The ACLU has announced its victory in Association for Molecular Pathology v. Myriad Genetics, the human genome breast cancer patent case, where the US Supreme court has unanimously invalidated the patents of two genes associated with hereditary breast and ovarian cancer. The ACLU and the Public Patent Foundation had filed a lawsuit 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 Supreme Court decision can be accessed here. The patents had initially allowed a Utah company, Myriad Genetics, to control access to the genes, known as BRCA1 and BRCA. The company limited the right of others from doing research or diagnostic testing of the genes, a crucial component for medical diagnosis. 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 result
The decision basically recognized and held that genes and the information they encode are not patent eligible simply because they have been isolated from the surrounding genetic material. The genes patented do not comply with the requirements of the patent act which permits patents to be issued to “[w]hoever invents or discovers any new and useful . . . composition of matter,” §101, but “laws of nature, natural phenomena, and abstract ideas”” ‘are basic tools of scientific and technological work’ ” that lie beyond the domain of patent protection.