The Federal Circuit recently affirmed a decision from the District Court for the Northern District of California granting appellee Cepheid’s summary judgment motion against appellant Roche Molecular Systems (“Roche”) and held that Roche’s patent was directed to patent ineligible subject matter under 35 U.S.C. § 101. 

Roche owns U.S. Patent No. 5,643,723 (“the ’723 patent”), which claims methods for detecting Mycobacterium tuberculosis (MTB)—a pathogenic bacterium, the infection of which causes tuberculosis. Previous MTB detection methods fell short in detecting MTB strains that are resistant to certain antibiotics, including rifampin, which is the standard of care for MTB treatment. Rifampin was known to have a unique site of action on a gene that encodes the β subunit of the rpoB gene, a gene that is naturally present in MTB. Roche scientists sequenced the rpoB gene in MTB and discovered that it contains 11 position-specific signature nucleotides that do not appear in the rpoB gene in other bacteria. From these 11 signature nucleotides, Roche inventors developed a diagnostic test to detect whether a sample of patient deoxyribonucleic acid (DNA) contained MTB, and if so, whether the MTB strain was resistant to rifampin treatment. The test utilized polymerase chain reaction (PCR) to amplify the rpoB gene, which if present would be marked by a set of primers at the gene’s beginning and end.