In 2015, Brazil enacted Federal Law #13,123 to enlarge the definitions provided by 1992 Convention on Biological Diversity (CBD), notably those related to genetic heritage and associated traditional knowledge.
As per the Article 47 of Federal Law #13,123, the grant of a patent by the BRPTO on a finished product or on reproductive material obtained from access to the Brazilian genetic heritage or associated traditional knowledge is conditioned upon the prior registration or authorization of the Genetic Heritage Management Council (CGEN).
When the information on whether the invention was a result from access to samples of components of the Brazilian genetic heritage and/or associated traditional knowledge is missing from the application, the BRPTO has started to issue formal office actions, regardless of the technical field. Such office action requests applicants to submit proof of registration and/or authorization of access to Brazilian genetic resources and associated traditional knowledge.
Should the application contain inventions obtained from access to samples of the components of the Brazilian genetic heritage or associated traditional knowledge, the applicant shall reply to the office action disclosing details on such access, the date and number of the registration or authorization given by the Genetic Heritage Management Council (CGEN) and information on the origin of the genetic material or associated traditional knowledge.
In case the applicant has not obtained the registration or authorization of the CGEN before the enactment of federal statute #13,123, it could fulfil such requirement by requesting the registration or authorization before the deadline of November 6, 2018. Failure to comply with this requirement may result in the permanent shelving of the patent application and fines ranging from 800 USD to 2,680,000 USD.
Although the BRPTO’s office action does not require a reply when no access had been made, we recommend our clients to file the negative declaration whenever the client confirms that no access has been made, for proper compliance with the Brazilian Law.
Article 2 of the 2015 statute provides a broad definition of genetic heritage and associated traditional knowledge. In this regard, (i) genetic heritage is defined as information of genetic origin of plant, animal, microbial species or species of other kinds, including substances from metabolism of these living beings and microorganism that has been isolated from substrates of the national territory, and (ii) associated traditional knowledge as the information or practice of indigenous population, traditional community or traditional farmer on the properties or uses direct or indirect associated with the genetic heritage.
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