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AMP v. Myriad: Gene Patents » Supreme Court to Hear PUBPAT Case Challenging Patents on Breast and Ovarian Cancer Genes

SUPREME COURT TO HEAR PUBPAT CASE CHALLENGING PATENTS ON BREAST AND OVARIAN CANCER GENES: PUBPAT and ACLU Filed on Behalf of Medical Associations, Geneticists, Patients and Breast Cancer and Women’s Health Groups

WASHINGTON – The U.S. Supreme Court announced today that it will hear arguments in a case seeking to invalidate patents for two genes associated with hereditary breast and ovarian cancer.

The original lawsuit was filed by the Public Patent Foundation (PUBPAT) and the American Civil Liberties Union (ACLU) on behalf of researchers, genetic counselors, patients, breast cancer and women's health groups, and medical professional associations representing 150,000 geneticists, pathologists and laboratory professionals. The patents allow a Utah company to control access to crucial genetic information used to make important medical decisions.

The lawsuit charges that the challenged patents are unlawful because genes are “products of nature” and restrict both scientific research and patients’ access to medical care.

A federal district court invalidated all of the challenged patents in 2010. In August, a divided federal appeals court ruled for the second time that companies can obtain patents on the genes. Its 2-1 ruling, in which one of the three appeals court judges dissented and stated he believed the patents are indeed invalid, followed a Supreme Court order directing the appeals court to reconsider its initial divided 2-1 decision in light of a related patent case decided by the Supreme Court last spring relating to the patentability of medical diagnostics.

“Myriad did not invent human genes, and has no right to claim ownership of them just because they removed them from the body,” said Daniel B. Ravicher, Executive Director of PUBPAT and a Lecturer in Law at Benjamin N. Cardozo School of Law. “The government does not have the right to give a corporation the exclusive power to control what we know about our own genetic makeup.”

The patents granted to Myriad Genetics and the University of Utah Research Foundation give the company the exclusive right to 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 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 from Myriad.

“The Court of Appeals failed to consider the Supreme Court’s most recent ruling on patent law,” said Chris Hansen, of the ACLU, which is co-counsel with the PUBPAT in the lawsuit. “It’s wrong to think that something as naturally occurring as DNA can be patented by a single company that limits scientific research and the free exchange of ideas.”

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. 

Lisbeth Ceriani, a breast cancer survivor and plaintiff in the case, was faced with having to pay over $4,000 for Myriad’s testing 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 a mutation.

“No woman should have to go through what I went through to take care of herself and her family,” said Ceriani. “My genes are my own. Knowledge about my own body shouldn’t belong to a corporation.”  

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 Ravicher and Sabrina Hassan of PUBPAT; and Hansen, Park, Aden Fine, Lenora Lapidus and Steven R. Shapiro of the ACLU.

For more information on this case, including a copy of the petition for cert granted by the Supreme Court today, please visit www.pubpat.org/brca.htm.

Support for this project comes from the Nathan Cummings Foundation.
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