Obligation of ANVISA’s consent for pharmaceutical patents

Recently, the Superior Court of Justice decided two cases involving pharmaceutical patents (REsp 1,753,535/TJ and REsp 1,543,826/RJ), determining the mandatory prior consent of the National Health Surveillance Agency (in Portuguese Agência Nacional de Vigilância Sanitária – ANVISA).In both cases, it was discussed the requirement of ANVISA’s prior consent for the granting of patents on pharmaceutical products and processes, pursuant to art. 229-C of Law No. 9,279/96 (Brazilian Industrial Property Law), in order to verify the existence of health risk. According to the Brazilian legislator, the creation of the aforementioned article was necessary, due to the fact that the “joint work between BPO (Brazilian Patent Office) [sic] and ANVISA guarantees [sic] the best technical standards in the pharmaceutical patent decision process, similarly to the procedures applied by the most advanced patent control and health surveillance systems in operation in developing countries”.
In the first case, the STJ understood that the absence of ANVISA’s prior consent is a remediable defect, allowing the autarchy to express its views on health-related issues during the invalidation lawsuit, in order to protect health surveillance standards. In the second case, the STJ decided that ANVISA can analyze the existence of potential risk to the health of its users, as well as the examination of patentability requirements. 

However, given the recent decision of the Constitutional Challenge (ADI) 5529, which annulled the sole paragraph of art. 40 of the Brazilian Industrial Property Law, rekindled the old discussion about the validity and need for prior consent by ANVISA in cases of pharmaceutical patents and the search to streamline the examination of patents. In this step, the creation of rules for the exclusion of art. 229-C of the Brazilian Industrial Property Law has increasingly appeared in the National Congress, as Provisional Measure 1040

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