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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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Index of Contents

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Table of Jurisprudence ........................................................................................ xv Australia ........................................................................................................ xv Canada ........................................................................................................... xv England ......................................................................................................... xv European Cases ........................................................................................... xvii The Gambia ................................................................................................ xviii Germany ..................................................................................................... xviii India ............................................................................................................. xix International ................................................................................................. xxi Japan .......................................................................................................... xxiii Kenya ......................................................................................................... xxiii Malawi ....................................................................................................... xxiv New Zealand .............................................................................................. xxiv South Africa ............................................................................................... xxiv United States .............................................................................................. xxiv Table of statutory instruments ........................................................................ xxvii Africa ........................................................................................................ xxvii Brazil ......................................................................................................... xxvii Canada ...................................................................................................... xxviii East African Community .......................................................................... xxviii European Union ....................................................................................... xxviii Germany ...................................................................................................... xxx India ............................................................................................................ xxx Kenya ........................................................................................................ xxxii South Africa ............................................................................................. xxxiv United States ............................................................................................ xxxiv Charters, treaties and conventions ............................................................. xxxv Bibliography ....................................................................................................... xli Articles .......................................................................................................... xli Books ........................................................................................................ lxxiv x Documents ................................................................................................. xciv Electronic Sources ..................................................................................... cxxii Interviews ..................................................................................................cxxiv Table of acronyms and abbreviations .............................................................. cxxv Deutsche Zusammenfassung ...........................................................................cxxxi 1. Hypothese und Methodik der Arbeit ..................................................... cxxxii 2. Grundlagen für die Fallstudien .............................................................cxxxiv 3. Kapitelgliederung ..................................................................................cxxxvi Part I: Intellectual Property Rights and the TRIPS: Legal Groundwork ............ 1 Chapter 1: Justifying pharmaceutical patents ...................................................... 3 1.1 Introduction ................................................................................................... 3 1.2 Hypotheses and thesis methodology ............................................................. 4 1.3 Basis for case study ....................................................................................... 5 1.4 Chapter dissection ......................................................................................... 8 1.5 The semantics of property ........................................................................... 11 1.5.1 Philosophical and economic definitions ......................................... 14 1.5.2 Property as defined in some jurisdictions ....................................... 16 1.6 Do IP rights belong in the “property” basket? ............................................ 20 1.7 The history of lP rights protection .............................................................. 22 1.8 IP regimes itemised ..................................................................................... 25 1.8.1 IP rights through the lens of the TRIPS and the Paris Convention ..................................................................................... 25 1.8.2 The subject matter of IP rights as demarcated by some courts ....... 27 1.9 Analysis of property rights theories ............................................................ 30 1.9.1 The natural right to property ........................................................... 31 1.9.2 Personality theory ........................................................................... 34 1.9.3 Utilitarian and economic justifications ........................................... 35 1.10 Applying property theories to drug patents ................................................. 39...

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