Sanjaya Mendis

The plaintiff, Glenn Bowles, moved to amend his Statement of Claim to add Katena Products Inc. and Abbott Medical Optics Canada Inc. (AMO) as defendants, arguing discoverability and misnomer, after the presumptive limitation period had expired.

AMO opposed, asserting the claim was statute-barred due to lack of due diligence in identifying them.

The court found that the plaintiff and his counsel exercised due diligence, as the identity of the manufacturers was not discoverable until Dr. Hillson's counsel disclosed it on June 26, 2015.

The court granted the motion to add both Katena and AMO as defendants, finding the doctrine of discoverability applied and the misnomer doctrine did not.

The moving parties (innovator drug manufacturers) brought a motion for summary judgment to dismiss the responding party's (generic drug manufacturer) claim for damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations.

The moving parties argued that the generic drug could not have been lawfully approved by Health Canada in April 2007 due to non-compliance with bioequivalence study guidelines, rendering the section 8 claim invalid.

The court dismissed the motion, finding that Health Canada's guidelines did not have the force of law and that the evidence established the generic drug would have received a Notice of Compliance in April 2007 but for the moving parties' prohibition proceedings.

The court also distinguished prior case law and held that the moving parties lacked standing to challenge the Minister's drug approval decisions in a section 8 damages action.

In this patent damages appeal under s. 8 of the Patented Medicines (Notice of Compliance) Regulations, the Court upheld the Federal Court of Appeal decision and dismissed the patentees' appeal.

The Court agreed with the majority's reasoning on liability period, market-entry assumptions, and compensation for lost sales tied to unapproved indications.