HUM-MOLGEN archive: ETHI: BRCA2 patenting

As recently reported in Nature, The Salt Lake Tribune and elsewhere, Myriad Genetics and an international research consortium are likely to be involved in a dispute over patent rights to the BRCA2 gene. The consortium has identified a portion of BRCA2 and Myriad claims to have identified and applied for a patent on the entire gene. Below are several quotes from the Salt Lake Tribune article about this development. Responsible comments, particularly from principals involved in this dispute, are solicited. Hans Goerl ETHI editor By Lee Siegel THE SALT LAKE TRIBUNE As word of the study spread worldwide Wednesday, Myriad announced it filed a U.S. patent application claiming the company found ``a strong candidate'' for the complete gene. The application ``covers all diagnostic and therapeutic uses of this newly discovered gene,'' the announcement said. ********************** ``The real winners are going to be patients and also patent attorneys,'' said Louis Ptacek, a professor of neurology and human genetics at the University of Utah. ``The competition is healthy to a certain extent. But a lot of people get so caught up in who is first that they lose sight of the ultimate goal, which is helping patients with diseases.'' ****************** ``There could be billions of dollars at stake,'' said Mark Keating, a professor of human genetics and medicine at the U. ``This [BRCA2 discovery] is not going to lead immediately to a cure for breast cancer, but it's also not pie in the sky. The question is how long it's going to take.'' Myriad's Meldrum said Wednesday that his company should get the patent for BRCA2 even if Stratton's international team was the first to find a piece of the gene. ``We know exactly where it is located and have the entire gene sequence, not just a chunk of the gene,'' Meldrum said. ``You cannot patent a gene unless you have the entire gene sequence and can demonstrate . . . the gene has some useful purpose in a diagnostic or therapeutic setting.'' Ptacek replied: ``It's crazy to say they [Myriad] have greater precedence because they have the whole gene. Having part of the gene and demonstrating disease-causing mutations in that part of the gene is as good as having the full-length gene.'' Keating also disputed Meldrum. ``Myriad is wrong in saying just having part of the gene isn't patentable.'' By now, the international team probably has found the entire gene, but hasn't yet published that discovery because of the long lag time until publication in a science journal, Keating said. Whether Myriad or the other team gets patent rights to the gene will depend on who can document they made the discovery first, and publishing a study as the international team did is ``one way of documenting an intellectual discovery,'' Ptacek said. Citing Myriad's need to protect its intellectual property rights, Meldrum declined to disclose who at Myriad found the full BRCA2 gene, when the discovery was made or when the patent application was filed. Meldrum said people at Myriad had not seen the Nature paper, but were contacted by reporters seeking comment. Asked if anyone at Myriad had advance knowledge of the study, Meldrum replied: ``Without canvassing every employee in Myriad, I can't answer that question.'' But he denied Myriad made its announcement in a bid to establish its own claim to BRCA2. The company ``would prefer to publish its findings in a scientific journal'' but, as a publicly traded company, was forced to issue a news release to inform investors of its own discovery and patent filing, Meldrum said. Keating said Stratton's team won the scientific race to identify BRCA2 by publishing in a journal first. He said Myriad put out a news release ``to counterbalance that potential loss by getting recognition in the lay press, which is in some ways more important to them than recognition in the scientific press. ``Myriad Genetics is a company . . . and their mission is to make a profit No. 1, and do good things No. 2,'' Keating added. ``The academic mission is to do good things No.1, and if you can make a little money on the side, that's terrific.'' He said he is certain Stratton's group also must have filed for a patent because ``if they haven't they're stupid.'' ****************************