Cases & Deals

Myriad Genetics prevails in closely watched Federal Circuit appeal concerning fundamental questions of patent eligibility for isolated DNA molecules

Client(s) Myriad Genetics, Inc.

In a widely followed case addressing fundamental questions of patent eligibility for isolated genetic material, a Jones Day team prevailed on behalf of Myriad Genetics on appeal in the U.S. Court of Appeals for the Federal Circuit. Myriad owns patents relating to its BRCA1 and BRCA2 genetic-analysis products, and to diagnostic and other methods using isolated DNA molecules. The ACLU assembled 20 plaintiffs to challenge Myriad's patents, and initiated a declaratory-judgment lawsuit against Myriad. Judge Robert W. Sweet of the U.S. District Court for the Southern District of New York entered summary judgment against Myriad, holding that Myriad's patent claims directed to compositions concerning isolated DNA did not constitute patentable subject matter under Section 101 of the Patent Act, because the molecules were allegedly unpatentable "products of nature." Myriad appealed.

On appeal, the U.S. Department of Justice filed a brief that disagreed with the Patent Office's longstanding policy and practice of issuing such patents on isolated genetic material, and the acting Solicitor General of the United States argued against Myriad in the Federal Circuit as amicus curiae. The appeal attracted in excess of 30 different amicus curiae briefs on both sides of the dispute. On July 29, 2011, the Federal Circuit ruled in Myriad's favor and "reject[ed] the district court's unwarranted categorical exclusion of isolated DNA molecules" as patentable subject matter. In doing so, the Federal Circuit determined that Myriad's patent claims directed to isolated DNA molecules "are drawn to patentable subject matter because the claims cover molecules that are markedly different—have a distinctive chemical identity and nature—from molecules that exist in nature." As explained in the concurring opinion of Circuit Judge Kimberly Moore, the decision has broad significance to the U.S. biotechnology industry: "Isolated DNA claims . . . represent crucial and exceedingly valuable property rights. . . . The settled expectations of the biotechnology industry—not to mention the thousands of issued patents—cannot be taken lightly and deserve deference."

The cross-office, cross-practice team representing Myriad included Intellectual Property practice co-chair Brian Poissant of New York, who led the team; Federal Circuit practice leader Greg Castanias of Washington, D.C., who argued the appeal before the Federal Circuit; Laura Coruzzi, Barry Satine, and Lynda Nguyen of New York; Sasha Mayergoyz of Chicago; and Eileen Falvey and Sebastian Martinek of Boston.

The Association for Molecular Pathology v. United States Patent and Trademark Office, Appeal No. 2010-1406 (Fed. Cir. July 29, 2011)