Drug: ramipril
In this quantification of s. 8 damages owed to Apotex by Sanofi, the Court first summarized the history of all the Notice of Compliance (NOC) proceedings that lead to this case pursuant to section 8 of the NOC Regulations. A number of factual and legal issues were also discussed.
The start date of the damages period was under dispute. Apotex had sent two separate Notices of Allegation (NOAs) in relation to one patent on the Patent Register; one alleging non-infringement and the second alleging invalidity. Proceedings were started in both cases, and prohibition was granted in the infringement allegation. However, the second proceeding resulted in a finding that Apotex’ allegation of invalidity was justified. The Court held that, if Apotex had pursued the invalidity and the non-infringement allegations in the same NOA, there would not have been a Prohibition Order. Thus, Sanofi was not entitled to rely on the Prohibition Order with respect to the non-infringement allegation for the purposes of determining the start date for s. 8 damages. As a result, the Court held that the date Apotex’ Apo-Ramipril product was put on patent hold was the appropriate date to begin the liability period.
The parties also disputed the end date for the damages period. Apotex argued that it should extend until the last NOC proceeding was dismissed. However, Apotex had received its NOC prior to that date as the Minister had determined that Apotex was no longer required to address the patents listed on the Patent Register. The Court held that the date the last prohibition proceeding was dismissed was really an arbitrary date as it had become moot when Apotex received its NOC. The end date was held to be the date the NOC issued.
The Court then considered the size of the generic market and Apotex’ share of the generic market. The Court held that once the generic company leads prima facia evidence of its losses, the evidential burden shifts to the innovator to show that other generics would have entered the market. The Court considered the timing of the launch of other generics that were sending NOAs during the relevant period. The Court also considered the timing of the launch of an authorized generic. The Court looked at the price of the generic medicine during the relevant time periods as well as Apotex’ costs. The Court held that Apotex was not entitled to claim for damages in the ramp-up period that occurred after the relevant period. Finally, the Court did not reduce the damages for sales associated with unapproved uses.
