Horizon Pharma v. Actavis (D.N.J. 14-7992; CAFC 17-2149) – Successfully defended Horizon Pharma’s Orange Book listed patents relating to its PENNSAID® 2% topical diclofenac sodium product in Hatch-Waxman litigation against generic applicant Actavis (now Teva). Following the district court ruling in Horizon’s favor, Teva appealed the ruling to the Federal Circuit. In a decisive win, on October 10, 2019, the Federal Circuit affirmed 3-0 the district court’s decision, which found Horizon’s ’913 patent to be nonobvious. As a result of this decision, Teva is enjoined from marketing a generic PENNSAID 2% product until the expiration of the ’913 patent on October 17, 2027.
Par v. Horizon Therapeutics (PTAB IPR2015-01117, CAFC 17-1451) – Successfully defended inter partes review proceeding relating to its RAVICTI® oral formulation for the treatment of Urea Cycle Disorders (UCD) in patients two months of age and older. Par appealed PTAB’s decision to the Federal Circuit. In a decisive win, on June 18, 2018, the Federal Circuit affirmed per curiam the PTAB’s decision upholding the patentability of Horizon’s ’012 patent.
Dexcel v. Takeda (D.N.J. 16-4957) – Successful declaratory judgment action against Takeda seeking a ruling that Dexcel’s approved lansoprazole orally disintegrating tablet OTC product does not infringe Takeda’s patents relating to its PREVACID® SoluTab™ product. As a result of the Court’s ruling of non-infringement, Dexcel launched the first lansoprazole ODT product sold Over-The-Counter (“OTC”) in the US market. Takeda did not appeal the judgment.