US Appeals Court Rules Breast Cancer Genes May Be Patented, but Nullifies Patents Comparing Sequences

In a 2-1 decision, a US Federal Appeals court once again partially reversed a lower court’s ruling in a case challenging patents on two human genes associated with hereditary breast cancer and ovarian cancer. The court ruled that companies can obtain patents on the genes but cannot patent methods to compare those gene sequences.

This is the second time the court has considered this lawsuit, brought by a group of patients and scientists represented by the American Civil Liberties Union (ACLU; New York, NY, USA) and the Public Patent Foundation (PUBPAT; New York, NY, USA). In 2011, the US Supreme Court ordered the case to be reheard after ruling in a similar case that patents cannot be issued on natural processes. The same three appeals court judges reheard the case.

“It is extremely disappointing that despite the Supreme Court’s ruling, the appeals court has failed to fully reconsider the facts of this case,” said Chris Hansen, a staff attorney with the ACLU Speech, Privacy and Technology Project. “This ruling prevents doctors and scientists from exchanging their ideas and research freely. Human DNA is a natural entity like air or water. It does not belong to any one company.”

The lawsuit against Myriad Genetics (Salt Lake City, UT, USA) and the University of Utah Research Foundation (Salt Lake City, UT, USA), which holds the gene patents, charged that the challenged patents are illegal and restrict both scientific research and patients’ access to medical care, and that patents on human genes violate the US First Amendment and patent law because genes are “products of nature.”

“Human genes are not like new genetic tools or drugs, which can be patented because they are manufactured,” said Daniel B. Ravicher, executive director of PUBPAT and co-counsel in the lawsuit. “It is absurd to think that a company can own naturally occurring human genes simply because they removed them from the body.”

The specific patents the lawsuit challenged are on the BRCA1 and BRCA2 genes. Mutations combined those genes are responsible for most cases of hereditary breast and ovarian cancers. Many women with a history of those cancers in their families choose to undergo genetic testing to determine if they have the mutations on their BRCA genes that put them at increased risk for these diseases. This information is crucial in helping these women decide on a plan of treatment or prevention, including increased surveillance, ovary removal, or preventive mastectomies.

Myriad’s monopoly on the BRCA genes allows it to set the terms and cost of testing and makes it unfeasible for women to access alternate tests or received a thorough second opinion about their results. It also allows Myriad to prevent researchers from even examining the genes without first getting permission.

“This is a devastating decision for a woman’s health,” said Sandra Park, staff attorney with the ACLU Women’s Rights Project. “Patients facing life-changing medical decisions deserve the best quality care and research available. They should not be blocked from getting that care because a company owns the exclusive right to access their genes.”

Several major organizations, including the American Medical Association, the March of Dimes, and the American Society for Human Genetics, filed amicus curiae [friend of the court] briefs in support of the challenge to the patents on the BRCA genes. Moreover, the United States Department of Justice filed a brief for the second time, arguing that many of the gene patents issued by the Patent Office are invalid.

Related Links:
American Civil Liberties Union
Public Patent Foundation