April 03, 2018

The firm won a victory for client Coherus Biosciences when Judge Leonard Stark of the Delaware district court granted Coherus’ motion to dismiss a patent infringement complaint brought by Amgen.   The patent at issue was directed to a step in the manufacturing process for purifying the protein present in Amgen’s Neulasta (pegfilgrastim) biological drug product, a blockbuster drug with annual sales of over $4.5-plus billion.   Neulasta is provided to patients after receiving cancer medications to help the body make white blood cells.   In December 2017, Magistrate Judge Christopher Burke issued a Report & Recommendation recommending that Coherus’ 12(b)(6) motion be granted with prejudice. Amgen objected, arguing that the report misinterpreted the claimed manufacturing process step and that since claim construction had not yet occurred in the case, the dismissal was premature.   

However, in adopting the report and dismissing the case with prejudice, Judge Stark agreed with Coherus’ arguments that Amgen had “clearly and unmistakably” surrendered claim scope during prosecution, and thus was now estopped from arguing that Coherus’ process (which was outside the literal language of the claims) infringed under the doctrine of equivalents.   

And although not addressed by the Magistrate’s report, Judge Stark also determined that Amgen dedicated to the public an aspect of the way Coherus purifies its product, meaning that Amgen cannot assert infringement against Coherus’ manufacturing process.

Dismissal of the suit is a step forward for Coherus, which hopes to launch its biosimilar Udenyca by mid-2018.

Led by Jenner & Block Partner Bradford P. Lyerla, co-chair of the firm’s Patent Litigation and Counseling Practice, and Louis E. Fogel, the firm team also included Aaron A. Barlow, Adam G. Unikowsky, and Shaun M. Van Horn; Associates Ethan A. Glickstein and Susan A. O’Brien; Department Counsel Yusuf Esat; former partners Joshua M. Segal and Paul D. Margolis; and former associate Chad Ray. Patent agent/technical specialist Christine Falaschetti and senior paralegal David Nelson also provided much needed assistance.