How far does a generic drug maker need to go to exclude liability for inducing patent infringement?
In drug patent cases the product monograph is key in assessing whether inducement exists. In the case of off-label uses, it is customary for a generic drug maker to exclude any references in the innovator’s product monograph that teach the off-label use. How far such edits must go is put in doubt by the Federal Court of Appeal decision in Apotex Inc. v. Janssen Inc., 2023 FCA 220.
The test for a finding of inducing infringement was confirmed by the Federal Court . . . [more]