On July 18, 2013, District Judge Sidney H. Stein dismissed plaintiffs (collectively “Purdue”) infringement actions against defendants Mylan Pharmaceuticals and Impax Laboratories. Purdue owns U.S Patent Nos. 7,674,799; 7,674,800; and 7,683,072 (collectively “the Low-ABUK Patents”) that are directed to both original and Reformulated OxyContin (an OxyContin formulation that is more resistant to abuse). Purdue has stopped selling original OxyContin and now manufactures and sells Reformulated OxyContin for the treatment of moderate and severe pain. Defendants’ filed ANDAs for approval to make both generic original and Reformulated OxyContin and listed the Low-AQBUK Patents in both paragraph IV certifications. In April 2013, the FDA determined that original OxyContin had been withdrawn from sale for reasons of safety and effectiveness, and was no longer an Orange Book “listed drug.” Therefore, original OxyContin could not be the subject of an ANDA. Thus, the court dismissed Purdue’s infringement claims as moot. The court also declined to exercise jurisdiction over defendants’ declaratory judgment counterclaims because defendants will have an opportunity to contest the validity of the Low-ABUK Patents in other instituted actions concerning Reformulated OxyContin ANDAs.
Case: In re OxyContin Antitrust Litigation, No. 10 Md. 1603 (SHS), 2013 BL 190668 (S.D.N.Y. July 18, 2013)