Newsletter 2014.08 – New Brazilian regulations concerning pharmaceutical trademarks: RDC 59/2014

The Brazilian pharmaceutical regulatory agency ANVISA – National Sanitary Vigilance Agency recently approved new rules for the use of trademarks in pharmaceutical products, through RDC – Resolution of the Board of Directors No. 59, of Oct. 10, 2014.

 

Such new regulations are very important, inasmuch as all pharmaceutical products in Brazil must be registered with ANVISA for their sale to be allowed. ANVISA not only assesses the efficacy of the product and other health-related technical matters, but it also sets forth how the labeling should be done and it approves the use of trademarks in the package.

 

As in Brazil there is no linkage between the regulatory registration by ANVISA and the issuance of patents or trademark registrations by the Brazilian Patent & Trademark Office (BPTO), the rules approved by ANVISA are, in practice, the only rules that govern the approval for commercialization and labeling of pharmaceutical products. If there is a conflict between a decision by ANVISA and one by the BPTO (e.g. concerning the risk of confusion between two trademarks belonging to two competitors) it is usually up to the Courts to solve such conflict.