Methods of analyzing DNA found unpatentable where claims are directed to a “natural law”

Genetic Technologies Limited v. Merial LLC, Nos. 2015-1202 and 2015-1203 (Fed. Cir. Apr. 8, 2016)

The patentee sued for infringement of a patent related to methods of analyzing sequences of DNA within an individual’s genome. Specifically, the patentee discovered a feature of genomic DNA called “linkage disequilibrium,” meaning that the coding regions (i.e., DNA that is ultimately expressed into protein) and non-coding regions (which do not code for protein) appear “linked” together in individuals’ genomes more often than probability would dictate.

The district court granted the patentees’ motion to dismiss, holding that the claims of the patent covered ineligible subject matter under 35 U.S.C. § 101, because they claimed a law of nature. The Federal Circuit affirmed, applying the two-step Alice test for patent eligibility under § 101, which “distinguish[es] patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts.”

First, the court found that the patent claim “is directed to a natural law—the principle that certain non-coding and coding sequences are in linkage disequilibrium with one another.” Second, the court held that the patent claim was not directed to any inventive concept. For instance, it involved no creation or alteration of DNA sequences, and did not purport to identify novel detection techniques. Rather, the claimed method simply applied well-known “amplifying” and “analyzing” steps to examine the non-coding DNA regions as a surrogate marker for the coding regions. The court rejected the patentability of this “mental process” step, whose purported novelty resided in the newly discovered natural law of linkage disequilibrium between coding and non-coding regions.

A copy of the opinion can be found here ►