PM(NOC): Notice of Compliance Based Upon a Cross-Reference
Sanofi Aventis Canada Inc. v. Canada (Health) and Laboratoire Riva Inc. 2009 FCA 169 (Linden, J.A., Sexton, J.A., Sharlow, J.A.)

May 26, 2009

Gunars Gaikis and Y. Lynn Ing for the Appellant, Sanofi Aventis Canada Inc. (“Sanofi”)
Arthur Renaud for the Respondent, Laboratoire Riva Inc. (“Riva”)
Rick Woyiwada for the Respondent, Minister of Health (“Minister”)

This was an appeal of the judgment of Hughes J. dismissing with costs the application of Sanofi for an order quashing the Minister’s decision to issue a notice of compliance (NOC) to Riva for a generic version of ramipril.

The Court of Appeal rejected Sanofi’s argument that Riva should have been barred from relying through “cross-reference” upon an abbreviated new drug submission (“ANDS”) submitted by Pharmascience that was linked to a later prohibition order against Pharmascience. The Court also rejected the assertion that Riva was circumventing the PM(NOC) Regulations. Riva’s submission for a NOC was of sufficient substance to engage the PM(NOC) Regulations, causing it to serve a NOA on Sanofi addressing the listed patents, and ultimately successfully defending the resulting prohibition application brought against it by Sanofi.

The appeal by Sanofi was dismissed with costs.

By: Etienne de Villiers, Dimock Stratton LLP