For the second time in as many weeks, the Federal Circuit has reversed a district court’s finding of patent ineligibility under Section 101 in the life science space, this time concluding that claims directed to methods of treating pain in renally impaired patients are patent-eligible. In Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc., the … Continue Reading
“We live in a natural world, and all inventions are constrained by the laws of nature . . . we must be careful not to overly abstract claims when performing the Alice analysis.”[1] These are the promising words from the Federal Circuit in its recent decision in Natural Alternatives v. Creative Compounds, in which the … Continue Reading
In Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC,[1] the Federal Circuit affirmed the district court’s ruling that claims covering methods for diagnosing neurological disorders by detecting autoantibodies are directed to a natural law together with conventional steps, and are therefore invalid under 35 U.S.C. § 101. Although the claims at issue were said to … Continue Reading
On June 27, 2016, the U.S. Supreme Court, without comment, denied Sequenom’s petition for certiorari, leaving in place the Court’s previous rulings prohibiting the patenting of laws of nature and natural phenomenon. Sequenom filed its writ of certiorari with the U.S. Supreme Court on March 21, 2016, asking the Court to provide clarification regarding the … Continue Reading
On March 21, 2016, Sequenom filed a writ of certiorari with the U.S. Supreme Court, asking the Court to provide clarification regarding the limits of 35 U.S.C §101 as it relates to patent eligibility of diagnostic tests. Sequenom’s petition presents the following question: Whether a novel method is patent-eligible where: (1) a researcher is the … Continue Reading
On February 16, 2016, Sandoz Inc. filed a petition for a writ of certiorari with the U.S. Supreme Court, asking the Court to review the Federal Circuit’s interpretation of the Biologics Price Competition and Innovation Act (BPCIA). The petition presents the following questions to the Court: Whether notice of commercial marketing given before FDA approval … Continue Reading
On December 2, 2015, an almost unanimous Federal Circuit decision was issued denying the en banc rehearing of Ariosa v. Sequenom, a case having significant consequences for diagnostic patents and Section 101 case law in general.[1] The concurrences and dissent in the Ariosa case offer insight into how the various judges perceive the existing Section … Continue Reading
In Prometheus Laboratories, Inc. v. Roxane Laboratories, Inc.,[1] a recent decision involving methods of treating a specific subset of patients, the Court of Appeals for the Federal Circuit (“Federal Circuit”) ruled that, although the claims of the patent at issue were invalid as obvious, singling out a particular subset of patients for treatment can still … Continue Reading
On October 16, 2015, the Court of Appeals for the Federal Circuit (“Federal Circuit”) opted not to rehear its previously issued split decision in the court’s first analysis of the Biologics Price Competition and Innovation Act (BPCIA) and rights and obligations of patent owners and biosimilar applicants under the Act. For now, the public is … Continue Reading