Pharmaceutical Patent Protection and World Trade Law: The unresolved problem of access to medicines

Cover
Title
Copyright
Dedication
Contents
List of cases
List of acronyms
Preface
1 Introduction
	1 Globalising intellectual property rights
		1.1 Knowledge: the new capital
	2 Access to medicines and the TRIPS Agreement
		2.1 Twenty years of TRIPS and the proliferation of RTAs
		2.2 Organisation of the book and areas of enquiry
Part I Evolution of intellectual property laws, and the introduction of IP protection in the multilateral trading system
	2 A jurisprudential enquiry into the justification of international IP rights protection, with particular reference to pharmaceutical patents
		1 Introduction
		2 Patent rights: origins, traditional views and economic foundations
			2.1 Intellectual property rights and the control of ‘knowledge’
			2.2 Patents: an economic analysis
			2.3 Expansion of intellectual property laws: the haunting colonial legacy
		3 IP rights policy vis-à-vis human rights: an analysis
			3.1 Access to medicines as human right
			3.2 Pharmaceutical corporations and the right to life-saving medicines
		4 Public right to health v. private right to restrict
		5 Conclusion
	3 Intellectual property in the multilateral trading system: forum shifting, TRIPS Agreement, Doha Declaration and TRIPS flexibilities
		1 Introduction
			1.1 The quest for stronger IP rights protection and forum shifting
			1.2 TNPCs and the inclusion of IP rights protection in the WTO
		2 TRIPS Agreement flexibilities and the Doha Declaration
			2.1 TRIPS implementation: the difficulties
	4 Undermining TRIPS flexibilities: FTAs, RTAs, EPAs, TRIPS-plus and stoppage in transit
		1 Introduction
		2 TRIPS-plus provisions, FTAS and the WTO
			2.1 Nature of IP provisions in FTAs
		3 FTAs: data exclusivity, compulsory licencing
			3.1 FTAs: parallel imports, patent linkage
		4 Conclusion
Part II TRIPS and developing countries: implementation, knowledge economy and IP policymaking
	5 Brazil: ambitious missions and early TRIPS implementation
		1 Brazil: right to health as a constitutional right
			1.1 Brazilian national health system: Sistema Único de Saúde (SUS)
		2 Response to HIV/AIDS epidemic: right to health and pharmaceutical patents
		3 Brazilian patent laws: from the nineteenth century alvará to TRIPS implementation
			3.1 Key provisions 1: parallel imports, Bolar exception and compulsory licencing
				3.1.1 Use of price negotiation and compulsory licencing provision
				3.1.2 Setback: seizure of generic medicines-in-transit
			3.2 Key provisions 2: prior consent, ANVISA and second use medical patent
			3.3 Mailbox legacy, backlog and the patent prosecution highway
			3.4 Access to health and medicines and judicial enforcement: trouble in paradise
			3.5 Brazil’s balancing act: the current state of play and proposed changes
		4 Conclusion
	6 China: the uneasy transition
		1 Introduction: in a league of its own
		2 Intellectual property laws: origins and evolution
			2.1 Market economy reforms and IP laws
		3 TRIPS compliance: new laws, national IP strategy and pharmaceutical patent rights
			3.1 Public health: TRIPS, compulsory licencing
			3.2 Public health: access to medicines and the right to health
		4 Conclusion
	7 India: the transition from process to product patent
		1 Introduction
		2 Indian patent laws: pre-independence
			2.1 Post-independence
			2.2 Justice Ayyangar Committee Report
			2.3 Indian Patent Act 1970
		3 WTO membership and TRIPS negotiation
			3.1 TRIPS compliance
		4 The Amendment Act 2005
			4.1 Compulsory licencing
				4.1.1 The first compulsory licence case: Natco v. Bayer
				4.1.2 BDR v. Bristol-Myers Squibb
				4.1.3 Lee Pharma v. AstraZeneca
				4.1.4 A closer look at the compulsory licence provision
		5 The aftermath
			5.1 Pre-grant and post-grant opposition
			5.2 Patentability and patent evergreening
		6 Interpreting section 3(d): the Novartis saga
			6.1 Case analysis
		7 Exhaustion of patent rights and parallel imports
			7.1 Indian pharmaceutical policy
		8 Conclusion
	8 South Africa: against all odds
		1 Sub-Saharan Africa: the Uruguay Round and IP rights
		2 South Africa: an introduction
			2.1 Democratic South Africa: hopes and setbacks
		3 The Medicines Act: the court and street battles
		4 TRIPS flexibilities, the Doha Declaration and sub-Saharan Africa
			4.1 Post-apartheid South Africa and the healthcare system
			4.2 Healthcare, human rights and the constitutional court
		5 Judicial interpretation of constitutional rights
			5.1 The implications of the court decisions
			5.2 The national health insurance and the National Health Act 2013
		6 Conclusion
	9 Kenya: can generics still reach the needy?
		1 Kenya: an introduction
		2 HIV/AIDS and other health care woes
		3 IP legislative framework: pre- and post-TRIPS era
			3.1 The Industrial Property Act 1989
			3.2 The Industrial Property Act 2001
		4 Kenya: the pharmaceutical hub of EAC
		5 The right to life: Anti-Counterfeit Act 2008, the new constitution and Patricia Asero Ochieng & 2 Others v. Attorney General & Another [2012]
			5.1 The Anti-Counterfeit Act 2008
			5.2 Patricia Asero Ochieng & 2 Others v. Attorney General & Another, and the ‘right to health’ under the new constitution
			5.3 The judgment and findings
		6 What was achieved?
		7 Conclusion: way forward
Part III TRIPS at what cost?
	10 TRIPS Agreement and the future of access to affordable medicines
		1 Introduction
			1.1 The costs and benefits of TRIPS to developing countries
		2 The promise of TRIPS: will it ever be realised?
		3 The role of non-state actors
		4 Conclusion: the forgotten right to health
Index