Patent Law Practice Center

FTC revives pay-for-delay complaint on generic Lidoderm

The Federal Trade Commission (FTC) recently announced that it had taken steps to resolve antitrust charges involving business activities employed by Irish/U.S. drugmaker Endo International designed to delay the entry of generic pain medications into the U.S. to preserve monopoly profits. The FTC filed a complaint for injunctive relief and a motion for entry of stipulated order for permanent injunction against Endo and others in the U.S. District Court for the Northern District of California (N.D. Cal.). These actions revive charges from a lawsuit filed by the FTC last March against Endo involving pay-for-delay patent settlements.

The FTC’s complaint identifies an anti-competitive reverse-payment agreement between Endo and Watson Laboratories, Inc. of Corona, CA, a company which was poised to introduce a generic version of Endo’s Lidoderm lidocaine patch into the U.S. market by the middle of 2012. Watson had filed an abbreviated new drug application (ANDA) for a generic Lidoderm patch with the FDA in January 2010, an application which included a paragraph IV certification claiming that Endo’s patent covering Lidoderm is invalid, unenforceable or uninfringed by Watson’s generic version. Endo earned $825 million from sales of Lidoderm during 2011, making up 30 percent of the company’s profits that year, according to the FTC’s suit. (more…)