As we previously reported in the Amgen v. Hospira district court litigation regarding Hospira’s proposed biosimilar of Epogen®/Procrit® (epoetin alfa), Amgen filed a motion for preliminary injunction seeking to enjoin Hospira from launching its biosimilar “until Hospira has complied with the requirement of 42 U.S.C. § 262(l)(8)(A)” (the notice of commercial marketing provision). According to a Stipulation and Proposed Order filed by the parties last week, Hospira requested that Amgen withdraw its Motion for a Preliminary Injunction in light of the Supreme Court’s decision in Sandoz Inc. v. Amgen Inc., and Amgen agreed that it would inform Hospira whether it would withdraw its Motion by June 14.
On June 19, 2017, Hospira informed the district court that Amgen “does not intend to withdraw its Motion but that it intends to serve a revised opening brief to address the 42 U.S.C. § 262(l)(8)(A) issue in view of the Supreme Court’s ruling in Sandoz v. Amgen.” Subsequently, Amgen filed a motion for leave to file an amended opening brief to replace the brief it previously filed. In its motion for leave, Amgen stated that the Supreme Court’s decision in Sandoz v. Amgen “impacts the issues raised in Amgen’s motion” for a preliminary injunction. Amgen’s amended opening brief and supplemental declaration were filed under seal and are not yet publicly available in redacted form. According to Amgen’s motion for leave, Hospira “opposes the relief Amgen seeks in the underlying Motion for a Preliminary Injunction,” but “does not take a position on whether Amgen should be permitted to file an Amended Opening Brief.”
We will continue to monitor this litigation. Stay tuned to Big Molecule Watch for further updates.