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Introductory note:The legal structure and the economic nature of intellectual property1

1.The legal structure of intellectual property2

(a)Intellectual property:The branch of law that protects business-differentiating intangible assets2

(b)The intrinsically exclusive nature of intellectual property11

2.The economic function of intellectual property:To promote the creation and the preservation of business differentiation13

(a)Intellectual property and the reduction of transaction costs17

3.Intellectual property:A spontaneous legal tool that has embbebed the structural fabric of every organized society since the dawn of civilization22

4.Patents,trade secrets,and patronage:Alternative mechanisms to differentiate and promote invention and innovation30

(a)The primary function of patents:To gauge inventions in a relatively accurate manner(as compared to trade secrets and state patronage)30

(ⅰ)The two best-known explanations of the functions of patents:The reward and the prospect theories31

(ⅱ)Primarily,patents are not rewards31

(ⅲ)Primarily,patents do not serve to prospect the market35

(b)Trade secrets and patents:Competing appropriation devices38

(ⅰ)Patents are more socially efficient than trade secrets insofar as they provide for a better quantification of technology and a better qualification of rights:The gauging function of patents39

(ⅱ)Injunctions issued to enforce trade secret protection:A problem of uncertainty resulting from the lack of a pre-determined term42

(ⅲ)Pro-competitive effects of patent disclosure42

(ⅳ)The residual social value of trade-secret protection43

(c)Patronage and patents:Competing and complementary mechanisms45

(d)The gauging function of patents in a nutshell47

5.A special note on the interface between patent and competition law47

(a)Patents and monopolies48

(b)Abuses of patent rights55

(c)Distinguishing abuses that are anti-competitive from those that are not57

(d)Industrial property,competition law,and repression of unfair competition59

6.TRIPS'flexibilities'60

(a)The concept of'flexibilities'60

(b)Four clusters of flexibilities62

(ⅰ)The first cluster:Transitional periods62

(ⅱ)The second cluster:Flexibilities regarding implementation of international obligations63

(ⅲ)Flexibilities as to standards of protection:Upwards(TRIPS plus)and downwards(exceptions and limitations)flexibilities;modalities of exceptions and limitations(internal and external);examples63

(ⅳ)Flexibilities in the field of enforcement:Injunctions and the principle of equity64

(c)Another approach to flexibilities:Three sequential moments in the life of rights and corresponding flexibilities65

(d)General principles that apply to flexibilities and conclusion66

PREAMBLE:AGREEMENT ON TRADE-RELATED ASPECTS OF INTELLECTUAL PROPERTY RIGHTS71

1.The scope,the nature,and the function of the TRIPS Agreement72

(a)The scope of the TRIPS Agreement72

(b)The dynamic dimension of the TRIPS Agreement74

(c)The nature and the function of the Agreement76

(ⅰ)The first objective of the TRIPS Agreement:To reduce distortions and impediments to international trade79

(ⅱ)The second objective of the TRIPS Agreement:To protect private property rights83

2.Intellectual property and trade84

(a)TRIPS and the GATT88

(b)The WTO and WIPO94

3.Patent protection and economic development100

PART Ⅰ:GENERAL PROVISIONS AND BASIC PRINCIPLES107

Article 1:Nature and Scope of Obligations107

1.The TRIPS Agreement:A minimum standards agreement108

2.Method of implementing the provisions of the TRIPS Agreement113

3.Implementation116

4.The scope of TRIPS Obligations122

Article 2:Intellectual Property Conventions125

1.The objective of the Paris Convention:The articulation of national industrial property systems125

2.The national treatment principle under the Paris Convention127

3.The principle of priority128

4.The principle of independence129

5.Article 5 of the Paris Convention and trade protectionism132

6.From the Paris Convention to the TRIPS Agreement133

7.The relationship between the TRIPS Agreement and the Paris Convention135

Article 3:National Treatment143

1.The'no less favourable'treatment standard of the TRIPS Agreement as opposed to the 'same'treatment standard of the Paris Convention143

2.The concept of 'necessity'in the TRIPS Agreement147

3.Two GATT panel reports on the national treatment principle and Article XX(d)of the GATT 1947151

4.The principle of national treatment in the European Communities cases153

5.Scope and reach of footnote 3156

Article 4:Most-Favoured-Nation Treatment161

1.The most-favoured-nation treatment principle161

2.The MFN principle and the national treatment principle:A rule of thumb162

3.The scope of the MFN principle163

4.Exemptions from the MFN principle165

Article 5:Multilateral Agreements on Acquisition or Maintenance of Protection169

1.The scope of the exemption under Article 5169

2.An example of an admissible exemption:Discriminatory reduction of fees171

Article 6:Exhaustion173

1.The meaning of Article 6173

2.Exhaustion176

3.The legal implications of international exhaustion184

4.Other modalities of exhaustion193

Article 7:Objectives197

1.The scope and the meaning of Article 7197

2.Transfer and dissemination of technology202

3.The meaning of the expression 'balance of rights and obligations'209

Article 8:Principles223

Paragraph 1223

1.The conditions of the application of Article 8.1224

2.Article 8.1 and non-violation complaints226

3.The TRIPS Agreement and public health227

4.The Doha Declaration on the TRIPS Agreement and Public Health233

(a)Introduction233

(b)Commentary235

Paragraph 2242

PART Ⅱ:STANDARDS CONCERNING THE AVAILABILITY,SCOPE,AND USE OF INTELLECTUAL PROPERTY RIGHTS245

Section 5:Patents245

Article 27:Patentable Subject Matter245

Paragraph 1245

1.The history of Article 27245

2.Prohibition of discrimination248

3.Article 27.1 and Article 1252

4.The scope of Article 27.1252

(a)How to distinguish patentable inventions from products of nature(discoveries)252

(ⅰ)The condition of artificiality253

(ⅱ)The condition of alternativeness256

(ⅲ)The condition of non-communicability262

(ⅳ)The condition of alternativeness of inventions:A corollary of the gauging function of patents264

(b)Patentable subject matter265

(ⅰ)Computer software265

(ⅱ)Business methods267

(ⅲ)Second uses270

5.Substantive examination276

6.Conditions of patentability:A minimum or a maximum?277

7.Discrimination as to the place of invention278

8.Discrimination as to the field of technology279

9.Discrimination as to the location of production:The local working requirement283

(a)The working requirement under the Paris Convention283

(b)The meaning of the last sentence of Article 27.1284

(c)The interface between international exhaustion and the local working requirement286

(d)A persuasive precedent of the GATT jurisprudence:The United States Manufacturing Clause287

(e)The cross-disputes between the United States and Brazil289

(f)The local exploitation requirement and Article XX(j)of the GATT 1947:An admissible exception to Article 27.1?292

Paragraph 2293

1.Exclusions from patentability on ethical grounds293

2.Morality and ordre public297

3.The two-step necessity test298

4.Exclusions from commercial exploitation as opposed to other forms of exploitation301

5.Article 27.2 and Article 4-quater of the Paris Convention301

Paragraph 3(a)304

Paragraph 3(b)306

1.Plant variety protection:The UPOV308

(a)The farmers'exemption312

(b)The breeders'exemption314

2.The relationship between the TRIPS Agreement and the CBD316

(a)The negotiations in the TRIPS council316

(b)The intersection of the TRIPS Agreement with the CBD320

(ⅰ)The precautionary principle and the TRIPS Agreement321

(ⅱ)Article 8(j)of the CBD and the TRIPS Agreement322

(ⅲ)Article 15 of the CBD and Articles 27 and 28 of the TRIPS Agreement325

(ⅳ)Article 16 of the CBD and the TRIPS Agreement329

(ⅴ)Article 18 of the CBD and the TRIPS Agreement331

(ⅵ)In a nutshell,there is no conflict between the CBD and the TRIPS Agreement332

3.The relationship between the TRIPS Agreement and the FAO International Treaty on Plant Genetic Resources for Food and Agriculture335

Article 28:Rights Conferred339

1.The meaning and scope of Article 28339

2.Administrative enforcement of patent rights by regulatory authorities:The patent linkage,a new trend?344

Article 29:Conditions on Patent Applicants347

1.Enabling disclosure347

2.Elements for assessing the sufficiency of the disclosure348

3.The best-mode disclosure350

4.Information concerning foreign applications352

5.The requirement to disclose the origin of genetic resources and prior informed consent of the use of traditional knowledge in patent applications353

(a)The objective of the Requirement353

(b)The Requirement:A formal requirement rather than a substantive one358

(c)The requirement as a condition of validity of intellectual property rights and applicable international law363

(ⅰ)The TRIPS Agreement363

(ⅱ)The UPOV Conventions368

(ⅲ)The Patent Cooperation Treaty369

(ⅳ)The Patent Law Treaty371

(ⅴ)The Convention on Biological Diversity372

(d)Current multilateral negotiations374

(e)In search of a solution for adopting the Requirement without unduly burdening the patent system and/or infringing upon international law391

(ⅰ)The TK holder:A co-inventor?391

(ⅱ)Non-statutory standards and the duty of disclosure:Unjust enrichment and uninformed consent396

(ⅲ)Revisiting a solution to the need for an additional disclosure requirement:The unclean hands doctrine403

(ⅳ)Another possible solution under current national and international patent law:Material contributions to the inventive activity may generate material interests in the patent407

(ⅴ)A word of caution:The limited value of the Requirement411

(ⅵ)In a nutshell,patents are certificates of inventive behaviour;patents should not be transformed into certificates of good behaviour413

Article 30:Exceptions to Rights Conferred415

1.The three conditions for the application of Article 30417

2.Article 30 and Article 27.1422

3.Examples of exceptions to rights conferred;the problems with exhaustion,manual handling of pharmaceutical preparations,and the prior user exceptions422

4.Article 30 and the implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health425

Article 31:Other Use Without Authorization of the Rights Holder427

Subparagraph(a)438

Subparagraph(b)439

Subparagraph(c)449

Subparagraph(d)452

Subparagraph(e)452

Subparagraph(f)453

1.The meaning and scope of Article 31(f)453

2.Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health456

3.The Decision of the WTO General Council of 30 August 2003,on the Implementation of Paragraph 6 of the Doha Declaration of the TRIPS Agreement and Public Health458

(a)Introduction458

(b)Commentary464

Subparagraph(g)495

Subparagraph(h)496

Subparagraph(ⅰ)498

Subparagraph(j)498

Subparagraph(k)498

1.The legislative history of subparagraph(k)498

2.Compulsory licenses and antitrust law500

3.Remuneration505

4.Adjudication505

5.Other issues506

Subparagraph(l)508

Article 32:Revocation/Forfeiture515

1.The meaning and the scope of Article 32515

2.Revocation or forfeiture of patents to remedy antitrust violations;divestiture and the fruit of the poisoned tree doctrine521

Article 33:Term of Protection525

Article 34:Process Patents:Burden of Proof531

Section 7:Protection of Undisclosed Information536

Article 39536

Paragraph 1536

1.Introduction536

2.The legislative history of Article 10-bis of the Paris Convention537

(a)Legislative history537

(b)Does Article 10-bis of the Paris Convention provide for mandatory protection of trade secrets?546

(c)Conclusions549

3.Do paragraphs 1 and 2 cover different subject matters?552

Paragraph 2553

1.The legislative history of Article 39.2 of the TRIPS Agreement553

2.Protection of trade secrets under Article 39.2568

3.Protection of confidential information in court procedures581

Paragraph 3584

1.The legislative history of Article 39.3584

(a)The origins of the protection of test data584

(b)The legislative history of Article 39.3586

(ⅰ)Proposals on test data in the first round of discussions(1987-1990)587

(ⅱ)Proposals on test data in the second(and last)round of negotiations593

2.Economic and social constraints over protection of test data602

3.The scope,the reach,and the application of Article 39.3606

(a)Test data protection under Article 39.3 of the TRIPS Agreement:A sui generis mechanism606

(b)Protection of undisclosed test data against unfair commercial use is mandatory as regards pharmaceutical and agricultural chemical products only609

(c)Protection against unfair commercial use612

(ⅰ)The meaning of 'unfair commercial use'612

(ⅱ)The first possible modality of protection:Data exclusivity615

(ⅲ)The second possible mechanism of protection:The right to remuneration622

(d)Exclusivity of data does not mean either exclusivity of information or product or market exclusivity625

(e)Requirements627

(ⅰ)Submission must be mandatory627

(ⅱ)The nature of the product628

(ⅲ)Novelty629

(ⅳ)Secrecy of the data633

(ⅴ)Considerable efforts required for obtaining the data636

(ⅵ)Approval of the relevant chemical entity637

(ⅶ)Opportunity638

(f)Protection against disclosure639

(g)Term of protection640

(h)The relationship between test data protection and patent rights:The 'patent linkage'643

(ⅰ)Exceptions and limitations to rights conferred647

(ⅰ)Fair use of test data647

(ⅱ)Non-commercial use651

(ⅲ)International exhaustion653

(j)A few additional issues653

(ⅰ)Restoration of terms of protection653

(ⅱ)Core dossier registrations and the protection of supplementary data655

(ⅲ)Biological products655

(k)Transition periods for least-developed-country WTO Members656

4.Recent developments concerning protection of test data;TRIPS plus'standards in the context of bilateral free trade agreements657

PART Ⅳ:ACQUISITION AND MAINTENANCE OF INTELLECTUAL PROPERTY RIGHTS AND RELATED INTER PARTES PROCEDURES663

Article 62663

Paragraph 1663

Paragraph 2664

Paragraph 4667

PART Ⅴ:DISPUTE PREVENTION AND SETTLEMENT669

Article 64:Dispute Settlement669

1.Objectives and nature of the Dispute Settlement Mechanism669

2.The new features of the Dispute Settlement Mechanism671

3.Conciliatory steps672

4.The outcome of the Dispute Settlement Mechanism673

5.Specific issues concerning the withdrawal of concessions in the TRIPS Agreement:The problem of cross-retaliation sanctions674

6.Non-violation and situation complaints677

7.Disputes683

(a)Patent-related disputes683

(b)Test data-related disputes686

8.The special(and overlooked)interest of LDCS in non-violation complaints686

9.Lessons from the Dispute Settlement Mechanism688

(a)First lesson:Good intentions do not count688

(b)Second lesson:More(protection)is always better than less689

(c)Third lesson:International trade has reasons that the reason does not know689

PART Ⅵ:TRANSITIONAL ARRANGEMENTS691

Article 65:Transitional Arrangements691

Paragraph 5691

1.Standstill691

2.Standstill and LDCS692

Article 66:Least-Developed Country Members698

Paragraph 1698

Paragraph 2704

Article 70:Protection of Existing Subject Matter709

Paragraph 1709

Paragraph 2712

Paragraph 3714

Paragraph 4715

Paragraph 6715

Paragraph 7716

Paragraph 8717

Paragraph 9719

Annex727

Part 1729

Agreement on Trade-Related Aspects of Intellectual Property Rights730

Paris Convention for the Protection of Industrial Property(1967)(excerpt)760

Part 2771

Declaration on the TRIPS Agreement and Public Health(WT/MIN(01)/DEC/2)773

Extension of the Transitional Period Under Article 66.1 of the TRIPS Agreement for Least-Developed Country Members for Certain Obligations with Respect to Pharmaceutical Products (IP/C/25)775

Least-Developed Country Members-Obligations Under Article 70.9 of the TRIPS Agreement with Respect to Pharmaceutical Products(WT/L/478)776

Implementation of Article 66.2 of the TRIPS Agreement(IP/C/28)777

Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health(WT/L/540)779

Minutes of Meeting(of the General Council)(WT/GC/M/82)784

Extension of the Transitional Period Under Article 66.1 for Least-Developed Country Members (IP/C/40)787

Amendment of the TRIPS Agreement(WT/L/641)789

Index795