Access To Medicines And Vaccines: Implementing Flexibilities Under Intellectual Property Law

Preface
Contents
Interpreting the Flexibilities Under the TRIPS Agreement
	1 Introduction
	2 Defining the TRIPS Flexibilities
	3 TRIPS Flexibilities in WTO Jurisprudence
	4 Interpretation of the TRIPS Agreement
		4.1 Precedential Value of GATT/WTO Jurisprudence
		4.2 Ordinary Meaning
		4.3 Context
		4.4 Object and Purpose
			4.4.1 Legal Weight of the Doha Declaration
	5 Conclusions
	References
Intellectual Property Exhaustion and Parallel Imports of Pharmaceuticals: A Comparative and Critical Review
	1 Introduction: The Relevance (and Resilience) of the Principle of Intellectual Property Exhaustion and Its Application to Pha...
	2 Intellectual Property Exhaustion and Paralle Trade: General Considerations and Application to Pharmaceuticals
		2.1 The Principle of Intellectual Property Exhaustion in International Trade: An Overview
		2.2 Patent Exhaustion and the Debate on Parallel Trade of Pharmaceuticals
	3 National Solutions to Patent Exhaustion and Parallel Trade of Pharmaceuticals
		3.1 Selected Jurisdictions in Asia
		3.2 Canada, United States, Australia, and New Zealand
		3.3 Selected Jurisdictions in Latin America
		3.4 European Union and Switzerland
		3.5 Selected Jurisdictions in Africa
	4 Overlapping Intellectual Property Rights and Parallel Trade of Pharmaceuticals
		4.1 Overview of Overlapping Rights and Enforcement of Copyright to Parallel Imports
		4.2 Enforcement of Trademark Rights to Parallel Imports of Pharmaceuticals
	5 Conclusion: A Call for a Wider Application of the Flexibility of Article 6 of the TRIPS Agreement in Developing and Least De...
	References
Compulsory Licenses and Government Use: Challenges and Opportunities
	1 Introduction
	2 Historical and Conceptual Roots
	3 The TRIPS Framework
	4 A Scan of the Use of TRIPS Flexibilities
	5 A Tale of Two Countries
		5.1 The Zimbabwean Case
			5.1.1 Compulsory Licences
			5.1.2 Government Use
			5.1.3 Lessons
		5.2 The South African Case
			5.2.1 Legal Framework
			5.2.2 AIDS Denialism
			5.2.3 US Pressure
			5.2.4 Judicial Deference
			5.2.5 New IP Policy Phase I
	6 Compulsory Licensing Options Under TRIPS
		6.1 Expanded Grounds for Compulsory Licences
		6.2 Government Use
		6.3 Adequate Remuneration
		6.4 Procedures for Compulsory Licensing Applications
		6.5 Collaboration and Cooperation in the Issuance of CLs
		6.6 A Compulsory Licensing Facility
	7 Conclusion
	References
	Cases
	Statutes and Statutory Instruments
	Books
	Contributions to Edited Books
	Journal Articles
	Online Journals
	Command Articles and Law Commission Reports
	Websites and Blogs
Access to CRISPR Genome Editing Technologies: Patents, Human Rights and the Public Interest
	1 Introduction
	2 The Human Genome
	3 The CRISPR-Cas9 Genome Editing Technique
	4 Lulu and Nana: The Chinese Genome-Edited Twins ``Immune from HIV´´
	5 Patenting the CRISPR-Cas9 Genome Editing Breakthrough
	6 Excluding Genome Editing Technologies from Patentability
	7 International Human Rights Law and Genome Editing
	8 International Initiatives on the Regulation and Governance of Gene Editing
	9 Concluding Remarks
	References
Bolar Exception
	1 Exceptions to Patent Rights
	2 Rationale for the Bolar Exception
		2.1 Marketing Authorization of Medical Products
		2.2 Relationship of Patent Protection, Marketing Authorization and Supplementary Legal Protection
		2.3 Role of Generic and Biosimilar Competition in Promoting Access
	3 History of the Bolar Exception
	4 Consistency with Article 30 of the TRIPS Agreement
	5 Crafting National Legal Frameworks for the Bolar Exception
	6 India Bolar Exception: Recent Developments
	7 Conclusions
	References
Patent Oppositions in India
	1 Introduction
	2 Patent Oppositions in India
		2.1 Gleevec Opposition
		2.2 Valcyte Opposition
		2.3 Herceptin Opposition
		2.4 Zykadia Opposition
		2.5 The Viread Oppositions
		2.6 Kaletra Opposition
		2.7 Reyataz Opposition
		2.8 Combivir Opposition
		2.9 Trizivir Opposition
		2.10 Ziagen Opposition
		2.11 Isentress Opposition
		2.12 Sanofi TB Drugs Oppositions
		2.13 Veklury Opposition
	3 Pendency of Oppositions in the Indian Patent Office
		3.1 Pre-grant Oppositions
		3.2 Post-grant Oppositions
		3.3 Pendency at the Intellectual Property Appellate Board (IPAB)
		3.4 Impact of Pendency
	4 Conclusion
	Annex: Opposition Pendency Data for the Period 2007-08 to 2019-2020
	References
Protection of Clinical Test Data and Public Health: A Proposal to End the Stronghold of Data Exclusivity
	1 Introduction: Test Data and Efficacy, Safety and Quality of Medicines
	2 Generic and Biosimilar Medicine Marketing Approval and the Use of Test Data
	3 Rationale for Data Exclusivity
		3.1 Data Exclusivity and Patents
		3.2 Data Exclusivity´s Effectiveness in Stimulating Innovation
	4 History of Data Exclusivity
		4.1 Data Exclusivity in the United States
		4.2 Data Exclusivity in the European Union
		4.3 Protection of Test Data and the Rules of the World Trade Organization
	5 Data Exclusivity in Free Trade Agreements (FTAs)
	6 Data Exclusivity and TRIPS Flexibilities
		6.1 Compulsory Licensing and Government Use in Drug Procurement
		6.2 Data Exclusivity and Compulsory Licensing
		6.3 Remedies to Data Exclusivity Barriers and Compulsory Licensing
		6.4 Data Exclusivity Waivers in FTAs
		6.5 EU Medicines Regulation and Compulsory Licensing
		6.6 EU Data Exclusivity Waiver and Compulsory Licence for Export
		6.7 Data Exclusivity Waivers in Voluntary Patent Licences
		6.8 Public Health Measures, Data Exclusivity and Competition Law
		6.9 EU Law Needs an Explicit Data Exclusivity Waiver
	7 Conclusion and Recommendations
	References
Courts and Pharmaceutical Patents: From Formalist Positivism to the Emergence of a Global Law
	1 Introduction
	2 Assessing the Role of Courts in TRIPS Flexibilities As Forms of Structural Change
	3 Access and Innovation in Legal Discourse: From Opposition to Coexistence
	4 Trastuzumab High Price Litigation in Brazil
	5 The Sofosbuvir Case in Brazil
	6 Theoretical Conclusions on the Role of Courts in IP Based on the Concrete Cases
	7 Concluding Remarks
	References
Robust Patent Examination or Deep Harmonization? Cooperation and Work Sharing Between Patent Offices
	1 Introduction
	2 Patent Examination: A Critical TRIPS Flexibility
	3 Approaches to Patent Harmonisation
		3.1 Normative Approaches
		3.2 Persuasive Approaches
			3.2.1 Technical Assistance
			3.2.2 Quality of Patents
	4 PCT Reforms
		4.1 Working Group on PCT Reforms
			4.1.1 Establishment of a Written Opinion on Patentability to Accompany the International Search Report
			4.1.2 Automatic Designation of all PCT Contracting Parties for National Phase Entry
			4.1.3 Establishment of an Optional Supplementary International Search
		4.2 New PCT Working Group
	5 Work Sharing Arrangements Between Patent Offices
		5.1 Trilateral Cooperation
		5.2 IP5 Cooperation
		5.3 The Vancouver Group
		5.4 PROSUR
		5.5 ASPEC
		5.6 IP BRICS
		5.7 Patent Prosecution Highway
	6 Opportunities and Challenges
		6.1 South-South Cooperation
		6.2 Safeguarding and Utilising TRIPS Flexibilities
		6.3 Use of Technology
		6.4 Administrative Law Oversight
	7 Conclusion
	References
Intellectual Property Rights (IPRs), Competition Law and Excessive Pricing of Medicines
	1 Introduction
	2 TRIPS and Competition Policy: Orientations and Enforcement Trends in the Pharmaceutical Sector
		2.1 The Interface Between IPRs and Competition Law
		2.2 TRIPS and Competition Law: Competition Law as Flexibility Tool
		2.3 Enforcement Trends of Competition Law in the Pharmaceutical Sector
	3 Excessive Pricing of Pharmaceuticals: An Emerging Enforcement Trend
		3.1 Pricing of Pharmaceuticals and IPRs
		3.2 Overview of the Case Law on Excessive Pricing of Pharmaceuticals
		3.3 Competition and IP Issues Raised by the Case Law on Excessing Pricing of Pharmaceuticals
			3.3.1 IP, Patent Term and Excessive Pricing of Pharmaceuticals
			3.3.2 Competition Law and Excessive Pricing of Pharmaceuticals: Market Conditions and Pricing
				Market Power, Size of the Market and High Pricing
				Absence of Substitutability and High Pricing of Pharmaceuticals
				Consumer Choice/Behavior (Rationality) and the Specificity of Pharmaceuticals
				The Issue of the Determination of an Excessive Price
	4 Excessive Pricing of Pharmaceuticals and TRIPS Flexibilities: Lessons from the Excessive Prices Cases
	5 Conclusions
	References
The Impact of `TRIPS-Plus´ Rules on the Use of TRIPS Flexibilities: Dealing with the Implementation Challenges
	1 Introduction
	2 Expensive Medicines: National Implications and Global Challenges
	3 Unequal Investment and More Monopoly
	4 The Double Taxation of Society
	5 More Pharmaceutical Patents, Weaker Innovation
	6 Increased IP Standards: From TRIPS-Minus to TRIPS-Plus
		6.1 The Flexibilities Explained
		6.2 Putting the Flexibilities into Use
		6.3 The Shift Towards TRIPS-Plus
		6.4 Impact and Examples of TRIPS-Plus Obligations
	7 What Could Be Done and What Is Done?
		7.1 Australia
		7.2 Chile
		7.3 What Others Are Doing and How They Are Doing It?
	8 Final Thoughts
	References
Patent Linkages and Its Impact on Access to Medicines: Challenges, Opportunities for Developing Countries
	1 Introduction
	2 Perspectives on Patent Linkage
		2.1 US
		2.2 EU
		2.3 Canada
		2.4 Australia
		2.5 Japan
		2.6 South Korea
		2.7 China
		2.8 Taiwan
		2.9 Russia
		2.10 Ukraine
		2.11 Thailand
		2.12 Philippines
		2.13 Singapore
		2.14 Malaysia
		2.15 Vietnam
		2.16 Indonesia
		2.17 Jordan
		2.18 Mexico
		2.19 United Arab Emirates (UAE)
	3 Patent Linkage Provisions in Regional and Bilateral Trade Agreements
		3.1 CPTPP
		3.2 US - Peru FTA
		3.3 AUSFTA
		3.4 RCEP
		3.5 KOREA - US FTA
	4 Indian Scenario
		4.1 Drugs and Cosmetics Act, 1940
		4.2 Bristol Myers Squibb v. Hetero Drugs Ltd. - 2008
		4.3 Bayer - Cipla Case
	5 Conclusions
		5.1 Suggestions
	References