SUFICIÊNCIA DESCRITIVA EM PEDIDOS DE PATENTE FARMACÊUTICA MEDIADOS PELA INTELIGÊNCIA ARTIFICIAL GENERATIVA À LUZ DOS ARTS. 24 E 32 DA LEI Nº 9.279/1996

Vollständiger Abstract

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This article investigates the extent to which the use of generative artificial intelligence in the preparation of pharmaceutical patent applications intensifies challenges related to sufficiency of disclosure, without altering the normative requirements set out in Articles 24 and 32 of Brazilian Law No. 9,279/1996. It adopts a qualitative legal-dogmatic study structured as a multiple-case study. The U.S. precedents In re Ruschig (1967), Biogen International GmbH v. Mylan Pharmaceuticals Inc. (2021), and Amgen Inc. v. Sanofi (2023) are examined as interpretative parameters in dialogue with Articles 24 and 32 of the Brazilian Industrial Property Law, Resolution INPI/PR No. 93/2013, and specialized scholarship on intellectual property and patents. U.S. law distinguishes proven possession of the invention from enablement for a person skilled in the art; their functions may be examined, by functional analogy, in relation to the unified requirement set out in Article 24 of the Brazilian Industrial Property Law. The findings indicate that generative artificial intelligence increases the risk that formally complete claims may fail to correspond to the technical knowledge demonstrated by the applicant. Technical proportionality is proposed as an analytical category for assessing that correspondence in the examination of pharmaceutical patent appllications.