Roche Molecular Systems, Inc. v. Cepheid, No. 17-1690 (Fed. Cir. 2018)Annotate this Case
Roche’s 723 patent, titled “Detection of a Genetic Locus Encoding Resistance to Rifampin in Microbacterial Cultures and in Clinical Specimens,” is directed to methods for detecting the pathogenic bacterium Mycobacterium tuberculosis, a major cause of tuberculosis. In 1994, before the priority date of the 723 patent, the general method of MTB detection in a tuberculosis patient was known as sputum examination by the acid-fast bacilli smear. The diagnostic test of the 723 patent involves subjecting DNA extracted from a biological sample taken from a patient to amplification by polymerase chain reaction using a short, single-stranded nucleotide sequence that can hybridize (bind) to at least one of the eleven position-specific signature nucleotides in the MTB rpoB gene. The Federal Circuit affirmed summary judgment, holding that the patent’s claims are directed to patent-ineligible subject matter and are therefore invalid under 35 U.S.C. 101. Roche’s discovery of the signature nucleotides on the MTB rpoB gene and the designing of corresponding primers are valuable contributions to science and medicine, allowing for faster detection of MTB in a biological sample and testing for rifampin resistance but groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the section 101 inquiry. The primers can be found in nature.
The court issued a subsequent related opinion or order on October 11, 2018.