Allergan plc a leading global pharmaceutical company, announced that the United States Court of Appeals for the Federal Circuit affirmed the United States District Court for the Eastern District of Texas' earlier decision that that each of three Allergan patents (U.S. Patent Nos. 7,030,149, 7,320,976 and 8,748,425) that are listed in the Orange Book for COMBIGAN® is valid. The Federal Circuit also affirmed the district court's finding that Sandoz' proposed generic version of COMBIGAN® does not infringe the '149 and '976 patents, and reversed the district court's decision that Sandoz' proposed generic product infringes the '425 patent.
Allergan expects to file petitions for rehearing and/or rehearing en banc of the appeals court decision within 30 days. Allergan does not believe the federal district court's injunction preventing final approval and launch of the Sandoz product will be lifted prior to a decision on Allergan's petitions.
In addition, Allergan and Sandoz are parties to a lawsuit in the United States District Court for the District of New Jersey in which Allergan asserts that Sandoz' proposed generic product infringes an additional patent listed in the Orange Book for COMBIGAN® (U.S Patent No. 9,770,453) that expires in April 2022. As a result Allergan believes that today's appeals court ruling will not result in the market formation for a generic COMBIGAN® product.
