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First Hearing Held in the Breast Cancer Gene Patents Challenge

Selene Kaye,
Director, Liberty Division,
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October 1, 2009

Fittingly, on the eve of Breast Cancer Awareness Month, plaintiffs had their first hearing in federal court yesterday in their challenge to the breast cancer gene patents. The government’s granting of exclusive rights to the BRCA1 and 2 human genes and Myriad Genetics’ aggressive enforcement of its patent rights means that some women cannot access genetic testing to find out if they are at increased risk for hereditary breast or ovarian cancer, and that no one can get a second opinion on their test results. It also means that Myriad controls whether scientific researchers can study the BRCA genes or develop new genetic tests.

For the 20 breast cancer and women’s health groups, individual women, genetic counselors, researchers, and scientific associations consisting of approximately 150,000 geneticists, pathologists, and laboratory professionals the ACLU represents, patents on human genes unacceptably restrict scientific freedom and access to information about one’s own genes. (For more information, read our post from May when the challenge was filed.)

Yesterday’s hearing was held on the motions to dismiss the case filed by the defendants — the U.S. Patent and Trademark Office and the patent holders, Myriad Genetics and the University of Utah Research Foundation — who claim that the plaintiffs have no right to sue in court. We argued that the case should be allowed to proceed because our plaintiffs’ rights are being violated by Myriad’s actions and by the Patent Office’s decision to issue gene patents in the first place, and that the court needs to provide a remedy because of the serious scientific and women’s health implications.

Major groups like the American Medical Association and the March of Dimes filed briefs in support of the plaintiffs’ position.

We expect a ruling this month. If the court allows the plaintiffs to proceed with their case, it will then hear further arguments on the plaintiffs’ claims.

To read the complaint, watch a video of our plaintiffs, and much more, visit

For people in the New York area who are interested in learning more about gene patents, there will be a film screening and panel discussion entitled, “The Breast Cancer Genes, Patents, and Access” held at the Cardozo School of Law on October 19. Details about the event are available here.

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