Sanofi-Aventis, et al. v. Apotex Inc., et al.

On October 30, the Supreme Court of Canada granted leave to appeal from the Federal Court of Appeal (FCA) decision in Apotex Inc. v. Sanofi-Aventis, et al, 2014 FCA 68.

Sanofi owned a series of patents for the drug Ramipril, the last of which were set to expire in 2005. In anticipation of the expiry, Apotex had received certain regulatory approvals from Health Canada in 2004; however, it did not receive its Notice of Compliance (NOC) until December 12, 2006. This was due to the fact that Sanofi exercised its rights under the PM (NOC) Regulations for a statutory stay of the issuance, which was later found unsustainable. Sanofi acknowledged that Apotex was entitled to damages for the delay but at issue were the relevant dates for computing the loss and the various assumptions and projections built into the assessment of damages.

In order to determine damages, the Trial Judge applied the test from Apotex Inc. v. Merck & Co. , 2011 FCA 329 that requires the Judge to consider the hypothetical question: What would have happened if Sanofi had not brought an application for prohibition? The parties disagreed on the outcome of eight factors that would determine the scope of Apotex's losses.

In regards to the relevant date for computing the loss suffered by Apotex, the Court looked at all of the Prohibition Orders obtained by Sanofi. Apotex had originally served a notice of allegation in August, 2003, alleging non-infringement of Sanofi's patent. Sanofi then attempted to obtain a Prohibition Order and was successful, effectively blocking the Minister from issuing a NOC. In November of 2003, Apotex filed a second notice of allegation, this time alleging invalidity of the patent. Once again, Sanofi attempted to obtain a Prohibition Order, however this time they were refused by the Court and Sanofi launched an appeal. Before the appeal could be heard, the patent expired and the appeal was dismissed for mootness. The Federal Court found that the second allegation effectively "unlocked" the door for Apotex to receive a NOC and therefore relevant date for assessing damages was the date that the Minister would have issued a NOC, April 26, 2004.

In assessing the relevant end date for assessing damages, Apotex argued that the correct date was May 2, 2008; the dismissal date of the last Prohibition proceeding. However, the Prothonotary dismissed the Prohibition application as moot, as the NOC had already been issued on December 12, 2006. Sanofi argued that...