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On November 28, 2025, the Federal Court of Appeal (FCA) upheld an injunction against the use of the trademark BYOOVIZ for an ophthalmic biosimilar, confirming the application judge's finding that the mark is likely to be confusing with Novartis' registered trademark BEOVU: Samsung Bioepis v Novartis, 2025 FCA 212, affirming the Federal Court's decision (see our previous article).
Background and Federal Court decision
Novartis owns a registration for the trademark BEOVU (No. TMA1072372), which it uses in association with an anti-vascular endothelial growth factor (anti-VEGF) biologic drug approved in Canada for treating neovascular age-related macular degeneration (commonly referred to as "wet AMD"). The active pharmaceutical ingredient in BEOVU is brolucizumab.
Samsung Bioepis and Biogen marketed an anti-VEGF drug for treating wet AMD under the brand name BYOOVIZ, a biosimilar of Novartis' LUCENTIS (ranibizumab).
Novartis commenced an application in the Federal Court alleging infringement, passing off and depreciation of goodwill.
The application judge concluded that Samsung Bioepis and Biogen's use of the BYOOVIZ trademark infringed Novartis' rights in its registered BEOVU trademark, contrary to paragraph 20 of the Trademarks Act, and that the companies were also liable for passing off under paragraph 7(b) of the Trademarks Act.
The application judge granted Novartis a permanent injunction. Samsung Bioepis and Biogen appealed, and the FCA stayed the injunction pending the determination of the appeal.
The FCA affirmed the application judge's decision finding infringement and passing off
In dismissing the primary ground of appeal, the FCA affirmed the application judge's finding that patients were relevant consumers in the likelihood of confusion analysis. It rejected the argument that the lower court should have only considered prescribing physicians and dispensing pharmacists. The appellants sought to rely on evidence showing that patients were not confronted with the BYOOVIZ mark and argued that patients were not relevant consumers because they did not encounter the mark "as used by the trademark owner".
The FCA rejected this submission for being incompatible with the hypothetical nature of the test for likelihood of trademark confusion and the Supreme Court of Canada's corresponding commentary in Mattel v 3894207 Canada Inc and Masterpiece v Alavida Lifestyles. Contrary to the caselaw predating these decisions relied on by the appellants, the FCA held that "in applying s. 6(2) [of the Trademarks Act] prospective consumers are not actually required to encounter the trademark as used by the owner." In other words, consideration of whether there is a likelihood of confusion may take into account hypothetical consumers who have not been exposed to the owner's actual use of a trademark.
The FCA also considered the Supreme Court's long-standing decision in Ciba‑Geigy Canada v Apotex, recognizing patients as relevant consumers of prescription tablets for purposes of assessing passing off. It specifically endorsed the application judge's reliance on the policy considerations articulated in Ciba‑Geigy for why patients too should have the protection of the Trademarks Act.
Outcome
The FCA dismissed the Appellants' appeal but granted a further stay of the injunction pending a possible leave application to the Supreme Court of Canada.
Prior to the issuance of the FCA decision, on November 7, Samsung Bioepis received marketing approval for a name change for its ranibizumab biosimilar, now named MELVIZO.
Should you have any questions, please do not hesitate to contact a member of the Pharmaceutical Litigation Group.
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