New court ruling may alter the legal landscape for gene patents.

and Trademark Of fice, Judge Robert Sweet struck down several patents for genes associated with susceptibility to breast and ovarian cancer.1 He found that they protect information, not inventions, and therefore fail to meet the criteria for patent validity. The ruling would negate most existing patents on genes and prevent the approval of future ones. The suit was brought by the American Civil Liberties Union (ACLU) along with several researchers, scientific organizations, and women who carry the genes. It targeted the patent-holders as additional defendants. These include a small biotechnology company, Myriad Genetics, Inc., and the University of Utah. The proceeding is commonly referred to as the Myriad Genetics case. The decision is certain to be appealed, and there is a good chance it will go all the way to the Supreme Court. The case will be closely watched as it proceeds. A ruling by the high court could establish the first clear legal guidelines on patents related to human genes. In the October 2009 issue of P&T, this column described the Myriad Genetics case after it had been filed.2 The outcome of the case, which is considered here, was a surprise to many. It gives new life to the movement to invalidate all patents on human genes.