Biologic and Biosimilar Litigation Updates

Below we provide updates in three pending litigations.

First, in an update on the Amgen v. Coherus appeal regarding Coherus’s biosimilar application for pegfilgrastim, Amgen filed its opening brief on August 20. Amgen’s statement of the issues reads:

1. Whether the district court erred in dismissing Amgen’s Complaint, with prejudice, based on prosecution history estoppel where the single filewrapper statement relied upon by the district court—that the pending claims recite a “particular combination of salts”—is at best ambiguous as to whether it was meant to limit the claims to three salt-pairs or whether it referred to the discovery that the salt combinations useful to obtain the benefits of the invention (i.e., increasing the dynamic capacity of the HIC column) are particularly selected for any specific protein to be purified, and in view of this ambiguity the statement is not a clear and unmistakable disclaimer of claim scope

2. Whether the district court erred in dismissing Amgen’s Complaint, with prejudice, based on the dedication-disclosure doctrine where the specification does not explicitly disclose the subject matter—use of the [REDACTED] practiced by Coherus—that was found to be dedicated to the public.

Second, we have been reporting on the Genentech v. Amgen trastuzumab litigation. Amgen had answered Genentech’s amended complaint with affirmative defenses and counterclaims of, among other things, non-infringement, invalidity and, with respect to one patent, unenforceability due to unclean hands and inequitable conduct. On August 23, Genentech filed a motion to dismiss Amgen’s counterclaims of unenforceability and its affirmative defense of unclean hands. Genentech alleges that Amgen’s counterclaims for unenforceability are “boilerplate assertions [that] do not meet the pleading requirements of Federal Rule of Civil Procedure 12(b)(6), much less the heightened pleading burden of Federal Rule of Civil Procedure 9(b) that is required for claims of inequitable conduct.” Genentech further alleges that Amgen’s unclean hands defense is “inadequate” because “Amgen does not allege that Genentech deliberately concealed references in its possession from the Patent Office.”

Finally, we had recent coverage of Immunex’s patent infringement suit regarding Sanofi and Regeneron’s Dupixent® (dupilumab) biologic and Immunex’s renewed motion to stay the district court proceeding pending the outcome of Sanofi’s IPR on the ’487 patent. On August 31, the district court denied that motion. While the court noted among other things that the close of discovery was several months away and trial not for another year, weighing slightly in favor of a stay, the IPR would not resolve all potentially case-dispositive invalidity defenses, and the IPR decision would be issued in advance of the deadline for filing summary judgement motions.  Further the court noted that “[t]o the extent that Plaintiff believes the PTAB will uphold the validity of the patents, a stay would merely draw out the litigation and thereby delay Plaintiff’s requested relief. To the extent that Plaintiff believes the PTAB will find the patents invalid, this raises a serious question as to whether this action was brought in good faith.”