The Federal Court of Appeal (FCA) has affirmed a Federal Court (FC) decision finding that the brand name of a biosimilar drug (BYOOVIZ) was confusingly similar with the brand name of a biologic drug (BEOVU), even though the two drugs have different active ingredients (APIs). As a result, the FCA upheld the FC’s finding that use of the BYOOVIZ mark infringed the registered BEOVU trademark.

Background

Novartis AG and Novartis Pharmaceuticals Canada Inc. (Novartis) own Canadian trademark registration TMA1072372 for BEOVU, in association with pharmaceutical preparations for use in ophthalmology, and for prevention and treatment of ocular disorders and diseases. Novartis uses BEOVU as the brand name of a biologic drug product that is sold in Canada to treat neovascular age-related macular degeneration (wet AMD). The API in the BEOVU product is brolucizumab.

Together, Samsung Bioepis Co., Ltd. and several Biogen companies (the Appellants) are approved to manufacture and market in Canada a drug product with the brand name BYOOVIZ. This drug product is also used to treat wet AMD, although it has a different API (ranibizumab). The BYOOVIZ product is a biosimilar version of LUCENTIS, another Novartis drug product.

The FC found trademark infringement and passing off

Novartis brought a proceeding before the FC, alleging that BYOOVIZ was confusing with BEOVU and thus violated its registered BEOVU trademark. The FC agreed and, on January 12, 2024, found trademark infringement and passing off under the Trademarks Act (TM Act) (our report here). The FC’s key finding was that the Appellants’ use of BYOOVIZ would likely lead to the inference, by the relevant consumer, that the goods associated with it and those associated with the registered BEOVU trademark are manufactured and sold by the same person.

The FC ordered a permanent injunction against the Appellants using BYOOVIZ in association with their drug product and $20,000 in damages to Novartis.

The FCA upheld the FC’s analysis on trademark confusion

The Appellants appealed to the FCA. On February 1, 2024, the FCA stayed the FC’s decision pending the appeal. The appeal focused on the FC’s finding that the trademarks were confusing under the statutory test in the TM Act. 

Relevant consumer: The Appellants argued that the FC erred in determining that patients were relevant consumers in the confusion analysis. According to the Appellants, pharmacists and ophthalmologists were relevant consumers, whereas patients were not because patients do not encounter the BYOOVIZ trademark as used by the Appellants (e.g., printed on the drug’s packaging). The FCA rejected the Appellants’ argument, finding that the test for confusion is hypothetical and considers a mythical casual consumer.  Accordingly, in applying the test, the hypothetical consumer is not actually required to encounter the trademark as used by the owner. The test assumes the relevant consumer is aware of both marks.  

The FCA also rejected the Appellants’ related argument that patients were not relevant consumers because they did not choose which drug they were treated with. Rather, the FCA found no error in the FC’s conclusion that patients did have a choice. Among other considerations, patients are told the brand name of the drug that will be administered, they sign a consent form, the brand name is on the syringe used for the injection, and they can refuse administration of the drug.  In addition, patients are the end-user of the drug and trademarks serve a public interest in assuring consumers of the source and quality they associate with a particular mark.

Section 6(5) factors: The Appellants further argued that the FC erred in its analysis of the factors in subsection 6(5) of the TM Act.  These factors inform the overall confusion analysis. The FCA rejected the Appellants’ arguments as asking the FCA to reweigh the evidence. Of note, the FCA found that the FC did not err in concluding that the sound of the two trademarks (BYOOVIZ and BEOVU) was a particularly important factor given the role of oral communication between health care professionals and with patients.

The FCA dismissed the appeal with costs. The Appellants can apply for leave to appeal to the Supreme Court of Canada. On December 18, 2025, the FCA ordered that the FC’s decision will remain stayed pending the Supreme Court’s decision on any leave application or, if leave is granted, any appeal.

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