35886  Sanofi-Aventis, et al. v. Apotex Inc., et al.  (Intellectual property — Patented Medicines (Notice of Compliance) Regulations)

On appeal from the judgment of the Federal Court of Appeal pronounced March 14, 2014. The applicants (collectively, “Sanofi”) are the patentees and have the rights to a series of Canadian patents for the drug, ramipril, used in the treatment of hypertension. The original ‘087 patent issued in 1985 and was set to expire in 2002. In an effort to extend that patent protection, Sanofi obtained a further series of patents for different indications for ramipril and listed them on the Patent Register. Between 2003 and 2008, these “new” ramipril patents were challenged by Apotex Inc. and other generic manufacturers under the PM(NOC) Regulations. Sanofi applied for prohibition orders in each case, triggering a 24-month statutory stay that kept the generic competitors off the ramipril market during that period of time. Only one prohibition application was successful. Apotex received its NOC to market Apo-ramipril in December, 2006. Sanofi commenced separate unsuccessful infringement actions against both Apotex and the other generic manufacturers. Apotex then brought an action under s. 8 of the PM(NOC) Regulations, to claim damages for its net lost profits during the period of the statutory stay. The Federal Court rendered four decisions related to Apotex’s entitlement to damages and the quantum of those damages. These four decisions were all appealed. The Federal Court of Appeal allowed an appeal by Apotex, dismissed two of Sanofi’s appeals and allowed one of Sanofi’s appeals solely to facilitate redetermination of quantum of damages.