Update in Amgen v. Sandoz

On August 31, 2015, to support the launch of its Zarxio™ (a biosimilar of Amgen’s Neupogen® (filigrastim) product), Sandoz filed an opposition to Amgen’s emergency motion for injunction pending en banc consideration and review.  The opposition can be found here:  Sandoz opposition 08-31-2015 — 17703935 v1.

Sandoz argues that Amgen’s emergency motion should be denied since it does not meet the “applicable standard for such an injunction.”  Specifically, Sandoz alleges that Amgen cannot make a strong showing of a likelihood of success on the merits on its en banc petition, and that Amgen has not shown a likelihood of irreparable harm.  Further, Sandoz states that the balance of hardship weighs in Sandoz’s favor (as “any further injunction would seriously jeopardize the first-to-market advantage Sandoz earned”), and that the requested injunction would “disserve the public interest” by harming the interests of cancer patients and purchasers.  Moreover, Sandoz argues that Amgen’s own delay in seeking injunction on any alleged patent rights (despite having received Sandoz’s biosimilar application on February 9, 2015) precludes the equitable relief it seeks. The panel decision on July 21, 2015 maintains the injunction over the launch of Zarxio™ through September 2, 2015.

Today, a divided (2-1) Federal Circuit rejected Amgen’s bid to block sales of Sandoz’s Zarxio™ during continued litigation between the companies. Without any explanation, the Court denied Amgen’s request for a new injunction while the full Federal Circuit considers Amgen’s petition for en banc rehearing. As a result, this decision clears the way for the first biosimilar approved under the Biologics Price Competition and Innovation Act. In fact, sales of Zarxio™ may begin as early as tomorrow. A copy of the order can be found here:  order.

The BRIC Wall Blog will continue to monitor the ongoing litigation between Amgen and Sandoz as well as Sandoz’s launch of Zarxio™.

This post was written by Lisa Mueller and Wei Yan.

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