Perspectives on properties of the human genome project /

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Bibliographic Details
Imprint:Amsterdam ; Boston : Elsevier/Academic Press, c2003.
Description:xxvi, 538 p. : ill. ; 24 cm.
Language:English
Series:Advances in genetics ; v.50
Subject:
Format: Print Book
URL for this record:http://pi.lib.uchicago.edu/1001/cat/bib/5058919
Hidden Bibliographic Details
Other authors / contributors:Kieff, F. Scott.
Epstein, Richard Allen, 1943-
ISBN:0120176505
Notes:Includes bibliographical references and index.
Table of Contents:
  • Contributors
  • Acknowledgment
  • Introduction
  • 1. Where We are and How We Got Here
  • 1. Patenting Life Forms: Yesterday, Today, and Tomorrow
  • I.. Introduction
  • II.. Patenting Life Forms
  • III.. What Happened Next?
  • IV.. What about Patenting Human Organs?
  • V.. Defining Human?
  • VI.. Epilogue
  • 2. The Evolution of Gene Patents Viewed from the United States Patent Office
  • I.. Introduction
  • II.. Are Gene-Related Inventions Patentable Subject Matter?
  • III.. Utility of Gene-Related Inventions
  • IV.. Do Gene-Related Inventions Satisfy the Enable and Written Description Requirements?
  • V.. Novelty and Nonobviousness
  • VI.. Summary
  • 3. Competition Policy in Patent Cases and Antitrust
  • I.. Introduction
  • II.. The Federal Circuit's Transformation of the Law
  • A.. Claim Construction
  • 1.. The Governing Law Before Markman
  • 2.. The Federal Circuit's Markman Decision
  • B.. Infringement by Equivalents and Prosecution History Estoppel
  • 1.. The Governing Law Before Festo as to Equivalents
  • 2.. The Governing Law Before Festo as to Prosecution Estoppel
  • 3.. The Festo Decision
  • 4.. Other Federal Circuit Efforts to Confine or Eliminate the Doctrine of Equivalents
  • a.. Specific Exclusion
  • b.. Foreseeability
  • c.. The Patent Specification Precludes Equivalence
  • III.. Competition Policy in the Treatment of Patents
  • A.. The Black/Douglas View of Patents in the Contex of Antitrust and Competition Policy in the 1940s and 1950s
  • 1.. Patent Law
  • 2.. Antitrust Law
  • B.. The Renunciation of the Black/Douglas View
  • 1.. Economic Beginnings
  • 2.. The Cases
  • 3.. The Antitrust Division's View of the Role of Innovation in Competition
  • IV.. Precise Notice to Competitors and Rule of Reason Analysis under the Antitrust Laws
  • V.. Conclusion
  • 4. Product Patents on Human DNA Sequences: An Obstacle for Implementing the EU Biotech Directive?
  • I.. Introduction
  • II.. Presumable Obstacles for Implementation
  • III.. The Case of Product Patents on DNA Sequences
  • IV.. The EU Biotech Directive in the Light of the Latest Scientific Developments
  • V.. Lessons to be Drawn from These New Developments
  • 5. Patenting Genetic Products and Processes: A TRIPS Perspective
  • I.. The Uruguay Round of GATT Negotiations
  • II.. Article 27 of the TRIPS Agreement
  • III.. Interpretive Controversies and Political Fallout Likely to Arise out of Article 27
  • A.. Interpretive Controversies Concerning Article 27
  • B.. The Political Fallout Produced by Article 27
  • IV.. Conclusion: Implications for Human Genomic Research and Patent Protection
  • 6. Enclosing the Genome: What Squabbles over Genetic Patents Could Teach US
  • I.. Introduction
  • II.. You Can't Own a Gene
  • A.. The Sacred
  • B.. The Uncommodifiable
  • C.. The Environmental Ethic
  • D.. The Common Heritage of Mankind
  • E.. The Rights of Sources
  • F.. Patentable Subject Matter
  • 1.. Novelty
  • 2.. Nonobviousness
  • 3.. Utility
  • G.. Innovation Policy
  • III.. The Limits of Intellectual Property Policy
  • A.. The Bipolar Disorders of Intellectual Property Policy
  • B.. Reasons to be Narrow: Take 3
  • IV.. Reconstructing Scholarship
  • A.. Questioning and Refining the Ideal of Perpetual Innovation
  • B.. From Public Goods to Public Choice
  • V.. Conclusion
  • 2. The Case for Property Rights
  • 7. Perusing Property Rights in DNA
  • I.. Introduction
  • II.. The Types and Rights of Ownership in DNA
  • A.. The Differences between These Types of Property
  • B.. The Interactions between These Types of Property
  • III.. The Object of Ownership in Patents
  • A.. The Rules about What is Not Owned
  • B.. The Rules about Disclosing What is Owned
  • C.. Applying These Rules to DNA
  • IV.. The Owner of Ownership in Patents
  • V.. The Implications of Ownership in Patents for Nonowners
  • A.. Ownership Operates Ex Ante to Bring Commercialization
  • B.. Transactions Operate Ex Post to Increase Output
  • VI.. Conclusion
  • 8. Steady the Course: Property Rights in Genetic Material
  • I.. All-or-Nothing on Property Rights
  • II.. Moral Arguments against Property Rights in the Genome and Elsewhere
  • III.. The Common versus Private Property
  • A.. A Mixed Equilibrium
  • B.. Multiple Monopolies
  • IV.. Forced Transfers of Patent Rights
  • A.. Condemnation
  • B.. Compulsory Licensing
  • 1.. Basic Proposal
  • 2.. Mechanics of Compulsory Licenses
  • V.. Contracting Strategies
  • VI.. On to the Genome
  • A.. The Patent Law
  • B.. Express Sequence Tags
  • VII.. Conclusion
  • 9. Varying the Course in Patenting Genetic Material: A Counter-Proposal to Richard Epstein's Steady Course
  • I.. Introduction
  • II.. Four Assumptions
  • A.. The Rational Patentee
  • B.. The Benign Patent
  • C.. The Malignant Compulsory License
  • D.. The Goals of Patent Law
  • III.. A Counter-Proposal
  • 10. Reaching through the Genome
  • I.. The Old Model: Genes as Products
  • II.. The New Model: Genes as Research Tools
  • III.. Reach-through Strategies
  • A.. Reach-through Licenses
  • B.. Reach-through Remedies
  • C.. Reach-through Claiming
  • IV.. Normative Assessment of Reach-through Mechanisms
  • V.. Conclusion
  • 11. The Human Genome Project in Retrospect
  • I.. Introduction
  • II.. The History, Structure, and Funding of the Human Genome Project
  • A.. A History of Private Challenges to the Human Genome Project
  • B.. Structural Options Considered at the Outset of the Human Genome Project
  • 1.. One Agency
  • 2.. Single-Agency Leadership
  • 3.. Interagency Agreement and Consultation
  • 4.. Interagency Task Force
  • 5.. Consortium
  • 6.. The Solution
  • C.. Funding Mechanisms
  • 1.. Direct Appropriations and Government Contracts
  • 2.. Grants to Individuals and Institutions
  • 3.. Cooperative Research and Development Agreements
  • D.. Goals of Structure and Funding
  • III.. A Proposal for Administration of Science
  • A.. A Sketch of a Retrospective Grant Institution
  • B.. Refinements
  • C.. Objections
  • D.. Assessment of the Proposal
  • IV.. Conclusion
  • 12. Goat-Boy Roams the Halls?
  • I.. Information and Advocacy of Reform
  • II.. Property Rights and Hybrid Regimes
  • III.. Goat-Boy Roams the Halls
  • IV.. A Final Adage
  • 13. Comment on the Tragedy of the Anticommons in Biomedical Research
  • 14. An Outsider Perspective on Intellectual Property Discourse
  • I.. Introduction
  • II.. Truthfulness/Completeness
  • III.. Typicality
  • IV.. From Theory to Practice
  • V.. Conclusion
  • 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
  • I.. Introduction
  • II.. Fallacy of the "All-or-Nothing" Approach
  • III.. The Semicommons as a Natural, Open-Source Community
  • IV.. From Semicommons to Anticommons: The Unbridled Proliferation of Exclusive Rights
  • V.. Database Protection or How to Elevate the Costs of Innovation Across the Entire Economy
  • VI.. Saving the System from Itself
  • VII.. A Comprehensive Solution
  • 16. Biotechnology's Uncertainty Principle
  • I.. Heterogeneity in the Patent Law
  • A.. The History of the Uniform Patent System
  • B.. Biotechnology Patent Cases
  • C.. The Divergent Standards
  • II.. Modulating Technology-Specificity
  • A.. The Role of the PHOSITA
  • B.. Misapplication of the PHOSITA Standard
  • C.. Obstacles to Applying the PHOSITA Standard Properly
  • III.. Innovation, Invention, and Uncertainty
  • A.. Theories of Biotechnology Patents
  • 1.. Prospect Theory
  • 2.. Anticommons Theory
  • B.. Designing Optimal Biotechnology Policy
  • C.. Designing Optimal Pharmaceutical Policy
  • IV.. Conclusion
  • 17. Commentary on the Panel Presentations
  • 18. Commenting on Biotechnology's Uncertainty Principle
  • I.. The Written Description and Enablement Requirements
  • II.. The Nonobviousness Requirement
  • III.. The Obviousness Requirement and the Doctrine of Equivalents
  • IV.. The PHOSITA in Biotechnology
  • V.. Innovation, Invention, and Uncertainty
  • 19. (Mostly) against Exceptionalism
  • I.. Introduction
  • II.. Adaptions versus Prescription: Exploring Technological Specificity and the Patent Law
  • A.. The Two Forms of Technological Specificty: Macro- and Micro-
  • B.. The Uncertain Effects of the PHOSITA
  • III.. The Hunt for Exceptionalism: The Technological Specificity of Parent Jurisprudence
  • A.. Patentability Jurisprudence
  • B.. Biotechnological "Jurisprudence"
  • C.. Reading the Cases: A (Brief) Response to Burk and Lemley
  • IV.. (Mostly) against Exceptionalism
  • 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
  • I.. Introduction
  • II.. Tool Companies and Their Business
  • III.. Vertical Disintegration of the Pharmaceutical Industry
  • IV.. Is the New Industry Structure Efficient?
  • V.. Concluding Thoughts
  • 21. Pharmacogenomics, Genetic Tests, and Patent-Based Incentives
  • I.. Introduction
  • II.. Pharmacogenomics and the Promise of Customized Drug Therapy
  • A.. Genomics and the Practice of Medicine
  • B.. Genetic Testing Technology
  • III.. The Impact of Genetic Tests on Profit and Social Welfare in the Market for Existing Drugs
  • A.. The Basic Model
  • B.. The Information Content of the Test
  • C.. Tests with No Medical Value
  • D.. Differentiated Drugs in a Duopoly Market
  • IV.. Incentives to Conduct and Develop Genetic Tests
  • A.. The Incentive to Conduct Genetic Testing
  • B.. The Incentive to Develop Genetic Tests
  • V.. Conclusion
  • 22. The Effect of Intellectual Property on the Biotechnology Industry
  • I.. Bringing New Drugs to Patients
  • II.. The U.S. Patent System: Promoting Innovation in the Biotech Industry
  • III.. Common Criticisms of Biotechnology Patents
  • IV.. Patent Policies Endangering the Biotechnology Industry
  • V.. Conclusion
  • 23. Are Real Business People So Easily Thwarted?
  • 5. Disputes over Genetics in Academia and Business
  • 24. One Size Fits All?
  • 25. Some Empirical Evidence on How Technologically Complex Issues Are Decided in Patent Cases in U.S. District Courts
  • 26. How Ordinary Judges and Juries Decide the Seemingly Complex Technological Questions of Patentability over the Prior Art
  • I.. Introduction: A Theory of Desert
  • II.. Novelty
  • III.. Nonobviousness
  • IV.. Conclusion
  • 27. The Difficult Interface: Relations between the Sciences and the Law
  • I.. Introduction
  • II.. The Norms of Science
  • III.. Recent History
  • IV.. Fraud and the Law
  • V.. Remedies?
  • Conclusion
  • Index