What The Court Got Wrong About Hatch-Waxman In Alcon

Law360, New York (February 1, 2016, 10:55 AM EST) -- In Alcon Laboratories Inc. v. Akorn Inc., 2016 WL 99201 (D.N.J. Jan. 8, 2016), the court sua sponte stayed a pending Hatch-Waxman action, but denied Alcon's request to extend the 30-month stay of U.S. Food and Drug Administration approval. The court reasoned that "it had discretion to extend the 30-month regulatory approval stay, but only if a party 'failed to reasonably cooperate in expediting the action.' 21 U.S.C. § 355 (1)(5)(B)(iii)." Id. at *2. Since neither party failed to cooperate, the court held that it was powerless to grant the requested extension. The court cited various decisions to support its holding, but some actually undercut its reasoning. More important, the ruling disregards the very purpose of the 30-month stay as apparent from the legislative history of the Hatch-Waxman Act....

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