Cases & Deals

Myriad Genetics maintains victory in reconsidered Federal Circuit appeal concerning fundamental questions of patent eligibility for isolated DNA molecules

Client(s) Myriad Genetics, Inc.

In a closely-watched case addressing fundamental questions of the patent eligibility of isolated DNA molecules, a Jones Day team successfully defended, for the second time, Myriad Genetics' patent claims directed to compositions concerning isolated DNA molecules that provide useful tools for the diagnosis and treatment of breast cancer. The Association for Molecular Pathology v. U.S. Patent and Trademark Office, Myriad Genetics, Inc. et al. (“Myriad”), was issued by the U.S. Court of Appeals for the Federal Circuit after reconsideration of its earlier judgment in light of the U.S. Supreme Court's March 2012 decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc.

The Myriad case began when 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 patent-eligible subject matter under Section 101 of the Patent Act, because the molecules were allegedly patent-ineligible "products of nature." Myriad appealed. The appeal attracted in excess of 30 different amicus curiae briefs on both sides of the dispute, including the U.S. Department of Justice, which disagreed with the Patent Office's longstanding policy and practice of issuing such patents on isolated genetic material.

In its original judgment, issued 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 patent-ineligible subject matter. In doing so, the Federal Circuit, in an opinion authored by Circuit Judge Alan Lourie, 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 had 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."

After the ACLU petitioned for Supreme Court review, the Supreme Court issued a GVR ("grant-vacate-remand") order in March 2012 for the Federal Circuit to reconsider its judgment in light of Mayo. Pursuant to the GVR order, the Federal Circuit ordered in Myriad a round of supplemental briefing and oral argument, again with over 30 different amicus parties, including the U.S. Department of Justice, also submitting briefs.

On August 16, 2012, the Federal Circuit issued its decision and once again determined that Myriad's patents on specific compositions of matter are patent-eligible. As Judge Lourie explained, the claimed isolated DNA molecules "are not found in nature" but instead "are obtained in the laboratory and are man-made, the product of human ingenuity." In her opinion again concurring in the judgment, Judge Moore reiterated the settled expectations of the biotechnology industry, noting that any failure to recognize those expectations and the Patent Office's longstanding policy and practice of issuing patents directed to isolated DNA molecules would improperly "strip an entire industry of the property rights it has invested in, earned, and owned for decades."

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

The Association for Molecular Pathology v. United States Patent and Trademark Office, Appeal No. 2010-1406 (Fed. Cir. Aug. 16, 2012)