As previously reported, the Federal Court of Appeal dismissed Apotex’s appeal of a decision relating to macitentan (Janssen’s OPSUMIT), which found that Apotex would induce infringement of Janssen’s patent. The patent claims macitentan in combination with a phosphodiesterase type-5 inhibitor (for example, tadalafil) to treat diseases where vasoconstriction is involved, including pulmonary arterial hypertension.

The Federal Court concluded Apotex would induce infringement, based in part on information in Apotex’s product monograph, though the product monograph did not include explicit instruction for combination treatment. Apotex filed an application for leave to appeal on January 8, 2024.

On June 6, 2024, the Supreme Court of Canada dismissed Apotex’s application for leave to appeal (Docket No. 41087).

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