On September 25, 2018, the 10-day bench trial came to an end in the Immunex v. Sandoz patent litigation under the BPCIA concerning Sandoz’s Erelzi™ (etanercept-szzs) biosimilar. As we previously reported, prior to the start of trial, the Court had entered a stipulation of infringement of certain asserted claims of U.S. Patent No. 8,063,182 (“the ‘182 patent”) and U.S. Patent No. 8,163,522 (“the ‘522 patent”), leaving the issue of invalidity for trial. On October, 23, 2018, the parties submitted initial post-trial briefs and proposed findings of fact and conclusions of law. (Sandoz submitted corrected papers on October 29, 2018.) The parties’ post-trial pleadings are available here: Immunex’s Post-Trial Brief; Immunex’s Findings of Fact & Conclusions of Law; Sandoz’s Corrected Post-Trial Brief; and Sandoz’s Corrected Findings of Fact & Conclusions of Law.
In its opening brief, Sandoz argues that the asserted claims of the ‘182 and ‘522 patents are invalid on grounds of (1) obviousness-type double patenting; (2) lack of written description and enablement; and (3) obviousness. Immunex argues in its opening brief that Sandoz has failed to prove its invalidity defenses.
The parties’ reply brief briefs are due next week, on November 6, 2018, and oral argument on the post-trial briefing is currently scheduled for November 19 at 10:00 am.
We will continue to monitor this litigation. Stay tuned to Big Molecule Watch for further updates.