Since November 26, 2015, Applicants declare, when filing a patent application in Brazil, if the claimed invention derives or not from access to Brazilian genetic heritage or traditional knowledge. The Brazilian PTO used to issue Office Actions of code 6.6 for those applications filed prior to November 26, 2015 inviting Applicants to confirm whether access to Brazilian genetic heritage or traditional knowledge occurred or not.

In order to expedite this confirmation process, as of February 27, 2018, the Brazilian PTO started to issue Office Actions of code 6.6.1 automatically, with no deeper analysis of each application. A huge number of Office Actions of code 6.6.1 has been issued as a consequence.

Differently from Office Action of code 6.6, there is no need to submit a negative declaration as to access to Brazilian genetic heritage or traditional knowledge, if this is the case. In absence of Applicant’s response to an Office Action of code 6.6.1, the Brazilian PTO will consider that no access took place.

Given that Office Actions of code 6.6 are still being issued and that it is not uncommon to observe requirements as to access to Brazilian genetic heritage or traditional knowledge in other Office Actions resulting from substantive examination, there is a widespread misunderstanding of when to file a reply or not. In sum, if access to components of Brazil’s genetic heritage or traditional knowledge took place, submission of a declaration in this regard will always be required.

On the other hand, where no access took place, submission of a declaration will only be optional when an Office Action of code 6.6.1 is issued and will be mandatory when an Office Action of code 6.6 or one resulting from substantive examination is published.