TevaCanada Limited v. Pfizer Canada Inc., 2014 FC 248 

Drug: venlafaxine

In this case, the Court made key findings as to the method of determining quantum of s. 8 damages, and sent the parties away to determine the actual quantum. As background, a predecessor to Teva, Ratiopharm, had filed an ANDS and agreed to await expiry of the patent on the Patent Register at that time. A second patent was listed on the Patent Register, and Ratiopharm sent a NOA with respect to that patent. It then brought a motion to have the patent removed from the Patent Register. That motion was successful, and Ratiopharm came to market with its venlafaxine product. Another predecessor to Teva, Novopharm, had entered into a licence with Pfizer to sell venlavaxine. The Court of Appeal held that the damages claim was not to be reduced by Novopharm’s gains under the licence (decision here; summary here). Ratiopharm also entered into a cross-licence agreement with another generic company, Pharmascience.

The Court considered the relevant period for damages, and held that although it is not in issue in this case, there is no discretion as to the end date for the period. With respect to the start date, in this case, the Patent Hold date preceded the expiry of the patent to which Ratiopharm had agreed to await.

The Court considered the applicability of this date, along with the arguments of Ratiopharm and Pfizer for other dates. Ratiopharm argued  that the start date should be the date that patent expired. Pfizer argued that the start date should be the date 45 days after Ratiopharm had sent a NOA on the second patent, because until that time, Ratiopharm had not met the requirements of the NOC Regulations. The Court held that the appropriate date was the expiry date of the patent because there was no loss claimed by Ratiopharm prior to that date.

The Court used actual sales of venlafaxine during the relevant period to determine the size of the market. Novopharm’s actual sales, with an adjustment for differences in provincial formulary listing dates was agreed to be the size of the generic market. The Court then considered Ratiopharm’s market share in the “but-for”  world together with the share of other generic companies. The Court held that Ratiopharm  must show that it was able to supply the market, and that Pfizer must prove when competitors would have entered the market. The Court then considered all of the other relevant factors, including formulary listing, trade-spend, ramp-up and interest.