Court Dismisses Amgen's Suit Over Coherus' Pegfilgrastim Biosimilar

On Monday, March 26, a Delaware court judge granted Coherus Biosciences’ motion to dismiss a lawsuit brought by Amgen over alleged infringement of a patent covering pegfilgrastim (Neulasta) for failure to state a claim for which relief could be granted.

The patent in question, US patent 8,273,707, is directed to a process for purifying proteins during which 2 specific salts are used in a loading solution, and Amgen claimed that Coherus infringed on the patent when it submitted an abbreviated Biologics License Application (aBLA) for its as-yet unapproved pegfilgrastim biosimilar, CHS-1701.

According to the court, Amgen previously acknowledged that Coherus did not “literally infringe” on the patent, although Coherus’ preparation process mixed salts that, in combinations, were equivalent to Amgen’s patented combinations.

Amgen argued that dismissal of the case was premature because there remained factual disputes, but according to the court, “the facts in the prosecution history here are undisputed,” and Amgen “merely disputes the interpretation of those facts.”

Amgen initially filed the suit after the parties completed the Biologics Price Competition and Innovation Act “patent dance,” and agreed that the patent would be subject to an immediate infringement action. Amgen argued that it did not have an adequate remedy at law, and that it was entitled to injunctive relief to prevent Coherus from any further infringement of its patent.

Dismissal of the suit is a step forward for Coherus, which announced earlier this month that it is close to resubmitting its aBLA for the proposed pegfilgrastim biosimilar. It hopes to launch the biosimilar by mid-2018.

In June of last year, the company received a Complete Response Letter from the FDA, in which the agency asked Coherus to perform a reanalysis of a subset of samples with a revised immunogenicity assay and to provide additional manufacturing-related process information. The FDA did not request a clinical study of CHS-1701 in oncology patients, however, and did not indicate that additional process qualification lots would be necessary. Coherus says that it also hopes to receive approval for the drug from the European Medicines Agency in the second half of this year.