by Bernardo Marinho Fontes Alexandre
June 01, 2011
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In Brazil, the rules for access to genetic heritage, the protection of and access to associated traditional knowledge of indigenous and local communities, sharing of benefits and access to and the transfer of technology for its conservation and sustainable use of biological diversity are defined in Provisional Measure (MP) No.2186-16 of August 23, 2001 which has the force of law.
Access to Brazilian genetic heritage or associated traditional knowledge depends on the authorization of the Federal Government. Its use, commercialization and employment, for any purpose, shall be submitted to inspection, restrictions and the sharing of the benefits. In addition, the MP created the Council for the Management of Genetic Heritage (CGEN), the national authority responsible for coordinating the implementation of genetic heritage management policies.
For the grant of a patent related to an invention, where its development involves an access to genetic heritage or associated traditional knowledge, the applicant must inform the Brazilian Patent Office (INPI) of the origin of the genetic material and/or the associated traditional knowledge. In order to define the form of proof of the access or not, CGEN issued Resolution No. 34, and INPI subsequently Resolution No.207.
Thus, during the prosecution of a patent application it must be informed, through a specific form, the origin of the genetic heritage or associated traditional knowledge, as well as the corresponding access authorization number, or the fact that the object of the patent application has not been obtained as a result of an access.
Between February and June of 2011, INPI issued an extremely high number of office actions (almost 8,000) asking whether the object of the patent application was or was not a result of an access to genetic heritage or associated traditional knowledge.
Access to genetic heritage and access to associated to traditional knowledge are defined in the MP as follows:
CGEN, through its Technical Guideline No.1, understands that "obtaining a sample of genetic heritage component" would be the activity carried out on the genetic heritage in order to isolate, identify or use information of genetic origin or molecules and substances from the metabolism of living beings and the extracts obtained from these organisms. This understanding would extrapolate the provisions of the MP, which is improper.
The MP does not have clear definitions and does not determine procedures for requesting an authorization to access genetic heritage or associated traditional knowledge. Such weaknesses may lead to undue delay, uncertainty in the process, barriers and/or impediments to research and technological development as well as a reduction in investments in the sustainable use of biological diversity.
In the same way, the MP states that any action or omission that violates its rules will be punished by, among other sanctions, warning, fine and confiscation of products derived from samples of the genetic heritage or associated traditional knowledge.
Based on this provision, a Brazilian environmental agency (IBAMA) in the end of 2010 performed a wide operation called "Novos Rumos" (New Directions). As a result, many research institutions and companies from various sectors such as pharmaceuticals, agriculture and cosmetics have been notified and/or fined by IBAMA.
The MP provides the possibility of regularization of activities related to access to genetic heritage and/or associated traditional knowledge and their economic use carried out not in line with its provisions and further relevant regulations. In this sense, CGEN issued Resolution No.35 that defines the guidelines and criteria for analyzing processes for the regularization of such activities.
However, in case of access to genetic heritage and/or associated traditional knowledge for the purposes of scientific research, bioprospecting or technological development carried without legal permission, the regularization will be performed without prejudice to the assessment of civil, criminal and administrative responsibilities by the competent authorities.
Finally, we point out that, regardless the filing of a patent application, an access without the proper authorization is subject to administrative, civil and criminal sanctions according to the pertinent legislation.