Newsletter Edition 26 - June 2021


Nagoya Protocol will encourage patents, but Brazilian Biodiversity Law will have to be adjusted

Brazil’s recent accession to the Nagoya Protocol — international normative for access to genetic resources and sharing of related benefits — may result in an increase in patent applications but, for this, the country will have to harmonize its legislation, pointed out the coordinators of ABPI’s Study Committees Luiz Ricardo Marinello and Alex Gonçalves de Almeida. According to them, the adjustment to the agreement will also require a new version of SisGen (National System for the Management of Genetic Heritage).

Marinello, from the Geographical Indications Study Committee, mentioned some adjustments that will be necessary for the Brazilian Biodiversity Law (Law 13,123/2015) to conform to the terms of the Nagoya Protocol. An example is a necessary harmonization between the general rule of non-retroactivity provided for in the Protocol and the Brazilian legal framework, which provides for retroactivity. Another, referring to the sharing of benefits, is clearer legislation authorizing the Brazilian citizen/legal entity to make monetary remittances abroad. “Some aspects for the harmonization of the Nagoya Protocol can be solved with Resolutions of the CGEN – Genetic Heritage Management Council – as is the case with the alteration of SisGen for registration and inspection of exotic species”, he explained.

Alex Almeida from the Biotechnology Study Committee noted that, although Law 13,123/2015 has advanced in several points, there are obligations set out in the Protocol that were partially addressed or are not covered by Brazilian legislation and that impact the national industry. “For example, when a national uses genetic resources and/or associated traditional knowledge originating from a foreign country”, he pointed out. Another issue indicated is the obligation to notify the Information Intermediation Center about the enabled accesses and the sharing of benefits. “This measure would not necessarily need an amendment to the Law and could be met through a resolution or internal regulation of the CGEN”, he said.

For the coordinator of the Geographical Indications Study Committee, the Protocol impacts intellectual property in several scenarios: patents, technology transfer, and benefit-sharing. According to him, with the accession to the Nagoya Protocol, the Brazilian industry should take precautions and know in advance the ABS (Access and Benefit-Sharing) legislation when making use of genetic heritage and/or associated traditional knowledge from abroad.

In turn, the coordinator of the Biotechnology Study Committee adds that national companies will have to observe and take actions to, for example, assess the feasibility of new projects involving access to genetic resources and/or associated traditional knowledge from other countries, to ensure compliance with both the obligations brought by the Protocol and those provided for by foreign legislation for access to their resources and/or traditional knowledge and the sharing of benefits.