We are receiving reports from Brazil that the Brazilian Attorney General of the Union (AGU) has adopted a position restricting the role of the National Agency for Sanitary Surveillance (ANVISA) in the patenting process for pharmaceutical products and processes.
Due to a lack of clarity in the Industrial Property Law, ANVISA has used its prior consent role to reject patent applications on the basis of novelty and inventiveness which is officially the role of the Brazilian Patent Office (BPTO). However, the AGU has made it clear that ANVISA’s sole responsibility is to proceed with the analysis of the sanitary risks of the patented drug to health. Any other analysis would entail an invasion of the BPTO’s competence.
The AGU’s opinion cannot be appealed and ANVISA must comply with its terms.