The Brazilian National Agency for Sanitary Surveillance (ANVISA) has published four manuals related to examination and prior consent with respect to pharmaceutical patent applications. The main purpose of these manuals is to provide clear and objective guidance in examining patent applications received from the Brazilian National Institute for Industrial Property (INPI).
In Brazil, all patent applications in the pharmaceutical field (including biotech cases) are sent to ANVISA to obtain prior consent. Once the prior consent is given by ANVISA, INPI resumes its prosecution. ANVISA is responsible for analyzing whether the subject matter of a patent application represents a threat to public health. 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 on patentability is not binding and is considered by INPI as a third-party observation. ANVISA’s manuals address the basis for prior consent. They also specify ANVISA’s understanding of patentability criteria, which differs from that of INPI in some significant respects. Thanks to SAMANTHA SALIM (Daniel Law) and RAFAEL SALOMAO (Daniel Law), Secretary of IPO’s Latin America Practice Committee, for submitting this update on behalf of the Committee.
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