Big Molecule Watch
August 26, 2015

Update in Amgen v. Apotex: Scheduling Report

As we reported in an earlier postAmgen v. Apotex is the first biosimilar litigation in which the parties have actually danced the entire “patent dance” through the “first wave.” The case, which concerns Apotex’s application to market a biosimilar version of Neulasta, has already been scheduled for trial beginning July 11, 2016.  (Order here).

Today, the parties filed a joint proposed scheduling report and discovery plan including the following paragraph which may be of interest to readers of this blog because it suggests Apotex and Amgen may be embroiled in litigation over a second biosimilar—referencing Amgen’s Neupogen product—by October:

The parties wish to bring to the Court’s attention the possibility that a related case may be filed in the next six weeks. As the Court is aware, this is one of the first cases brought under the provisions of the Biologics Price Competition and Innovation Act (“the BPCIA”). Under the BPCIA, Apotex’s filing of its abbreviated Biologic License Application (“aBLA”) to market a biosimilar version of Neulasta triggered a series of orchestrated information exchanges between Apotex and Amgen. Amgen subsequently filed this action on August 6. Apotex has also filed an aBLA seeking authorization to market a biosimilar version of Amgen’s Neupogen product. While the details of the parties’ information exchanges are not public, the parties note that under the BPCIA, Amgen could file a second lawsuit in or before October of this year. Assuming a second lawsuit between the parties were to develop, in the interests of judicial economy and to minimize litigation costs, it may be appropriate to seek consolidation, potentially with a modest extension of the trial date and discovery deadlines.

We will continue to monitor developments in this case and will post them here on the Big Molecule Watch.