On November 9, 2023, the Federal Court of Appeal (the FCA) issued its decision in Apotex Inc. v Janssen Inc., 2023 FCA 220, finding that the marketing and sale by Apotex Inc. (Apotex) of its Apo-Macitentan product would induce infringement of Canadian Patent No. 2,659,770 (the Patent).

The Patent is concerned with the treatment of certain vasoconstrictive diseases by a combination of macitentan and another drug.  Apotex sought marketing approval for Apo-Macitentan as a monotherapy and the Federal Court (FC) enjoined Apotex from various activities involving Apo-Macitentan until the expiry of the Patent (2022 FC 996).  Apotex appealed.

On appeal, the FCA found that the FC correctly summarized the three prongs of the legal test in determining inducement of infringement, namely:

  1. The acts of infringement must have been completed by the direct infringer;
  2. 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; and
  3. The influence must be knowingly exercised by the inducer; in other words, the inducer knows that this influence will result in the completion of the acts of infringement.

The FCA’s analysis focused on the second and third prongs, as the parties agreed that the first prong of the test was met.

Apotex asserted that the FC erred in finding that the Apo-Macitentan Product Monograph (PM) could be the source of influence sufficient to satisfy the second prong of the test because: (i) the relevant section of the PM does not mention combination treatment; and (ii) the PM omits mention of scientific data suggesting the use of macitentan in combination with other drugs.  The FCA disagreed with Apotex’s assertions, finding that, while explicit instruction and intention of direct infringement may be relevant, neither is required to satisfy the second prong of the test.  The FCA thus found that it was open to the FC to reach the conclusions it did, including that the PM would influence physicians to prescribe combination treatment despite it not explicitly mentioning such treatment.

Regarding the third prong, the FCA rejected Apotex’s arguments that the FC erred in: (i) conflating the second and third prongs of the test; (ii) improperly shifting the burden of proof to Apotex; (iii) failing to give sufficient weight to the evidence of Apotex’s expert witness; and (iv) finding that there was no evidence as to Apotex’s knowledge of influence and overlooking evidence that Apotex does not intend to advise third parties as to the use of Apo-Macitentan.  Accordingly, the FCA held that it was open to the FC to conclude that Apotex knew or should have known that the Apo-Macitentan PM would influence physicians’ prescribing decisions.

Ultimately, the FCA dismissed Apotex’s appeal with costs.

Summary By: Steffi Tran


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