Innovation in the Life Sciences:
Intellectual Property and Public Investment
for Pharmaceuticals and Agriculture
May 20 and 21, 2004
The Kellogg Center, School of International and Public Affairs (SIPA)
118th Street at Amsterdam Ave., 15th floor
Columbia University in the City of New York
Motivation and Objectives
This workshop arises out of increasing concerns about recent trends in the organization, funding and incentives for R&D in the life sciences and the development of new technologies in pharmaceuticals and agriculture. The biosciences now offer unprecedented opportunities to improve public health, nutritional status and human well-being – and the need for institutional change to deliver on this promise has never been greater. Our goal is to respond to this need with one or more specific policy proposals, including legal reforms affecting patent rights, the funding and governance of public laboratories and universities, and the use of prizes to reward public-domain innovations.
With the discovery of DNA fifty years ago, the rise of molecular biology has transformed the process of innovation for both medical and agricultural applications. In many countries part of the policy response has been a significant increase in public funding for basic science in these areas. But public funding has largely been constrained not to support the development of new products. New product development has been assumed to be the province of private firms. The principal public policy vehicle for stimulating the development of products, and final applications more generally has been to offer stronger and broader utility patents, extending private intellectual-property rights to biological processes which under previous rules would have remained in the public domain.
The watershed policy changes underlying the privatization of biological technologies occurred first in the U.S. in 1980 with the Chakravarty decision and the Bayh-Dole Act, and then internationally through the TRIPS agreement and other policy changes. A growing body of research argues that this expansion of patent protection is restricting the pace and direction of innovation, causing the neglect of innovations whose benefits cannot be appropriated through product sales. The May 20-21 workshop will help improve our understanding of the current innovation system, and help us to identify one or more particularly-promising new policy initiatives for refinement and implementation.
Part I of the workshop involves three sessions on the current context, which will review recent changes in medical R&D for pharmaceutical technologies, and in agricultural R&D for new seeds and crop chemicals. These presentations will describe the evolution of the division of labor between for-profit firms, universities and public laboratories, the funding mechanisms that support their work and the intellectual-property rules under which their results are disclosed and applied. They will also cover intellectual property and the controversies arising from the recent proliferation of utility patents over biological technologies, with a presentation covering pharmaceuticals and another covering agriculture. Presentations will address funding mechanisms for R&D in the public domain, especially research in universities and public laboratories, giving consideration both to what kind of work is funded publicly, and on the present political constraints on the magnitude and content of public sector research. Much of this discussion will focus on the U.S. , but we will also address the international dimensions of R&D among industrialized countries and for developing regions, including particularly free-ridership where spillovers occur and the problem of "orphan regions" where place-specific research is needed.
Parts II and III of the workshop will turn to the identification and assessment of particular proposals. These have been widely circulated prior to the workshop, and call for new institutions to guide and support bioscience-based R&D, including particularly precommitments for vaccine purchase; ex-post prizes for public-domain agricultural technologies; differential enforcement of patent rights; compulsory licensing subject to liability rules; and clearinghouses or public-access commitments for patent-protected technology. The second day of the workshop will be entirely devoted to discussion of these proposals, led by panels of participants representing industry, government and the activist community who can provide a broad spectrum of responses, with respect to the proposals' feasibility and desirability.
In Part I, the current-context sessions will allow twenty minutes per speaker, followed by fifteen minutes of discussion per panel. In Part II, the presentation of proposals will allow up to fifteen minutes per speaker, followed by thirty minutes of discussion per panel. In Part III, the responses to the proposals will allow ten minutes per speaker, followed by twenty minutes of discussion per panel. There will also be open-discussion sessions at the end of each day. We expect the net result to be a remarkable opportunity for participants to engage with each other in substantive dialogue, leading to new insights and perhaps wider agreement on the specific initiatives that are most likely to help the life sciences meet human needs.