Intellectual Property Rights in the WTO and Access to Medicines

Taking into account the universal character of the World Trade Organization, it is definitely worth trying to analyze those WTO regulations that pertain to intellectual property rights as well as affect or may affect possible access to medicinal products. Therefore, the contents of the obligations imposed in this regard on WTO Members should be verified. The range of possible measures relating to intellectual property rights should be determined as well, which could help increase access to medicines within the WTO system, particularly for developing countries. The analysis was carried out in accordance with customary rules of interpreting international treaties codified in particular in Articles 31 and 32 of the Vienna Convention on the Law of Treaties.

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
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
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