BIO Comments on INPI Guidelines for Examination of Biotechnology Patent Applications in Brazil

BIO commends the INPI for their efforts to devise guidelines for examining biotechnology related inventions. Given the technological advances and the innovation that spurs it are the primary drivers of economic growth in the modern era, it is critical that patent laws and practices properly motivate and reward innovation. While BIO agrees with many of the proposed Guidelines, BIO is concerned that several of the proposed Guidelines would not achieve this objective with respect to biotechnology inventions.

BIO is concerned that aspects of the Guidelines, if adopted, would have significant consequences in all sectors of biotechnology and for patients and consumers in Brazil. Most troublesome, the proposed Guidelines would exclude from patent protection any isolated and/or purified biological material, whether a gene or otherwise, that may have the same sequence as naturally occurring biological material, despite the fact that the isolated and/or purified biological products are manmade and are structurally and functionally different from their natural counterparts. In addition, several Guidelines interfere with the ability of innovators to obtain meaningful protection for their genetically engineered innovations. Implementation of these proposals would prevent the patenting of a vast amount of biological innovations, to the detriment to the people of Brazil.

Moreover, there are several proposals that BIO believes require further clarification and others that BIO believes depart from the principle that patent applications must be evaluated on a case-by-case basis. Furthermore, BIO remains concerned about patentability requirements mandating disclosure of the source and origin of biological materials.

The following comments by BIO raise these issues in more detail and provide our perspective on some of the specific provisions within the proposed Guidelines.