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Apotex Accuses Amgen of Sham BPCIA Litigation

Amgen recently sued Apotex under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) over Apotex’s proposed biosimilar of Amgen’s Neulasta (pegfilgrastim), a long-lasting version of Neupogen.  This is the first BPCIA suit to reach the courts after completion of the BPCIA’s pre-suit information exchange, the so-called patent dance.  On October 5, 2015, Apotex filed its Answer with Counterclaims.  Despite agreeing on which patents should be the subject of immediate patent infringement litigation under the BPCIA, Apotex now alleges that Amgen’s suit on one of those patents is sham litigation in violation of the Sherman Act:

Despite the conclusive and irrefutable proof provided to [Amgen as part of the information exchange] that the method of producing Apotex’s Pegfilgrastim Product covered by Apotex’s BLA does not and cannot infringe Amgen’s ‘138 patent, [Amgen] nonetheless filed this lawsuit which included an objectively baseless claim alleging infringement of the ‘138 patent . . . for the purpose of significantly delaying Apotex’s entry into relevant markets.

Apotex also raises several patent- and BPCIA-specific declaratory judgment counterclaims.  As to the ‘138 patent, Apotex seeks declarations of noninfringement and invalidity as well as a declaration of unenforceability due to patent misuse.  As to the BPCIA, Apotex seeks declarations that a notice of commercial marketing under 42 U.S.C. § 262(l)(8)(A) is not mandatory (i.e., that non-compliance is subject only to the consequences of 42 U.S.C. § 262(l)(9)(B)), and that no injunctive relief is available for failure to comply with the notice of commercial marketing provision.

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