District court finds patent covering Cephalon’s wakefulness improving drug Nuvigil^®, valid in ANDA litigation

The U.S. District Court for the District of Delaware ruled in favor of Finnegan clients Cephalon Inc., Cephalon France, and Teva Santé SAS, finding valid the listed patent for the active ingredient in Cephalon’s wakefulness improving drug, Nuvigil^®. Having already conceded infringement prior to trial, four generic pharmaceutical companies alleged that the listed patent, claiming a particular polymorphic form of armodafinil, was anticipated and obvious. Finding that the generic defendants failed to demonstrate inherent anticipation, Chief Judge Sleet held that the generic defendants’ experts did not show clearly and convincingly that the claimed form of armodafinil was the “necessary and inevitable result” of practicing the prior art patent. The court further held that the polymorphic form of armodafinil claimed in the patent would not have been obvious to one of ordinary skill in the art. Chief Judge Sleet enjoined the generic defendants from manufacturing, using, offering for sale, or selling their proposed armodafinil ANDA products, and further enjoined the FDA from approving the defendants’ ANDAs, before the expiration of Cephalon’s patent covering Nuvigil^®.