The Federal Court of Appeal (FCA) has allowed an appeal concerning induced infringement in an action under the Patented Medicines (Notice of Compliance) Regulations (Regulations). The FCA found that the Federal Court (FC) had erred by applying an elevated causation requirement. The FCA also rejected an appeal by the generic from the finding that the patent was valid and directly infringed. 

Background

Janssen markets INVEGA SUSTENNA® (paliperidone palmitate) in Canada for the treatment of schizophrenia and related disorders. Teva sought to bring generic paliperidone palmitate prefilled syringes to the Canadian market. In response, Janssen initiated an action under subsection 6(1) of the Regulations against Teva, asserting infringement of Canadian Patent 2,655,335 (335 Patent). Teva denied infringement and alleged that the asserted claims of the 335 Patent were invalid for obviousness. 

As we reported, the FC rejected Teva’s allegation that the claimed dosing regimens were obvious. The FC also found that Teva would directly infringe the 335 Patent’s prefilled syringe claims (relating to prefilled syringes adapted for administration according to the claimed dosing regimens) and “Swiss-type” claims (relating to use of paliperidone in the manufacture/preparation of a “medicament” adapted for administration according to the claimed dosing regime). However, the FC found that Teva would neither directly infringe or induce prescribing physicians to infringe the asserted use claims of the 335 Patent.

On appeal, Teva challenged the FC’s findings on obviousness and direct infringement. Janssen cross-appealed from the FC’s finding on induced infringement.

Product Monograph statements amount to requisite influence for induced infringement 

The FCA agreed with Janssen that the FC erred in rejecting allegations of induced infringement, applying an elevated standard of causation that was not supported in the jurisprudence.

This issue turned on the FC’s interpretation of the FCA’s 2011 decision in Corlac Inc v Weatherford Canada Inc (Corlac), where the FCA set out the tripartite test for inducing infringement as follows:

  • The act of infringement must have been completed by the direct infringer;
  • The completion of the acts of infringement must be influenced by the acts of the alleged inducer to the point that, without the influence, direct infringement would not take place;
  • 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.

Janssen challenged the FC’s holding that the “‘but for’ influence required in the second prong of the Corlac test requires a higher threshold for establishing inducement than was applied in the earlier cases”. This error, Janssen argued, led the FC to “incorrectly focus only on the skill and judgment of prescribing physicians to the exclusion of the role played by Teva in inducing infringement of the use claims in suit.”

The FCA explained that Corlac did not change the law regarding the requisite influence required to meet the second prong of the test for inducement. It held: “At the second step of the analysis, what is required is proof that that the putative infringer influenced the party that directly infringes to the point that, without such encouragement, infringement would not have occurred (or in the case of an application under the PMNOC Regulations, would not occur).”

The FCA highlighted that in the pharmaceutical context, there is a line of cases that holds that inclusion of the alleged infringing use as one of the recommended uses within the Product Monograph can be sufficient to satisfy the second prong. 

Appling the correct test for inducement to the facts, the FCA held that all three prongs of the test for inducing infringement were met.

Direct infringement: no reviewable error

Teva argued that the FC erred in finding that its proposed product would incorporate a fixed maintenance dose, which was an essential element of the claims for which direct infringement was found. The FCA disagreed, noting that “evidence that a generic company proposes to make or sell its product for the patented use (even if it is only one use among others) is enough to establish direct infringement” in an action under section 6 of the Regulations.

Obviousness: no reviewable error

The FCA also rejected both of Teva’s appeals concerning obviousness:

  • First, Teva argued that since the FC did not find the claimed dosing windows to be an essential element, the FC erred in relying on these dosing windows as one of the non-obvious distinctions between the prior art and the asserted claims of the 335 Patent. The FCA found that the FC did indicate that the dosing windows are an essential claim element, and addressed other essential elements which Teva failed to prove were obvious. 
  • Second, Teva argued that the FC failed to account for prior art evidence that the pharmacokinetic profile of paliperidone was known at the priority date. The FCA found that the evidence in question failed to specifically disclose the pharmacokinetic profile of paliperidone palmitate and its therapeutic concentration range, the determination of which would have required more than routine tests.

Links to decisions:

Trial decision: Janssen Inc. v Teva Canada Ltd, 2020 FC 593

Appeal decision: Teva Canada Limited v Janssen Inc., 2023 FCA 68