FCA Clarifies Law on Induced Infringement for Generic/Biosimilar Drugs
In Teva Canada Limited v. Janssen Inc. 2023 FCA 68 (“Teva-Paliperidone”), the Federal Court of Appeal overturned a trial judge’s infringement finding, and provided guidance on how to assess the infringement of patents that cover uses of pharmaceutical medicines (“use” patents).
For context, generic/biosimilar medicines manufacturers typically argue they do not directly infringe “use” patents because it is a third party (e.g., physician or patient) that ultimately uses the medication. In Canada, infringement by inducement can be established against generic/biosimilar manufacturers through the application of a tripartite test:
- The act(s) of infringement must have been completed by the direct infringer;
- The completion of the act(s) of infringement were influenced by the acts of the alleged inducer to the point that, without the influence, direct infringement would not take place; and
- The influence must knowingly be exercised by the inducer, that is, the inducer knows that this influence will result in the completion of the act of infringement.
Many cases (including this one) turn on the application of prong two, which is known as the “but for” element of the test.
At trial, the Federal Court held Teva would not induce the infringement of certain claims that generally covered a particular maintenance dose of the medication because the “but for” requirement of the inducement test had not been met. The trial judge found that the plaintiff had not established Teva’s Product Monograph (or label) “influences physicians to prescribe the claimed maintenance doses to the point that, absent the dosing information in the Teva [Product Monograph], direct infringement would not occur.” The Federal Court rationalized this finding because “it found that the selection of maintenance doses would ultimately be made by physicians based on various factors beyond what was set out in the Teva [Product Monograph].”
The Federal Court of Appeal reversed the trial judge’s holding, finding the lower court’s error led the court to apply “an unduly onerous requirement at the second prong of the analysis for inducement and to incorrectly focus only on the skill and judgement of prescribing physicians to the exclusion of the role played by Teva in inducing infringement of the use claims in suit”.
Contrary to the trial judge’s holding, the Federal Court of Appeal held it does not matter that physicians use their own skill and judgment for the purpose of the inducement test: “It matters not that physicians use their own skill and judgment in dispensing the drug, nor that they must make an active choice to perform the infringing use, as physicians invariably exercise similar skill and judgment whenever a drug is prescribed to a patient.” Instead, the Federal Court of Appeal found the “but for” element can be established through the content of the generic/biosimilar Product Monograph (or label):
“[I]nclusion as one of the recommended uses within the PM for the drug of the alleged infringing use, among others, has been found to be sufficient to constitute the requisite encouragement to satisfy the second prong of the test for inducement.”
Here the Federal Court found that the capable, approved and intended use for the Teva product incorporated all the dosing and administration elements of the product claims. As such “this finding inevitably leads to the conclusion that Teva would induce infringement of the use claims.” Teva would be both a direct and indirect infringer if it came on the market.
 Janssen Inc. v. Teva Canada Ltd., 2020 FC 593.
 FCA at para. 50.
 FCA at para 82.
 FCA at para 110.
 FCA at para 110 (emphasis added).
 FCA at para 112.
FCA inducement Patents infringement FC PMNOC