End of ANVISA's prior consent

Posted on: 2/9/2021


On August 26, 2021, Law No. 14,195 was enacted with the purpose of modernizing and reducing bureaucracy in the business environment in Brazil. Among other measures, this law revokes Article 229-C of the Brazilian Industrial Property Law, which established that the granting of patents for pharmaceutical products and processes depended on the prior consent of the Brazilian National Health Surveillance Agency - ANVISA, wherein the Agency examines the object of the patent application in the light of public health.

The revocation ends a cycle of discussions and legal disputes. As known, until 2017 the patentability analysis was performed by ANVISA before the patent application was examined by the Brazilian Patent and Trademark Office (BPTO), which meant, in practice, a double analysis of merit. By means of Joint Ordinance No. 1/2017, signed by BPTO and ANVISA, it was decided that ANVISA would analyze patent applications in light of public health, with consent being denied when the pharmaceutical product or process resulted in a substance of prohibited use in Brazil. According to Article 5 of this Ordinance, ANVISA could issue an opinion concerning the patentability requirements for patent applications containing a pharmaceutical product or process considered of interest to pharmaceutical assistance policies within the scope of the Brazilian Public Health System (SUS). In this case, ANVISA’s opinion would correspond to subsidies for the technical examination performed by the BPTO.

Thus, after more than 20 years of controversies and impasse involving ANVISA's participation in the prosecution of patent applications, the mandatory prior consent comes to an end, thereby making the examination of patent applications in the pharmaceutical area fluid and even faster.

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