Epilogue:

Chairman's Remarks

The NRC conference, “Finding the Path: Access to Research Resources”, presents us with a mixture of new and not-so-new problems, all of which strike to the heart of the health and future of the scientific enterprise and the effective application of science to further the public good. While there are few completely new issues revealed here, the conference brought together concerns in a wide range of fields, and there is a new urgency as science and its commercial applications accelerate. The stakes are increasing every year.

The changing face of patent issues in the life sciences, most participants felt, has had a major effect in recent years on the conduct and the atmosphere of academic research. The 1980 Supreme Court decision in Diamond v Chakrabarty opened the door to patents on microorganisms and genes, and was key to the rise of the US biotechnology industry in the subsequent 20 years. But disagreement over what types of genetic material should be eligible for patenting is strong and continues today, as illustrated in the comments of Steve Holtzman and Craig Venter at the conference. When panelists were asked why so few institutions or companies had responded to the Patent and Trademark Office's request for comments on its proposed guidelines for patenting expressed sequence tags (ESTs), several suggested that their organizations had no confidence that a satisfying and workable policy would be crafted. Lacking any other venue for resolution in advance of issuance of a patent, these matters will continue to be settled case by case in the Court of Appeals for the Federal Circuit.

Another set of closely related issues concern material transfer agreements and licensing negotiations between academia and industry, which many feel have for a decade been an impediment to the efficient and equitable sharing of research materials. Despite numerous meetings that have described the issues and put forward model agreements to simplify sharing, uniformity



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OCR for page 30
FINDING THE PATH: Issues of Access to Research Resources Epilogue: Chairman's Remarks The NRC conference, “Finding the Path: Access to Research Resources”, presents us with a mixture of new and not-so-new problems, all of which strike to the heart of the health and future of the scientific enterprise and the effective application of science to further the public good. While there are few completely new issues revealed here, the conference brought together concerns in a wide range of fields, and there is a new urgency as science and its commercial applications accelerate. The stakes are increasing every year. The changing face of patent issues in the life sciences, most participants felt, has had a major effect in recent years on the conduct and the atmosphere of academic research. The 1980 Supreme Court decision in Diamond v Chakrabarty opened the door to patents on microorganisms and genes, and was key to the rise of the US biotechnology industry in the subsequent 20 years. But disagreement over what types of genetic material should be eligible for patenting is strong and continues today, as illustrated in the comments of Steve Holtzman and Craig Venter at the conference. When panelists were asked why so few institutions or companies had responded to the Patent and Trademark Office's request for comments on its proposed guidelines for patenting expressed sequence tags (ESTs), several suggested that their organizations had no confidence that a satisfying and workable policy would be crafted. Lacking any other venue for resolution in advance of issuance of a patent, these matters will continue to be settled case by case in the Court of Appeals for the Federal Circuit. Another set of closely related issues concern material transfer agreements and licensing negotiations between academia and industry, which many feel have for a decade been an impediment to the efficient and equitable sharing of research materials. Despite numerous meetings that have described the issues and put forward model agreements to simplify sharing, uniformity

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FINDING THE PATH: Issues of Access to Research Resources remains only a goal, in part because many parties, in both academia and industry, seek terms that are not mutually compatible and resist streamlining the process in seeking their own perceived advantage. While there is great heterogeneity in this area, fault can easily be found on both sides. Many universities stand accused of overvaluing their nascent technology, and industry is often blamed for overreaching; seeking far-reaching rights to future discoveries in exchange for research support and proprietary information, and for efforts to perpetuate publication delays. While some institutions, individuals and companies are culpable, full understanding of the processes of commercialization and the mechanisms for protection of inventors and investors is not common. Between their institutions and the commercial sector many academic scientists appear to be caught in the middle. The issues raised with a special new urgency at the conference are connected to the rise of the database as a critical research resource, not only for geneticists, molecular, computational and structural biologists, but also for ecologists, anthropologists, zoologists, botanists, crystallographers and social scientists as well. It is a simple fact that computer accessible databases will soon become a dominant research tool in research of all stripes. In the case of genomic databases, the prospect of the private sector holding close a large segment of valuable information presents a daunting challenge to publicly funded science: either commit to duplicating the databases for public use at significant cost or resolve to pay the costs of access to private resources. The public responsibility of assuring that the data will be there for the science of the future is a intimidating one. There are arguments that support one or the other solution for a variety of data types, but the answer will likely be a mixed strategy. Databases in other fields have different, but no less real, costs associated with organization and maintenance. Making databases into usable public resources requires investment in their infrastructure. Responsibilities accruing to the providers of such databases include: protecting the underlying sources of information (for example, human identities or museum and culture collection specimens), developing standard formats for data contributions and data presentation on-line, supporting the creation of interoperable, flexible and powerful computational tools to search, retrieve and analyze the data, and establishing a common set of values to balance the interests of data contributors and database users. Perhaps it is now time to re-examine both the old and new issues from a different perspective. For example, we often speak of the traditional missions and needs of the different parties involved in resource sharing as though they were well-defined for all time, but much of the tension over materials transfer agreements and licensing and even over data sharing reflects a more complex, changing system of interests and values. Although our attention at the conference was focused on the points at which conflicts arise, these issues cannot be solved until we grasp more fully the factors that shape the values and

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FINDING THE PATH: Issues of Access to Research Resources interests of the several parties. To do that, we need a better understanding of the changing nature of the scientific enterprise, including the proper extent and structure of industry-university research alliances and the implications of the parallel research programs in the commercial and academic sectors. Consequently, we need to evaluate the effects of basic federal policies, such as patent policy and the policies emanating from the Bayh-Dole Act, on university research broadly, and on the behavior of universities, industry, and individual scientists in both sectors. We should assess whether they are having their intended effects, what their unintended effects are, and to what extent they are promoting the public benefit from science. We must be concerned not only with encouraging important commercial applications in the short term, but also with the long-term health of the scientific endeavor. If we are asking scientists to collaborate to develop and use new research tools, we must ask whether federal policies, funding levels and spending priorities are commensurate with our expectations. Life science is evolving rapidly, and judging from the history of other scientific disciplines, it is now clear that there is no going back to the “way it used to be”. Given the opportunities for furthering the science and the public good that so many kinds of cooperation present, I would argue that we should not wish to return to the ways of the past. As we approach the new century it is evident that the many public declarations that the 21st century will be the century of the life sciences are likely to be true. We must remember, however, that it is deeply in the national interest for us to understand the cultural, social, legal, and financial forces that shape the infrastructure and context of the enterprise of all science. As we develop the policies and structures for the future we need to understand their ramifications in all sectors and work hard to enable the enormous opportunities of science for the public good to be fully realized. David Galas Conference Chairman