Flexibilities Under TRIPS: An Analysis of the Proposal for Reforming Brazilian Patent Law

Abstract

This article analyses the proposal for reforming the Brazilian patent system pending before the Brazilian Parliament as Bill No. 5402/13. The proposed legislation addresses such issues as the assumed insufficiency of the inventive step requirement in preventing unjustified “monopolies”, the proliferation of so-called secondary patents, and the extension of market exclusivity positions through strategic filings, which are being debated also in Europe and the US. In analyzing the reform attempt, this article pursues two purposes. First, starting from the provisions of the Bill, it explores the flexibilities that WTO members enjoy under the TRIPS Agreement in designing rules and procedures in their patent acts. Second, it examines whether the changes proposed by Bill No. 5402/13 are consistent with its proclaimed goals, such as the aim to reserve patent protection only to “genuine innovations”, to hamper so-called “evergreening” practices by pharmaceutical applicants and to foster incremental innovations by domestic actors. Specific attention is given in this regard to the proposals to introduce: (i) as separate criteria for patentability a “significant technical advance” in all technological fields and an “enhanced efficacy” in the chemical sector; (ii) a general prohibition of use patents; and (iii) a pre-grant and post-grant opposition system.

Keywords: TRIPS, pharmaceutical patents, inventive step, section 3(d) Indian patent Act, Brazil patent reform, use patents, pre-grant and post-grant oppositions