Yesterday a federal court ruled that the breast/ovarian cancer genes BRCA1 and BRCA2 are not patentable, invalidating seven patents for the only diagnostic test for mutations of these genes (BRACAnalysis). [See the New York Times story.]
The ruling has been long awaited and the implications are far reaching. At the heart of the matter is the question of whether patents for the identification of specific gene sequences stifles or promotes genetic research and development.
The case pitted the American Civil Liberties Union and the Public Patent Foundation (a not-for-profit organization affiliated with Benjamin N. Cardozo School of Law in New York) and individual cancer patients against Myriad Genetics and the University of Utah Research Foundation, which holds the patents for these gene sequences.
The ACLU—with amici curiae from the American Medical Association, the American Society of Human Genetics, the American College of Obstetricians and Gynecologists, the American College of Embryology, and the Medical Society of the State of New York—argued that genes cannot be patented and that such patents restrict both scientific research and patients’ access to medical care. In particular, the plaintiffs argued that the patents constituted a monopoly and prevented women from independently confirming their test results.
Myriad argued that without the ability to patent genetic sequences, there is no incentive to genetic investigation and the development of new diagnostic tests. In the promised age of personalized medicine, such research and development represents not only improved patient care but also a burgeoning industry, in which millions of dollars are at stake.
This story is far from over yet. The company plans to appeal the ruling, in the meantime leaving other existing gene-based patents in limbo.
—Kerri Wachter ( @knwachter on Twitter)
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