Federal Circuit Reverses Indefiniteness Ruling Based on Point of Novelty Analysis

In Cox Communications, Inc. v. Sprint Communication Co., the Federal Circuit reversed a district court ruling holding six of Sprint’s patents invalid as indefinite. The definiteness dispute centered on the term “processing system,” which performed the function of transforming and routing telephone signals through a data network. Cox argued that “processing system” is a structural…

Court Requires the FDA to Reassess Decisions Rendered Under its Old Interpretation of Five-Year NCE Exclusivity

U.S. District Judge Rudolph Contreras found that the FDA’s prior interpretation of the Federal Food, Drug, and Cosmetics Act’s (“FDCA”) five-year exclusivity provision was arbitrary and capricious. Ferring Pharm., Inc. v. Burwell, No. 15-0802 (D.D.C. Sep. 9, 2016).  This provision—known as NCE exclusivity—provides a five-year period of marketing exclusivity for drugs in which “no active…