Dockets:
A-462-11
A-27-12
Citation: 2014 FCA 66
CORAM:
SHARLOW J.A.
PELLETIER J.A.
MAINVILLE J.A.
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Docket:
A-462-11
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BETWEEN:
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SANOFI-AVENTIS,
SANOFI-AVENTIS DEUTSCHLAND GmbH and SANOFI-AVENTIS CANADA INC.
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Appellants
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and
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APOTEX INC.
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Respondent
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Docket:
A-27-12
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AND BETWEEN:
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SANOFI-AVENTIS, SANOFI-AVENTIS DEUTSCHLAND GmbH and
SANOFI-AVENTIS CANADA INC.
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Appellants
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and
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APOTEX INC.
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Respondent
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REASONS
FOR JUDGMENTS
MAINVILLE J.A.
[1]
These reasons concern two appeals brought by Sanofi-Aventis,
Sanofi-Aventis Deutschland GmbH and Sanofi-Aventis Canada Inc. (collectively
referred to herein as “Sanofi”) in dockets
A-462-11 and
A-27-12. These appeals were heard with appeals in
dockets A-191-12, A-193-12,
A-397-12 and
A-474-12 concerning an action commenced by Apotex Inc. (“Apotex”) on August 14,
2009 seeking compensation from Sanofi pursuant to section 8 of the Patented
Medicines (Notice of Compliance) Regulations, SOR/93-133 (“NOC Regulations”)
with respect to its generic version of the drug ramipril.
[2]
This Court has concurrently issued judgments for the
appeals in dockets A-191-12, A-193-12, A-397-12 and A-474-12 for reasons cited as
2014 FCA 68. These reasons should be read in conjunction with the reasons
issued in the other related appeals.
[3]
The appeal in docket A-462-11 is from an order of
Snider J. of the Federal Court (“Trial Judge”) dated November 25, 2011 which
dismissed Sanofi’s appeal from an order of Prothonotary Aalto dated October 12,
2011 denying its motion seeking amendments to its statement of defence to
include allegations respecting the two following issues.
[4]
The first amendment sought to assert that in the
hypothetical market which had to be established to determine the level of
compensation owed to Apotex under section 8 of the NOC Regulations, Pharmascience
Inc. (“Pharmascience”) would have been the first generic drug manufacturer to
enter the generic ramipril market.
[5]
The second amendment sought to add to the statement of
defence that the HOPE indications (Heart Outcomes Prevention Evaluation i.e.
use of ramipril in the prevention of cardiovascular events and of stroke,
diabetes and congestive heart failure) for Apotex’s generic version of ramipril
was a significant unapproved indication, and that section 8 of the NOC Regulations
does not contemplate recovery of damages in respect of lost sales of a generic drug
product for such an unapproved indication.
[6]
The appeal in docket A-27-12 is from another order of
the Trial Judge dated January 11, 2012 which granted in part a motion brought
by Apotex seeking to strike certain portions of Sanofi’s expert reports. As a
result of that order, passages from the report of Dr. Carbone that quantified
the impacts of the HOPE indications on Apotex’s market share were struck out,
as well as passages from the report of Mr. Hamilton that sets out his estimate
of Apotex’s lost profits in the scenario where Pharmascience was regarded as
the first generic drug manufacturer entering the generic ramipril market.
[7]
At the time it submitted its motion for amendments to
its defence in the Apotex litigation, Sanofi was also involved in additional
litigation involving ramipril and section 8 of the NOC Regulations with
other generic drug manufacturers, notably Laboratoire Riva Inc. and Teva. Sanofi
sought similar amendments in all three proceedings, and all these motions were
heard and decided together by Prothonotary Aalto.
[8]
Prothonotary Aalto noted that Sanofi had sought these
amendments to its pleadings (with a related motion to examine a representative
of Pharmascience) some three months prior to the trials in both the Teva and
Apotex proceedings. The prothonotary also noted that Sanofi had cast the two
amendments in dispute as mere “clarifications” or house keeping amendments.
[9]
After a careful review of the parties’ submissions, Prothonotary
Aalto took the view that, contrary to Sanofi’s representations, both suggested
amendments added new, substantial and largely speculative allegations. The prothonotary
further took into account the late timing of the amendments relative to the
then-looming trial dates, and concluded that Apotex would be prejudiced by the
real risk of having the trial adjourned as a result of the need to alter expert
reports which had already been exchanged between the litigants.
[10]
Reviewing the prothonotary’s decision de novo, the
Trial Judge dismissed Sanofi’s appeal for essentially the same reasons as those
given by the prothonotary. The Trial Judge concluded, in light of all the
circumstances, that the interests of justice would not be served by allowing
the amendments.
[11]
In her subsequent order striking out passages from the
reports of Dr. Carbone and Mr. Hamilton, the Trial Judge found that these
passages were directly related to the struck pleadings and therefore could not be
admitted into evidence.
[12]
The litigants rightfully acknowledge that the result of
the appeal on the amendments governs the result in the other appeal.
[13]
The facts that are relevant to Sanofi’s appeal on
the amendments, and the applicable principles, are substantially the same as those
in docket A-460-11 (Sanofi v. Teva Canada Limited), and the outcome must
be the same. Judgment dismissing the appeal in docket A-460-11 was rendered
concurrently with this one, for reasons cited as 2014 FCA 65. Sanofi’s appeal
on the amendments in this case will be dismissed for same reasons. It
necessarily follows that Sanofi’s appeal of the order striking passages from
the reports of Dr. Carbone and Mr. Hamilton must also be dismissed.
[14]
I would therefore dismiss both appeals, with costs in favour of Apotex.
"Robert M. Mainville"
“I agree.
Karen Sharlow J.A.”
“I agree.
J.D. Denis Pelletier J.A.”
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