The Federal Court has ordered that the trial of two actions brought under the post-CETA Patented Medicines (Notice of Compliance) Regulations (the Regulations), against two separate generics, be heard concurrently, on issues of invalidity. This decision highlights the Federal Court’s push to streamline section 6 actions. The court rejected the defendant Taro’s arguments that the common hearing of issues reduces the likelihood that Taro will benefit from any “first to market” advantage.
Taro and Apotex are both seeking to market a generic version of Biogen’s FAMPYRA (fampidrine) product in Canada. Both generics served Notices of Allegations (NOAs) alleging that each of their products will not infringe Canadian Patent 2,562,277 (the 277 Patent) and that the 277 Patent is invalid. In response, Biogen commenced section 6 actions against both generics; first, the Taro action on June 15, 2018 (T-1163-18), and subsequently, the Apotex action on July 24, 2018 (T-1416-18).
The Court first set the Taro action down for trial to begin on March 2, 2020. When scheduling the Apotex action, Biogen and Apotex advised that they could also be ready for a trial on March 2, 2020. With Biogen’s consent, Apotex intended to amend its pleadings to include Taro’s invalidity allegations and the two parties therefore proposed that the issues of validity raised in both actions be heard concurrently. Despite Biogen’s offer to permit matching amendments to its pleadings, Taro opposed the idea of a concurrent hearing.
Concurrent trial does not deprive the “first” generic of any commercial advantage
Taro argued that a concurrent trial would result in simultaneous judgments, depriving Taro of any commercial advantage of being first to market with a generic fampidrine product. The Case Management Judge disagreed, explaining that a concurrent trial may or may not result in Apotex having its judgment at the same time as Taro. In any event, the Court noted that “[b]eing the first to send out a [NOA] in respect of a particular medicine does not entitle a generic to be the first to obtain a judgment in an action pursuant to the Regulations, or guarantee it that result.”
Efficient use of judicial resources dictates a concurrent trial
The Court held that a concurrent trial on common validity issues is the most efficient use of the Court and the parties’ time and resources. This was based on a number of common elements across both actions: same judge; similar invalidity issues; same counsel for Biogen in both actions; and the same inventors.
In conclusion, the Court stated that a concurrent trial would “achieve the just, most efficient and least expensive determination of the issues in both actions, and would not likely result in prejudice to Taro’s substantive or procedural rights, including any rights it may have pursuant to the Regulations.” The Court ordered accordingly, holding that the Apotex trial would be adjourned following the conclusion of the case on invalidity in order to permit argument on infringement in the Taro case. The Apotex case would then resume on issues of infringement at a later date.