Canada Patented Medicines: Federal Court of Appeal Confirms Mootness of Innovator Appeals after Generic Marketing Authorization is Granted

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“Asking a court to prohibit a notice of compliance after it has issued is like asking someone to close the barn door after the horses have escaped.”

With this analogy, the Federal Court of Appeal in Janssen Inc. v. Teva Canada Limited, 2015 FCA 36 has confirmed that an appeal from an order dismissing a prohibition application under the PM(NOC) Regulations becomes moot once the generic notice of compliance is issued. The Court dismissed Janssen’s appeal noting that it does not serve judicial economy to hear moot appeals.

In fact, the FCA has only exercised its discretion to hear such a moot PM(NOC) appeal once before, in Abbott Laboratories v. Apotex, 2007 FCA 153.

In the present case, Janssen argued that a specific appeal provision in the Comprehensive Economic and Trade Agreement between Canada and the EU creates unusual circumstances that should prompt the FCA to exercise its discretion to hear an otherwise moot appeal. The FCA rejected this argument, noting that a decision-maker cannot exercise its discretion in accordance with a law that has not yet come into force. The FCA also rejected Janssen’s assertion that a subsequent regulatory submission filed by Teva created an adversarial context that should prompt the exercise of discretion. The FCA reasoned that no adversarial context could arise in the absence of a corresponding prohibition application by Janssen, and even if such an adversarial context were to arise, it would be unrelated to the present proceeding.

appeal PM(NOC)



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