Executive Summary: Key Legal and Evidentiary Issues

• Novartis brought an action under subsection 6(1) of the PM(NOC) Regulations against Zydus over two patents and the medicine sacubitril-valsartan.
• Zydus sought leave to bring a motion for summary trial on infringement of the 598 Patent only, which Novartis opposed as inefficient.
• Central to the dispute was whether Zydus's proposed drug product contains a hemipentahydrate salt said to be an essential element of the asserted 598 Patent claims.
• Because the 511 Patent expires on November 8, 2026, the Court weighed whether a summary trial could dispose of the action or instead cause piecemeal litigation.
• Guiding the analysis were Rule 216(5) of the Federal Courts Rules and the efficiency and proportionality factors drawn from Viiv Healthcare and related authorities.
• Justice Furlanetto found the infringement issue suitable for summary trial and permitted Zydus to proceed.

Facts of the case

The proceeding is an action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations, brought by Novartis Pharmaceuticals Canada Inc. and Novartis AG (together, Novartis) against Zydus Lifesciences Limited (Zydus). It concerns two patents — Canadian Patent Nos. 2,590,511 (the 511 Patent) and 2,703,598 (the 598 Patent) — and the medicine sacubitril-valsartan. Novartis commenced the action on February 20, 2026. On March 19, 2026, the Case Management Judge, Associate Judge Crinson, issued a scheduling order and required any party intending to bring a motion for summary trial or summary judgment to notify the Court and opposing counsel by March 31, 2026. The Judicial Administrator set the matter down for a 10-day trial on dates in October and November 2027. On March 31, 2026, Zydus advised that it wished to bring a motion for summary trial and requested a case management conference. Following case management conferences on April 14 and April 30, 2026, and further written submissions on May 8, 2026, Justice Furlanetto was asked to decide whether the summary trial should be allowed to proceed.

Statutory and procedural provisions at issue

The motion turned on Rule 216(5) of the Federal Courts Rules, under which a judge may allow a summary trial only where satisfied that the issues raised are suitable for that procedure and that it will assist in the efficient resolution of the action. The parties agreed to have the Court consider Rule 216(5)(b), directed at the efficiency of bringing the motion. The decision is discretionary and guided by the objectives of Rule 3 and the principles of proportionality and fair access to timely, affordable and just adjudication, as set out in Viiv Healthcare v Gilead Sciences. Drawing on Wenzel Downhole Tools v National-Oilwell and Hoffmann-La Roche Limited v Pfizer Canada Inc, the Court weighed whether a summary trial would save significant time and cost, produce efficiencies, and help resolve the proceeding rather than fragment it into piecemeal litigation. Also relevant were section 8 of the PM(NOC) Regulations and the fact that the 511 Patent was set to expire on November 8, 2026.

The court's reasoning and analysis

The narrow question for any summary trial was whether Zydus's proposed drug product includes a hemipentahydrate salt of the active ingredient, which Zydus pleads is an essential element of each asserted claim of the 598 Patent. Zydus argued that, because the 511 Patent would expire before trial, a successful summary trial could end the action entirely and avoid the expense of expert reports not otherwise due until April 9 and July 16, 2027; even if unsuccessful, it would narrow the remaining issues. Zydus also pointed to prejudice from delayed market entry, given that the market had already gone generic. Novartis countered that a summary trial addressing only the 598 Patent would not resolve the 511 Patent issues — which it argued were not rendered moot by expiry, relying on Astrazeneca Canada Inc v Sandoz Canada Inc — and would produce litigation in slices, duplicative expert evidence, and wasted judicial and party resources. Novartis further submitted that Zydus was unlikely to succeed, noting that Zydus had been unsuccessful in establishing the absence of the hemipentahydrate salt in proceedings in the United States. Justice Furlanetto was satisfied that the infringement issue was appropriate for summary trial and likely to yield overall efficiencies. She accepted that it was not a foregone conclusion the 511 Patent would need to be litigated, since it would remain relevant only if Zydus succeeded on the 598 Patent, its product was approvable before the 511 Patent expired, and it advanced a section 8 claim — and Zydus had indicated that section 8 might not be in issue. Distinguishing Astrazeneca, which involved an unopposed motion, the Court found that any residual 511 Patent issues could be dealt with outside the statutory 24-month period, that the outcome of the United States litigation was not binding and supported no conclusions here, and that eliminating the need for further expert reports would create sufficient efficiencies to justify the summary trial, even though discovery on the validity of the 598 Patent would still proceed on a later track.

Ruling and outcome

The Court granted the request and permitted Zydus to move for summary trial on the infringement issue set out in its proposed notice of motion of April 27, 2026, directing that the notice be formalized, served, and filed within seven days and that Zydus serve its affidavit of documents by May 20, 2026. The parties were ordered to submit their joint availability for a further case management conference and for a four-day summary trial in January 2027. The successful party on this motion was the defendant, Zydus, whose request to proceed by summary trial was allowed over Novartis's objection. As an interlocutory procedural order permitting the motion to proceed, it ordered no costs, damages, or other monetary sum — no amount was stated.