Análise da anuência prévia da ANVISA na concessão de patentes farmacêuticas à luz do princípio da legalidade
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2016-11
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Porto, Antônio José Maristrello
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This work focuses on the so-called "privious consent" made by the ANVISA, understood as an integral part of the patent granting procedures for drugs products. Traditionally, the entire procedure for granting patents of all kinds is responsibility of the National Institute of Industrial Property - INPI, which holds such expertise. INPI is an institute created specifically for the control of immaterial properties, being structurally fitted for such activity. In order to prevent issues related to collective health and to protect health surveillance standards, the legislator now requires the joint examination of ANVISA before INPI grants the right of exploration of medicinal products. The writing of the device that created the duty in question was economic, not specifying the limits of ANVISA's action, which, in return, also began to examine the objective criteria of patentability, overlapping the INPI’s examine, creating legal uncertainty. It was verified that this operation characterizes deviation of function and if ANVISA can normalize the own action, without hurting the principle of legality and the reservation of the law.