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From Health Law Daily, April 16, 2013

AMA urges Supreme Court to invalidate patents on human genes

By Sheila Lynch-Afryl, JD, MA

The American Medical Association (AMA) is urging the U.S. Supreme Court to end patents on human genes in an amicus brief it filed with other health care organizations in Association for Molecular Pathology v Myriad Genetics, Inc. The brief defended a ruling by the Federal Circuit that invalidated patents held by Myriad Genetics on the BRCA1 and BRCA2 genes.

“Exclusive patent rights over human genes conflict with long-standing principles of medical ethics regarding the sharing of natural scientific information to further advance science, technology and medical care,” said Jeremy Lazarus, MD, President of the AMA. He asserted that blocking medical innovations that provide insight into natural human biology interferes with diagnosis and treatment of patients and inhibits new medical discoveries.

Court proceedings. In 2009, the American Civil Liberties Union Foundation (ACLU) and the Public Patent Foundation (PPC) filed a declaratory judgment action alleging that certain of Myriad’s patents were ineligible under sec. 101 of the Patent Act. The district court invalidated Myriad’s claims, and Myriad appealed. A divided panel of the Federal Circuit reversed, with each judge writing a separate opinion on the patentability of human genes.

Supreme Court precedent. The AMA argued in its amicus brief that human gene patents conflict with the Supreme Court’s holding on subject matter eligibility in Mayo Collaborative Services v Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012), which held that laws of nature, natural phenomena, and abstract ideas are not patentable subject matter. Myriad did not invent the DNA sequences covered by the patents, the AMA argued; rather, Myriad removed them from the body using common, longstanding techniques.

Interference with diagnosis and treatment. Further, the AMA asserted, because a patent on the sequence of a human gene grants the patent holder complete control over that sequence for the life of the patent, the patent holder can prohibit health care providers from using even unpatented methods to learn the sequence of a patient gene. According to the AMA, the patenting of the BRCA1 and BRCA2 breast cancer mutations has forced patients to undergo tests that are inferior and more expensive than what are available in other countries. It also prevents women from getting an independent second opinion on positive test results, which could cause them to have their breast or ovaries removed due to a false positive on a BRCA1 or BRCA2 test.

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