AN INTERNATIONAL LAW PERSPCTIVE ON THE5PROTECTION OF HUMAN RIGHTS IN THE TRIPS AGREEMENTPDF电子书下载

1. Introduction 1

Ⅰ. The Issue 1

Ⅱ. Approach to the Argument of this Book 9

Ⅲ. Focus of this Book 10

Ⅳ. Scheme of this Book 10

PART ONE PRELIMINARY 15

2. The International Human Rights Context 15

Ⅰ. The Right to Health in International Law 15

A. Wide Recognition 15

1. International Recognition 16

2. National Recognition 18

3. Significance of the Recognition 23

B. Scope and Content of the Right to Health 23

1. Scope 24

2. Elements in Content 25

(a) Curative and Preventive Elements 25

(b) Underlying Preconditions 26

(c) Essential Elements 27

3. Obligations of States 29

(a) Legal Obligations 30

(Ⅰ) To Respect 30

(Ⅱ) To Protect 31

(Ⅲ) To Fulfil 32

(b) International Obligations 34

(c) Core Obligations 34

4. Summary 35

C. Public Health under the Right to Health 36

1. The Right to Health Originates from Public Health 36

2. The Right to Health Realises Public Health 37

3. The Right to Health Depends on Public Health 40

4. The Right to Health Limits other Rights under Public Health 41

Ⅱ. The Right to Life in International Law - Refusal of Access to Life-Saving Facilities 41

A. The Right to Life 42

1. Scope of the Right to Life 42

2. Content of the Right to Life 44

B. Relationship between the Right to Life and the Right to Health 46

C. Summary 50

Ⅲ. The Right to Property and the Right to Fruits of Creation 50

A. The Rights 51

1. The Right to Property and Intellectual Property Rights 51

(a) The Right to Property 51

(b) Scope 52

(c) Content 55

(Ⅰ) Peaceful Enjoyment 55

(Ⅱ) Interference with Property 55

(Ⅲ) Legality of Interference 56

(d) The Implication 57

(Ⅰ) Compulsory Licensing Interference 57

(Ⅱ) Status of the Norm 58

2. The Right to Fruits of Creation and Patent Rights 59

(a) UDHR and ICESCR 59

(b) Scope and Content 60

(c) Summary 63

B. Human Rights Approach to Patents 64

1. History and Justification of Patent Protection 64

(a) The Development of Patent Protection 64

(b) Justifications 66

2. Connections between Human Rights and Patent 70

(a) Views 70

(b) Relationships between the Two Regimes 71

(ⅰ) Right to the Benefits of Scientific Progress and Patent 71

(ⅱ) Balance with Other Human Rights 73

3. Conflict or Coexistence between Human Rights Norms and TRIPS 75

Ⅰ. TRIPS and the Right to Health 75

A. The History of TRIPS 76

B. Patent Protection in TRIPS and the Right to Health 78

1. Intellectual Property Protection in TRIPS 78

2. Pharmaceutical Patent Protection and the Right to Health 79

(a) Article 27 (1) - Non-discrimination 79

(b) Article 27(2) - The Exclusion and Its Proviso 80

(c) Article 8(1) - The Principles and The "Limitation" 80

Ⅱ. Limitation and Derogation in the Regimes - an Internal Mechanism 81

A. Limitation and Derogation in Human Rights 81

1. Limitation 82

(a) Clauses 82

(b) Elements 84

(Ⅰ) Principle of Legality 84

(Ⅱ) General Welfare in Democratic Society 86

(c) Grounds 87

(Ⅰ) Public Order and Ordre Public 87

(Ⅱ) Morality and Public Morals 88

(Ⅲ) Public Health 88

2. Derogation-Public Emergency 90

3. Application 90

B. Use of Limitation and Derogation Language in TRIPS 92

1. Terms used in TRIPS and in WTO Jurisprudence 92

(a) Terms used in TRIPS 92

(b) WTO Jurisprudence 95

2. Two-tiered Test under GATT Article XX 97

(a) The Test 97

(b) TRIPS and the Article XX Two-tiered Test 100

C. Relationship of the Concepts in the Two Regimes 101

Ⅲ. Human Rights in TRIPS-Is an External Mechanism Needed 101

A. Integration or Fragmentation 104

B. Resolution of the Conflict 107

PART TWO INTERPRETATION OF TRIPS 115

4. Rules of Interpretation of Public International Law 115

Ⅰ. Application of VCLT by the WTO 115

A. Article 31(1) of VCLT and Its Application 116

1. Ordinary Meaning-Article 31(1) 116

2. Application 118

B. Contextual Material-Article 31(2) of VCLT 120

C. Article 31(3) of VCLT and Its Application 121

1. Non-contextual Materials-Article 31(3) 121

(a) Subsequent Agreement-Article 31 (3)(a) 122

(b) Subsequent Practice-Article 31(3)(b) 122

(c) Relevant Rules of International Law Article 31(3)(c) 125

(Ⅰ) Scope 125

(Ⅱ) Parties 127

(Ⅲ) Inter-temporality 128

(d) Application Relationship 130

2. Application of Article 31 (3)(c) in WTO 130

D. Supplementary Means - Article 32 and Its Application 132

1. Article 32 132

2. Application 133

E. Summary 134

Ⅱ. Consistent Interpretation of TRIPS and WTO Laws 134

A. TRIPS and Other Covered Agreements 134

1. Historical Link 135

2. Textual Link 136

B. TRIPS and Incorporated Conventions 138

Ⅲ. Evolutionary Interpretation 139

5. Examination of TRIPS in Light of the Interpretive Analyses 143

Ⅰ. Coverage and Flexibilities Offered by TRIPS 143

Ⅱ. Object and Purpose of TRIPS 146

A. Ordinary Language Used in TRIPS 146

1. Preamble 147

2. Articles 7 and 8 150

3. Summary 154

B. Subsequent Agreement and Practice 154

1. Doha Declaration 154

2. The 2003 Decision 157

3. 2005 Decision-Proposed Amendment of Article 31bis 158

Ⅲ. Interpreting Specific Provisions 160

A. Article 27 - Non-discrimination and Exclusion of Protection 160

1. Patentability 160

(a) Three Criteria 161

(b) Interpretation 162

2. Non-discrimination 163

(a) Place, Product and Process, and Field of Technology 163

(b) Canada - Pharmaceutical Patents 164

(c) Open-endedness 165

3. Interpreting Open-ended Language 165

4. Second Use Patent 167

(a) Ordinary Meaning 167

(b) Contextual Interpretation 169

5. Exclusion of Patentability 169

(a) Ordre Public or Morality 170

(Ⅰ) Contextual Interpretation 170

(Ⅱ) Relationship with GATT Article XX(b) 174

(Ⅲ) Summary 176

(b) Diagnostic, Therapeutic and Surgical Methods 177

(c) Plants and Animals 177

B. Article 28 - Rights Conferred 178

1. Product and Process Patents 179

(a) Product Patents 179

(b) Process Patents 180

2. Exhaustion in Article 6 181

C. Article 6 - Exhaustion of Rights 182

1. The Article 182

(a) Parallel Import and Exhaustion 182

(Ⅰ) Exhaustion of Rights 182

(Ⅱ) Parallel Import 184

(b) Open Interpretation 185

2. Relationship with GATT and Incorporated Conventions 186

(a) Relationship with Paris Convention 186

(b) Relationship with GATT 187

(Ⅰ) Relationship 187

(Ⅱ) Interpretation of Relationship 188

D. Article 31 - Compulsory Licensing 191

1. The Title and Chapeau 193

2. Individual Merits 194

3. Circumstances 194

(a) Prior Negotiation 195

(b) National Emergency and Extreme Urgency 196

(c) Public Non-commercial Use 198

4. Scope and Duration 202

(a) Duration-Temporary 203

(b) Scope-Proportional 204

5. Domestic Supply and the Paragraph 6 Problem 204

(a) The Problem 204

(Ⅰ) Legal Issues 206

(Ⅱ) Economic Scale Concern 207

(Ⅲ) Practical Issues 207

(b) Subsequent Agreement 210

(Ⅰ) Legal Value and Objective of the 2003 Decision and 2005 Decision 211

(Ⅱ) Clarification of Practical Issues 214

(c) Subsequent Practice 217

(d) Interpretation 218

(Ⅰ) Contextual Interpretation 218

(Ⅱ) Article 6 in the Interpretation 220

(Ⅲ) WTO Covered Agreement 220

6. Adequate Remuneration 221

E. Article 30 - Limited Exceptions 222

1. Relationship with Articles 27.1, 28 and 31 222

2. Article 30 - Exceptions to Rights Conferred 223

(a) Exceptions to be Limited 224

(b) Unreasonable Conflict with Normal Exploitation of Patent 227

(c) Unreasonable Prejudice to Legitimate Interests 227

3. Interpretation 229

(a) Health Related Exceptions 229

(b) Ordinary Meaning 231

(c) Contextual Interpretation 233

(d) Supplementary Means 234

F. Article 73 - Security Exception 235

1. Coverage of the Exception 236

2. Limit of the Exception 237

6. Application of Human Rights Norms 239

I. TRIPS and Human Rights Norms 239

A. TRIPS is Not Self-contained 239

1. WTO is Not a "Closed Legal Circuit" 239

(a) WTO Law is Broader than GATT 240

(b) The Text of WTO DSU 241

(c) Evolutionary Manner of Interpretation of WTO Laws 242

(d) Extraneous Sources in WTO Jurisprudence 244

2. TRIPS should not be Isolated from Human Rights Norms 244

B. TRIPS Invites the Use of Human Rights Norms 245

1. The Aim of TRIPS 245

2. Article 3l(3)(c) of VCLT 247

3. The Language Used in TRIPS 248

4. The Regime Shift in Intellectual Property Protection 250

Ⅱ. Rights to Health, Property and Fruits of Creation in TRIPS 251

A. Application 251

1. Hierarchical Status of Various Human Rights Norms 251

(a) Human Rights Sources and UN Human Rights Bodies 251

(b) The Status of the Human Rights Norms 252

(ⅰ) Customary International Law 253

(ⅱ) Treaty Law 254

(ⅲ) Soft Law 256

(ⅳ) Vital Interest Protection 260

2. The Impact of Reference to Human Rights 261

(a) Human Rights Limit Patent Protection 262

(b) Human Rights Reinforce Patent Protection 266

(c) Human Rights Realisation through Interpretation of TRIPS 267

B. Applying GATT Interpretation Methods to TRIPS 272

1. Links Between Human Rights and GATT 272

2. Application of GATT Interpretation Method 274

Ⅲ. The Right to Health in TRIPS 275

A. Object and Purpose 275

B. Specific Provisions 279

1. Article 27 279

2. Article 28 281

3. Article 31 282

(a) Grounds 282

(b) Duration 284

(c) Scope 286

(d) Supply and Parallel Importation 287

(e) Remuneration 288

(f) Summary 289

4. Article 30 290

5. Article 73 291

PART THREE IMPACTS OF INTERPRETATION 297

7. Impacts on TRIPS-Plus in FTAs 297

Ⅰ. Interpretive Relationship Between TRIPS and FTAs 297

A. Relationship in the Interpretation 297

1. Choice of Forum and Interpretation Rules in FTAs 297

2. Impacts on Interpretation 300

B. Relationship with TRIPS 302

Ⅱ. Heightened Patent Protection in FTAs 304

A. Heightened Patent Protection in FTAs 304

B. Justification for Heightened Patent Protection in FTAs 309

C. Implication of the Justification 311

Ⅲ. Interpretation and Human Rights 314

A. Flexibility in FTAs 314

B. Interpretation 317

1. Compulsory Licensing 317

2. Side Letters 320

3. Non-derogation Provisions 321

C. Human Rights 323

1. TRIPS Language 323

2. Non-derogation Provisions 323

3. Reference to TRIPS 324

4. Counter-regime of Human Rights 324

Ⅳ. Summary 325

8. Conclusion 327

Bibliography 333

Index 353