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The article aims to develop a critical and historical analysis of the prior consent of patents for pharmaceutical products and processes by the Brazilian Health Regulatory Agency (Anvisa) from its creation until its extinction. Firstly, (i) we examine the emergence of the institute; and (ii) we analyze the history of institutional divergence between the Brazilian National Institute of Industrial Property (INPI) and Anvisa concerning the subject. Subsequently, we analyze recent events concerning the extinction of prior consent: (i) the main aspects of Recurso Especial n. 1.543.826, judged in 2021, in which the Superior Tribunal of Justice in Brazil brought a paradigmatic decision on the subject; and (ii) the revocation process of article 229-C of the Brazilian Intellectual Property Law and its repercussions. We defend the convenience of conducting further studies on the subject and conclude, preliminarily, by the importance of redesigning a new, more stable, and effective Anvisa's prior consent mechanism.
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Barbosa et al. (2024) studied this question.
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