Brazil’s ANVISA will stop examining pharmaceutical patent applications

September 2021

Twenty-two years after the approval of the Brazilian Patent Law (Law 9.279/96), the obligation (article 229-C) for all pharmaceutical patents to be subject to prior approval by ANVISA (National Health Surveillance Agency, equivalent to the FDA in the USA -Food and Drug Administration) so that the Brazilian Patent Office (the INPI) could subsequently carry out its own examination, will no longer be required.

As a consequence of the approval, on 26 August 2021, of Law 14.195, it will no longer be necessary for ANVISA to be involved prior to the examination of a patent by the INPI. The main objective of this is to reduce bureaucracy in the examination of a patent application, with the INPI alone being responsible for deciding on the inventive step and novelty of an application.

From 1945 to 1996 (the year in which the Brazilian Patent Law was passed) the country did not grant any patents for pharmaceutical inventions. In 1996, the current Patent Law was passed, which allowed the granting of pharmaceutical patents, but not without the prior approval of ANVISA before examination by INPI.

As of ANVISA´s creation in 1999 several disputes reached the Brazilian Courts due to the dubious legal competence that ANVISA should have to carry out this “patentability examination” in addition to the one that corresponds in any case to the Patent Office.

This dispute was somehow settled in 2017, when both agencies (ANVISA and INPI) decided to publish a joint regulation agreeing that the former would carry out a limited analysis relating only to public health issues.

With the enactment of Law 14.195 / 2021, this conflict has come to an end. The new regulation establishes the end of ANVISA’s prior consent as a result of the Provisional Measure 1040/2021 that specifically proposed the revocation of the aforementioned precept 229-C, based on the arduous bureaucracy imposed on the process of examining patents for pharmaceutical products and processes in the Latin American country.

Therefore, it seems that this new Law will come hand in hand with significant changes in the processing of patent applications in Brazil since, from now on, prior review by ANSIVA will not be necessary, so that the substantive investigation steps will be reduced, as well as the average time to obtain a final decision on the patentability of the invention in question.

Eduardo Zamora | Sara del Río

Image: Cristina Craft on Unsplash