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Apotex Challenges Minister’s Refusal To Approve Apo-rasagiline

Apotex is seeking judicial review of a decision to decline to issue a Notice of Compliance (“NOC”) to Apotex for its Apo-rasagiline product.

According to the Notice of Application, Apotex’s submission was put on “patent hold” in April 2013. Notwithstanding having purportedly met all regulatory requirements, Apotex alleges that the Minister is allegedly “not willing to grant or not being permitted to grant” an NOC for Apo-rasagiline because it is manufactured at Apotex’s facilities in India that are subject to an import ban imposed by the Minister of Health. Apotex argues that this ban is unrelated to the safety of its products and is a response to the publicity caused by articles in the Toronto Star that impugned as defective the Indian pharmaceutical manufacturing facilities of Apotex and other manufacturers. Apotex is challenging the import ban in a separate proceeding.

Apotex argues that the Minister has no discretion to refuse to issue an NOC when the requirements for the issuance of an NOC have been met. Apotex also alleges that the Minister’s reliance on the import ban to deny the NOC was “arbitrary, discriminatory and unfair” and that Apotex was not afforded an opportunity to be heard before the decision was made.