Federal Circuit Reverses N.Y. District Court: Claims to 'Isolated' DNA Are Eligible for Patent Protection

On July 29, 2011, the U.S. Court of Appeals for the Federal Circuit reversed in part the U.S. District Court for the Southern District of New York's ruling in Association for Molecular Pathology v. USPTO, Myriad Genetics, et al.1 ("Myriad") and held that claims to "isolated" DNA molecules were patent-eligible. The district court ruling had unsettled the biotechnology industry by invalidating certain patent claims directed to the genes BRCA1 and BRCA2, which, if mutated, increase susceptibility to breast cancer, and to methods of diagnosis using BRCA sequences. The plaintiffs, including the ACLU, a number of medical associations and doctors, and the Public Patent Foundation, challenged Myriad's patents as invalid and unconstitutional, and the district court granted their motion for summary judgment. The district court reasoned that isolated DNA was patent-ineligible because it is a product of nature and the claims to diagnostic methods were ineligible because they constituted nothing more than natural phenomena. Myriad appealed.

On appeal, the Federal Circuit applied the same test as the district court: Isolated DNA would be considered patent-eligible if it was "markedly different" from naturally occurring DNA. However, the Federal Circuit focused on chemical properties rather than the genetic information properties of the "isolated" DNA. Because the chemical properties of the isolated DNA were markedly different when compared to its natural context, the district court's ruling was overturned with respect to the claims to isolated DNA. The Federal Circuit also reversed the district court's decision that Myriad's claim to screening potential cancer therapeutics via changes in cell growth rates was directed to a patent-ineligible scientific principle. However, the Federal Circuit affirmed the district court's finding that method claims reciting only "comparing" or "analyzing" DNA sequences are patent-ineligible because those claims do not include transformative steps and cover only patent-ineligible, abstract mental steps.

Not surprisingly, the Federal Circuit reviewed U.S. Supreme Court decisions such as Chakrabarty and Funk Brothers, in which the Court faced questions of patent eligibility for genetically modified bacteria and mixtures of plant seeds, respectively. An apparent distinction was developed between compositions that, even if combined or altered in a manner not found in nature, nevertheless have characteristics similar to the...