After filing a new drug submission for its ustekinumab biosimilar PYZCHIVA (Janssen’s STELARA), Samsung commenced the underlying action against Janssen for impeachment of Canadian Patent No. 3,113,837. Janssen sought to add a counterclaim for infringement after Samsung received a notice of compliance (NOC) for PYZCHIVA. On October 29, 2024, Associate Judge Horne of the Federal Court dismissed Janssen’s motion, holding that the proposed counterclaim was not adequately particularized and did not disclose a reasonable cause of action: Samsung Bioepis v Janssen, 2024 FC 1715.
Background
In case management of Samsung’s impeachment action, Janssen advised of its intention to commence a counterclaim for infringement once Samsung’s product received an NOC. Samsung opposed determination of infringement issues in the present action and sought to fix trial dates within about 24 months.
In August 2024, Samsung received an NOC for PYZCHIVA and its product monograph identified Sandoz as a distributor. Janssen brought the present motion to institute the counterclaim after Samsung refused to consent to Janssen’s proposed Statement of Defence and Counterclaim. Janssen proposed a trial on all validity and infringement issues about four months after the trial dates previously set aside, but not fixed, for the impeachment action.
Analysis
The Court dismissed Janssen’s motion. Associate Judge Horne determined that the proposed pleading, which was not framed as a quia timet proceeding, contained “no clear allegation that Samsung is now selling, or that Sandoz is now distributing, PYZCHIVA in Canada”. These activities could not be assumed immediately upon receipt of an NOC. In denying the motion, the Court concluded that “Janssen does not know what Samsung and Sandoz are presently doing with PYZCHIVA beyond obtaining regulatory approval, but is hoping to use the discovery process to find out. This is not a proper pleading.”
Having dismissed the motion, Associate Judge Horne acknowledged the benefits of having all issues determined at the same time, but did not comment on how any separate infringement proceeding should be scheduled.
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