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Hospira Moves to Dismiss Amgen’s BPCIA Claims in Epogen Biosimilars Suit


Last month, Amgen sued Hospira in Delaware under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) over Hospira’s proposed biosimilar version of Amgen’s Epogen (epoetin alfa).  In addition to claims for patent infringement, Amgen brought, among others, two BPCIA-specific claims under 42 U.S.C. § 262(l)(2)(A) (relating to Hospira’s alleged failure to provide the required manufacturing information) and 42 U.S.C. § 262(l)(8)(A) (relating to Hospira’s allegedly ineffective 180-day notice of commercial marketing).  On October 13, Hospira moved to dismiss the BPCIA claims, arguing that Congress did not create a private right of action to enforce them since “[p]aragraphs (2)(A) and (8)(A) contain no ‘rights-creating language’ entitling Amgen to bring a private right of action to remedy any purported injury.”  As to paragraph (2)(A), Hospira also argued that, in Amgen v. Sandoz, 794 F.3d 1347 (Fed. Cir. 2015), “the Federal Circuit expressly held that mandating compliance with paragraph (2)(A) in all circumstances would render paragraph (9)(C) and § 271(e)(2)(C)(ii) superfluous,” and that, as a result, “Amgen’s only remedy is to sue for patent infringement under Section 271, something it has already done.”  As to paragraph (8)(A), Hospira argued that, because it “timely produced its aBLA to Amgen, it is not required to provide any notice of commercial marketing.”  Hospira further argued that, in any event, there is “no evidence that Congress intended to provide any remedy for the failure to provide notice under paragraph (8)(A) besides that specified in paragraph (9)(B).”  Hospira did not address how, under its theory, the Federal Circuit was able to enforce paragraph (8)(A) in Amgen v. Sandoz (by enjoining Sandoz from marketing its biosimilar until the expiration of the 180-day notice period in paragraph (8)(A)).  The issues raised in Hospira’s motion to dismiss are currently before the Federal Circuit in Amgen’s and Sandoz’s petitions for rehearing en banc.

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