In a public decision dated August 8, 2024, Justice Furlanetto of the Federal Court found Boehringer Ingelheim’s Canadian Patent No. 2,591,083 (the 083 patent) valid and infringed by JAMP in an action under the Patented Medicines (Notice of Compliance) Regulations relating to OFEV® (nintedanib): Boehringer Ingelheim (Canada) Ltd v JAMP Pharma Corporation, 2024 FC 1198.

The 083 patent relates to the use of nintedanib and its esylate salt in the prevention or treatment of idiopathic pulmonary fibrosis (IPF) – a rare, chronic and incurable lung disease that typically leads to respiratory failure and death.

The Court found that the 083 patent is not invalid for anticipation, double patenting, lack of sound prediction of utility or obviousness. In particular, the 083 patent provided the skilled person with a sound prediction of utility that was “more than mere speculation or hypothesis, but one grounded in the accepted in vivo model for evaluating potential efficacy”.

In addition, the Court concluded that JAMP’s import and sale of JAMP Nintedanib is sufficient to constitute direct infringement of the 083 claims that are directed to the medicine (nintedanib esylate) and pharmaceutical composition of the medicine for use in the prevention or treatment of IPF. JAMP had stipulated that it would induce infringement of the 083 claims.

With respect to the second patent at issue relating to a formulation of nintedanib esylate (Canadian Patent No. 2,726,267), the Court found that JAMP Nintedanib does not infringe the asserted claims and declined to consider the invalidity defences raised by JAMP.

Either party may appeal as of right.

[View source.]