FCA upholds issuance of NON-W letter and cancellation of reconsideration process for Apotex omeprazole magnesium tablet ANDS
May 30, 2019

by: Abigail Smith

On April 24, 2019, the Federal Court of Appeal (FCA) affirmed the Federal Court’s (FC) dismissal of Apotex’s application for judicial review of a decision by the Minister of Health relating to its Apo-Omeprazole (omeprazole magnesium) delayed release tablets: Apotex Inc v Canada (Health), 2019 FCA 97. The Minister had issued a Notice of Non-Compliance – Withdrawal (NON-W) letter in respect of Apotex’s abbreviated new drug submission on the basis that the tablets were not bioequivalent to the relevant Canadian reference product. Apotex sought reconsideration, but after the parties could not agree on the formulation of the question for reconsideration, the Minister cancelled the reconsideration process and issued a final NON-W letter.

On judicial review of that decision (reported here), Apotex argued that the Minister had improperly fettered her discretion by insisting that the question include consideration of bioequivalence. Justice Roy concluded that the Minister’s question was reasonable, and that excluding bioequivalence in favour of safety and efficacy only “would be outside the scope of the Regulations.”

On appeal, Apotex additionally argued that the Minister had no authority to cancel the reconsideration process entirely, and that it had a legitimate expectation that the reconsideration process would continue in spite of its ongoing dispute with the Minister regarding the proper question. The FCA declined to consider the legitimate expectations issue on the basis that it was not properly before them and, for the reasons given by the FC, was satisfied that the question as framed by the Minister was reasonable.

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