Addressing patent eligibility under 35 USC § 101 for
gene-related patents, the US Court of Appeals for the Federal
Circuit affirmed the district court's grant of summary judgment
of invalidity, finding that the primers used to determine the
presence of the pathogenic bacteria were indistinguishable from
naturally occurring DNA. Roche Molecular Systems, Inc. v. Cepheid, Case No.
17-1690 (Fed. Cir. Oct. 9, 2018) (Reyna, J) (O'Malley,
J, concurring).
Roche owns a patent directed to a diagnostic test and methods of
using the test to determine the presence of the pathogenic bacteria
Mycobacterium tuberculosis (MTB). The underlying technology was
based on a discovery by Roche scientists that MTB contains 11
"signature nucleotides" that could be used as a
fingerprint identifier. The inventors subsequently developed a
diagnostic test involving amplification by polymerase chain
reaction (PCR) of a patient's DNA sample to determine if any of
the signature nucleotides are
