The Federal Court dismissed Pharmascience Inc.’s (Pharmascience) motion to determine a question of law on the issue of whether a first person can commence an action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) for a drug for which there are no patents listed on the patent register. The Court held that the facts required to determine the motion were contested so answering the question of law would not determine the dispute as between the parties. It also stated that, in the context of the PM(NOC) Regulations, such motions may not provide any efficiencies.

Background

Teva Canada Innovation (Teva) has a patent covering two strengths of glatiramer acetate (20 mg/ml and 40 mg/ml); however, it only listed the patent against the 40 mg/ml strength. Pharmascience obtained a Notice of Compliance (NOC) to sell the 20 mg/ml strength. When Pharmascience filed a Supplementary New Drug Submission (SNDS) for the second strength (40 mg/ml), Teva brought an action against Pharmascience under the PM(NOC) Regulations with respect to both strengths.

We have previously reported on a motion by Pharmascience to strike allegations in Teva’s statement of claim in respect of the 20 mg/ml strength. What remained was an allegation that Pharmascience’s SNDS pertained to both the 20 mg/ml strength as well as the 40 mg/ml strength. The Federal Court of Appeal denied leave to appeal that motion.

No Leave for Proposed Preliminary Question

Pharmascience proposed the following preliminary question:

Does subsection 6 (1) of the Patented Medicines (Notice of Compliance) 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?

Prothonotary Tabib found that Pharmascience’s motion: (1) was not a question of pure law, (2) would not dispose of the action or a substantial part thereof, and (3) would save neither time nor money.

Prothonotary Tabib found that the motion was premised on contested factual assumptions relating to whether or not Pharmascience’s SNDS related to the 20 mg/ml strength. The Court concluded it could not determine a question of law where the facts required to make the determination were contested.

For the same reason determining the question would not dispose of any issues between the parties because the factual issues would still have to be proved at trial.

For the same reason, there were no efficiencies to be gained. To the extent there were, these efficiencies were outweighed by the need to meet the 24-month period to hear PM(NOC) cases imposed by the PM(NOC) Regulations.

The case isMillennium Pharmaceuticals Inc. v Teva Canada Limited2019 FC 1394.