Divided Appeals Court Rules That Companies May Patent Breast Cancer Genes, but Invalidates Patents on Comparing the Genes

In a 2-1 decision, a federal appeals court today 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.

The ruling follows a lawsuit brought by a group of patients and scientists represented by the American Civil Liberties Union and the Public Patent Foundation (PUBPAT) and calls into question the validity of patents now held on approximately 4,000 human genes.

"Today's ruling is a blow to the idea that patent law cannot impede the free flow of ideas in scientific research," said Chris Hansen, a staff attorney with the ACLU Speech, Privacy and Technology Project. "Human DNA is not a manufactured invention, but a natural entity like air or water. To claim ownership of genetic information is to unnecessarily block the free exchange of ideas."

The lawsuit against Myriad Genetics and the University of Utah Research Foundation, which hold the patents on the genes, 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 First Amendment and patent law because genes are "products of nature."

"As the dissent from today's decision explains, pieces of the human genome are not patentable," said Daniel B. Ravicher, executive director of PUBPAT and co-counsel in the lawsuit. "This is because no one 'invents' genes. Inventions are things like new genetic tools or drugs, all of which can be patented because they are not genes themselves."

The specific patents the lawsuit challenged are on the BRCA1 and BRCA2 genes. Mutations along those genes are responsible for most cases of hereditary breast and ovarian cancers. Many women with a history of those cancers in their families opt 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 critical in helping these women decide on a plan of treatment or prevention, including increased surveillance, preventive mastectomies or ovary removal.

One of the judges on the panel dissented in part with the decision, writing that patents on the genes should be invalid. "...[E]xtracting a gene is akin to snapping a leaf from a tree," Judge William C. Bryson of the U.S. Court of Appeals for the Federal Circuit wrote. "Like a gene, a leaf has a natural starting and stopping point. It buds during spring from the same place that it breaks off and falls during autumn. Yet prematurely plucking the leaf would not turn it into a human-made invention."

The lawsuit, Association for Molecular Pathology, et al. v. Myriad Genetics, Inc., was filed on behalf of breast cancer and women's health groups, individual women, geneticists and scientific associations representing approximately 150,000 researchers, pathologists and laboratory professionals. Because the ACLU's lawsuit challenges the whole notion of gene patenting, its outcome could have far-reaching effects beyond the patents on the BRCA genes. Approximately 20 percent of all human genes are patented, including genes associated with Alzheimer's disease, muscular dystrophy, colon cancer, asthma and many other illnesses.

The patents granted to Myriad gave the company the exclusive right to perform diagnostic tests on the BRCA1 and BRCA2 genes and to prevent any researcher from even looking at the genes without first getting permission from Myriad. Myriad's monopoly on the BRCA genes makes it impossible for women to access alternate tests or get a comprehensive second opinion about their results. It also allows Myriad to charge a high price for its tests.

"The court has made the wrong decision for a women's health," said Sandra Park, staff attorney with the ACLU Women's Rights Project. "No corporation should be able to claim ownership of a woman's own genetic information."

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

Attorneys on the case include Hansen and Aden Fine of the ACLU Speech, Privacy and Technology Project; Park and Lenora Lapidus of the ACLU Women's Rights Project; and Ravicher and Sabrina Hassan of PUBPAT.

Today's decision can be found online at:
www.aclu.org/womens-rights/association-molecular-pathology-et-al-v-myriad-genetics-inc-appeals-court-decision

More information about the case, including an ACLU video featuring breast cancer patients, plaintiff and supporter statements and declarations and the legal complaint, can be found online at: www.aclu.org/brca