As previously reported, the Federal Court found Janssen's Canadian Patent No. 2,661,422 (422 patent)—which relates to treatment of prostate cancer in humans by co-administration of abiraterone acetate (Janssen's ZYTIGA) and prednisone—invalid in actions under the Patented Medicines (Notice of Compliance) Regulations (Regulations) against Apotex, Dr. Reddy's, and Pharmascience. The Federal Court of Appeal upheld the invalidity of the 422 patent on appeal.
Dr. Reddy's seeks damages from Janssen pursuant to the amended section 8 of the Regulations for its lost sales of abiraterone acetate (the "DRL action") and the trial is scheduled to start on June 5, 2023. Apotex and Pharmascience were pursuing similar actions; Apotex's section 8 action has since been dismissed on consent.
In the DRL action, Janssen pleads that if DRL entered the market earlier than its date of approval in the real world, other generic pharmaceutical companies—including Apotex and Pharmascience—would have competed with DRL. As previously reported, Justice Southcott denied DRL's motion for a preliminary determination of law on this issue.
On February 14, 2023, Justice Southcott ordered Apotex and Pharmascience—non-parties in the DRL action—to produce documents relevant to this defence. Apotex appealed the order ("Apotex's appeal") and produced the documents without prejudice to its appeal, which sought to have the material returned or destroyed if successful.
In the present motion, Janssen sought to adjourn the DRL trial to await the disposition of Apotex's appeal. On March 30, 2023, Justice Southcott dismissed Janssen's motion as not in the interests of justice: Dr. Reddy's Laboratories Ltd v Janssen Inc, 2023 FC 448.
The Federal Court has broad discretion to adjourn its own proceedings but held that "requesting an adjournment is not a trivial matter". The Court is required to assess whether "in all the circumstances, the interests of justice support the stay or the hearing being delayed".
Janssen argued it had not used the documents at issue to prepare its trial strategy as it normally would because of the uncertainty resulting from Apotex's appeal. Further, Janssen argued that if the documents were used by Janssen to prepare for trial or at trial and the Apotex's appeal was subsequently successful, the Court would segregate the tainted information or retry the case, resulting in wasted court time.
Justice Southcott concluded that a number of factors weighed against granting the adjournment including that Janssen's reason for requesting the adjournment and prejudice to Janssen were possible, but speculative, depending on how Janssen decides to use the documents at issue, as well as the timing and result of the Apotex's appeal. On the other hand, DRL will suffer prejudice if the trial is adjourned, having prepared for a two-week trial that is now imminent (two months away).
Following this decision, Apotex's appeal was dismissed on consent.
Should you have any questions, please do not hesitate to contact a member of the Pharmaceutical Litigation Group.
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