District Court Hears Oral Arguments in Case Challenging Gene Patent Constitutionality

On February 2, 2010, oral arguments in Association for Molecular Pathology v. U.S. Patent and Trademark Office, the case challenging the patenting of isolated DNA, generally turned away from the constitutional arguments that dominated the debate thus far and moved toward the issue of patent eligibility under Section 101 of the Patent Act. A declaratory judgment complaint in May 2009 against the PTO and co-defendants Myriad Genetics and the directors of the University of Utah Research Foundation alleged that patents on two human genes associated with breast and ovarian cancer monopolistically stifle research that could lead to cures, limit women’s options regarding their medical care, and are unconstitutional. The complaint challenged the validity of 15 claims of the patents as nonstatutory subject matter under Section 101 of the Patent Act. The plaintiffs put forth that argument in a motion for summary judgment in August 2009, alleging that the claims at issue fall within one of the three judicially-recognized exceptions to patentability—natural phenomena, laws of nature, and abstract ideas. The debate about the patentability of the method claims touched on the “machine or transformation” nonobviousness test established in In re Bilski. Finnegan partner Laura Masurovsky filed a recent amicus brief supporting Myriad’s position on behalf of the Genetic Alliance, in which she argued that Congress “acted to specifically facilitate” gene patents by referring in Section271(e)(1) to patented inventions “primarily manufactured using recombinant DNA.”