Docket:
A-400-10
Citation:
2013 FCA 282
CORAM: EVANS J.A.
STRATAS
J.A.
WEBB
J.A.
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BETWEEN:
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APOTEX INC.
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Appellant
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and
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ELI LILLY CANADA INC.
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Respondent
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and
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ELI LILLY AND COMPANY LIMITED
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Respondent/Patentee
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and
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MINISTER OF HEALTH
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Respondent
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REASONS FOR JUDGMENT OF THE COURT
(Delivered from the
Bench at Toronto, Ontario, on December 4, 2013).
EVANS J.A.
[1]
This is an appeal by Apotex Inc. (Apotex) from a
decision of Justice Gauthier (Judge) when a Judge of the Federal Court
dismissing a motion by Apotex under rule 399 of the Federal Courts Rules,
SOR/98-106. The decision is reported at 2010 FC 952.
[2]
In its motion Apotex had requested the Court
to set aside an order granted to Eli Lilly Canada Inc. (Lilly), the respondent
in this appeal, prohibiting the Minister of Health (Minister) from issuing a
Notice of Compliance (NOC) to Apotex with respect to its olanzaprine products
until the expiry of Lilly’s Canadian Letters Patent No. 2,041,113 (’113
patent). In addition, Apotex requested that the Judge dismiss the application
that resulted in the order of prohibition.
[3]
The nub of the Judge’s decision was that, even
if the ’113 patent were ultimately held invalid in an action impeaching its
validity, which at that time had not been finally resolved, that would not be a
matter arising after the order of prohibition for the purpose of rule 399(2)(a).
Following the hearing of the motion, the Federal Court of Appeal held in Apotex
Inc. v. Syntex Pharmaceuticals International Inc., 2010 FCA 155 (Syntex)
that “there is no need to set aside the prohibition order when the patent
expires through a declaration of invalidity” (para. 30 of the Judge’s reasons).
[4]
In appealing the Judge’s order Apotex acknowledges
that it is asking the Court reconsider a question that it has already decided,
and that if the Court declines this request its appeal cannot succeed.
[5]
The question at issue is whether a declaration
that a patent is invalid enables the Court to vary its earlier order and
dismiss an application for a prohibition under subsection 6(1) of the Patented
Medicines (Notice of Compliance) Regulations, SOR/93-133 (Regulations)
in which the Court had granted an order prohibiting the Minister from issuing a
NOC pending the expiry of a patent on the list submitted by an applicant in
respect of a new drug, and listed by the Minister on the patent register in
respect of that drug.
[6]
This Court has unequivocally held on several
occasions that a finding that a patent is invalid does not enable the Court to
reach back and retroactively dismiss an application for an order of prohibition
granted earlier on the ground that an allegation of non-infringement or
invalidity in a Notice of Allegation was not justified: see, in particular, Syntex
at para. 36; Pfizer Canada Inc. v. Ratiopharm, 2011 FCA 215 (Ratiopharm).
[7]
The practical significance of this issue is that
a generic pharmaceutical manufacturer may claim damages under section 8 of the
Regulations if an application for an order of prohibition under subsection 6(1)
is withdrawn or discontinued, dismissed, or reversed on appeal. Since a
subsequent declaration that a patent listed on the register is invalid is none
of these, it does not give rise to a claim by the generic manufacturer for
damages for loss of profits sustained during the time that the prohibition
order kept its product off the market.
[8]
Because this Court is normally bound by its own
decisions, Apotex can only succeed in this appeal if it satisfies us that Syntex
and Ratiopharm should not be followed because they are “manifestly
wrong” within the narrow meaning of Miller v. Canada (Attorney General),
2002 FCA 370 at paras. 8, 10, and 22 (Miller). They were not per
incuriam, nor subsequently overruled or seriously attenuated by decisions
of the Supreme Court of Canada.
[9]
We would emphasize that an important basis of Miller
is the public interest in avoiding the waste of scarce judicial, and other,
resources through the re-litigation of decided questions.
[10]
The principal argument advanced by Apotex in the
present appeal for our revisiting the issue decided in Syntex and Ratiopharm
is that the Court relied on a decision of the English Court of Appeal, Unilin
Beheer BV v. Berry Floor N V, [2007] EWCA Civ. 364 (Unilin), which
was subsequently overruled by the Supreme Court of the United Kingdom in Virgin
Airways Limited v. Zodiac Seats UK Limited, [2013] UKSC 46.
[11]
We do not agree that this argument establishes
that Syntex and Ratiopharm were “manifestly wrong” in the Miller
sense. In particular, we are not satisfied that they, or the decision in the
present appeal, were based on Unilin to such an extent that they should
be reconsidered by this Court. They involved the interpretation of the very
particular statutory regime created by the Regulations, including the statutory
cause of action under section 8. Unilin did not. Subsequent decisions of
foreign courts that may be somewhat analogous do not normally demonstrate that
a contrary decision by a Canadian court was “manifestly wrong”.
[12]
Whatever the merits of Apotex’ arguments that Syntex
and Ratiopharm are bad law and inconsistent with the overall scheme and
purposes of the Regulations, they are more appropriately addressed in an
application for leave to appeal to the Supreme Court of Canada.
[13]
For these reasons, and despite the very able
arguments of counsel for Apotex, we are not persuaded that the Judge committed
any reviewable error in exercising her discretion to deny the motion.
Accordingly, the appeal will be dismissed with costs.
"John M. Evans"
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