The Ass’n for Molecular Pathology, et al. v. U.S. Patent and Trademark Office and Myriad
Genetics, Inc., No. 2010-1406 (Fed. Cir. Aug. 16, 2012).

Myriad appeals from the district court’s decision granting summary judgment that the claims at issue are drawn to non-patentable subject matter under 35 U.S.C. §101. The claims included composition claims directed to “isolated” DNA sequences covering some or all of the BRCA gene related to breast cancer in humans, as well as method claims covering methods of comparing DNA sequences and methods of testing for the presence of the DNA sequences using transformed cells.

The Federal Circuit had previously held that the challenged claims did satisfy §101; that holding was vacated by the Supreme Court and remanded to the Federal Circuit to reconsider in light of the Court’s holding in Mayo Collaborrative Servs. v. Prometheus Labs., Inc., 132 S.Ct. 1289 (2012).

On remand, the Federal Circuit again held that claims directed to “isolated” DNA sequences were patentable subject matter under §101. The panel authored three decisions, with J. Lourie writing for the majority in concluding that:

While [the claimed isolated DNA molecules] are prepared from products of nature, so is every other composition of matter. All new chemical or biological molecules, whether made by synthesis or decomposition, are made from natural materials. For example, virtually every medicine utilized by today’s medical practitioners, and every manufactured plastic product, is either synthesized from natural materials (most often petroleum fractions) or derived from natural plant materials. But, as such, they are different from natural materials, even if they are ultimately derived from them. The same is true of isolated DNA molecules.

Slip. Op. at 38-39. However, the court did maintain that the method claims directed to a comparison of two gene sequences did not satisfy §101 because “they claim only abstract mental processes.” Id. at 56. Where the method claims further required cells that had been transformed with the claimed DNA sequences, the court held that was sufficient to meet the requirements of §101.

The panel also addressed the threshold question of declaratory judgment jurisdiction, holding that all but one of the declaratory judgment plaintiffs lacked sufficient case or controversy to establish jurisdiction where they “were not the target of any enforcement action or offered license agreements by [patentee] and had made no preparation to undertake potentially infringing activities.” Id. at 36.

A copy of the opinion can be found here.