High Court To Hear Key Case On Human Gene Patents.

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The New York Times (4/15, A1, Pollack, Subscription Publication) reports that the Supreme Court "is poised to take up the highly charged question of whether human genes can be patented," but "another question could trump it: Has the field of genetics moved so far so fast that whatever the court decides, it has come too late to the issue?" The Times continues, "The hearing comes as rapid scientific advances are producing an explosion of new information about human genes, as well as those of animals, plants and microbes, yielding new approaches to detecting and combating diseases."

        The Christian Science Monitor (4/14, Richey) reports, "The issue arises in a challenge to patents held by Myriad Genetics, a Utah-based diagnostic testing and research firm that developed a way to detect genetic mutations (called BRCA1 and BRCA2) that scientists associate with a higher risk of breast and ovarian cancer. The process is described by the company's lawyers as akin to locating a particular grain of sand in a space the size of the Empire State Building. The tests have helped over a million patients identify risks and develop treatment strategies," but "the American Civil Liberties Union and the Public Patent Foundation charge that Myriad Genetics is actually hindering scientific innovation and undercutting access to medical care for patients who need it."

        Bloomberg News (4/12, Stohr, Decker) reports that "trade groups for the biotechnology, agriculture and drug industries are siding with Myriad," claiming that "gene patents have led to valuable treatments." Meanwhile, "doctor groups such as the American Medical Association are backing the challengers to the patents. They have partial support from the Obama administration, which is urging the court to uphold parts of Myriad's patents and void other aspects."

        The Philadelphia Inquirer (4/15, Sell) reports that "research groups, patient advocates, and the American Medical Association, among others, argue that Myriad's assertion of patent rights to the genes stifles future research and the use of existing, lower-cost diagnostic tools because they involve those genes. Armed with the patent-induced market exclusivity, Myriad charges about $3,000 for a test for which other labs previously charged $200 or less." According to Myriad, "separating pieces of genes requires skilled human intervention and creates a new entity, worthy of a patent, and that 30 years of patent protocol should not be changed."

        The Salt Lake (UT) Tribune (4/15, Harvey) reports that, "without that patent protection, the company says it is unlikely that kind of money would have been poured into research and development. It also points out that research by others has not been stifled, with 10,000 research papers published about BRCA1 and BRCA2." The Tribune notes that "Myriad officials have said that the patents in question are only a small part of its portfolio, and that a negative decision won't have a significant impact on the publicly traded company's finances."

        Also reporting on the story are the Boston Herald (4/15, Kantor), Boston Business Journal (4/15, Subscription Publication) on its "Bioflash" blog, Reuters (4/15, Begley), The Hill (4/15, Baker) on its "Healthwatch," Atlantic Wire (4/15, Estes), Forbes (4/12, Fisher), McClatchy (4/12, Doyle), and Modern Healthcare (4/13, Subscription Publication).

        More Commentary. The Washington Post (4/15) editorializes, "The legal precedent stresses that products of nature aren't patentable, so the justices may well rule against Myriad. But either way, their ruling shouldn't be the end of it. Balancing the benefits of free-flowing research against the value of mobilizing private money to detangle genetic code is a hard policy call that Congress should make."

        The New York Times (4/15, Subscription Publication) editorializes, "The petitioners in the case - doctors, scientific researchers and women's health organizations - argue that the isolated genes are not materially different from genes before extraction, and that allowing Myriad a patent on them would allow the patenting of nature itself, at untold cost to scientific research, medical treatment and patients. We agree with the petitioners, while recognizing that this case is one of the most important and complex disputes involving the intersection of science, law and commerce in a generation." The Times notes that the Administration is conflicted over the case. "The patent office sees the patents as valid and consistent with its duty to protect and promote invention; Solicitor General Donald Verrilli Jr. and the Justice Department oppose them on grounds that what nature makes cannot be patented and Myriad's isolation of DNA did not change it enough to alter nature and be eligible for a patent."

        USA Today (4/14) editorializes, "By locking up the BRCA genes and making its $3,340 test the only one doctors can use without the company's permission, Myriad stifles independent scientific inquiry and the sort of competition that might produce better or cheaper tests. Myriad says it spent hundreds of millions of dollars developing its test, and no one could reasonably object if the company patented only its test. But the gene patents go too far."

        In an op-ed for USA Today (4/14) Peter D. Meldrum, president and CEO of Myriad Genetics, Inc., writes, "To create tests for hereditary breast cancer and ovarian cancer, our company and its investors spent more than $500 million over 17 years before we were able to recoup this investment." Meldrum continues, "Our tests have been used by more than 1 million women to determine whether they are at increased risk of developing hereditary breast, colon, uterine and ovarian cancer. We think it is right for a company to be able to own its findings, just as pharmaceutical and other companies do all the time."

        In an opinion piece in the Dallas Morning News (4/12), Jeffrey A. Rosenfeld, assistant professor of medicine at the New Jersey Medical School, writes about how "DNA belongs not to you but rather to many companies and institutions that have patents on the DNA from your cells. Forty-one percent of the genes in your genome are not legally yours, according to a long list of gene patents granted since the 1980s." Referring to the Myriad Genetics case, Rosenfeld concludes: "Fortunately, the Supreme Court has a chance to rectify this genetic injustice."

        Despite the controversy surrounding the case, columnist Bradley J. Fikes writes in the U-T San Diego (4/13, Fikes), "No matter which way the Supreme Court rules on the Myriad Genetics BRCA breast cancer gene test patenting case, the importance of such patents is diminishing over time. Biotechnology is moving beyond patents derived from naturally occurring gene sequences. The most important biotech patents nowadays are becoming synthetic gene and RNA sequences, proteins and other indisputable contrivances of human ingenuity."

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