Anticipating a series of federal recommendations on gene patents coming out tomorrow, a former Senator and four executives at biotech companies and biotech trade groups criticized the Department of Health and Human Services (HHS) for taking, they said, a stand that would undermine the the technology transfer objectives of the Bayh-Dole Act and the biotech industry generally in the United States.
Based on draft proposals, HHS's Secretary's Advisory Committee on Genetics, Health and Society (SACGHS) is expected to issue six recommendations. The first is the most contentious, suggesting that Congress should enact laws to exempt gene patents from infringement liability—potentially allowing anyone to use any gene patent.
This worries biotech companies because, as James Davis, an executive vice president at Human Genome Sciences pointed out, gene patents typically cover far more than the A-C-G-T sequence of nucleic acids in a gene. The patents also cover proteins produced by the gene, antibodies for those proteins, and other downstream products of the gene. Without protection for all those pieces, companies have no incentive to invest in research, Davis argued, and he and others feared the recommendation would find sympathetic ears in Congress.
The other five recommendations—for instance, that companies be forced to divulge more business secrets, or that the U.S. Patent and Trademark Office receive more technical advice—received less attention from the executives, who were brought together by the Biotechnology Industry Organization (BIO). But the executives did criticize the other five points as onerous.
Although the SACGHS recommendations are limited to gene patents, much of the biotech criticism accused the proposals of striking at the heart of the 1980 Bayh-Dole Act, which helped universities commercialize discoveries and move them into the marketplace. Before Bayh-Dole, potentially useful products often languished. Former Senator Birch Bayh, who co-authored the act, joined the executives in their criticism today, calling the SACGHS recommendations an attempt "to reimpose the failed policies of the past, policies that just didn't work."
Jon Soderstrom, the head technology licensing official at Yale University, echoed that comment, saying, "What frightens me is that [the recommendations] reconstitute the world as it existed before 1980."
Coincidentally, the HHS recommendations are appearing at the same time that a federal court in New York is hearing an important case, ACLU v. Myriad, on whether gene patents violate the Constitution. Myriad owns the patents on two key breast cancer genes.