Co-authored with Emily Johnston
On November 28, 2025, the Federal Court of Appeal (Per Woods JA and Laskin JA) (“FCA”) held that the Federal Court (per Pallotta J) (“FC”) did not err in (1) enjoining Samsung Bioepis (“Samsung”) and Biogen, et al (collectively “Biogen”), as well as their licensees, from using the trademark BYOOVIZ in association with their biosimilar ophthalmology drug; and (2) awarding Novartis AG and Novartis Pharmaceuticals Canada Inc. (collectively “Novartis”) $20,000 in nominal damages.
Samsung Bioepis v. Novartis, 2025 FCA 212
Background:
The parties are competitors in the pharmaceutical field, each manufacturing and/or marketing an anti-VEGF biologic drug used to treat age-related macular degeneration. Novartis sells its drug in Canada using the registered trademark BEOVU and Samsung and Biogen sold their biosimilar drug using the trademark BYOOVIZ. Novartis sued Samsung and Biogen for trademark infringement, passing off, and depreciation of goodwill in its trademark under the Trademarks Act (RSC 1985, c T-13) (“TMA”).
The FC concluded that Samsung and Biogen’s use of the BYOOVIZ trademark was likely to cause confusion in the marketplace and thus infringed Novartis’ rights in its registered trademark BEOVU and constituted passing off. Novartis had not made out a cause of action for depreciation of goodwill under section 22 of the TMA. The FC decision is discussed in more detail in our blog found here.
Issues on Appeal:
Samsung and Biogen appealed the FC finding of trademark infringement and passing off, and Novartis cross-appealed the grant of only nominal damages.
The FCA dismissed the appeal and cross appeal. Two main points arose from the appeal decision that could be of interest to trademark owners in the pharmaceutical industry.
- Patients are relevant “consumers”
The parties disagreed as to the relevant consumer for the purpose of analyzing the likelihood of confusion between the BYOOVIZ and BEOVU trademarks for use with anti-VEGF biologic drugs used to treat age-related macular degeneration.
Novartis argued that physicians, pharmacists, and patients were relevant consumers for the confusion analysis. Samsung and Biogen argued that trademark use in the context of specialized medicines administered by a physician does not reach the patient level. The FC rejected Samsung and Biogen’s argument, finding that, although the drugs are administered by physicians in a clinical setting, patients still have multiple choices when it comes to specialized medication, including being told the brand name of the drugs they receive, signing consent forms for the medication, refusing the medication if they so choose, and in some instances, selecting between different specialized ophthalmology drugs. Patients are sufficiently involved in the decision making of which specialized medications they receive to be considered a relevant consumer in the confusion analysis.
The FCA held that the FC did not make a palpable and overriding error in this regard. Prospective consumers are not required to encounter the trademark as used by the owner for the purpose of analyzing the likelihood of confusion between two trademarks. Such a requirement would go against the principles established in the landmark trademark cases Mattel v. 3894207 Canada, 2006 SCC 22 and Masterpiece v. Alavida Lifestyles, 2011 SCC 27, namely, that the test for confusion is hypothetical while taking into consideration the consumer’s surrounding circumstances.
Nor did the FC make palpable and overring errors when it came to other arguments as to why patients should not be considered consumers for the purpose of the confusion analysis. The FCA agreed that the principles from Ciba-Geigy Canada Ltd. v Apotex Inc. (1992 CanLII 33 (SCC)) support the view that patients are relevant consumers in this case.
- Remedies
Samsung and Biogen argued that the FC erred in law in granting an injunction because, at the time Novartis brought its application, Samsung and Biogen were not yet marketing and selling their biosimilar product. Since Novartis’ application had not been brought on a quia timet basis, Samsung and Biogen argued there was no reason to grant an injunction.
The FCA disagreed and found that the FC made no reviewable error in granting an injunction since, by the time of the hearing, Samsung and Biogen were actually promoting and selling BYOOVIZ as a drug in Canada. The FCA noted that all parties had confirmed that, by the time of the hearing, BYOOVIZ was “on the market” in Canada. The FC was correct to conclude from these statements that “on the market” not only implies promotion, but also sales of the product. Regardless, promotion alone without sales is also actionable under s. 20(1)(a) of the TMA.
The FCA held that the FC did not err in awarding only nominal damages because Novartis elected this remedy in its closing submissions at trial, and did not seek to vary the judgment after its issuance.
Conclusion: Samsung and Biogen have 60 days to seek leave to appeal to the Supreme Court of Canada.