This endorsement addresses a refusals motion where the defendants, Eli Lilly, sought to question the plaintiff, Apotex, regarding communications with the government during Apotex's abbreviated new drug submission (ANDS) process.
Apotex argued that its drug approval process was immune from challenge by Lilly.
The court distinguished between an impermissible collateral attack on Health Canada's regulatory approval and a permissible inquiry into factors that might affect the "start date" for damages under s. 8(1)(a)(ii) of the Patented Medicines (Notice of Compliance) Regulations.
The court found Lilly's request to be probative of a properly pleaded issue concerning the quantum of damages, rather than the validity of the approval itself.
Consequently, the motion was granted, and the question was ordered to be answered.