Access to Medicines and Vaccines : : Implementing Flexibilities under Intellectual Property Law.

• Author: Correa, Carlos M.
• TeilnehmendeR: Hilty, Reto M.
• Place / Publishing House: Cham : : Springer International Publishing AG,, 2021.; ©2022.
• Year of Publication: 2021
• Edition: 1st ed.
• Language: English
• Physical Description: 1 online resource (373 pages)

Table of Contents

Intro -- 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 Exclusivityś 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?.