Surprise Reversal of U.S. Government Position Frames the Issues in Myriad Genetics’ Federal Circuit Appeal


The past two weeks have seen important developments in Myriad Genetics, Inc.’s appeal to the United States Court of Appeals for the Federal Circuit in Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al., No. 2010-1406, a case with significant implications for the biotechnology industry. Myriad’s appeal challenges the ruling of the United States District Court for the Southern District of New York that patent claims directed to isolated DNA molecules and diagnostic methods using those isolated molecules are invalid because they do not claim patent-eligible subject matter.

On October 22, 2010, Myriad filed its Brief in the Federal Circuit. On October 29, 2010, the United States filed a brief as amicus curiae, nominally in support of neither party. Although the United States agreed with Myriad that the district court erred in invalidating patent claims directed at synthetic complementary DNA molecules (cDNA), the United States argued that the district court correctly found that isolated and purified DNA molecules are not patentable. The United States acknowledged that this position was contrary to the long-standing positions and practices of several government agencies, including the PTO, but argued that it was consistent with older Supreme Court precedent regarding patentable subject matter.

There will be additional briefing in the case, and oral argument is expected in the spring of 2011, with an opinion likely in late summer or early fall of 2011.

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