Sanofi-Aventis Canada Inc v Teva Canada Limited – 2014 FCA 65
This appeal arose from an action commenced by Teva seeking compensation from Sanofi pursuant to s. 8 of the Patented Medicines (Notice of Compliance) Regulations, with respect to the drug ramipril. 
This appeal is from an order of Snider J. of the Federal Court, which dismissed Sanofi’s appeal from an order of Prothonotary Aalto denying its motion seeking amendments to its statement of defence to include allegations respecting the following two issues:  first, Sanofi sought to assert that in a hypothetical market used for calculating damages under s. 8, Pharmascience would have been the first generic entrant. The second amendment sought to add to the statement of defence that under s. 8, loss of sales related to certain unapproved indications of ramipril was not recoverable. 
Appeal is dismissed. 
The Court rejected Sanofi’s position that pleading amendments should be permitted at any time provided allowing the amendment would not be unjust. The Court emphasized that “at least two independent criteria…must be met to allow an amendment: (a) any injustice to the other party is capable of being compensated by an award of costs, and (b) the interests of justice would be served.”  (emphasis original)
In assessing interests of justice, some factors to be considered are the timeliness of the motion, the extent to which the proposed amendment would delay the proceedings, the manner in which the party who seeks the amendment has comported itself throughout the proceedings, and efficiency of the judicial process itself. 
The Court noted that Sanofi had offered no explanation for lateness of its proposed amendments, from which the Court drew the inference that there was no acceptable explanation.  The Court further pointed out that in addition to being late, allowing Sanofi’s amendment would have considerably delayed the trial.