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...