FCA Gives Guidance For Common PM(NOC) Trials Involving Multiple Actions

• Published date: 28 May 2020
• Author: Mr Fortunat Nadima Nadima, Christopher Guerreiro and Judith Robinson
• Subject Matter: Intellectual Property, Food, Drugs, Healthcare, Life Sciences, Patent, Food and Drugs Law
• Law Firm: Norton Rose Fulbright Canada LLP

The Federal Court of Appeal has reversed the Federal Court's decision to add two additional generic defendants (Taro Pharmaceuticals Inc. and Sandoz Canada Inc.) to an upcoming common trial under the Patented Medicines (Notice of Compliance) Regulations. The common trial will determine patent validity issues in Bayer Inc.'s actions against Teva Canada limited and Apotex Inc. concerning generic versions of XARELTO' (rivaroxaban).

Background

This is an appeal by Teva and Apotex from a decision of the Federal Court allowing Taro and Sandoz to join Teva and Apotex in a trial of common validity issues. As we reported, the Federal Court agreed to add Taro and Sandoz as defendants to the hearing of common validity issues for two main reasons:

• Taro and Sandoz were ready to proceed in accordance with the schedules set for the first two generic defendants (Teva and Apotex); and
• the interests of justice favoured hearing the evidence and submissions of all of the parties before making ruling on claims construction and invalidity.

In a later decision, the Federal Court denied a motion by a fifth generic (Dr. Reddy's Laboratories Ltd.) to join the common trial. As we reported, the Federal Court's reasons focused on the need to determine actions against the earlier generic defendants within the respective 24-month stays of generic approval provided by the Regulations, as well as the possibility that the outcome of the earlier actions could help narrow the issues in Dr. Reddy's action.

Meanwhile, Teva and Apotex appealed the decision adding Taro and Sandoz to the common trial.

Section 6.02 of the Regulations prohibits more than just consolidation

On appeal, Teva and Apotex argued that the common trial of validity issues raised by four generics violated the rule against joinder of actions in section 6.02 of the Regulations. The Court agreed.

Following an extensive bilingual analysis of the legislation, the Court held that the prohibition on joinder of section 6 actions "captures more than just the consolidation of proceedings". It also captures other procedural arrangements that could make it less likely that a section 6 action be determined within its 24-month deadline. Here, the Court considered that hearing four generic defendants together would likely lengthen the duration of the common trial issues and delay Teva's and Apotex's trials on infringement issues.

In reaching its conclusion on this issue, the Court noted that the Regulations place the burden on the...