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
Established in 1925 by professor
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.
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.
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.
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
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
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.
The Use and Promise of HES cells
Molecular switches that turn on and off the genes of development.
Tissue and organ replacement
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?
“Stem” Beliefs of WARF
Stem cell patents encourage innovation.
Provide incentive to inventors.
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.
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.
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.
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!
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.
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?
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
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