Court rules against patenting human genes

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© Michael Rosenfeld/Science Faction/Corbis

In a decision that could have broad ramifications for future genetic research and medical practice, United States District Court Judge Robert W. Sweet ruled Monday that patents on two genes linked to ovarian and breast cancer, BRCA-1 and BRCA-2, were invalid. The case brought by a group including the American Civil Liberties Union, the Public Patent Foundation at the Benjamin N. Cardozo School of Law in New York and several medical institutions and individual patients, argued that, because genes are products of nature, they cannot be patented, The New York Times reports. Sweet ultimately agreed with this argument, dismissing claims from Myriad Genetics, which holds the contested gene patents, that the process of isolating genes makes them patentable. (Drawing on a 1980 Supreme Court decision in favor of patents on living organisms, many expected the federal judge to rule in favor of the patent holder, the New York Times reports.) Yet, ultimately, Sweet found the patents to be in violation of a “law of nature,” and openly condemned the argument that gene isolation should influence patentability, calling it ““a ‘lawyer’s trick’ that circumvents the prohibition on the direct patenting of the DNA in our bodies but which, in practice, reaches the same result.”

The ruling from the U.S. Court for the Southern District of New York state, has two major implications. First, if it withstands appeal, “it should greatly widen access to BRCA testing in the US, where Myriad’s patent has inflated the cost,” according to the Times of London. Currently, women have to pay Myriad Genetics some $3,000 in order to get tested for BRCA-1 or BRCA-2, NPR reports. In Europe, where patents on the two genes are either limited or shared with cancer research organizations, there is already wider access to the tests, according to the Times of London.

Yet beyond the significance for these two specific genes, the ruling could call into question some 2,000 existing patents—representing about 20% of all human genes. Speaking with Business Week, ACLU lawyer Christopher Hansen said, “The principal that an isolated gene is the same as a gene is a broad principal and may have an impact on other gene patents.” Myriad announced that it plans to appeal the March 29 ruling, setting in motion a legal process that could take several years and could likely reach the U.S. Supreme Court.

Read the full 152-page decision here (PDF).

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