Big Molecule Watch
August 21, 2015

Amgen v. Sandoz Update:  Both Sides Have Filed Petitions For Rehearing En Banc

In the latest development in the closely-watched Amgen v. Sandoz appeal, Amgen and Sandoz have filed cross-petitions seeking en banc review of the panel’s July 21, 2015 decision holding that (1) a biosimilar applicant may opt out of the BPCIA “patent dance”; and (2) when the applicant opts out, the 180 day notice of commercial launch set forth in the BPCIA is mandatory, and must be given after FDA approval in order to be effective.

In its brief, Amgen took issue with the panel’s holding that the patent dance is optional.  Amgen states that the “panel decision in this appeal was fractured,” that it agrees with Judge Newman’s dissent, and that “[i]n holding that a Sponsor and the courts have no ability to compel an Applicant to comply with the BPCIA [patent dance], the majority erred in deciding an issue of first impression important to these parties and to the entire biopharmaceutical industry.  The full Court should hear this issue en banc to correct that error.”

For its part, Sandoz contests the panel’s ruling concerning the 180-day notice period. Sandoz states that “the majority . . . effectively granted 180 days of exclusivity for all biologic products beyond what Congress expressly provided in the BPCIA.  In doing so, the majority ignored the only remedy provided by Congress in the BPCIA – the right to initiate patent litigation – and instead created a new automatic injunction remedy.”

We here at Big Molecule Watch are scrutinizing the parties’ briefs and will share our analysis shortly . . .