Transcript A University Licensing Approach: U.C. Berkeley’s Socially

Research Tools Retold:
Bayh-Dole, Research Tools, and the Scientific Enterprise
David Winickoff, JD, MA
Associate Professor, Bioethics and Society
University of California, Berkeley
April 29, 2011
Science and its contracts:
Placing research tools in context
• Post WWII formulation of “Social contract for science”
• Long term historical question of how property rights in
IP could be allocated to best realize societal benefit
from the scientific enterprise
• Bayh-Dole Act as an important structuring term in the
social contract for science
• B-D operates as background condition for an
increasingly contractual private-ordering
environment: e.g., proliferation of MTAs
Research tool policies:
• aim to construct a larger research commons
through contracts
• have been strongly endorsed by scholars,
NIH, AUTM, NAS
• Have mostly failed to do much productive
work
How did research tool policies emerge, what
do they do, where do they fail, and what to do
about it?
Lita Nelson, 1998 essay in Science on “The Rise
of IP Protection in The American University”
• “new importance of IP in academia reflects a changing
view of the relation of universities to surrounding society”
– “research” no longer relatively “isolated from the demands of
economic utility.”
– Positive effects of U licensing: local economies and town/gown
relations, teaching
• “conflict between free dissemination of knowledge (widely
accepted as the university’s primary mission), industry
needs for confidentiality and control of IP, and the
university’s obligation to foster the development of its IP for
public economic development” (cites Oncomouse)
Oncomouse controversy
• 1988 Harvard invention, licensed exclusively to
DuPont
– Onerous and controlling pricing and proprietary constraints
(reach through) on Cre-Lox mouse
• Researchers organize against property restrictions:
Cold Spring Harbor meeting in 1992
• NIH head (Varmus) intervenes:
– Aug 1998 agreement with DuPont to lower prices and
remove reach through
Science, May 1998
• tragedy of the commons:
– resource over utilized because too many users have
the right to use it.
• tragedy of the anti-commons:
– underutilization because too many property holders
have the right to exclude others from using it, &
transaction cost of purchasing rights of use becomes
too high.
(“patent thicket”)
Based in “innovation economics”:
critique of over-patenting of basic science
• Group of scholars stresses importance of
scientific commons in the innovation process
– E.g., Ken Arrow, Paul David, Richard Nelson,
Nathan Rosenberg, David Mowery
• Defends V. Bush post WW-II vision in
“Endless Frontier”
• Provides a grounding for “patent thicket”
critique
Working Group on “Research Tools”
(1998 NIH)
• What is a “research tool”?
– Something to research with, input into research
– But, a provider may see it as end product
• Interviewed University TT officers, bench
scientists and firms
• General agreement among stakeholders that
– IP on “research tools” put significant burdens on
the research process, NIH should promote free
dissemination where possible
– MTAs were proliferating
1999 NIH Guidelines on Disseminating Biomedical
Research Resources
• Aimed to facilitate further research in the face
increasing IP constraints
• Comments on prior draft
– Conflict between obligations under Bayh-Dole
(commercialize) and the NIH draft guidelines (minimize IP
encumbrance)?
• Principles:
– Encourages broad and non-exclusive licensing for research
tools
– Policy against reach through rights on tools, but licensing
fees to commercial entities OK
– Promotes a model MTA “simple agreement”
Commercialization
Economic engine
Scientific discovery
Research/Knowledge
NIH’s normative re-balancing act?
“Recipients [of NIH funds] are subject to the
dual obligations of disseminating unique
research resources while promoting
utilization, commercialization and public
availability of their inventions. The NIH does
not see a conflict between these obligations.”
1999 NIH Guidelines
AUTM, “In the Public Interest: Nine Points to Consider
in Licensing University Technology”
AUTM, “In the Public Interest: Nine Points to Consider
in Licensing University Technology”
Changes in TT practices
• Guidelines from AUTM:
– In general, no exclusive licenses for tools any more
– Reserve rights to use any research tools and
disseminate them through a non-exclusive licenses
– Exemptions for non-commercial academic use
• Construction of a de facto research use
exemption (cf. Madey v. Duke)
• A form of contractually constructed commons
for research use (in theory)
Why were ‘research tools’ as a category
successful in the licensing context?
Compliance was not costly
– Hortatory only
– Fairly easy to implement with full agency given to rights
holder
– “Research tool” is hard to define
Why was ‘research tools’ as a regulatory
category successful in the licensing context?
It expressed and accommodated three ethical claims:
1.
Strong property rights of universities should be maintained;
2.
The ethos of science as a communal enterprise should be
preserved;
3.
Social benefits of the scientific enterprise should be
maximized.
What value has “research tool” as a regulatory
category or policy added?
• Reducing MTAs?
– Failure of the UBMTA
• Freeing materials?
– Materials withholding and delays
• Commons in research?
– Evidence that researchers infringe anyhow
• Anticommons?
– Doesn’t reduce problems of patent proliferation, overlap, and
too little information
The conspicuous problem of “research tools”
that block large fields
• Community ire aimed at WARF policies post 2001
– Licensing to non-profits, but with $5K price
– No transfer to third parties
– Research sponsored at universities on stem cells required
a commercial license ($100K)
• WARF changes after heated negotiations
– No fees or reach-throughs to academic institutions
• Debate invoked traditions, e.g. non-exclusive
licenses, but norms are/were in flux
So, how to retool research ?
1.Patent reform: more utility in biology patents
2.Government use license
3.Incentivized IP clearinghouses and cell line
collections
Katherine Strandburg, norms and the sharing of
research materials and tacit knowledge
• suggests that sharing norms will be strengthened by initiatives
aimed at
• i) reducing sharing costs through standardization,
• ii) spreading sharing costs through central distribution,
• iii) providing rewards in proportion to the extent to which
materials are shared, and
• iv) reducing the private payoffs of exclusivity. Though motivated
by studies of sharing of research materials, the analysis also
applies to sharing of extensive datasets and tacit knowledge.