Federal Circuit Breathes Fire Into Biotechnology Patents and Holds Claims to Isolated DNA Molecules Patentable

August 2012Alerts Intellectual Property Alert

In welcomed news for biotechnology and pharmaceutical companies, the U.S. Court of Appeals for the Federal Circuit held claims to isolated DNA molecules and methods of screening potential anti-cancer therapeutics are patentable subject matter in view of the U.S. Supreme Court decision in Prometheus.

Myriad Genetics, Inc. and the Directors of the University of Utah Research Foundation (Myriad) appealed from the decision of the U.S. District Court for the Southern District of New York holding that an assortment of medical organizations, researchers, genetic counselors and patients (plaintiffs) had standing under the Declaratory Judgment Act to challenge Myriad’s patents. Ass’n for Molecular Pathology v. U.S. Patent & Trademark Office, 669 F. Supp. 2d 365 (S.D.N.Y. 2009) (DJ Op.).

Myriad also appealed from the district court’s decision granting summary judgment that all of the challenged claims were drawn to non-patentable subject matter under 35 U.S.C. § 101. Ass’n for Molecular Pathology v. U.S. Patent & Trademark Office, 702 F. Supp. 2d 181 (S.D.N.Y. 2010) (SJ Op.). The Federal Circuit affirmed in part and reversed in part.

This appeal has returned to the Federal Circuit as a petition for certiorari was filed from the Federal Circuit's decision of July 29, 2011 and The Supreme Court of the United States granted the petition, vacated the Federal Circuit’s decision and remanded the case to the Federal Circuit for further consideration in light of its decision in Mayo Collaborative Services v. Prometheus, Inc., 566 U.S. ___, 132 S. Ct. 1289 (2012). Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 132 S. Ct. 1794 (2012).

The Federal Circuit's decision on remand reversed the district court’s decision that Myriad’s composition claims to "isolated" DNA molecules cover patent-ineligible products of nature under §101 because each of the claimed molecules represents a non-naturally occurring composition of matter. The Federal Circuit also reversed the district court’s decision that Myriad’s method claim to screening potential cancer therapeutics via changes in cell growth rates of transformed cells is directed to a patent-ineligible scientific principle. The Federal Circuit affirmed the court’s decision, however, that Myriad’s method claims directed to "comparing" or "analyzing" DNA sequences are patent ineligible as such claims include no transformative steps and cover only patent-ineligible abstract, mental steps.

In reaching its decision, the Federal Circuit “further note[d] … that patents on life-saving material and processes, involving large amounts of risky investment, would seem to be precisely the types of subject matter that should be subject to the incentives of exclusive rights.”

For more information, please contact Gerard P. Norton , chair of Fox Rothschild’s Intellectual Property Department , or Jianming Jimmy Hao.