AMGEN V. SANDOZ: PEGFILGRASTIM LITIGATION UPDATE

Amgen v. Sandoz (pegfilgrastim)

On July 17, 2017, in the ongoing Amgen v. Sandoz litigation regarding Sandoz’s proposed biosimilar of Neulasta® (pegfilgrastim), the magistrate judge ordered, among other things, that Amgen is entitled to discovery from Sandoz regarding the anticipated approval, marketing, and sales of Sandoz’s proposed pegfilgrastim biosimilar. Sandoz argued that the discovery was not needed and that injunctive relief did not have to be tried to a jury, because Sandoz will not be in a position to launch its product for a year or more after the March 2018 trial in this case. The magistrate judge denied this request noting that Sandoz had not moved to bifurcate the issue of injunctive relief.

Subsequently, on July 28, 2017, Sandoz filed a motion to separate equitable relief, seeking to separate out injunction proceedings from infringement and invalidity proceedings. Sandoz then sought to stay the ordered production pending resolution of the motion to separate. The magistrate judge denied the motion to stay because it was premised on bifurcation of injunctive relief and Amgen not prevailing on validity and infringement – neither of which, according to the magistrate judge, is certain. The magistrate judge ruled that, in view of the upcoming trial in March 2018 and the rapidly approaching expert discovery deadlines, Amgen’s trial preparation would be prejudiced if the ordered discovery is stayed and noted that Sandoz had failed to prove that the existing protective order would not sufficiently protect Sandoz against improper use of the discovery.

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