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In a public decision dated July 6, 2022 in an action under the Patented Medicines (Notice of Compliance) Regulations, Justice Pallotta of the Federal Court found that Apotex would infringe Janssen’s patent relating to Janssen’s OPSUMIT (macitentan) by selling APO-MACITENTAN: Janssen Inc v Apotex Inc, 2022 FC 996. Apotex did not challenge validity.

Canadian Patent No. 2,659,770 (770 Patent) was the subject of an earlier s. 6(1) action involving Janssen and Sandoz, in which the Court rejected Sandoz’s validity attacks. The 770 Patent relates to macitentan in combination with a phosphodiesterase type-5 inhibitor (PDE5-I) (for example, sildenafil) to treat diseases where vasoconstriction is involved, including pulmonary arterial hypertension (PAH).

The Court held:

  1. Apotex would not directly infringe claims 1-5 and 10-20; and
  2. Apotex would indirectly infringe claims 1-5 and 21-31 by inducing others, notably prescribing physicians, to infringe.

While the specific indication in Apotex’s product monograph was redacted in the Reasons, Apotex argued that “the PM does not suggest that physicians or patients should use APO-MACITENTAN in combination with a PDE5-I” and the Court noted that “Based on a side-by-side comparison of the OPSUMIT and APO-MACITENTAN PMs, the APO-MACITENTAN PM does not include certain references to combination therapy that are found in the [OPSUMIT] PM”.

Direct infringement: The Court found that Apotex would not infringe claims 1-5 and 10-20 directly, as the evidence did not show that Apotex would (i) make, use or sell a product that contains macitentan in combination with a PDE5-I; (ii) combine a product that contains macitentan with a PDE5-I to treat PAH; or (iii) use macitentan in combination with a PDE5-I to manufacture a medicament.

Indirect infringement: The Court however found that Apotex would indirectly infringe, finding Janssen had shown that each element of the Corlac Inc v Weatherford Canada Ltd, 2011 FCA 228 three-prong test had been met:

  1. Direct Infringement: The expert witnesses agreed that combination therapy is the standard of care for most PAH patients.  The evidence establishes that physicians and patients will directly infringe the 770 Patent, and, if approved, APO-MACITENTAN will be combined with a PDE5-I (sildenafil, or more commonly, tadalafil) for the treatment of PAH;
  2. Influence: The Court found that prescribing physicians will review the information in the APO-MACITENTAN product monograph, which included a clinical trial called the SERAPHIN trial, a landmark study showing that both monotherapy and combination therapy was effective in PAH patients, and rely on that information before prescribing APO-MACITENTAN; and
  3. Knowledge: The Court found that Apotex knows or ought to know that the content of the APO-MACITENTAN product monograph will influence physicians to complete the acts of infringement.

Apotex has appealed (A-131-22).

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

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