Federal Court Of Appeal Affirms Cancellation Of Reconsideration Of ANDS For Apo-Omeprazole

The Federal Court of Appeal has dismissed an appeal by Apotex Inc. (Apotex) in its unsuccessful application for judicial review of a decision by the Minister of Health (the Minister) to cancel the reconsideration of approval for Apo-omeprazole.

Background

As we reported, the Minister revoked Apotex's Notice of Compliance (NOC) for Apo-omeprazole and declined to issue the NOC again in 2013 due to inadequate evidence of bioequivalence in its Abbreviated New Drug Submission. Apotex sought reconsideration of the Minister's decision by an external expert panel on the basis of safety and efficacy. The Minister took the position that the issue for reconsideration was bioequivalence, and cancelled the reconsideration process when the parties could not agree on the question to put to the panel.

The Federal Court dismissed Apotex's application for judicial review of the Minister's decision to cancel the reconsideration process. The Court held that Apotex had no legitimate expectation that the Minister's discretion would be exercised in its favour. The Court further held that the Minister did not fetter her discretion in requiring the reconsideration process to focus on bioequivalence.

Apotex's Appeal Dismissed

On appeal, Apotex recast its position to argue that the Minister had no authority to cancel the reconsideration process entirely. Apotex asserted that it had a legitimate expectation that the reconsideration process would continue, despite the continued disagreement regarding the question to be put to the panel.

The Court of Appeal rejected this argument, as it was not raised in Apotex's Notice of Application and was not properly before the Court. In its Notice of Application, Apotex had not sought relief to compel the Minister to continue the reconsideration process — instead, it focused exclusively on requiring the Minister to frame the question for the panel without regard to bioequivalence.

Based on the...