AAAS Scientific Responsibility, Human Rights and Law Program

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Report on Science and Human Rights

Spring 2004 Vol XXIV, No. 1

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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