Breast Cancer Gene Patent Suit Heads Back To High Court

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The American Civil Liberties Union (ACLU) this week asked the U.S. Supreme Court to invalidate patents for two genes used to test for hereditary breast and ovarian cancer held by a Utah Company.

The lawsuit against Myriad Genetics of Utah – which holds the patents on genes called BRCA1 and BRCA 2 – charges that the patents are “illegal and restrict both scientific research and patients’ access to medical care.’’  In the 15 years that Myriad had held the patent, the cost for the test has more than doubled to about $3,340 —and plaintiffs say that the cost is too expensive for some women.

The ACLU and the Public Patent Foundation filed the lawsuit against Myriad in 2009 on behalf of 20 plaintiffs including Ellen Matloff of New Haven, a research scientist in genetics at the Yale School of Medicine and director of Cancer Genetic Counseling at the Yale Cancer Center.

The suit also raises broad legal and ethical questions under the First Amendment about whether genes are “products of nature’’ or commercial commodities.

Myriad has previously stated: “Since a landmark US Supreme Court decision in 1980, the US Patent and Trademark Office has granted tens of thousands of genetic and genetic related patents which cover a large number of life-saving pharmaceutical and diagnostic products…Myriad strongly believes that its patents are valid and enforceable and will be upheld by the courts.”

For women who have had breast or ovarian cancer before the age of 50, and/or have immediate family members who had had one of these cancers, the BRCA1 and BRCA2 genetic test could be a lifesaver.  Precautions can be taken by those who discover they have the mutation. The testing also detects familial risk in men. Yet many uninsured and underinsured candidates are finding Myriad’s monopoly testing costs out of reach, the lawsuit says.

Connecticut has the second highest incidence of female breast cancer in the nation – with 2,920 new breast cancer cases diagnosed in 2008—and ranks 35th in the nation for breast cancer mortality. The U.S Preventive Services Task Force estimates that 2 percent of all women – which would include about 2,700 of the uninsured women in Connecticut—are likely candidates for the BRAC Analysis test.

Sandra Park, staff attorney with the ACLU Women’s Rights Project, said, “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.  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.”

In July 2011, the U.S. Court of Appeals upheld the patents.  The appeals court decision was appealed to the U.S. Supreme Court and in March, the high court issued an order directing the appeals court to reconsider its initial decision in light of a related patent case decided by the court a year earlier.  In August, by a 2-to-1 vote, the appeals court ruled Myriad could hold the patents.


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