Case:Alexion Pharmaceuticals Inc. v
Attorney General of Canada, 2016 FC 716 (Court File No.
Drug: SOLIRIS® (eculizumab)
Nature of case: Application for declaratory
relief that ss. 80-86 and part of 87(1) of the Patent Act,
RSC 1985, c P-4 (Patent Act) are
unconstitutional and ultra vires the Parliament of Canada
and prohibition order preventing the PMPRB from proceeding with a
hearing under s. 83.
Successful party: Attorney General of
Date of decision: June 23, 2016
In January 2015, the Patented Medicine Prices Review Board
(PMPRB or Board) commenced a
proceeding against Alexion Pharmaceuticals Inc. alleging it had
sold its drug SOLIRIS® (eculizumab) at an excessive
price. As a result of the ongoing PMPRB proceeding, Alexion brought
an application seeking declaratory relief that sections 80 through
86, and the words "in any proceeding under section
83" of section 87(1) of the Patent Act
(Impugned Provisions) are unconstitutional and
ultra vires the federal powers granted to Parliament.
Alexion also sought an order prohibiting the PMPRB from continuing
the proceeding against Alexion.
The Attorney General of Canada (AG) brought a
motion to strike the application on the grounds that the
constitutionality of the Impugned Provisions has been fully
determined in prior case law, and therefore the application is
bereft of any chance of success.
The Court granted the AG's motion and struck Alexion's
application with costs.
The Impugned Provisions are Constitutional
Alexion argued that the prior line of case law had not dealt
with the constitutionality of the Impugned Provisions directly, and
the evidence submitted by Alexion provides a complete record for a
full analysis of the pith and substance of the provisions. For this
reason, Alexion argued that the application is not bereft of any
chance of success.
The AG's position was that the constitutionality of the
Impugned Provisions had been determined in prior jurisprudence and
the application should be struck. The Court reviewed the line of
case law relied upon by the AG and concluded that the provisions of
the Patent Act dealing with pricing of patented medicines
fell within the federal jurisdiction and were constitutional.
The Court noted that the most recent decision on this matter,
Attorney General (Canada) v. Sandoz Canada Inc., 2015 FCA
249 (Sandoz), is the subject of an
application for leave to appeal to the Supreme Court of Canada, the
outcome of which is currently pending (reported
here). The central issue in the Sandoz decision was
whether the lower court properly held that Sandoz, a generic
manufacturer, fell outside the jurisdiction of the PMPRB and was
not a "patentee" under the Patent Act. The Court
in Sandoz also commented on the constitutionality of the
Impugned Provisions and held that the lower court correctly held
that "the control of prices charged for patented medicines
comes within the jurisdiction conferred on Parliament over
Alexion's Application is Struck
Neither party sought a stay of the proceeding pending the
outcome of Sandoz's leave to appeal to the Supreme
Court of Canada. The Court held that the doctrine of stare
decisis applied in this situation and the decision of the
Federal Court of Appeal in Sandoz was sufficient to
dispose of the motion. As a result, the Court granted the motion of
the AG and struck the application brought by Alexion.
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