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 confirm the purpose of the medicine and its other characteristics?
If approval by ANVISA is rejected based on the non-availability of the drug name as a trademark, can drug makers take other steps at the INPI to ensure a successful registration process? Would further information on the purpose and characteristics of the medicine, which may have been registered at the INPI with a broad specification of goods, be sufficient to overcome a denial by the ANVISA? Can the approval process at the ANVISA be put on hold until a trademark registration is secured at the INPI?
These are all new questions that will have to be addressed with the new link between the drug name approval and trademark registration processes. As with any new set of guideless, one can expect that some decisions will be contradictory and so challengeable at Brazilian courts.
It is noteworthy that the judicial review of administrative decisions by either the ANVISA or the INPI is widely available in Brazil. This means that drug makers can consider adding litigation to secure those first-choice names to be marketed in Brazil.
While there is a common sense that litigating against government entities (like ANVISA and INPI) is costly and time consuming, a study covering almost 1,000 decisions issued by the Federal Court of Rio de Janeiro on trademark cases shows a surprising success rate. Moreover, recent modifications to the court’s structure and the civil procedure rules have made the timeframe of these lawsuits much quicker than administrative appeals at the INPI. And the costs associated with this kind of litigation are substantially lower than in comparison to other countries.
Due to the concentration of lawsuits against the INPI at the Federal Court of Rio de Janeiro there are now five district judges and two groups of appellate judges assigned to review these cases, which led to an upgrade of the technical qualification of these courts and consequently led to better grounded decisions.
Based on all decisions rendered by these specialised judges between 2015 and 2016, the overall chances of overturning the rejection of a trademark application are 50.8% at trial level. The chances of securing this registration at appellate level are even better: 67.4%. The overall likelihood of cancelling a trademark registration granted by the INPI is 45.8% at trial level and 36.6% if the cases go to appellate level.
This unofficial data was collected independently by review of the existing cases and decisions.
A deeper analysis of the case law shows that the Federal courts have an accommodating understanding about the coexistence of similar trademarks and are less stringent on the analysis of distinctiveness than the INPI. This is one of the reasons why there are slightly better chances of overturning a rejection of a trademark application than to cancel trademark registrations.
Perhaps a drug name will have already reached trademark registration, but it may not be approved by ANVISA. Or vice versa. Is it worth challenging one of the administrative decisions to secure a first-choice drug name? It is certainly an option.