Court of Appeal Upholds Decision to Deny Amendments to Statement
of Defence in Section 8 Proceeding
Sanofi-Aventis Canada Inc. v. Teva Canada Limited,
2014 FCA 65
Drug: ramipril
This appeal was heard in the context of an action commenced by Teva
Canada Limited ("Teva") seeking compensation from
Sanofi-Aventis Canada Inc. and Sanofi-Aventis Deutschland GmbH
(collectively "Sanofi") pursuant to section 8 of the
NOC Regulations. The appeal was heard together with two
other appeals: 2014 FCA 67 and 2014 FCA 69 (summary below).
This appeal was from an order of the Federal Court which dismissed
Sanofi's appeal from an order of Prothonotary Aalto denying its
motion seeking amendments to its statement of defence to include
allegations respecting two issues: (1) that in the hypothetical
market which had to be established, Pharmascience Inc. would have
been the first generic drug manufacturer to enter the generic
ramipril market; and (2) that the use of ramipril for specified
indications for Teva's generic version of ramipril was a
significant unapproved indication, and that section 8 of the
NOC Regulations does not contemplate recovery of damages
with respect to loss sales of a generic product for such an
unapproved indication.
The Court of Appeal dismissed Sanofi's appeal. While the Court
of Appeal noted that the Federal Court Rules provide for a
liberal approach to amendments, it ultimately decided that the
timing of Sanofi's motion (3 months prior to trial) was
"tardy" and that the amendments "almost certainly
ensured that the trial would be considerably delayed". The
Court of Appeal found these reasons sufficient to dispose of the
appeal.
Court of Appeal Upholds Decision Awarding Section 8 Compensation
Where Sales Related to "Unauthorized
Indications"
Sanofi-Aventis Canada Inc. v. Teva
Canada Limited, 2014 FCA 69
Drug: ramipril
This was an appeal by Sanofi-Aventis Canada Inc. and Sanofi-Aventis
Deutschland GmbH (collectively "Sanofi") from a judgment
of the Federal Court which dismissed Sanofi's submissions with
respect to validity, applicability or operability of section 8 of
the NOC Regulations. Sanofi appealed on the question of
whether section 8 of the NOC Regulations can validly allow
compensation to be paid to a generic drug manufacturer for lost
sales attributable to so-called "unapproved" indications,
such as "Heart Outcomes Prevention Evaluation"
("HOPE") indications in this case.
The initial Canadian patent for ramipril expired in 2002. It was
found that, in an effort to extend patent protection for ramipril,
Sanofi later obtained two further patents which concerned the use
of ramipril for HOPE indications.
The trial judge held that, in the hypothetical market constructed
to determine the compensation owed under section 8, both Teva and
Apotex would not have included in their product monographs for
their respective versions of ramipril reference to anything other
than hypertension, but that nevertheless, some sales of those
generic drugs would have related to HOPE indications. The trial
judge refused to discard these sales from the calculation of
Teva's and Apotex's section 8 compensation.
The Court of Appeal noted that, in the real market, Sanofi had
taken no measure to enforce its patents covering the HOPE
indications. As a result, the Court of Appeal found that there was
no reason to find that the situation would be different in the
hypothetical markets involving Teva and Apotex. Sanofi argued,
however, that as a matter of jurisdiction, section 8 of the NOC
Regulations cannot allow compensation to be paid to generic
drug manufacturers with respect to sales for unauthorized
indications such as the HOPE indications.
The Court of Appeal agreed with the trial judge and held that
"compensation under section 8 of the NOC Regulations
for sales related to unauthorized indications may be precluded if
the facts so justify." However, in this case, the Court of
Appeal found no such facts to support Sanofi's position. The
Court of Appeal referred to the decision in Merck Frosst Canada Ltd. v. Apotex
Inc., 2009 FCA 187 where the validity of the NOC
Regulations was confirmed. Sanofi's appeal was dismissed
with costs.
Copyright
Class Action Settlement Agreement Found to be
'Unfair', 'Unreasonable' and 'Not in the Best
Interests of the Class Members'
Waldman v. Thomson Reuters Canada
Limited, 2014 ONSC 1288
In this certified class action, the Plaintiff, Lorne Waldman
("Waldman") brought a motion for approval of a settlement
of a copyright infringement class action against Thomson Reuters
Canada Limited ("Thomson"). The action was commenced
because Thomson, through its legal publishing branch known as
Carswell, makes available court documents authored by the lawyers
who constitute the Class Members. Waldman and Thomson signed a
Settlement Agreement which included the following terms: (i) a
$350,000 cy-près trust fund to support public interest
litigation; (ii) that Thomson would make changes to the copyright
notices on its "Litigator" service and to the terms of
its contract with subscribers; and (iii) the Class Members receive
no monetary award, but they are required to sign a release and
grant a non-exclusive license of their copyrights to Thomson. Class
Counsel also moved for approval of its contingent fee agreement and
for approval of counsel fees. The Settlement Agreement was
supported by many different parties, counsel and associations, but
was opposed by seven (7) Class Members.
The Court ultimately concluded that the proposed Settlement was
"not fair, reasonable, and in the best interests of the Class
Members." The motions for settlement and fee approval were
therefore dismissed.
The Court conducted a detailed review of the criteria for
settlement approval and applied those criteria to the case at bar.
The Court found that while the Settlement Agreement was fair and
reasonable for Waldman, Class Counsel and Thomson, it was not fair,
reasonable and in the best interests of the Class Members as a
whole. The Court agreed with the general sentiment of the objectors
to the Agreement that (i) it is more beneficial to Class Counsel
than it is to the Class Members; and (ii) in its practical effect,
the Settlement expropriates the Class Members' property rights
in exchange for a charitable donation from Thomson. The Court noted
that "the purpose of class actions is not to fund worthy
projects [i.e. through the creation of the cy-près trust
fund] but to provide procedural and substantive access to justice
to Class Members." In this case, the Court felt that there was
no access to substantive justice for the claims of the Class
Members and no meaningful behaviour modification for Thomson. The
Court also held that the "optics of this class action are
bad" primarily because Class Counsel was to receive a fee of
$825,000 and the Class Members a "notional benefit" of a
$350,000 cy-près trust fund. For these reasons, the Court
did not approve the Settlement Agreement and, as a result, the
question of Class Counsel fee approval was rendered moot.
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and
Beverley Moore ,
Adrian Howard and
Ryan Steeves
