Supreme Court Decision Alert - June 17, 2013

Keywords: patent infringement, generic drugs, driver's privacy protection act

Patent-Infringement Suits - Generic Drugs - Reverse-Payment Settlement Agreements

Federal Trade Commission v. Actavis, Inc., No. 12-416 (previously discussed in the December 10, 2012, Docket Report)

Under the Drug Price Competition and Patent Term Restoration Act (i.e., the Hatch-Waxman Act), a generic-drug manufacturer may obtain FDA approval to market and sell a generic version of a patent-protected drug by certifying that the patent is invalid or unenforceable. 21 U.S.C. § 355(j)(2)(A)(vii)(IV). The patent holder may then initiate a patent-infringement suit against the generic-drug manufacturer, in what is known as "Paragraph IV litigation." FTC v. Actavis, Inc. , arose from the settlement of one such lawsuit. Under a 2006 settlement agreement, the patent holder, Solvay Pharmaceuticals, and the generic-drug manufacturers, Watson Pharmaceuticals and Paddock Laboratories, entered into