In
Roche Molecular Systems, Inc. v Cepheid, (Slip Op. 2017-1690,
October 9, 2018), the Federal Circuit held that patent claims
directed to primers and methods of detecting pathogenic bacteria
using the primers are invalid for failing to claim patent-eligible
subject matter. The decision summarizes this panel's current
thinking on the patent-eligibility of unmodified polynucleotides
and methods to detect "natural phenomena" using
"conventional" tools. Also, the panel deferred opining on
the patent-eligibility of modified polynucleotides and the use of
polynucleotides as therapeutics.
U.S. Patent No. 5,643,723 – Detecting Rifampin
Resistance
U.S. Patent No. 5,643,723 ("the '723 Patent"),
titled "Detection of a Genetic Locus Encoding Resistance to
Rifampin in Microbacterial Cultures and in Clinical Specimens"
is owned by Appellant Roche Molecular Systems, Inc.
("Roche"). The '723 Patent claims methods for
detecting pathogenic bacterium Mycobacterium