Many multinational drug makers are active in Brazil. However, they must often forgo their first choice for a brand and move forward with less desirable options because of the difficulties during the registration process. New rules on the approval of medicine names, together with easier access to Brazilian courts, can help with new strategies for pharmaceutical brands in the country.
When selecting and clearing a new name, drug makers must still choose a brand that can be registered as a trademark before the Brazilian Patent and Trademark Office (INPI) and be approved by the Brazilian Federal Drug Agency (ANVISA). However, the lack of communication between the agencies, which have independent registration processes, previously made it hard to predict if a name would be accepted and approved in both instances.
In December 2017, ANVISA rolled out a new resolution that specifically requires in the approval process a search on the INPI's database to confirm the availability of a trademark registration. Therefore, the full set of procedures to approve a drug name by ANVISA now involve searches on the agency's internal database, external medicine databases and the INPI database, to access the availability of the proposed name in terms of graphic and phonetic similarities with existing names, risk of error and the level of safety of the name in terms of prescriptions, dispensing, administration or use.
Despite the apparent progress in communication between the agencies, it is still unclear how the ANVISA examiners are being trained to decide on the approval of a new drug name in the face of a trademark registration. At the still early stages of the new guidelines it is useful to review the existing criteria established to approve a new drug name. These are:
Purpose of use of the medicine; How the medicine should be used; How the medicine works; What are the benefits of the medicine; The risks associated with the use of the medicine; What steps can be taken to ensure safe use of medicine; and The intrinsic characteristics of the medicine If the above standards are applied, ANVISA examiners will review the risk of confusion between similar drug names not based on their graphic and phonetic aspects only, but also on how they will be used in practice, including associated risks and benefits of the medicine.
In the case of pharmaceutical brands registered at the INPI with a broad specification of goods, will the ANVISA examiners be able to...