Federal Court Permits Counterclaim As Of Right Against Non-Asserted Patent Claims In S. 6(1) PMNOC Actions

• Law Firm: Smart & Biggar
• Subject Matter: Employment and HR, Intellectual Property, Food, Drugs, Healthcare, Life Sciences, Employee Benefits & Compensation, Employee Rights/ Labour Relations, Patent
• Author: Mr Ryan Wong
• Published date: 10 April 2023

On February 17, 2023, the Federal Court ruled that Sandoz and Sun Pharma may counterclaim as of right against non-asserted patent claims in separate actions pursuant to the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations): Boehringer Ingelheim v Sandoz; Boehringer Ingelheim v Sun Pharma, 2023 FC 241. However, the Plaintiffs may move to strike such counterclaims, including on the grounds that they may prejudice or delay the fair trial of the action, or are otherwise an abuse of process.

Boehringer Ingelheim (BI) commenced separate patent infringement actions against Sandoz and Sun Pharma pursuant to subsection 6(1) of the PMNOC Regulations relating to empagliflozin (BI's JARDIANCE). In each action, BI asserted infringement of a subset of claims of six patents. Sandoz and Sun Pharma defended and counterclaimed that all of the claims of the six patents, including the non-asserted claims, are invalid and not infringed.

BI moved for summary judgment to dismiss the counterclaims insofar as they assert the invalidity of non-asserted claims. BI argued that a defendant may counterclaim against a non-asserted claim in a subsection 6(1) action only with leave of the Court, citing paragraph 6(3)(a) of the PMNOC Regulations:

(3) The second person [here, Sandoz and Sun Pharma] may bring a counterclaim for a declaration

(a) under subsection 60(1) or (2) of the Patent Act in respect of any patent claim asserted in the action brought under subsection (1);

Justice Fothergill held that the question of law ' whether the Defendants can counterclaim against the non-asserted claims without leave of the Court ' was appropriate for adjudication by way of summary judgment.

In Janssen Inc v Apotex Inc, 2022 FCA 184, the Federal Court of Appeal (FCA) held that the PMNOC Regulations do not prohibit counterclaims against non-asserted claims in subsection 6(1) actions with leave of the Court. While the FCA left open the question of...