Brazil: FDA issues guidelines for examination and prior consent of patent applications

Managing IP is part of Legal Benchmarking Limited, 4 Bouverie Street, London, EC4Y 8AX

Copyright © Legal Benchmarking Limited and its affiliated companies 2025

Accessibility | Terms of Use | Privacy Policy | Modern Slavery Statement

Brazil: FDA issues guidelines for examination and prior consent of patent applications

Sponsored by

daniel-400px.png
christina-victoria-craft-whsnkiwwpec-unsplash.jpg

Rafael Salomão Romano and Samantha Salim of Daniel Law outline how the instructions will improve transparency and accountability in the Brazilian pharmaceutical patent scene

The Brazilian National Agency for Sanitary Surveillance (ANVISA – Brazilian FDA) has issued four guidelines related to examination and prior consent of pharmaceutical patent applications. The main purpose of these guidelines is to provide clear and objective guidance to the examiners of the agency in examining patent applications received from the Brazilian National Institute for Industrial Property (INPI – Brazilian PTO), in addition to providing greater transparency for patent owners and attorneys in relation to the steps and criteria used during examination.

In Brazil, all patent applications from the pharmaceutical field (including biotech cases) are sent to ANVISA to obtain prior consent, in addition to the ordinary prosecution held at INPI. Once the prior consent is given, INPI resumes its prosecution. ANVISA is responsible for analysing whether the subject matter of a patent application represents a threat to public health, through the protection of substances/products whose use is prohibited in Brazil.




However, whenever the claimed matter of an application may be of interest to the Brazilian universal healthcare system (SUS), prior consent is usually accompanied by a technical opinion on patentability, in addition to public health issues. ANVISA’s opinion is not binding and is considered by INPI as third-party observations. 



ANVISA’s guidelines specify therapeutic destinations that serve as the basis for the publication of prior consent with subsidies to the examination, as well as the understanding of this agency in relation to the patentability criteria, which differs from INPI in some relevant aspects, such as the protection of invention of selection, polymorphism, hybridoma and second medical use claims.



With the guidelines, it is expected that the agency’s actuation will be subject to more transparency and accountability. 





Rafael Salomão Romano

Partner, Daniel Law

E: rafael.salomao@daniel-ip.com



Samantha Salim

Patent specialist, Daniel Law

E: samantha.salim@daniel-ip.com

more from across site and SHARED ros bottom lb

More from across our site

The Getty Images v Stability AI case, which will hear untested points of law, is a reminder of the importance of the legal system and the excitement it can generate
Firms explain the IP concerns that can arise amid attempts by brands to show off their ‘Canadianness’ to consumers
Counsel say they will be monitoring issues such as the placement of house marks, and how Mondelēz demonstrates a likelihood of confusion in its dispute with Aldi
The EUIPO expanding its mediation services and a new Riyadh office for Simmons & Simmons were also among the top talking points this week
David Boundy explains why Pierson Ferdinand provides a platform that will allow him to use administrative law to address IP concerns
Developments included an anti-anti-suit injunction being granted for the first time, and the court clarifying that it can adjudicate over alleged infringements that occurred before June 2023
Griffith Hack’s Amanda Stark, one of our ‘Top 250 Women in IP’, explains how peer support from male colleagues is crucial, and reveals why the life sciences sector is thriving
The case, which could offer clarity on the training of AI models within the context of copyright law, will go to trial in the UK next week
CMS IndusLaw co-founder Suneeth Katarki says he plans to hire a patent team in India and argues that IP should play a major role within full-service firms
Partners at the firm explain why they’ve seen more SEP cases at the ITC, and why they are comfortable recommending the forum to clients
Gift this article