Access to genetic resources: The Biodiversity Legislation in Brazil
Impact on business activities and patent applications
Two decades after the issuance of the first Brazilian rules regulating the exploration of the Brazilian biodiversity, that is, the presently revoked Provisional Measure No. 2186/2001 (which succeeded Provisional Measure No. 2052/2000), a new law (No. 13123/2015) was sanctioned on May 20, 2015. The new law brings many changes that will certainly affect a wide range of businesses dealing with the Brazilian biodiversity.
The new Law entered into force on November 17, 2015 and it is regulated by the Federal Decree n. 8,772/2016, published on May 11, 2016 – (“Regulation”), which gives relevant details on benefit sharing, database registration, definition of access, patent applications, among others.
Since the year 2000 the main aspect of the Brazilian rules on activities involving components of the Brazilian biodiversity revolves around the concept of “access”. Under the prior rules, any access to the so called genetic heritage and also to associated traditional knowledge was subject to governmental authorization that should be obtained before the access itself. Moreover, what would constitute an “access” was not clearly defined.
Under the new law, it is now clearly defined that an access subject to governmental control will only take place when one performs research or technological development. The former is understood to be related to academic activities while the latter is defined by the new law as a “systematic work performed on the genetic heritage or associated traditional knowledge … in order to develop new materials, products or devices and to improve or develop new processes of economic use”. This new definition will probably bring comfort to companies operating in Brazil since under the old regime the mere use of ingredients of the local biodiversity, without any sort of technical development could sometimes be considered as an “access” and therefore subject to previous 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 commonplace products.
Another significant change is a clearer definition of what constitutes the genetic heritage. This is defined as ‘information of genetic origin’ resulting from plant, animal, microbial species or species of other nature, including substances coming from the metabolism of such living beings”. It is now clear under the law that access to metabolic substances – and not only to genetic information – is subject to governmental control.
The law makes it clear that microorganisms are also within the scope of governmental control.
Another feature of this Law is that the access to the Brazilian genetic resources is now conditioned to registration of the activities in a database called “SisGen” already operational, under CGEN – the Executive Office of the National Council of Genetic Resources – CGEN. Such a system will be managed by CGEN which will issue eventually a certificate of registration.
The Law 13,123 and its Regulation states inter alia that companies that wish to perform access (i.e., R&D) to genetic resources, file patent applications, etc. should perform a registration (“cadastro“) before an electronic database called “SISGEN – National System of Management of Genetic Heritage and Associated Traditional Knowledge”, which is already operational since November 6, 2017. Please see article 12 §2 of Law 13,123:
“Art. 12. The following activities shall be registered:
I – access to genetic heritage or associated traditional knowledge within the Country by any natural person or national, public or private legal entity;
II – access to genetic heritage or associated traditional knowledge by legal person located abroad associated with national institution for scientific and technological research, public or private;
III – access to genetic heritage or associated traditional knowledge conducted abroad by any natural person or national, public or private legal entity;
IV – shipment of genetic heritage component samples abroad with the purpose of access, in the hypotheses of items II and III of this caput; and
V – sample containing genetic heritage sent by national, public or private legal entity in order to provide services abroad as part of a research or technological development.
- 1 The registration referred to in this article shall be defined in a regulation.
- 2 The registration shall be carried out prior to shipping or to the request of any intellectual property right, commercialization of the intermediate product, disclosure of results, final or partial, in scientific publications or in the media, or to the notification of finished product or reproductive material developed as a result of access.
- 3 The information contained in the database referred to in item IX of §1st of Article 6th are public, except for those that could hinder the research activities or scientific and technological development, or commercial activities of third parties, this information being able to be made available upon user authorization.”
If a new product is created as a result of an access to the Brazilian genetic resources, it must be communicated to the designated governmental agency (CGen) and the corresponding benefit sharing agreement must be presented within 1 year. Benefit sharing can take several forms but it is believed that the most common form will be the payment of up to 1% of the net sales price worldwide of the applicable product to a governmental fund (National Benefit Sharing Fund – FNRB), which is already operational.
Anyone that performed access to the Brazilian genetic heritage as of June 30, 2000 must conform to the this law within specific time frames. The main assessment in this regard is whether the activities performed in Brazil can be characterized as an “access” or not. This can be particularly critical when such activities have in the past been considered as an “access” and were even resulted in the imposition of fines as a result of the so called Operações Novos Rumos I e II (New Paths Operations I and II).
Any violation to the new law, in special: (i) irregular access to the genetic heritage and associated traditional knowledge, (ii) irregular sale of products derived from such access, and, (iii) lack of payment of benefit sharing, etc. is subject to a number of administrative sanctions provided for in the new law, such as fines, product seizure, interdiction of the offending company and others. The law does not provide for criminal sanctions.
The new law also defines conditions for the remittance abroad of material derived from the Brazilian biodiversity.
It should also be clarified that the referred law brings impacts on patent applications arising from access to Brazilian genetic heritage or associated traditional knowledge, filed before the Brazilian PTO (Patent and Trademark Office). Referring to the Brazilian patent law, the applicant must indicate in the filing form whether the claimed invention derives from an access to Brazilian genetic resources.
Considering that the businesses has already performed access activities involving Brazilian genetic heritage or Associated traditional knowledge and intends to apply for patent rights involving such product, shall have to comply to Law 13,123 and its Regulation provisions. Please note that all needed registration and regularization before CGEN and its database SisGen shall occur before the filing of the patent application, according to articles 109 and 118 of the Regulation:
“Article 109. To comply with the provisions of § 2 of Article 12 of Law 13,123, of 2015, the user, upon requesting protection for any intellectual property right, shall indicate whether there was access to genetic resources or associated traditional knowledge, as well as whether there is a registration of access according to this Decree.”
“Article 118. The user that requested protection for any intellectual property right, economically exploited finished product or reproductive material, or has reported final or partial results, in scientific or communication circles, between November 17, 2015 and the date of availability of the registration, shall register the activities referred to in Article 12 of Law 13,123, of 2015, and notify the finished product or the reproductive material developed as a result of access.
- The period for registration or notification referred to in the head provision will be one (1) year from the date of availability of registration by CGen.
- After the timely registration or notification, the user will not be subject to administrative sanction.”
As a final comment, it is important to analyze each specific activity carried out in Brazil as of June 2000 in order to determine what steps should be taken – if any – in order to conform to the new Law and its Regulation, even assuming the businesses should perform a Term of Commitment with the Federal Government to regularize past access activities.
Finally, it is important to bear in mind that Brazil has already ratified Nagoya Protocol on 04th March, 2021, and the possible impacts on the Brazilian biodversity law should be evaluated.
Given the importance of this topic that 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 objective of the aforementioned event was the adoption of an international legal instrument with the aim of increasing the effectiveness, transparency and quality of the patent system and preventing patents from being erroneously granted for inventions that are not new or inventive in relation to genetic resources and the 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 topic, but practices vary in several aspects. Therefore, understanding how access to genetic resources and associated traditional knowledge works at a global level requires special dedication on the part of those who work with R&D, production and commercialization of products based on biodiversity and associated traditional knowledge.
As a result of the aforementioned 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 conferred solely on the basis of the failure of the application to disclose the information specified in Article 3 of this Treaty.
This treaty will come into force three months after 15 eligible parties referred to in its art. 12 have deposited their instruments of ratification or accession.
In this scenario, 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 deal with R&D, manufacturing and marketing products based on biodiversity.
Authors:
Ana Claudia Mamede Carneiro – [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