Federal Circuit Summary

Before O’Malley, Reyna, and Hughes. Appeal from the District Court for the Northern District of California.

Summary: Testing for the presence of a bacterium that causes tuberculosis and the primers used in that testing were directed to patent-ineligible subject matter because the primers were indistinguishable from naturally occurring DNA.

Roche Molecular Systems, Inc. (“Roche”) brought a patent infringement case against Cepheid asserting that Cepheid’s product, Xpert® MTB/RIF Assay, infringed Roche’s patent directed to a primer that can bind to a tuberculosis bacterium and a diagnostic test using that primer. Cepheid filed a motion for summary judgment, arguing that all of the asserted claims are patent-ineligible under 35 U.S.C. § 101. The District Court granted Cepheid’s motion, finding both the primer claims and the method claims invalid.

The Federal Circuit affirmed the District’s Court’s decision. The Federal Circuit applied the Alice/Mayo two-step framework to the primer claims and the method claims separately. Regarding the primer claims, the Federal Circuit agreed that they are directed to nonpatentable subject matter because the primers are indistinguishable from their corresponding nucleotide sequences on naturally occurring DNA. Regarding the method claims, the Federal Circuit held that the claims are directed to a relationship between the signature nucleotides and tuberculosis, which is a naturally occurring phenomena and ineligible for patenting. The Federal Circuit held that the method claims do not contain an inventive concept that transforms the signature nucleotides into patent-eligible subject matter as the amplification and detection techniques were routine at the time the application was filed. Accordingly, the Federal Circuit affirmed the District’s Court’s decision.

Judge O’Malley concurred, writing separately to express her belief that the Federal Circuit’s prior holding in In re BRCA1- & BRCA2-Based Hereditary Cancer Test Patent Litig., 774 F.3d 755 (Fed. Circ. 2014), which O’Malley agreed with the majority compelled the conclusion in this case, was unduly broad and that the conclusion should be revisited en banc.