The U.S. Supreme Court unanimously invalidated patents on two genes associated with hereditary breast and ovarian cancer in response to a lawsuit filed by the Public Patent Foundation (PUBPAT) and the American Civil Liberties Union on behalf of researchers, genetic counselors, patients, breast cancer and women's health groups, and medical professional associations representing 150,000 geneticists, pathologists, and laboratory professionals.
The patents allowed a Utah company, Myriad Genetics, to control access to the genes, known as BRCA1 and BRCA2, thereby giving them the right to limit others from doing research or diagnostic testing of the genes, which can be crucial for individuals making important medical decisions. The patents also allowed Myriad to set the terms and cost of testing and made it difficult for women to access alternate tests or get a comprehensive second opinion about their results.
“The Court rightfully found that patents cannot be awarded for something so fundamental to nature as DNA,” said Daniel B. Ravicher, Executive Director of PUBPAT. "Bottom line, diagnostic genetic testing is now free from any patent threat, forever, and the poor can now have their genes tested as freely as the rich."
The Court found that the patents on human genes are invalid, which represents a major shift in patent law and overturns current Patent Office policy. The Court also found that patents on complementary DNA, or cDNA, are patent-eligible. Scientists can provide genetic testing without relying on cDNA. Thus, the Court’s ruling lifted the patent obstacle to offering genetic diagnostic testing.