Patents On Some Science Findings Would Present Problems

Date: November 23, 1992 Editor's Note: Indications are that the National Institutes of Health's controversial gene-patenting initiative, now widely seen as moribund, is really as good as dead. At press time, a final decision on the matter was still in the hands of Secretary of Health and Human Services Louis Sullivan, but sources at HHS feel the initiative is on insecure legal footing and will be dropped. Before the proposal more or less gave up its ghost, however, it served to stimulate animated and--one hopes--enduringly valuable debate over the validity of a scientist's or institution's claim of proprietorship of a research discovery. New York University professor Dorothy Nelkin--a sociologist and seasoned observer of the science world--was among the commentators who felt deeply about the NIH proposal, its implications for basic research, and its potentially negative impact. In the following--written before it became apparent that the NIH proposal was to fail--Nelkin presents her views on gene patenting in relation to the concept of science, which she prefers to see maintained as "a relatively disinterested source of neutral information." An expanded version of Nelkin's essay appeared in the Oct. 12, 1992, edition of The Times Higher, a British publication. The recent dispute over the National Institutes of Health application to patent the gene sequences emerging from human genome research has brought several problems into focus. By laying claim to gene sequences, the NIH, according to its director, Bernadine Healy, was preserving the right to control future developments, and thereby to assure that they would be directed toward the public interest. But genome researchers thought the applications premature, and were outraged that so many claims were made on such a limited basis. Angry responses came from the American Society of Human Genetics, from European researchers, and, especially, from American scientists working on human genome research in NIH-supported university laboratories: All were worried about the effect of proprietary claims on the research. The Human Genome Project has been called a gigantic experiment in data sharing. Researchers around the world are working on pieces of a large and intricate puzzle, and they depend on access to the cell lines and probes developed by their colleagues. The issue of data sharing is critical for genomic researchers because much of the usefulness of their information depends on its cumulative context. Access to the whole map is important for locating specific genes, avoiding redundancy, and allowing the validation and verification essential to a rapidly developing field. The competition for patents, it was feared, would stop the exchange of information. The first director of the genome project, James Watson, held a strong ideological commitment to data sharing as fundamental to the project's success. Indeed, the NIH patenting decision infuriated Watson and prompted his resignation. Balancing secrecy against the open exchange of ideas has always been a part of the competitive culture of science, evident in the long history of priority disputes. But the economic incentives now at stake have further encouraged protection of data and ideas. In the universities where much of the genome research is carried out, the patent race bears significantly on research relationships. The point of patenting is to encourage the disclosure and utilization of information by assuring the protection of proprietary rights. But when an active research field holds promise of continuing commercial applications, secrecy remains a problem. This is especially troubling in biotechnology research because of the difficulty of differentiating basic from applied knowledge. With boundaries blurred, secrecy can be extended to research areas well beyond those with immediate commercial potential. The prospect of a patent may delay publication until the patent is filed, although American law provides a one-year grace period in which to publish. But even after filing, a scientist may be reluctant to share data that may bear on future patent rights. Added to these concerns is the hovering threat of litigation. Patent applications in genetics often seek to control not only discoveries and inventions, but the very means of doing research. Expressed Sequence Tags, for example, are markers, used as research tools. Those who use a patented technology can be sued, or the courts can impose an injunction on research in progress if a patent infringement is suspected. While some research may be exempt, the blurred lines between academic research and commercial pursuits in biotechnology have also blurred the principle of "research exemption." But the most contentious issue that has emerged in the debate over the NIH decision is the potential implications of the premature filing of patent applications, and this suggests that ownership more than secrecy has become the primary concern. The patenting decision was stimulated by the work of Craig Venter, an NIH scientist who had used an existing automated technique to sequence partially the genes expressed in the brain, claiming that his approach would lower the cost and accelerate the pace of discovery. Venter was able to identify gene fragments with this technique, but could not determine their function or utility--a far more costly and difficult process. Yet he and the NIH filed for patent rights. American law requires that inventions must have demonstrated utility, so that these patent applications, filed before their utility was apparent, may never be granted. But the very act of laying proprietary claims could discourage whole areas of research; for the difficult research involved in working out the structure and function of the gene would not be eligible for patenting once proprietary rights to the genes and their commercial applications are established. Scientists also worry about their potential involvement in prolonged disputes over patent rights. They have observed the bitter and extended controversy between NIH researcher Robert Gallo and France's Pasteur Institute over the patent rights to a blood test for HIV, the virus that can cause AIDS. Victor McKusick, founding president of the Human Genome Organisation [an international genome-research coordinating body], warned of the enormous cost of the legal maneuvering that usually follows commercially interesting patent applications. The implications of premature filing of patent applications must be considered in light of the growing commercial involvement of universities. Institutions in the business of research for profit necessarily evaluate research in terms of its economic potential. Universities are no exception. An area of research may be scientifically important, but if someone already has a license, it holds little economic appeal. In this context, scientists may be pulled in several directions. Their scientific ideals may conflict with the economic goals of their universities. And their own economic interests in potentially lucrative research may conflict with the intellectual appeal of more basic science. The effect of prospecting for pat-ents on the long-term progress of genetics and biotechnology research remains to be seen. But the quest for proprietary rights is changing the norms and practices of science in commercially promising areas. The extraordinary competitiveness of research areas in genetics raises a set of economic and legal issues that dwarf the earlier concerns about communication and collegiality. The preemptive nature of patents is skewing research directions, threatening to compromise the independence of the scientific research process. And the threat of litigation that is part of the patenting process is creating a sense of uncertainty. As scientists become prospectors and as maintaining proprietary rights becomes a priority, there are serious implications for the concept of science as a relatively disinterested source of neutral information. And as universities become increasingly receptive to business initiatives, there are significant implications for the concept of the academy as a relatively independent and inviolable institution.

Patents On Some Science Findings Would Present Problems

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