Intellectual Property Aspects related to Access to Genetic Resources in Brazil

The Convention on Biological Diversity, signed in Rio de Janeiro, Brazil, back in 1992, established that genetic resources should no longer be considered as a heritage of the Humanity, but rather that each country should have sovereignty over its own resources.

Brazil has signed the Convention in 1992, such International Treaty having been ratified in Brazil by means of Decree No. 2,519 of March 16, 1998. However, it was only in 2000 that a legislation regulating the access to Brazilian genetic resources and associated traditional knowledge was enacted.

Particularly, in compliance with the Convention on Biological Diversity (CBD), more specifically, its articles 1, 8, letter “j”, 10 letter “c”, 15 and 16 items 3 and 4, Provisional Ruling 2,186-16/01, still in full force, was enacted to regulate the access to, and use of, genetic heritage and associated traditional knowledge (TK) in the Brazilian territory, the fair and equitable benefit sharing and the access and transfer of technology for the conservation and use of biological diversity. It also created the Genetic Heritage Management Council (CGEN), which is the Council responsible for the application of the dispositions of the Provisional Ruling in this country.

In what concerns Intellectual Property, Provisional Ruling 2,186-16/01, in its article 31[1], establishes that the granting of industrial property rights involving products and/or processes obtained from a sample of a component of the national genetic heritage shall depend on the compliance with said provisional ruling.

Following the provision of article 31 above, CGEN ruled on the procedures to be observed upon filing a patent application in Brazil.

CGEN established by means of Resolution 34 of February 12, 2009, that in order to comply with what is set forth in provisional Ruling 2,186-16/01, applicants of patent applications for a product and/or a process resulting from access to a sample of the Brazilian genetic heritage, effected as of June 30, 2000, should declare before the Brazilian PTO having complied with the rules in force, also informing the number and date of the corresponding Authorization for Access granted by CGEN.

In consonance with the dispositions of Provisional Ruling 2,186-16/01 and CGEN’s Resolution 34, the Brazilian PTO, through Resolution No. 207/2009, recently remembered as 69/2013, standardized the procedures relative to the statutory disclosure of the access to the samples of genetic resources. More specifically, Article 2 of Resolution 69/2013 establishes that: “The Applicant of a patent application whose object has been obtained through access of a sample of a component of national genetic heritage, as from June 30, 2000, shall inform, in a specific form, created by this Act (…), the origin of the genetic material and the associated traditional knowledge, as appropriate, as well as the number of the corresponding Authorization for Access.”

Such disclosure is mandatory and should be preferably made upon filing of the patent application in Brazil, since, according to the Law in force, the access to components of genetic heritage can only be made with the prior consent of CGEN or of one of the accredited institutions, namely, IBAMA (Brazilian Institute of Environment and Renewable Natural Resources), CNPq (National Council of Technological and Scientific Development) or IPHAN (Historic and Artistic National Institute Heritage Institute), by means of the issuance of an Authorization for Access.

CGEN determined exemption to the obligation of having authorization for access. Examples are commercial varieties of sugar cane, Saccharum spp., registered in the National Variety Registry (RNC) within the Ministry of Agriculture and plant species defined in the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA), when used for conservation, research, improvement and training related to food and agriculture.

It should be also stressed that the failure to observe the dispositions of Provisional Ruling 2186-16/01 constitutes a violation punishable with administrative sanctions, as established in Article 30 of the ruling. Particularly, concerning Intellectual Property rights, Article 30, items VIII and IX determines the possibility of suspending or cancelling of the registration, patent, license or authorization related to the products or processes obtained through the access to genetic heritage.

Brazil is at this point in time awaiting that a new and definitive Law ruling on the access to genetic resources is enacted. The expectation is that such Law both restrains biopiracy and also enables the sustainable exploitation of the huge potential of our Biodiversity, to the benefit of Humanity.