• Summary of the Association for Molecular Pathology v. US Patent and Trademark Office and Myriad Genetics, Inc., 2010-1406
  • February 21, 2013
  • Law Firm: Sughrue Mion PLLC - Washington Office
  • Federal Circuit, August 16, 2012, 2010-1406

    In the most recent Myriad decision, issued on August 16, 2012, the Federal Circuit reversed-in-part the district court’s decision that Myriad’s composition claims to “isolated” DNA molecules cover patent-ineligible products of nature under 35 U.S.C. § 101 because each of the claimed molecules denote a non-naturally occurring composition of matter.

    The Federal Circuit issued this opinion in light of a remand from the U.S. Supreme Court for further consideration in light of Mayo Collaborative Services v. Prometheus Laboratories, Inc., which held that claims directed to the relationship between the concentrations of blood metabolites and response to a therapeutic drug were unpatentable, stating that they "effectively claim the underlying laws of nature themselves."

    According to the majority opinion of the Federal Circuit, “[T]he compositions here are not natural products. They are the products of man, albeit following, as all materials do, laws of nature.” The critical question is whether the claimed DNA has “markedly different characteristics” from naturally occurring DNA. The majority emphasized that isolated DNA molecules do not exist in nature, and they are a creation of human ingenuity because they can only be obtained by chemical manipulation in a laboratory, and therefore are patent eligible subject matter 35 U.S.C. § 101.