Tests for cancer genes BRCA1 and BRCA2 cannot be patented
Two genes called BRCA1 and BRCA2 can be passed on from parent to child and increase the risk of developing breast and ovarian cancer. Angelina Jolie, who has a family history of ovarian cancer, recently had a double mastectomy after having a positive test for BRCA1. She has a 50% lifetime risk of ovarian cancer, and plans to have her ovaries removed in the future. She drew attention to the high cost of the tests (approximately £2000) in a New York Times article.
The tests are available only from the US firm Myriad Genetics, which was granted a US patent in 1998 that gave it a monopoly over who can provide laboratory tests for the BRCA genes. The American Civil Liberties Union, representing 150,000 patients, geneticists and other laboratory and medical professionals challenged the patents in a US District Court. On 30 March 2010 that court ruled the patents invalid because Myriad had simply removed DNA that exists naturally in the body. The subsequent course of appeals is outlined in our news articles on 13 April 2010 and 8 August 2011.
The American Civil Liberties Union together with the Public Patent Foundation was finally able to take their challenge to the US Supreme court. On 13 June 2013 the court gave a unanimous ruling that human DNA was a product of nature, a basic tool of scientific and technological work, and so lay beyond the domain of patent protection.
The cost of BRCA tests is likely to be considerably lower without patent protection, and other laboratories will now be able to perform the tests. Patients will also be able to obtain a second opinion, which Myriad Genetics has previously not allowed.