The US Court of Appeals for the Fifth Circuit upholds the FTC’ s ruling regarding an unlawful pay-for-delay agreement in the pharmaceutical sector (Endo / Impax)

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On April 13, 2021, the U.S. Court of Appeals for the Fifth Circuit upheld the Federal Trade Commission’s (“FTC” or “Commission”) ruling that the “reverse-payment” settlement agreement between Endo Pharmaceuticals Inc. (“Endo”) and Impax Laboratories LLC (“Impax”) violated federal antitrust laws. The Fifth Circuit’s decision—which upholds the FTC’s first fully-litigated reverse-payment case since the Supreme Court’s landmark 2013 ruling in FTC v. Actavis (“Actavis”)—found the FTC’s findings that Endo and Impax entered into an unlawful “pay-for-delay” agreement to be supported by “substantial evidence.” Significantly, the panel also rejected Impax’s primary argument that the FTC needed to do more under the rule of reason to balance the anticompetitive conduct against procompetitive justifications—namely that the FTC needed to evaluate the strength of the patents at issue and assess whether it was likely Impax would have entered the market earlier absent the settlement. The court “disagree[d] that Actavis requires the Commission to assess the outcome of the patent case in order to find anticompetitive effects”—focusing heavily on the mere size of the alleged payment—and found the fact that generic competition was “possible” absent the settlement, combined with the large payment, was enough to infer anticompetitive effect under the framework outlined in Actavis.