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Federal Trade Commission v. Actavis, Inc. | 570 U.S. 136 (2013)

If a patent-infringement suit culminates in a settlement agreement, typically the alleged infringer compensates the patent holder. But that’s not always the case. In reverse-payment settlements, which arise almost exclusively in the pharmaceutical context, a patent-holding drug manufacturer pays a generic manufacturer to drop its patent challenges and keep its generic off the market. In Federal Trade Commission versus Actavis, Incorporated, the Supreme Court explored the intersection of patent law and antitrust law to determine the legality of such agreements.

In nineteen ninety-nine, to comply with the Hatch-Waxman Act, which regulated the marketing of brand-name and generic drugs, Solvay Pharmaceuticals applied to the Food and Drug Administration, or F D A, for approval of its new product, AndroGel. The application was approved, and Solvay subsequently acquired a patent.

Shortly thereafter, Actavis, Incorporated, filed an F D A application for a generic equivalent. The application certified that Solvay’s patent was invalid or that the generic didn’t infringe it. Two other manufacturers made the same assertion.

Solvay sued Actavis and the other manufacturers for patent infringement. Prior to a decision, the parties entered a reverse-payment settlement under which Solvay paid millions to each manufacturer for a promise not to bring its generic to market for nine years, a period shorter than the life of Solvay’s patent.

The Federal Trade Commission sued Solvay, Actavis, and the other manufacturers, alleging that their agreement was anticompetitive and violated antitrust law. The manufacturers countered that reverse-payment settlements were immune from antitrust challenges if their anticompetitive effects ended before the relevant patent expired, because patent holders have a right to exclude others from the market for a patent’s duration.

The district court agreed with the manufacturers and dismissed the complaint, and the Eleventh Circuit affirmed. The United States Supreme Court granted cert.

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