Brazilian FDA and BPTO close to reaching an agreement on prior consent

21st March, 2017

The Brazilian FDA (ANVISA) and the Brazilian Patent and Trademark Office (BPTO) have, for many years, disagreed about the legal provision that instituted the mechanism of “prior consent”, which established that ANVISA would examine patent applications in the pharmaceutical area so as to authorize the grant of the corresponding patents, before the BPTO could do the same. 

Both organizations have now reached an agreement about a new format of “prior consent”, recently approved by ANVISA's Collegiate Board of Directors, and which will lead to more legal certainty in the proceedings. 

ANVISA will keep on being the first to examine the applications, and will send their technical report to the BPTO that may accept, or not, ANVISA's opinion. In case the conclusions are not the same, the BPTO's opinion should prevail. Also, ANVISA will restrict the examination to public health issues, leaving to the BPTO the examination of the patentability requirements.

The implementing regulations of the agreement should be published in the near future. We hope to have more details about this clear advancement in Brazilian IP practice shortly. 

Attached Files

ANVISA-INPI Statement

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