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Procedural decisions in actions under the PMNOC Regulations: Common invalidity issues raised by different generics to be heard concurrently; only “second persons” can be named as defendants

In Bayer v Apotex; Bayer v Teva, 2019 FC 191, the Court ordered that common validity issues in actions relating to Bayer's rivaroxaban (XARELTO) against Apotex and Teva will be heard concurrently. Bayer objected to the concurrent hearing, arguing that consolidating the trials would constitute a joinder of actions and thus be prohibited by s. 6.02 of the PMNOC Regulations. Prothonotary Tabib concluded that the application of s. 6.02 is limited to the joinder of actions as a whole and did not prohibit the common trial of an action. Relying on Biogen v Taro, 2018 FC 1034 (see our article here), which arose in similar circumstances, she held that the common trial of issues in complex cases under the PMNOC Regulations “constitutes the most efficient use of the Court and the parties' time and resources.”

In Genentech v Celltrion Healthcare, 2019 FC 293, the Court refused to allow the plaintiffs to name additional Teva parties as further defendants in three actions relating to Celltrion’s HERZUMA, a trastuzumab biosimilar of Roche’s HERCEPTIN. The Court reasoned that only “second persons” may be named as defendants in actions under the PMNOC Regulations. The Court left open the possibility that a “second person” could include a person other than the person who filed the regulatory submission. However, the plaintiffs did not plead “sufficient material facts that if proven would enable the Court to make a finding that [Celltrion] was an agent, acting as a nominal second person, directed and controlled by the [Teva parties]”. The Court however allowed the plaintiffs to amend the pleadings to claim that Celltrion will infringe the patents at issue by common design or acting in concert with the Teva parties.