International Public Goods and Transfer of Technology Under a Globalized Intellectual Property Regime

COVER......Page 1
HALF-TITLE......Page 3
TITLE......Page 5
COPYRIGHT......Page 6
CONTENTS......Page 7
CONTRIBUTORS......Page 12
PREFACE......Page 15
SECTION 1 The concept of public goods in the expanding knowledge economy......Page 19
1 The globalization of private knowledge goods and the privatization of global public goods......Page 21
I. Introduction and conceptual framework......Page 22
A. International public goods and intellectual property rights......Page 26
B. Technology transfer after the TRIPS agreement......Page 29
II. Re-regulating the global marketplace to protect knowledge as a private good......Page 33
A. Legal and organizational impediments to the creation and diffusion of knowledge goods......Page 34
1. Preserving temporary competitive advantages with international intellectual property standards......Page 35
2. Instability and loss of balance in developed intellectual property regimes......Page 38
3. Exporting a dysfunctional system to the rest of the world?......Page 41
B. Impact of intellectual property standards on the reserved welfare powers of WTO members......Page 45
III. Balancing public and private interests in an emerging transnational system of innovation......Page 51
A. Developing countries as defenders of the competitive ethos......Page 53
1. A moratorium on stronger international intellectual property standards......Page 54
2. An institutional infrastructure for reconciling existing IPRs with national and regional systems of innovation......Page 57
1. Dynamic properties of knowledge as a global public good......Page 59
2. Nurturing a transnational system of innovation......Page 61
Abstract......Page 64
I. Public goods and preferences......Page 67
II. Distinguishing public goods......Page 70
A. The regulation of artifacts......Page 73
B. The regulation of skill-embodied information......Page 75
C. The regulation of norm-dependent public goods: The private shaping of public goods......Page 78
IV. Preferences, power, and the regulation of public goods......Page 79
Conclusion......Page 82
1. Distinctive problems of the world political economy......Page 83
2. Strategic and institutional solutions......Page 84
3. Conclusion......Page 86
I. Introduction......Page 87
II. Embedded distributive values......Page 88
III. Distribution/policymaking at the international level......Page 89
IV. A typology of distributional issues......Page 91
V. A suggested approach......Page 94
SECTION 2 Preserving the cultural and scientific commons......Page 97
Abstract......Page 99
I. The argument......Page 100
II. Knowledge, information economics and the "three P's"......Page 103
III. Intellectual property rights protections in economic theory and history......Page 106
IV. Forces behind the recent policy push for a stronger global IPR regime......Page 111
V. ICTs, "weightless" goods and services, and databases in the new economy......Page 117
VI. The E.U.'s sui generis property right in databases and its implications......Page 121
VII. Reconsidering the traditional economic rationale for copyright protection......Page 125
VIII. Modest proposals: IPR policies to preserve the public knowledge commons......Page 131
IX. Conclusion......Page 137
I. Introduction......Page 139
II. Practice and understanding evolve together......Page 142
III. The provision of public science......Page 146
A. The role of patent law......Page 150
B. Universities and the scientific commons......Page 153
COMMENTARY I Comment: Public goods and public science......Page 157
6 Sustainable access to copyrighted digital information works in developing countries......Page 160
I. Introduction......Page 161
II. The normative equation of the international copyright system: Creativity and access......Page 165
A. Defining access......Page 166
B. The access landscape in international copyright relations......Page 167
III. The new copyright environment......Page 170
A. TRIPS and its progeny: Incorporation, coordination and interpretation of international copyright rules......Page 171
B. From Stockholm to Paris......Page 174
1. The move from coordination to institutions......Page 176
2. Consolidating the organizational framework......Page 177
3. Legitimacy, sequential revision and accommodation strategies......Page 178
A. Structure of the Berne Appendix......Page 180
B. Critical observations......Page 184
A. Creative access......Page 186
1. Jurisdiction of the three-step test under the TRIPS Agreement......Page 190
2. The idea/expression dichotomy......Page 191
3. The Berne Appendix and the WCT......Page 193
A. Rescuing access from digital bondage......Page 196
B. Specific proposals......Page 199
1. An international fair use doctrine......Page 200
3. Berne, TRIPS and side deals: Contending with strategic negotiations......Page 201
4. Developing a proportional approach to access......Page 202
5. Developing doctrines to address violations of copyright's underlying public policy......Page 203
VII. Conclusion......Page 204
1. Introduction......Page 206
2. Science links, IPRs and public-private investments in research for inventions used in agriculture......Page 208
2.2 The agricultural chemical revolution......Page 209
2.3 The crop genetic improvement (Green) revolution......Page 210
2.4 The livestock industrialization revolution......Page 211
3. The Green Revolution and the SPIA study......Page 212
4. The Gene Revolution: Regulatory and IPR issues......Page 221
5. Innovation-imitation capacity in developing countries......Page 225
6. The future of agricultural research......Page 229
7. Needed reforms......Page 232
COMMENTARY II Using intellectual property rights to preserve the global genetic commons: The International Treaty on Plant Genetic Resources…......Page 235
SECTION 1 Technology transfer under international intellectual property standards......Page 243
Introduction......Page 245
I. Transfer of technology and IPRs......Page 247
A. Objectives and principles......Page 250
B. Control of anti-competitive practices in contractual licenses......Page 254
C. Disclosure of patent information......Page 256
1. Lack of or insufficient working......Page 258
2. Refusal to deal......Page 261
E. Compulsory licenses as vehicles for technology transfer......Page 265
III. Transfer of technology to least developed countries (LDCs)......Page 268
IV. Conclusions......Page 272
I. Technology transfer on the international agenda......Page 275
II. IPRs and transfer of technology......Page 278
III. The contributions to this volume......Page 279
I. Introduction......Page 283
2. Economics of access to foreign technology......Page 285
2.1 Recipient country characteristics......Page 286
2.3 Intellectual property rights and technology transfer......Page 288
3. A model of the choice between investment and licensing......Page 291
4. Evidence supporting the hypothesis......Page 296
5. Policy conclusions......Page 298
I. Introduction......Page 300
2a. Hypotheses......Page 301
2c. A Statistical Mirage......Page 302
2d. What is Really Happening?......Page 304
10 Proprietary rights and collective action: The case of biotechnology research with low commercial value......Page 306
A. Increases in upstream proprietary rights......Page 308
B. Do upstream proprietary rights impede follow-on research?......Page 310
II. The prospect of collective action......Page 315
III. Public-sector efforts at collective action......Page 318
A. The role of the private sector......Page 322
B. Obstacles unrelated to intellectual property......Page 323
V. Conclusion......Page 324
SECTION 2 Stimulating local innovation......Page 325
Introduction......Page 327
I. Patents and innovation: Historical evidence......Page 329
II. The Japanese experience......Page 330
III. Patents and technology transfer......Page 335
Summary......Page 338
I. Introduction......Page 339
2.1 A tentative definition......Page 341
2.2 Empirical evidence......Page 342
3 Patents and markets for technology......Page 343
4 Markets for technology and international technology transfer......Page 349
5 Policy implications for developing countries......Page 351
6 Conclusion......Page 354
13 Using liablity rules to stimulate local innovation in developing countries: Application to traditional knowledge......Page 355
I. Introduction and historical background......Page 356
A. Critique of the standard proposals......Page 358
B. Historical and comparative roots of a proposed compensatory liability regime......Page 360
II. Designing a compensatory liability regime......Page 366
1. Descriptive analysis......Page 367
2. General observations......Page 369
B. Application of liability rules to the protection of traditional knowledge......Page 372
1. Understanding the problem: Traditional knowledge is know-how......Page 374
2. Solving the problem: A TK model of compensatory liability......Page 375
C. Further observations......Page 380
III. Conclusion......Page 383
Introduction......Page 385
I. Historical background......Page 386
A. The road to UPOV......Page 388
1. Plant variety protection under the Paris Convention......Page 390
2. The Paris Conferences on special protection of 1957 and 1961......Page 391
3. Additional Act of 1972......Page 392
 5.The Revision of 1991......Page 393
II. Implementing the differential treatment of patentable inventions and plant varieties......Page 395
A. Distinguishing the subject matters of protection......Page 396
1. The European experience......Page 397
2. Overlapping protection in the United States......Page 398
B. What is a plant variety for purposes of article 27.3(b) of the TRIPS Agreement?......Page 399
C. Technical issues concerning the sui generis protection of plant varieties......Page 400
III. The Treaty on Plant Genetic Resources......Page 404
IV. Farmers' Rights......Page 406
V. Access to PGRFA and the Doha negotiating agenda......Page 408
SECTION 1 Developing and distributing essential medicines......Page 409
15 Managing the Hydra: The herculean task of ensuring access to essential medicines......Page 411
I. The concept of essential medicines......Page 412
II. Public goods, private markets and public finance......Page 413
1. The question of leadership......Page 414
2. At the national level......Page 415
3. At the multilateral level......Page 419
D. Socio-cultural factors and political responses......Page 421
A. Regulatory streamlining......Page 422
B. Intersection of regulatory review and patents......Page 423
C. Rights in data and solutions......Page 424
A. Patents as obstacles......Page 426
1. Compulsory licensing and government use......Page 429
2. Paragraph 7 and Least-Developed Countries......Page 433
3. Parallel trade and differential pricing......Page 434
V. Bulk procurement and related mechanisms......Page 436
VI. Local production, transfer of technology, and the public sector......Page 437
A. The general R&D problem......Page 438
B. Drugs for neglected diseases......Page 440
VIII. The emergence of competitors......Page 441
IX. Conclusions – The hydra without Hercules......Page 442
16 Theory and implementation of differential pricing for pharmaceuticals......Page 443
1. Introduction......Page 444
2. The cost structure of research-based pharmaceuticals and the economic role of patents......Page 446
3. Efficient payment for R&D: Ramsey pricing......Page 449
3.1 Ramsey price differentials vs. profit-maximizing differentials......Page 451
3.2 Regulation versus competition......Page 453
3.3 Welfare conclusions on price discrimination......Page 455
4.1 The breakdown of market separation: Parallel importation and external referencing......Page 456
4.2 Cross-national price differentials......Page 459
4.3 Price differentials within the U.S.......Page 460
5.1 Defining patents based on national boundaries, including the right to bar parallel trade......Page 462
5.3 Implementing differential pricing through confidential rebates......Page 463
5.4 Structured discounts and a global tiered pricing structure......Page 466
6. Compulsory licensing and the use of generics: Doha and beyond......Page 470
7. Conclusions......Page 473
I. Introduction......Page 475
2a. Costs and risks......Page 477
2b. R&D returns......Page 478
2c. The critical significance of patents in pharmaceuticals......Page 480
3a. Push and pull incentive programs......Page 481
3b. Characteristics of the Orphan Drug Act......Page 482
3c. Orphan drug designation and approvals......Page 483
3d. Costs of orphan drugs......Page 485
3e. Revenues from marketed orphan drugs......Page 487
3f. Health benefits of orphan drugs......Page 488
3g. The ODA and new drugs for the neglected diseases of poor countries......Page 490
4. An amended Orphan Drug Act for neglected diseases......Page 492
4a. Transferable patent exclusivity rights......Page 493
4c.Purchase guarantees......Page 495
5. Summary and conclusions......Page 497
I. Introduction......Page 499
2. Public health and access to medicines......Page 502
3. Towards a legal regime that promotes public health......Page 506
4. Conclusion......Page 509
SECTION 2 Protecting traditional knowledge......Page 511
Introduction......Page 513
A. Broader and narrower definitions......Page 514
B. Negative definitions......Page 517
C. The question of ownership......Page 519
II. The economic value of traditional knowledge......Page 522
III. Legal measures to protect traditional knowledge......Page 523
1. Disclosure of origin proposals......Page 524
2. Compiling databases of traditional knowledge to serve as prior art......Page 527
3. A misappropriation regime......Page 529
1. Sui generis IP regimes......Page 532
2. Database rights......Page 534
3. Global biocollecting society......Page 535
IV. Strategic considerations......Page 536
19 Saving the village: Conserving jurisprudential diversity in the international protection of traditional knowledge......Page 539
I. Introduction: Protect the knowledge but betray the tradition?......Page 540
II. The paradox: To globalise diversity holistically......Page 543
A. The point of access as the fulcrum of protection......Page 545
B. The international layer of TK protection: What practical choices?......Page 546
C. Recognizing customary laws and protocols beyond IP law......Page 548
D. Revisiting the public domain: Which public, and whose domain?......Page 551
A. Further reflections on the definition of traditional knowledge......Page 553
B. Locating the normative centre of TK protection......Page 557
C. Revisiting the boundaries of intellectual property and the public domain......Page 559
IV. TK protection as a global public good......Page 564
V. Options for recognition of customary law in the IP system......Page 569
A. Implications for the international context......Page 573
B. What international mechanisms can do justice to customary law?......Page 575
C. Conclusion: What kind of international system?......Page 580
20 Legal perspectives on traditional knowledge: The case for intellectual property protection......Page 583
Introduction......Page 584
A. Limits of existing law and pending initiatives......Page 586
1. The public domain as point of departure......Page 587
2. International instruments in brief......Page 589
B. Traditional knowledge as an appropriate subject of intellectual property protection......Page 594
1. Traditional knowledge as a knowledge good......Page 596
2. TK protection as a benefit to developing countries......Page 597
3. Need for an international system......Page 599
II. A proposal for traditional IP rights in traditional knowledge......Page 600
2. Rights holders......Page 601
B. The content and scope of rights......Page 602
1. Content......Page 603
2. Scope of protection......Page 604
C. The duration of rights......Page 606
1. Registration requirements......Page 607
2. Opposition procedures and judicial review......Page 608
1. The complementary function of geographical indications......Page 609
2. Relation to plant breeders' rights......Page 610
Conclusions......Page 611
COMMENTARY Comment: Traditional knowledge, folklore and the case for benign neglect......Page 613
I. An anthropological view of traditional knowledge......Page 617
II. The intellectual property conundrum......Page 620
III. Cross-cultural relations and respect for religious diversity......Page 622
IV. Respecting the holistic nature of traditional knowledge......Page 624
V. Political dimensions......Page 626
VI. Human rights, cultural diversity, and public goods......Page 629
SECTION 1 Balancing public and private interests in the global intellectual property system......Page 633
Abstract......Page 635
Introduction......Page 636
A. International integration of the patent granting function......Page 639
B. Standards for granting a patent......Page 641
A. Infringement and defenses......Page 644
B. Exhaustion and parallel trade......Page 646
B. Patent granting institutions and appeal process......Page 647
C. Litigation and appeal......Page 648
D. Supervision......Page 650
E. Financial and international political issues......Page 651
Abstract......Page 653
I. Differences in national rules enable IP arbitrage......Page 654
A. Software license terms prohibiting reverse engineering......Page 657
B. Products of research tools......Page 658
C. Country codes......Page 659
D. Peer-to-peer file-sharing technologies......Page 660
E. Factors affecting IP arbitrage......Page 661
A. Enhancing domestic protections......Page 662
B. Putting pressure on the "rogue" nation......Page 664
C. Filing a complaint with the WTO......Page 665
D. Proposing more detailed harmonization......Page 666
E. Choosing isolation......Page 667
Conclusion......Page 668
24 An agenda for radical intellectual property reform......Page 671
I. Capture of intellectual property law......Page 672
II. Globalization of laws......Page 673
III. Implications of the WTO......Page 675
IV. A radical agenda for reform......Page 676
V. Compulsory arbitration......Page 677
VI. Improving the measurement of grants......Page 678
VIII. Conclusion......Page 679
I. Background......Page 680
II. Building more informed negotiators......Page 682
III. Towards a new system of rule-making......Page 683
25 Diffusion and distribution: The impacts on poor countries of technological enforcement within the biotechnology sector......Page 687
I. Introduction......Page 688
II. Biotechnology as regime change......Page 689
A. The need for plant variety protection......Page 690
B. International protection of plant breeders' rights......Page 692
C. Technological enforcement through genetic use restriction technologies (GURTs)......Page 694
D. Determination of the fair use of proprietary materials......Page 695
E. Policy interests in the use of plant varieties for further R D......Page 697
A. Impacts of technological enforcement – Static and dynamic dimensions......Page 700
B. Impacts of GURTs on diffusion......Page 701
C. Benefits from technological enforceability......Page 703
IV. Predicting industry's response by extrapolating from hybrid maize......Page 704
A. Comparative performance of crops with and without technological enforceability......Page 705
B. Forecasting the impacts of technological enforceability......Page 707
V. Conclusion......Page 711
I. Biodiversity-based innovation as a cooperative tradeoff between developed and developing countries......Page 713
II. Equitable sharing of benefits upon mutually agreed terms – The legal framework......Page 714
A. Sharing of what?......Page 715
B. From "agreed dominance" to better balanced terms of trade......Page 717
C. Clarifying the uncertain status of a local working requirement......Page 719
III. Towards a cooperative, not a confrontational approach......Page 722
SECTION 2 The role of competition law......Page 725
1. Introduction......Page 727
A. Non-rivalry and non-excludability......Page 729
B. IP laws as a response to a public goods problem?......Page 730
C. The new concept of global public goods......Page 731
A. IP law and competition law in general......Page 734
B. Competition law, social interests, and their international dimension......Page 737
1. The economics of local markets......Page 738
2. The case of international exhaustion......Page 740
3. Limiting IPRs for social reasons......Page 741
IV. Conclusions......Page 742
28 Expansionist intellectual property protection and reductionist competition rules: A TRIPS perspective......Page 744
Introduction......Page 745
A. Points of departure......Page 748
1. National antitrust control over the exercise of domestic IPRs......Page 749
2. The requirement that national competition policy should be TRIPS-consistent......Page 754
3. The dissemination concern......Page 756
1. Innovation and the unilateral exercise of exclusive rights in the information economy......Page 758
2. Toward group innovation incentives: Pooling, cross-licensing, joint research and development......Page 762
1. From competition policy to innovation policy......Page 764
2. The European Union's example......Page 766
3. Outlook for the TRIPS Agreement......Page 768
Conclusion......Page 772
I. Introduction......Page 776
II. An American history......Page 777
III. The European Union......Page 780
IV. Shifting the balance: Shrinking immunity......Page 782
V. The international mission......Page 785
COMMENTARY I Comment: Competition law as a means of containing intellectual property rights......Page 788
I. Introduction......Page 792
II. TRIPS freedom to operate in the competition realm......Page 793
A. Article 8.2......Page 794
B. Article 40......Page 796
A. Why minimal standards?......Page 798
B. Institutional considerations......Page 799
C. Substantive minima......Page 802
1. Anticompetitive license restrictions......Page 803
2. Unilateral anticompetitive conduct......Page 806
3. Patent misuse......Page 808
IV. Conclusion......Page 810
I. Introduction......Page 811
II. The inseparability of intellectual property rights and competition policy......Page 813
III. Baselines for intellectual property systems......Page 820
IV. The Architecture of TRIPS and the Indian Competition Bill......Page 824
Articles 6 and 31: Exhaustion and compulsory licensing......Page 825
Articles 13 and 30: Limitations on rights.......Page 826
B. A look at the Indian Competition Bill......Page 828
V. Looking ahead......Page 829
Index......Page 927