Azurity Pharmaceuticals, Inc. v. Alkem Laboratories Ltd., decided April 8, 2025

Azurity's U.S. Patent No. 10,959,948 relates to a liquid vancomycin formulation. The appeal follows a district court ruling that Alkem's Abbreviated New Drug Application (ANDA) for a generic version did not infringe Azurity's patent. The central issue revolved around whether Azurity disclaimed the inclusion of propylene glycol during the patent's prosecution. The court affirmed the lower court's decision, finding that Azurity did clearly disclaim propylene glycol, and because Alkem's proposed generic product contains it, no infringement occurred.