Sanofi-Aventis Canada Inc v Teva Canada Limited – 2014 FCA 69

This was an appeal brought by Sanofi from a judgment of Snider J. of the Federal Court, 2012 FC 551, which dismissed Sanofis’s submissions with respect to the validity, applicability or operability of s. 8 of the Patented Medicines (Notice of Compliance) Regulations. [1] The sole issue on appeal was “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.” [14]

Appeal is dismissed.

Sanofi argued 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.” [23] The Court rejected this argument and stated that whether there can be recovery for unauthorized indications is a question of fact. [24]

The Court noted that Sanofi had patents on the unauthorized indications in question, and had listed these patents. In addition, Sanofi had initiated prohibition proceedings under the NOC Regulations based on these patents, thereby delaying the generics from entering the market. [25] The Court then pointed out that the purpose of s. 8 is to compensate generics for this type of delay. [26]

Finally, the Court emphasized its earlier decision in Alendronate, 2009 FCA 187, holding that the NOC Regulations, including s. 8, are valid. [29]