Federal Circuit Decides Myriad: Holds Isolated Genomic DNA Patentable


On July 29th, the Federal Circuit handed down its decision in the much-discussed Association for Molecular Pathology v. U.S. Patent and Trademark Office (commonly known as the “Myriad Genetics” case). The Federal Circuit split the baby — finding Myriad’s isolated BRCA DNA claims patentable, but its method claims for analyzing patients for mutations in these genes unpatentable.

Myriad Genetics (“Myriad”) owns various patents related to human BRCA1 and BRCA2 genes (Breast Cancer Susceptibility Genes 1 and 2). Some of the claims at issue were directed to the isolated DNA for these genes, while others claimed methods for analyzing these sequences for mutations associated with propensity for breast cancer. As a result of aggressive enforcement of the seven patents-in-suit, Myriad has been essentially the sole U.S. provider of diagnostic tests for these mutations.

A number of Medical Associations and individual doctors — assisted by the American Civil Liberties Union and the Public Patent Foundation — sued Myriad for a declaration that the patents were invalid because they were directed to unpatentable subject matter under § 101 of the Patent Code (and incidentally, that the Myriad patents violate the First Amendment to the Constitution because they restrict the communication of information).

In a surprising and highly controversial ruling, Judge Sweet of the Southern District of New York District Court ruled for the plaintiffs on their § 101 claims, finding that isolated DNAs corresponding to genomic DNA sequences are unpatentable products of nature, and that Myriad’s method claims were unpatentable because the method did not effect any meaningful transformation.

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