CaseSanofi-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

DrugRamipril (ALTACE®)

Nature of caseSection 8 of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) – quantification of damages

Successful partiesApotex Inc., et al.

Date of decision: April 20, 2015

Summary

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”.

Background

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 thePMNOC 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 case-by-case basis.
  • 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 adjustment.
  • 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 case-by-case basis.

Link to SCC Docket:

SCC Docket 35886 may be found here.