Roche Molecular Sys., Inc. v. Cepheid United States Court of Appeals of the Federal Circuit, 2018 905 F.3d 1363

On motion for summary judgment, a district court invalidated for lack of patent eligibility claims directed towards PCR-based methods for detecting antibiotic resistant forms of pathogenic bacterium Mycobacterium tuberculosis (M. tuberculosis or MTB), and also claims reciting primers that would be used in performing the method. The Federal Circuit affirmed. With respect to the primer claims, the court found that, because the claimed primers had genetic sequences identical to those found in nature, their patent eligibility was precluded by the Federal Circuit's 2014 decision in In re BRCA1- & BRCA2-Based Hereditary Cancer Test Patent Litig., 774 F. 3d 755, 760 (Fed. Cir. 2014) (BRCA1), which found similar primer claims patent ineligible. The court was not persuaded by Roche's argument that the claimed primers were chemically and structurally distinct from naturally occurring MTB DNA, in particular due to the presence of both a 3-prime end and a 3-prime hydroxyl group on the primer DNA which is not present in naturally occurring DNA. Turning to the method claims, the Federal Circuit applied the Alice/Mayo test and found that under step one of the test the claims were directed towards a natural phenomenon, i.e., the relationship between "signature" nucleotide sequences unique to MTB and the presence of MTB in a sample. The court then concluded that the method claims lacked sufficient inventive concept to satisfy step two of the Alice/Mayo test, given that the "main action step" of the claimed methods is polymerase chain reaction (PCR) amplification, and that PCR implication and detection were "routine" when the patent application was filed in 1994. Judge O'Malley filed a concurring opinion agreeing with the majority that the BRCA1 decision compelled its conclusion that the claims are patent ineligible, but then urging the court to revisit BRCA1 en banc. In the view of Judge O'Malley, BRCA1 was a poor vehicle for deciding the patent eligibility of DNA primers due to the procedural posture of the case (review of a denial of patent owner's motion for preliminary injunction), and the court should reconsider en banc whether the chemical and structural differences between naturally occurring chromosomal DNA and synthetic PCR primers might be sufficient to render PCR primers patent eligible under the test set forth by the Supreme Court in Myriad.