Case: Sanofi-Aventis et al. v. Apotex Inc.
et al. (SCC No. 35886) – Appeal from the judgment of the
Federal Court of Appeal Nos. A-191-12, A-193-12, A-397-12 and
A-474-12, 2014 FCA 68, denied with costs
Drug: Ramipril (ALTACE®)
Nature of case: Section 8 of the Patented
Medicines (Notice of Compliance) Regulations (PMNOC
Regulations) – quantification of damages
Successful parties: Apotex Inc., et
Date of decision: April 20, 2015
On April 20, 2015, the Supreme Court of Canada
(SCC) heard Sanofi-Aventis' appeal of the
Federal Court of Appeal section 8 quantification decision with
respect to the drug Ramipril. Intervenor status was granted to
Canada's Research-Based Pharmaceutical Companies (Rx&D) and
to the Canadian Generic Pharmaceutical Association.
After hearing from all parties, the SCC dismissed the appeal
from the bench with costs "substantially for the reasons of
the majority of the Court of Appeal".
As we previously
reported on the decision to grant leave to the SCC, this
hearing marked the SCC's first consideration of section 8 of
the PMNOC Regulations. As a result of the SCC's
dismissal of Sanofi-Aventis' appeal, the Federal Court of
Appeal decision has been
affirmed. The quantification of section 8 damages remains a
highly fact-specific inquiry.
The determination of the entry of
generic competitors into the hypothetical market in which section 8
damages are assessed is a fact-based inquiry to be made on a
While the trial judge in Ramipril
declined to exercise her discretion under subsection 8(5) of the
PMNOC Regulations to reduce the amount of compensation in
light of the aggregate liability of the defendant across multiple
section 8 actions, the Court retains discretion to make such an
While Apotex was awarded compensation
for unapproved indications in this case, there remains no rule of
general application on this point. Whether a section 8 claimant has
sustained a loss in respect of such a claim must be considered on a
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