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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?


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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Table of Jurisprudence


Australia Aktiebolaget Hassle v. Alphapharm Pty Ltd, [2003] Case 14 HCA, Part 3. Avail- able at: [accessed July 2010]. Anaesthetic Supplies Pty Ltd v. Rescare Ltd, [1994] 28 IPR 383, RR 586. Arrow Pharmaceuticals Limited v. Merck & Co. Inc., [2004] FCA 1282. Campomar Sociedad Ltd v. Nike International Ltd, [2000] 202 CLR 45. Massey Ferguson (Australia) Ltd’s Patent, [1977] RPC, 94(8), 168-74. Minister for Immigration & Multicultural & Indigenous Affairs v. Al Masri, [2003] FCAFC 70. Polo/Lauren Company L.P. v. Ziliani Holdings Pty Ltd, [2008] FCA 49. The Minister of State for the Army v. Dalziel, [1944] 68 CLR. Yanner v. Eaton, [1999] HCA 53. Canada Apotex Inc. v. Sanofi-Synthelabo Canada Inc., [2008] 3 S.C.R. 265, SCC 61. AstraZeneca Canada v. Canada (Minister of Health), [2006] SCC 49. England American Cyanamid Co’s (Fenbufen) Patent, [1990] RPC, 107(12), 309-40. Auchincloss v. Agricultural & Veterinary Supplies Ltd, [1999] RPC, 116(11), 397-408. Bayer AG (Meyer’s) Application, [1984] RPC, 101(1), 11-16. Betts v. Wilmott, [1870-71] LR. 6 Ch. App. 239. Biogen Inc., v. Medeva PLC, [1997] RPC, 114(1), 1-54. Cabot Safety Corp’s Patent, [1992] RPC, 109 (3), 39-64. Case 434/85-Allen and Hanbury v. Generic (UK) Ltd, [1988] ECR, 1245. xvi CFPH LLC Applications, [2006] RPC, 123 (8), 259-88. Chiron Corporation v. Organon Teknika Ltd and Others, [1995] 33, FSR, (1995). Chiron Corporation v. Murex Diagnostics Ltd, [1996] RPC, 113(18), 535-64. Ciba-Geigy’s AG (Durr’s) Applications, [1977] RPC, 94(8), 83-89. CoreValve Inc. v. Edwards Life Sciences AG & Edwards Life Sciences PVT, Inc...

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