Case:Amgen Canada Inc. v Apotex Inc.,
2016 FCA 196 (Court File No. A-501-15)
Nature of case: Motion for dismissal of an appeal from an
application for prohibition pursuant to section 6 of the
Patented Medicines (Notice of Compliance) Regulations,
SOR/93-133 (the Regulations)
Successful party: Apotex Inc.
Date of decision: July 15, 2016
Amgen Canada Inc. and Amgen Inc. (collectively,
Amgen) market and sell filgrastim in Canada under
the name NEUPOGEN® for use in the treatment of
neutropenia. In November 2015, the Federal Court dismissed
Amgen's application for an order prohibiting the Minister of
Health from issuing a Notice of Compliance (NOC)
to Apotex Inc. for its subsequent-entry biologic (or biosimilar) of
filgrastim for two dosage strengths (reported here). Apotex received an NOC for one of the
dosage strengths in December 2015.
Amgen sought an expedited appeal of the dismissal, and Apotex
moved to have the appeal dismissed for mootness.
Apotex argued that the Minister had already issued an NOC to
Apotex, and therefore a prohibition order would serve no purpose.
Amgen opposed the motion by pointing to Apotex filing a claim for
damages pursuant to section 8 of the Regulations.
Apotex's claim was triggered by the dismissal of Amgen's
application. Amgen argued that a reversal of the decision would
extinguish Apotex's right to bring this claim, and therefore,
as Apotex's section 8 action was live and not a mere
possibility, the appeal would have a real and practical effect on
the parties' rights.
The Federal Court of Appeal dismissed Amgen's appeal. The
court confirmed that an appeal is moot when an NOC has already
issued, and held that it should not exercise its discretion to hear
the moot appeal. Although the court agreed with Amgen that a live
section 8 claim impacts the parties rights "in a real and
practical way," this was not adequate to distinguish previous
cases. The court confirmed that when a patentee can assert its
patent, including in the context of section 8, the pending appeal
loses any practical utility and hearing the appeal would serve only
to waste scarce judicial resources.
Amgen has sought leave to appeal to the Supreme Court.
Prohibition proceeding: Amgen Canada Inc v Canada (Minister
of Health), 2015 FC 1261
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