Janssen v. Celltrion: CAFC & District Court Litigation Update

Biologics Litigation  •  Biosimilar News  •  Janssen v. Celltrion (infliximab)  •  U.S. Biosimilar Litigation News

As we previously reported last year, in the ongoing Janssen v. Celltrion litigation concerning Celltrion’s Inflectra®, a biosimilar of Janssen’s Remicade® (infliximab), Janssen appealed the district court’s partial final judgment of invalidity of Janssen’s ’471 patent based on a finding of obviousness-type double patenting.  The Federal Circuit is treating that appeal as a companion case for oral argument purposes with Janssen’s related appeal from an ex parte reexamination ruling by the USPTO that the ’471 patent’s claims are unpatentable for obviousness-type double patenting.  The parties completed briefing these two appeals in April and June, respectively.  Last week, the Federal Circuit scheduled the oral argument for these companion cases for October 3, 2017.  The oral argument will be held in the Ceremonial Courtroom at the U.S. Court of International Trade in New York City.

In the pending district court litigation in the District of Massachusetts, the parties recently submitted a Joint Report summarizing the parties’ positions regarding (1) whether the Court should stay discovery related to damages; and (2) regarding the pretrial schedule and trial dates.

Celltrion argued that discovery should be stayed until the Court rules on its motion to dismiss Janssen’s complaint because (a) its motion to dismiss is meritorious; (b) the down-side to staying discovery is minor; (c) the benefit of staying discovery is high because Janssen’s discovery requests are fulsome; and (d) much of the discovery sought by Janssen is highly sensitive and confidential.

Janssen, on the other hand, argued that a stay of such discovery is unwarranted because it is “highly unlikely that [Celltrion] will ultimately manage to avoid discovery on damages, regardless of the outcome of [Celltrion’s] pending motion to dismiss.”  Janssen further argued that the requested discovery will not be unduly burdensome on Celltrion because the cost of the requested discovery is low “considering the importance of the issues at stake in the action, the amount in controversy, the parties’ relative access to relevant information, the parties’ resources, the importance of the discovery in resolving the issues, and whether the burden or expense of the proposed discovery outweighs its likely benefit.”

The parties also offered competing pre-trial schedules and trial dates in the Joint Report. Celltrion asked the Court to order a schedule that includes a trial beginning the “week of September 10 or 17, 2018,” whereas Janssen requested a schedule with a trial commencing the “week of May 7, 2018.”

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