FCA Finds Teva Would Directly Infringe And Induce Infringement Of Janssen's Paliperidone Palmitate Patent

As previously reported, the Federal Court (FC) found that Teva would directly infringe but not induce infringement of certain claims of Canadian Patent No. 2,655,335 (335 patent) regarding its paliperidone palmitate product (Janssen's INVEGA SUSTENNA) and that the claims were not obvious.

The 335 patent relates to dosing regimens for long-acting paliperidone palmitate depot formulations for treatment of schizophrenia.

Teva appealed on obviousness and direct infringement, and Janssen cross-appealed on the finding that Teva would not induce infringement. The Federal Court of Appeal (FCA) dismissed Teva's appeal and allowed Janssen's cross-appeal: 2023 FCA 68.

Obviousness

The FCA concluded that there was no basis for interfering with the FC's findings on obviousness:

1. The FC did not err in requiring Teva to show that the dosing windows of the dosing regimen were obvious as the alleged error was premised on a misreading of the FC's reasons that the dosing windows were not essential; and
2. Teva's allegation that the FC ignored or overlooked evidence as to the starting point for establishing doses within the dosing regimen amounted to a request to reconduct the obviousness analysis, which is not something an appellate court can do.

Direct Infringement

The FCA held that in the context of product claims and Swiss-type product claims, 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 brought under section 6 of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations). The FCA therefore found no error in the FC's analysis of direct infringement.

Induced Infringement

According to the FCA, the three-prong test for inducing infringement from Corlac Inc v Weatherford Canada Inc, 2011 FCA 228 requires a patentee to establish:

1. the act(s) of infringement must have been completed by the direct infringer;
2. 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
3. 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.

The FC found that Janssen had established the first of the Corlac factors but not the second; it did not consider the third. The focus of Janssen's cross-appeal was therefore the second factor and specifically the FC's finding that Corlac called for "a more stringent test than had previously been required such that a defendant now will not be found to induce infringement of a patent unless the patentee establishes that, 'but for' the acts of the defendant [...] would not occur" in the context of an action under the PMNOC Regulations.

Following an extensive review of the inducing infringement jurisprudence, the FCA concluded that the FC erred in law in holding that Corlac changed the law by incorporating a higher degree of causality at the second step. Further, "inclusion as one of the recommended uses within the [product monograph] 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". The facts in this case were similar, if not stronger than a previous case, Hospira where the Court found infringement where the infringing use was one of several taught by the generic product monograph. The FCA stated that "[i]t 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." Finally, the FC's finding that the capable, approved and intended use for the Teva product incorporated all the dosing and administration elements of the product claims inevitably leads to the conclusion that Teva would induce infringement of the use claims.

As for the third element, as was the case in Hospira, this was easily met as Teva must be presumed to have been aware of the contents of its product monograph and what it recommended.

The FCA therefore declared that the making, constructing, using or selling of Teva-Paliperidone would induce infringement.

Any further appeal would require leave from the Supreme Court of Canada.

Should you have any questions, please do not hesitate to contact a member of the Pharmaceutical Litigation Group.

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