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Patentes Wisconsin Geron

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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 Steenbock’s 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?
    • It’s 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?
    • WARF’s “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 can’t 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.
  • 8.  
  • 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
      • Parkinson’s disease
      • Tissue and organ replacement
  • 10. Should Universities Own Patents on Stem Cells?
    • Does patent ownership serve or subvert the University’s 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.
    • WARF’s 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
      • WiCell’s 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  Madison, WI 53705 Tel: (608) 263-2500  Fax: (608) 263-1064 Internet Site: www.wisc.edu/warf

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