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Intellectual Property Rights and Research Tools in Molecular Biology: Summary of a Workshop Held at the National Academy of Sciences, February 15–16, 1996 1 Introduction Intellectual property rights have been a recurring source of controversy in the biomedical sciences in recent years. A variety of developments have contributed to the increasing salience of intellectual property in biomedical research, including strong and growing commercial interest in the field, legal decisions that have clarified the availability of patent protection for a wide range of discoveries related to life forms, and changes in federal policy to encourage patenting of the results of government-sponsored research. Protection of intellectual property rights has helped researchers and institutions to attract research funding and has helped firms to raise investment capital and pursue product development. But it has also periodically generated complaints and concerns about its effect on the progress of science and on the dissemination and use of new knowledge. The concerns have been particularly pressing for scientists when intellectual property rights have threatened to restrict access to materials and techniques that are critical for future research. Controversy over intellectual property rights in biomedical research has waxed and waned over the years (Weiner 1989). The current wave of concern was triggered in 1991 when NIH filed its first patent application on partial cDNA sequences, or expressed sequence tags (ESTs). Despite the later withdrawal of the patent applications, the concern over access to DNA sequence information continued to generate debate, both in the US and internationally. Another focal point of concern has been the patenting and licensing of polymerase chain reaction (PCR) technology. In 1992, the pharmaceutical giant Hoffman-La Roche, who holds the patent on the enzyme used in PCR (Taq polymerase), sued the biotechnology company Promega for breach of contract over the distribution of enzyme. During
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Intellectual Property Rights and Research Tools in Molecular Biology: Summary of a Workshop Held at the National Academy of Sciences, February 15–16, 1996 the course of the litigation, many research scientists received a letter from Promega suggesting to them they had been named as infringers against the Roche patent. Although Roche stated they had no intention of naming any scientists in the suit, the letter sent a chill throughout the research community and raised fears that patents might be blocking access to research tools. In addition to those controversies, less notorious controversies have surrounded other research tools in molecular biology. Attitudes toward patenting in the research community have changed substantially since the late 1970s, when Stanford University's decision to patent the recombinant DNA technology developed by Stanley Cohen and Herbert Boyer met considerable resistance among academic scientists. Today, universities and academic scientists routinely pursue patent rights, often in competition with their counterparts in the private sector. University patenting steadily increased from 1965 to about 1980, when there was a sharp increase in patenting that has continued into the 1990s. From 1965 to 1992, university patents increased by a factor of over 15 from 96 to 1500, whereas total patents increased by only about 50% (Henderson and others 1994, 1995). The greatest portion of the increase in university patenting has been in biomedical sciences, and many university patents cover inventions that are useful primarily for scientific research. There is no clear line separating the interests of the public and private sectors in intellectual property. It is sometimes celebrated and sometimes criticized throughout the research community, not always in the same terms or for the same reasons. University scientists complain that the eagerness of private firms to preserve intellectual property poses a threat to open scientific communication, that the prospect of obtaining patents influences research agendas, that overly broad patents stifle research, and that licensing practices impede access to and use of genetic materials and DNA technology. Yet few scientists today would voice wholesale opposition to patenting itself; scientists' concern is more likely to be how to ensure access to patented inventions on reasonable terms. Representatives of the private sector have a somewhat different list of complaints, including the overeagerness of university technology transfer managers to file patent applications, their overestimation of the value of their intellectual property and the underestimation of the additional investment required to turn a research discovery into a product, and their readiness to grant exclusive, rather than nonexclusive, licenses. Increasing alliances among academe, industry, and government, driven by a combination of economic and legal changes, have challenged institutions in the public and private sectors to balance their sometimes competing interests in the protection of intellectual property. Over the last two decades, public investment in research has been rewarded by a dazzling series of advances in molecular biology. At the same time, scientists have had to adapt to declines in the growth of public funding to explore these research frontiers. The commercial potential of the advances has motivated the private sector to provide additional resources,
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Intellectual Property Rights and Research Tools in Molecular Biology: Summary of a Workshop Held at the National Academy of Sciences, February 15–16, 1996 and a series of laws, beginning in 1980 with the Bayh-Dole Act, have encouraged the pooling of public and private research funds (see box). This environment has been favorable for the development of small, research-intensive biotechnology companies with close links to universities. Indeed, most of the early biotechnology companies were founded by university professors, and many universities now offer ''incubator space'' for start-up biotechnology companies working in collaboration with university researchers. Pharmaceutical companies are also increasingly eager to establish collaborations with university researchers. Changing Direction in Federal Technology Law In 1980, Congress passed both the Bayh-Dole Act1 and the Stevenson-Wydler Technology Innovation Act2. Together these Acts allowed government contractors, small businesses, and nonprofit organizations to retain certain patent rights in government-sponsored research and permitted the funded entity to transfer the technology to third parties. The stated intent of Bayh-Dole was to ensure that the patented results of federally-funded research would be broadly and rapidly available for all scientific investigation. Bayh-Dole effectively shifted federal policy from a position of putting the results of government-sponsored research directly into the public domain for use by all, to a pro-patent position that stressed the need for exclusive rights as an incentive for industry to undertake the costly investment necessary to bring new products to market. The policy was based on a belief that private entities, given the incentives of the patent system, would do a better job of commercializing inventions than federal agencies. The Act for the first time established a largely uniform government-wide policy on the treatment of inventions made during federally supported R and D. Stevenson-Wydler is the basic federal technology law. A principal policy established by that Act is that agencies should ensure the full use of the results of the nation's federal investment in R and D. Another is that the law requires federal laboratories to take an active role in the transfer of federally-owned or originated technology to both state and local governments and to the private sector. Stevenson-Wydler required agencies to establish Offices of Research and Technology Applications at their federal laboratories, and to devote a percentage of their R and D budgets to technology transfer. References Tribble, JL. 1995. Gene ownership versus access: meeting the needs. In: Genes for the Future: Discovery, Ownership, Access. Nat'l Agricultural Biotechnology Council, Ithaca, New York. Rudolph, L. 1994. Overview of Federal Technology Transfer. Risk: Health, Safety & Environment 5: 133–142. 1 Pub. Law No. 96-517, 6(a), 94 Stat. 3015, 3019–27 (1980). 2 Pub. Law No. 96-480, 94 Stat. 2311 (1980).
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Intellectual Property Rights and Research Tools in Molecular Biology: Summary of a Workshop Held at the National Academy of Sciences, February 15–16, 1996 The pervasive intertwining of public and private interests makes molecular biology a particularly useful focal point for considering the effect of intellectual property rights on the dissemination and use of research tools. The potential implications of advances in molecular biology for human health raise the stakes of getting the balance between public and private right, particularly when public attention is riveted on the rising costs of health care. Which approaches to handling intellectual property will best serve the goals of fostering continued scientific discovery and ensuring adequate incentives for commercial development of discoveries to promote human health? This report seeks to shed light on that question from three angles (following the structure of the workshop itself). The first session presented legal, economic, and sociologic perspectives on the issue of intellectual property protection and access to research tools. Rebecca Eisenberg provides a legal orientation to the problem of intellectual property rights in research tools and reviews legal and commercial developments of the last 15 years that have made intellectual property issues particularly prominent in molecular biology. Drawing from his collaboration with Roberto Mazzoleni, Richard Nelson reviews and critiques various theories about the economic costs and benefits of patenting. Stephen Hilgartner presents his observations on differences in the extent of intellectual property protection in the life sciences and on the role of patents in changing the degree of secrecy among biomedical researchers. The second section was the heart of the workshop: the case studies. The case studies were chosen to illustrate approaches to the protection of intellectual property that have been used in different contexts by different types of institutions. An important goal of the workshop was to examine the consequences of those approaches from different institutional perspectives. The following cases studies were chosen: Cohen-Boyer recombinant DNA technology A patented research tool, nonexclusively licensed with low fees. Partial cDNA sequences, or ESTs Three models for disseminating unpatented research tools. Polymerase Chain Reaction (PCR) technology and Taq polymerase A patented research tool for which licensing agreements were controversial. DNA and protein sequencing instrumentations Research tools for which strong patent protection promoted broad access. Research tools in drug discovery Intellectual property protection of complex biological systems. By design, the case studies present differences that caution against facile generalizations about ideal practices that should be implemented through uniform rules. Nonetheless, a number of interesting themes emerged, and their
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Intellectual Property Rights and Research Tools in Molecular Biology: Summary of a Workshop Held at the National Academy of Sciences, February 15–16, 1996 emergence suggested that the experience gained through various experiments in technology transfer and the management of intellectual property can, indeed, provide some guidance for those concerned with the management of intellectual property in research tools in molecular biology. Those themes are discussed in the final two sessions, which include a section on different perspectives represented by the workshop participants and a general summary of the workshop. REFERENCES Henderson R, Jaffe AB, Trajtenberg M. 1995. Universities as a source of commercial technology—a detailed analysis of university patenting 1965–1988. Working paper No. 5068. National Bureau of Economic Research Inc. Henderson R, Jaffe AB, Trajtenberg M. 1994. Numbers up, quality down? Trends in university patenting 1965–1992. Paper presented at the CEPR/AAAS conference "University Goals, Institutional Mechanisms, and the 'Industrial Transferability' of Research." Weiner C. 1989. Patenting and academic research: Historical case studies. In: Weil V and Snapper JW, editors. Owning Scientific and Technical Information. New Brunswick, NJ: Rutgers University Press.
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