Amgen v. Apotex: Amgen Appeals Non-Infringement Judgment in Filgrastim/Pegfilgrastim Dispute

Biosimilar News

Last week, Amgen filed a notice of appeal to the Federal Circuit from the district court’s judgment of non-infringement.  The Federal Circuit has docketed the appeal as Case No. 17-1010.  Amgen’s opening brief will be due in early December, absent any extensions of time or other delays in the appeal proceedings.

This is the second appeal to the Federal Circuit in connection with this action. As we have reported, Apotex previously appealed the district court’s ruling that Apotex’s pre-licensure notice of commercial marketing was ineffective, and the court’s grant of a preliminary injunction precluding Apotex’s launch of its filgrastim biosimilar until 180 days after it serves an effective, post-licensure notice of commercial marketing.  The Federal Circuit affirmed, and Apotex has since filed a petition for certiorari with the Supreme Court, challenging the Federal Circuit’s interpretation of the “notice of commercial marketing” provision of the BPCIA.

Stay tuned to Big Molecule Watch for further updates regarding Amgen’s appeal and Apotex’s cert. petition.

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