History: In May 1996, a new Patent Law No. 9279 was adopted, replacing Brazil's Industrial Property Code (Law No. 5772) of 1971. The new law came into force on 15 May 1997.
Membership: WIPO, Paris, PCT
Admin: National Institute of Industrial Property, Praca Maua n. 7 - Centro, Rio de Janeiro RJ, CEP 20081- 240. Email:
Provisions until now: Brazil 1971 IPR Code did not provide patent protection on foodstuffs, pharmaceutical products or processes, chemical products or metal alloys, and was ambiguous on life forms and biotechnological processes.
Changes to conform to TRIPS: The May 1996 Patent Law was amended to exclude from patentability the following:
Are not considered inventions or utility models: All or part of natural living beings and biological material found in nature, or isolated therefrom, including the genome or the germplasm of any natural living being, and any natural biological processes.
Are not patentable: - anything contrary to morality, decency or public safety, order and public health - living beings, in whole or in part, except for transgenic microorganisms meeting the three requirements of patentability – novelty, inventive step and industrial application – in accordance with Article 8 and which are not mere discoveries. For the purpose of this law, transgenic microorganisms mean organisms, except for plants or animals in whole or in part, that due to direct human intervention in their genetic composition express a characteristic that cannot normally be achieved by the species under natural conditions.
Therefore, plants and animals are not patentable "as such" but transgenic microorganisms are. Human genes, as parts of animals, appear to be excluded as such from patent protection. (Hathaway, 1997) However, inventive processes -- including biotechnological processes -- for the production or transformation of any product whatsoever may be patented, with patent privileges extending to the product of such processes.
Opposition possibility: Nullity proceedings may be instituted at the request of any person with a legitimate interest within five years from grant. PLANT VARIETY PROTECTION History: In January 1996, the government presented a bill to establish plant variety protection in Brazil, under the impression that the deadline to join UPOV before accession to the 1978 treaty would soon expire. Nevertheless, the bill was modelled on the UPOV 1991 treaty. NGO pressure succeeded in restricting the monopoly rights afforded through the law but could not stop its passage. On 25 April 1997 Brazil adopted Law No. 9456 on the Protection of Plant Varieties ("Lei de Proteção de Cultivares"). The regulatory decree was approved on 5 November 1997.
Membership UPOV: Brazil filed its application to join UPOV on 28 April 1997. Admission is still pending.
Provisions: Provides protection for new or essentially derived varieties, satisfying the DUS criteria, of any species. Varieties may also be protected if an application is filed within one year for varieties marketed within the last ten years and they need protection as sources of essentially derived varieties. The right of the breeder does not extend to on-farm reproduction and exchange of protected varieties by individual farmers or to the non-commercial reproduction and exchange of protected seeds by officially authorised associations of smallholder farmers. It also does not extend to those using the protected variety as food. Importantly, the law states that no other law can restrict the free use of plants or seeds in Brazil. The rights granted are basically those of UPOV 78 plus some provisions for essentially derived varieties from UPOV 91. However, the rules governing protection of essentially derived varieties are not clear, like in many countries. ACCESS TO GENETIC RESOURCES Brazil's first draft Law No. 306/95 on Access to Genetic Resources was introduced into the Senate in November 1995 by Senator Marina Silva. It has been revised several times since. The most recent draft of 18 September 1997 has to be approved by the Senate, sent to the House of Representatives and endorsed by the Congress in full. As of January 1998, Senate approval was still not achieved so it will still be several months, at the least, before the bill is adopted by Congress. The current version of the bill, described below, is being widely debated by NGOs and other sectors in Brazilian society.
The Law aims to regulate access to genetic resources and their derived products, found in both in- and ex- situ conditions, whether existing on Brazilian territory or of which Brazil is country of origin. It would equally regulate access to traditional knowledge of indigenous and local communities associated with said genetic resources and their derived products, including crops domesticated or "semi-domesticated" in Brazil. The draft is founded on the principle that genetic resources and their derived products are "public goods of special use to the Brazilian nation". Therefore, contracts of access would be made under this law without prejudice to material and immaterial rights concerning natural resources, private collections, and traditional knowledge of indigenous and local communities containing or relating to the genetic resources in question.
The bill provides for the sharing of just and equitable benefits – monetary or commercial rights -- derived from access to genetic resources and associated knowledge. Access to human genetic material, to be subject to further specific legislation, would only be legal if authorised by the federal government and depending on the prior informed consent of the individual donor. Any act carried out with, or right conceded over, any genetic resource obtained outside of this law would be illegal.
Under the current version of the bill, any act to access genetic resources in in-situ conditions would require permission from the competent authority. The authority would empower "access agencies" (public institutions or nonprofit NGOs) at the local level to act on behalf of communities in negotiating terms of access to resources and knowledge and administering the benefits. Therefore, there it contemplates three parties to any agreement: the applicant, the State and the access agency at the local level. Detailed requirements for access are meant to ensure utmost transparency of all information involved in the process. In the case of crops or traditional knowledge, plans for sharing benefits must be annexed to the access agreement. Provisional contracts for bioprospecting can be granted for a maximum non-renewable term of one year. However, commercial use of materials collected under such a provisional contract would be prohibited.
The competent authority, as devised in the current draft, also has power to grant rights of access to materials in ex-situ collections on Brazilian territory or in other territories where Brazil is country of origin of the material. Pertinent provisions drawn up for access to in-situ materials shall apply. The competent authority must also authorise material transfer agreements between ex-situ genetic resources centres, subject to benefit sharing provisions and to consideration of comments raised by any interested party.
In both cases, the State would recognise and protect the rights of indigenous populations and local communities to benefit collectively from their traditional knowledge and to be compensated for conserving genetic resources, be it through provision of monetary remuneration, goods, services, technology transfer, intellectual property rights or other. The rights of communities to traditional knowledge are said to be exclusive and are considered inalienable. Access to genetic resources as such may be prohibited when communities believe it threatens the integrity of their culture or natural environment (Art 45, párafo único). Intellectual property rights on products or processes related to traditional knowledge accessed outside of this law would not be recognised. A national registry of traditional knowledge is to be developed.
Under transfer of technology, the draft says that the State will support traditional uses and practices of local communities and indigenous populations. The use of foreign biotechnology would be subject to regulations on biosafety and full liability of the foreign agent.
In addition to the federal law, various states of Brazil are independently enacting legislation on access to genetic resources. This is the case in Acre, which adopted its own access rules in reaction to local "biopiracy" in August 1997. The state of Amapá also signed an access bill into law in the last days of December 1997.
In the discussion going on in Brazil over how best to regulate access and benefit sharing, one key question is whether to criminalise biopiracy. In other words, should disregard for regulations be subject to civil or criminal law? FARMERS' RIGHTS In the FAO, Brazil takes the position that Farmers' Rights should be implemented through legal frameworks at both the national and international level. However, no separate law on Farmers' Rights is being contemplated in Brazil. Legislators have instead incorporated limited provisions to protect some rights of farmers in the Plant Variety Protection and (still draft) Access Laws. Under the new PVP Law, farmers may plant-back seeds of protected varieties, and smallholder associations may exchange such seeds on a non-commercial basis. Under the terms of the Access draft, these can include rights to deny access to domesticated varieties or knowledge of genetic resources, or to provide access subject to negotiated conditions (such as funds, goods, services, etc.) in a quid pro quo for conserving and making available genetic resources, but no mention is made of rights to land ownership. COMMUNITY RIGHTS (See below) RIGHTS RELATED TO CBD ART. 8(J) Brazil's Federal Constitution of 1988 recognises "original rights" as perpetual usufruct rights to land and natural resources for indigenous communities. A new Statute of Indigenous Societies is supposed to replace the previous Statute of the Indian. The new Statute, of which the latest draft dates from June 1994, provides for intellectual property rights of indigenous societies in the classic sense of IPR and recognising the dominant patent system, both relevant to biodiversity and associated knowledge. However, these rights only apply in a commercial relationship. Research of an academic nature can be conducted irrespective of these "rights". These provisions in the bill, stalled in the lower house of Congress (Chamber of Deputies) for over three years, are likely to be revised in the light of current discussions on access legislation. OTHER LAWS Brazil is currently reviewing its legal and regulatory framework to deal with the whole problem of biopiracy. The recommendation to do so comes from a report of the "Biopiracy Committee" of the House of Representative. The Committee, formally entitled House of Representatives External Committee Created to Investigate Charges of Exploitation and Illegal Trade of Genetic Material in the Amazon, worked from August to November 1997. It thoroughly examined over a dozen cases of biopiracy in the Amazon and came to a series of recommendations touching on intellectual property, access, international scientific cooperation, biodiversity conservation, etc. As such, the report shakes up the legal and political climate of biodiversity management in Brazil today. The Committee report is being discussed publicly and in various scientific, legal and political circles. Where the recommendations lead to is yet to be seen but they will cut through the very question of who has rights to conserve, develop, commercialise and control Brazilian biodiversity and how.
SOURCES: - Lei No 9.456 de 25 de abril de 1997 Instituti a Lei de Proteção de Cultivares e dá outras providências - Lei No. 9.279 de 14 de maio de 1996 Regula direitos e obrigações relativos à propriedade industrial. Published in English in Industrial Property and Copyright, WIPO, Geneva, November 1996. - Estudio sobre alterações no projeto de Lei No. 306/95 de acesso a recursos genéticos, trabalho em elaboração, versão de 18 de setembre de 1997. - Gabriele Muzio, "Brazil: Collective Intellectual Rights and Control of Access to Biological Resources", 30 March 1996, in Intellectual Property Rights, Collective Rights, Biodiversity: The Movement for Collective Intellectual Rights, Occasional Papers 1, draft, The Gaia Foundation, London, April 1996. - David Hathaway, personal communications, 22 September and 30 December 1997. - Gisela de Alençar, Nilo Diniz and David Hathaway, oral presentations at the BIOTHAI/GRAIN international seminar on sui generis rights, Bangkok, 1-6 December 1997. - Relatório Final da Comissão Externa Criada para Apurar Denúncias de Exploração e Comercialização Ilegal de Plantas e Material Genético na Amazônia, 18 de novembre de 1997.
Further information about the situation in Brazil can be obtained from: Mr David Hathaway, AS-PTA - Fax: 55-24-5226763 or Email: