Apotex Inc. v. Acorda Therapeutics, Inc.

Apotex filed suit alleging that Acorda filed a sham citizen petition with the FDA to hinder approval of Apotex's competing formulation of a drug for treating spasticity, in violation of Section 2 of the Sherman Act, 15 U.S.C. 2, and that Acorda violated the Lanham Act's, 15 U.S.C. 1125(a)(1), proscription on false advertising. The district court ruled that the simultaneous approval by the FDA of Apotex’s drug application and its denial of Acorda’s citizen petition was by itself insufficient to support a Sherman Act claim. The district court then granted summary judgment and dismissed all of Apotex’s false advertising claims on the grounds that (with the exception of one graph) no representation was literally false or likely to mislead consumers. In regard to the graph, Apotex failed to show that the false depiction would meaningfully impact consumers’ purchasing decisions. The court concluded that, although precedent supports an inference that a citizen petition is an anticompetitive weapon if it attacks a rival drug application and is denied the same day that the application is approved, that inference has been undercut by recent FDA guidance.  As to false advertising, the court agreed with the district court that no reasonable jury could have found that Acorda made literally false or misleading representations in its advertisements, with the exception of a single representation that Apotex has failed to show affected decisions to purchase. Accordingly, the court affirmed the judgment. View "Apotex Inc. v. Acorda Therapeutics, Inc." on Justia Law