Drug: ramipril

This was an appeal by Sanofi-Aventis Canada Inc. and Sanofi-Aventis Deutschland GmbH (collectively “Sanofi”) from a judgment of the Federal Court which dismissed Sanofi’s submissions  with respect to validity, applicability or operability of section 8 of the NOC Regulations. Sanofi  appealed on the question of whether section 8 of the NOC Regulations can validly allow compensation  to be paid to a generic drug manufacturer for lost sales attributable to so-called “unapproved”  indications, such as “Heart Outcomes Prevention Evaluation” (“HOPE”) indications in this case.

The initial Canadian patent for ramipril expired in 2002. It was found that, in an effort to extend patent protection for ramipril, Sanofi later  obtained two further patents which concerned the use of ramipril for HOPE indications.

The trial judge held that, in the hypothetical market constructed to determine the compensation  owed under section 8, both Teva and Apotex would not have included in their product monographs for  their respective versions of ramipril reference to anything other than hypertension, but that nevertheless, some sales of those generic drugs would  have related to HOPE indications. The trial judge refused to discard these sales from the  calculation of Teva’s and Apotex’s section 8 compensation.

The Court of Appeal noted that, in the real market, Sanofi had taken no measure to enforce its  patents covering the HOPE indications. As a result, the Court of Appeal found that there was no reason to find that the situation would be different in the hypothetical markets involving Teva and  Apotex. Sanofi argued, however, that as a matter of jurisdiction, section 8 of the NOC Regulations  cannot allow compensation to be paid to generic drug manufacturers with respect to sales for  unauthorized indications such as the HOPE indications.

The Court of Appeal agreed with the trial judge and held that “compensation under section 8 of the  NOC Regulations for sales related to unauthorized indications may be precluded if the facts so justify.” However, in this case, the  Court of Appeal found no such facts to support Sanofi’s position. The Court of Appeal referred to  the decision in Merck Frosst Canada Ltd. v. Apotex Inc., 2009 FCA 187 where the validity of the NOC Regulations was confirmed. Sanofi’s appeal was dismissed with costs.