Genetic Tech. v. Merial (Fed. Cir. 2016)
Lincoln famously explained the role of the patent system of adding “the fuel of interest to the fire of genius.” In GTG, the court simplified the phrase by finding that genetic testing patents only value may be literally as fuel.
The decision by Judge Dyk and joined by Chief Judge Prost and Judge Taranto affirms a lower court’s dismissal on-the-pleadings of GTG’s patent infringement claim. The holding is that the claimed method for analyzing DNA for linkage disequilibrium is ineligible for as effectively claiming a law of nature. The basic idea stems from the inventors discovery that coding regions (exons) typically correlate with “linked” certain non-coding regions (introns).
The parties agreed that claim 1 of the GTG ‘179 patent was representative for purposes of the eligibility issues. The claim encompasses methods of detecting a particularly genetic allele using the two step process of (1) amplifying and then (2) analyzing the linked intron region.
The similarity of claim 1 to the claims evaluated in Mayo and Ariosa requires the conclusion that claim 1 is directed to a law of nature. . . . The claim is directed to a natural law—the principle that certain non-coding and coding sequences are in linkage disequilibrium with one another. We hold that claim 1 is directed to unpatentable subject matter at the first step of the Mayo/Alice test. . . .
Claims directed to laws of nature are ineligible for patent protection when, “(apart from the natural laws themselves) [they] involve well-understood, routine, conventional activity previously engaged in by researchers in the field.” Mayo.
We conclude that the additional elements of claim 1 are insufficient to provide the inventive concept necessary to render the claim patent-eligible.
GTG is an Australian company that had previously sued a few dozen companies for infringing the ‘179 patent. The claims have been reexamined (at Merial’s request) and patentability confirmed.
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 The courts found that claims 1-25 and 33-36 of U.S. Patent No. 5,612,179 are ineligible under Section 101.
 Mayo Collaborative Serv. v. Prometheus Lab., Inc., 132 S.Ct. 1289 (2012)
 Ariosa Diagnostics, Inc. v. Sequenom, Inc., 726 F.3d 1296 (Fed. Cir. 2013); rehearing en banc denied by Ariosa Diagnostics, Inc. v. Sequenom, Inc., 809 F.3d 1282 (Fed. Cir., Dec. 02, 2015); on petition for writ of certiorari (No. 15-1182, filed March 21, 2016).