As we previously reported, Amgen sued Pfizer and its affiliate Hospira in July 2018 based on Hospira’s submission of an aBLA for a biosimilar of NEULASTA (filgrastim).  That same month, Pfizer obtained FDA-approval and, in October 2018, it launched its biosimilar in the United States as NIVESTYM (filgrastim-aafi).  Since that time, the parties have engaged in discovery, claim construction proceedings, and a number of discovery disputes, gearing up for a jury trial in June 2020.

Earlier this week, the district court entered a stipulated amended scheduling order that, among other things, postponed the trial start date from June 15, 2020 to May 17, 2021. The parties’ stipulation explains that the amended schedule stems from an order of the court at a December 6, 2019 discovery dispute hearing that required the parties to meet and confer regarding an amended case schedule that would enable Amgen to seek discovery on the defendants’ on-sale bar and public use defenses. Amgen had asked the court to exclude those invalidity defenses from the case on grounds that the defendants raised these invalidity theories only after the close of fact discovery, prejudicing Amgen.

Stay tuned to Big Molecule Watch for further developments.