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.
