Janssen Inc. and Actelion Pharmaceuticals Ltd. filed a patent action against Sandoz Canada Inc. under the Patented Medicines (Notice of Compliance) Regulations. The action involved OPSUMIT®, a medication for pulmonary arterial hypertension. OPSUMIT® belonged to a class of drugs called endothelin receptor antagonists (ERAs), which worked by blocking the vasoconstricting effects of the endothelin pathway. The plaintiffs alleged that Sandoz's generic version would infringe on their patent, but Sandoz claimed the patent was invalid. However, Sandoz failed to establish the invalidity of the claims, and the plaintiffs were entitled to a declaration of infringement. The court declared that Sandoz would infringe the patent and was prohibited from making, using, selling, or marketing its macitentan tablets in Canada. Sandoz was required to surrender or destroy all related materials under oath, except for copies required by law. No ruling on costs was made.

No uploaded documents