ENZO LIFE SCIENCES, INC. v. ROCHE MOLECULAR SYSTEMS, INC.

ENZO LIFE SCIENCES, INC. v. ROCHE MOLECULAR SYSTEMS, INC., Appeal Nos. 2017-2498 -2499, -2545 and -2546 (Fed. Cir. July 5, 2019).  Before Prost, Reyna, and Wallach.  On appeal from D. Del. (Chief Judge Stark).  (Enabling Disclosure)

Background:

Enzo Life Sciences (Enzo) sued Roche Molecular Systems, Inc. and others (Roche) for infringement of two patents, drawn to hybridizable non-radioactively labeled polynucleotides that are detectable upon hybridization.  These materials and earlier radioactively labeled polynucleotides are known as “probes” in the art and are used to detect the presence of nucleic acid sequences of interest.  Non-radioactively labeling was just developing at the time of the claimed inventions.  The first successful non-radioactively labeled probes were developed in 1981 and a patent portfolio covering this technology was exclusively licensed to Enzo.  Enzo soon thereafter filed an initial application in 1982, from which priority was claimed by the applications, filed in 1995, that became the two patents in suit.

The claims in the narrower of the two patents are not directed to any specific polynucleotide, nor do they focus on the chemistry or linker used to attach a label, the number of labels to attach to a polynucleotide, or where within the polynucleotide to attach those labels. Instead, the claims encompass all polynucleotides with labels attached to a phosphate,[1] as long as the polynucleotide remains hybridizable and detectable upon hybridization.

A motion for summary judgment by Roche on grounds of patent invalidity for lack of enablement was granted.  Enzo appealed to the Federal Circuit.

Issue/Holding:

Did the district court err in granting summary judgment to Roche? (continue reading)

Summary by:  Harris Pitlick

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[1] A single nucleotide is made up of a sugar, a phosphate, and a nitrogenous base.