Apotex Loses Tizanidine Appeal Against Acorda
The 2nd Circuit Court of Appeals has upheld a New York federal court ruling that granted Acorda Therapeutics’ motion to dismiss an Apotex anti-trust claim and also granted summary judgment to Acorda on Lanham Act false advertising claims. The appeals court decision says the case concerned two distinct questions: the circumstances under which the filing of a citizen petition with FDA provides grounds for an antitrust claim, and the scope of false advertising liability under the Lanham Act.
Kramer Levitt attorneys say in a blog post that the appeals court adopted the rule that “representations commensurate with information in an FDA label generally cannot form the basis for Lanham Act liability.” The court noted, they say, that the rule reflects proper deference to FDA expertise and insulates companies from liability when they engage in commercial speech consistent with labeling requirements. And, they add, it rejected Apotex’ challenges to Acorda’s advertising statements that did not appear on the FDA-approved label as the statements were consistent with the label information.
Apotex had charged that Acorda filed a sham citizen petition with FDA to hinder agency approval of Apotex’ generic form of Acorda’s Zanaflex (tizanidine). The competition between the two companies, the appeals court wrote, focused on the relative efficacy of tablets or capsules in controlling somnolence, one of tizanidine’s side effects.
The lower court had ruled that the simultaneous approval by FDA of Apotex’ ANDA and its denial of the Acorda citizen petition was not sufficient to support an anti-trust claim. In upholding the district court’s ruling, the 2nd Circuit said that although earlier cases supported 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, recent FDA guidance has undercut that inference. The court found that the agency guidance favors making such decisions simultaneously so that the need to act on a petition doesn’t force it into an early decision on the approvability of an application.
On the false advertising claim, the lower court said that with the exception of one graph, no Acorda representation was false or likely to mislead consumers. In that one graph, it ruled, Apotex failed to show that the false depiction would meaningfully affect consumers’ purchasing decisions. The Kramer Levitt attorneys report that the court held that “falsity alone does not make a false advertising claim.”