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ARTICLE · 28 JUNE 2022

Federal Court Finds Janssen's Macitentan Combination Therapy Patent Valid

Smart & Biggar
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Sandoz submitted that the 770 Patent is invalid on the grounds of obviousness, lack of utility, overbreadth, and insufficiency, but conceded infringement.

CanadaIntellectual Property
Chen Li
Chen Li
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On May 31, 2022, the Federal Court released a decision by Justice Pallotta in a patent infringement action pursuant to subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations in relation to macitentan (Janssen's OPSUMIT). The Court found claims 21-31 (the Asserted Claims) of Canadian Patent No. 2,659,770 (the 770 Patent) valid and granted a declaration of infringement: Janssen Inc v Sandoz Canada Inc, 2022 FC 715.

Macitentan belongs to a class of drugs known as endothelin receptor antagonists (ERAs). Janssen markets macitentan in Canada for the treatment of pulmonary arterial hypertension (PAH). 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 PAH.

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The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.

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