Drug & Device News

Last July, the U.S. Court of Appeals for the Federal Circuit handed a favorable ruling to drug manufacturers in Association for Molecular Pathology v. Myriad Genetics, a case concerning the patentability of isolated genes. That case was brought by The American Civil Liberties Union (ACLU) and the Public Patent Foundation against several defendants, including Myriad Genetics Inc., which lost its method patents but won its fight to protect patents on two genes chemically separated from DNA associated with ovarian and breast cancer. On July 20 of this year, however, the parties were back in court, arguing before the Federal Circuit over whether the March 2012 U.S. Supreme Court decision in Mayo Collaborative Services v. Prometheus Laboratories Inc. dictates a different outcome. In Mayo, the Court invalidated patents on a method for determining the optimum drug dosage for individuals with certain diseases. The Supreme Court reasoned that the disputed method involved “laws of nature,” but not in an inventive manner, so no patent could be awarded on it. After issuing its Mayo decision, the Court invalidated the Federal Circuit's 2011 ruling and returned the case to it for reconsideration in light of Mayo. On re-argument, Jones Day partner Gregory Castanias asserted that the Federal Circuit had already concluded in its previous decision that the patents it upheld in Myriad involved “non-naturally-occurring, human-made inventions.” Thus, the Mayo decision should not alter the outcome, he said. The ACLU countered that Mayo applies to Myriad because it dealt with the issue of whether a disputed patent prevents scientists from conducting research involving a law or product of nature. If it does, and the patent is upheld, it could squelch scientific research and hinder the invention of useful products.