Current barriers to biotech in Brazil


Gabriel Di Blasi

Current barriers to biotech in Brazil

Gabriel Di Blasi outlines the existing impediments to developing new biotechnology products in Brazil, and considers recent efforts to improve the situation.

The Brazilian government intends to improve regulation for patents, especially in the biotechnology sector. Last March, the Brazilian Minister of Development, Industry and Foreign Trade announced measures to improve the Brazilian regulations related to patents, especially in the field of biotechnology, mainly with regard to changing the rules of IP law and permits for research in biotech.

The ultimate purpose of these changes is to enhance opportunities for researchers and investors in biotech, providing full access to Brazilian genetic resources, as well as the development of related inventions, but the current legislation presents several bureaucratic hurdles that may hamper the development of the patent process.

Currently, the regulating laws of this matter are: i) Industrial Property Law No. 9,279 of 1996; ii) Provisional Measure No. 2,186-16 of 2001, which regulates access to the Brazilian genetic heritage; and iii) Resolution No. 69 of 2013 of the Brazilian patent and trademark office (INPI), which deals with patents derived from the genetic heritage.

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Biotechnology, Brazil, INPI, CGEN, Product development