February 15 2021 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.