Patents On Breast Cancer Genes Ruled Invalid in ACLU/PubPat Case

March 30, 2010

DETROIT – Patents on genes associated with hereditary breast and ovarian cancer are invalid, ruled a New York federal court yesterday. The precedent-setting ruling marks the first time a court has found patents on genes unlawful and calls into question the validity of patents now held on approximately 2,000 human genes. 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).

"The ruling is a victory for women, science and access to information," said Kary L. Moss, ACLU of Michigan executive director. "This
groundbreaking decision is the first step in putting an end to patents that restrict access to our genetic information and interfere with medical care. The court recognized  that gene patents are a public health issue and that human genome was discovered, not created, and therefore should not be patented.”

The ACLU and PUBPAT lawsuit was filed in May 2009 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 against the U.S. Patent and Trademark Office, as well as Myriad Genetics and the University of Utah Research Foundation, which hold the patents on the human genes, BRCA1 and BRCA2. The lawsuit 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."

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 court recognized the far-reaching impact of the case on medical research and public health. The opinion stated, "…the resolution of the issues presented to this Court deeply concerns breast cancer patients, medical professionals, researchers, caregivers, advocacy groups, existing gene patent holders and their investors, and those seeking to advance public health."

"The human genome, like the structure of blood, air or water, was discovered, not created," said Chris Hansen, a staff attorney with the ACLU First Amendment Working Group. “There is an endless amount of information on genes that begs for further discovery, and gene patents put up unacceptable barriers to the free exchange of ideas."

The specific patents the ACLU had challenged are on the BRCA1 and BRCA2 genes. Mutations along the BRCA1 and 2 genes are responsible for most cases of hereditary breast and ovarian cancers. Many women with a history of breast and ovarian cancer 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 or preventive mastectomies or ovary removal.

The patents granted to Myriad give 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 and allows Myriad to charge a high rate for their tests.

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.

Attorneys on the case include Hansen and Aden Fine of the ACLU First Amendment Working Group; Sandra Park and Lenora Lapidus of the ACLU Women's Rights Project; and Daniel B. Ravicher and Sabrina Hassan of PUBPAT.

On April 20, 2010, the ACLU of Michigan will host a public event entitled “Liberating the Breast Cancer Genes” at 7 p.m. at the Fetzer Center of Western Michigan University at 2350 Business Court, Kalamazoo. ACLU national staff attorney and lead attorney on the case, Chris Hansen, will discuss yesterday’s landmark ruling and how it will affect men and women in Michigan. More information about the event can be found at www.aclumich.org. In addition, Hansen will appear in Detroit on April 19. He will be available for press interviews on both dates. To schedule an interview, contact Rana Elmir, ACLU of Michigan communications director at 313.578.6816.

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