Federal Court Finds Janssen's Macitentan Combination Therapy Patent Valid

• Published date: 28 June 2022
• Subject Matter: Intellectual Property, Food, Drugs, Healthcare, Life Sciences, Patent, Biotechnology & Nanotechnology
• Law Firm: Smart & Biggar
• Author: Ms Chen Li

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.

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

Asserted Claims not obvious

As a preliminary matter, the parties disagreed on how to define the skilled person. Sandoz...