Health Agency issues new resolution regarding medicine names
In Brazil, trademark registrations (including those which identify medicines) are granted by the Brazilian Patent and Trademark Office (INPI) after a thorough examination performed in accordance with the Brazilian Industrial Property Law.
However, owners of trademarks which identify medicines must also obtain registration of the medicine name with the Brazilian Health Agency (ANVISA). Therefore, both INPI and ANVISA play important roles in the examination of medicine trademarks/names. Although the procedures for obtaining a trademark registration before INPI and those for registering a medicine name before ANVISA are distinct and independent, the criteria adopted by both agencies should be harmonised so that trademark owners are able to obtain registrations for the same name with both agencies.
On October 10 2014 ANVISA issued Resolution No 59, which governs the names of medicines, their complements and the formation of family of medicines. This resolution, which came into effect on October 13, does not apply to generic and immunotherapy medicines, but applies to all other types of medicines registered with ANVISA. It should be noted that medicine names which were allowed by ANVISA before October 13 2014 will not be re-examined under the criteria set forth in the new resolution.
The resolution establishes the definition of a 'name complement' and of a 'family of medicines', and sets forth new criteria regarding the formation of medicine names and conflicts between such names.
With regard to families of medicines, it is important to mention that, according to Resolution No 59, companies must adopt supplementary measures through labelling in order to better differentiate the medicines (Article 6).
Amongst the criteria established in connection with the names of medicines, the following points are worth mentioning:
- ideally, such names should be composed of a single word, whose pronunciation in Portuguese should be directly related to its spelling; and
- such names must be sufficiently distinct from earlier registered medicine names.
Article 15 of the new resolution also sets forth the types of designations, denominations, words and expressions which are not accepted as part of the names of medicines and their complements. Further, the resolution establishes criteria for complements of medicine names, and provides that companies which adopt those complements must justify their interest in doing so from a technical perspective.
This update is a mere summary of some of the important issues addressed by ANVISA’s new resolution. Pharmaceutical companies are advised to follow the rules provided in the resolution in order to ensure that their medicine names will be registered by ANVISA. In this regard, the resolution itself states (in Article 18) that it is the company’s responsibility to assess whether their name of interest fulfils the requirements set forth by ANVISA.
Patrícia Lusoli, Guerra Propriedade Industrial, Rio de Janeiro
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