Canada: Infringement Based On Making/Selling Under Existing NOC For One Strength Struck From Action Under The PMNOC Regulations Triggered By NOA Based On Different Strength

The Federal Court has granted in part Pharmascience's motion to strike out portions of Teva's statement of claim under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) relating to glatiramer acetate (Teva's COPAXONE; Pharmascience's GLATECT): Teva Canada v Pharmascience Inc, 2019 FC 595.

Teva holds notices of compliance (NOCs) for COPAXONE in 20 mg and 40 mg strengths but listed Canadian Patent No. 2,702,437 against COPAXONE for the 40 mg strength only. Pharmascience previously obtained an NOC for GLATECT 20 mg and filed a supplemental new drug submission (SNDS) for the 40 mg strength. In its action, Teva sought a declaration of infringement for both GLATECT 20 mg and 40 mg, as well as relief for past and current infringement in relation to GLATECT 20 mg. Pharmascience moved to strike on the basis that the claim improperly joined a cause of action in infringement in respect of a drug product for which Pharmascience already holds an NOC and which is not addressed in its notice of allegation.

Assuming the SNDS relates to GLATECT 20 mg (in addition to the 40 mg) as Teva alleged, the Court declined to strike Teva's claim pursuant to subsection 6(1) for a declaration of infringement in relation to this strength. It was not plain and obvious that Teva has no reasonable cause of action since the claim raises complex issues of statutory interpretation of subsection 6(1) in the context of a new regulatory scheme. The Court also declined to strike out Teva's allegations that the SNDS relates to the 20 mg product on the evidence.

The Court, however, struck out Teva's claim under subsection 6(1) in respect of past and current infringement by the 20 mg product. There was no reasonable cause of action as past and current making, constructing, using and selling of this product were not alleged to be, and could not be, "in accordance with" the SNDS as required by the PMNOC Regulations.

Further, the Court found that it is plain and obvious that section 6.02 of the PMNOC Regulations prohibits the joinder of a regular infringement action under the Patent Act with an action pursuant to subsection 6(1) of the PMNOC Regulations. Since Teva's cause of action in respect of past or current infringement by GLATECT 20 mg arises only pursuant to section 55 of the Patent Act, its inclusion as part of Teva's subsection 6(1) action was clearly prohibited and accordingly struck as an abuse of process. Teva can assert this cause of action as part of a separate proceeding.

If you have any questions or would like further information, please contact a member of our  Pharmaceutical and  Life Sciences group.

The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.

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