Sandoz Initiates Declaratory Judgment Action Against Amgen Concerning Manufacturing of Filgrastim and Pegfilgrastim Biosimilars

On February 21, 2019, Sandoz initiated a lawsuit against Amgen in the Northern District of California seeking a declaration that its biosimilar filgrastim and pegfilgrastim products do not infringe the Amgen’s ’997 patent.

The ’997 patent relates to a method of protein purification and is in the same patent family as Amgen’s ’878 patent.  In December 2017, the Northern District of California granted Sandoz’s motion for summary judgment that the ’878 patent is not infringed by the manufacturing of either of Sandoz’s filgrastim and pegfilgrastim biosimilars.  Amgen appealed that decision to the Federal Circuit, and oral argument in the appeal is scheduled for March 4, 2019.

The ’997 patent issued in May 2017, during the pendency of the suits involving the ’878 patent.  According to Sandoz’s new complaint, Amgen advised Sandoz that Sandoz’s manufacturing process for filgrastim and pegfilgrastim infringed the ’997 patent.  Sandoz then “invited” Amgen to add the ’997 patent to the pending filgrastim and pegfilgrastim litigation, but Amgen did not.  The complaint alleges that more than 20 months have passed and Amgen has still not asserted the ’997 patent.

On February 21, 2019, Sandoz gave its 180-day notice of commercial marketing of its pegfilgrastim product.  Noting that Amgen had “not disavowed the intention to seek a preliminary injunction,”  Sandoz filed the declaratory judgment suit “to ensure that any issues with respect to the ’997 patent, including any preliminary injunction motion,”  are resolved in advance of its launch.

Amgen has also asserted the ’997 patent in Amgen v. Adello, Amgen v. Hospira, and Amgen v. Mylan.