The Federal Court (FC) has found the brand name of a biologic drug to be confusingly similar to the brand name of a drug used to treat the same disorder, but with a different active ingredient. The application of the ordinary test for trademark confusion was not affected by the fact that the names of both products had been approved by Health Canada.

Background 

Novartis AG and Novartis Pharmaceuticals Canada Inc. (Novartis) own the trademark BEOVU  (TMA1072372), registered in association with pharmaceutical preparations used in ophthalmology and in relation to ocular disorders and diseases. BEOVU (brolucizumab) is marketed in Canada to treat neovascular age-related macular degeneration, also known as wet AMD.

Samsung Bioepis Co, Ltd. and Biogen Inc., the Respondents, collectively manufacture and commercialize a drug under the name BYOOVIZ, also used to treat wet AMD and other ophthalmic indications. BYOOVIZ (ranibizumab) was approved as a biosimilar equivalent to another Novartis drug used for treating wet AMD, LUCENTIS. At the time of this decision, Biogen Inc. had a pending trademark application for BYOOVIZ (application no. 2044395).

Overview

Novartis brought an action against the Respondents for infringement of the BEOVU trademark (sections 19 and 20 of the Trademarks Act (TMA)), for passing off (subsection 7(b) of the TMA), and for use of the BEOVU trademark in a manner which depreciates the goodwill attached to it (section 22 of the TMA).

The FC found the Respondents liable for infringement on the basis that BYOOVIZ was confusingly similar to theBEOVU registered mark (section 20), as well as passing off (subsection 7(b)). As the BEOVU and BYOOVIZ marks are not identical and the Respondents had not used the BEOVU mark, the FC determined that sections 19 and 22 were inapplicable.

Likelihood of confusion

The parties agreed that the outcome of the case turned on whether there was a likelihood of confusion between BEOVU and BYOOVIZ, but disagreed on the application of the test.

  • Test for confusion. The FC held that confusion arises if “the use of both trademarks in the same area would be likely to lead to the inference that the goods or services associated with the trademarks are manufactured, sold, leased, hired, or performed by the same person, whether or not the goods or services are of the same general class,” having regard to all of the surrounding circumstances.
  • The relevant consumer. The parties disagreed as to whether the patient (in addition to ophthalmologists and pharmacists) was a relevant consumer for the purposes of analysing the likelihood of confusion between the marks. The evidence was that patients had no direct access to either BEOVU or BYOOVIZ. However, patients would hear the brand name of the drug spoken to them, may have seen the brand name on the syringe prior to its administration, and in some cases, may have been given a choice between drugs in the class. The FC held that because a patient could grant or refuse consent to being injected with a drug that is identified by its trademark, it was a relevant consumer.
  • The relevant time for assessing confusion. The Court distinguished the likelihood of confusion at the time of a consumer’s first encounter from the likelihood of confusion by the time this consumer pays for their purchase. The FC reiterated that the test is one of first impression, and not the likelihood that a consumer may base their ultimate choices on that first impression. It is irrelevant whether or not a consumer’s initial confusion is later remedied. The Court also held that protocols used to prevent medication error were not relevant to the first-impression test for confusion.
  • The marks were confusingly similar. The FC found that Novartis had shown a likelihood of confusion for all three classes of consumers (patients, ophthalmologists, and pharmacists), and that the likelihood is higher when considered from a patient’s perspective. In finding that the trademarks were likely to be confused, the Court focused on sound as a driving factor.

Relief

The Court granted a permanent injunction against the Respondents using the BYOOVIZ trademark in association with specified categories of goods. The Court also ordered the Respondents to deliver up, destroy, or alter materials that would be contrary to the injunction, and to pay Novartis $20,000 in damages.

What about brand name review by Health Canada?

Health Canada has the regulatory authority to consider brand names and may reject a proposed name if it considers the name to be misleading or that it may result in safety concerns if confused with the name of another product authorized for use in Canada (see Guidance Document for Industry – Review of Drug Brand Names and the Guidance for Industry – Drug Name Review: Look-alike Sound-alike (LA/SA) Health Product Names).

The FC heard evidence that concerns had been raised about confusion by the European Medicines Agency and Health Canada. The FC also heard that “Health Canada and other regulatory agencies have concluded the name BYOOVIZ is acceptable, including in some cases after having considered the BYOOVIZ name relative to BEOVU.” However, the Court does not appear to have given weight to these assessments in its analysis of confusion.

The FC also acknowledged that, as a result of the injunction, it would be necessary for Health Canada to approve a new name following a process that could take a year. However, the FC noted that the Respondents had not sought or established the need for a stay of injunctive relief in light of these requirements.

Link to decision

Novartis AG v Biogen Inc, 2024 FC 52