Executive Summary: Key Legal and Evidentiary Issues

• Natco Pharma sought leave to move for summary trial in a patent infringement action under the PM(NOC) Regulations after the time and place for trial had already been fixed

• Rule 213 of the Federal Courts Rules ordinarily requires a summary trial motion be brought before trial dates are set, but the Court retains discretion under Rule 55 to dispense with this requirement

• The Court applied the five-factor test from Hoffmann-La Roche v Pfizer Canada Inc to assess whether special circumstances warranted granting leave despite the timing issue

• AstraZeneca argued Natco was attempting to "jump the queue" ahead of two co-pending proceedings involving the same patent and medicinal ingredient, but the Court found no demonstrated prejudice

• Two discrete infringement issues regarding low hygroscopicity of a matrix polymer in the 400 Patent were identified as capable of bringing the entire proceeding to an end before a full trial

• Natco's unsolicited post-hearing correspondence to the Court was deemed entirely inappropriate and disregarded in its entirety

Background and parties to the dispute

AstraZeneca Canada Inc. and Kudos Pharmaceuticals Limited (collectively, AstraZeneca) brought a patent infringement action against Natco Pharma (Canada) Inc. (Natco) pursuant to the Patented Medicines (Notice of Compliance) Regulations in Federal Court Docket T-3922-25. The statement of claim was issued on October 8, 2025, and a scheduling order followed on November 27, 2025. That order set out deadlines for document production, discoveries, interlocutory motions, and expert reports. The scheduling order fixed trial dates and was silent as to any motions for summary judgment or summary trial. The trial was scheduled to begin on June 22, 2027 in Ottawa. Justice Fothergill was assigned to the trial at the time the scheduling order was issued.

Natco's request for summary trial

On March 19, 2026, Natco wrote to the Court and advised of its intention to move for summary trial. A draft notice of motion was enclosed. A case management conference was held on March 27, 2026. In advance of the conference, the parties sent joint correspondence to the Court setting out their respective positions. During the conference, each side confirmed that they had sufficient opportunity to address their positions in writing, and that they were ready to make submissions as to why a summary trial should or should not be scheduled. Associate Judge Trent Horne determined he was content to decide the issue on that basis, seeing nothing to be gained by requiring the parties to file formal motion records.

Natco submitted that there were two infringement issues to be determined summarily in respect of the 400 Patent: whether a matrix polymer that exhibits low hygroscopicity is an essential element of each asserted claim, and whether the matrix polymer in the Natco Product exhibits low hygroscopicity.

The Rule 213 timing issue

Natco took the position that the time and place for trial had not been fixed. The Court disagreed, finding that unless the Court ordered otherwise, the trial would commence on June 22, 2027 in Ottawa. The fact that the place of trial was provisionally set, or that there was a possibility the place of trial might be revisited, did not mean the time and place for trial had not been fixed. However, the Court emphasized that the fixing of the time and place for trial did not absolutely preclude a party from moving for summary trial. Under Rule 55, the Court has discretion to vary a Rule or dispense with compliance of a Rule, and can proceed with a summary trial notwithstanding the timing issue in Rule 213, as recognized in Janssen Inc v Apotex Inc, 2022 FC 107.

Application of the Hoffmann-La Roche factors

The Court assessed whether to exercise its discretion using the factors set out in Hoffmann-La Roche Limited v Pfizer Canada Inc, 2018 FC 932. These factors include: (i) whether special circumstances exist; (ii) whether there will be a significant savings of costs, savings of time and efficiencies from permitting the motion to proceed; (iii) whether any of the parties would be prejudiced; (iv) the level of cooperation of the moving party exhibited to date in the proceeding as required by section 6.09 of the PMNOC Regulations; and (v) whether the moving party seeks to bring the motion in a timely manner. On timeliness, the Court noted it was not ideal that Natco waited until four months after the scheduling order to express an interest to the Court in a summary trial, especially since Justice Fothergill was not available on any of the dates proposed by the parties, although another member of the Court's IP Chambers was. On cooperation, the Court found the parties had cooperated with each other over the course of the proceeding, with disagreements on the timetable resolved quickly and a potential dispute relating to production of samples resolved without the need for the Court's intervention. This stood in contrast to the conduct in Hoffmann-La Roche, where improper conduct was described to include obstructive jockeying and delays.

Prejudice and co-pending proceedings

AstraZeneca did not argue that, if a summary trial is scheduled, it would suffer prejudice that cannot be compensated by an award of costs. AstraZeneca did, however, point out that there are two other ongoing proceedings (T-3096-25 and T-5200-25) involving the same medicinal ingredient and the same patent. AstraZeneca submitted that Natco was trying to "jump the queue" to have its motion for summary trial heard before the first trial in the other proceedings, noting the advantages of being the first generic on the market. The Court could not agree that this was a reason to refuse to schedule a summary trial. There was no demonstrated prejudice to the parties, at least no prejudice that could not be compensated in costs. The fact that Natco may prevail in a summary trial before another matter is adjudicated does not prejudice AstraZeneca. The defendants in T-3096-25 and T-5200-25 made strategic decisions in their own litigation and elected not to move for summary judgment or summary trial. The Court was not satisfied that co-pending litigation, on its own, constitutes prejudice to the parties that should preclude the scheduling of a summary trial.

Potential for efficiency and the risk of duplication

The Court acknowledged that, in proceedings under the PM(NOC) Regulations, it is not possible to stay the action pending summary judgment or summary trial. The parties had conducted examinations for discovery on all issues in about May 2026, with refusals motions to be argued in August 2026. Expert reports in chief were due to be served on November 18, 2026, and responding reports were due on February 26, 2027. If the summary trial were heard in late October or early November 2026 as Natco desired, it was extremely unlikely that a decision would be made before the first round of expert reports were due. There was a risk of duplication of effort, specifically if the parties spent time and money on validity reports that may not be required if the overall outcome turned on infringement. The primary burden of inefficiency during this window would be borne by Natco. Natco acknowledged that it may be preparing a validity report while the summary trial was pending, and that such a report was likely to be ultimately unnecessary if the Court determined there was no infringement. Natco was aware of that risk and was willing to take it. For AstraZeneca, scheduling a summary trial may have the practical consequence of expediting their infringement report, but they had not argued that they were unable to do so, or that scheduling a summary trial would constitute prejudice that cannot be compensated in costs.

The Court further noted that the compressed nature of PMNOC litigation was not an inherent reason to refuse to schedule a summary trial, as such a rule would effectively preclude litigants in these cases from seeking that relief. The PM(NOC) Regulations do not preclude a party from moving for summary judgment or summary trial.

The ruling and overall outcome

Associate Judge Horne was satisfied that the possibility of resolving the entire proceeding by way of a determination of a discrete infringement issue, the potential associated savings of time and cost, and the potential to more efficiently use the Court's resources, constituted special circumstances such that Natco should be granted leave to move for summary trial after the time and place for trial had been fixed. The Court ordered that Natco is granted leave to move for summary trial on the issues set out in the joint letter to the Court dated March 26, 2026, with hearing dates and a timetable to be determined, targeting late October or early November 2026. The timing and procedure for any disputes relating to reply expert evidence would be determined by the judge assigned to hear the summary trial. The Court also admonished Natco for sending unsolicited correspondence after the hearing containing additional facts and reference to further authorities, without consulting AstraZeneca. The Court deemed this entirely inappropriate and disregarded the letter in its entirety. Natco was the successful party on this procedural motion. No monetary award was at issue, as the order pertained solely to whether leave would be granted to move for summary trial.