BRAZIL: ANVISA publishes Guidelines regarding the examination and prior consent of patent applications for pharmaceutical products and processes

ANVISA publishes Guidelines regarding the examination and prior consent of patent applications for pharmaceutical products and processes

The Brazilian Health Surveillance Agency (ANVISA, in its Portuguese acronym) published, on 19 November 2020, Guidelines regarding the examination and prior consent of patent applications for pharmaceutical products and processes.

As currently required by Article 229-C of Brazilian IP Law, ANVISA continues to issue prior consent over a Patent application for pharmaceutical products or processes, since ANVISA limits its analysis to the risk of the product or process to the public health.

The aim of this Guideline is to establish a standard and clear procedure regarding the actions performed by ANVISA. This Guideline covers the procedure and is divided in four sections, one for each of 4 (four) different stages:

1. Identification of patent applications for pharmaceutical products and processes which require prior consent;
2. Health risk analysis in patent applications for pharmaceutical products and processes under prior consent;
3. Identification and analysis of patent applications for pharmaceutical products and processes under prior consent that are subject to the offer of subsidies for the BRPTO (Brazilian Patent and Trademark Office) patentability examination; and
4. Examination of patentability requirements by BRPTO of patent applications for pharmaceutical products and processes with prior consent.