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Opening Stem Cell Research and Development: a Policy Proposal for the Management of Data, Intellectual Property, and Ethics

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Opening Stem Cell Research and Development: a Policy Proposal for the Management of Data, Intellectual Property, and Ethics Opening Stem Cell Research and Development: A Policy Proposal for the Management of Data, Intellectual Property, and Ethics David E. Winickoff,*† Krishanu Saha, ‡† and Gregory D. Graff§† INTRODUCTION .................................................................................................. 54 I. BOTTLENECKS IN THE TECHNICAL, PROPRIETARY, AND ETHICAL DOMAINS............................................................................................................. 59 A. TECHNICAL DOMAIN: SCIENTIFIC DATA AND MATERIALS SHARING ......... 61 B. PROPRIETARY DOMAIN: PATENT RIGHTS AND INNOVATION ...................... 72 C. ETHICAL DOMAIN: ETHICAL AND REGULATORY COMPLEXITY .................. 75 D. CURRENT EFFORTS TO ADDRESS THESE PROBLEMS................................... 81 1. ETHICS AND REGULATION ....................................................................... 81 2. SHARING DATA AND MATERIALS ACCESS .............................................. 84 3. PATENTS AND INNOVATION..................................................................... 88 II. DESIGN ELEMENTS FOR OPENING UP STEM CELL R&D........................... 89 A. INTEGRATION ACROSS TECHNICAL, PROPRIETARY, AND ETHICAL DOMAINS.......................................................................................................... 89 B. BALANCING ACCESS AND PROPERTY THROUGH A PROTECTED COMMONS ........................................................................................................ 94 1. PIPRA AS A MODEL OF A PROTECTED COMMONS .................................. 96 * Assistant Professor of Bioethics and Society at University of California, Berkeley. † Authors contributed equally to this work. The authors thank P. Taylor, J. Auerbach, G. Daley, B. Wright, K. Bergman, and B. Edgar, as well as those commenting on the work at the U.C. Berkeley Stem Cell Center Conference at Asilomar, Spring 2007, and the Stanford Center for Biomedical Ethics Research Seminar. This work was supported in part by the Greenwall Faculty Scholarship in Bioethics and the Kennedy Institute of Ethics (DEW). ‡ Postdoctoral associate at the Whitehead Institute for Biomedical Research, Cambridge, Massachusetts. § Assistant Professor of Agricultural and Resource Economics at Colorado State University. 52 OPENING STEM CELL RESEARCH AND DEVELOPMENT 2. LESSONS FROM PIPRA FOR STEM CELL RESEARCH ............................. 100 C. PUSH FROM FUNDERS ................................................................................ 101 D. USE OF A CONTRACTUAL LEGAL REGIME................................................. 104 E. AN INTERNATIONAL SCOPE ....................................................................... 105 F. SELF-REFLEXIVITY AND MULTIVALENT EVALUATION ............................. 106 III. INSTITUTIONAL COLLABORATION FOR STEM CELL RESEARCH AND DEVELOPMENT: A MULTI-STAGE ROADMAP ................................................ 107 A. BUILDING AN INTERNATIONAL COLLABORATIVE DATA ARCHITECTURE 108 1. CARROTS AND STICKS TO PROMOTE RESEARCH SHARING ................... 109 2. CONTENTS OF THE COLLABORATIVE DATA ARCHITECTURE ................ 110 3. PROMOTION OF MATERIALS SHARING AND STEM CELL BANKS........... 113 4. HOW OPEN?........................................................................................... 114 B. CONDUCTING ANALYSIS OF KEY CONSTRAINTS....................................... 114 C. POOLING, CROSS-LICENSING, AND OTHER SOLUTIONS ............................ 116 IV. DISCUSSION: INCENTIVE ANALYSIS OF KEY ACTORS............................. 120 A. PERSPECTIVE OF RESEARCH FUNDERS...................................................... 121 B. PERSPECTIVE OF INDIVIDUAL RESEARCH LABS ........................................ 122 C. PERSPECTIVE OF UNIVERSITIES ................................................................. 123 D. PERSPECTIVE OF COMPANIES .................................................................... 125 CONCLUSION .................................................................................................... 126 53 YALE JOURNAL OF HEALTH POLICY, LAW, AND ETHICS IX:1 (2009) INTRODUCTION Intellectual property scholars and the biomedical community have noted a decline in the tradition of openness and sharing in the biomedical sciences over the past thirty years.1 This decline appears to be a function of multiple factors. First, and best known, are changes in intellectual property (IP) law, specifically the Federal Circuit’s re-interpretation of patent law to expand the scope of patentable claims;2 the passage of the Bayh-Dole Act of 1980, allowing universities to patent inventions made in the course of federally-funded research;3 and the creation of new legal rights and mechanisms for the privatization and commercialization of scientific data.4 Second, and perhaps as a direct consequence, universities and their life science researchers have significantly increased interaction with the private sector, whether through accepting sponsored research, licensing IP, or spinning off companies.5 These activities have dramatically increased the exchange of discoveries, capital, and labor across the industrial-academic interface, and they have added more private money to the 1. See, e.g., NAT’L RESEARCH COUNCIL, SHARING PUBLICATION-RELATED DATA AND MATERIALS: RESPONSIBILITIES OF AUTHORSHIP IN THE LIFE SCIENCES 1 (2003) [hereinafter SHARING DATA & MATERIALS], available at http://newton.nap.edu/catalog/10613.html. 2. See Rebecca S. Eisenberg, Biotech Patents: Looking Backward While Moving Forward, 24 NATURE BIOTECH. 317, 318 (2006) (noting how “[o]ver the past quarter century, following the Supreme Court’s broad directive in Diamond v. Chakrabarty, the Federal Circuit has gradually eviscerated what once appeared to be time-honored categorical exclusions from the patent system for such subject matter as ‘business methods’ and ‘mathematical algorithms’ in favor of a ‘big tent’ approach to patent eligibility”). 3. Bayh-Dole Act of 1980, Pub. L. No. 96-517, 94 Stat. 3015 (codified as amended at 35 U.S.C. §§ 200-212 (2000) (specifically empowering federal research grantees and contractors to seek patent protection on subject inventions made using government funds and to license those inventions with the goal of promoting their utilization, commercialization, and public availability); see generally Arti K. Rai & Rebecca S. Eisenberg, Bayh-Dole Reform and the Progress of Biomedicine, 68 LAW & CONTEMP. PROBS. 289 (2003). 4. See, e.g., J.H. Reichman & Paul F. Uhlir, A Contractually Reconstructed Research Commons for Scientific Data in a Highly Protectionist Intellectual Property Environment, 66 LAW & CONTEMP. PROBS. 315, 319-21 (2003) (arguing at 320 that these “new laws pose the danger of disrupting the normative customs at the foundation of public science, especially the traditional and cooperative sharing ethos, by producing both the pressures and the means to enclose the scientific commons and to greatly reduce the scope of data in the public domain”). 5. See, e.g., DAVID C. MOWERY ET AL., IVORY TOWER AND INDUSTRIAL INNOVATION: UNIVERSITY-INDUSTRY TECHNOLOGY TRANSFER BEFORE AND AFTER THE BAYH-DOLE ACT IN THE UNITED STATES 85-98 (2004); P. Mirowski & E. Sent, The Commercialization of Science and the Response of STS, in THE HANDBOOK OF SCIENCE AND TECHNOLOGY STUDIES 635-89 (Michael Lynch, Olga Amsterdamska & Ed Hackett eds., 2008). 54 OPENING STEM CELL RESEARCH AND DEVELOPMENT mix of research support for university life sciences.6 But the increase in university participation in economic life has also introduced tensions between the emerging commodification of knowledge7 and longstanding scientific norms regarding open access and dissemination of research results, data, research tools, and other scientific advances.8 In traditional sociological accounts, the advance of science is predicated upon mechanisms of open information, peer review, and materials exchange, which are socially reinforced by norms that undergird open access.9 Knowledge that is withheld from community scrutiny cannot be validated or agreed upon by the community. On this basis, it is presumed that greater degrees of openness promote not only efficiency in the advance of science, but also trust in the scientific endeavor by society.10 Moreover, in standard economic accounts, the mechanisms of open exchange also have important efficiency, equity, and ethical implications in terms of the direct contributions that science makes to social welfare, particularly in the development of new technologies, products, and services. In theory, actors across industrial and state sectors can put scientific knowledge to efficient and equitable use when it is freely accessible as a public 11 good, assuming full information and virtually costless transactions. When the 6. See Henry Etzkowitz, Bridging the Gap: The Evolution of Industry–University Links in the United States, in INDUSTRIALIZING KNOWLEDGE: UNIVERSITY–INDUSTRY LINKAGES IN JAPAN AND THE UNITED STATES 203-233 (Lewis Branscomb & Fumio Kodama eds., 1999). 7. See Reichman & Uhlir, supra note 4, at 319 (noting the “progressive privatization and commercialization of scientific data” and “the attendant pressures to hoard and trade them like other private commodities”). 8. See generally PAUL A. DAVID, THE DIGITAL TECHNOLOGY BOOMERANG: NEW INTELLECTUAL PROPERTY RIGHTS THREATEN GLOBAL ‘OPEN SCIENCE,’ available at http://129.3.20.41/eps/dev/papers/0502/0502012.pdf; see also Sara Boettiger & Alan B. Bennett, Bayh-Dole: If We Knew Then What We Know
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