Prosecution of Pharmaceutical Patents in Brazil: Tensions Between the Brazilian Patent Office and ANVISA

Introduction

Current Intellectual Property Law No. 9,279 of May 14, 1996 and the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement allow for patenting of pharmaceuticals in Brazil. Notwithstanding, in 2001, the Brazilian IP Law was amended and the prosecution of pharmaceutical patent applications changed substantially. In this regard, instead of being exclusively prosecuted at the Brazilian Patent Office, called Instituto Nacional da Propriedade Industrial—INPI, the pharmaceutical patent applications must also be approved by Agência Nacional de Vigilância Sanitária — ANVISA, which is the local agency responsible for determining whether products or services may potentially be harmful to public health, and for granting market approval for products, including pharmaceuticals.

In view of this change in the law, pharmaceutical patent applications started being reviewed not only by the INPI, but also by ANVISA. And ANVISA, instead of issuing opinions on public health, which is its legal attribution, when reviewing these patent application also examined patentability requisites, which is the competence of the INPI.

The purpose of this article is to review the current situation involving the specific prosecution for pharmaceutical patent applications through the INPI and ANVISA and the respective violations of Brazilian legal principles and legislations.

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