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Review Article

Vol. 6 No. 1

The pharmaceutical patent process: National Health Surveillance Agency and National Institute of Industrial Property act differently in the process



The National Institute of Industrial Property (INPI) is the government body responsible for granting patents in the national territory; in the case of medicines, they need to be registered with the National Health Surveillance Agency (ANVISA) in order to be marketed. There was a divergence in legal interpretation (of Art. 229-C of the IPL) which caused damage to entrepreneurs, laboratories and the community in general, as there was no express provision as to whether ANVISA's opinion would be binding on the INPI's decision on patent issues. The aim of this research was to analyze this problem, raising its main points and demonstrating how dangerous and damaging bureaucracy and inefficient and obscure normative acts that give rise to dubious interpretation can be, based on the application of hermeneutic and dialectical methods. In 2021, the Superior Court of Justice (STJ), in Special Appeal n. 1543826, held that ANVISA's opinion would be a valid prerequisite for granting patents for pharmaceutical products or processes. It was found that the STJ decision increased ANVISA's "powers", but with the repeal of Art. 229-C of the IPL, the dilemma was extinguished and the competencies of each body re-established. It is therefore of the utmost importance to fill legal gaps and issue clear and specific laws so as not to leave room for harmful interpretations, guaranteeing original competences and legal certainty.


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