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Product Monograph Carve-Outs May Not Avoid Infringement

Justice Locke, writing a unanimous decision for the Federal Court of Appeal in Apotex v Janssen, 2023 FCA 220, dismissed Apotex’s appeal of 2022 FC 996, and expressly agreed with the determination that Apotex would induce infringement of Canadian Patent 2,659,770 (“770 Patent”) with their Apo-Macitentan product.

The 770 Patent claimed the use of macitentan in combination with a PDE5 inhibitor for treating pulmonary arterial hypertension.  Apotex argued at first instance that their Apo-Macitentan product would not induce infringement because Apotex was only seeking approval to sell this product for use in monotherapy for pulmonary arterial hypertension, and not in combination with a PDE5 inhibitor. The Apo-Macitentan product monograph did not include an indication for the combination therapy, and omitted mentioning scientific data that suggested the use of macitentan in combination with other drugs.

The lower Court found that Apotex’ product monograph would induce infringement in part because it referred to the Seraphin clinical trial which was described as a “landmark clinical study” which showed that combination treatment, in addition to monotherapy, was safe and effective and on the basis that the product monograph did not suggest that physicians should depart from “well-established prescribing practices, principally combination treatment.”

At the FCA, the main areas of disagreement between the parties concerned the second and third prongs of the three-prong test for inducing infringement from Corlac:

  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.

Apotex argued that their product monograph does not mention the combination treatment and omits scientific data that suggests the combination use, such that Apotex would not be allowed to market their product in combination with a PDE5 inhibitor. Apotex conceded that its product would be prescribed for the patented combination but argued that this use would not be due to its influence under the second prong of the Corlac test.

Justice Locke observed that the weakness of this argument was that:

[17] “…it assumes that an absence of explicit instruction and of intention that direct infringement should result equals an absence of influence sufficient to satisfy the second prong.  That is not necessarily the case. While explicit instruction and intention may be relevant to the issue of influence, I do not accept that either is required. Even without explicit reference to combination treatment, the Federal Court was entitled to find that the Apo-Macitentan PM would influence use of macitentan in that way.”

The FCA commented that although the FC’s reasons for its conclusion that Apotex’ product monograph would have sufficiently influenced prescribers could have been more fulsome, this did not amount to a palpable and overriding error. Further, that because the FC clearly understood the Corlac test, it could be inferred that the FC was convinced that Apotex’ product monograph would sufficiently influence prescribers, and without it, direct infringement would not occur.

With respect to the third prong, Apotex argued that there was no evidence that Apotex knew physicians would be influenced by its product monograph to prescribe the drug in a way that would infringe the 770 Patent. The FC found Apotex knew, or should have known, that it’s product monograph would induce infringement based on the facts relevant to the second prong of the Corlac test. Apotex argued that the FC conflated the second and third prongs of the test, improperly shifted the burden of proof to Apotex, failed to give sufficient weight to their expert witness, and erred in finding that there was no evidence from Apotex as to its knowledge of influence. Justice Locke found no merit to these arguments and found that the FC’s reason that the absence of “evidence before the Court about Apotex’s efforts to remove information from the PM” allowed the lower Court to draw the inference that Apotex knew or should have known that its product monograph would influence physician’s prescribing decisions.

The full decision can be read here.