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

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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

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