by Gustavo de Freitas Morais
December 01, 2009
In Brazil, patent protection is regulated by Law Nº 9,279 of May 14, 1996 ("IP Law"). This law also defines non-patentable inventions, which may be divided into two groups: those that are considered neither inventions nor utility models because they lack novelty, inventive activity or industrial application, as established in Article 10 of the IP Law, and those that cannot be patented by political reasons, determined in Article 18 of the IP Law.
Among the objects and processes that are not regarded as inventions/utility models, Article 10 (IX) mentions natural living beings, in whole or in part, and biological material, including the genome or germ plasm of any natural living being, when found in nature or isolated therefrom, and natural biological processes.
Among the objects and processes that may be considered inventions/utility models but which are not patentable, Article 18 (III) lists the whole or any part of living beings. However, the same item III determines that this does not extend to transgenic microorganisms that are new, inventive and have industrial application.
Another example of non-patentable matter are the Genetic Use Restriction Technologies ("GURTs").
According to Law Nº 11,105 of March 24, 2005 ("Biosafety Law"), GURT is any process by which human intervention generates or multiplies genetically-modified plants to produce sterile reproductive structures, as well as any manner of genetic manipulation that aims at activating or deactivating fertility-related plant genes by using external chemical inducers. In 2000, the United Nations’ Convention on Biological Diversity (CBD) recommended that "in the current absence of reliable data on genetic use restriction technologies, without which there is an inadequate basis on which to assess their potential risks, and in accordance with the precautionary approach, products incorporating such technologies should not be approved by Parties for field testing until appropriate scientific data can justify such testing, and for commercial use until appropriate, authorized and strictly controlled scientific assessments with regard to, inter alia, their ecological and socio-economic impacts and any adverse effects for biological diversity, food security and human health have been carried out in a transparent manner and the conditions for their safe and beneficial use validated." The aforementioned Biosafety Law was probably influenced by CBD’s recommendation and therefore, in Brazil, it is a crime to use, sell, register, patent and license GURTs.
However, it is in principle possible to protect via patents in Brazil: microorganisms genetically modified through human intervention (yeasts, funguses, mildews, bacteria, actinomycetes, algae, virus, etc.), modified DNA/RNA sequences and genes (in Brazil, DNA is not considered a part of a living being, but instead chemical compound), modified proteins, enzymes, polypeptides, antibodies, hybridomas, vectors and plasmids; any process of genome modification; chemical compositions characterized by its intrinsic features, even if including naturally occurring biological material; processes for obtaining, isolating, modifying, manufacturing and using biological materials and living beings (except humans in view of the Biosafety Law).
Other examples of allowable claims are:
Method of pest or weed control using certain agrochemicals and/or plants, and
Chapter 2: Plant Variety Protection
The International Union for the Protection of New Varieties of Plants (UPOV) is an intergovernmental organization with headquarters in Geneva (Switzerland). It was established by the Convention for the Protection of New Varieties of Plants held in Paris in 1961 and was revised in 1972, 1978 and 1991. Currently, there are two treaties in force: the 1978 Act of the UPOV Convention ("UPOV/1978") and the 1991 Act of the UPOV Convention ("UPOV/1991"). A number of developing countries, including Brazil, is signatory to UPOV/1978, whereas most developed countries are signatories to UPOV/1991.
In Brazil, the PVP Law of April 25, 1997 regulated by Decree Nº 2366 of November 5, 1997, was enacted in order to protect any new plant variety which is distinguishable from other plant species and cultivars by a set of minimum genetically-inherited morphological, physiological, biochemical or molecular characteristics. These characteristics, known as descriptors, must be homogeneous and stable through successive generations.
This PVP Law encompasses provisions of UPOV/1978 and of UPOV/1991. As an example, essentially derived plant varieties are covered, which broaden the rights of the breeders. This law was enacted after the signature of UPOV/1978 and, according to the Brazilian legal system, since the law came into force later, it may be argued that it supersedes UPOV/1978 as far as individual rights are concerned.
The PVP Law does not regulate activities per se, but rather determines the nature of plant variety rights, how to protect and exercise them and their limitations. Such activities may be regulated by other statutes, such as the Seed Law, Agrochemicals Law, Biosafety Law and others.
In summary, the scope of protection of PVP Law is the following:
It covers the vegetative reproduction or multiplication material of the whole plant;
• It provides for civil sanctions (seizure, damages and fee payment), but no criminal penalties.
The abovementioned rule only regulates the protection of plant varieties, whereas patent protection is a separate instrument that seeks to protect another type of innovation, which can obviously be incorporated in a new plant variety.
The scope of protection of plant varieties differs from the scope of patent protection. The correct interpretation of Article 2 of the PVP Law is that it only regulates the intellectual property rights in plant varieties, without restricting the patent protection scope. Coexistence between plant variety protection and the protection afforded by the Patent Law is possible.
Intellectual property rights in plant varieties in no way interfere with intellectual property rights provided by patent protection. Plant varieties and inventions, which are the basis for the granting of said intellectual property rights, are different: plant varieties result from the improvement work of breeders, who obtained a variety different from the others, while the invention can be, for example, a gene inserted into the plant or an inventive process which modifies that variety, imparting it a novel feature (for instance, resistance to a certain type of herbicide). This gene or process can be patented if the traditional patentability requirements (such as novelty) are met. When an invention is added to the product of the work of the breeders, two human achievements and two distinct rights will meet: the right of the breeder, who has bred and developed a variety different from the others, and the right of the inventor, who has created, e.g., the gene or process incorporated into the plant.
As already mentioned, coexistence between plant variety protection and patent protection is possible. While the plant variety protection certificate focuses on the product achieved by the breeder, who succeeded in producing a new variety that is different from others, the patent recognizes the existence of an invention when the conditions of novelty, inventive step and industrial application are met, and said invention can focus on a modified gene or a gene mutation, whether incorporated or not to a plant variety.
Therefore, there is no obstacle in Brazil to the double (or triple, for that matter) protection of intellectual property. A plasma television, as an example, may have the following protections: protection film composition for a plasma display panel protected by patents, wallpaper protected by copyright, design protected by industrial design, not to mention the possibility of protection of as a three-dimensional trademark.
Any interpretation of the afomentioned Art. 2º of the PVP Law in the sense that it forbids patent protection to a plant already protected by a PVP certificate would be a violation of the Brazilian Constitution and of TRIPS.
Article 10 of the PVP Law defines exemptions. According thereto, anyone may store and plant seeds for his own use, sell or use as foodstuff or raw material or use the plant variety as a variation source for genetic improvement and scientific research. This last item is not valid if the original plant variety must be repeatedly used or in case of essentially derived varieties.
Moreover, being a small rural producer and given circunstances, he may multiply the seed for donation or exchange.
There is also the so-called "sugar cane exception" in paragraph 1 of article 10, which reads as follows:
Article 9 limits the PVP protection right to commercial reproduction and other commercial activities. Therefore, breeder or transformation activities cannot be prohibited by the right holder. Consequently, the authorization from the right holder is not necessary.
In addition, although §1 states that the provisions of the caput do not apply in the case of sugar cane, it refers to the requirement for the producer (farmer), involved in commercial activities. Not being a producer, we understand that §1 is not applicable to the breeder.
In addition to these limitations, there is the possibility of compulsory licensing and declaration of restricted public use, as set forth in Articles 28 and 36 of the PVP Law.
The applications for the protection of plant varieties, which include new varieties and essentially derived varieties, are filed with the National Plant Variety Protection Service – SNPC, an agency of the Ministry of Agriculture, Livestock and Supply (MAPA).
According to Brazilian rules, the candidate plant variety must meet the following criteria:
It should be the result of an improvement work;
It should not have been offered for sale in other countries for more than 4 years (or 6 years in the case of trees and vines);
It should not have been offered for sale in Brazil for more than a year;
It should be distinct;
It should be homogenous; and
It should be stable.
The last three requirements are supported by means of specific testing, namely Distinctness, Homogeneity and Stability Tests. In Brazil the breeders are responsible for implementation of the tests.
A variety is judged to be distinct if it is clearly distinguishable from any other variety of common knowledge at the time of the application. Distinctness is established on the basis of individual morphological characteristics. A variety is judged to be uniform or homogenous if it is sufficiently uniform in its relevant characteristics. Finally, a variety is stable if it remains unchanged after repeated propagation.
The protection is granted for 15 years as a rule and 18 years for vines and fruit, forest and ornamental trees, not covering the plant as a whole, but only the reproductive material or vegetative propagation.
It must be stressed that this protection in Brazil falls only on the reproductive or vegetative propagating material of the plant. Moreover, only new plant varieties or the essentially derived plant varieties that have all their descriptors known and their protection already authorized by SNPC will be liable to protection under the Brazilian PVP Law.
Until May 12, 2008, 1050 plant variety protection certificates were issued by SNPC for 44 different species, 358 of which are for soybeans and 72 for sugar cane.
According to Article 9 of the PVP Law, protection shall afford to its holder the right to commercial reproduction on the territory of Brazil (positive right), third parties being prohibited during the term of protection from producing for commercial purposes, offering for sale or marketing propagating material of the plant variety without his authorization (negative right).
Chapter 3: Biodiversity Access Legislation
Another important aspect to mention is Provisional Measure no. 2.186-16 of August 23, 2001 ("Provisional Measure"), which regulates access to the genetic heritage, protection of and access to associated traditional knowledge, sharing of benefits and access to and transfer of technology for their conservation and use. This Provisional Measure is the basis for a proposed bill, which is still under public consultation.
According to Article 31 of Provisional Measure, the applicant seeking protection for intellectual property rights must inform the origin of the genetic material, the genetic knowledge and the associated traditional knowledge, as appropriate.
Brazilian Patent Office Resolution No. 134 of December 13, 2006 states that every applicant for a patent must declare on filing whether or not the corresponding subject-matter of the application was obtained as a result of access to a sample of a component of the Brazilian genetic heritage and/or associated traditional knowledge. If this is the case, the date and number of the access certificate as issued by the competent Brazilian authority should also be provided. A misleading declaration could result in loss of the patent rights, among other penalties.