New Law in Brazil extinguishes the need for prior consent by Anvisa to grant pharmaceutical patents

On August 26, 2021, President Jair Bolsonaro passed Law No. 14,195/2021, repealing, with immediate effect, art. 229-C of the Industrial Property Law (“LPI”).

The repealed article required prior consent of the National Health Surveillance Agency (“Anvisa”) as a condition for the Brazilian Patent and Trademark Office (“BPTO”) to grant patents on pharmaceutical products and processes.

According to the rapporteur of Provisional Measure 1,040/21 (“MP”) in the House of Representatives, Congressman Marco Bertaiolli (PSD-SP), the repealing of the article presents the potential to save up to two years in the process of analyzing and granting new patents: “Anvisa is overloaded with applications for analysis that in most cases will have no commercial interest. They are ideas.  We removed this obligation and gave Anvisa room to worry about what has value,” says the rapporteur.

The analysis conducted by Anvisa assesses whether a formula contains or may result in a substance prohibited for use in Brazil, in addition to gauging the safety of the product or pharmaceutical process. With the legislative change, this analysis is no longer necessary for granting a patent, but is still required to obtain authorization to market the drug.

Within this context, the BPTO have been publishing notices communicating that the flow of patent applications between the Office and Anvisa has been terminated as of August 27, 2021, and that patent applications for pharmaceutical products and processes are already being returned by Anvisa for normal processing at the BPTO.

Demarest’s Intellectual Property and Innovation team is available to provide more information or clarification on this matter.