Brazilian pharmaceutical patents no longer subject to ANVISA’s prior approval

Back in March this year, the Brazilian Federal Government issued the Provisional Measure No. 1,040/2021. Their aim is to improve the business environment in Brazil and elevate the country’s position in the World Bank’s “Doing Business” ranking. President Bolsonaro has now sanctioned this measure and the corresponding Law No 14.195 entered into force on August 26th, 2021.

As discussed in an earlier blog post, one outcome of the measure has been to remove Article 40 of the Patent Statute. According to which the 20-year patent term, which begins when an application is filed, cannot be less than 10 years from the patent grant. The Brazilian Supreme Court ruled that the revocation will only be applied retroactively to pharmaceutical patents.

With the objective of providing legal measures to modernise and improve the Brazilian business environment, Law No. 14.195/21 also revokes Article 229-C of the Brazilian Patent Statute. According to which the grant of pharmaceutical patents required the National Health Surveillance Agency’s (ANVISA’s) prior approval. This has been subject to heated debates and lawsuits in the past few years. Now that this measure has passed, there should be more legal certainty to the prosecution of patent applications related to pharmaceutical products and processes. It also speeds up the Brazilian National Institute for Industrial Property’s (INPI’s) grant procedure. This should help to reduce INPI’s backlog for patent applications in the pharmaceutical industry.

Using PatBase Analytics V3 to examine the patent landscape in Brazil shows that patents related to pharmaceuticals take up a large percentage of overall patent applications in Brazil. This search covered all patent documents from Brazil, with the graph being focussed on the last 10 years for a more current picture. Removing the extra step in the INPI’s grant procedure for pharmaceutical patents should help them to maintain a faster time-to-grant period for all applications.

With access to full text Brazilian data and Minesoft’s powerful analytics platform included as standard with all PatBase subscriptions, it’s easy to interrogate this data further. For more information about PatBase, go to

Did you know that PatBase has the most extensive South American full text coverage in the industry?

*Data taken from WIPO INSPIRE