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The groundbreaking work of modern genetics that culminated in the Human Genome Project has blazed new pathways in both science and law. As the assertion of property rights generally, and patents in particular, has become increasingly common surrounding the new products and processes of modern biotechnology, the transactions that must occur for downstream research and development to occur have shifted in important ways, in both academic and business settings. Perspectives on Properties of the Human Genome Project addresses the problems raised in this complex area under different regimes of laws and norms to offer hope and help as we wrestle to ensure optimal use of such essential innovations. This unique collection of authors, views, and topics is essential reading for academics, policy-makers, and practitioners in medicine, biology, sociology, management, ethics, law, and economics, and anyone else interested in gaining perspective on the broad interface between biotechnology and property.

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• Contributors(p. xvii)
• Acknowledgment(p. xix)
• Introduction(p. xxiii)
• 1 Where We are and How We Got Here
• 1 Patenting Life Forms: Yesterday, Today, and Tomorrow(p. 3)
• I. Introduction(p. 3)
• II. Patenting Life Forms(p. 4)
• III. What Happened Next?(p. 5)
• IV. What about Patenting Human Organs?(p. 8)
• V. Defining Human?(p. 9)
• VI. Epilogue(p. 11)
• 2 The Evolution of Gene Patents Viewed from the United States Patent Office(p. 13)
• I. Introduction(p. 13)
• II. Are Gene-Related Inventions Patentable Subject Matter?(p. 14)
• III. Utility of Gene-Related Inventions(p. 16)
• IV. Do Gene-Related Inventions Satisfy the Enable and Written Description Requirements?(p. 17)
• V. Novelty and Nonobviousness(p. 18)
• VI. Summary(p. 21)
• 3 Competition Policy in Patent Cases and Antitrust(p. 23)
• I. Introduction(p. 26)
• II. The Federal Circuit's Transformation of the Law(p. 26)
• A. Claim Construction(p. 26)
• 1. The Governing Law Before Markman(p. 26)
• 2. The Federal Circuit's Markman Decision(p. 27)
• B. Infringement by Equivalents and Prosecution History Estoppel(p. 29)
• 1. The Governing Law Before Festo as to Equivalents(p. 30)
• 2. The Governing Law Before Festo as to Prosecution Estoppel(p. 33)
• 3. The Festo Decision(p. 35)
• 4. Other Federal Circuit Efforts to Confine or Eliminate the Doctrine of Equivalents(p. 38)
• a. Specific Exclusion(p. 39)
• b. Foreseeability(p. 40)
• c. The Patent Specification Precludes Equivalence(p. 41)
• III. Competition Policy in the Treatment of Patents(p. 42)
• A. The Black/Douglas View of Patents in the Contex of Antitrust and Competition Policy in the 1940s and 1950s(p. 42)
• 1. Patent Law(p. 43)
• 2. Antitrust Law(p. 45)
• B. The Renunciation of the Black/Douglas View(p. 48)
• 1. Economic Beginnings(p. 48)
• 2. The Cases(p. 49)
• 3. The Antitrust Division's View of the Role of Innovation in Competition(p. 56)
• IV. Precise Notice to Competitors and Rule of Reason Analysis under the Antitrust Laws(p. 60)
• V. Conclusion(p. 62)
• 4 Product Patents on Human DNA Sequences: An Obstacle for Implementing the EU Biotech Directive?(p. 65)
• I. Introduction(p. 65)
• II. Presumable Obstacles for Implementation(p. 67)
• III. The Case of Product Patents on DNA Sequences(p. 70)
• IV. The EU Biotech Directive in the Light of the Latest Scientific Developments(p. 74)
• V. Lessons to be Drawn from These New Developments(p. 76)
• 5 Patenting Genetic Products and Processes: A TRIPS Perspective(p. 79)
• I. The Uruguay Round of GATT Negotiations(p. 81)
• II. Article 27 of the TRIPS Agreement(p. 83)
• III. Interpretive Controversies and Political Fallout Likely to Arise out of Article 27(p. 87)
• A. Interpretive Controversies Concerning Article 27(p. 88)
• B. The Political Fallout Produced by Article 27(p. 93)
• IV. Conclusion: Implications for Human Genomic Research and Patent Protection(p. 95)
• 6 Enclosing the Genome: What Squabbles over Genetic Patents Could Teach US(p. 97)
• I. Introduction(p. 98)
• II. You Can't Own a Gene(p. 100)
• A. The Sacred(p. 101)
• B. The Uncommodifiable(p. 101)
• C. The Environmental Ethic(p. 102)
• D. The Common Heritage of Mankind(p. 102)
• E. The Rights of Sources(p. 103)
• F. Patentable Subject Matter(p. 104)
• 1. Novelty(p. 104)
• 2. Nonobviousness(p. 104)
• 3. Utility(p. 105)
• G. Innovation Policy(p. 105)
• III. The Limits of Intellectual Property Policy(p. 106)
• A. The Bipolar Disorders of Intellectual Property Policy(p. 107)
• B. Reasons to be Narrow: Take 3(p. 110)
• IV. Reconstructing Scholarship(p. 113)
• A. Questioning and Refining the Ideal of Perpetual Innovation(p. 114)
• B. From Public Goods to Public Choice(p. 116)
• V. Conclusion(p. 118)
• 2 The Case for Property Rights
• 7 Perusing Property Rights in DNA(p. 125)
• I. Introduction(p. 126)
• II. The Types and Rights of Ownership in DNA(p. 127)
• A. The Differences between These Types of Property(p. 127)
• B. The Interactions between These Types of Property(p. 130)
• III. The Object of Ownership in Patents(p. 135)
• A. The Rules about What is Not Owned(p. 135)
• B. The Rules about Disclosing What is Owned(p. 138)
• C. Applying These Rules to DNA(p. 140)
• IV. The Owner of Ownership in Patents(p. 142)
• V. The Implications of Ownership in Patents for Nonowners(p. 144)
• A. Ownership Operates Ex Ante to Bring Commercialization(p. 145)
• B. Transactions Operate Ex Post to Increase Output(p. 146)
• VI. Conclusion(p. 150)
• 8 Steady the Course: Property Rights in Genetic Material(p. 153)
• I. All-or-Nothing on Property Rights(p. 154)
• II. Moral Arguments against Property Rights in the Genome and Elsewhere(p. 156)
• III. The Common versus Private Property(p. 160)
• A. A Mixed Equilibrium(p. 160)
• B. Multiple Monopolies(p. 162)
• IV. Forced Transfers of Patent Rights(p. 168)
• A. Condemnation(p. 168)
• B. Compulsory Licensing(p. 171)
• 1. Basic Proposal(p. 171)
• 2. Mechanics of Compulsory Licenses(p. 175)
• V. Contracting Strategies(p. 179)
• VI. On to the Genome(p. 181)
• A. The Patent Law(p. 182)
• B. Express Sequence Tags(p. 188)
• VII. Conclusion(p. 193)
• 9 Varying the Course in Patenting Genetic Material: A Counter-Proposal to Richard Epstein's Steady Course(p. 195)
• I. Introduction(p. 195)
• II. Four Assumptions(p. 196)
• A. The Rational Patentee(p. 196)
• B. The Benign Patent(p. 199)
• C. The Malignant Compulsory License(p. 201)
• D. The Goals of Patent Law(p. 203)
• III. A Counter-Proposal(p. 204)
• 10 Reaching through the Genome(p. 209)
• I. The Old Model: Genes as Products(p. 210)
• II. The New Model: Genes as Research Tools(p. 213)
• III. Reach-through Strategies(p. 214)
• A. Reach-through Licenses(p. 214)
• B. Reach-through Remedies(p. 217)
• C. Reach-through Claiming(p. 218)
• IV. Normative Assessment of Reach-through Mechanisms(p. 224)
• V. Conclusion(p. 230)
• 11 The Human Genome Project in Retrospect(p. 231)
• I. Introduction(p. 232)
• II. The History, Structure, and Funding of the Human Genome Project(p. 234)
• A. A History of Private Challenges to the Human Genome Project(p. 235)
• B. Structural Options Considered at the Outset of the Human Genome Project(p. 236)
• 1. One Agency(p. 238)
• 2. Single-Agency Leadership(p. 238)
• 3. Interagency Agreement and Consultation(p. 240)
• 4. Interagency Task Force(p. 240)
• 5. Consortium(p. 241)
• 6. The Solution(p. 241)
• C. Funding Mechanisms(p. 242)
• 1. Direct Appropriations and Government Contracts(p. 243)
• 2. Grants to Individuals and Institutions(p. 244)
• 3. Cooperative Research and Development Agreements(p. 244)
• D. Goals of Structure and Funding(p. 245)
• III. A Proposal for Administration of Science(p. 249)
• A. A Sketch of a Retrospective Grant Institution(p. 250)
• B. Refinements(p. 253)
• C. Objections(p. 256)
• D. Assessment of the Proposal(p. 258)
• IV. Conclusion(p. 260)
• 12 Goat-Boy Roams the Halls?(p. 263)
• I. Information and Advocacy of Reform(p. 263)
• II. Property Rights and Hybrid Regimes(p. 266)
• III. Goat-Boy Roams the Halls(p. 270)
• IV. A Final Adage(p. 270)
• 13 Comment on the Tragedy of the Anticommons in Biomedical Research(p. 271)
• 14 An Outsider Perspective on Intellectual Property Discourse(p. 275)
• I. Introduction(p. 275)
• II. Truthfulness/Completeness(p. 280)
• III. Typicality(p. 281)
• IV. From Theory to Practice(p. 283)
• V. Conclusion(p. 285)
• 3 Comparisons with Other Technologies and Other Legal Regimes
• 15 Saving the Patent Law from Itself: Informal Remarks Concerning the Systemic Problems Afflicting Developed Intellectual Property Regimes(p. 289)
• I. Introduction(p. 289)
• II. Fallacy of the "All-or-Nothing" Approach(p. 291)
• III. The Semicommons as a Natural, Open-Source Community(p. 293)
• IV. From Semicommons to Anticommons: The Unbridled Proliferation of Exclusive Rights(p. 295)
• V. Database Protection or How to Elevate the Costs of Innovation Across the Entire Economy(p. 297)
• VI. Saving the System from Itself(p. 299)
• VII. A Comprehensive Solution(p. 301)
• 16 Biotechnology's Uncertainty Principle(p. 305)
• I. Heterogeneity in the Patent Law(p. 307)
• A. The History of the Uniform Patent System(p. 308)
• B. Biotechnology Patent Cases(p. 309)
• C. The Divergent Standards(p. 318)
• II. Modulating Technology-Specificity(p. 320)
• A. The Role of the PHOSITA(p. 320)
• B. Misapplication of the PHOSITA Standard(p. 325)
• C. Obstacles to Applying the PHOSITA Standard Properly(p. 328)
• III. Innovation, Invention, and Uncertainty(p. 334)
• A. Theories of Biotechnology Patents(p. 334)
• 1. Prospect Theory(p. 334)
• 2. Anticommons Theory(p. 339)
• B. Designing Optimal Biotechnology Policy(p. 344)
• C. Designing Optimal Pharmaceutical Policy(p. 350)
• IV. Conclusion(p. 353)
• 17 Commentary on the Panel Presentations(p. 355)
• 18 Commenting on Biotechnology's Uncertainty Principle(p. 361)
• I. The Written Description and Enablement Requirements(p. 361)
• II. The Nonobviousness Requirement(p. 363)
• III. The Obviousness Requirement and the Doctrine of Equivalents(p. 364)
• IV. The PHOSITA in Biotechnology(p. 364)
• V. Innovation, Invention, and Uncertainty(p. 366)
• 19 (Mostly) against Exceptionalism(p. 367)
• I. Introduction(p. 367)
• II. Adaptions versus Prescription: Exploring Technological Specificity and the Patent Law(p. 370)
• A. The Two Forms of Technological Specificty: Macro- and Micro-(p. 370)
• B. The Uncertain Effects of the PHOSITA(p. 372)
• III. The Hunt for Exceptionalism: The Technological Specificity of Parent Jurisprudence(p. 375)
• A. Patentability Jurisprudence(p. 375)
• B. Biotechnological "Jurisprudence"(p. 378)
• C. Reading the Cases: A (Brief) Response to Burk and Lemley(p. 379)
• IV. (Mostly) against Exceptionalism(p. 379)
• 4 Transactions Over Genetics in Academia and Business
• 20 O Brave New Industry, That Has Such Patents in It! Reflections on the Economic Consequences of Patenting DNA(p. 385)
• I. Introduction(p. 385)
• II. Tool Companies and Their Business(p. 387)
• III. Vertical Disintegration of the Pharmaceutical Industry(p. 388)
• IV. Is the New Industry Structure Efficient?(p. 392)
• V. Concluding Thoughts(p. 396)
• 21 Pharmacogenomics, Genetic Tests, and Patent-Based Incentives(p. 399)
• I. Introduction(p. 400)
• II. Pharmacogenomics and the Promise of Customized Drug Therapy(p. 403)
• A. Genomics and the Practice of Medicine(p. 403)
• B. Genetic Testing Technology(p. 405)
• III. The Impact of Genetic Tests on Profit and Social Welfare in the Market for Existing Drugs(p. 407)
• A. The Basic Model(p. 407)
• B. The Information Content of the Test(p. 411)
• C. Tests with No Medical Value(p. 414)
• D. Differentiated Drugs in a Duopoly Market(p. 416)
• IV. Incentives to Conduct and Develop Genetic Tests(p. 419)
• A. The Incentive to Conduct Genetic Testing(p. 419)
• B. The Incentive to Develop Genetic Tests(p. 421)
• V. Conclusion(p. 425)
• 22 The Effect of Intellectual Property on the Biotechnology Industry(p. 427)
• I. Bringing New Drugs to Patients(p. 427)
• II. The U.S. Patent System: Promoting Innovation in the Biotech Industry(p. 430)
• III. Common Criticisms of Biotechnology Patents(p. 433)
• IV. Patent Policies Endangering the Biotechnology Industry(p. 437)
• V. Conclusion(p. 439)
• 23 Are Real Business People So Easily Thwarted?(p. 441)
• 5 Disputes over Genetics in Academia and Business
• 24 One Size Fits All?(p. 449)
• 25 Some Empirical Evidence on How Technologically Complex Issues Are Decided in Patent Cases in U.S. District Courts(p. 459)
• 26 How Ordinary Judges and Juries Decide the Seemingly Complex Technological Questions of Patentability over the Prior Art(p. 471)
• I. Introduction: A Theory of Desert(p. 472)
• II. Novelty(p. 473)
• III. Nonobviousness(p. 476)
• IV. Conclusion(p. 482)
• 27 The Difficult Interface: Relations between the Sciences and the Law(p. 483)
• I. Introduction(p. 483)
• II. The Norms of Science(p. 485)
• III. Recent History(p. 492)
• IV. Fraud and the Law(p. 494)
• V. Remedies?(p. 504)
• Conclusion(p. 507)
• Index(p. 511)