Introductory note:The legal structure and the economic nature of intellectual property 1
1.The legal structure of intellectual property 2
(a)Intellectual property:The branch of law that protects business-differentiating intangible assets 2
(b)The intrinsically exclusive nature of intellectual property 11
2.The economic function of intellectual property:To promote the creation and the preservation of business differentiation 13
(a)Intellectual property and the reduction of transaction costs 17
3.Intellectual property:A spontaneous legal tool that has embbebed the structural fabric of every organized society since the dawn of civilization 22
4.Patents,trade secrets,and patronage:Alternative mechanisms to differentiate and promote invention and innovation 30
(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 theories 31
(ⅱ)Primarily,patents are not rewards 31
(ⅲ)Primarily,patents do not serve to prospect the market 35
(b)Trade secrets and patents:Competing appropriation devices 38
(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 patents 39
(ⅱ)Injunctions issued to enforce trade secret protection:A problem of uncertainty resulting from the lack of a pre-determined term 42
(ⅲ)Pro-competitive effects of patent disclosure 42
(ⅳ)The residual social value of trade-secret protection 43
(c)Patronage and patents:Competing and complementary mechanisms 45
(d)The gauging function of patents in a nutshell 47
5.A special note on the interface between patent and competition law 47
(a)Patents and monopolies 48
(b)Abuses of patent rights 55
(c)Distinguishing abuses that are anti-competitive from those that are not 57
(d)Industrial property,competition law,and repression of unfair competition 59
6.TRIPS'flexibilities' 60
(a)The concept of'flexibilities' 60
(b)Four clusters of flexibilities 62
(ⅰ)The first cluster:Transitional periods 62
(ⅱ)The second cluster:Flexibilities regarding implementation of international obligations 63
(ⅲ)Flexibilities as to standards of protection:Upwards(TRIPS plus)and downwards(exceptions and limitations)flexibilities;modalities of exceptions and limitations(internal and external);examples 63
(ⅳ)Flexibilities in the field of enforcement:Injunctions and the principle of equity 64
(c)Another approach to flexibilities:Three sequential moments in the life of rights and corresponding flexibilities 65
(d)General principles that apply to flexibilities and conclusion 66
PREAMBLE:AGREEMENT ON TRADE-RELATED ASPECTS OF INTELLECTUAL PROPERTY RIGHTS 71
1.The scope,the nature,and the function of the TRIPS Agreement 72
(a)The scope of the TRIPS Agreement 72
(b)The dynamic dimension of the TRIPS Agreement 74
(c)The nature and the function of the Agreement 76
(ⅰ)The first objective of the TRIPS Agreement:To reduce distortions and impediments to international trade 79
(ⅱ)The second objective of the TRIPS Agreement:To protect private property rights 83
2.Intellectual property and trade 84
(a)TRIPS and the GATT 88
(b)The WTO and WIPO 94
3.Patent protection and economic development 100
PART Ⅰ:GENERAL PROVISIONS AND BASIC PRINCIPLES 107
Article 1:Nature and Scope of Obligations 107
1.The TRIPS Agreement:A minimum standards agreement 108
2.Method of implementing the provisions of the TRIPS Agreement 113
3.Implementation 116
4.The scope of TRIPS Obligations 122
Article 2:Intellectual Property Conventions 125
1.The objective of the Paris Convention:The articulation of national industrial property systems 125
2.The national treatment principle under the Paris Convention 127
3.The principle of priority 128
4.The principle of independence 129
5.Article 5 of the Paris Convention and trade protectionism 132
6.From the Paris Convention to the TRIPS Agreement 133
7.The relationship between the TRIPS Agreement and the Paris Convention 135
Article 3:National Treatment 143
1.The'no less favourable'treatment standard of the TRIPS Agreement as opposed to the 'same'treatment standard of the Paris Convention 143
2.The concept of 'necessity'in the TRIPS Agreement 147
3.Two GATT panel reports on the national treatment principle and Article XX(d)of the GATT 1947 151
4.The principle of national treatment in the European Communities cases 153
5.Scope and reach of footnote 3 156
Article 4:Most-Favoured-Nation Treatment 161
1.The most-favoured-nation treatment principle 161
2.The MFN principle and the national treatment principle:A rule of thumb 162
3.The scope of the MFN principle 163
4.Exemptions from the MFN principle 165
Article 5:Multilateral Agreements on Acquisition or Maintenance of Protection 169
1.The scope of the exemption under Article 5 169
2.An example of an admissible exemption:Discriminatory reduction of fees 171
Article 6:Exhaustion 173
1.The meaning of Article 6 173
2.Exhaustion 176
3.The legal implications of international exhaustion 184
4.Other modalities of exhaustion 193
Article 7:Objectives 197
1.The scope and the meaning of Article 7 197
2.Transfer and dissemination of technology 202
3.The meaning of the expression 'balance of rights and obligations' 209
Article 8:Principles 223
Paragraph 1 223
1.The conditions of the application of Article 8.1 224
2.Article 8.1 and non-violation complaints 226
3.The TRIPS Agreement and public health 227
4.The Doha Declaration on the TRIPS Agreement and Public Health 233
(a)Introduction 233
(b)Commentary 235
Paragraph 2 242
PART Ⅱ:STANDARDS CONCERNING THE AVAILABILITY,SCOPE,AND USE OF INTELLECTUAL PROPERTY RIGHTS 245
Section 5:Patents 245
Article 27:Patentable Subject Matter 245
Paragraph 1 245
1.The history of Article 27 245
2.Prohibition of discrimination 248
3.Article 27.1 and Article 1 252
4.The scope of Article 27.1 252
(a)How to distinguish patentable inventions from products of nature(discoveries) 252
(ⅰ)The condition of artificiality 253
(ⅱ)The condition of alternativeness 256
(ⅲ)The condition of non-communicability 262
(ⅳ)The condition of alternativeness of inventions:A corollary of the gauging function of patents 264
(b)Patentable subject matter 265
(ⅰ)Computer software 265
(ⅱ)Business methods 267
(ⅲ)Second uses 270
5.Substantive examination 276
6.Conditions of patentability:A minimum or a maximum? 277
7.Discrimination as to the place of invention 278
8.Discrimination as to the field of technology 279
9.Discrimination as to the location of production:The local working requirement 283
(a)The working requirement under the Paris Convention 283
(b)The meaning of the last sentence of Article 27.1 284
(c)The interface between international exhaustion and the local working requirement 286
(d)A persuasive precedent of the GATT jurisprudence:The United States Manufacturing Clause 287
(e)The cross-disputes between the United States and Brazil 289
(f)The local exploitation requirement and Article XX(j)of the GATT 1947:An admissible exception to Article 27.1? 292
Paragraph 2 293
1.Exclusions from patentability on ethical grounds 293
2.Morality and ordre public 297
3.The two-step necessity test 298
4.Exclusions from commercial exploitation as opposed to other forms of exploitation 301
5.Article 27.2 and Article 4-quater of the Paris Convention 301
Paragraph 3(a) 304
Paragraph 3(b) 306
1.Plant variety protection:The UPOV 308
(a)The farmers'exemption 312
(b)The breeders'exemption 314
2.The relationship between the TRIPS Agreement and the CBD 316
(a)The negotiations in the TRIPS council 316
(b)The intersection of the TRIPS Agreement with the CBD 320
(ⅰ)The precautionary principle and the TRIPS Agreement 321
(ⅱ)Article 8(j)of the CBD and the TRIPS Agreement 322
(ⅲ)Article 15 of the CBD and Articles 27 and 28 of the TRIPS Agreement 325
(ⅳ)Article 16 of the CBD and the TRIPS Agreement 329
(ⅴ)Article 18 of the CBD and the TRIPS Agreement 331
(ⅵ)In a nutshell,there is no conflict between the CBD and the TRIPS Agreement 332
3.The relationship between the TRIPS Agreement and the FAO International Treaty on Plant Genetic Resources for Food and Agriculture 335
Article 28:Rights Conferred 339
1.The meaning and scope of Article 28 339
2.Administrative enforcement of patent rights by regulatory authorities:The patent linkage,a new trend? 344
Article 29:Conditions on Patent Applicants 347
1.Enabling disclosure 347
2.Elements for assessing the sufficiency of the disclosure 348
3.The best-mode disclosure 350
4.Information concerning foreign applications 352
5.The requirement to disclose the origin of genetic resources and prior informed consent of the use of traditional knowledge in patent applications 353
(a)The objective of the Requirement 353
(b)The Requirement:A formal requirement rather than a substantive one 358
(c)The requirement as a condition of validity of intellectual property rights and applicable international law 363
(ⅰ)The TRIPS Agreement 363
(ⅱ)The UPOV Conventions 368
(ⅲ)The Patent Cooperation Treaty 369
(ⅳ)The Patent Law Treaty 371
(ⅴ)The Convention on Biological Diversity 372
(d)Current multilateral negotiations 374
(e)In search of a solution for adopting the Requirement without unduly burdening the patent system and/or infringing upon international law 391
(ⅰ)The TK holder:A co-inventor? 391
(ⅱ)Non-statutory standards and the duty of disclosure:Unjust enrichment and uninformed consent 396
(ⅲ)Revisiting a solution to the need for an additional disclosure requirement:The unclean hands doctrine 403
(ⅳ)Another possible solution under current national and international patent law:Material contributions to the inventive activity may generate material interests in the patent 407
(ⅴ)A word of caution:The limited value of the Requirement 411
(ⅵ)In a nutshell,patents are certificates of inventive behaviour;patents should not be transformed into certificates of good behaviour 413
Article 30:Exceptions to Rights Conferred 415
1.The three conditions for the application of Article 30 417
2.Article 30 and Article 27.1 422
3.Examples of exceptions to rights conferred;the problems with exhaustion,manual handling of pharmaceutical preparations,and the prior user exceptions 422
4.Article 30 and the implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health 425
Article 31:Other Use Without Authorization of the Rights Holder 427
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 Health 456
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 Health 458
(a)Introduction 458
(b)Commentary 464
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 law 500
3.Remuneration 505
4.Adjudication 505
5.Other issues 506
Subparagraph(l) 508
Article 32:Revocation/Forfeiture 515
1.The meaning and the scope of Article 32 515
2.Revocation or forfeiture of patents to remedy antitrust violations;divestiture and the fruit of the poisoned tree doctrine 521
Article 33:Term of Protection 525
Article 34:Process Patents:Burden of Proof 531
Section 7:Protection of Undisclosed Information 536
Article 39 536
Paragraph 1 536
1.Introduction 536
2.The legislative history of Article 10-bis of the Paris Convention 537
(a)Legislative history 537
(b)Does Article 10-bis of the Paris Convention provide for mandatory protection of trade secrets? 546
(c)Conclusions 549
3.Do paragraphs 1 and 2 cover different subject matters? 552
Paragraph 2 553
1.The legislative history of Article 39.2 of the TRIPS Agreement 553
2.Protection of trade secrets under Article 39.2 568
3.Protection of confidential information in court procedures 581
Paragraph 3 584
1.The legislative history of Article 39.3 584
(a)The origins of the protection of test data 584
(b)The legislative history of Article 39.3 586
(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 negotiations 593
2.Economic and social constraints over protection of test data 602
3.The scope,the reach,and the application of Article 39.3 606
(a)Test data protection under Article 39.3 of the TRIPS Agreement:A sui generis mechanism 606
(b)Protection of undisclosed test data against unfair commercial use is mandatory as regards pharmaceutical and agricultural chemical products only 609
(c)Protection against unfair commercial use 612
(ⅰ)The meaning of 'unfair commercial use' 612
(ⅱ)The first possible modality of protection:Data exclusivity 615
(ⅲ)The second possible mechanism of protection:The right to remuneration 622
(d)Exclusivity of data does not mean either exclusivity of information or product or market exclusivity 625
(e)Requirements 627
(ⅰ)Submission must be mandatory 627
(ⅱ)The nature of the product 628
(ⅲ)Novelty 629
(ⅳ)Secrecy of the data 633
(ⅴ)Considerable efforts required for obtaining the data 636
(ⅵ)Approval of the relevant chemical entity 637
(ⅶ)Opportunity 638
(f)Protection against disclosure 639
(g)Term of protection 640
(h)The relationship between test data protection and patent rights:The 'patent linkage' 643
(ⅰ)Exceptions and limitations to rights conferred 647
(ⅰ)Fair use of test data 647
(ⅱ)Non-commercial use 651
(ⅲ)International exhaustion 653
(j)A few additional issues 653
(ⅰ)Restoration of terms of protection 653
(ⅱ)Core dossier registrations and the protection of supplementary data 655
(ⅲ)Biological products 655
(k)Transition periods for least-developed-country WTO Members 656
4.Recent developments concerning protection of test data;TRIPS plus'standards in the context of bilateral free trade agreements 657
PART Ⅳ:ACQUISITION AND MAINTENANCE OF INTELLECTUAL PROPERTY RIGHTS AND RELATED INTER PARTES PROCEDURES 663
Article 62 663
Paragraph 1 663
Paragraph 2 664
Paragraph 4 667
PART Ⅴ:DISPUTE PREVENTION AND SETTLEMENT 669
Article 64:Dispute Settlement 669
1.Objectives and nature of the Dispute Settlement Mechanism 669
2.The new features of the Dispute Settlement Mechanism 671
3.Conciliatory steps 672
4.The outcome of the Dispute Settlement Mechanism 673
5.Specific issues concerning the withdrawal of concessions in the TRIPS Agreement:The problem of cross-retaliation sanctions 674
6.Non-violation and situation complaints 677
7.Disputes 683
(a)Patent-related disputes 683
(b)Test data-related disputes 686
8.The special(and overlooked)interest of LDCS in non-violation complaints 686
9.Lessons from the Dispute Settlement Mechanism 688
(a)First lesson:Good intentions do not count 688
(b)Second lesson:More(protection)is always better than less 689
(c)Third lesson:International trade has reasons that the reason does not know 689
PART Ⅵ:TRANSITIONAL ARRANGEMENTS 691
Article 65:Transitional Arrangements 691
Paragraph 5 691
1.Standstill 691
2.Standstill and LDCS 692
Article 66:Least-Developed Country Members 698
Paragraph 1 698
Paragraph 2 704
Article 70:Protection of Existing Subject Matter 709
Paragraph 1 709
Paragraph 2 712
Paragraph 3 714
Paragraph 4 715
Paragraph 6 715
Paragraph 7 716
Paragraph 8 717
Paragraph 9 719
Annex 727
Part 1 729
Agreement on Trade-Related Aspects of Intellectual Property Rights 730
Paris Convention for the Protection of Industrial Property(1967)(excerpt) 760
Part 2 771
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
Index 795