After years of an impasse between the Brazilian Patent and Trademark Office – BPTO and the Brazilian Health Regulatory Agency – ANVISA, both entities have recently reached an understanding regarding the procedures to be followed by each one in the analysis of pharmaceutical patent applications.

Said impasse began when a statutory provision allowed Anvisa to get involved with the processes for the granting of pharmaceutical patents, the so-called “prior consent” after the patent examination by the BPTO. The justification for the “prior consent” was that the analyses done by Anvisa would be more thorough and more critical than the one made by the BPTO.

However, the inclusion of a second federal entity (Anvisa) for the analysis of pharmaceutical patents has greatly delayed the examination of patent applications.

The situation got worse when in 2009 the Office of the General Counsel for the Federal Government – AGU published an opinion limiting the acting powers of Anvisa. Such Opinion determined that Anvisa was to be limited to the evaluation of the safety and efficacy of medicinal products claimed in a patent application.

In 2012, the flow of examination was reversed in the sense that all processes in the pharmaceutical area would be first analyzed by Anvisa, and then analyzed by the BPTO. This measure, despite being put into practice, did not generate effective results in the granting of patents (i.e. the queue of processes waiting for a solution only increased).

The impasse came to an end when on March 14, 2017 the BPTO and Anvisa reported that a Joint Decree is soon to be published, defining the attributions of each Organ in the evaluation of pharmaceutical patent applications. In short, the analysis of data related to health will be tasked to Anvisa and the evaluation of data pertaining to patentability (novelty, inventive step and industrial application), to the BPTO.

It can be said that the examination done by Anvisa will support the technical examination of the BPTO, i.e. once Anvisa has issued a technical opinion, the case will be forwarded to the BPTO, which may accept or reject Anvisa’s evaluation. Besides, the BPTO’s position shall prevail in case it goes against Anvisa. Every decision, however, will need to be justified.

Source: Bhering Advogados