University Ownership of Patents: The Bayh-Dole Act and Using Patents for the Public Good Carl E. Gulbrandsen Managing Dire...
WARF Overview <ul><li>Established in 1925 by professor  </li></ul><ul><li>Harry Steenbock.  </li></ul><ul><li>Commercializ...
The WARF Mission To manage the intellectual property developed at the University of Wisconsin - Madison to: <ul><li>Suppor...
Is Bayh-Dole Appropriate for Key  Early-Stage Medical Discoveries? <ul><li>It’s been 20+ years since enactment of Bayh-Dol...
Criticisms of Bayh-Dole Pertinent To Early-Stage Discoveries <ul><li>Patenting inhibits access by academic institutions to...
Stem Cells Are a  Breakthrough Technology  <ul><li>James Thomson, Ph.D in developmental biology, successfully cultured imm...
What is so “special” about HES cells?   <ul><li>Stem Cell = a cell which will reproduce itself and is also capable of givi...
 
The Use and Promise of HES cells <ul><li>Drug discovery </li></ul><ul><ul><li>Molecular switches that turn on and off the ...
Should Universities Own Patents on Stem Cells? <ul><li>Does patent ownership serve or subvert the University’s mission? </...
“Stem” Beliefs of WARF <ul><li>Stem cell patents encourage innovation. </li></ul><ul><ul><li>Provide incentive to inventor...
Licensing strategy for HES cells. <ul><li>WARF focused on the importance of this technology for research. </li></ul><ul><l...
WiCell agreement with PHS of September 4, 2001 <ul><li>WiCell (WARF) agreed to: </li></ul><ul><ul><li>Provide WiCell HES c...
Additional research licensing <ul><li>WARF/WiCell has to date entered in agreements  patterned on the PHS agreement with 1...
Commercial licensing <ul><li>Geron Corporation </li></ul><ul><ul><li>Provided funding at a critical time. </li></ul></ul><...
What if WARF Had Not Patented Human Embryonic Stem Cells? <ul><li>Federal Government may have patented the technology. Wis...
Serving the public good. <ul><li>University patents can serve the public good by guarding against abuse and by responsible...
Wisconsin Alumni Research Foundation “ The Value of An Idea is in the Using of It” Thomas Alva Edison 614 Walnut Street  ...
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Patentes Wisconsin Geron

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Patentes Wisconsin Geron

  1. 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. 2. WARF Overview <ul><li>Established in 1925 by professor </li></ul><ul><li>Harry Steenbock. </li></ul><ul><li>Commercialized Steenbock’s discovery that UV radiation produced vitamin-d in food, preventing rickets. </li></ul><ul><li>The exclusive patent management organization for the UW-Madison. </li></ul><ul><li>A tax exempt, not-for-profit corporation, maximizing research grants to the UW-Madison. </li></ul>
  3. 3. The WARF Mission To manage the intellectual property developed at the University of Wisconsin - Madison to: <ul><li>Support research at the University of Wisconsin - Madison. </li></ul><ul><li>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. </li></ul>WARF Charter
  4. 4. Is Bayh-Dole Appropriate for Key Early-Stage Medical Discoveries? <ul><li>It’s been 20+ years since enactment of Bayh-Dole </li></ul><ul><li>For research tools critical to academic research, can Bayh-Dole still: </li></ul><ul><ul><li>Facilitate timely transfer of both information and research materials to academic institutions? </li></ul></ul><ul><ul><li>Transfer early stage technologies appropriately for commercial development? </li></ul></ul><ul><ul><li>Support domestic small business fairly? </li></ul></ul><ul><li>WARF’s “case study” with human embryonic stem cells shows that Bayh-Dole effectively supports both academic research and commercialization objectives. </li></ul>
  5. 5. Criticisms of Bayh-Dole Pertinent To Early-Stage Discoveries <ul><li>Patenting inhibits access by academic institutions to research materials (“it takes too long,” or “we can’t get the materials,” etc.) </li></ul><ul><li>Licensing of patent rights occurs too soon before the research and commercial potential can appropriately be assessed </li></ul><ul><li>Patenting and licensing “shrinks” the knowledge commons otherwise available to the scientific community </li></ul>
  6. 6. Stem Cells Are a Breakthrough Technology <ul><li>James Thomson, Ph.D in developmental biology, successfully cultured immortal, human embryonic stem cells in 1997. </li></ul><ul><ul><li>Culmination of 17 years of research. </li></ul></ul><ul><ul><li>Science 282: 1145-1147 (1998) </li></ul></ul><ul><ul><li>1999 Science Magazine “Breakthrough of the Year”. </li></ul></ul><ul><ul><li>Thomson on the cover of Time Magazine as one of the top scientists in the U.S.; numerous other news stories. </li></ul></ul><ul><ul><li>Two U.S. patents – assigned to WARF </li></ul></ul>
  7. 7. What is so “special” about HES cells? <ul><li>Stem Cell = a cell which will reproduce itself and is also capable of giving rise to a more specialized cell. </li></ul><ul><li>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. </li></ul>
  8. 9. The Use and Promise of HES cells <ul><li>Drug discovery </li></ul><ul><ul><li>Molecular switches that turn on and off the genes of development. </li></ul></ul><ul><li>Cell Therapy </li></ul><ul><ul><li>Heart disease </li></ul></ul><ul><ul><li>Diabetes </li></ul></ul><ul><ul><li>Parkinson’s disease </li></ul></ul><ul><ul><li>Tissue and organ replacement </li></ul></ul>
  9. 10. Should Universities Own Patents on Stem Cells? <ul><li>Does patent ownership serve or subvert the University’s mission? </li></ul><ul><ul><li>What is the mission of the University? </li></ul></ul><ul><li>Does patent ownership frustrate or encourage creativity in the University setting ? </li></ul><ul><li>Does patent ownership serve the public good? </li></ul>
  10. 11. “Stem” Beliefs of WARF <ul><li>Stem cell patents encourage innovation. </li></ul><ul><ul><li>Provide incentive to inventors. </li></ul></ul><ul><ul><li>Facilitate publication. </li></ul></ul><ul><li>WARF’s patents help support research. </li></ul><ul><ul><li>Protect academic freedom to conduct research. </li></ul></ul><ul><ul><li>Royalty income funds further research. </li></ul></ul><ul><li>Stem cell patents serve the public good by guarding against abuse and by responsible licensing. </li></ul>
  11. 12. Licensing strategy for HES cells. <ul><li>WARF focused on the importance of this technology for research. </li></ul><ul><li>Whatever licensing strategy was used, it had to permit free access for researchers both at Wisconsin and elsewhere. </li></ul>
  12. 13. WiCell agreement with PHS of September 4, 2001 <ul><li>WiCell (WARF) agreed to: </li></ul><ul><ul><li>Provide WiCell HES cells to PHS (NIH) researchers at low cost and with few restrictions. </li></ul></ul><ul><ul><ul><li>Bioethical restrictions remain. </li></ul></ul></ul><ul><ul><li>Provide a research license at no cost. </li></ul></ul><ul><ul><li>No reach-through rights required. </li></ul></ul><ul><ul><li>Agree to use similar agreement for federally funded researchers outside of PHS. </li></ul></ul><ul><ul><li>Automatic research license for non-WiCell HES cells under certain conditions. </li></ul></ul>
  13. 14. Additional research licensing <ul><li>WARF/WiCell has to date entered in agreements patterned on the PHS agreement with 100 institutions world-wide. </li></ul><ul><ul><li>New agreements executed weekly </li></ul></ul><ul><ul><li>WiCell’s HES cells have thus far been distributed to 130 research groups and are being shipped weekly. </li></ul></ul><ul><li>An extraordinary national research project has been launched! </li></ul>
  14. 15. Commercial licensing <ul><li>Geron Corporation </li></ul><ul><ul><li>Provided funding at a critical time. </li></ul></ul><ul><ul><li>Limited exclusive rights in select cell therapy and diagnostic fields. </li></ul></ul><ul><ul><li>All other right non-exclusive. </li></ul></ul><ul><li>Other companies are licensed non-exclusively. </li></ul>
  15. 16. What if WARF Had Not Patented Human Embryonic Stem Cells? <ul><li>Federal Government may have patented the technology. Wisconsin would still own the cells. </li></ul><ul><li>Geron may have received greater rights and would have filed its own applications. </li></ul><ul><li>Query: Would Geron or the federal government made this technology as available to researchers as has UW/WARF? </li></ul>
  16. 17. Serving the public good. <ul><li>University patents can serve the public good by guarding against abuse and by responsible licensing. </li></ul><ul><li>Case in point: </li></ul><ul><ul><li>Thomson – Human Embryonic Stem Cell </li></ul></ul>
  17. 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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