Federal Circuit, April 8, 2016, 2015-1202, 2015-1203

Author: Ryan Davies

The Federal Circuit upheld a district court's dismissal for failure to state a claim and its finding of invalidity of Genetic Technologies' patent based on 35 USC § 101 because it claimed only a law of nature.  The patent claimed a method for analyzing DNA sequences based on the "linkage disequilibrium" phenomenon discovered by the inventor.  Specifically, the representative claim involved detecting a coding region allele by amplifying and analyzing a linked non-coding region sequence of a gene.  After a lengthy discussion of the scientific basis of the invention, the opinion concluded that "claim 1 is thus broad in scope", and encompasses methods of detecting the coding region allele by analyzing any linked non-coding region found in a gene or intergenic region.

The district court found the claims to be patent-ineligible under § 101 because they claimed a law of nature, and any additional steps added to the claim "collectively consist only of well-understood, routine, conventional activity already engaged in by the scientific community."  The Federal Circuit agreed and adopted the district court's position.

Applying the now "well-established" two-step Mayo test, the Federal Circuit confirmed that the claims were directed to a law of nature, namely, linkage disequilibrium, and do not include an "inventive concept" (or "something more") that would render them patent-eligible.  For example, the claim called for no "creation or alteration of DNA sequences".  Also, there were no "novel detection techniques" included in the claim, but rather only conventional physical activities and mental steps which do not create the requisite inventive concept to convert into patent-eligible subject matter.  Furthermore, the Federal circuit found that the product of the claimed method was merely information about a patient's natural genetic makeup, which only becomes meaningful in light of the linkage disequilibrium phenomenon, which is "indisputably a universal inherent feature of human DNA."  The Federal Circuit stressed the similarity to the invalidated claims in Mayo, and noted that the novelty of the discovery of a natural phenomenon cannot be relied upon for patent eligibility.