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

Managing IP is part of Legal Benchmarking Limited, 1-2 Paris Gardens, London, SE1 8ND

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

Ed White at Clarivate provides an exclusive insight into the innovation power clusters reshaping Europe and the Middle East’s IP landscape, and why quality is the new currency of invention
In the first in a new podcast series celebrating the tenth anniversary of IP Inclusive, we look back at the network’s origins and discuss its mission
Rebecca Schwarz at Haynes Boone shares how her team secured victory for biopharma client RedHill in a licensing dispute involving a developmental cancer drug
News of a breakaway firm launching in Germany and a spike in vaccine-related patent applications were also among the top talking points
A flurry of hiring activity among UK firms suggests they are confident of mounting a serious challenge at the UPC
With the submission deadline approaching, we sat down with our research team to provide top tips on how to make your firm stand out
EA, owner of video games including Madden and The Sims, will be sold to a consortium including Saudi Arabia’s Public Investment Fund and a firm owned by Donald Trump’s son-in-law
New arrival marks Mewburn Ellis' second partner hire in ten days as firm looks to boost patent litigation and prosecution capabilities
In-house counsel and teams are invited to submit information for the 21st annual Managing IP Awards
The 2025 list of Rising Stars and Corporate Stars, produced by Managing IP’s accreditation title IP STARS, is now available
Gift this article