Apotex Inc. v. Janssen Inc., 2023 FCA 220

Justice Mactavish; Justice Locke; Justice Monaghan - 2023-11-09

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This appeal concerns an allegation by the respondents, collectively, Janssen, that the marketing and sale by the appellant, Apotex, of a pharmaceutical product called Apo-Macitentan would induce infringement of the respondents’ Patent by inducing physicians to prescribe the drug to patients to be taken in combination with a PDE5 inhibitor to treat a rare disease called pulmonary arterial hypertension. In an action pursuant to the PMNOC Regulations, the Federal Court (2022 FC 996) agreed with the respondents’ allegation and enjoined Apotex from various activities involving Apo-Macitentan until the expiry of the Patent. ... For the reasons set out below, I would dismiss the present appeal. The issue of inducing infringement is central in this case because the Patent is concerned with the treatment of vasoconstrictive diseases (such as PAH) by a combination of macitentan and a PDE5 inhibitor, whereas Apotex would sell macitentan alone. Apotex would not take part in the ultimate act of direct infringement by use of the patented combination. ... Though Apotex acknowledges that Apo-Macitentan would be prescribed for the patented combination treatment, it argues that such use would not be because of its influence. Though Janssen’s Opsumit product is intended to be used in combination treatment, and its associated PM so indicates, Apotex argues that its own PM omits references to combination treatment.

Decision relates to:


Canadian Intellectual Property