University Ownership of Patents: The Bayh-Dole Act and Using Patents for the Public Good Carl E. Gulbrandsen Managing Director Wisconsin Alumni Research Foundation

WARF Overview n n Established in 1925 by professor Harry Steenbock. n n Commercialized Steenbocks discovery that UV radiation produced vitamin-d in food, preventing rickets. n n The exclusive patent management organization for the UW-Madison. n n 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: n Support research at the University of Wisconsin - Madison. n 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

Is Bayh-Dole Appropriate for Key Early-Stage Medical Discoveries? n Its been 20+ years since enactment of Bayh-Dole n For research tools critical to academic research, can Bayh- Dole still: ç Facilitate timely transfer of both information and research materials to academic institutions? ç Transfer early stage technologies appropriately for commercial development? ç Support domestic small business fairly? n WARFs 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 n Patenting inhibits access by academic institutions to research materials (it takes too long, or we cant get the materials, etc.) n Licensing of patent rights occurs too soon before the research and commercial potential can appropriately be assessed n Patenting and licensing shrinks the knowledge commons otherwise available to the scientific community

Stem Cells Are a Breakthrough Technology n James Thomson, Ph.D in developmental biology, successfully cultured immortal, human embryonic stem cells in ç Culmination of 17 years of research. ç Science 282: (1998) ç 1999 Science Magazine Breakthrough of the Year. ç Thomson on the cover of Time Magazine as one of the top scientists in the U.S.; numerous other news stories. ç 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. 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. 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 n Drug discovery ç Molecular switches that turn on and off the genes of development. n Cell Therapy ç Heart disease ç Diabetes ç Parkinsons disease ç Tissue and organ replacement

Should Universities Own Patents on Stem Cells? n Does patent ownership serve or subvert the Universitys mission? ç What is the mission of the University? n Does patent ownership frustrate or encourage creativity in the University setting ? n Does patent ownership serve the public good?

Stem Beliefs of WARF n Stem cell patents encourage innovation. ç Provide incentive to inventors. ç Facilitate publication. n WARFs patents help support research. ç Protect academic freedom to conduct research. ç Royalty income funds further research. n Stem cell patents serve the public good by guarding against abuse and by responsible licensing.

Licensing strategy for HES cells. n WARF focused on the importance of this technology for research. n 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 n WiCell (WARF) agreed to: ç Provide WiCell HES cells to PHS (NIH) researchers at low cost and with few restrictions. Bioethical restrictions remain. Bioethical restrictions remain. ç Provide a research license at no cost. ç No reach-through rights required. ç Agree to use similar agreement for federally funded researchers outside of PHS. ç Automatic research license for non-WiCell HES cells under certain conditions.

Additional research licensing n WARF/WiCell has to date entered in agreements patterned on the PHS agreement with 100 institutions world-wide. ç New agreements executed weekly ç WiCells HES cells have thus far been distributed to 130 research groups and are being shipped weekly. n An extraordinary national research project has been launched!

Commercial licensing n Geron Corporation ç Provided funding at a critical time. ç Limited exclusive rights in select cell therapy and diagnostic fields. ç All other right non-exclusive. n Other companies are licensed non- exclusively.

What if WARF Had Not Patented Human Embryonic Stem Cells? n Federal Government may have patented the technology. Wisconsin would still own the cells. n Geron may have received greater rights and would have filed its own applications. n Query: Would Geron or the federal government made this technology as available to researchers as has UW/WARF?

Serving the public good. n University patents can serve the public good by guarding against abuse and by responsible licensing. n Case in point: ç 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 Tel: (608) Fax: (608) Internet Site: