Procedures And Strategies For Pharmaceutical Brands

Sweeping amendments to the Trademarks Act are expected to be implemented in 2019 which will bring Canada into line with international practices, allowing it to accede to the Madrid Protocol, the Nice Agreement and the Singapore Treaty. Canadian businesses will be better positioned to compete globally and it should also be easier for foreign companies to expand their operations into Canada. The legislative amendments will fundamentally affect the way in which all trademark owners will need to approach their selection, clearance and registration strategies, and the pharmaceutical industry is no exception.

Selection, clearance and registration

Drug name approval by Health Canada is distinct from the trademark registration process handled by the Canadian Intellectual Property Office (CIPO) and approval by one branch of government will not necessarily lead to approval by the other. Therefore, drug names must be selected and cleared having regard to both regulatory and trademark registration issues. While both processes deal with the potential for confusion between proposed brand names, the confusion analysis associated with each system differs. Health Canada assesses drug name confusion based on health and safety concerns, while CIPO examiners focus on the likelihood of confusion as to the source of origin of the trademarked products.

Drug names, confusion and regulatory approval

Under the Food and Drug Regulations, a drug's proposed brand name must be submitted to Health Canada for approval. Health Canada can refuse to issue a notice of compliance for new drugs or a drug identification number for new and existing drugs if confusion between a proposed drug name and an existing drug name is considered likely to result in health and safety issues.

Health Canada is not bound by drug name approvals in other jurisdictions and accordingly, a brand name approved and used internationally is not guaranteed to be allowed in the Canadian market.

The current Health Canada guidance document dealing with the drug name review process for lookalike, soundalike (LASA) drug names came into effect on June 13 2015. The guidance provides that a sponsor must first carry out an initial brand name review to determine whether the name is misleading with respect to the composition, effectiveness or safety, and then provide a LASA brand name assessment to determine the likelihood of confusion between the proposed name and authorised product names. The testing of LASA attributes involves a multi-step approach, including:

searching relevant drug name and medication error databases and identifying drug names with a combined orthographic and phonetic similarity score of 50% or more; assessing the confusability of a proposed name using simulations; and synthesising the evidence obtained from the database search results and the simulations. Non-prescription products and natural health products are excluded from the scope of the guidance.

Raw data to be submitted is limited to database search results (although Health Canada reserves the right to request additional material where necessary). Psycholinguistic tests are not required.

Drug names, confusion and trademark registration

Clearance searches for prior confusing marks will be fundamentally different once the new Canadian trademark legislation is implemented, although the analysis for assessing confusion will remain the same.

For a trademark to be registrable in Canada, it cannot cause a likelihood of confusion with a trademark previously used, applied for, registered or made known in Canada as to the origin of the goods or services with which the mark is associated. When assessing likelihood of confusion, several factors are examined, including the nature of the goods and services associated with the marks and...