Roundup of Upcoming BPCIA Cases

Amgen v. Apotex (pegfilgrastim)  •  Amgen v. Hospira (epoetin alfa)  •  Amgen v. Sandoz (filgrastim)  •  Janssen v. Celltrion (infliximab)  •  U.S. District Court Decisions  •  U.S. Federal Circuit Decisions

As we have written about extensively, here, here, and here, the Federal Circuit recently interpreted two key provisions of the BPCIA in Amgen v. Sandoz. Three cases currently pending before District Courts raise related issues and each have the potential to reach the Federal Circuit. In this post, we provide a summary of the procedural posture of each of these cases and an educated guess as to which case will reach the Federal Circuit first.

In Janssen v. Celltrion, currently pending before the U.S. District Court for the District of Massachusetts, briefing on cross motions for summary judgment and for preliminary and permanent injunctions completed on September 28, 2015, as we reported here. As stated by Defendants in an October 30, 2015 letter to the Court asking for a hearing, there are now three pending and contested outstanding substantive motions in the case:
1. Janssen’s motion to stay the proceedings with respect to U.S. patent 6,284,471;
2. The cross motions for summary judgment in light of the Federal Circuit’s Amgen v. Sandoz decision
3. Janssen’s motion to modify the protective order and Celltrion’s alternative cross motion to stay Janssen’s motion.
The Court has not responded to this letter and no hearing is scheduled.

In Amgen v. Apotex, currently pending before the U.S. District Court for the Southern District of Florida, trial is currently scheduled for July 11, 2016, and a hearing on a motion for preliminary injunction is scheduled for December 3, 2015. In an interesting twist, Janssen filed a motion for leave to file an amicus brief in support of Plaintiffs’ motion for preliminary injunction. The Court denied Janssen’s motion on November 2, 2015.

Amgen v. Hopira, currently pending before the United States District Court for the District of Delaware, is currently at the motion to dismiss stage; defendants have not yet filed an answer to the Complaint.

Because of Amgen v. Hospira’s early stage, it is a toss-up between Janssen v. Celltrion and Amgen v. Apotex as to which will reach the Federal Circuit first. An appealable ruling could be handed down in Janssen at any time, while an appealable ruling in Amgen could be handed down at any time after December 3, 2015. Because of the upcoming Thanksgiving holiday, there is very little difference between these two cases, time–wise. We will have to wait and see which case reaches the Court first.

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