Breaking News: Summary Judgment of Non-Infringement for Sandoz in Filgrastim/Pegfilgrastim Case

As we previously reported, in Amgen v. Sandoz, which relates to both Sandoz’s filgrastim biosimilar (Zarxio) and its pegfilgrastim biosimilar, Sandoz had filed motions for summary judgment regarding non-infringement of Amgen’s ‘878 patent — the only remaining patent at issue in the case — and damages. Amgen opposed both motions, and moved to defer consideration of non-infringement until completing further discovery on pending modifications to Sandoz’s allegedly infringing process.

Today, the district court ruled in favor of Sandoz on all motions. The court found that Sandoz does not literally infringe the ‘878 patent, which is directed to methods of protein purification, because the method employed by Sandoz does not have the required sequential washing and eluting steps. Specifically, the court found that Sandoz’s process involves continuously applying one solution to a protein separation matrix rather than applying three distinct solutions in separate sequential steps. The court further found that Sandoz does not infringe the ‘878 patent under the doctrine of equivalents because its process performs a different function by removing an unwanted contaminant prior to purification, produces a different solution that requires additional purification, and works in a substantially different way.

Because it found that Sandoz does not infringe the ‘878 patent, the court denied the second motion on damages as moot. Finally, the court denied Amgen’s motion in opposition, finding that the process modifications on which Amgen sought additional discovery were not material to the infringement question.  Sandoz has been directed to submit a proposed final judgment no later than January 5, 2018.

This ruling comes on the heels of Sandoz’s recent appellate victory in this case before the Federal Circuit, which held that Amgen’s state law claims seeking to enforce compliance with the patent dance were preempted by federal law.