IP Newsflash

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.

In the Matter of Certain Activity Tracking Devices, Systems, and Components Thereof, ALJ Lord found two of Jawbone’s health- and sleep-tracking device patents invalid for being directed to ineligible subject matter. Applying the two-part Mayo test, ALJ Lord held that the asserted claims were (1) directed to abstract ideas and (2) did not provide an inventive concept. Jawbone’s U.S. Patent No. 8,961,413 is directed to a wearable device for sleep monitoring, while U.S. Patent No. 8,073,707 is directed to a wearable health and wellness data monitoring device.

On December 2, 2015, the Federal Circuit denied a petition for rehearing en banc to consider whether a three-judge panel had correctly affirmed a judgment of invalidity under 35 U.S.C. § 101. The court determined that although the nature of the claimed invention is such that it should be patentable, the Federal Circuit’s hands are tied by the Supreme Court’s two-part test in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012). The court also expressed concern about the implications of decisions like this on medical diagnostics patents: Judge Lourie stated, “[i]t is said that the whole category of diagnostic claims is at risk. It is also said that a crisis of patent law and medical innovation may be upon us, and there seems to be some truth in that concern.”