E-News No.46

E-News No.46

New Brazilian Law on Biodiversity

by Leonor Magalhães Galvão (Magellan IP – Brazil)

After nearly 14 years since the enactment of Provisional Measure No. 2,186/2001, the Brazilian Biodiversity Law (Federal Law No. 13.123/2015) was signed by President Dilma Roussef on May 20, 2015. The new law regulates the access to Brazilian genetic resources and to associated traditional knowledge of indigenous communities, as well as the sharing of benefits derived from the access to Brazilian genetic resources, and it has revoked Provisional Measure No. 2186/2001.

The new legal framework seeks to simplify and accelerate the process for accessing Brazil’s genetic resources. The new law provides that researchers, R&D institutions and national companies may access said resources, provided such access is registered in an electronic registry database. Foreign companies can also apply for access to genetic resources in a similar way, provided such access is performed in association with Brazilian R&D institutions. This procedure replaces the previous authorization process to access Brazilian genetic resources, which required the submission of documentation and reports to the Board of Management of Genetic Heritage (CGEN), which was extremely bureaucratic, time consuming and costly.

The new law also establishes the National Benefit Sharing Fund (FNRB), which will receive between 0.1% and 1% of the annual net revenue from proven commercial benefits of the manufactured final products produced as a result of access to Brazilian genetic resources or traditional knowledge, and will distribute part of these benefits to traditional and indigenous communities.

Another change introduced by Law No. 13.123/2015 is a more profound involvement of civil society in the Genetic Heritage Management Council (CGEN). CGEN, which was previously managed entirely by federal administrative bodies, will now have at least 40% of its membership represented by business and academic sectors, indigenous communities and traditional farming communities.

Regarding IP rights, the new law establishes in article 12 that “the access registration must be performed prior to the request of any intellectual property rights” (e.g. the filing of a patent application). However, article 47 states that “the granting of intellectual property rights by the competent body, regarding a final product or reproductive material obtained as a result of the access to genetic resources or to associated traditional knowledge is subject to registration or authorization provided by this law”. This apparent contradiction between the two articles may give rise to legal uncertainty as users of the IP system will be unsure as to whether such registration must be performed prior to the request of an IP right or if such registration may be performed up to the granting of such rights.

The new law, which came into force on November 17, 2015, was expected to be regulated before then. However, it was only on April 5, 2016 that a proposal for a regulating Decree has been published. The text is now open for public consultation until May 2, 2016 and a regulatory decree is expected to be approved in the coming months, finally allowing the full implementation of Law No 13.123/2015.