Under Article 225, paragraph 1, II of the 1988 Brazilian Federal Constitution, it is incumbent upon the Government to preserve the diversity and integrity of the country's genetic assets and to monitor the entities involved in the research and handling of genetic material, which shows the legislator's care and concern with the results and effects of activities related to biotechnology or genetic engineering. In the light of the Convention on Biological Diversity, "biotechnology" means any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes.
One biotechnology-related issue which is raising extensive discussions and controversies is the legality of patenting life forms. The leading case of this subject was judged by the United States Supreme Court, where General Electric and its employee Ananda Mohan Chakrabarty filed in 1972 a patent application on a bacteria whose function was to reduce water pollution resulting from oil spills. The Supreme Court decided to grant the patent application, in a case where the United States Patent and Trademark Office - USPTO, which had denied the patent application, was defeated (Diamond vs. Chakrabarty case).
As to the Brazilian legislation, article 18, III, of Law no. 9.279/96 (Brazilian Intellectual Property Law – "LPI"), provides for the possibility of patenting genetically modified microorganisms, which through direct human intervention, posses a trait normally not achievable by the species under natural conditions, except for all plants or animals or parts thereof, and which are not a mere discovery.
Genetically modified microorganisms may be subject to patentability upon fulfillment of the 3 general requirements provided for in article 8 of the LPI, namely (i) novelty, that is, a validly granted patent requires that genetically modified microorganisms be absolutely novel; (ii) inventive activity, which always means that for a specialist in the subject, the activity does not result in evident or obvious manner from the state of the art (article 13, LPI); and (iii) industrial application, where the genetically modified microorganisms may be used in the industrial process of any type of industry (article 15, LPI).
In case the essential biological material for the practical execution of an invention, in this case the microorganism, cannot be described and is not accessible to the public, the corresponding patent application must be supplemented by the deposit of a sample of said biological material with an institution authorized by the Brazilian Patent and Trademark Office - "BPTO" or appointed by international accord (article 24, sole paragraph, LPI).
The international accord which recognizes the deposit of microorganisms for patent procedure is the Budapest Treaty dated of April 28th, 1997, of which Brazil is not a signatory. One of the purposes of the treaty is to eliminate or limit the various deposits of biological materials, and reduce them to only one in applicable depositary centers, named "International Depositary Authorities", recognized worldwide by the member countries.
Although Brazil is not a signatory to the Budapest Treaty, the BPTO recognizes the filings made in the International Depositary Authorities, given that Brazil does not have an accredited institution for such purposes yet.
Lastly, Resolution 207/2009, issued by the BPTO, establishes that the applicant of an invention patent, which scope was obtained as a result of access to a sample of a component of the national genetic assets as of June 30th, 2000, must inform the BPTO through a specific form, the origin of the genetic material and associated traditional knowledge, as the case may be, as well as the number of the corresponding access authorization.
The terms and conditions related to access to genetic resources in Brazil are essentially regulated by Provisional Presidential Decree 2186-16, and the interested party must obtain the access authorization from the Genetic Assets Management Council ("Conselho de Gestão do Patrimônio Genético - CGEN"), the agency in charge of requests for access to genetic assets and associated traditional knowledge.
Thus, in a brief summary, despite the ethical-political debates on the patenting of life forms, it is possible to patent genetically modified microorganisms in Brazil, except for all plants or animals or parts thereof, provided that (i) such microorganisms meet the novelty, inventive activity and industrial application requirements; (ii) the biological material is filed in applicable international depositary authorities; and (iii) the origin of the material and number of authorization obtained from CGEN is informed to the BPTO through a specific form.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
