Federal Court of Appeal declines raised requirement of evidence for caused violation in paliperidone case

The Federal Court of Appeal ( FCA) has actually permitted an appeal worrying caused violation in an action under the Patented Medicines (Notification of Compliance) Laws ( Laws). The FCA discovered that the Federal Court ( FC) had actually erred by using a raised causation requirement. The FCA likewise turned down an appeal by the generic from the finding that the patent stood and straight infringed.


Janssen markets INVEGA SUSTENNA ® (paliperidone palmitate) in Canada for the treatment of schizophrenia and associated conditions. Teva looked for to bring generic paliperidone palmitate prefilled syringes to the Canadian market. In action, Janssen started an action under subsection 6( 1) of the Laws versus Teva, asserting violation of Canadian Patent 2,655,335 ( 335 Patent). Teva rejected violation and declared that the asserted claims of the 335 Patent were void for obviousness.

As we reported, the FC turned down Teva’s claims that the declared dosing routines were apparent. The FC likewise discovered that Teva would straight infringe the 335 Patent’s prefilled syringe claims (connecting to prefilled syringes adjusted for administration according to the declared dosing routines) and “Swiss-type” claims (connecting to utilize of paliperidone in the manufacture/preparation of a “remedy” adjusted for administration according to the declared dosing program). Nevertheless, the FC discovered that Teva would neither straight infringe or cause recommending doctors to infringe the asserted usage claims of the 335 Patent.

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

Item Essay declarations total up to requisite impact for caused violation

The FCA concurred with Janssen that the FC erred in turning down claims of caused violation, using a raised requirement of causation that was not supported in the jurisprudence.

This concern switched on the FC’s analysis of the FCA’s 2011 choice in Corlac Inc v Weatherford Canada Inc ( Corlac), where the FCA set out the tripartite test for causing violation as follows:

  • The act of violation need to have been finished by the direct infringer;
  • The conclusion of the acts of violation need to be affected by the acts of the supposed inducer to the point that, without the impact, direct violation would not occur;
  • The impact need to purposefully be worked out by the inducer, that is, the inducer understands that this impact will lead to the conclusion of the act of violation.

Janssen challenged the FC’s holding that the “‘ however for’ impact needed in the 2nd prong of the Corlac test needs a greater limit for developing incentive than was used in the earlier cases”. This mistake, Janssen argued, led the FC to “improperly focus just on the ability and judgment of recommending doctors to the exemption of the function played by Teva in causing violation of the usage declares in match.”

The FCA discussed that Corlac did not alter the law relating to the requisite impact needed to satisfy the 2nd prong of the test for incentive. It held: “At the 2nd action of the analysis, what is needed is evidence that that the putative infringer affected the celebration that straight infringes to the point that, without such support, violation would not have actually happened (or when it comes to an application under the PMNOC Laws, would not take place).”

The FCA highlighted that in the pharmaceutical context, there is a line of cases that holds that addition of the supposed infringing usage as one of the suggested usages within the Item Essay can be adequate to please the 2nd prong.

Appling the appropriate test for incentive to the realities, the FCA held that all 3 prongs of the test for causing violation were fulfilled.

Direct violation: no reviewable mistake

Teva argued that the FC erred in finding that its proposed item would include a repaired upkeep dosage, which was a vital component of the claims for which direct violation was discovered. The FCA disagreed, keeping in mind that “proof that a generic business proposes to make or offer its item for the trademarked usage (even if it is just one usage to name a few) suffices to develop direct violation” in an action under area 6 of the Laws

Obviousness: no reviewable mistake

The FCA likewise turned down both of Teva’s appeals worrying obviousness:

  • Initially, Teva argued that considering that the FC did not discover the declared dosing windows to be a vital component, the FC erred in depending on these dosing windows as one of the non-obvious differences in between the previous art and the asserted claims of the 335 Patent. The FCA discovered that the FC did show that the dosing windows are a vital claim component, and resolved other important components which Teva stopped working to show were apparent.
  • 2nd, Teva argued that the FC stopped working to represent previous art proof that the pharmacokinetic profile of paliperidone was understood at the concern date. The FCA discovered that the proof in concern stopped working to particularly divulge the pharmacokinetic profile of paliperidone palmitate and its healing concentration variety, the decision of which would have needed more than regular tests.

Hyperlinks to choices:

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

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

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