In Genetic Technologies Limited v. Merial L.L.C., the Federal Circuit upheld a district court’s determination that many claims of a patent relating to methods of analyzing sequences of DNA are invalid under 35 U.S.C. § 101.1 According to the opinion, Dr. Simons, the named inventor of U.S. Patent No. 5,612,179, discovered that amplifying and analyzing non-coding, or “junk” DNA could be used to detect genetic disorders.
The Federal Circuit emphasized the Mayo and Alice decisions, in which the Supreme Court articulated a two-step test for patent eligibility under Section 101.2 The Federal Circuit then applied the two-step test to claim 1 of U.S. Patent No. 5,612,179, the only claim at issue in the appeal. With respect to the first step of the Mayo/Alice test, the court found that claim 1 is “directed to a natural law—the principle that certain non-coding and coding sequences are in linkage disequilibrium with one another,”3 and is thus unpatentable subject matter.
The second step of the test is to determine whether the claims “do significantly more than simply describe [a] natural relation,” and for patent eligibility, such claims “must provide something inventive, beyond mere ‘well-understood, routine, conventional activity.’”4 The court concluded that the remaining elements of claim 1 failed to provide the “inventive concept necessary to render the claim patent-eligible.”5
The Federal Circuit stated that the two physical “implementation” steps recited in claim 1 – “amplifying” genomic DNA with a primer pair, and “analyzing” the amplified DNA to provide a user with information, were both “clearly well known, routine, and conventional at the time the ‘179 patent was filed.”6
Genetic Technologies Limited (GTG), the patent owner, argued that claim 1 instructs users “to detect the [coding region] allele,” which no one had done before the ‘179 patent was filed, and thus “provide[d] sufficient inventive concept to pass step two of the Mayo/Alice test.”7 The Federal Circuit disagreed, stating that the term “to detect the allele” was merely a “mental process step,” which “merely sets forth a routing comparison that can be performed by the human mind.”8 Such method steps “embody the ‘basic tools of scientific and technological work’ that are free to all men and reserved exclusively to no one.’”9