Federal Court Clarifies Right of Action under Subsection 6(1) of PM(NOC) Regulations

On May 7, 2019, the Federal Court (the "Court") issued the decision Teva Canada Innovation v Pharmascience Inc., 2019 FC 595 in which it clarified the scope of actions that can be brought under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (the "Regulations").  Subsection 6(1) allows patentees to bring an action for a declaration that the future distribution of a drug would infringe their patent.  The decision addressed the issue of whether subsection 6(1) could also accommodate an action for damages based on past and current patent infringement.

This case arose after Pharmascience Inc. ("Pharmascience") served Teva Canada Innovation ("Teva") with a Notice of Allegation ("NOA") disputing a patent Teva had listed for the 40 mg/mL dose of glatiramer acetate.  Pharmascience intended to distribute the same drug and dose under the name Glatect 40.  Subsequently, Teva brought a declaratory action under subsection 6(1) regarding the Pharmascience drug.  Teva also brought an action under subsection 6(1) for patent infringement damages for Pharmascience’s past and current sale of the drug’s 20 mg/mL dosage.   A key issue was whether Teva's claim alleging past and current infringement could be brought under subsection 6(1) of the Regulations.

Actions for past and current patent infringements are normally brought under section 55 of the Patent Act.  However, section 6.01 of the Regulations bars actions involving patents that are the subject of an NOA, unless the action is brought under subsection 6(1).  Teva submitted that subsection 6(1) must be flexible enough accommodate their infringement action; otherwise, section 6.01 would prevent patentees from bringing any infringement actions if their patent is the subject of a NOA.

In striking Teva’s claim, the Court clarified that section 6.01 only bars infringement actions that could have been brought under the prescribed conditions set out in subsection 6(1).  Teva’s past and current infringement action was not one of those actions.  Consequently, the Court found that while the plain wording of subsection 6(1) could not accommodate Teva’s action, Teva would not be barred from bringing it under section 55 of the Patent Act.

Summary By: Sam Hargreaves