Markwell Clarizio LLP

Inducing Infringement with a Skinny Label: FCA Weighs-In

The Federal Court of Appeal (Locke JA writing for the Court) held that Apotex will induce infringement of patent claims to a combination of two active ingredients to treat a condition even though Apotex is seeking approval to market only one of the active ingredients as a monotherapy for the same condition.
Janssen is the owner of Canadian Patent 2,659,770 (770 Patent) that has claims to the use of a combination of macitentan and a phosphodiesterase type-5 inhibitor (PDE5 inhibitor) to treat pulmonary arterial hypertension (PAH). Apotex filed a submission to market APO-Macitentan as a monotherapy to treat PAH and served Janssen with a Notice of Allegation alleging that none of the claims of the 770 Patent will be infringed. Janssen brought an action for a declaration of infringement and an injunction prohibiting Apotex from marketing APO-Macitentan until expiry of the 770 Patent.

After a 10-day trial, the trial judge agreed with Janssen and held that Apotex will induce infringement (Janssen v Apotex 2022 FC 996). Apotex appealed, arguing that it could not induce infringement because its product monograph (PM) for APO-Macitentan will refer only to monotherapy treatment even though Apotex conceded that physicians will prescribe APO-Macitentan for use in combination with a PDE5 inhibitor.

The Federal Court of Appeal (FCA) began its analysis by confirming that the PM is in fact relevant to the question of the possible influence that Apotex will have on prescribing physicians’ decisions, and the issue in this case was whether Apotex’s PM provided sufficient influence. The FCA then noted that the trial judge had made certain findings relating to the issue of influence, including two of some significance: 1) prescribing physicians were aware of the the landmark clinical study known as SERAPHIN which showed that both monotherapy and combination therapy were safe and effective to treat PAH, and 2) a significant portion of the information in Apotex’s PM is clinical trial data from the SERAPHIN study but there is nothing in the PM suggesting that physicians should depart from the standard of care, namely, combination treatment.

Based on these findings, the FCA concluded that the trial judge did not err in holding that “the PM would influence physicians to prescribe combination treatment, even though it does not explicitly mention such treatment” and “the influence of the PM was sufficient that, without it, direct infringement would not occur.” The FCA also found that Apotex had the requisite knowledge that it was influencing physicians to prescribe APO-Macitentan for use in combination therapy because Apotex was aware of the content of its PM and knew that APO-Macitentan would be available to physicians treating PAH.