Today, Thu., Aug. 16, 2012, in Ass’n for Molecular Pathology v. USPTO (“The Myriad Case”), , No. 2010-1406, the Federal Circuit (Lourie, Bryson (concur/dissent) and Moore (concur)) issued its anticipated decision in the Myriad case on whether certain composition and method claims to isolated DNA molecules were patentable subject matter. This Myriad decision will have a substantial impact in the biomedical, chemical and related arts. The decision provides only incremental insight to computer-based or similar inventions, and also provides incremental insight into declaratory judgment jurisdiction.
The Court first addressed the threshold issue of whether any of the numerous named plaintiff’s had standing to bring a declaratory judgment action. The Court ruled that various industry organizations lacked standing because they were neither the target of enforcement actions nor offered licenses, and they made no preparations to undertake potentially infringing activities. The Court found that one named plaintiff – an individual researcher – did have standing.
The Court then addressed the issue of subject matter eligibility under § 101. The Court stated that § 101 is construed broadly, and noted some known exceptions: laws of nature, natural phenomena, abstract ideas, mental processes and products of nature. The Court also emphasized that its decision was limited to the sole issue of patent eligibility, and it was not addressing other issues such as obviousness, enablement, public policy about medical inventions, etc.
The Court ruled that claims to isolated DNA molecules were patent eligible because they were not found in nature. A policy basis supporting that determination was that the Patent Office had been granting patents on DNA molecules for 30 years, and Court’s should leave the issue to Congress before disturbing long-settled expectations of what is patentable.
The Court ruled that method claims directed to “comparing” or “analyzing” two gene sequences were not patent eligible, because “they claim only abstract mental processes.” This portion of the analysis (pages 56-59), though focused on the biomedical art, may provide some incremental insight to computer-based patents and method claims directed to only mental processes (such as in the recent Bancorp decision of July 26, 2012).
The Court ruled that method claims directed to performing known steps to “transformed cells” were patent eligible because the “transformed cells” limitation concerned things that are “a product of man, not of nature.”