THE END OF ANVISA´S EXAMINATION OF PATENT APPLICATIONS IN BRAZIL

In Brazil, all patent applications from the pharmaceutical and biotech areas were sent to the prior analysis/approval by the National Sanitary Surveillance Agency (ANVISA) instead of being exclusively prosecuted at the Brazilian Patent and Trademark Office – BPTO. Once the prior approval from ANVISA was published, the BPTO could proceed with the technical examination.

Until 1996, Brazil granted no patents for pharmaceutical inventions. In 1996, based on still in force Industrial Property Act (Federal Law 9,279/1996), pharmaceutical patents started to be accepted, but in February 2001 Federal Law 10,196/2001 formalized the intervention by ANVISA as a precondition for such patents granting, thus creating a burdensome procedure for such patent applications. Since then, several attempts to simplify such procedure and creating a more harmonic environment have been witnessed, with dozens of resolutions, manuals, adjustments and learning phases from both ANVISA and BPTO.

ANVISA – the equivalent authority in Brazil of the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), was responsible for analyzing whether the subject of a patent application represent a health risk, through the protection of substances/products whose use is prohibited in Brazil.

In cases where the pharmaceutical product and/or process contained in the patent application were of interest to the Brazilian Public Healthcare System (SUS), the prior approval decision was also usually published by ANVISA accompanied by a technical opinion on patentability and other legal requirements. In such cases, ANVISA’s opinion was not binding and was considered by the BPTO as third-party observations.

Federal Law 14,195/2021, published on August 26^th, 2021, has put an end to this requirement of prior approval by ANVISA, measure received with great enthusiasm for the well awaited system simplification. On this direction, the BPTO had already published a communication stating the following:

• The flow of patent applications between the BPTO and ANVISA has been extinct since August 27, 2021;
• Patent Applications returned by ANVISA will have normal procedure at the BPTO after a specific publication in the Official Gazette;
• Requests concluded by ANVISA and sent to BPTO before the revocation of such compulsory prior approval have already been published in Official Gazette (section of RPI) nº 2763;
• The BPTO already received 1,284 applications that were on August 30^th, 2021 being analyzed by ANVISA;
• There are only 19 applications pending to be sent from ANVISA to the BPTO.