Federal Court Confirms Defendants’ Right to Challenge Non-Asserted Claims in PM(NOC) Actions
The Federal Court has recently affirmed by way of summary judgment motion that a Defendant to an action commenced under the Patented Medicines (Notice of Compliance) Regulations may challenge, by right, any of the non-asserted claims of a patent asserted against them.
In Boehringer Ingelheim (Canada) Ltd. v. Sandoz Canada Inc. and Boehringer Ingelheim (Canada) Ltd. v. Sun Pharma Canada Inc., the ongoing actions concern six patents listed on the Patent Register for Boehringer’s empagliflozin product JARDIANCE. Boehringer’s Statements of Claim asserted 102 out of 121 total patent claims against Sandoz and Sun, and those Defendants counterclaimed seeking declarations that all six patents and each of their claims are invalid and that none of the claims have been infringed or induced to be infringed. Boehringer moved for summary judgment to dismiss the counterclaims in respect of any patent claim not asserted in the Statements of Claim and to limit the scope of the counterclaims to the asserted claims.
On this motion, the Court held that summary judgment was appropriate because the question whether the Defendants could counterclaim against the Non-Asserted Claims without leave of the court (i.e., by right) was a pure question of law. This question was explicitly left open by the Court of Appeal in Janssen Inc v Apotex Inc, 2022 FCA 184 [Abiraterone FCA]. See our report on Abiraterone FCA here.
However, the Federal Court was not satisfied that the precise relief sought by Boehringer was available on summary judgment. Specifically, the Court declined to “automatically limit” the scope of the Defendants’ counterclaims to the claims asserted by the Plaintiffs, because the record did not permit adjudication of a patent claim that was currently asserted but may not be in the future. Moreover, if Boehringer decided to drop any patent claim, Abiraterone FCA enabled the Defendants to seek leave of the Court to proceed with a counterclaim relating to that claim.
Relying on Abiraterone FCA, the Federal Court decided the summary judgment motion in favour of Sandoz and Sun. Justice Fothergill emphasized that Boehringer’s arguments about efficiency, the Regulations constituting a complete code, and the need for close judicial supervision of actions commenced under subsection 6(1) had all been before the Court of Appeal. The Federal Court was therefore bound by stare decisis to find that paragraph 6(3)(a) of the Regulations is permissive and “does not explicitly prohibit anything”. The same analysis supported an interpretation allowing counterclaims challenging non-asserted claims by right.
The Court also rejected the argument that a defendant must first bring a counterclaim challenging the asserted claims, and then seek leave under Rule 75 to amend the counterclaim to include non-asserted claims. The Court found Boehringer’s proposed procedure to be inconsistent with Rule 200, which allows pleadings amendments without leave; Rule 221, which provides for motions to strike; and the Court’s effective case management of actions under the Regulations.
A copy of the decision can be found here.