Hoffmann-La Roche Limited and InterMune, Inc. brought four patent infringement actions under the Patented Medicines (Notice of Compliance) Regulations against Sandoz Canada Inc. regarding pirfenidone, used to treat idiopathic pulmonary fibrosis.
The plaintiffs alleged that Sandoz's generic pirfenidone products would infringe or induce infringement of two patents covering a dose escalation regimen and treatment for patients exhibiting abnormal liver function.
The Federal Court construed the claims as use claims, found no direct infringement, and concluded that Sandoz would induce infringement of certain claims of the 654 Patent.
However, the Court held that the asserted claims of both patents were invalid for obviousness and for constituting unpatentable methods of medical treatment, and that the 997 Patent claim was additionally invalid for obviousness-type double patenting.
The actions were dismissed with costs awarded to the defendant.