March 30, 2013
Partner
WASHINGTON, DC - On March 30, 2013, Cephalon Inc., Cephalon France, and Teva Santé SAS received a favorable decision from the U.S. District Court for the District of Delaware in In Re Armodafinil Patent Litigation, 1:10-md-2200.The court found 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 (U.S. patent no. 7,132,570), claiming a particular polymorphic form of armodafinil, was anticipated and obvious. Chief Judge Gregory M. Sleet found that the generic defendants failed to demonstrate inherent anticipation and he 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®.
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