ROCHE MOLECULAR SYSTEMS, INC. V. CEPHEID
- Oct 9 2018 |
- Category: CAFC Updates
Appellant Roche owns U.S. Patent No. 5,643,723 directed to methods for detecting the pathogenic bacterium Mycobacterium tuberculosis (“MTB”), and sued Appellee Cepheid who makes and sells “Xpert® MTB/RIF Assay,” an assay that can detect MTB in a biological sample and can identify rifampin-resistant MTB. The District Court found that the asserted claims of the ’723 patent are directed to patent-ineligible subject matter and are therefore invalid under 35 U.S.C. § 101. Roche appeals from a grant of summary judgment of invalidity. The CAFC finds that the claimed primers are indistinguishable from their corresponding nucleotide sequences on the naturally occurring DNA, and that the primer claims, therefore, are patent-ineligible within the meaning of § 101. The CAFC also holds that the method claims do not contain an inventive concept that transforms the eleven position-specific signature nucleotides of the MTB rpoB gene into patent-eligible subject matter. Thus, the CAFC affirms. Judge O’Malley concurs in a separate opinion.