Apotex Inc. v. Canada (Health), 2013 FC 1217 

Drug: telmisartan

Apotex brought this application for judicial review of a decision of the Therapeutic Products Directorate (TPD) refusing to review Apotex’ Abbreviated New Drug Submission (ANDS) for its Apo-Telmisartan product. The Court granted the application, requiring the Minister to reconsider its decision not to accept the ANDS for review.

The dispute centred over the medicinal ingredient in the product. The Court held that there was no breach of procedural fairness. However, the Court also held that the principles 
of statutory interpretation do not support the Minister’s approach. In particular, the term “medicinal ingredients” should have a consistent meaning in the Regulations. Thus, the Court held that Apotex had been subjected to an inconsistent approach that differs from its generic predecessors. Thus, the Minister’s decision regarding the interpretation of “identical medicinal ingredient” was held to not be reasonable.