Claims Directed to Detection of Gene Variants Patent-Ineligible, Notwithstanding Mental Activity Requirement

Genetic Technologies Ltd. v. Merial L.L.C., __ F.3d __ (Fed. Cir. Apr. 8, 2016) (Prost, DYK, Taranto) (D. Del.: Stark) (4 of 5 stars)

Federal Circuit affirms judgment that patent claims are invalid under § 101.

Genetic Technologies' claims are directed to methods for detecting alleles (i.e., alternative forms or mutations) of certain genes in a DNA sample. Central to the claims is the notion of "linkage disequilibrium"—the principle that certain DNA regions that code for proteins are "linked" or correlated in an individual's genome with certain DNA regions that do not code for protein, even though the sequences may be located far apart on the chromosome. Specifically, the claims describe amplifying and analyzing DNA regions that are non-coding, but are known to be "linked" to coding regions, so as to infer that the non-coding region is present or absent.

The Federal Circuit held that the district court did not err in finding these claims unpatentable. Applying step 1 of Alice Corp. v. CLS Bank International, 134 S. Ct. 2347, 2355 (2014), the opinion describes how the claims broadly covered "essentially all applications . . . of the law of linkage disequilibrium to the problem of detecting coding sequences of DNA." Slip op. at 9. As in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289, 1296-97 (2012), and Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1373-74, 1376 (Fed. Cir. 2015), petition for cert. filed, No. 15-1182 (U.S. Mar. 21, 2016), the central relationship at issue was a consequence of natural processes.

Applying Alice step 2, none of the additional recited elements provided an inventive concept necessary to confer patent eligibility. The claimed method's steps of "amplifying" and "analyzing" DNA were well-known when the patent application was filed. And claim 1's requirement that the DNA analysis be performed to "detect the [coding region] allele" was "a mental process step, one that provides claim 1 with a purpose but does not create the requisite inventive concept, because it merely sets forth a routine comparison that can be performed in the human mind." Slip op. at 16. The opinion reasons (citing Ariosa and In re BRCA1- & BRCA2-Based Hereditary Cancer Test Patent Litigation, 774 F.3d 755, 762-65 (Fed. Cir. 2014)), that the aspects of the patentee's claims that were potentially patent-eligible did not add enough to distinguish the claim from the underlying abstract idea. That the underlying discovery concerning linkage disequilibrium seems to have been novel was insufficient to confer patent eligibility.