Legislation on biodiversity, access to genetic heritage and associated traditional knowledge in Brazil
Impact on commercial activities, patent applications and updates to the National System for the Management of Genetic Heritage and Associated Traditional Knowledge (SisGen)
Two decades after the advent of the first Brazilian rules regulating the exploitation of Brazilian biodiversity, namely the revoked Provisional Measure No. 2186/2001 (which succeeded Provisional Measure No. 2052/2000), a new law (Law No. 13.123/2015) was sanctioned on May 20, 2015. The new law brought relevant regulatory changes that affect a wide range of businesses that deal with Brazilian biodiversity.
Law No. 13.123/2015, in force since November 17, 2015, is regulated by Federal Decree No. 8.772/2016, published on May 11, 2016 – (“Regulation”), which provides relevant details on benefit sharing, database registration, definition of access, patent applications, among others.
Since the 2000s, the main aspect of Brazilian rules on activities involving components of Brazilian biodiversity has revolved around the concept of “access”. Under the previous rules, any access to so-called genetic heritage and/or associated traditional knowledge was subject to government authorization that had to be obtained before the access itself. Furthermore, what constituted “access” was not clearly defined.
Under Law No. 13,123/2015, it is now clearly defined that access subject to government control will only occur when someone carries out research or technological development (R&D). The former is understood to be related to academic activities, while the latter is defined as “systematic work carried out on genetic heritage or associated traditional knowledge… in order to develop new materials, products or devices and improve or develop new processes for economic use”.
When compared to the previous regulatory parameters, this new definition brings more clarity to companies operating in Brazil, since under the old regime, the mere use of ingredients from local biodiversity, even without any kind of technological development, could be considered “access” and therefore subject to prior authorization, benefit sharing, etc. In practice, sanctions were imposed on companies that simply bought ingredients on the market and used them in the manufacture of common products.
Another significant change is a clearer definition of what constitutes genetic heritage. This is defined as “information of genetic origin’ resulting from plants, animals, microbial species or species of another nature, including substances originating from the metabolism of these living beings”. It is now clear under the law that access to metabolic substances – and not just genetic information – is subject to government control.
The law makes it clear that microorganisms are also included in the scope of government control.
Another feature of this law is that access to Brazilian genetic resources is now subject to registration of activities in a database called the National System for the Management of Genetic Heritage and Associated Traditional Knowledge (SisGen), which is already in operation under the National Council for Genetic Resources (CGEN).
Currently, there is a mobilization and effort on the part of Brazil’s Ministry of the Environment to enable the internationalization of SisGen. Although it is still in the testing phase, with operations expected to begin in the second half of 2025, the updates to SisGen are aimed at enabling and facilitating the registration of access activities by foreign institutions without consolidated representation in Brazil.
While the current system only allows the registration of Brazilian individuals and companies, the new system promises the possibility of registering foreign individuals and companies, facilitating administrative associations with the Brazilian institutions that are part of the RPBio network1 , pre-registration of activities involving access to Brazilian genetic heritage and notification of products relating to the economic exploitation of accessed materials.
1 The acronym refers to the Biodiversity Partners Network, a list of national public scientific and technological research institutions available for administrative association with institutions based abroad that do not have a representative in Brazil.
This system, even after updates, will continue to be managed by CGEN, which will eventually issue a registration certificate. Under the terms of Law 13.123/2015 and its Regulatory Decree, such registration with SisGen will be necessary for companies or those interested in accessing genetic resources and/or associated traditional knowledge (i.e. performing R&D) and submitting patent applications resulting from this access. Article 12, §2 of Law 13.123/2015 is worth highlighting in this regard:
Art. 12. The following activities must be registered:
I – access to genetic heritage or associated traditional knowledge within the country carried out by a national, public or private natural or legal person;
II – access to genetic heritage or associated traditional knowledge by a legal entity based abroad associated with a national public or private scientific and technological research institution;
III – access to genetic heritage or associated traditional knowledge carried out abroad by a national, public or private natural or legal person;
IV – shipment of a sample of genetic heritage abroad for the purpose of access, in the cases of items II and III of this heading; and
V – sending a sample containing genetic heritage by a national legal entity, public or private, to provide services abroad as part of research or technological development.
- 1º The registry referred to in this article will be defined by regulation.
- 2º Registration must be carried out prior to the shipment, or to the application for any intellectual property rights, or to the commercialization of the intermediate product, or to the disclosure of the results, final or partial, in scientific or communication media, or to the notification of the finished product or reproductive material developed as a result of the access.
- 3º The information contained in the database referred to in item IX of § 1 of art. 6 is public, with the exception of that which may harm scientific or technological research or development activities or the commercial activities of third parties, and this information may be made available with the user’s authorization. If a new product is created as a result of access to Brazilian genetic resources, it must be registered with the designated government agency (CGen) and the corresponding benefit-sharing agreement must be submitted within one year. Benefit-sharing can take various forms, but it is believed that the most common form is the payment of up to 1% of the worldwide net selling price of the product to a government fund (Fundo Nacional de Participação nos Benefícios – FNRB), which is already in operation.
Any person (natural or legal) who has accessed Brazilian genetic heritage after June 30, 2000, must comply with this law within specified deadlines. The main assessment in this regard is whether the activities carried out in Brazil can be characterized as “access” or not. This can be particularly critical when, in the past, these activities were considered to be “access” and even resulted in the imposition of fines because of the so-called Operação Novos Rumos I and II (Operações de Novos Caminhos I and II).
Any violation of the law, in particular: (i) irregular access to genetic heritage and associated traditional knowledge, (ii) irregular sale of products derived from this access and (iii) non-payment of benefit sharing, among others, is subject to various administrative sanctions such as fines, seizure of products, interdiction of the offending company, among others. It should be noted, however, that the law does not provide for criminal sanctions.
Law 13.123/2015 defines the conditions for sending material derived from Brazilian biodiversity abroad, as well as having an impact on patent applications resulting from access to Brazilian genetic heritage or associated traditional knowledge, filed with the National Institute of Industrial Property (INPI). Referring to Brazilian patent law, the applicant must indicate on the filing form whether the claimed invention derives from an access carried out.
Considering that companies have already carried out access activities involving Brazilian genetic heritage or associated traditional knowledge and intend to apply for patent rights involving this product, they must comply with Law No. 13,123/2015 and the provisions of the Regulatory Decree. Note that all the necessary registration and regularization with CGEN and its database (SisGen) must take place before the patent application is filed, in accordance with articles 109 and 118 of the Regulation:
Art. 109. In order to comply with the provisions of §2 of art. 12 of Law no. 13.123, of 2015, the user, when applying for an intellectual property right, must inform whether there has been access to genetic heritage or associated traditional knowledge, as well as whether there is a registration of access carried out under the terms of this Decree.
Art. 118. The user who applied for any intellectual property right, economically exploited a finished product or reproductive material, or disclosed results, final or partial, in scientific or communication media, between November 17, 2015 and the date on which the registration is made available, must register the activities referred to in art. 12 of Law No. 13,123, of 2015 and notify the finished product or reproductive material developed as a result of the access.
- 1 – The deadline for the registration or notification referred to in the caput shall be one (1) year from the date on which the CGen makes the registration available.
- 2 – Once registration or notification has been carried out in good time, the user will not be subject to administrative sanctions.
In conclusion, it is important to analyze each specific activity carried out in Brazil as of June 2000, in order to determine what measures should be taken – if any – in order to comply with the new Law and its Regulatory Decree, and whether the company should sign a Term of Commitment with the Federal Government to regularize previous access activities.
It is important to bear in mind that Brazil ratified the Nagoya Protocol on May 4, 2021, and the possible impacts of this accession on current Brazilian biodiversity legislation must be assessed.
Given the importance of this issue, which extends internationally, the Diplomatic Conference on Intellectual Property, Genetic Resources and Associated Traditional Knowledge was held from May 13 to 24, 2024 at the headquarters of the World Intellectual Property Organization (WIPO) in Geneva (Switzerland). The aim of the event was to adopt an international legal instrument to increase the effectiveness, transparency and quality of the patent system and prevent patents from being erroneously granted for inventions that are not new or inventive in relation to genetic resources and traditional knowledge associated with genetic resources”.
Many jurisdictions do not have legislation on access to genetic resources and associated traditional knowledge. On the other hand, there are those that have specific legislation on the subject, but with practices that differ in various respects. In this way, understanding how access to genetic resources and traditional knowledge works at a global level requires special dedication by those involved in R&D, production and marketing of products based on biodiversity and associated traditional knowledge.
As a result of the conference, this instrument was published, in which we positively highlight its article 5.3, which establishes that:
Art. 5.3. Subject to Article 5.4, no Contracting Party shall revoke, invalidate or render unenforceable patent rights granted solely on the basis of the applicant’s failure to disclose the information specified in Article 3 of this Treaty
This treaty will enter into force three months after the 15 eligible parties referred to in Article 12 have deposited their instruments of ratification or accession.
Against this backdrop, it is important to continue discussions on this topic to understand the legislation regarding access to genetic resources and associated traditional knowledge and how to conduct R&D, production and manufacture of products based on biodiversity.
Authors: Ana Claudia Mamede Carneiro – [email protected]
and Renan Sangalli Brochi – [email protected]
Dannemann Siemsen
Av. Rodolfo Amoedo, 300 – Barra da Tijuca
22620-350 Rio de Janeiro- RJ
Tel.: (21) 2237 8700
E-mail: [email protected]
Av. Brigadeiro Faria Lima, 4.221 – 3º andar
04538-133 São Paulo – SP
Tel.: (11) 2155 9500
E-mail: [email protected]
Internet: www.dannemann.com.br