University Ownership of Patents: The Bayh-Dole Act and Using Patents for the Public Good

University Ownership of Patents: The Bayh-Dole Act and Using Patents for the Public Good

Carl E. GulbrandsenCarl E. Gulbrandsen

Managing DirectorManaging Director

Wisconsin Alumni Research FoundationWisconsin Alumni Research Foundation

carl@warf.orgcarl@warf.org

http://www.warf.orghttp://www.warf.org

WARF OverviewWARF 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.

The WARF MissionThe WARF Mission

To manage the intellectual property developed at the University of Wisconsin - Madison to:

Support research at the University Support research at the University of Wisconsin - Madison.of Wisconsin - Madison.

Move inventions and discoveries Move inventions and discoveries which result from UW-Madison which result from UW-Madison research to the marketplace, for research to the marketplace, for the benefit of the UW-Madison, the benefit of the UW-Madison, the inventor and society as a the inventor and society as a whole.whole.

WARF Charter

Is Bayh-Dole Appropriate for Key Early-Stage Medical Discoveries?Is Bayh-Dole Appropriate for Key Early-Stage Medical Discoveries?

It’s been 20+ years since enactment of Bayh-DoleIt’s been 20+ years since enactment of Bayh-Dole For research tools critical to academic research, can Bayh-For research tools critical to academic research, can Bayh-

Dole still:Dole still: Facilitate timely transfer of both information and research materials to Facilitate timely transfer of both information and research materials to

academic institutions?academic institutions? Transfer early stage technologies appropriately for commercial Transfer early stage technologies appropriately for commercial

development?development? Support domestic small business fairly?Support domestic small business fairly?

WARF’s “case study” with human embryonic stem cells WARF’s “case study” with human embryonic stem cells shows that Bayh-Dole effectively supports both academic shows that Bayh-Dole effectively supports both academic research and commercialization objectives.research and commercialization objectives.

Criticisms of Bayh-Dole Pertinent To Early-Stage DiscoveriesCriticisms of Bayh-Dole Pertinent To Early-Stage Discoveries

Patenting inhibits access by academic institutions Patenting inhibits access by academic institutions to research materials (“it takes too long,” or “we to research materials (“it takes too long,” or “we can’t get the materials,” etc.)can’t get the materials,” etc.)

Licensing of patent rights occurs too soon before Licensing of patent rights occurs too soon before the research and commercial potential can the research and commercial potential can appropriately be assessedappropriately be assessed

Patenting and licensing “shrinks” the knowledge Patenting and licensing “shrinks” the knowledge commons otherwise available to the scientific commons otherwise available to the scientific communitycommunity

Stem Cells Are a Breakthrough Technology Stem Cells Are a Breakthrough Technology

James Thomson, Ph.D in developmental biology, James Thomson, Ph.D in developmental biology, successfully cultured immortal, human embryonic stem successfully cultured immortal, human embryonic stem cells in 1997.cells in 1997. Culmination of 17 years of research.Culmination of 17 years of research. Science 282: 1145-1147 (1998)Science 282: 1145-1147 (1998) 1999 Science Magazine “Breakthrough of the Year”.1999 Science Magazine “Breakthrough of the Year”. Thomson on the cover of Time Magazine as one of Thomson on the cover of Time Magazine as one of

the top scientists in the U.S.; numerous other news the top scientists in the U.S.; numerous other news stories.stories.

Two U.S. patents – assigned to WARF Two U.S. patents – assigned to WARF

What is so “special” about HES cells? What is so “special” about HES cells?

Stem Cell = a cell which will reproduce itself and Stem Cell = a cell which will reproduce itself and is also capable of giving rise to a more specialized is also capable of giving rise to a more specialized cell.cell.

HES Cell = derived from the inner mass cells of HES Cell = derived from the inner mass cells of an embryo, is an embryo, is pluripotentpluripotent i.e. capable of giving i.e. capable of giving rise to rise to anyany cell type in the body; and is cell type in the body; and is immortalimmortal i.e. continued, indefinite, replication without i.e. continued, indefinite, replication without differentiation under proper culture conditions.differentiation under proper culture conditions.

The Use and Promise of HES cellsThe Use and Promise of HES cells

Drug discoveryDrug discovery Molecular switches that turn on and off the Molecular switches that turn on and off the

genes of development.genes of development.

Cell TherapyCell Therapy Heart diseaseHeart disease DiabetesDiabetes Parkinson’s diseaseParkinson’s disease Tissue and organ replacementTissue and organ replacement

Should Universities Own Patents on Stem Cells?Should Universities Own Patents on Stem Cells?

Does patent ownership serve or subvert the Does patent ownership serve or subvert the University’s mission?University’s mission? What is the mission of the University?What is the mission of the University?

Does patent ownership frustrate or encourage Does patent ownership frustrate or encourage creativity in the University setting ?creativity in the University setting ?

Does patent ownership serve the public good?Does patent ownership serve the public good?

“Stem” Beliefs of WARF“Stem” Beliefs of WARF

Stem cell patents encourage Stem cell patents encourage innovation.innovation. Provide incentive to Provide incentive to

inventors.inventors. Facilitate publication.Facilitate publication.

WARF’s patents help support WARF’s patents help support research.research. Protect academic freedom to Protect academic freedom to

conduct research.conduct research. Royalty income funds further Royalty income funds further

research.research. Stem cell patents serve the public Stem cell patents serve the public

good by guarding against abuse good by guarding against abuse and by responsible licensing.and by responsible licensing.

Licensing strategy for HES cells.Licensing strategy for HES cells.

WARF focused on the importance of this WARF focused on the importance of this technology for research.technology for research.

Whatever licensing strategy was used, it had to Whatever licensing strategy was used, it had to permit free access for researchers both at permit free access for researchers both at Wisconsin and elsewhere. Wisconsin and elsewhere.

WiCell agreement with PHS of September 4, 2001WiCell agreement with PHS of September 4, 2001

WiCell (WARF) agreed to:WiCell (WARF) agreed to: Provide WiCell HES cells to PHS (NIH) researchers at Provide WiCell HES cells to PHS (NIH) researchers at

low cost and with few restrictions.low cost and with few restrictions. Bioethical restrictions remain.Bioethical restrictions remain.

Provide a research license at no cost. Provide a research license at no cost. No reach-through rights required.No reach-through rights required. Agree to use similar agreement for federally funded Agree to use similar agreement for federally funded

researchers outside of PHS.researchers outside of PHS. Automatic research license for non-WiCell HES cells Automatic research license for non-WiCell HES cells

under certain conditions.under certain conditions.

Additional research licensingAdditional research licensing

WARF/WiCell has to date entered in agreements WARF/WiCell has to date entered in agreements patterned on the PHS agreement with 100 patterned on the PHS agreement with 100 institutions world-wide.institutions world-wide. New agreements executed weeklyNew agreements executed weekly WiCell’s HES cells have thus far been distributed to WiCell’s HES cells have thus far been distributed to

130 research groups and are being shipped weekly.130 research groups and are being shipped weekly. An extraordinary national research project has An extraordinary national research project has

been launched!been launched!

Commercial licensingCommercial licensing

Geron CorporationGeron Corporation Provided funding at a critical time.Provided funding at a critical time. Limited exclusive rights in select cell therapy and diagnostic Limited exclusive rights in select cell therapy and diagnostic

fields.fields. All other right non-exclusive.All other right non-exclusive.

Other companies are licensed non-Other companies are licensed non-exclusively.exclusively.

What if WARF Had Not Patented Human Embryonic Stem Cells?What if WARF Had Not Patented Human Embryonic Stem Cells?

Federal Government may have patented the Federal Government may have patented the technology. Wisconsin would still own the cells.technology. Wisconsin would still own the cells.

Geron may have received greater rights and would Geron may have received greater rights and would have filed its own applications.have filed its own applications.

Query: Would Geron or the federal government Query: Would Geron or the federal government made this technology as available to researchers as made this technology as available to researchers as has UW/WARF?has UW/WARF?

Serving the public good.Serving the public good.

University patents can serve the public good by University patents can serve the public good by guarding against abuse and by responsible guarding against abuse and by responsible licensing.licensing.

Case in point:Case in point: Thomson – Human Embryonic Stem CellThomson – Human Embryonic Stem Cell

Wisconsin Alumni Research FoundationWisconsin Alumni Research Foundation

“The Value of An Idea is in the Using of It”

Thomas Alva Edison

614 Walnut Street Madison, WI 53705Tel: (608) 263-2500 Fax: (608) 263-1064

Internet Site: www.wisc.edu/warf