Apotex Inc. v. Sanofi-Aventis, 2014 FCA 68

Drug: ramipril

In May, 2012, the Federal Court quantified damages owed to Apotex pursuant to s. 8 of the NOC Regulations (decision here, summary here). Similarly, damages were quantified to Teva, as discussed in the case below. Both parties appealed. In a split decision, the Federal Court of Appeal (FCA) upheld the trial judge’s findings with respect to all issues but the date upon which Teva would have entered the market.

The FCA considered Sanofi’s arguments that  the combined effect of the decisions of the Trial Judge in this case and the Teva case below was that the hypothetical generic market exceeds the size of the actual generic market. However, the Court rejected this argument, holding that the Trial Judge was correct in her interpretation of the NOC Regulations. The NOC Regulations should only be disregarded with respect to the determination of the beginning of the liability period. All other dates must be determined on the basis that the NOC Regulations exist. As a result, the hypothetical worlds in different cases will not be the same. The FCA invited Parliament or the Governor-in-Council to remedy the NOC Regulations if this is a problem.

The FCA held that the generic parties would have behaved in the hypothetical world just as they did in the real world. This included seeking summary dismissal of NOC Proceedings as soon as they considered they had a fair chance of success. However, the Court saw no reason to conclude that this would have happened any earlier in the hypothetical world than it did in the real world. Thus, Teva would not have entered the market during Apotex’ s. 8 liability period and the only competition to Apotex would have been the authorized generic.