Corporate & Securities Law

FTC Sues Cephalon for Blocking Entry of Generic Provigil

By Matthew S. Wild

February 13, 2008.   The FTC sued Cephalon for exclusionary conduct that is preventing generic competition with its branded drug Provigil.  The FTC alleged that Cephalon settled with four different generic manufacturers.  These generic manufacturers dropped their patent challenges to Provigil in exchange for cash payments.   Under the vagaries of the Hatch-Waxman Act, generic entry is not possible until 180 days after one of these generic manufacturers enters the Provigil — which because their patent challenges have settled, will not be until after Provigil’s patent expires in 2012. The FTC adopted a new litigation strategy in this case.  In the past, the FTC challenged these types of settlements in administrative proceedings and claimed that the basis for the “unfair method of competition” was a contract in restraint of trade — a violation of Section 1 of the Sherman Act.  However, in FTC v. Schering-Plough, 402 F.3d 1056 (11th Cir. 2005), the FTC’s administrative decision was reversed by the Eleventh Circuit on petition for review.  The Eleventh Circuit held that a reverse patent settlement is not by itself a Section 1 violation.The FTC’s current litigation strategy avoids the implication of Schering-Plough in two respects.  First, by avoiding administrative proceedings altogether and commencing the action in the United States District Court for the District of the District of Columbia, the FTC avoids review by the 11th Circuit.  Second, the FTC is proceeding under a different theory of liability.  The alleges that Cephalon willfully maintained its monopoly over Provigil through the patent settlements in violation of Section 2 of the Sherman Act.  Accordingly, Schering-Plough – a Section 1 case — is inapposite.  The FTC Press Release and Complaint are attached. FTC Press Release (Cephalon), FTC Complaint (Cephalon)

Full post as published by Antitrust Commentary on March 03, 2008 (boomark / email).