By Kevin Noonan --
Several years ago, it became current among certain academic commentators to opine that patenting genes could become a "tragedy of the anticommons." By this they meant that permitting gene patenting would restrict progress, inhibit academic freedom and prevent scientists from working cooperatively. Significantly, most of these commentators had neither a science background nor any experience as patent attorneys. Their warnings rang hollow to those who had either type of experience, but they had (and continue to have) influence with policymakers, Congressional aides, and the Patent Office.
As it turns out, they were wrong, at least with regard to academic freedom and cooperation. In a revealing new study, LeRoy Walters of the Kennedy Institute of Ethics and Georgetown University and colleagues reports "consensus, diversity and flexibility in intellectual property management" (see Nature Biotechnology 24: 31-39 (2006)). The authors found that research university practices were influenced primarily by market forces related to licensing opportunities, and also by guidelines from the National Institutes of Health.
Licensing provides substantial economic benefit to universities; for example, Columbia University received $370 million between 1983 and 2000 for the Axel patents. The report reveals that universities actively promote licensing patent rights to for-profit companies, but that the licenses are rarely exclusive. Indeed, the report finds that even exclusive licenses are limited, either due to "field of use" restrictions or serial "exclusive" licensing to different companies. Large companies are much less likely to require an exclusive license than smaller start-up companies, who require exclusivity in order to attract investment.
Universities have increasingly used the concept of "shop rights" to retain a research exemption, even to exclusively-licensed technology, to permit their own scientists to practice licensed technology. Many universities have expanded the scope of this exemption to permit scientists to transfer rights to practice a patented invention to scientists at other universities doing basic (non-commercial) research. Inclusion of such terms has become more important since the Madey v. Duke decision by the Federal Circuit, which eliminated the illusion of a common-law research exemption.
Finally, the cause of the supposed problem, the profusion
of gene patents, seems to be fading. The
39,000 DNA patents issued by the Patent and Trademark Office encompass only 20%
of genes identified in human genomic databases. Moreover, the number of gene patents granted per year has declined every
year since 2001, a trend the authors indicate will continue.
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