ACLU and PUBPAT Ask Supreme Court to Rule that Patents on Breast Cancer Genes Are Invalid

Lawsuit Filed on Behalf of Medical Associations, Geneticists, Patients and Breast Cancer and Women’s Health Groups

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WASHINGTON – The American Civil Liberties Union and the Public Patent Foundation today asked the U.S. Supreme Court to invalidate patents for two genes associated with hereditary breast and ovarian cancer that allow a Utah company to control access to crucial genetic tests that could lead to life-saving treatment.

A federal district court previously had invalidated all of the challenged patents. In August, a federal appeals court ruled for the second time that companies can obtain patents on the genes. Its 2-1 ruling followed a Supreme Court order directing the appeals court to reconsider its initial decision in light of a related patent case decided by the court last spring.

The lawsuit against Myriad Genetics and the University of Utah Research Foundation, which hold the patents on the genes, charges that the challenged patents are illegal and restrict both scientific research and patients’ access to medical care. Under well-established law, patents cannot be obtained on either “laws of nature” or “products of nature.” For example, neither the law of gravity nor minerals, like iron, can be patented. The lawsuit contends that patents on human genes violate this core principle of patent law and the Constitution.

“In our view, the court of appeals did not fully consider or correctly apply the Supreme Court’s most recent and relevant patent law decisions, said Chris Hansen, staff attorney with the ACLU Speech, Privacy and Technology Project. “DNA occurs naturally in the human body and cannot be patented by a single company that can then use its patents to limit scientific research and the free exchange of ideas.”

The patents granted to Myriad give the company the exclusive right to perform tests on the BRCA1 and BRCA2 genes and thus to control the diagnostic care provided to hereditary breast and ovarian cancer patients and people at high risk for these diseases. 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 tests that provide more comprehensive information about their genes or get a second opinion about their results. It also allows Myriad to prevent researchers from even looking at the genes without first getting permission from Myriad.

“Our genes were given to us by our creator, and not inventions created by Myriad,” said Daniel B. Ravicher, executive director of PUBPAT and co-counsel in the lawsuit. “The patenting of human genes, even in isolated form, has the effect of giving ownership over human genes to corporations, allowing them to decide who is allowed to know what they have inside their own body.”

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 breastcancer 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 through a more comprehensive set of tests 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 they are capable of providing this comprehensive screening and would do so were it not for the patents.

“We are asking the Supreme Court to rule in favor of women who are counting on access to the best possible medical care and research,” said Sandra Park, staff attorney with the ACLU Women’s Rights Project. “No single company should be able to stop the brightest scientific minds from advancing what we know about two genes that are connected to devastating diseases.”

Lisbeth Ceriani, a breast cancer survivor and plaintiff in the case, was faced with having to pay $4,000 for Myriad’s 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 does indeed carry a mutation that would not have been detected had she opted for Myriad’s standard and less expensive test. .

"I became a plaintiff in this case because I don't want other women to face the obstacles I did in obtaining personal genetic information in order to make life-and-death medical decisions,” Ceriani said. “My genes are my own. No corporation should be allowed 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. Attorneys on the case include Hansen, Park, Aden Fine, Lenora Lapidus and Steven R. Shapiro of the ACLU; and Ravicher and Sabrina Hassan of PUBPAT.

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