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International studies in human rights.
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Annotation
This book analyses the relationship between the TRIPS Agreement and the right to health and relevant human rights norms by using the tools of treaty interpretation of public international law.
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Table of Contents
- Contents
- Abstract
- Preface
- Acknowledgement
- Chapter 1 Introduction
- I. The Issue
- II. Approach to the Argument of this Book
- III. Focus of this Book
- IV. Scheme of this Book
- Part One Preliminary
- Chapter 2 The International Human Rights Context
- I. The Right to Health in International Law
- A. Wide Recognition
- 1. International Recognition
- 2. National Recognition
- 3. Significance of the Recognition
- B. Scope and Content of the Right to Health
- 1. Scope
- 2. Elements in Content
- (a) Curative and Preventive Elements
- (b) Underlying Preconditions
- (c) Essential Elements
- 3. Obligations of States
- (a) Legal Obligations
- (i) To Respect
- (ii) To Protect
- (iii) To Fulfil
- (b) International Obligations
- (c) Core Obligations
- (a) Legal Obligations
- 4. Summary
- C. Public Health under the Right to Health
- 1. The Right to Health Originates from Public Health
- 2. The Right to Health Realises Public Health
- 3. The Right to Health Depends on Public Health
- 4. The Right to Health Limits other Rights under Public Health
- A. Wide Recognition
- II. The Right to Life in International Law – Refusal of Access to Life-Saving Facilities
- A. The Right to Life
- 1. Scope of the Right to Life
- 2. Content of the Right to Life
- B. Relationship between the Right to Life and the Right to Health
- C. Summary
- A. The Right to Life
- III. The Right to Property and the Right to Fruits of Creation
- A. The Rights
- 1. The Right to Property and Intellectual Property Rights
- (a) The Right to Property
- (b) Scope
- (c) Content
- (i) Peaceful Enjoyment
- (ii) Interference with Property
- (iii) Legality of Interference
- (d) The Implication
- (i) Compulsory Licensing Interference
- (ii) Status of the Norm
- 2. The Right to Fruits of Creation and Patent Rights
- (a) UDHR and ICESCR
- (b) Scope and Content
- (c) Summary
- 1. The Right to Property and Intellectual Property Rights
- B. Human Rights Approach to Patents
- 1. History and Justification of Patent Protection
- (a) The Development of Patent Protection
- (b) Justifications
- 2. Connections between Human Rights and Patent
- (a) Views
- (b) Relationships between the Two Regimes
- (i) Right to the Benefits of Scientific Progress and Patent
- (ii) Balance with Other Human Rights
- 1. History and Justification of Patent Protection
- A. The Rights
- I. The Right to Health in International Law
- Chapter 3 Conflict or Coexistence between Human Rights Norms and TRIPS
- I. TRIPS and the Right to Health
- A. The History of TRIPS
- B. Patent Protection in TRIPS and the Right to Health
- 1. Intellectual Property Protection in TRIPS
- 2. Pharmaceutical Patent Protection and the Right to Health
- (a) Article 27 (1) – Non-discrimination
- (b) Article 27(2) – The Exclusion and Its Proviso
- (c) Article 8(1) – The Principles and The “Limitation”
- II. Limitation and Derogation in the Regimes – an Internal Mechanism
- A. Limitation and Derogation in Human Rights
- 1. Limitation
- (a) Clauses
- (b) Elements
- (i) Principle of Legality
- (ii) General Welfare in Democratic Society
- (c) Grounds
- (i) Public Order and Ordre Public
- (ii) Morality and Public Morals
- (iii) Public Health
- 2. Derogation – Public Emergency
- 3. Application
- 1. Limitation
- B. Use of Limitation and Derogation Language in TRIPS
- 1. Terms used in TRIPS and in WTO Jurisprudence
- (a) Terms used in TRIPS
- (b) WTO Jurisprudence
- 2. Two-tiered Test under GATT Article XX
- (a) The Test
- (b) TRIPS and the Article XX Two-tiered Test
- 1. Terms used in TRIPS and in WTO Jurisprudence
- C. Relationship of the Concepts in the Two Regimes
- A. Limitation and Derogation in Human Rights
- III. Human Rights in TRIPS – Is an External Mechanism Needed
- A. Integration or Fragmentation
- B. Resolution of the Conflict
- I. TRIPS and the Right to Health
- Part Two Interpretation of TRIPS
- Chapter 4 Rules of Interpretation of Public International Law
- I. Application of VCLT by the WTO
- A. Article 31(1) of VCLT and Its Application
- 1. Ordinary Meaning – Article 31(1)
- 2. Application
- B. Contextual Material – Article 31(2) of VCLT
- C. Article 31(3) of VCLT and Its Application
- 1. Non-contextual Materials – Article 31(3)
- (a) Subsequent Agreement – Article 31(3)(a)
- (b) Subsequent Practice – Article 31(3)(b)
- (c) Relevant Rules of International Law – Article 31(3)(c)
- (i) Scope
- (ii) Parties
- (iii) Inter-temporality
- (d) Application Relationship
- 2. Application of Article 31(3)(c) in WTO
- 1. Non-contextual Materials – Article 31(3)
- D. Supplementary Means – Article 32 and Its Application
- 1. Article 32
- 2. Application
- E. Summary
- A. Article 31(1) of VCLT and Its Application
- II. Consistent Interpretation of TRIPS and WTO Laws
- A. TRIPS and Other Covered Agreements
- 1. Historical Link
- 2. Textual Link
- B. TRIPS and Incorporated Conventions
- A. TRIPS and Other Covered Agreements
- III. Evolutionary Interpretation
- I. Application of VCLT by the WTO
- Chapter 5 Examination of TRIPS in Light of the Interpretive Analyses
- I. Coverage and Flexibilities Offered by TRIPS
- II. Object and Purpose of TRIPS
- A. Ordinary Language Used in TRIPS
- 1. Preamble
- 2. Articles 7 and 8
- 3. Summary
- B. Subsequent Agreement and Practice
- 1. Doha Declaration
- 2. The 2003 Decision
- 3. 2005 Decision – Proposed Amendment of Article 31bis
- A. Ordinary Language Used in TRIPS
- III. Interpreting Specific Provisions
- A. Article 27 – Non-discrimination and Exclusion of Protection
- 1. Patentability
- (a) Three Criteria
- (b) Interpretation
- 2. Non-discrimination
- (a) Place, Product and Process, and Field of Technology
- (b) Canada – Pharmaceutical Patents
- (c) Open-endedness
- 3. Interpreting Open-ended Language
- 4. Second Use Patent
- (a) Ordinary Meaning
- (b) Contextual Interpretation
- 5. Exclusion of Patentability
- (a) Ordre Public or Morality
- (i) Contextual Interpretation
- (ii) Relationship with GATT Article XX(b)
- (iii) Summary
- (b) Diagnostic, Therapeutic and Surgical Methods
- (c) Plants and Animals
- (a) Ordre Public or Morality
- 1. Patentability
- B. Article 28 – Rights Conferred
- 1. Product and Process Patents
- (a) Product Patents
- (b) Process Patents
- 2. Exhaustion in Article 6
- 1. Product and Process Patents
- C. Article 6 – Exhaustion of Rights
- 1. The Article
- (a) Parallel Import and Exhaustion
- (i) Exhaustion of Rights
- (ii) Parallel Import
- (b) Open Interpretation
- (a) Parallel Import and Exhaustion
- 2. Relationship with GATT and Incorporated Conventions
- (a) Relationship with Paris Convention
- (b) Relationship with GATT
- (i) Relationship
- (ii) Interpretation of Relationship
- 1. The Article
- D. Article 31 – Compulsory Licensing
- 1. The Title and Chapeau
- 2. Individual Merits
- 3. Circumstances
- (a) Prior Negotiation
- (b) National Emergency and Extreme Urgency
- (c) Public Non-commercial Use
- 4. Scope and Duration
- (a) Duration – Temporary
- (b) Scope – Proportional
- 5. Domestic Supply and the Paragraph 6 Problem
- (a) The Problem
- (i) Legal Issues
- (ii) Economic Scale Concern
- (iii) Practical Issues
- (b) Subsequent Agreement
- (i) Legal Value and Objective of the 2003 Decision and 2005 Decision
- (ii) Clarification of Practical Issues
- (c) Subsequent Practice
- (d) Interpretation
- (i) Contextual Interpretation
- (ii) Article 6 in the Interpretation
- (iii) WTO Covered Agreement
- (a) The Problem
- 6. Adequate Remuneration
- E. Article 30 – Limited Exceptions
- 1. Relationship with Articles 27.1, 28 and 31
- 2. Article 30 – Exceptions to Rights Conferred
- (a) Exceptions to be Limited
- (b) Unreasonable Conflict with Normal Exploitation of Patent
- (c) Unreasonable Prejudice to Legitimate Interests
- 3. Interpretation
- (a) Health Related Exceptions
- (b) Ordinary Meaning
- (c) Contextual Interpretation
- (d) Supplementary Means
- F. Article 73 – Security Exception
- 1. Coverage of the Exception
- 2. Limit of the Exception
- A. Article 27 – Non-discrimination and Exclusion of Protection
- Chapter 6 Application of Human Rights Norms
- I. TRIPS and Human Rights Norms
- A. TRIPS is Not Self-contained
- 1. WTO is Not a “Closed Legal Circuit”
- (a) WTO Law is Broader than GATT
- (b) The Text of WTO DSU
- (c) Evolutionary Manner of Interpretation of WTO Laws
- (d) Extraneous Sources in WTO Jurisprudence
- 2. TRIPS should not be Isolated from Human Rights Norms
- 1. WTO is Not a “Closed Legal Circuit”
- B. TRIPS Invites the Use of Human Rights Norms
- 1. The Aim of TRIPS
- 2. Article 31(3)(c) of VCLT
- 3. The Language used in TRIPS
- 4. The Regime Shift in Intellectual Property Protection
- A. TRIPS is Not Self-contained
- II. Rights to Health, Property and Fruits of Creation in TRIPS
- A. Application
- 1. Hierarchical Status of Various Human Rights Norms
- (a) Human Rights Sources and UN Human Rights Bodies
- (b) The Status of the Human Rights Norms
- (i) Customary International Law
- (ii) Treaty Law
- (iii) Soft Law
- (iv) Vital Interest Protection
- 2. The Impact of Reference to Human Rights
- (a) Human Rights Limit Patent Protection
- (b) Human Rights Reinforce Patent Protection
- (c) Human Rights Realisation through Interpretation of TRIPS
- 1. Hierarchical Status of Various Human Rights Norms
- B. Applying GATT Interpretation Methods to TRIPS
- 1. Links between Human Rights and GATT
- 2. Application of GATT Interpretation Method
- A. Application
- III. The Right to Health in TRIPS
- A. Object and Purpose
- B. Specific Provisions
- 1. Article 27
- 2. Article 28
- 3. Article 31
- (a) Grounds
- (b) Duration
- (c) Scope
- (d) Supply and Parallel Importation
- (e) Remuneration
- (f ) Summary
- 4. Article 30
- 5. Article 73
- I. TRIPS and Human Rights Norms
- Part Three Impacts of Interpretation
- Chapter 7 Impacts on TRIPS-Plus in FTAs
- I. Interpretive Relationship Between TRIPS and FTAs
- A. Relationship in the Interpretation
- 1. Choice of Forum and Interpretation Rules in FTAs
- 2. Impacts on Interpretation
- B. Relationship with TRIPS
- A. Relationship in the Interpretation
- II. Heightened Patent Protection in FTAs
- A. Heightened Patent Protection in FTAs
- B. Justification for Heightened Patent Protection in FTAs
- C. Implication of the Justification
- III. Interpretation and Human Rights
- A. Flexibility in FTAs
- B. Interpretation
- 1. Compulsory Licensing
- 2. Side Letters
- 3. Non-derogation Provisions
- C. Human Rights
- 1. TRIPS Language
- 2. Non-derogation Provisions
- 3. Reference to TRIPS
- 4. Counter-regime of Human Rights
- IV. Summary
- I. Interpretive Relationship Between TRIPS and FTAs
- Chapter 8 Conclusion
- Bibliography
- Index
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