The Impact of the Bayh-Dole Act on Genetic Research and Development Evaluating the Arguments and Empirical Evidence to Date
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The Impact of the Bayh-Dole Act on Genetic Research and Development Evaluating the Arguments and Empirical Evidence to Date
(08/13/06 draft)The Impact of the Bayh-Dole Act on Genetic Research and Development: Evaluating the Arguments and Empirical Evidence to DateByCharles The Impact of the Bayh-Dole Act on Genetic Research and Development Evaluating the Arguments and Empirical Evidence to Date R. McManis*& Sucheol Noh"The past two decades have witnessed a growing debate in the United States over patenting genetic products and processes. At the heart of the debate are two interrelated questions—1) whether granting patents on the results of ‘•upstream" genetic research* 1 undermines the no The Impact of the Bayh-Dole Act on Genetic Research and Development Evaluating the Arguments and Empirical Evidence to Daterms of the biological research community; and 2) whether such patenting promotes or retards biomedical innovation, technology transfer, and/or the devThe Impact of the Bayh-Dole Act on Genetic Research and Development Evaluating the Arguments and Empirical Evidence to Date
elopment of downstream commercial products and processes. Much of this debate has focused on the impact of a 1980 piece of legislation codified as a c(08/13/06 draft)The Impact of the Bayh-Dole Act on Genetic Research and Development: Evaluating the Arguments and Empirical Evidence to DateByCharles The Impact of the Bayh-Dole Act on Genetic Research and Development Evaluating the Arguments and Empirical Evidence to Dateperty St Technology Law Program, and Director of the Center for Research on Innovation & Entrepreneurship, Washington University. I am indebted to Dr. Wei-Ling Wang. J.S.D. Washington University. 2004. whose dissertation. TECHNOLOGY TRANSFER FROM ACADEMIA TO PRIVATE INDUSTRY: A CRITICAL Examination The Impact of the Bayh-Dole Act on Genetic Research and Development Evaluating the Arguments and Empirical Evidence to DateOF THE BAYH-DOLE act (2004). helped shape my understanding of the Bayh-Dole Act and greatly facilitated the research for this Chapter. I am also grateThe Impact of the Bayh-Dole Act on Genetic Research and Development Evaluating the Arguments and Empirical Evidence to Date
ful to Professor Jay Dratler and the law faculty at the University of Akron for inviting me to deliver the 2005 Albert & Vem Oldham Intellectual Prope(08/13/06 draft)The Impact of the Bayh-Dole Act on Genetic Research and Development: Evaluating the Arguments and Empirical Evidence to DateByCharles The Impact of the Bayh-Dole Act on Genetic Research and Development Evaluating the Arguments and Empirical Evidence to Dateoreover, neither this research project nor the Center's inaugural November 4-6, 2005 academic conference on the topic, “Commercializing Innovation,” would have been possible without the generous financial support that the Ewing Marion Kauffman Foundation and Washington University's own Skandalaris C The Impact of the Bayh-Dole Act on Genetic Research and Development Evaluating the Arguments and Empirical Evidence to Dateenter for Entrepreneurial Studies, Center for Interdisciplinary Studies, and Whitney R. Hanis Institute of Global Legal Studies have provided for theThe Impact of the Bayh-Dole Act on Genetic Research and Development Evaluating the Arguments and Empirical Evidence to Date
directed research activities of the Center for Research on Innovation & Entrepreneurship. Nor would (he conference or this volume have come to pass, w(08/13/06 draft)The Impact of the Bayh-Dole Act on Genetic Research and Development: Evaluating the Arguments and Empirical Evidence to DateByCharles The Impact of the Bayh-Dole Act on Genetic Research and Development Evaluating the Arguments and Empirical Evidence to Datediting and publication of this volume. I am also indebted to my co-author for his meticulous research and editorial assistance throughout this project. Finally. I am grateful for having had the opportunity to present this paper and receive feedback at the 2006 Intellectual Property Scholars Conferen The Impact of the Bayh-Dole Act on Genetic Research and Development Evaluating the Arguments and Empirical Evidence to Datece, held at the University of California-Berkeley, on August 10-11, 2006. See http:.'7www.law.berkeley.edu’mstitutes’bclt'ipsc/about.html." Visiting FThe Impact of the Bayh-Dole Act on Genetic Research and Development Evaluating the Arguments and Empirical Evidence to Date
ellow, Center for Research on Innovation & Entrepreneurship. Washington University. 2005-2006: J.S.D. Washington University of Law, 2001.1 “Upstream r(08/13/06 draft)The Impact of the Bayh-Dole Act on Genetic Research and Development: Evaluating the Arguments and Empirical Evidence to DateByCharles The Impact of the Bayh-Dole Act on Genetic Research and Development Evaluating the Arguments and Empirical Evidence to Date of Speculative Gene Patents, (hereinafter Adelman, Speculative Gene Patents] in UNIVERSITY Entrepreneurship and TECHNOLOGY transfer: PROCESS. DESIGN. AND INTELLECTUAL PROPERTY 123. 125 (Gary Libecap. ed.)(2OO5)[herelnafter Libecapl; David A. Adelman. A Fallacy of (he Commons In Biotech Patent Polic The Impact of the Bayh-Dole Act on Genetic Research and Development Evaluating the Arguments and Empirical Evidence to Datey. 20 BERKELEY TECH. L. J. 985, 989 (2005)[hereinafter Adelman, Fallacy of the Commons]. For a discussion of the controversy over the patenting of resThe Impact of the Bayh-Dole Act on Genetic Research and Development Evaluating the Arguments and Empirical Evidence to Date
earch tools, and the impact of such patenting on the norms of the biological research community, biomedical innovation, technology transfer, and the d(08/13/06 draft)The Impact of the Bayh-Dole Act on Genetic Research and Development: Evaluating the Arguments and Empirical Evidence to DateByCharles The Impact of the Bayh-Dole Act on Genetic Research and Development Evaluating the Arguments and Empirical Evidence to Date. 96-517. § 6(a). 94 Stat. 3018-3028 (1980) (codified as amended at 35 u.s.c. §§ 200-212 (1994). For a brief introduction to the major provisions of the Bayh-Dole Act, see1The Bayh-Dole Act effected a major change in U.S. policy with respect to the ownership of intellectual property rights in federa The Impact of the Bayh-Dole Act on Genetic Research and Development Evaluating the Arguments and Empirical Evidence to Datelly funded research, and was designed to promote technology transfer by allowing universities, small businesses and other research institutions, in thThe Impact of the Bayh-Dole Act on Genetic Research and Development Evaluating the Arguments and Empirical Evidence to Date
e absence of special circumstances, to retain ownership of the patent rights resulting from federally funded research, subject to a number of obligati(08/13/06 draft)The Impact of the Bayh-Dole Act on Genetic Research and Development: Evaluating the Arguments and Empirical Evidence to DateByCharles The Impact of the Bayh-Dole Act on Genetic Research and Development Evaluating the Arguments and Empirical Evidence to Dateayh-Dole Act, patent rights were in principle retained by the federal funding agencies themselves, though actual patent policies of federal funding agencies varied considerably, with some agencies allowing universities to patent publicly funded research discoveries under certain circumstances.* 4 Al The Impact of the Bayh-Dole Act on Genetic Research and Development Evaluating the Arguments and Empirical Evidence to Datethough the Bayh-Dole Act governs the patenting of federally-funded research in all fields of technology, university patenting and licensing pursuant tThe Impact of the Bayh-Dole Act on Genetic Research and Development Evaluating the Arguments and Empirical Evidence to Date
o the Act have thus far overwhelmingly involved the life sciences.5Proponents of the Bayh-Dole Act argue that the Act was necessary because prior to 1(08/13/06 draft)The Impact of the Bayh-Dole Act on Genetic Research and Development: Evaluating the Arguments and Empirical Evidence to DateByCharles The Impact of the Bayh-Dole Act on Genetic Research and Development Evaluating the Arguments and Empirical Evidence to Dateework for federalAssociation of University Technology Managers. Bayh-Dole Act [hereinafter- AUTM. Bayh-Dole Act], available at http^/www.autm.net/aboutTT/'aboutTT bavhDoleAct.cfm. For a more detailed summary of the legislative history of this Act, see Rebecca s. Eisenberg, Public Research and Privat The Impact of the Bayh-Dole Act on Genetic Research and Development Evaluating the Arguments and Empirical Evidence to Datee Development: Patents and Technology Transfer In Government-Sponsored Research, 82 VA. L. REV. 1663,1688-1695 (1996>[hereinafter Eisenberg. Public ReThe Impact of the Bayh-Dole Act on Genetic Research and Development Evaluating the Arguments and Empirical Evidence to Date
search and Pr ivate Development]. See also Infra note 3.33 For a summary of the major provisions of the Act. see AUTM. Bayh-Dole Act. supra note 2. Th(08/13/06 draft)The Impact of the Bayh-Dole Act on Genetic Research and Development: Evaluating the Arguments and Empirical Evidence to DateByCharles The Impact of the Bayh-Dole Act on Genetic Research and Development Evaluating the Arguments and Empirical Evidence to Dateunded research ... [replacing] the 26 different agency policies now in effect... with two parent policies .. .[1] Non-profit research institutions and small businesses are given preferential treatment. [2] The legislation establishes a presumption that ownership of all patent rights in government fu The Impact of the Bayh-Dole Act on Genetic Research and Development Evaluating the Arguments and Empirical Evidence to Datended research will vest in any contractor who is a non-profit research institution or a small business.H. R. Rep. No. 96-1307 (Part I) at 5. 1980 U.S.The Impact of the Bayh-Dole Act on Genetic Research and Development Evaluating the Arguments and Empirical Evidence to Date
CODE CONG. & ADSON. NEWS 6464 (1981). The Bayh-Dole Act requires contractors to: 1) disclose of Inventions "within a reasonable time": 2) inform the (08/13/06 draft)The Impact of the Bayh-Dole Act on Genetic Research and Development: Evaluating the Arguments and Empirical Evidence to DateByCharles The Impact of the Bayh-Dole Act on Genetic Research and Development Evaluating the Arguments and Empirical Evidence to Dateernment support and that the Government has certain rights to the invention: and 4) provide periodic reporting, as required by the funding agency. 35 u.s.c. § 202 (c)( 1 )-(6). Non-profit organizations must, among other things, share royalties with the inventor and apply the balance of royalties “fo The Impact of the Bayh-Dole Act on Genetic Research and Development Evaluating the Arguments and Empirical Evidence to Dater the support of scientific research or education." 35 U.S.C. § 202(c)(7XB) &(C). For additional powers that the Act vests in federal agencies, see inThe Impact of the Bayh-Dole Act on Genetic Research and Development Evaluating the Arguments and Empirical Evidence to Date
fra note 119. In 1983, President Reagan directed heads of executive departments and agencies to extend the benefits of the Bayh-Dole Act to all govern(08/13/06 draft)The Impact of the Bayh-Dole Act on Genetic Research and Development: Evaluating the Arguments and Empirical Evidence to DateByCharles The Impact of the Bayh-Dole Act on Genetic Research and Development Evaluating the Arguments and Empirical Evidence to Datef Executive Departments and Agencies: Government Patent Policy, Pub. Papers 248 (Feb. 18, 1983). Congress acquiesced to this extension in a 1984 housekeeping amendment to the Act, Trademark Clarification Act of 1984, § 501(13), Pub. L. 98-620, codified at 35 u.s.c. §210(c).4 See supra note 3. See ge The Impact of the Bayh-Dole Act on Genetic Research and Development Evaluating the Arguments and Empirical Evidence to Datenerally DAVID c. MOWERY. Richard R. nelson. BHAVEN N. S.AMPAT, & ARVIDS A. ZIEDONIS, IVORY Tower .and Industrial Innovation: University-Industry TRANSThe Impact of the Bayh-Dole Act on Genetic Research and Development Evaluating the Arguments and Empirical Evidence to Date
FER BEFORE AND AFTER THE BAYH-DOLE ACT IN THE UNITED States 87-93 (2004)(hereinafter Mowery et al.].See, e.g. Council on Governmental Relations, The B(08/13/06 draft)The Impact of the Bayh-Dole Act on Genetic Research and Development: Evaluating the Arguments and Empirical Evidence to DateByCharles The Impact of the Bayh-Dole Act on Genetic Research and Development Evaluating the Arguments and Empirical Evidence to Datesurvey of the Association of University Technology Managers reports that 70% of the active licenses of responding institutions are in the life sciences).2technology transfer, producing tremendous economic benefits not just lor universities and private industry, but for the U.S. economy as a whole.6 The Impact of the Bayh-Dole Act on Genetic Research and Development Evaluating the Arguments and Empirical Evidence to Date* Critics of the Bayh-Dolc Act. on the other hand, question the theoretical and empirical assumptions on which die Bayh-Dole Act is based, and go on tThe Impact of the Bayh-Dole Act on Genetic Research and Development Evaluating the Arguments and Empirical Evidence to Date
o argue that the use OÍ patents in such areas as basic biological research may frustrate basic norms OÍ ‘‘open science" in the research community, andGọi ngay
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