6.3. The problem of insufficient manufacturing capacities / 121
6.3.1. Problem outline / 121 6.3.2. Course of negotiations / 122
6.3.3. Decision of the General Council of August 30, 2003 / 127 6.3.4. Assessment attempt / 133
6.4. Concluding remarks / 136
Table of Contents 7 7. Parallel import / 137
8. Delaying the obligation to implement the treaty regulations / 142 9. The role of other international organizations / 144
10. Practical possibilities to promote access to medicinal products: the case of India / 148
11. Summary / 153 Chapter Three
Agreements going beyond the standards of the TRIPS Agreement / 157 1. The TRIPS Agreement as a minimum standard of protection / 157 2. Bilateral agreements liberalizing trade and investment
protection / 158
3. Agreements of universal scope of application / 163
3.1. The Anti-Counterfeiting Trade Agreement (ACTA) / 163 3.2. Trans-Pacific Partnership Agreement (TPP) / 167 4. Summary / 168
Chapter Four
Access to medicinal products as a component of the right to health / 171 1. Intellectual property rights and human rights – conflict or
convergence? / 171
2. The right to health in international human rights law / 175 3. Obligations of countries to ensure access to medicinal products / 180 4. The right to health within the World Trade Organization system / 187 5. Summary / 192
Conclusions / 197 Bibliography / 199
