As discussed in earlier coverage, Amgen has now made good on its intention to seek a preliminary injunction against Apotex. Amgen looks to block Apotex from marketing its Neulasta biosimilar before the expiration of the 180-day pre-marketing notice following FDA approval.
Apotex has previously argued that the Federal Circuit’s panel decision in Amgen v. Sandoz renders the BPCIA’s 180-day notice provision non-mandatory for parties engaging in the patent dance. In Amgen’s briefing papers supporting its motion for a preliminary injunction, the company argues that the language of the statute makes clear the 180-day notice of commercial launch is mandatory. Amgen further argues that the Amgen v. Sandoz court found the 180-day notice provision mandatory for all biosimilar manufacturers and effective only once the FDA has approved the biosimilar for commercial marketing, and cites heavily to the Court’s language that “A question exists, however, concerning whether the “shall” provision in paragraph (l)(8)(A) is mandatory. We conclude that it is.” Amgen’s full briefing and supporting materials are available here.
Apotex’s opposition is due on November 6, 2015. We will continue to provide coverage of Amgen v. Apotex as the case develops.