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Big Molecule Watch
November 2, 2015

Court Denies Janssen’s Motion for Leave to File Amicus Brief in Amgen v. Apotex

Last Friday, Oct. 30, Janssen filed a motion for leave to file a brief as amicus curiae in support of Amgen in Amgen v. Apotex.  As we’ve covered in previous posts, Janssen is one of the plaintiffs litigating the question of what is required under the BPCIA’s 180-day notice of commercial marketing provision in Janssen v. Celltrion (D. Mass.).  In its motion, Janssen urged that  “the Court may benefit from an additional perspective on the seemingly arcane but highly consequential question at issue in [Amgen’s] motion [for a preliminary injunction],” i.e. what is required of biosimilar applicants under the BPCIA’s (l)(8) notice of commercial marketing provision.

The court today denied Janssen’s motion for leave to file an amicus brief, stating “Janssen’s only interest in this litigation is its status as a plaintiff in another case involving similar issues. Janssen will not be bound by the outcome of this litigation. Furthermore, the Court finds that the Plaintiffs in this case are well-represented by counsel and additional assistance is not necessary.”

We will post any further developments in this case and others here on the Big Molecule Watch.