Governing digitally integrated genetic resources, data, and literature : global intellectual property strategies for a redesigned microbial research commons

목차 (Table of Contents)

• CONTENTS
• Preface = xvii
• Acknowledgments = xxi
• 1 Uncertain Legal Status of Microbial Genetic Resources in a Confl icted Geopolitical Environment = 1
• Ⅰ. Introduction = 1
• Ⅱ. The Changing Nature of Microbial Research = 7
• A. The 'Wet Lab' Era = 8
• B. The Revolution in Genetic Science = 10
• C. Cutting-Edge Applications of Microbiology in Response to Major Global Challenges = 13
• 1. Improving Human Health and Mitigating Pandemics = 14
• 2. Enhancing Agricultural Production and Food Security = 16
• 3. Protecting the Natural Environment and Conserving Biodiversity = 17
• 4. Addressing the Energy Challenge by Producing Biofuels = 18
• D. A New Research Paradigm for the Life Sciences = 19
• Ⅲ. Limits of the Emerging Movement to Digitally Integrate Research Inputs into the 'New Biology' = 22
• A. Recognizing Institutional and Legal Challenges to the Existing Microbial Research Infrastructure = 23
• B. Towards a Redesigned Microbial Research Commons = 27
• PART ONE : INTERNATIONAL REGULATION OF GENETIC RESOURCES AND THE ASSAULT ON SCIENTIFIC RESEARCH
• 2 Between Private and Public Goods : Emergence of the Transnational Research Commons for Plant and Microbial Genetic Resources = 37
• Ⅰ. Historical Importance of Genetic Resources as Global Public Goods = 37
• A. Dependence of Wet-Lab Microbiology on Cross-Border Exchanges of Validated Reference Strains from Public Culture Collections = 38
• 1. Formation of an International Consortium of Public Service Microbial Culture Collections = 39
• 2. An Ancillary Research Commons for Infl uenza Viruses = 44
• B. Early Efforts to Form an Agricultural Research Commons for Plant Genetic Resources = 46
• 1. Emergence of an International Consortium for the Preservation and Improvement of Cultivars Essential for Food Security = 47
• 2. Short-Lived Recognition of Plant Genetic Resources as the Common Heritage of Mankind = 50
• Ⅱ. Impinging Intellectual Property Rights Promoted by the Developed Countries = 52
• A. Sui Generis Plant Breeders' Rights and Related Biotechnology Patents = 53
• 1. Strengthened International Protection for Commercial Plant Breeders = 53
• 2. The Developing Countries Assert Countervailing Proprietary Rights of Their Own = 57
• B. Mandatory Protection of Some Microbial-Related Inventions Under the TRIPS Agreement of 1994 = 60
• 1. Increasing Reliance on Patents and Trade Secrecy Laws to Protect Commercial Applications of Microbial Genetic Resources = 65
• 2. Possible Patent Thickets = 70
• Ⅲ. Mounting Impediments to Research Uses of Genetic Resources = 72
• A. The Revolt Against the WHO's First Pandemic Infl uenza Research Commons = 75
• B. Implications for the Present Study = 78
• 3 Tightening the Regulatory Grip : From the Convention on Biological Diversity in 1992 to the Nagoya Protocol in 2010 = 82
• Ⅰ. Regulatory Measures Controlling Access to Genetic Resources Promoted by the Developing Countries = 82
• A. Bioprospecting or Biopiracy? = 84
• B. Foundations of an International Regime of Misappropriation to Govern Genetic Resources = 87
• 1. Indigenous Communities (and Their State Sponsors) as Emerging Stakeholders = 87
• 2. Access and Benefit Sharing Under the Convention on Biological Diversity = 91
• C. Critical Evaluation of the CBD = 96
• 1. The CBD as an Incomplete International Regime of Misappropriation = 97
• 2. The Threat to Public Scientific Research on Plant and Microbial Genetic Resources = 100
• Ⅱ. Destabilizing the Exchange of Plant and Microbial Genetic Resources as Global Public Goods = 111
• A. The Public Microbial Culture Collections Consider Defensive Options = 112
• B. The CGIAR's Agricultural Research Infrastructure on the Verge of Collapse = 115
• Ⅲ. An International Treaty to Rescue and Expand 'The Global Crop Commons' = 118
• A. Basic Concepts of the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) = 119
• B. Establishing the Multilateral System for Access and Benefi t-Sharing = 121
• 1. The "Facilitated Access" Regime = 123
• 2. Notifi cation, Benefit Sharing, and the Standard Material Transfer Agreement = 125
• C. Strengths and Weaknesses of the International Treaty on Plant Genetic Resources for Food and Agriculture = 130
• 1. Demonstrable Achievements = 131
• 2. Major Weaknesses = 135
• IV. New Constraints and Opportunities for Scientific Research Under the Nagoya Protocol = 142
• A. Clarifying the Broad Economic Scope of the CBD = 146
• B. Facilitating Scientific Research = 149
• 1. Recognizing the Link Between Public Science and Commercial Benefits = 150
• 2. Prescriptions for Strict Enforcement of the Newly Codifi ed Global Regime of Misappropriation = 155
• Ⅴ. Challenging Prospects for the Existing Microbial Research Commons = 160
• PART TWO : PRESERVING THE PUBLIC RESEARCH FUNCTIONS OF MICROBIAL GENETIC RESOURCES AFTER THE NAGOYA PROTOCOL
• 4 The Existing Microbial Research Commons Confronts Proprietary Obstacles = 167
• Ⅰ. Evolution of Microbial Culture Collections as Basic Scientific Infrastructure = 167
• A. The Pivotal Role of the World Federation for Culture Collections = 170
• 1. Aggregate Holdings and Capacity = 171
• 2. Servicing the Broad Microbiological Research Community = 173
• 3. The Perennial Problem of Funding = 177
• B. From Culture Collections to Biological Resource Centers = 179
• C. Beyond the WFCC : Regional and Global Networks of BRCs = 186
• 1. Disparities Among the WFCC Member Collections = 186
• 2. The Emerging BRC Networks = 198
• Ⅱ. Contractual Restrictions on Access to and Use of Upstream Microbial Genetic Resources in Both Developed and Developing Countries = 199
• A. The Advent of a Proprietary Model in Response to Government Neglect in the United States = 201
• B. Diffusion of a More Proprietary Approach to Other Public Culture Collections = 205
• Ⅲ. The Research Community Pushes Back = 210
• A. Efforts to Negotiate More Research Friendly Material Transfer Agreements = 212
• 1. The Uniform Biological Material Transfer Agreement in the United States and Its Progeny = 212
• 2. The Core MTA of the European Union Culture Collections' Organization = 214
• 3. The European Commission's Regulation on Access to and Use of Genetic Resources = 219
• B. Opting Out or Opting In? Limits of the Trusted Intermediary Approach = 225
• Ⅳ. From the Bilateral to the Multilateral Approach = 231
• A. Basic Concepts of the WHO's Pandemic Influenza Preparedness Framework Agreement (2011) = 233
• B. Governance and Related Issues = 238
• C. Lessons for a Redesigned Microbial Research Commons = 241
• 1. Trading Downstream Benefi ts from the Bilateral System for Essential Public Goods = 243
• 2. Opting into a Multilateral Approach in Order to Stimulate More Downstream Benefits from the Bilateral System = 246
• 5 Facilitating Transnational Exchanges of Genetic Resources within a Redesigned Microbial Research Infrastructure = 250
• Ⅰ. Reconciling Upstream Research Needs with Benefit-Sharing Under the Nagoya Protocol = 250
• A. How the Existing Modalities of Exchange Fail the Needs of Scientific Research = 250
• 1. Social Costs of the Case-by-Case Transactional Approach = 251
• 2. The Flawed Premise of the Proprietary Ethos = 253
• 3. Lessons from the Informal Exchange Practices = 255
• B. Formalizing the Informal Sector : Premises for a Multilateral Regime of Facilitated Access to Microbial Genetic Resources = 257
• Ⅱ. Designing a Third Option : Ex Ante "Take and Pay" Rules for Stimulating Research and Applications = 260
• A. Legal and Economic Foundations of a Compensatory Liability Regime = 261
• B. Operational Logic of a Multilateral Common Pool Resource = 265
• C. Key Components of the Proposed Multilateral Regime for Facilitated Exchanges of Microbial Genetic Resources = 270
• 1. Quality Standards as a Threshold Requirement = 271
• 2. Duty to Respect Reputational Benefits = 274
• 3. Tracking Mechanisms to Maintain the Chain of Custody = 278
• 4. The Calculus of Royalties from Commercial Applications = 284
• 5. An Enabling Governance Structure = 289
• Ⅲ. Modeling a Sequence of Hypothetical Transactions = 291
• A. The Standard Deal in Six Scenarios = 292
• 1. Identifying and Depositing the Microbe = 292
• 2. Collections A and B Join the Proposed Microbial Research Commons = 293
• 3. Microbe RURI 500／OCCI 8000 Elicits Research Interest = 295
• 4. Development of a Commercial Product = 297
• 5. Sales of the Product Trigger the Liability Rule and Distribution of Royalties = 299
• 6. Lottery Effects and the Possibility of Leakage = 302
• B. Accommodating More Complicated Transactions = 307
• 1. Multiple Owners and Possible Royalty Stacking = 307
• 2. Derivatives or Modifi cations that Incorporate Materials Accessed from the Multilateral System = 309
• 3. Modifi cations Based on Data Pertaining to Microbial Materials Accessed from the Multilateral System = 310
• C. Advantages of the Scheme = 312
• PART THREE : A DIGITALLY INTEGRATED INFRASTRUCTURE FOR MICROBIAL DATA AND INFORMATION
• 6 Legal and Institutional Obstacles Impeding Access to and Use of Scientific Literature and Data = 319
• Ⅰ. Potentially Boundless Scientific Opportunities in the Digital Environment = 319
• Ⅱ. Copyright and Related Laws as Digital Gridlock = 324
• A. Two Conceptual Approaches in the Application of Copyright Law to Science = 326
• 1. Harmonizing the Designated Limitations and Exceptions that Weakly Defend Science in the European Union = 328
• 2. Limits of the Fair Use Approach in the United States = 330
• B. Digital Locks and Contractual Overrides in the Online Environment = 334
• C. Exclusive Rights in Noncopyrightable Collections of Data = 336
• Ⅲ. Automated Knowledge Discovery Tools as Instruments of Massive Infringements = 342
• A. What Digital Science Would Really Need from Any Serious Legislative Reform = 344
• 1. A Tailor-Made Exception for Scientific Research = 345
• 2. Breaking the Digital Locks = 346
• 3. Disciplining Contractual Overrides = 349
• 4. Aligning Database Protection Laws with Tailor-Made Exceptions for Science in Copyright Law = 351
• 5. Adjusting the International Legal Framework to Accommodate the Needs of Science = 352
• B. The Hard Reality : More, Not Less Protection, Is on the Way = 355
• Ⅳ. Institutional Constraints on Digital Knowledge Resources = 357
• A. The Changing Role of Publishing Intermediaries = 357
• B. Impediments to the Pooling of Data and Digitally Networked Collaboration = 362
• Ⅴ. Final Observations = 367
• A. Bridging the Disconnect Between Private Rights and Public Science = 368
• B. Reconciling the Goals of Innovation Policy with the Needs of Science Policy = 370
• C. Towards a Digitally Integrated Infrastructure for Microbial Literature and Data = 371
• 7 Enabling the Microbiological Research Community to Control Its Own Scholarly Publications = 373
• Ⅰ. Response of the Scientifi c Community to Restrictions on Published Research Results = 373
• Ⅱ. Surveying the Practices of the Microbiological Journals = 375
• A. Contractual Provisions of Selected Leading Journals = 378
• B. Results of Broader Survey = 380
• 1. A Growing Number of Open Access Microbiology Journals = 382
• 2. Self-Archiving by Authors Who Publish in Subscription Journals = 388
• 3. Disposition of Copyrights = 389
• 4. Costs of the Open-Access Option = 390
• 5. Postscript = 391
• Ⅲ. Redefi ning the Role of Publishing Intermediaries under Current Institutional Constraints = 393
• A. Refl ections on the Law Journal Model = 396
• B. Funders' Ability to Contractually Regulate Access to, Use, and Reuse of Scientific Literature = 399
• C. Integrating Intermediaries' Functions into Transnational Digital Knowledge Environments = 402
• 8 Fully Exploiting Data-Intensive Research Opportunities in the Networked Environment = 406
• Ⅰ. Early Release Policies to Manage the Deluge of Genomic Reference Data = 406
• A. The Bermuda, Fort Lauderdale, and Toronto Data Policy Guidelines = 409
• B. Evaluating the Mandatory Early Release Policies and Their Conceptual Framework = 412
• 1. Selected Examples of Compliance in the Field of Microbiology = 414
• 2. The International Human Microbiome Consortium = 415
• 3. Evaluating the Trend = 419
• Ⅱ. Beyond Early Release : Diverse Networked Sharing Strategies to Manage and Exploit the Deluge of Data = 421
• A. Selected Taxonomic and Related Microbiological Reference Data Collections = 422
• B. Online Aggregators of Data and Information about Microbial Materials Available from Public Culture Collections = 425
• 1. The World Data Center for Microorganisms = 426
• 2. The StrainInfo Bioportal = 429
• C. Understanding the Data Sharing Movement and Its Future Potential = 431
• 1. Benefi ts and Drawbacks of the Data Sharing Ethos = 433
• 2. Beyond the Public Versus Private Distinction = 440
• Ⅲ. Building Transnational Open Knowledge Environments = 441
• A. Examples of Incipient Open Knowledge Environments on the Frontiers of Microbiology = 441
• 1. The Genomic Standards Consortium (GSC) – Interactive Portal and Open Access Journal = 441
• 2. The Community Cyber-Infrastructure for Advanced Marine Microbial Ecology Research and Analysis (CAMERA) = 445
• 3. The Systems Biology Knowledgebase (KBase) of the U.S. Department of Energy = 447
• 4. The Program on Microbiology of the BUILT Environment (MoBe) = 451
• B. The Future of Open Knowledge Environments = 453
• 1. Lessons from the Empirical Models = 453
• 2. Operationalizing the Core Concepts = 456
• 3. Funding and Other Governance Considerations = 465
• C. Linking the Open Knowledge Environment to the Materials Infrastructure = 467
• PART FOUR : GOVERNING PUBLIC KNOWLEDGE ASSETS WITHIN A REDESIGNED MICROBIAL RESEARCH COMMONS
• 9 Institutional Models for a Transnational Research Commons = 473
• Ⅰ. Theoretical Refl ections on Designing a Knowledge Commons = 476
• A. Applying Commons Theory to the Microbial Research Infrastructure = 480
• 1. Distinctive Characteristics of Genetic Materials as a Common-Pool Resource = 484
• 2. Factoring in the Unprecedented Power of Digital Networks = 486
• 3. Potential Payoffs from a Well-Designed Governance Model = 489
• B. Three Governance Prototypes for Globally Pooled Research Assets = 492
• Ⅱ. Selected Empirically Relevant Governance Approaches = 494
• A. The Global Crop Commons : A Treaty-Based Intergovernmental Entity = 496
• 1. A Two-Headed Governance Construct = 496
• 2. Implementation of the Multilateral Regime = 499
• B. Hybrid Pooling Arrangements Among Governments, Para-Statal Entities, and Nongovernmental Stakeholders = 504
• 1. The World Federation for Culture Collections (WFCC) = 505
• 2. The Global Biodiversity Information Facility (GBIF) = 510
• 3. The Group on Earth Observations (GEO) = 514
• 4. The International Human Microbiome Consortium (IHMC) = 519
• C. The Market-Like Nongovernmental Enterprise = 526
• 1. The Global Biological Resource Centers Network (GBRCN) Demonstration Project = 528
• 2. A Questionable Blueprint for the Future = 538
• 3. The Next Step : The Microbial Resource Infrastructure (MIRRI) as a European Stepping Stone to the GBRCN = 541
• Ⅲ. In Search of a Politically Acceptable and Scientifi cally Productive Operational Framework = 544
• A. Evaluating the Existing Legal and Institutional Landscape = 544
• 1. Comparing Science-Managed NGOs with a Treaty-Based IGO = 545
• 2. Advantages of a Hybrid International Framework Agreement = 550
• B. Reconciling National Sovereignty over Microbial Genetic Resources with a Global Public Goods Approach = 554
• 1. Avoiding the Wrong Incentives = 555
• 2. Facilitated Access to Upstream Research Assets and Benefi t-Sharing Under a Multilateral System = 560
• C. Toward a More Science-Driven Organizational Model for the Digital Age = 563
• 1. Avoiding an Unduly Narrow Scientific Mission = 564
• 2. Giving Scientists a Voice in the Decision-Making Process = 566
• 10 Governing Digitally Integrated Genetic Resources, Data, and Literature = 568
• Ⅰ. Premises for Constructing a Common Pool Resource = 568
• A. The Political Economy of a Global Approach = 568
• B. The Critical Role of Effective Leadership = 574
• C. The Need for Political Cover = 576
• Ⅱ. Organizational and Structural Considerations = 579
• A. Membership and Decision Making = 581
• B. Ancillary Membership Issues = 585
• C. Observer Status = 587
• D. The Core Institutional Components = 589
• 1. A Governing Body and an Executive Committee = 591
• 2. A Scientifi c Coordination Council (SCC) and a Small Secretariat = 593
• 3. Advisory Committees = 597
• Ⅲ. Implementing the Multilateral Regime for Facilitated Access to Ex Situ Microbial Genetic Resources = 598
• A. Promoting and Certifying Quality Standards = 599
• B. Defi ning the Conditions of Legitimate Exchange = 601
• C. Drafting an SMTA to Establish the Compensatory Liability Regime : The Critical Issues = 603
• 1. The Question of a Users' Surcharge = 605
• 2. Quantum and Duration of Royalties = 607
• 3. Protocols for the Distribution of Royalties = 609
• 4. New Uses of Pre-1992 Microbial Materials = 613
• 5. Genetic Sequences and Other Related Data = 614
• 6. Prescribing Minimum Conditions of Reciprocity = 615
• 7. Mediation and Dispute Resolution = 618
• 8. Recognizing the Importance of Nonmonetary Benefits = 622
• D. Digitally Integrating Knowledge Assets Available from the Multilateral System = 624
• 1. The Core Project = 624
• 2. Optional Longer Term Projects = 628
• E. Relations with Developing Countries = 628
• F. Other Issues for the Governing Body to Consider = 632
• 1. Devising Policies for Earlier Release of Materials Used in Basic Research = 632
• 2. Possible Negotiations Concerning Access to In Situ Microbial Genetic Resources = 634
• 3. Biosafety and Security Considerations = 635
• Ⅳ. Funding and Institutional Stability = 637
• A. The Need for Adequate and Dependable Funding = 637
• B. Hidden Costs of Not Funding a Redesigned Microbial Research Commons = 642
• V. Concluding Observations = 645
• Index = 651