Canada’s Intellectual Property Firm

Federal Court of Appeal and Federal Court release three decisions relating to macitentan (Janssen’s OPSUMIT)

Authored byKatie Lee

Update: On June 6, 2024, the Supreme Court of Canada dismissed Apotex’s application for leave to appeal.

Federal Court of Appeal (FCA) dismisses appeal on finding of inducement: Apotex Inc v Janssen Inc, 2023 FCA 220

Apotex appealed the trial decision, finding that Apo-Macitentan would infringe Canadian Patent No. 2,659,770 (770 Patent). Even though Apotex would only sell Apo-Macitentan by itself, the Federal Court (FC) found that Apotex would induce physicians to prescribe the drug to patients in combination with a phosphodiesterase type-5 inhibitor (PDE5-i) for pulmonary arterial hypertension (PAH). The FC’s conclusion was based in part on references in Apotex’s product monograph to clinical trial data from the SERAPHIN study, which was the pivotal trial that established the safety and efficacy of macitentan as a monotherapy and as combination therapy with a PDE5-i.

The FCA dismissed Apotex’s appeal based on the three-prong inducement test as follows:

  • Direct infringement: the parties agreed that this prong was met.
  • Inducement: the absence of (i) explicit instruction in Apotex’s product monograph and (ii) the alleged infringer’s intention that direct infringement should result, does not equal an absence of influence for the second prong.  While relevant, neither are required. Even without explicit reference to combination treatment, the FC was entitled to find that Apotex would influence use of macitentan in that way.
  • Knowledge: the FC was entitled to draw inferences about Apotex’s knowledge from the evidence. Apotex was aware of the content of Apotex’s product monograph, and the fact that it would be available to physicians treating PAH. It was open to the FC to conclude that Apotex knew or should have known that Apotex’s product monograph would influence physicians’ prescribing decisions.

Federal Court of Appeal dismisses appeal on finding of sound prediction: Sandoz Canada Inc v Janssen Inc, 2023 FCA 221

Sandoz appealed the trial decision, finding that the 770 Patent was valid and granting a declaration of infringement. In its oral submissions, Sandoz only addressed the ground of lack of utility based on lack of sound prediction.  The FC based its finding of sound prediction on rat studies.

Sandoz argued that the FC did not mention the Eli Lilly Canada v Novopharm Limited, 2010 FCA 197 (Eli Lilly) decision, which held that for a prediction to be sound, a party must establish a “prima facie reasonable inference of utility”.  Sandoz alleged as a result, the FC implicitly and erroneously applied a lower threshold.

The FCA rejected this argument, finding that the FC cited correct principles from Apotex Inc v Wellcome Foundation Limited, 2002 SCC 77 (Wellcome). The FCA stated that Eli Lilly did not depart from the test outlined in Wellcome, but instead sought to clarify the threshold for a finding that a prediction is sound. According to the FCA, a complete reading of Wellcome can be summarized as that while it is not necessary that the prediction be certain, or to a regulatory standard, the public is entitled to a teaching that is solid, accurate, meaningful, and based not on speculation but exact science. 

The FCA found that the threshold for sound prediction was not high, and that “the terms ‘prima facie’ and ‘reasonable inference’ leave considerable space for a fact-finding body in reaching its conclusion.” 

The factual conclusions cited by Sandoz in its appeal did not lead the FCA to conclude that the FC applied a threshold lower than a prima facie reasonable inference of utility. 

Therefore, the FCA dismissed the appeal.

Federal Court directs scheduling of summary trial on infringement: Janssen Inc v Sandoz Canada Inc, 2023 FC 1231

Sandoz filed a second regulatory submission for macitentan, distinct from the subject of the decision above, and alleged non-infringement of the 770 Patent. Sandoz sought to schedule a motion for summary trial.  Janssen brought a motion opposing the scheduling, arguing that summary trial motions in the context of Patented Medicines (Notice of Compliance) Regulations proceedings should be rare, and that a summary trial will have the effect of seeking a full trial on an expedited timeline when proceedings are already compressed compared to other patent actions.

However, Associate Judge Horne of the FC stated that Sandoz has a right to bring a motion for summary trial in accordance with Rule 213(1) and to deny that right requires compelling evidence and argument to demonstrate it is apparent that a motion for summary trial should not even be assigned a hearing date. 

As the FC was not persuaded that Janssen met such standard, the FC dismissed Janssen’s motion, and directed scheduling of the summary trial motion with proposed dates approximately 10 months away. However, the FC noted that it made no finding as to the sufficiency of the evidence to adjudicate the matter, or whether it would be unjust to decide the issues by summary trial.

Should you have any questions, please do not hesitate to contact a member of the Pharmaceutical Litigation Group.

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