patent ineligible : CAFC Alert

The Patent-Ineligibility trend continues to be infectious…

| October 29, 2018

Roche Molecular Systems, Inc. v. Cepheid

October 9, 2018

Before O’Malley, Reyna and Hughes. Opinion by Reyna. Concurring opinion by O’Malley.


The contended patent, U.S. Patent No. 5,643,723 (‘723 patent), owned by Roche is directed to methods for detecting the pathogenic bacterium Mycobacterium tuberculosis (MTB). Prior to the priority date, the general methods of detection were slow (could take three to eight weeks), and they had limitations in that they could not identify if a patient has an antibiotic-resistant strain. The standard of care at the time was treatment with the antibiotic rifampin. However, outbreaks resulted due to delays in diagnosing and reporting of the rifampin-resistant tuberculosis. In 1994, rpoB became a prime candidate for studying rifampin resistance in MTB.

The inventors of the ‘723 patent sequenced the rpoB gene in MTB and discovered that that the rpoB gene in MTB contains eleven “position-specific” “signature nucleotides” (i.e., naturally occurring single nucleotide mutations) that are only present in MTB but not in other bacteria. Based on these eleven MTB-specific signature nucleotides, the Roche inventors devised a diagnostic test that could (1) identify whether or not a biological sample contains MTB, and (2) if MTB is present, predict whether that MTB is a strain that is resistant to rifampin treatment.

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