The United States Court for the District of Columbia affirmed summary judgment dismissing a class action brought by wholesalers of brand name drugs, which alleged that Biovail misused its patent for Tiazac – a hypertension drug – to keep a generic version from the market. Meijer, Inc. v. Biovail Corp., Nos. 05-7066, 05-7069, 06-7118, 2008 WL 2853281 (D.C. Cir. July 25, 2008) (attached Meijer v. Biovail). Plaintiffs claimed that Biovail falsely asserted to the FDA its newly acquired patent protected Tiazac from generic competition. After Andrx – the first-to-file generic manufacturer — advised the FDA that it disagreed with Biovail’s claim, Biovail brought an action for patent infringement action. Under the Hatch-Waxman Act scheme, commencement of the patent infringement action barred Andrx from bringing a generic to market for either 30 months from the date that Andrx certified to the FDA that its generic did not infringe Biovail’s patent or when it prevailed in the litigation. While the litigation was pending, Andrx encountered difficulty sourcing its generic. The D.C. Circuit affirmed summary judgment holding that plaintiffs lacked antitrust injury because they failed to demonstrate but-for Biovail’s conduct, Andrx would have been able to enter the market with its generic. Id. at *6.
Aug
11
Posted by : | On : August 11, 2008
Mar
03
Posted by : | On : March 3, 2008
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 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)