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Court declines to direct preliminary determination on interpretation of subsection 6(1) of PMNOC Regulations

On November 7, 2019, Prothonotary Tabib dismissed Pharmascience’s motion for an order directing a preliminary determination of a question of law in the context of a patent infringement action brought by Teva pursuant to the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) relating to glatiramer acetate (Teva’s COPAXONE; Pharmascience’s GLATECT): Teva v Pharmascience, 2019 FC 1394. The motion was dismissed on the ground that the issue for determination, although a pure question of law, was not premised on undisputed facts.


Teva holds notices of compliance (NOCs) for COPAXONE in strengths of 20 mg/mL and 40 mg/mL, and listed Canadian Patent No. 2,702,437 (437 Patent) against the 40 mg/mL strength only. Pharmascience, who had already obtained an NOC for GLATECT 20 mg/mL, filed a supplementary new drug submission (SNDS) for GLATECT 40 mg/mL comparing it to COPAXONE 40 mg/mL and sent Teva a notice of allegation regarding same. Teva, however, commenced an action seeking a declaration of infringement of the 457 Patent for both GLATECT strengths.


Pharmascience argued that Teva’s action with respect to GLATECT 20 mg/mL is improper and brought a motion to direct the preliminary determination by the trial judge of the following question: Does section 6(1) of the PMNOC Regulations permit first persons to pursue an action thereunder in respect of a drug against which there is no listed patent and for which no section 5 obligations are triggered? The question was essentially the same as that raised in an earlier motion to strike, which was dismissed (see our brief here, leave to appeal to Federal Court of Appeal dismissed).

Prothonotary Tabib first considered whether the question posed by Pharmascience was a pure question of law. She found that it did frame a pure question of law but was premised on two assumptions: one assumption—that no patents were listed against COPAXONE 20 mg/mL—was uncontested, while the other assumption—that GLATECT 20 mg/mL does not trigger the obligations under section 5 of the PMNOC Regulations—was an issue of mixed fact and law that was vigorously disputed by Teva. She concluded that the motion could not be granted since the jurisprudence indicated that the Court cannot make a preliminary determination by assuming the truth of a disputed issue of fact and law.

Although this conclusion was determinative, Prothonotary Tabib considered additional factors in case her interpretation of the jurisprudence turned out to be incorrect, all of which supported dismissal of the motion. She found that the determination of the question would not be conclusive of the action or a substantial portion thereof since the issue of whether section 5 obligations were triggered would still need to be determined through a trial. Furthermore, any reduction in time at trial was found not to be justified by the distraction, time and costs involved in preliminarily resolving the question of law. Lastly, she noted that it would be improper to isolate the interpretation of section 6(1) from the interpretation of section 5 of the PMNOC Regulations, as to do so would go against the principle of statutory interpretation that provisions must be interpreted contextually and in harmony with the statute as a whole.

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