March 27, 2012

Breast Cancer Gene Patent Case Heads Back To Appeals Court

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The U.S. Supreme Court has ordered a federal appeals court to review its decision to grant patents to Myriad Genetics for two genes that are predictive for hereditary breast and ovarian cancer.

A lawsuit, challenging the patenting of BRCA 1 and BRCA 2 genes, was brought by the American Civil Liberties Union and the Public Patent Foundation, on behalf of 20 plaintiffs, representing more than 150,000 interested parties.  One of the individual plaintiffs is 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 challenged Myriad’s right to patent genes and set prices that “lock out” some women from getting the test.  The suit claims that the patents unfairly limit both scientific research and patient options for genetic testing, and raises broad legal and ethical questions under the First Amendment about whether genes are “products of nature” or commercial commodities. (To read previous story on the case click here.)

In July 2011, a federal appeals court upheld Myriad Genetics’ gene patent eligibility—involving tests on isolated DNA in the BRCA 1 and 2 genes.  The ACLU appealed that decision to the Supreme Court.

This week’s order comes after a recent high court ruling that a blood test developed by Prometheus Laboratories of California, was not eligible for a patent because it was a “simple application of a law of nature.”

“In light of recent rulings from the court that mere laws of nature cannot be patented, we hope that the lower court will come to the correct conclusion this time around,” said Chris Hansen, staff attorney with the American Civil Liberties Union (ACLU) Speech, Privacy and Technology Project.  “It’s inconceivable that a company can own a patent on something as naturally occurring as DNA.”

“Preventing the free flow of ideas regarding genetic testing is not only unlawful, it is dangerous to patients,” said Sandra Park, staff attorney with the ACLU Women’s Rights Project.

Peter Meldrum, president and CEO of defendant Myriad Genetics of Salt Lake City, said in a statement posted on Myriad’s website that the company is “… prepared to vigorously defend the patent claims granted to Myriad by the U.S. Patent and Trademark Office and believe that we will be successful.”  Meldrum doesn’t believe the ruling will have any direct impact to Myriad and its operations because of their “extensive patent estate” and because “…it has great importance to the medical, pharmaceutical, biotechnology and other commercial industries, as well as the hundreds of millions of people whose lives are bettered by the products these industries develop based on the promise of strong patent protection.”

Daniel B. Ravicher, executive director of Public Patent Foundation and co-counsel for the plaintiffs, said, “Nobody ‘invents’ genes, so no one should be able to claim ownership of them.  We are not talking about a new drug or a new tool to fight cancer. We are talking about a genetic marker that occurs naturally in the human body. That cannot, and should not, be patented.”

For women who have had breast or ovarian cancer before the age of 50, and/or have an immediate family member who has had one of these cancers, the BRCA 1 and BRAC 2 genetic test could be a lifesaver.  Yet many uninsured and underinsured candidates are finding Myriad’s monopoly testing costs out of reach.

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 – or about 2,700 of the uninsured women in Connecticut—are likely candidates for the BRAC Analysis test.  Precautions can be taken by those who know they have the mutation.

Research shows that 5 to 10 percent of all breast cancers are in people who have inherited BRCA mutations. The mutations can signal a 60 to 85 percent lifetime risk for more than one primary breast cancer, and a 15 to 50 percent lifetime risk for ovarian cancer. The risk statistics for the general population are 12.2 percent for breast cancer, and 1.4 percent for ovarian cancer.

The testing also detects risk in men. If a man’s sister or mother has the BRCA 1 or BRAC 2 mutation, he has a 50 percent chance of also having it. Men carrying the mutation have a 6 to 7 percent chance of having male breast cancer, compared to less than 1 percent in the general population.

Since beginning their BRAC Analysis testing in 1996, Myriad has more recently added a second, related, patent-protected test called BART.  The BART test, so far, is not widely covered by any insurance, yet is deemed essential by many genetic counselors for those identified at risk for these cancers.

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