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9780844742564

Biotechnology and the Patent System Balancing Innovation and Property Rights

by ;
  • ISBN13:

    9780844742564

  • ISBN10:

    0844742562

  • Edition: 1st
  • Format: Paperback
  • Copyright: 2007-09-27
  • Publisher: Aei Press

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Summary

Barfield and Calfee clearly explain arcane issues of patent law and the tremendous effect that they can have on our economy, our technological progress, and our health. As Congress considers sweeping changes to the patent law, this book is a timely evaluation of the strengths and weaknesses of the current system and the risk of overly aggressive reform.

Biotechnology and the Patent System analyzes the role of intellectual property protection in biomedical research, one of America's leading growth industries. Barfield and Calfee explore ways in which patent law fosters future research and venture capital investment; they also evaluate whether the current system could potentially impede genomic research and the development of new treatment and diagnostic tools. With these competing concerns in mind, the authors evaluate proposals currently under discussion in Congress (S 1145 and HR 1908) and how they would affect biotechnological innovation and, in turn, the quality of our health care.

These proposals have created passionate disagreements among affected industries, with technology and software companies pressing for fundamental reforms that would shift the balance of power from patent holders to patent challengers. Biotechnology, pharmaceutical, and manufacturing firms, as well as large research universities and venture capital associations, contend that the reform proposals are too radical and would undercut U.S. international competitiveness and retard innovation.

In just a few decades, the U.S. biotechnology industry has gone from a handful of startups to a major industry with a market capitalization of $400 billion and payroll of over 130,000 people. Yet the industry's growth can't mask a simple fact of life for most biotech companies: it is difficult to make a profit because of the high costs, high risks, and extremely long development times in developing biotechnological therapies and devices. In 2006, the industry as a whole lost $5 billion.

Potential changes to existing patent law would f

Author Biography

Claude Barfield is a resident scholar at AEI.

John E. Calfee is a resident scholar at AEI.

Table of Contents

Acknowledgmentsp. ix
Introductionp. 1
Biotechnology and Healthp. 3
The Emergence of the Modern Biotechnology Industryp. 3
The First Wave of Modern Biotechnologyp. 5
Research Prospectsp. 6
The Sources of Biotechnology R&Dp. 10
Basic Researchp. 10
Research in Academiap. 12
Private Sector Researchp. 13
Essential Features of the Biotechnology Industryp. 15
Lengthy Product Development Timesp. 15
The Costs and Uncertainty of Bringing New Drugs to Marketp. 18
Competition among Biotechnology Drugsp. 21
The Role of Intellectual Property Rightsp. 24
The Foundations of Intellectual Propertyp. 24
Why Intellectual Property Protection Is Necessary in Biotechnologyp. 25
The Value of Patents to Innovationp. 26
The Evolving Economic Rationale for Biotechnology Patentsp. 29
Challenges to the Biotechnology Property Rights Systemp. 36
Property Rights and the U.S. Research Enterprisep. 36
Madey v. Duke Universityp. 38
The 2005 NAS Studyp. 39
Recent Studies: 2006-07p. 40
Self-Correcting Remediesp. 43
Positive Institutional Responsesp. 45
USPTOp. 45
Judicial Decisionsp. 46
The NIH: Public Science and the Bayh-Dole Actp. 48
National Academy of Sciencesp. 49
Bayh-Dole and the NIHp. 51
The Way Forward for NIH: Better Safe than Sorryp. 52
The Drive for Legislative Solutionsp. 56
Legislative Proposalsp. 59
The Politics of Patent Reformp. 60
Evaluation and Recommendationsp. 65
Proposals Thoroughly Vetted, With Substantial Consensusp. 66
Shift to a First-Inventor-to-File Systemp. 67
Publication of All Pending Patent Applications within Eighteen Monthsp. 68
Grace Periodp. 68
Assignmentp. 68
"Bounded Opposition": Proposals to Introduce More Information into the Systemp. 69
Pre-Issuance Submissionsp. 69
Post-Grant Opposition Proceedingsp. 70
Legislative Proposals in the 110th Congressp. 71
An Optimum Systemp. 71
Disagreement with Proposed New Legislationp. 72
Subjective Elements of Patent Litigationp. 75
Best Modep. 75
Inequitable Conductp. 75
Willful Infringementp. 76
Let the Process Work-or the Courts Decidep. 77
Apportionment of Damagesp. 77
Preliminary Injunctionsp. 79
Substantive Rulemaking Authority and Continuation Proceedingsp. 80
The USPTOp. 87
Summary and Afterwordp. 90
Notesp. 93
Referencesp. 101
About the Authorsp. 117
Table of Contents provided by Ingram. All Rights Reserved.

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