Supreme Court of Canada Updates

Recent developments in two pharmaceutical patent cases are reported below. In the first, leave to appeal the Supreme Court of Canada (SCC) was granted. In the second, an appeal to the SCC was discontinued. SCC to Consider Quantification of Section 8 Damages under PM(NOC) Regulations On October 30, 2014, the SCC granted Sanofi-Aventis leave to appeal from the judgment of the Federal Court of Appeal (FCA) in Sanofi-Aventis v Apotex Inc, 2014 FCA 68, where the FCA quantified damages relating to the delayed market entry of generic Apotex ramipril under Section 8 of the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations). This marks the first time that the SCC will consider substantive issues relating to the remedy that compensates generics for delayed market entry caused by withdrawn, discontinued or dismissed prohibition proceedings under the scheme of the PM(NOC) Regulations. This case should provide innovators and generics with a legal framework for quantifying section 8 damages. The FCA decision (Justice Mainville dissenting in-part) reviewed select issues relating to the construction of the hypothetical market in which losses to the generic, Apotex, were calculated. The FCA affirmed the Federal Court’s findings (2012 FC 553), except for the finding that a second generic, Teva, would have also entered the hypothetical market during the section 8 liability period. The SCC is expected to address the key issue of whether or not all generic competitors in the hypothetical market are subject to the scheme of the PM(NOC) Regulations (SCC Case No. 35886). Apotex Discontinues Supreme Court Appeal in PLAVIX® Case On November 3, 2014, Apotex discontinued its appeal to the SCC regarding the validity of Sanofi-Aventis’ patent claiming the drug clopidogrel bisulfate (PLAVIX). As a result, the hearing scheduled for November 4, 2014 has been cancelled (Press Release). Had the appeal proceeded, the SCC was expected to provide guidance on Canada’s “promise doctrine” of utility and the test for sound prediction of utility (previously reported in E-TIPS®). Summary by: Junyi Chen