Pharma company Apotex loses patent infringement case at the Federal Court of Appeal

Apotex wanted to market and sell a generic version of Janssen's product Opsummit

Pharma company Apotex loses patent infringement case at the Federal Court of Appeal

The Federal Court of Appeal has dismissed Apotex's appeal concerning a patent infringement claim commenced by Janssen.

The dispute in Apotex Inc. v. Janssen Inc., 2023 FCA 220, started when Apotex sought marketing approval for its Apo-Macitentan product as a generic version of Janssen's previously approved macitentan product called Opsummit. Janssen initiated a lawsuit, alleging that Apotex's marketing and sale of Apo-Macitentan would infringe Janssen's patent by inducing physicians to prescribe the drug to patients to be taken in combination with a phosphodiesterase type-5 (PDE5) inhibitor to treat a rare disease called pulmonary arterial hypertension (PAH).  

The Federal Court agreed with Janssen and prohibited Apotex from various activities involving Apo-Macitentan until Janssen’s patent expiry. Apotex raised the matter to the Federal Court of Appeal.

Janssen's patent is concerned with treating vasoconstrictive diseases, such as PAH, by combining macitentan and a PDE5 inhibitor, while Apotex would sell macitentan alone. The court noted that the test for inducing patent infringement includes the requirement that the acts of the alleged inducer influence the acts of direct infringement to the point that, without the influence, direct infringement would not take place.

Apotex argued that its Apo-Macitentan product would be marketed for non-infringing monotherapy, not the patented combination treatment. The distinction Apotex relied on was that Apo-Macitentan was to be used alone rather than in combination with a PDE5 inhibitor, as contemplated in the product monograph (PM) for Janssen's Opsumit.

The appeal court ultimately found that the Federal Court made no error of law regarding the test for inducing infringement. The court found that the Federal Court was convinced that the PM would influence physicians to prescribe combination treatment, even though it does not explicitly mention such treatment.

Moreover, since the Federal Court understood the legal test, the appeal court was convinced that the influence of the PM was sufficient, and that direct infringement would not occur without it.

The appeal court also noted that the test for inducing patent infringement requires that the inducer know that their influence will result in the completion of the acts of infringement. Apotex relied on an absence of evidence that it knew that the Apo-Macitentan PM would influence physicians to prescribe the drug in a way that infringes the patent.

However, the Federal Court found that Apotex knew or should have known that its PM would influence physicians' prescribing decisions. The appeal court ruled that the Federal Court was entitled to draw inferences about Apotex's knowledge from the evidence before it.

The appeal court found that Apotex was aware of the content of the Apo-Macitentan PM and the fact that it would be available to physicians treating PAH. Based on the evidence, the court pointed out that it was open to the Federal Court to conclude that Apotex knew or should have known that the Apo-Macitentan PM would influence physicians' prescribing decisions. Accordingly, the court dismissed Apotex's appeal.

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