Drug: raipril

This appeal was heard in the context of an action commenced by Teva Canada Limited (“Teva”) seeking  compensation from Sanofi-Aventis Canada Inc. and Sanofi-Aventis Deutschland GmbH (collectively  “Sanofi”) pursuant to section 8 of the NOC Regulations. The appeal was heard together with two  other appeals: 2014 FCA 67 and 2014 FCA 69 (summary below).

This appeal was from an order 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 two issues: (1) that in the hypothetical market which had to be established,  Pharmascience Inc. would have been the first generic drug manufacturer to enter the generic  ramipril market; and (2) that the use of ramipril for specified indications for Teva’s generic  version of ramipril was a significant unapproved indication, and that section 8 of the NOC  Regulations does not contemplate recovery of damages with respect to loss sales of a generic product for such an  unapproved indication.

The Court of Appeal dismissed Sanofi’s appeal. While the Court of Appeal noted that the Federal  Court Rules provide for a liberal approach to amendments, it ultimately decided that the timing of  Sanofi’s motion (3 months prior to trial) was “tardy” and that the amendments “almost certainly  ensured that the trial would be considerably delayed”. The Court of Appeal found these reasons  sufficient to dispose of the appeal.