Apotex Files Reply Brief in Support of Its Motion to Expedite Appeal of Preliminary Injunction Ruling

As part of our continuing coverage, we are following the parties’ briefing in the appeal of the preliminary injuction, which prohibits Apotex’s launch of its pegfilgrastim biosimilars, in Amgen v. Sandoz.  As we have previously reported, Apotex filed a motion to expedite the appeal of the preliminary injunction.

Last week, Apotex filed its reply brief in support of its motion to expedite, responding to the arguments made in Amgen’s recent opposition brief.  In its reply brief, Apotex asserts, among other things, that:

  1. Amgen “misses the mark” with its argument that Apotex cannot demonstrate harm without showing that it will receive FDA approval during the appeal period; only FDA knows that information.
  2. The preliminary injunction requiring 180 days’ notice upon FDA approval will cause immediate harm by delaying the launch of Apotex’s biosimilar pending the appeal.
  3. Amgen’s reliance on the Federal Circuit’s Amgen v. Sandoz decision to show there is no need for an expedited decision in this case is misplaced, as that decision is “instructive” but “does not control” this case.
  4. Amgen was eager to expedite an appeal when the decision was adverse to Amgen, pointing to Amgen’s own motion to expedite the appeal in Amgen v. Sandoz.  Given this previous desire to expedite, Apotex calls Amgen’s opposition to an expedited appeal in this case “surprising.”
  5. An expedited appeal would resolve the same or similar issues pending in several other cases.

You can find Apotex’s reply brief in support of its motion to expedite here. Apotex’s opening appeal brief is due on December 30, 2015. Stay tuned for further updates.