Breast and Ovarian Cancer Gene Patents Invalidated by US Supreme Court

On June 13, 2013, the US Supreme Court (Washington DC, USA) unanimously invalidated patents on two genes tied to ovarian and hereditary breast cancer in response to a lawsuit filed by the American Civil Liberties Union (ACLU; New York, NY, USA) and the Public Patent Foundation (PUBPAT; New York, NY, USA) on behalf of genetic counselors, patients, researchers, breast cancer and women’s health groups, and medical professional associations representing 150,000 geneticists, pathologists, and laboratory specialists.

The patents allowed Myriad Genetics (Salt Lake City, UT, USA) to control access to the genes, known as breast cancer1 (BRCA1) and BRCA2, thus giving them the right to restrict others from doing diagnostic or research 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 hard for women to gain access to alternate testing or acquire a comprehensive second opinion about their test findings.

“Today, the court struck down a major barrier to patient care and medical innovation,” said Sandra Park, senior staff attorney with the ACLU Women’s Rights Project. “Myriad did not invent the BRCA genes and should not control them. Because of this ruling, patients will have greater access to genetic testing and scientists can engage in research on these genes without fear of being sued.”

The court found that the patents on human genes are invalid, which represents a vital shift in patent law and overturns current Patent Office policy. The court also found that patents on complementary DNA (cDNA), are patent-eligible. Scientists can provide genetic testing without relying on cDNA. Thus, the court’s ruling lifted the patent hurdle to offering genetic diagnostic testing.

“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 and co-counsel in the lawsuit.

A US federal district court invalidated all of the challenged patents in 2010. In 2012, for the second time, a US federal appeals court ruled that the patents on the genes were lawful. Its 2-1 decision followed a Supreme Court order directing the appeals court to reconsider its initial decision in light of a related patent case decided by the Supreme Court the spring of 2012.

Related Links:
American Civil Liberties Union
Public Patent Foundation
Myriad Genetics