This appeal concerns damages claimed by Apotex for lost sales of its generic drug Apo-lansoprazole due to proceedings initiated by Abbott and Takeda under section 6 of the Patented Medicines (Notice of Compliance) Regulations.
The motion judge dismissed the defendants' motion for summary judgment, finding that Apotex would have received regulatory approval on April 17, 2007, but for the section 6 proceedings.
The appellants argued that Apotex's submission was deficient because it lacked a high-fat meal bioequivalence study.
The Court of Appeal upheld the motion judge's decision, finding no legal requirement for such a study and ample evidence supporting approval on the original submission.