Supreme Court Says Genes Can’t Be Patented

It wasn’t even close. All nine judges in last week’s U.S. Supreme Court ruling said that human genes are not patentable. The rare 9-0 ruling went against Myriad Genetics, a Utah company that had patented BRCA1 and BRCA2, genes whose presence signify a much higher probability that their human hosts will get breast or ovarian cancer.

Myriad had been sued by the American Civil Liberties Union (ACLU) and the Public Patent Foundation (PUBPAT) 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 Myriad to control access to the genes. That means they could limit other research on or diagnostic testing for the genes. A woman, such as Angelina Jolie, who famously had her breasts removed after learning that she carried the BRCA1 gene, can’t make informed medical decisions without having this genetic information. The patents also enabled Myriad to dictate the cost of the tests and make it difficult for people who paid to get a comprehensive second opinion about the results.

Many U.S. labs have been prevented from providing comprehensive BRCA screening for fear of being sued by Myriad, and many patients have been denied comprehensive diagnosis either because they had no access to the testing, or couldn’t afford it.

The court’s decision confirmed that Myriad didn’t create or invent BRCA genes, that you can’t patent something fundamentally natural. It did, however, rule that synthetic genetic material is patentable.

To learn more about breast cancer, see our backgrounder. To learn more about genetic testing, see our newsletter, “Learning Your Own DNA Sequence: the Promise and Peril of Genetic Testing.”