The Federal Court recently confirmed that an infringement action under the Patent Act cannot be joined with an infringement action under the Patented Medicines (Notice of Compliance) Regulations (the Regulations) while the Regulations prohibit the Minister from granting a NOC. The Court stated that an infringement action under the Patent Act could instead be brought in a separate proceeding.

With cooperation between the parties and simultaneous scheduling of the trial of common issues, separate Patent Act and Regulations infringement proceedings could proceed efficiently without formal joinder. The Court's position is consistent with its recent decision in Bayer Inc. v Teva Canada Limited, 2019 FC 191 (Tabib P.).

Background: Pharmascience seeks to market a new dosage form

Teva markets glatiramer acetate in Canada under the brand name Copaxone in two dosage strengths: 20 mg/mL and 40 mg/mL. Copaxone is used in the treatment of multiple sclerosis. Teva listed Canadian Patent No. 2,702,437 (the 437 Patent) on the Patent Register in respect of 40 mg/mL Copaxone; however, no patents were listed against 20 mg/mL Copaxone.

Pharmascience obtained a Notice of Compliance (NOC) to market its own 20 mg/mL glatiramer acetate product, Glatect 20 mg, in August 2017. Pharmascience was not required to address the 437 Patent because it was not listed against the 20 mg/mL product.

In November 2018, Pharmascience filed a Supplementary New Drug Submission (SNDS) for approval to market Glatect 40 mg and was therefore required to address the 437 Patent, which it did by way of Notice of Allegation (NOA). Teva responded by filing an infringement action pursuant to subsection 6(1) of the Regulations, asserting that:

  • Pharmascience would infringe the 437 Patent by marketing Glatect 20 mg and Glatect 40 mg in accordance with the SNDS; and
  • Pharmascience was already infringing the 437 Patent through its past or current activities relating to Glatect 20 mg.

This decision concerns a motion by Pharmascience to strike Teva's pleadings relating to Glatect 20 mg.

Strict rule against joinder: the Court strikes Teva's infringement claim in part

The Federal Court struck Teva's infringement claim relating to Pharmascience's past or current activities relating to Glatect 20 mg because they were not done "in accordance with the submission or supplement" that precipitated the NOA underlying the proceeding, as required by subsection 6(1) of the Regulations. Rather, they were done pursuant to Pharmascience's earlier submission for Glatect 20 mg, which did not trigger the Regulations.

Having found that Teva's claim for past and current infringement could not be grounded in subsection 6(1) of the Regulations, the Court went on to consider whether it could be supported by subsection 55(1) of the Patent Act instead. The Court held that Teva was free to bring such a claim. In particular, the Court confirmed that such a claim would not be barred by section 6.01 of the Regulations because it could not have been brought pursuant to subsection 6(1).

However, the Court found that once properly constituted under subsection 55(1) of the Patent Act, Teva's claim for past and current infringement could not be joined with the subsection 6(1) action due to the rule against joinder in section 6.02 of the Regulations. The Court held that this provision strictly prohibits the combination of subsection 6(1) actions with any other rights under the Patent Act while the Minister is prohibited from granting a NOC by the statutory stay under subsection 7(1) of the Regulations. The Court found that this mandatory prohibition on joinder left no discretion to the Court, unlike the rule of joinder under the Federal Courts Rules.

Accordingly, Teva's infringement claim regarding Pharmascience's past or current activities marketing Glatect 20 mg was struck as failing to disclose a reasonable cause of action.

Pharmascience also argued that the balance of Teva's claim in respect of Glatect 20 mg should be struck on the basis that the SNDS in issue only pertained to Glatect 40 mg — as such, Pharmascience would not make, construct, use, or sell Glatect 20 mg in accordance with the SNDS even after it issued. The Court rejected this argument on the basis of Teva's pleading that Pharmascience's SNDS related to both Glatect 20 mg and Glatect 40 mg. In doing so, the Court refused to consider affidavit evidence filed by Pharmascience to contradict the pleading in the statement of claim, finding that it was required to take the pleading as true for the purpose of determining whether the pleading disclosed a reasonable cause of action.

The Court also dismissed Pharmascience's assertion that Teva's claim was frivolous, vexatious, or an abuse of process. In reaching its conclusion on this issue, the Court found that it was permitted to receive evidence, but stated that it had significant doubts as to the propriety of using such a motion as a means of adducing evidence that goes specifically to disproving the truth of an allegation of fact made in a pleading.

Teva Canada Innovation v Pharmascience Inc., 2019 FC 595 (Tabib P.)

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