The document discusses the Wisconsin Alumni Research Foundation (WARF) and its role in patenting and licensing the human embryonic stem cell technology discovered by James Thomson at the University of Wisconsin-Madison. It argues that WARF's ownership and licensing of the stem cell patents facilitated widespread availability of the technology for research purposes while also providing funding to support further research. The broad licensing agreements ensured access for academic researchers around the world and commercial partnerships helped advance potential medical applications.
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1. University Ownership of Patents: The Bayh-Dole Act and Using Patents for the Public Good Carl E. Gulbrandsen Managing Director Wisconsin Alumni Research Foundation [email_address] http://www.warf.org
2. WARF Overview Established in 1925 by professor Harry Steenbock. Commercialized Steenbocks discovery that UV radiation produced vitamin-d in food, preventing rickets. The exclusive patent management organization for the UW-Madison. A tax exempt, not-for-profit corporation, maximizing research grants to the UW-Madison.
3. The WARF Mission To manage the intellectual property developed at the University of Wisconsin - Madison to: Support research at the University of Wisconsin - Madison. Move inventions and discoveries which result from UW-Madison research to the marketplace, for the benefit of the UW-Madison, the inventor and society as a whole. WARF Charter
4. Is Bayh-Dole Appropriate for Key Early-Stage Medical Discoveries? Its been 20+ years since enactment of Bayh-Dole For research tools critical to academic research, can Bayh-Dole still: Facilitate timely transfer of both information and research materials to academic institutions? Transfer early stage technologies appropriately for commercial development? Support domestic small business fairly? WARFs case study with human embryonic stem cells shows that Bayh-Dole effectively supports both academic research and commercialization objectives.
5. Criticisms of Bayh-Dole Pertinent To Early-Stage Discoveries Patenting inhibits access by academic institutions to research materials (it takes too long, or we cant get the materials, etc.) Licensing of patent rights occurs too soon before the research and commercial potential can appropriately be assessed Patenting and licensing shrinks the knowledge commons otherwise available to the scientific community
6. Stem Cells Are a Breakthrough Technology James Thomson, Ph.D in developmental biology, successfully cultured immortal, human embryonic stem cells in 1997. Culmination of 17 years of research. Science 282: 1145-1147 (1998) 1999 Science Magazine Breakthrough of the Year. Thomson on the cover of Time Magazine as one of the top scientists in the U.S.; numerous other news stories. Two U.S. patents assigned to WARF
7. What is so special about HES cells? Stem Cell = a cell which will reproduce itself and is also capable of giving rise to a more specialized cell. HES Cell = derived from the inner mass cells of an embryo, is pluripotent i.e. capable of giving rise to any cell type in the body; and is immortal i.e. continued, indefinite, replication without differentiation under proper culture conditions.
9. The Use and Promise of HES cells Drug discovery Molecular switches that turn on and off the genes of development. Cell Therapy Heart disease Diabetes Parkinsons disease Tissue and organ replacement
10. Should Universities Own Patents on Stem Cells? Does patent ownership serve or subvert the Universitys mission? What is the mission of the University? Does patent ownership frustrate or encourage creativity in the University setting ? Does patent ownership serve the public good?
11. Stem Beliefs of WARF Stem cell patents encourage innovation. Provide incentive to inventors. Facilitate publication. WARFs patents help support research. Protect academic freedom to conduct research. Royalty income funds further research. Stem cell patents serve the public good by guarding against abuse and by responsible licensing.
12. Licensing strategy for HES cells. WARF focused on the importance of this technology for research. Whatever licensing strategy was used, it had to permit free access for researchers both at Wisconsin and elsewhere.
13. WiCell agreement with PHS of September 4, 2001 WiCell (WARF) agreed to: Provide WiCell HES cells to PHS (NIH) researchers at low cost and with few restrictions. Bioethical restrictions remain. Provide a research license at no cost. No reach-through rights required. Agree to use similar agreement for federally funded researchers outside of PHS. Automatic research license for non-WiCell HES cells under certain conditions.
14. Additional research licensing WARF/WiCell has to date entered in agreements patterned on the PHS agreement with 100 institutions world-wide. New agreements executed weekly WiCells HES cells have thus far been distributed to 130 research groups and are being shipped weekly. An extraordinary national research project has been launched!
15. Commercial licensing Geron Corporation Provided funding at a critical time. Limited exclusive rights in select cell therapy and diagnostic fields. All other right non-exclusive. Other companies are licensed non-exclusively.
16. What if WARF Had Not Patented Human Embryonic Stem Cells? Federal Government may have patented the technology. Wisconsin would still own the cells. Geron may have received greater rights and would have filed its own applications. Query: Would Geron or the federal government made this technology as available to researchers as has UW/WARF?
17. Serving the public good. University patents can serve the public good by guarding against abuse and by responsible licensing. Case in point: Thomson Human Embryonic Stem Cell
18. Wisconsin Alumni Research Foundation The Value of An Idea is in the Using of It Thomas Alva Edison 614 Walnut Street 件 Madison, WI 53705 Tel: (608) 263-2500 件 Fax: (608) 263-1064 Internet Site: www.wisc.edu/warf