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

Jinwon Chun discusses the need for vigilance, his love for iced coffee, and preparing for INTA
Karl Barnfather’s new patent practice will focus on protecting and enforcing tech innovations in the electronics, AI, and software industries
Partner Ranjini Acharya explains how her Federal Circuit debut resulted in her convincing the court to rule that machine learning technology was not patent-eligible
Paul Hastings and Smart & Biggar also won multiple awards, while Baker McKenzie picked up a significant prize
Burford Capital study finds that in-house lawyers have become more likely to monetise patents, but that their IP portfolios are still underutilised
Robert Reading and Faidon Zisis at Clarivate unpick some of the data surrounding music-related trademarks
China's latest IP litigation statistics and a high-profile hire by O'Melveny were also among the top talking points this week
David Aylen, who spent more than 20 years at Gowling WLG, has joined United Trademark and Patent Services as of counsel in the UAE
Europe is among the most lucrative legal markets for PE firms to bet on, but clients’ reactions will decide whether external investment drives success
Rulings of note covered pre-June 2023 infringements and jurisdiction over non-UPC states, while winners of Managing IP’s EMEA Awards acted in multiple cases
Gift this article