EEP 143 Lecture 17 Patent ThicketsPatent Thickets: ConcernsPatent thickets: Golden Rice as early counter-example?Slide 4Golden Rice: Triumph of IPR Access?Golden Rice: Reality CheckSlide 7REAPING THE BENEFITS OF GENOMIC AND PROTEOMIC RESEARCH Intellectual Property Rights, Innovation and Public HealthCommittee MembershipCommittee ChargeWalsh, Cho, Cohen Survey (commissioned by NAS study)Committee Findings: Research ImpactCommittee Findings: Research Impact continuedCommittee Findings: TrendsCommittee Findings: International DifferencesCommittee ConclusionsCommittee Conclusions, continuedSlide 18Slide 19RecommendationsRecommendations, continuedSlide 22Slide 23Bergman and Graff: “The Global Stem Cell Patent Landscape” Nature Biotech April 2007Slide 25Slide 26Slide 27Slide 28Slide 29Slide 30Slide 31Slide 32Slide 33Slide 34Jensen and Murray “IP Landscape of the Human Genome” Science 14 October 2005Slide 36Slide 37Slide 38Conclusions?EEP 143 Lecture 17Patent Thickets•Golden Rice•Hypoallergenic Wheat•Human Genome?•Stem Cells?Patent Thickets:Concerns•Multiple overlapping patent claims•Some blocking patents •Injunction threat?•Uncertainty re ‘Freedom to Operate”•Multiple layers of transaction costs•Stack royalty demands beyond what the product can bear•Slow innovationPatent thickets: Golden Rice as early counter-example?•Claims:–“Anticommons” problem in ag. biotech–“Freedom to operate” a problem for public sector, nonprofits, private startups–Licensing access: Private sector will not risk its reputation, resources in negotiation for low-value uses by public, north or south–Public and nonprofits cannot solve anticommons problem by integration““Golden Rice”Golden Rice”Over 120 million children worldwide are deficient in vitamin A. Rice has been engineered to accumulate b-carotene, Incorporation of this trait into rice cultivars and widespread distribution could prevent 1 to 2 million deaths each year.Golden Rice: Triumph of IPR Access?•up to 70 patents•Widely-publicized multi-party IPR donations•“…the recent example of Golden Rice shows that patented technologies need not necessarily be a barrier.” (Nuffield Council on Bioethics 2004 p. xix)Golden Rice: Reality Check•Patents are NATIONAL in scope•There were few or no valid patents in major rice-consuming countries (pre-TRIPS environment).•Most rice not traded where most patents held (Binembaum et al, Econ. Dev. And C. Chg.)Golden Rice: Reality Check•Material Transfer Agreements (MTAs) for golden rice construct, not patent licenses, were key IPRs.•Rights to large farmers established by firms contractually, even if no valid patents existed•Large negotiation costs supported by Syngenta for reputational/image concernsREAPING THE BENEFITS OF GENOMIC AND PROTEOMIC RESEARCHIntellectual Property Rights, Innovation and Public HealthA Joint Committee of The National Academies’Board on Science, Technology, and Economic PolicyCommittee on Science, Technology, and LawBriefing of the National Institutes of HealthNovember 17, 2005Committee MembershipShirley M. Tilghman (Co-Chair), Princeton University Roderick R. McKelvie (Co-Chair), Covington & BurlingAshish Arora, Carnegie Mellon UniversityHelen M. Berman, Rutgers UniversityJoyce Brinton, Harvard University (retired)Stephen Burley, Structural GenomiX, Inc. (SGX)Q. Todd Dickinson, General Electric CoRochelle Dreyfuss, New York University School of LawRebecca S. Eisenberg, University of Michigan Charles M. Hartman, CW GroupDaniel J. Kevles, Yale UniversityDavid Korn, Association of American Medical Colleges George M. Milne, Jr., Radius Ventures Richard Scheller Genentech Rochelle Seide Arent Fox PLLC Robert H. Waterston, University of WashingtonNancy Wexler, College of Physicians and Surgeons of Columbia University and Hereditary Disease Foundation Brian Wright, University of California, Berkeley StafStephen A. Merrill, Board on Science, Technology, and Economic Policy Anne-Marie Mazza, Committee on Science, Technology, and LawCommittee ChargeStudy the granting of intellectual property rights and the licensing of discoveries relating to genetics and proteomics and the effects of these practices on research and innovation. Specifically, 1.report on trends in the number and nature of U.S.-issued patents being granted on technologies related to genomics and proteomics;2.report on the standards that USPTO and other patent offices (specifically in Europe and Japan) are applying in acting on these applications; 3.report on how the patenting of genomic and proteomic inventions and/or licensing practices for these inventions is affecting research and innovation; and 4.based on the committee's findings in the first three areas, recommend steps that NIH and others might take to ensure the productivity of research and innovation involving genes and proteins.Walsh, Cho, Cohen Survey (commissioned by NAS study)Performers: J Walsh and C Cho, UIC; W Cohen, Duke UniversitySample Size: 1688 from 11 society membership rosters, 300 from publications on 3 pathwaysReponses: 655 responses (148 industry) = 33 percent response rate + 90 working on pathways-- range of fields, basic to applied research, and research team sizesIssues/Questions: involvement with IP acquisition, industry funding, start-ups motivations for research experience with others' IP experience with MTAs and data sharingCommittee Findings: Research Impact•The number of projects abandoned or delayed as a result of technology access difficulties is reported to be small•The number of occasions in which investigators revise their protocols to avoid intellectual property complications or pay high costs to obtain access to intellectual property is small•A large proportion of biomedical researchers have experience with patent acquisition but that is not a big influence on research choicesCommittee Findings: Research Impact continued•On the other hand, the proportion of academic researchers who seek to determine if their work involves the use of other IP and if it does negotiate access is very small and has not significantly increased in recent years•Holders of patents are active in asserting their rights and some pursue v. restrictive licensing strategies. This has had a significant impact on clinical lab behavior, with some curbing of follow-on researchCommittee Findings: Trends•Patenting varies greatly among biotech