Sequence Patents

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Science  28 Mar 1997:
Vol. 275, Issue 5308, pp. 1861-1865
DOI: 10.1126/science.275.5308.1861b


In Eliot Marshall's News & Comment article of 7 February (p. 777), it is suggested that the National Institutes of Health's (NIH's) insistence on rapid release of gene sequence information arising from their large-scale sequencing programs and avoidance of patent filing on such information is in violation of the Bayh-Dole Act. This is not correct.

Sequence fragments of unknown utility, although important starting points for further research, are likely not to be inventions, and hence not within the Bayh-Doyle purview. NIH's early applications to patent such sequences, as discussed clearly in Marshall's companion article (News & Comment, 7 Feb., p. 780), were considered unpatentable by the U.S. Patent and Trademark Office (PTO), and although there was no appeal to trigger a more final decision, few if any patents of a similar nature have since been issued.

Furthermore, it is not likely that commercialization will be thwarted by publication of a sequence, as confirmed by the decision In re Deuel (1) (patentability of partially published protein sequence). Instead of wasting PTO and applicant time and money on trying to patent the unpatentable, the focus should be on protecting the commercially important invention. Most often, that invention will be the identification of how a particular sequence can be used and patent coverage for a diagnostic or therapeutic modality that can actually be incorporated into a product useful to the public. NIH and the universities have no reluctance to file for patents and encourage commercialization of inventions such as these.

The record is clear that we recognize the role of patents in advancing the health and welfare of the communities we serve and in encouraging economic competitiveness. It is perfectly consistent with the Bayh-Dole Act to encourage more dissemination of sequence information, so that the actual inventions can be made.