District Court Enters Judgment of Non-Infringement in Amgen v. Mylan

As we previously reported, in the Amgen v. Mylan litigation concerning Mylan’s FULPHILA (pegfilgrastim-jmdb), a biosimilar of NEULASTA, Amgen and Mylan filed a joint status report in which the parties stipulated that Mylan does not infringe the asserted claims of US Patent 8,273,707. On August 21, 2019, after reviewing the status report, the District Court concluded that “Amgen’s claims of infringements … cannot proceed” and accepted the parties’ stipulation.

As part of the stipulation, the Court granted Mylan’s Renewed Motion for Judgment on the Pleadings, and entered a judgment of non-infringement as to all claims related to the ’707 patent. The parties further stipulated that Amgen retained its right to seek appeal of any final judgment regarding the ’707 patent, including underlying decisions related to claim construction.  The Order also stated that it has no impact on the claims or defenses for US Patent 9,643,997, the remaining patent asserted by Amgen.

In view of the pendency of Amgen’s petition for rehearing en banc before the Court of Appeals for the Federal Circuit in Amgen v. Sandoz, Nos. 2018-1551, 2018-1552, the Court stayed the case.  The Court also noted that it did not anticipate that the stay would delay the trial date.

Finally, the Court ordered the parties to file a joint status report if there are any significant developments regarding Amgen’s petition for rehearing en banc in Amgen v. Sandoz and that the parties file a joint status report on or before September 20, 2019 regarding “all relevant” Federal Circuit proceedings.