Patenting Pharmaceutical Inventions on Second Medical Uses in Brazil

Abstract

The current Brazilian industrial property law (Law 9279 of 14 May 1996) allows patents for pharmaceuticals, along with the Agreement on Trade Related Aspects of Intellectual Property Rights provisions. Since 1999, after an amendment in the legislation, two governmental authorities—the Instituto Nacional da Propriedade Industrial (INPI) and the Agência Nacional de Vigilância Sanitária (ANVISA)—have been concomitantly acting in the patent‐granting procedures for pharmaceuticals. The INPI is the office usually responsible for the examination and granting of patents, and the ANVISA is the agency primarily responsible for the granting of marketing approval of drugs. In a peculiar situation, the two institutions have been responsible for the granting or denial of applications and have very often been divergent in their positions. The patentability of pharmaceutical inventions claiming second medical use is an example. The purpose of this work is to analyze the current situation of the Brazilian patent‐granting system in the pharmaceutical field, with a special focus on the patentability of inventions claiming second medical use. It debates the two governmental positions and questions whether the existing conflicts are harmful to the system.