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United Food & Commercial Workers Local 1776 v. Takeda Pharmaceutical Co.

Purchasers of brand diabetes drug ACTOS brought suit against the manufacturer (“Takeda”) for improperly describing its patents to the Food and Drug Administration, in effect extending the duration of its patent protection over ACTOS and delaying generic competition. The district court denied Takeda’s motion to dismiss, concluding that the alleged patent descriptions were incorrect under the Hatch–Waxman Act and pertinent regulations. On this interlocutory appeal, we hold that under the “Listing Requirement” of 21 U.S.C. § 355(b)(1), a combination patent does not “claim” any of its component drug substances past their individual patent expiration dates. We further hold that the purchasers were not required to allege that Takeda’s interpretation of the Listing Requirement was unreasonable in order to plead a monopolization claim under the Sherman Act. AFFIRMED and REMANDED.

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