Aug

11

D.C. Circuit Affirms Dismissal of Class Action Against Biovail

Posted by : Matthew Wild | On : August 11, 2008

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.

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