Yesterday the Federal Circuit granted Amgen’s motion for an injunction pending appeal in Amgen v. Sandoz, the first appeal to squarely address the patent litigation provisions of the Biologics Price Competition and Innovation Act (BPCIA).
Sandoz’s Zarxio, a biosimilar version of Amgen’s Neupogen (filgrastim) drug, was the first biosimilar approved under the BPCIA. Before the approval, Amgen filed a lawsuit asserting that Sandoz had violated the patent dispute resolution procedures of the BPCIA and that Zarxio infringed a method patent covering Neupogen. After an FDA advisory committee recommended the approval of Zarxio, Amgen brought a motion for a preliminary injunction based on Sandoz’s violations of the BPCIA.
On March 19, the district court for the Northern District of California denied the motion and granted judgment as a matter of law to Sandoz on these claims. Amgen filed an expedited appeal to the Federal Circuit, which will be heard on June 3. Amgen also asked the district court for an injunction pending appeal. The district court denied Amgen’s request on April 15. Amgen then moved for the same relief in the Federal Circuit. Sandoz opposed the injunction request, but agreed to refrain from launching Zarxio until the earlier of May 11 or a Federal Circuit decision on Amgen’s motion.
Yesterday the Federal Circuit issued a short order (as is typical for orders on motions for stays pending appeal) granting Amgen’s motion. The order states that Amgen’s motion for an injunction is granted “effective immediately.” It also gave the parties one week each to file briefs addressing “what amount of a bond, if any, should be posted for each day that the injunction is in place.”
Because likelihood of success on the merits is one of the factors governing whether to issue a stay pending appeal, the Federal Circuit’s terse order indicates, at a minimum, that it takes Amgen’s arguments on the merits seriously. The issues in the appeal are generally agreed to be questions of first impression, and have attracted multiple amicus briefs on both sides. Even the district court acknowledged this point in denying Amgen’s motion, describing the issues on appeal as “significant and novel,” but finding Amgen’s showing of irreparable harm, another requirement for a temporary injunction, to be “tenuous and highly contingent.” The Federal Circuit weighed the issues differently.
We will learn more about the Federal Circuit’s views at the June 3 hearing and, of course, in its ultimate decision on the appeal. Because of yesterday’s interim order, Sandoz will not be able to launch Zarxio in the meantime