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

A principal at Schwegman Lundberg & Woessner explains how AI tools, including DeepIP, can position the firm to help clients
The firm explains why AI-empowered data analytics could make it more efficient advocates for its clients
Penelope Aspinall, of IP wellbeing charity Jonathan’s Voice, explains why managers should take a three-tiered approach to looking after workers’ mental health
Heath Hoglund talks about the value proposition of patent pools and why it went ahead with its first-ever series of pool meetings in China
Ryan Richardson, Chris O’Brien, and Jean Selep of Sterne Kessler analyse the treatment of SEPs at the UPC and ITC and highlight why SEP holders and implementers should be mindful of current developments in both forums
A ruling concerning the UPC’s jurisdiction, questions over costs transparency, and a missed deadline by Amazon were among the top talking points this fortnight
Exclusive data and analysis reveal how firms can differentiate themselves when it comes to costs and value
The Berlin office will mark the firm’s fourth German base and tenth overall
As we build up to another busy year for the IP STARS rankings and Managing IP Awards, we give a rundown of some of the major IP firms and trends in the UK
Three firms have received at least 13 nominations, while a further three have 12 nominations each
Gift this article