Apotex filed an ANDS seeking a Notice of Compliance (NOC) for its Apo-ASA product. Health Canada considered it necessary for Apotex to establish bioavailability with the referenced product. Apotex did not challenge that decision but rather submitted that its ANDS does include such evidence. The Minister disagreed, finding the results of one of the included studies do not meet the necessary standards in its guidelines.
The Trial Division dismissed Apotex’ application for judicial review, finding that the question as to whether bioequivalence has been proven is a question of fact to be determined by the Minister reviewable on the standard of reasonableness. The Court held that the Minister’s decision not to accept Apotex’ demand for a NOC on the basis of non-compliant data was not unreasonable. The Court of Appeal found that this decision was reasonable and dismissed the appeal.