Court Rules Sandoz Did Not Infringe on Amgen's Filgrastim, Pegfilgrastim Patent

On December 19, Richard Seeborg, US district judge for the Northern District of California, granted a summary judgment of noninfringement in Amgen v Sandoz.

As Big Molecule Watch reports, biosimilar developer Sandoz had filed a motion for a summary judgment that it did not infringe Amgen’s US Patent 8,940,878 (the ‘878 patent), which covers a method of purifying proteins, when it developed its biosimilar filgrastim and pegfilgrastim molecules.

Amgen claimed that a single step in Sandoz’s process for purifying its filgrastim and pegfilgrastim infringed on claim 7 of its patent, and moved to defer consideration of noninfringement until further discovery on upcoming modifications to Sandoz’s process. Amgen asked the court to wait to make a decision on noninfringement until Sandoz has submitted an application for approval of its modified production process to the FDA (which Sandoz is expected to do in 2018) and produces both its submission and related documents to Amgen.

The court found that Sandoz’s process did not infringe on claim 7, and further denied Amgen’s motion for further discovery, saying that the information Amgen hoped to discover was not material to the finding of noninfringement: “the method claimed by the ’878 patent involves multiple steps and multiple solutions while Sandoz’s accused method involves only one continuous step and only one solution. This substantial difference between the methods will not be altered by the replacement of the current matrix with the new matrix,” according to the ruling.

The summary judgment is further good news for biosimilar developer Sandoz: this week’s legal development follows the federal circuit’s ruling in favor of Sandoz in Amgen v Sandoz, in which the court held that state law cannot compel drug makers to participate in the so-called “patent dance” provided for in the Biologics Price Competition and Innovation Act because state law cannot preempt federal law.

Sandoz, which has already launched its FDA-approved filgrastim biosimilar (Zarxio) in the United States, suffered a regulatory setback with its pegfilgrastim in 2016 when the FDA issued the biosimilar developer a complete response letter. However, Sandoz recently released news results from a phase 1 clinical trial of its proposed pegfilgrastim biosimilar, LA-EP2006, showing that its product matched Amgen’s reference Neulasta in terms of safety, pharmacokinetics, pharmacodynamics, and immunogenicity in healthy subjects, and the proposed biosimilar is currently under review by the European Medicines Agency.