Big Molecule Watch
December 15, 2015

Apotex Moves to Expedite Briefing on Appeal in Amgen v. Apotex

As we covered last week (here), Apotex is appealing the district court’s grant of a preliminary injunction to Amgen in Amgen v. Apotex.

Apotex has now moved to expedite the briefing schedule on its appeal in the Federal Circuit.  In its motion, Apotex explains: “Under the district court’s order, Apotex suffers immediate harm because the launch of its biosimilar product(s) is delayed by 180 days. Although FDA does not give early indication as to when a drug product will be finally approved, Apotex believes FDA may approve its product(s) within the next several months. Therefore, even under an expedited schedule, FDA may approve Apotex’s product(s) before the Federal Circuit issues an opinion.” (emphasis added).  Apotex also noted that the issue on appeal–whether a biosimilar applicant who follows the patent dance steps must provide a 180-day notice of commercial marketing after FDA licensure of the product–is “of great significance to the biosimilar industry as a whole.”

Apotex’s requested expedited schedule would proceed as follows:

  • Appellants’ [i.e. Apotex’s] Opening Brief: December 30, 2015
  • Appellees’ [i.e. Amgen’s] Responsive Brief: January 19, 2016
  • Appellants’ Reply Brief: January 27, 2016
  • Joint Appendix: January 29, 2106

Apotex’s motion also requests that the Federal Circuit schedule oral argument “during the first available argument calendar week after the Joint Appendix is filed.”

Stay tuned for further updates.

UPDATED Dec. 15, 2015: The Court has ordered that Amgen’s opposition to Apotex’s motion to expedite the briefing schedule is due December 18, 2015, and any reply in support of the motion is due no later than December 22, 2015.  Apotex’s opening brief will be due December 30, 2015.