ABBVIE V. AMGEN: Amgen Agrees To Comply With The BPCIA Notice Of Commercial Marketing Requirements

AbbVie v. Amgen (adalimumab)

Today, in the AbbVie v. Amgen adalumimab case, Judge Robinson entered a stipulated order that dismissed Count XI of AbbVie’s Complaint.  With its Count XI, AbbVie sought an order compelling Amgen to comply with the “notice of commercial marketing” provision of 42 U.S.C. § 262(l)(8)(A).  In the Complaint, AbbVie had alleged that Amgen had not confirmed whether it “would provide AbbVie with at least 180 days’ notice of commercial marketing should it receive a license from the FDA,” and that its failure to confirm “suggests that it will refuse to comply with the notice provision of the BPCIA, which will injure Abbvie by depriving it of the procedural protections of the BPCIA and by subjecting it to the burden of unnecessary litigation.”

With the joint stipulation entered by the Court today, Amgen agreed that it will comply with the notice requirements of 42 U.S.C. § 262(l)(8)(A).  Amgen also stipulated that “if the law changes so that it is not required to give such notice, in addition to any other notice or action required by law, Amgen Inc. will still provide AbbVie, Inc. with at least 21 days’ notice before the first commercial marketing of Amgen Inc.’s adalimumab biosimilar in the United States.”  In light of Amgen’s stipulations, AbbVie dismissed Count XI of its Complaint.

Stay tuned to the Big Molecule Watch for further updates on this litigation.

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