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The Legal Duel: The TRIPS Agreement and Drug Access Issues

Is the Agreement Actually the Cunning Manoeuvre it has been Dubbed?

Series:

Brenda Mey

This thesis discusses the flexibilities built into the Agreement on Trade Related Aspects of Intellectual Property Rights that are relevant for ensuring access to and availability of new medicines for the treatment of life-threatening diseases. Using Kenyan and Indian patent laws as case studies, the thesis examines the experience these countries have had in making use of the flexibilities. The thesis concludes that besides the TRIPS flexibilities, the resolution of the problem of access to medicines requires a concrete and a potent mix of country specific non-IP strategies. To test the hypotheses advanced in it, the thesis applies descriptive, qualitative and quantitative methodologies as well as interpretive analysis of court cases.

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Part I Intellectual Property Rights and the TRIPS: Legal Groundwork

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3 Chapter 1: Justifying pharmaceutical patents 1.1 Introduction For centuries, intellectual property (hereinafter referred to as IP) law was com- prised of highly incongruent legal regimes lumping together disparate forms of intellectual property rights (hereinafter referred to as IP rights) and was consi- dered an obscure and monotonous unit of commercial law.1 The historical foun- dations of the various IP rights and laws differed according to the domestic laws of each country. Thus, their administration, protection and enforcement also varied significantly.2 In recent decades, however, unprecedented and fast-paced technological advances have transformed IP law and the categories of rights it seeks to protect into hot-button issues. The issues are now widely recognised as an important component of international trade and economic development. As a result, IP law is now a part of a web of seamless inter-related proprietary rights that are no longer dealt with in isolation.3 Alongside these developments, the foundations of IP law have been built step by step through negotiations, founding treaties, accession agreements and conventions, beginning with the Paris Con- vention for the Protection of Industrial Property (hereinafter referred to as the Paris Convention),4 and ending with the World Trade Organisation’s (hereinafter referred to as the WTO) Trade Related Aspects of Intellectual Property Rights Agreement (hereinafter referred to as the TRIPS).5 The TRIPS has been hailed as one of the most significant milestones in the global development of IP rights protection. By pure coincidence, the coming into force of the TRIPS in 1994 coincided...

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