Litigation Update: Motions in Janssen v. Celltrion for Entry of Final Judgment and Case Scheduling


As we posted previously, the District Court in Janssen v. Celltrion has ruled that the ‘471 patent is invalid for obviousness-type double patenting on the two grounds raised in the defendants’ motions for summary judgment on that patent.

The defendants last week moved for an entry of final judgment on the plaintiffs’ infringement allegations for the ‘471 patent.  In their brief filed in support  of their motion for entry of final judgment, the defendants request that the Court “certify the judgment for appeal under Rule 54(b)” because:

(1) Janssen’s claim for infringement of the ‘471 patent is separable from the remaining claims at issue in the case, i.e. “(1) Janssen’s claim that Defendants violated the ‘patent dance’ information-exchange procedures of BPCIA; and (2) Janssen’s claims that Defendants infringe the ’083 patent”;

(2) “There is no risk that the Federal Circuit will have to decide the same issues more than once” because this requested final judgment relates only to the ‘471 patent and not to the remaining issues in the case; and

(3) “Delaying this appeal would frustrate the BPCIA goal of resolving patent issues ‘expeditiously’ and providing certainty to all involved, and would vitiate the Court’s efforts to reach prompt decisions on Defendants’ summary judgment motions.”

Plaintiffs filed their opposition to the motion for entry of final judgment today, arguing that the motion “should be denied because there is a just reason to delay entry of judgment until after the Patent and Trademark Office (‘PTO’) renders its impending decision in the reexamination of the ‘471 Patent.” Plaintiffs explain in their opposition brief that the PTAB has scheduled Janssen’s appeal in the ‘471 reexamination for September 28, 2016, “and its decision is expected shortly thereafter, typically within about a month of the hearing.”  The plaintiffs oppose the motion on following grounds:

(1)  “Granting defendants’ motion would be inequitable.”  Janssen argues that granting the motion would effectively force Janssen to file an appeal “on the defendants’ preferred timetable” rather than on its own timetable.  According to Janssen, this would prejudice the plaintiffs because it would “deprive Janssen of its ability to pursue the pending reexamination proceedings to their conclusion on the merits,” whereas “the lack of an immediate appeal by Janssen [would] cause no harm to the defendants, because Janssen is not seeking a preliminary injunction based on the ‘471 Patent, and under any scenario defendants intend to launch their biosimilar product long before Janssen’s appeal would be resolved.”

(2) “The interests of judicial administration call for denying the motion” because “[i]f Janssen’s appeal in the reexamination proceeding does not succeed, it has the option to appeal to the Federal Circuit.”  If Janssen also files an appeal in this case on the ‘471 patent ruling, “the Federal Circuit will be required either to consider the same issue twice, or to consolidate the two appeals, in which case the premature entry of the judgment will have been purposeless.”  Janssen also argues that the remaining issues in the case are not separable from final resolution of the ‘471 patent issues because Janssen’s BPCIA claim–“that Celltrion violated the BPCIA by failing to engage in the requisite exchange of information and insisting that Janssen file suit to preserve its claim to lost-profits damages and injunctive relief”–“is intertwined with the ‘471 Patent infringement count because the resolution of the BPCIA claim will determine the extent of available damages under the infringement count.”

Also, last Friday, the parties filed a joint motion regarding a proposed briefing schedule for Defendants’ motion to dismiss the complaint that Plaintiffs filed in a separate suit earlier this year, which alleges infringement of the ‘083 patent.  That case, also filed in the District Court for the District of Mass., has been consolidated with the pending Janssen v. Celltrion case.  The joint motion also proposes to extend the deadline for the defendants to file an answer to the complaint.


Stay tuned to the Big Molecule Watch for further updates.