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BPTO launches public consultation on draft of examination guidelines of biotechnology patent application

On February 6, 2019, the Brazilian Patent and Trademark Office (BPTO) launched a public consultation regarding the new draft of guidelines for examination of patent applications in Biotechnology area.

Among the proposed amendments, a clarification as to antibodies patentability stands out. According to the proposal, solely antibodies whose production occurs by significant human intervention can be considered as an invention. Therefore, when the antibody sequence already exists in the nature or when the antibody is obtained from an organism that is naturally exposed to the antigen, the antibody will not be entitled to protection.

Moreover, the BPTO included the possibility of patent protection for products, processes of obtainment and application of human embryonic stem cells. The BPTO’s position derived from Federal Attorney’s Opinion No. 00037/2018/PROCGAB/PFE-INPI/PGF/AGU, which concluded that such protection did not infringe the Brazilian Biosafety Law 11,105/2005.

Interested parties may send comments and suggestions up to April 6, 2019. The consultation webpage and electronic form are available (in Portuguese) at

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