Update on the Amgen v. Adello Filgrastim Litigation

On April 15, 2019, the parties filed their opening claim construction briefs (Amgen’s Brief; Adello’s Brief) in the Amgen v. Adello BPCIA litigation concerning Adello’s aBLA for a biosimilar of Neupogen® (filgrastim).  The patents at issue are U.S. Patent Nos. 8,940,878; 9,643,997; 8,952,138; and 9,856,287, each generally directed to the production of proteins in non-mammalian expression systems using recombinant DNA technology.  Per the scheduling order entered in the case, the parties’ responsive briefs are due on June 3, 2019.

On April 16, 2019, the PTAB designated as precedential its prior decision from February 14, 2019, related to Adello’s petition (PGR2019-00001) for post-grant review of Amgen’s U.S. Patent No. 9,856,278, which is one of the four asserted patents in the parties’ pending BPCIA litigation.  In the now-precedential decision, the PTAB granted Adello’s motion to amend its list of interested parties after filing its post-grant review petition.  In its petition, Adello had listed Amneal Pharmaceuticals Inc. and others as interested parties, but did not list a subsidiary, Amneal Pharmaceuticals LLC.  Amgen argued that because Adello did not identify all the real parties-in-interest in its petition, that Adello is “indisputably time-barred from bringing a PGR.”  The PTAB rejected Amgen’s argument that Adello’s omission amounted to “gamesmanship or bad faith,” and noted that Adello’s omission was accidental, not intentional, nor did the omission result in undue prejudice to Amgen.