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

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

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Bibliographic Details
:
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
Online Access:
Physical Description:1 online resource (373 pages)
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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?.

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