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Aragon Pharmaceuticals Inc. and Janssen Inc. v Sandoz Canada Inc.

Executive Summary: Key Legal and Evidentiary Issues

  • Two decisions in this Federal Court patent action addressed successive motions for letters rogatory seeking evidence from witnesses in the United States, Switzerland, and England.
     
  • Sandoz Canada Inc. sought this evidence to establish the publication date of an academic abstract underlying its invalidity defence against Janssen Inc.'s infringement claim.
     
  • Associate Judge Trent Horne dismissed the first motion entirely, finding no good grounds to conclude that the witnesses would not attend trial voluntarily.
     
  • A subsequent change in circumstances, namely the Internet Archive witness becoming unresponsive, led the Court to grant letters rogatory to the United States on the second motion.
     
  • The renewed request concerning an ESMO-affiliated witness in England was dismissed as an abuse of process by re-litigation.
     
  • Unproven allegations that Sandoz misled the Court on the first motion ultimately cost Janssen its claim to costs on the second.
     


Facts of the case

Aragon Pharmaceuticals, Inc. and Janssen Inc. sued Sandoz Canada Inc. under the Patented Medicines (Notice of Compliance) Regulations, seeking a declaration that Sandoz would infringe Canadian patent 2,885,415 (the 415 Patent) by making, using, and selling apalutamide. Sandoz denied infringement and pleaded that the 415 Patent was invalid, relying in part on an academic abstract by Smith, MR, et al, published in the Annals of Oncology, which it argued anticipated and rendered obvious the patented invention. The priority date for the 415 Patent is September 26, 2012. Sandoz took the position that the abstract was published by the European Society for Medical Oncology (ESMO) at least as early as September 17, 2012, before that priority date, even though the associated conference did not begin until September 28, 2012. Sandoz noted that the European Opposition Division had already found the European equivalent of the 415 Patent not novel over the same abstract. To prove the abstract's publication date at trial, Sandoz moved twice for letters rogatory: first, in a motion decided June 8, 2026, seeking evidence from an Internet Archive employee in the United States and ESMO representatives in Switzerland, and second, in a motion decided July 20, 2026, renewing the request for the Internet Archive witness and seeking, for the first time, evidence from an ESMO-affiliated individual, Dr. Lewis Rowett, in England.

Policy and legislative provisions at issue

The central legislative provision was subrule 272(1) of the Federal Courts Rules, which allows the Court to order the issuance of a commission, letters rogatory, or a letter of request for evidence to be given outside Canada. The Court described the issuance of such a commission as an extraordinary procedure reserved for cases where special circumstances and the proper administration of justice require it, engaging considerations of judicial comity and respect for foreign courts. Drawing on Boily v Canada, the Court applied a four-factor test: the application must be made bona fide; the issue must be relevant to the proceedings; the witness's evidence must be material; and there must be good grounds to conclude the witness cannot or will not attend trial. Potential prejudice to the orderly progression of the trial, discussed in Sanofi-Aventis Canada Inc v Apotex Inc, was also a live consideration in both motions. On the second motion, the doctrine of abuse of process by re-litigation, as articulated in Toronto (City) v CUPE, Local 79 and more recently in Patrick Street Holdings Ltd v 11368 NL Inc, became central to the Court's treatment of the renewed request concerning Dr. Rowett.

Reasoning and analysis

On the first motion, the Court found that the Internet Archive employee had unequivocally stated he was willing to attend trial remotely or in person, so there were no good grounds to conclude he would not attend, and a "just in case" order was not a proper use of Court resources. As for the Swiss witnesses, the Court held that Sandoz had not adequately explained its delay in bringing the motion given that a discovery motion on the same issue had been heard in October 2025, and that Sandoz had not shown the Swiss examination process could be completed without prejudicing the trial, then scheduled to begin August 17, 2026. Critically, Sandoz had not established that it had ever asked an ESMO representative to voluntarily attend trial before seeking letters rogatory. The Court also expressed concern over Sandoz's partial disclosure and redaction of an email from Dr. Rowett of ESMO, though it found it unnecessary to resolve the relevance and privilege dispute given the motion's outcome on other grounds. On the second motion, the Court found a material change in circumstances regarding the Internet Archive witness, who had become unresponsive to Sandoz's communications, justifying the issuance of letters rogatory notwithstanding the proximity to trial. By contrast, the request concerning Dr. Rowett was dismissed as an abuse of process: the Court found that Sandoz had, in substance, already litigated the same issue against ESMO in the first motion, had made a strategic choice not to pursue Dr. Rowett at that time, and had refused to disclose the very communications with him that it now relied upon. No new facts justified revisiting the issue, and permitting the second attempt would undermine judicial economy, consistency, and finality.

Ruling and overall outcome

The outcome across both decisions was mixed. The first motion was dismissed in its entirety, with the parties directed to attempt to agree on costs or file submissions if no agreement could be reached. The second motion was granted in part and dismissed in part: the Registry was directed to issue a letter of request to the United States District Court for the Northern District of California to compel the Internet Archive representative's examination, limited to one hour, while the request concerning Dr. Rowett in England was dismissed as an abuse of process. No costs were ordered on the second motion; although the Court noted it would ordinarily have been inclined to award costs to Janssen given Sandoz's abuse of process on that portion of the motion, Janssen's unsubstantiated allegation that Sandoz had misled the Court disentitled Janssen to costs. No monetary amount was awarded to either party in either decision.

Federal Court
T-9-25
Intellectual property
Not specified/Unspecified
Other
02 January 2025