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Science and Intellectual Property in Seattle and Beyond
Stephen Hansen
The Science & Intellectual Property in the Public Interest project (SIPPI)
participated in several events focusing on science and intellectual property
during the AAAS Annual Meeting in Seattle, which included two symposia and an
open discussion forum. Speakers for the symposia featured members of SIPPI project
advisory committee and as well as project staff.
The first symposium "Intellectual Property Resources for International
Development in Agriculture and Health," co organized by SIPPI advisory
committee member Alan Bennett (U.C. Davis) and SIPPI project manager Stephen
Hansen, focused on some of the successes of public/private partnerships to remove
many obstacles to food production and health care in the developing world caused
by the present intellectual property system.
Since the early 1980s, agricultural researchers have increasingly obtained
intellectual property rights to their inventions, and licensed or transferred
ownership of these rights to commercial interests. This has had many benefits,
but the practice of granting exclusive licenses, combined with the increased
concentration of IP in a limited number of firms, is also encumbering and ultimately
limiting research opportunities to develop novel subsistence crops for the developing
world, an activity primarily undertaken within by the public sector. Public
research institutions are finding that in many cases, they have to negotiate
agreements with multiple IP owners, a process that is time consuming, expensive,
and uncertain. As a result, potentially useful research tools and products are
not as widely shared and disseminated as in the past.
Interestingly, the situation in agricultural research and development is paralleled
in the development of so-called "orphan" drugs that have little commercial market
in the developed world but have the potential to dramatically improve health
care in the developing world. As with subsistence crops in developing countries,
a need exists, but the market that these orphan drugs represent does not justify
commercial exploitation by industry while the public sector is not equipped
with IP clearances to undertake the necessary research and development. Over
the last two years a number of creative partnerships have been developed to
resolve intellectual property "logjams" that have impeded research and development
targeted to international development in agriculture and health care. Some of
these partnerships are entirely within the private sector; others are entirely
within the public sector and others are beginning to reflect true private/public
partnerships. A central theme, however, has been a move towards collective action
to overcome intellectual property barriers for clearly articulated humanitarian
goals.
Panel presentations were "The IP Landscape and Public Sector Research" (Stephen
Hansen, AAAS), "Public Sector Intellectual Property Resources for Agriculture"
(Allan Bennett, UC Davis), "Innovative IP for novel and affordable TB Drugs"
(Gerald Siuta, The Global Alliance for Tuberculosis Drug Development), "Global
Sustainability through the Development of Food and Health Care Systems" (David
Zilberman, University of California, Berkeley) "Intellectual Property and Malaria
Vaccines: Help or Hindrance?" (Melinda Morree, Malaria Vaccine Initiative),
and "Private Sector Support for Agricultural Development: The African Agricultural
Technology Foundation" (David Fischoff, Monsanto Company).
A second symposium "Intellectual Property and the Research Exemption:
Its Impact on Science," organized by SIPPI co director Audrey Chapman,
focused on the research or experimental use exemption and how it may be affected
by the recent Madey v. Duke court decision. Until very recently, it had been
unquestioned that an experimental use exemption exists for purely scientific
research to study and understand a patented invention, including its limited
use to make new innovations that may or may not be outside the scope of the
original patent. In a recent decision, Madey v. Duke, the Court of Appeals for
the Federal Circuit, with exclusive jurisdiction over appeals in patent cases,
effectively eliminated any practical application of an experimental use defense
to patent infringement by both commercial and non-profit entities. In June 2003,
the Supreme Court decided not to review the case. The scientific and academic
communities are very concerned about the chilling effect this ruling may have
on their ability to perform research. This symposium considered the implications
for conducting scientific research in the shadow of the recent Madey v. Duke
ruling and explored potential models to establish and codify a research exemption
in this country.
The symposium addressed the following issues and questions: what is the public
interest related to the status of the research exemption in this country; what
are the implications of the Madey v. Duke decision for scientific research in
the public and private sectors; what are the key complexities and problems in
defining the scope of an experimental research exception; what are the hurdles
in establishing a more secure research exemption, and; what is the relevance
of the models and experiences of other countries?
Panel presentations included "Madey v. Duke: Implications for the 'Research
Exemption" (Reid Adler, The Center for the Advancement of Genomics), "Complexities
of Designing a Research Exemption" (Arti K. Rai, Duke Law School and SIPPI advisory
committee member), "Corporate Perspective: Pharmaceuticals" (Stephen Caltrider,
Lilly), "The Research Exemption: Is There a University Perspective?" (Alan Bennett,
UC Davis), and "Research Exemption: Public Interest Dimensions" (Anthony So,
Duke University and SIPPI advisory committee member).
The open forum "Intellectual Property Issues and the Contemporary Scientist"
provided an opportunity for annual meeting participants to share their experiences
and concerns about the effects of intellectual property on their work and to
suggest issues appropriate for AAAS to pursue.
Further Work on the Research Exemption
SIPPI will continue work on the research exemption. The project is currently
conducting a study of the effects of the Madey v. Duke decision on university
research. In addition, it will be convening a working group to explore developing
a humanitarian use exemption, which would allow researchers in developing countries
free access to patented technologies for food production and essential health
care.
New Issues Tracking System
In order to provide timely news and updates on intellectual property issues
to the public, SIPPI has launched a new feature on the project's web site entitled
"Science & IP News." This site tracks domestic and international policy,
current U.S. IP legislation and litigation that affect the scientific community
and the general public. In addition, it features news items, meetings and events
(including Congressional hearings), and a list of organizations working in IP.
Science & IP News can be accessed at: http://sippi.aaas.org/ipissues.
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