Big Molecule Watch
August 31, 2015

BREAKING NEWS – Amgen v. Sandoz:  Sandoz’s Response to Amgen’s Emergency Motion for an Injunction Pending En Banc Consideration and Review

Sandoz has filed its opposition to Amgen’s motion seeking an “emergency”  injunction from the Federal Circuit to extend the injunction blocking Sandoz from launching its Zarxio biosimilar past September 2, the date the injunction is currently set to expire.  In its opposition, Sandoz blasts Amgen’s motion as “perfunctory” and not meeting “the applicable standard for such an injunction.”  Sandoz argues that Amgen cannot demonstrate a likelihood that it will succeed in its petition for en banc review of the panel’s holding that the “patent dance” is optional, or that it is entitled to have the Federal Circuit “fashion a[n injunctive] remedy” that the BPCIA does not expressly authorize.  Sandoz also argues that Amgen has not established that such relief would be equitable, since any emergency is Amgen’s fault:  It could have sought injunctive relief from the Federal Circuit—or the district court—more than a month ago, when the Federal Circuit first ruled, but instead waited until last week.  According to Sandoz, this delay also shows that Amgen’s claim that it will be “irreparably harmed” without an injunction is not credible.

We will continue to update our readers regarding further developments in this case.