It's not often that heads of state wade into a furious quarrel in the scientific community, but both President Clinton and British Prime Minister Tony Blair did so this week. On 14 March, the two leaders announced that they enthusiastically support the rapid release of human genome sequence data, a principle long advocated by Francis Collins, director of the National Human Genome Research Institute (NHGRI), and other scientists in the nonprofit sector.
Clinton released a joint statement with Blair today, arguing for the rapid release of human genome data. Afterward, he made some personal remarks that went even further. Speaking at the annual medal of science ceremony at the White House, Clinton urged private companies to "make raw [DNA] data publicly available" and make "responsible use of patents." The statements were carefully worded to support patents on "new gene-based health care products." But they seemed directed at the activities of some private data marketing companies--such as Celera Genomics and Incyte--that have been engaged in high-volume sequencing of human DNA and collecting genes and genetic variations.
Although the high-level attention to this debate is new, the debate itself is not. The largest DNA sequencing labs funded by the U.S. government and by the Wellcome Trust, a British charity, endorsed very similar principles for data release at a meeting of top genome sequencers in Bermuda in 1996. Typically, these big labs release new human DNA data within 24 hours of production, posting results on the Internet. But the labs' insistence on this practice has caused some friction with the private sector. Recently, for example, talks broke down between Celera and a group of nonprofit centers over how they might collaborate on completing the sequence of the human genome. They clashed specifically on public access to data (Science, 10 March, p. 1723).
In addition to giving Collins's side of the debate a boost, this high-level endorsement of the Bermuda rules may have an impact on discussions within the U.S. Patent and Trademark Office (PTO). For several years, Collins and former National Institutes of Health director Harold Varmus have tried to persuade PTO leaders they should not grant patents on simple gene discoveries. In letters and speeches, both have argued that only inventors who clearly describe the "utility" of a gene, such as a plan to develop a medical product, deserve to win a patent. While the PTO has proposed tighter policies, it hasn't gone as far as Collins would like (Science, 18 February, p. 1196).
Collins calls the Clinton-Blair announcement a "very encouraging" and "gratifying endorsement" of NHGRI's strategy. But presidential enthusiasm may not carry much legal weight. PTO biotech section leader John Doll says: "It doesn't seem like this is going to affect biotech patenting at all." And Celera said in a statement that the company "welcomes" the Clinton-Blair policy, calling it "completely consistent" with Celera's plan to publish the human genome in a peer-reviewed journal and make the information "available to researchers for free."
Although the announcement may carry no legal weight, it has already had a big financial impact on genomics companies. Fearing that the government might restrict gene patents, stockholders began dumping shares after the White House announcement. By late afternoon, the wave of negative publicity had depressed the value of both Celera and Incyte stock by 21%; many other biotech companies suffered losses as well.