New Brazilian Law on Biodiversity

The Brazilian government has just signed the new Brazilian Act No. 13,123/15, which regulates the access to the national biodiversity. This Law, which will become effective in November, comes as a substitute for the current Provisional Act No.  2.186-16/01 that currently  regulates access to national genetic heritage, as well as the associated traditional knowledge.

The new law aims to improve that field, by promoting sustainable development, aligned with the preservation of the environment and the rights related to the natural resources. By doing that, the Brazilian government clearly intends to reduce biopiracy, ensuring that the genetic heritage and associated traditional knowledge providers can receive fair compensation from the profits generated by the product they helped create. In addition, the law implements new concepts related to biodiversity in general, such as untraceable associated traditional knowledge, adjustment term, technological development among others.

In order to explore the genetic heritage or the associated traditional knowledge, the user will have to sign an agreement to share the profits from the commercialization made out of the raw material.  This instrument is called a Benefits Sharing Agreement and must be presented not later than 1 year after the user has notified the government informing that the product is ready to be commercialized.

The amount due and its destination may vary. When related to genetic heritage and untraceable associated traditional knowledge, the range of payments will be between 0,1% and 1% of the net income from the exploitation of the product, sent to the National Fund for the Sharing of Benefits (FNRB, in Portuguese). Otherwise, when it involves traceable associated traditional knowledge, the percentage will be agreed between the user and the provider, under the values of fairness and justice.

The law stablishes two procedures whereby users with pending applications before the government to use of national biodiversity can come current. The first procedure stipulates that all the authorizations requested during the Provisional Act must be adapted to the new simple requirements under the law, via an online form.

The second procedure applies parties involved in any activities that made use of the biodiversity without having taken the necessary measures stated in the Provisional Acts or having authorization. They will be required to become compliant by entering into an adjustment term agreement, in accordance with the new Law.  Compliance with the mentioned adjustment will have the power of reducing the administrative penalty on 90%.

The new law also regulates pending patent applications that make use of genetic heritage and associated traditional knowledge. The applicants will have to fulfil an online form to report use; and, upon its presentation to INPI, the application will follow the usual procedure for examination.

Notwithstanding, according to the new law, all the new patent applications, whose objects derive  from genetic heritage or associated traditional knowledge material, will require will require the applicant to file an online record of use prior to submitting the patent application.