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).
Should you have any questions, please do not hesitate to contact a member of the Pharmaceutical Litigation Group.
The preceding is intended as a timely update on Canadian intellectual property and life sciences regulatory law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.
Related Publications & Articles
-
Alexion awarded injunction against Amgen in SOLIRIS patent action; Court considers anticipation by incorporation by reference
The Federal Court has granted Alexion a declaration of infringement and an injunction preventing Amgen from manufacturing, using, and selling its proposed biosimilar eculizumab product, BEKEMV, in Can...Read More -
Update on biosimilars in Canada – June 2025
This article provides an update on developments in the biosimilar space in Canada—regulatory, approvals, pending submissions, litigation, and market access.Read More -
Health Canada must redetermine exemption requests for psilocybin (magic mushroom)-assisted psychotherapy training
TheraPsil, a patient advocacy organization, and 73 healthcare practitioners (HCPs) have succeeded in the Federal Court of Appeal to overturn the refusal of the Minister of Mental Health and Addictions...Read More