ACLU and PUBPAT Argue Against Patents on Breast Cancer Genes in Appeals Court

Patents for two genes associated with hereditary breast and ovarian cancer should be invalidated, attorneys from the American Civil Liberties Union and the Public Patent Foundation (PUBPAT) told a federal appeals court today.

The patents allow a Utah company, Myriad Genetics, to stop all other laboratories from offering genetic tests that are crucial to making informed medical and treatment decisions.

"Patent law was never intended to interfere with the rights of scientists and doctors to conduct their research and exchange ideas freely," said Chris Hansen, staff attorney with the ACLU Speech, Privacy and Technology Project. "Human DNA occurs in nature. It cannot belong to a particular company."

Last year, a divided U.S. Court of Appeals for the Federal Circuit ruled that companies can obtain patents on the genes but invalidated patents on methods of comparing gene sequences. A federal district court previously had invalidated all of the challenged patents. This year, the U.S. Supreme Court vacated the appellate court decision and sent the case back for re-consideration after ruling in a similar case that patents cannot be issued on natural processes.

"Genes are not 'invented,' so they cannot be said to be owned by anyone," said Daniel B. Ravicher, executive director of PUBPAT. "This is a case about whether a company own genes that occur naturally in our bodies simply because they removed them from the body. This is a genetic marker that occurs naturally in the human body. That should never be patented."

Myriad's monopoly on the BRCA genes allows it to set the terms and cost of testing and makes it impossible for women to access alternate tests or get a comprehensive second opinion about their results. It also allows Myriad to prevent researchers from even looking at the genes without first getting permission.

The restrictions on examining the BRCA genes can have devastating results. Kathleen Maxian of Buffalo, N.Y. is suffering from late-stage ovarian cancer that she believes could have been prevented. Her sister, who is a breast cancer survivor, obtained a test from Myriad that did not look for all known genetic mutations associated with cancer and was told she was negative for mutations. Years later her sister learned that she did, in fact, have a BRCA genetic mutation -- information that Maxian could have relied on to seek preventive surgery. Numerous labs across the country have stated that they are capable of providing this comprehensive screening and would do so were it not for the patents.

"Understanding genetic risk for breast and ovarian cancer is crucial for many women facing life-changing medical decisions," said Sandra Park, staff attorney with the ACLU Women's Rights Project. "Patients deserve access to the best quality care and research available, and that can't happen when only one company controls access to the genes."

Lisbeth Ceriani, a breast cancer survivor and plaintiff in the case, was faced with having to pay for Myriad's $4,000 test to determine if she carried a genetic mutation associated with hereditary ovarian cancer because Myriad had refused to enter into a contract with her insurance company. She was forced to wait 18 months before she was able to obtain the test through a grant, at which point she learned she did indeed carry the mutation.

"I had no other options available to me when I was seeking genetic testing for a potentially life threatening health issue," said Ceriani. "No one corporation should be able to deny me the right to look at a piece of my body."

The lawsuit was brought by researchers, genetic counselors, patients, breast cancer and women's health groups, and medical professional associations representing 150,000 geneticists, pathologists and laboratory professionals.

For more information on this case, please visit www.aclu.org/brca