By judgment dated May 12, 2021, the Federal Court dismissed patent infringement actions related to Sandoz’s pirfenidone capsules and tablets for the treatment of idiopathic pulmonary fibrosis (IPF) (Roche’s ESBRIET): Hoffmann-La Roche v Sandoz, 2021 FC 384. The actions were pursuant to subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations). At issue were Patent Nos. 2,667,654 and 2,709,997.

The Court found that Sandoz would not directly infringe the claims of either patent but would induce infringement of certain claims of the 654 patent.

The Court however accepted Sandoz’s defences of invalidity on the basis of obviousness and claiming methods of medical treatment. The Court did not accept Sandoz’s defences of invalidity on the basis of anticipation, utility, over claiming, insufficiency and ambiguity.

Roche has appealed.