The Linked Inheritability Between Two Regions of DNA is an Unpatentable Law of Nature
Genetic Technologies Limited v. Merial L.L.C. (Fed. Cir. Apr. 8, 2016)
Genetic Technologies sued Merial and Bristol-Myers Squibb in Delaware district court for violation of patent on methods for detecting genetic variations. The district court dismissed for failure to state a claim, ruling that the patent claims were ineligible for protection under 35 U.S.C. § 101 because they were directed to a law of nature. The Federal Circuit agreed that claim’s subject matter was unpatentable and thus affirmed the district court’s finding.
Dr. Simons, inventor under the 5,612,179 patent, discovered that non-coding regions of DNA (introns, colloquially ‘junk DNA’) are linked to nearby coding regions (exons) and inherited together more often than probability would dictate if gene recombination was random, a phenomenon known as linkage disequilibrium. The ‘179 patent describes a method for detecting exons by amplifying linked introns. Genetic Technologies claimed this method was advantageous to prior art because it allowed the amplification and sequencing of significantly shorter segments of DNA.
The ‘179 patent at its core claimed a patent over the relationship between introns and exons, broadly covering all applications of the concept of linkage disequilibrium, a universal and inherent feature of all human DNA. This situation was analogous to the recent decision in Mayo Collaborative Servs. v. Prometheus Labs., Inc., where the Supreme Court concluded that the claims were directed toward an underlying law of nature, even if substantial human ingenuity was required to implement the discovery.
JD Supra has a good in-depth analysis of the case and the peril that patentees of diagnostic inventions face under the current regime.