Today, in what could be a landmark biotechnology patent case, the Federal Circuit heard oral argument in Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al. If the plaintiffs are able to survive the lack of standing challenge, the Court will decide whether isolated human DNA is patent-eligible. A district court in the Southern District of New York invalidated under 35 U.S.C. § 101 (section 101) certain patents to genes known to be risk indicators for breast cancer owned by Myriad Genetics, Inc. (Myriad). This decision is in stark contrast to the stated policy and actions of the United States Patent and Trademark Office (Patent Office), which has traditionally granted patents to isolated DNA. The United States Department of Justice, representing the federal government in the case, has taken the position that certain isolated gene patents should be invalidated but that other gene patents, where the genetic product does not exist in nature, should be upheld.

The Federal Circuit is addressing two questions on appeal: 1) whether plaintiffs had standing to file a declaratory judgment action against Myriad seeking to invalidate its patents; and, if so, 2) whether isolated DNA is patent-eligible subject matter. A decision affirming the district court and finding that isolated human DNA is not patent-eligible subject matter would be a substantial shift in patent law.