New rules regarding ANVISA’s prior consent

Posted on: 12/4/2017

New rules regarding ANVISA’s prior consent

The president of the Brazilian PTO and the Director-President of National Agency for Sanitary Surveillance - ANVISA signed on April 12, 2017, a joint Ordinance formalizing the new rules regarding ANVISA’s examination of patent applications related to pharmaceutical products/processes. 


According to the Ordinance, ANVISA will examine patent applications related to the pharmaceutical area, focusing on public health issues and will only deny the prior consent for the applications considered against the public health, that is, those containing pharmaceutical product or process related to a substance that has been prohibited in Brazil (or representing a risk to human health). The application having the prior consent denied by ANVISA on such grounds will be forwarded to the Brazilian PTO for the publication of the denial of the prior consent and the filing away of the application.


However, with regard to applications directed to pharmaceutical products or processes that are listed as relevant for the public health system, ANVISA shall be able to issue a technical opinion on the patentability requirements, that is, on the aspects related to novelty and inventive activity, as subsidies, support, to the technical examination, which will be analyzed by the Brazilian PTO during the technical examination of the application. 

The provisions of the Ordinance shall apply to the pending applications and those that had their administrative proceedings before ANVISA concluded.

This Ordinance solves a 16-year issue related to the scope of ANVISA’s examination and should help in reducing the backlog of examination of patent applications in the pharmaceutical area.

This joint Ordinance will come into force as of June 11, 2017.

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