Janssen v. Celltrion: Trial Postponed, Briefing and Hearings Scheduled on Standing, Damages Issues

Approved Biosimilar Products  •  Biosimilar News  •  BPCIA and Related U.S. Statutes  •  Janssen v. Celltrion (infliximab)  •  U.S. Biosimilar Litigation News

As we previously reported, a jury trial in the ongoing infliximab biosimilar litigation, Janssen v. Celltrion (D. Mass., J. Wolf), was scheduled to begin on February 13, 2017.  The district court, however, recently cancelled the originally scheduled trial date and is now scheduled to hold a hearing to address damages issues related to Defendants’ challenge to Janssen’s standing in the suit, an issue that has come to light in briefing to the court over the past few weeks.

On Wednesday, the Court issued a memorandum and order summarizing the remaining issues to be briefed in the case and to be resolved before trial.  The memorandum order explains that, following a scheduling conference last month, the district court had ordered the parties to file memoranda addressing issues that the parties had raised during the scheduling conference.  Defendants then filed an initial memorandum in which they argued “that plaintiffs failed to join all co-owners of the ’083 Patent” in the suits Plaintiffs have filed asserting infringement of that patent, “and, therefore, lack[] standing.”  Mem. Order at 1.  The Court’s order further explains:

A plaintiff’s failure to join all co-owners in an action for patent infringement requires dismissal without prejudice for lack of jurisdiction…. Defendants contend that, pursuant to the [BPCIA], dismissal without prejudice would limit plaintiffs’ potential damages to a reasonable royalty on the product covered by the ‘083 Patent because any subsequent suit would be filed more than 30 days after the parties agreed, pursuant to 42 U.S.C. §262(1) (4), to a list of patents that would be subject to an infringement action…. Plaintiffs contend that the 30-day period never began running because defendants did not properly participate in the process prescribed by the BPCIA before suit was filed.

On February 8, 2017, the court heard oral argument on the issue of standing and found that it raises serious questions concerning its jurisdiction. As the parties agreed, those questions required the postponement of trial to permit the filing of a motion to dismiss for lack of jurisdiction and, possibly, limited additional discovery.

Mem. Order at 2-3.

The Court’s order sets a deadline of February 22, 2017 for the filing of a motion to dismiss for lack of standing, and a briefing schedule on the motion to be completed by March 22, 2017.  According to another order entered today, the hearing next week will address three issues:

a. Whether, independent of the Biologics Price Competition and Innovation Act (the “BPCIA”), if infringement of U.S. Patent No. 7,398,083 (the “083 Patent”) is proven plaintiffs would be entitled to recover lost profits or whether their damages would be limited to a reasonable royalty.

b. Whether, if these cases are dismissed without prejudice because the present plaintiffs lack standing, and infringement of the ‘083 Patent is proven in a case filed in the future, plaintiffs would be limited to recovering only a reasonable royalty pursuant to 35 U.S.C. § 271(e) (6) (A) & (B). See Amgen Inc. v. Apotex Inc., 827 F. 3d 1052, 1058 (Fed. Cir. 2016).

c. Hospira Inc.’s Motion for Partial Summary Judgment.

Stay tuned to the Big Molecule Watch for future developments.

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