The Federal Court of Appeal (FCA) recently upheld an injunction against the use of the trademark BYOOVIZ for a biosimilar ophthalmic drug, reinforcing the legal principle that similar marks can create confusion in the marketplace. The decision, Samsung Bioepis v Novart, 2025 FCA 212, marks a critical moment in trademark law, underscoring the importance of monitoring and preventing consumer confusion.
The Dispute: BEOVU vs. BYOOVZ
Novartis holds the registered trademark BEOVU for its anti-VEGF drug, used to treat wet age-related macular degeneration (AMD). The active ingredient in BEOVU is brolucizumab. Samsung Bioepis and Biogen launched a biosimilar under the brand name BYOOVIZ, a product designed to mimic Novart, a drug used for the same condition.
Novartis filed a lawsuit alleging trademark infringement, passing off, and damage to its goodwill. The trial court found that the BYOOVIZ mark was likely to confuse patients and healthcare professionals, violating Canada’s Trademarks Act. A permanent injunction was issued to block the use of BYOOVIZ.
Samsung Bioepis and Biogen appealed, arguing the injunction should be stayed pending review. The FCA rejected this, affirming the trial court’s ruling.
Key Legal Rulings: Patients as Consumers
A central issue in the appeal centered on whether patients, not just physicians or pharmacists, should be considered relevant consumers for assessing trademark confusion.
The FCA ruled that patients must be included in the analysis. The court emphasized that the test for likelihood of confusion is hypothetical, not dependent on actual exposure to the trademark. This aligns with recent Supreme Court decisions, including Mattel v 3894207 Canada Inc and Masterpiece v Alavida Lifestyles, which stress that trademark law protects consumers’ ability to make informed choices.
The court also cited Ciba-Geigy Canada v Apotex, a landmark case recognizing patients as stakeholders in prescription drug trademarks. The FCA endorsed the trial court’s reliance on this precedent, highlighting the broader policy goal of preventing consumer deception.
Implications for Businesses
The ruling reinforces that trademark similarity alone can trigger legal action, regardless of actual market overlap. Companies must proactively monitor for potential conflicts, especially in sectors where patient safety and treatment clarity are paramount.
For pharmaceutical firms, the decision underscores the need to balance innovation with respect for existing trademarks. Biosimilar manufacturers, in particular, face heightened scrutiny due to the critical nature of their products.
The case also signals a shift in judicial focus toward protecting consumer trust. Courts are increasingly prioritizing the role of end-users in trademark disputes, ensuring brands are held accountable for potential confusion.
Outcome and Next Steps
The FCA dismissed the appeal but granted a stay of the injunction, pending a potential Supreme Court review. Prior to the ruling, Samsung Bioepis had already rebranded its product as MELVIZO, signaling a strategic move to avoid further legal entanglements.
This case serves as a reminder for businesses navigating trademark law. Confusability is not just a legal risk - it’s a reputational and operational one. Monitoring, early intervention, and strategic naming are essential to avoid costly disputes and protect brand integrity.
IP Defender monitors national trademark databases for conflicts and infringements, helping businesses stay ahead of potential threats. By tracking 50+ countries, including the EU, USA, and Australia, IP Defender ensures comprehensive protection against rogue or confusable registrations.
The importance of proactive trademark monitoring cannot be overstated. With IP Defender’s expertise in identifying and mitigating risks, companies can safeguard their intellectual property and avoid the pitfalls of legal disputes.