Cover -- Authors note -- Index of Contents -- Table of Jurisprudence -- Australia -- Canada -- England -- European Cases -- The Gambia -- Germany -- India -- International -- Japan -- Kenya -- Malawi -- New Zealand -- South Africa -- United States -- Table of statutory instruments -- Africa -- Brazil -- Canada -- East African Community -- European Union -- Germany -- India -- Kenya -- South Africa -- United States -- Charters, treaties and conventions -- Bibliography -- Articles -- Books -- Documents -- Electronic Sources -- Interviews -- Table of acronyms and abbreviations -- Deutsche Zusammenfassung -- 1. Hypothese und Methodik der Arbeit -- 2. Grundlagen für die Fallstudien -- 3. Kapitelgliederung -- Part I Intellectual Property Rights and the TRIPS: Legal Groundwork -- Chapter 1: Justifying pharmaceutical patents -- 1.1 Introduction -- 1.2 Hypotheses and thesis methodology -- 1.3 Basis for case study -- 1.4 Chapter dissection -- 1.5 The semantics of property -- 1.5.1 Philosophical and economic definitions -- 1.5.2 Property as defined in some jurisdictions -- 1.6 Do IP rights belong in the "property" basket? -- 1.7 The history of lP rights protection -- 1.8 IP regimes itemised -- 1.8.1 IP rights through the lens of the TRIPS and the Paris Convention -- 1.8.2 The subject matter of IP rights as demarcated by some courts -- 1.9 Analysis of property rights theories -- 1.9.1 The natural right to property -- 1.9.2 Personality theory -- 1.9.3 Utilitarian and economic justifications -- 1.10 Applying property theories to drug patents -- 1.10.1 The importance of the right to health -- 1.10.2 Pharmaceutical patents -- 1.10.2.1 Life science sector: cornerstone justifications -- 1.10.2.2 The developing country stance -- Chapter 2: The pre-TRIPS sketch -- 2.1 The Paris Convention -- 2.2 The GATT -- 2.3 Enter the TRIPS.

2.3.1 The reasons for signing the TRIPS -- 2.3.2 The nuggets that make the TRIPS a benchmark agreement -- 2.4 The international law rules of treaty interpretation -- 2.4.1 Article 31.1 of the Vienna Convention -- 2.4.2 Ministerial declarations/decisions and state practice -- 2.4.3 Article 31.3c of the Vienna Convention -- 2.5 Further principles of treaty interpretation -- 2.5.1 The principle of effectiveness -- 2.5.2 The dubio mitius principle -- Chapter 3: The "get-out" Flexibilities in the TRIPS -- 3.1 Introduction -- 3.2 The take-off point: the Preamble -- 3.3 The saving clause in article 1 -- 3.4 Articles 3 and 4 -- 3.4.1 National treatment rule -- 3.4.2 The favour one favour all rule -- 3.5 Article 6 -- 3.5.1 The rationale for the patent exhaustion doctrine -- 3.5.2 PIs from the Paris Convention/GATT and the TRIPS perspectives -- 3.5.3 The concept of national exhaustion -- 3.5.4 The regime of regional exhaustion -- 3.5.5 Exhaustion at the global level -- 3.5.6 Potential conflicts between articles 6 and 28 of the TRIPS -- 3.5.7 The patent holder's consent -- 3.6 Articles 7 and 8 of the TRIPS -- 3.7 Article 27 of the TRIPS -- 3.7.1 The public health flexibility in article 27.1 of the TRIPS -- 3.7.2 The elbow room in article 27.2 of the TRIPS -- 3.7.3 The policy space in article 27.3.a of the TRIPS -- 3.7.4 Article 27 as read with article 28 of the TRIPS -- 3.7.4.1 Product and process patents -- 3.7.4.2 The end of reverse engineering? -- 3.7.4.3 Patentability of second pharmaceutical use claims -- 3.8 Article 30 -- 3.9 Article 31 of the TRIPS -- 3.9.1 Some pros and cons of CLs -- 3.9.2 CLs under the TRIPS and the Paris Convention -- 3.9.3 Compulsory licensing as drug access expanding tool -- 3.9.4 The effect of the systematic use of the CLs -- 3.10 The Doha Declaration: a magic wand? -- 3.10.1 What the Doha Declaration offers.

3.10.2 The Declaration's weak points -- 3.10.3 The August 2003 Decision/article 31bis of the TRIPS: focal points -- 13.10.3.1 The August 2003 Decision as a public health asset -- 3.10.3.2 Wading through the quicksand of the August 2003 Decision -- Part II Case studies -- Chapter 4: Patent laws in Kenya and India -- 4.1 Introduction -- 4.2 Sticky ground realities in Kenya and India -- 4.2.1 Kenya -- 4.2.2 India -- 4.3 Legal history and recent developments -- 4.3.1 Kenya -- 4.3.1.1 The road to the TRIPS -- 4.3.1.2 The IPA, 2001 -- 4.3.2 India -- 4.3.2.1 The amendments to India's patent regime in 1999 -- 4.3.2.2 The 2002 patent law amendments -- 4.3.2.3 The Patents Act, 1970 (2005) -- 4.4 Special Issues in Kenya and India -- 4.4.1 The Kenya Anti-Counterfeit Act, 2008 -- 4.4.1.1 The scope of the problem of counterfeit drugs -- 4.4.1.2 Controversial provisions in the Anti-Counterfeit Act -- 4.4.1.3 A legal victory against the Anti-Counterfeit Act -- 4.4.2 Patentability requirements in India and implications thereof -- 4.4.2.1 The litigators' Eldorado -- 4.4.2.2 Implications of section 3.d -- 4.4.2.3 Evergreening of patents: extant concerns -- 4.4.2.4 The Novartis case and section 3.d -- 4.5 Parallel imports in Kenya -- 4.6 Parallel imports in India -- 4.7 Compulsory licensing in Kenya and India -- 4.7.1 Kenya -- 4.7.2 India -- 4.8 Government use order in Kenya and India -- 4.8.1 Kenya -- 4.8.2 India -- 4.9 Voluntary licences in Kenya and India -- 4.10 Bolar provisions in Kenya and India -- Chapter 5: Drawing the curtains:a potpourri of reforms -- 5.1 Introduction -- 5.2 Royalty fees for CLs -- 5.2.1 The TRIPS and royalty payments -- 5.2.2 The patent holder's fee as set by some courts -- 5.2.3 State/institutional practices regarding royalty payment -- 5.2.4 The appropriate royalty payment model -- 5.3 Possible net gains in traditional medicines.

5.3.1 Incidences of biopiracy of TMs -- 5.3.2 International initiatives -- 5.3.3 TM protection in Kenya -- 5.3.4 TM protection in India -- 5.3.5 The most pressing need of the hour -- 5.4 The push for the domestic production of pharmaceuticals -- 5.4.1 The problems likely to hinder drug production -- 5.4.2 Justifying pharmaceutical production -- 5.4.2.1 Pharmaceutical tariff reductions -- 5.4.2.2 Drug price control in Kenya and India -- 5.4.2.3 Other drug price-slashing initiatives -- 5.5 A framework to support in-situ healthcare R&D -- 5.5.1 Investing in neglected tropical diseases -- 5.5.2 Benefits of institutional and country collaborations -- 5.5.3 Legislating national laws for neglected diseases -- 5.6 Avoiding bilateral TRIPS-plus arrangements -- 5.6.1 The dangers of bilateral agreements -- 5.6.2 Bilateral agreements signed with Kenya and India -- 5.7 Conclusion -- Annexes -- Annex 1 -- Annex 2 -- Annex 3 -- Annex 4 -- Annex 5 -- Annex 6.