Drug & Device News

Although the U.S. Supreme Court asked the U.S. Court of Appeals for the Federal Circuit to revisit its decision in Association for Molecular Pathology v. Myriad Genetics, the outcome was ultimately the same: the Fed Circuit says human genes can be patented. The Aug. 16 holding followed a rehearing in July on the question of whether Myriad Genetics Inc. could legitimately patent two genes chemically separated from DNA associated with ovarian and breast cancer. The Federal Circuit found that the March 2012 U.S. Supreme Court decision in Mayo Collaborative Services v. Prometheus Laboratories Inc., which had prompted the high court to seek rehearing in Myriad, was inapplicable. Mayo invalidated patents on methods for determining the optimum dose of medication for individuals with certain diseases ' methods that the Supreme Court deemed to be based on laws of nature that are unpatentable. But the Federal Circuit determined that the Myriad patents were unlike the invalidated claims in Mayo because they “are a product of man, not of nature.” “Mayo does not control the question of patent-eligibility of such claims,” stated the court. “They are claims to compositions of matter, expressly authorized as suitable patent-eligible subject matter ' . [W]hen cleaved, an isolated DNA molecule is not a purified form of a natural material, but a distinct chemical entity that is obtained by human intervention.” In his opinion concurring in part and and dissenting in part, Judge William Bryson wrote, “I respectfully dissent from the court's holding that Myriad's BRCA gene claims and its claims to gene fragments are patent-eligible. In my view, those claims are not directed to patentable subject matter, and the court's decision, if sustained, will likely have broad consequences, such as preempting methods for whole-genome sequencing, even though Myriad's contribution to the field is not remotely consonant with such effects ' to argue that the isolated BRCA gene is patentable because in its native environment it is part of a much larger structure is no more persuasive than arguing that although an atom may not be patentable, a subatomic particle is patentable because it was previously part of a larger structure.”