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ARTICLE · 23 OCTOBER 2018

Diagnostic Method Claims And Primer Tools Lack Patent-Eligibility

The decision summarizes this panel's current thinking on the patent-eligibility of unmodified polynucleotides and methods to detect "natural phenomena" using "conventional" tools.

United StatesIntellectual Property

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

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