In Roche Molecular Systems, Inc. v. Cepheid,
the Federal Circuit affirmed the summary judgment decision of the
U.S. District Court for the Northern District of California that
held nucleotide primer claims and detection method claims invalid
under 35 USC § 101. This decision may be at odds with USPTO
guidance that claims directed to a method of detection without a
diagnostic correlation are patent-eligible. Judge
O'Malley's concurrence highlights the problem of giving
precedential effect to patent eligibility decisions rendered on
limited factual records.
The Detection Method And Primers At Issue
The patent at issue was Roche's U.S. Patent No. 5,643,723,
which relates to primers and methods for detecting M.
tuberculosis based on the detection of certain
"signature" nucleotides for M. tuberculosis
(MTB). According to the patent, the "invention
provides a rapid, sensitive and specific process for detecting
in vitro the presence of [MTB] and its
