Federal Court of Appeal Upholds Trademark Injunction Against Samsung Bioepis' BYOOVIZ Biosimilar
核心洞察
The Federal Court of Appeal confirmed that Samsung Bioepis (搜索) and Biogen's BYOOVIZ trademark for their ranibizumab biosimilar infringes Novartis' BEOVU trademark rights.
The court rejected arguments that only physicians and pharmacists should be considered in trademark confusion analysis, affirming that patients are relevant consumers.
Samsung Bioepis (搜索) has since received approval to rename its ranibizumab biosimilar to MELVIZO (搜索), while the injunction remains stayed pending a potential Supreme Court appeal.
The Federal Court of Appeal of Canada has upheld a permanent injunction against Samsung Bioepis (搜索) and Biogen's use of the BYOOVIZ trademark for their ranibizumab biosimilar, confirming that the mark creates likelihood of confusion with Novartis' registered BEOVU trademark. The November 28, 2025 decision affirms the lower court's finding of trademark infringement and passing off in the competitive wet age-related macular degeneration (AMD) treatment market.
Trademark Dispute Over Anti-VEGF Therapies
The legal battle centers on two anti-VEGF (搜索) drugs used to treat neovascular age-related macular degeneration (搜索). Novartis owns the registered trademark BEOVU for its brolucizumab-based therapy, while Samsung Bioepis (搜索) and Biogen marketed their ranibizumab biosimilar under the BYOOVIZ brand name. BYOOVIZ serves as a biosimilar to Novartis' LUCENTIS (ranibizumab), creating a complex competitive landscape in ophthalmology treatments.
The Federal Court initially found that Samsung Bioepis (搜索) and Biogen's use of BYOOVIZ infringed Novartis' trademark rights under paragraph 20 of the Trademarks Act and constituted passing off under paragraph 7(b). The application judge granted Novartis a permanent injunction, prompting Samsung Bioepis and Biogen to appeal while securing a stay of the injunction pending the appeal's determination.
Court Affirms Patient-Centered Analysis
In a significant ruling for pharmaceutical trademark law, the Federal Court of Appeal rejected Samsung Bioepis (搜索) and Biogen's argument that only prescribing physicians and dispensing pharmacists should be considered in the likelihood of confusion analysis. The appellants contended that patients were not relevant consumers because they did not encounter the BYOOVIZ mark "as used by the trademark owner."
The FCA dismissed this submission as "incompatible with the hypothetical nature of the test for likelihood of trademark confusion." The court referenced Supreme Court of Canada decisions in Mattel v 3894207 Canada Inc and Masterpiece v Alavida Lifestyles, stating 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."
The court also endorsed the Supreme Court's precedent in Ciba-Geigy Canada v Apotex, which recognized patients as relevant consumers of prescription medications for trademark protection purposes. The FCA specifically supported the application judge's reliance on policy considerations from Ciba-Geigy regarding why patients deserve protection under the Trademarks Act.
Resolution and Market Impact
The Federal Court of Appeal dismissed the appellants' appeal but granted a further stay of the injunction pending a possible leave application to the Supreme Court of Canada. This decision maintains the legal uncertainty surrounding BYOOVIZ's market presence while providing Novartis with continued trademark protection.
Prior to the FCA decision, Samsung Bioepis (搜索) received marketing approval on November 7 for a name change for its ranibizumab biosimilar, now branded as MELVIZO (搜索). This rebranding represents a strategic response to the ongoing trademark dispute and may resolve the confusion concerns that formed the basis of Novartis' successful legal challenge.
The case establishes important precedent for pharmaceutical trademark disputes, particularly regarding the scope of relevant consumers in likelihood of confusion analyses. The court's patient-inclusive approach reflects recognition of the broader healthcare ecosystem's complexity and the need to protect all stakeholders in pharmaceutical markets.