Part 6
Comparative analysis of regulations in Mercosur

Chapter 1
Regulation of intellectual property

Introduction

The Mercosur countries have taken significant steps to adapt their patent systems to the provisions of the TRIPS Agreement83. In September 1995, Argentina approved a new legal regime for invention patents84, while in 1996 Brazil passed a new Patent Law85. Uruguay did the same in 1999 and Paraguay adopted its law in November 200086. Patent protection has been significantly strengthened by extending the term of validity to 20 years, introducing pharmaceutical patents, reversing the burden of proof in litigation on process patents, and protecting against unfair use of secret information for the registration of pharmaceutical products.

Countries did not engage in identifying common approaches on this issue. This lack of coordination has led to different laws with different regulations for protection in each country. The members of Mercosur did not take the opportunity to coordinate their policies on patents and to resist external pressures, which are currently being expressed in the intention of the US pharmaceutical industry to question certain standards of protection of national legislation, and the US government, which is trying to lift regulations on protection in the region, in negotiations on the Free Trade Area of the Americas (FTAA).

Differences in regulatory protection (CORREA, 2001)

Using the leeway authorized by the TRIPS Agreement, the four national legal systems include new key aspects, which have no corresponding standard in all countries. Differences and similarities in significant aspects of protection are analyzed below:

Validity of the patent

Industrial property laws of Argentina, Brazil, Paraguay and Uruguay provide a period 20 years for validity of patents, counted from the date of application. Brazil has introduced the idea of awarding a minimum of 10 years counted from the date of granting the patent, if there is any delay in granting the patent due to lawsuits or force majeure.

Parallel imports

Argentina allows parallel imports when the product has been legally placed in commerce in a foreign market. Paraguay and Uruguay allow the performance of commercial acts related to the protected product, relying on its introduction into lawful trade in any country by the owner or by legally authorized persons. Brazil does not provide for the possibility of parallel imports when the product protected by a patent has been legally placed in commerce in the external market, although it exclusively authorizes importation of living matter on condition of not it being used for commercial propagation.

Compulsory licenses

Brazilian law grants licenses due to lack of exploitation, patent dependency, in cases of emergency or public interest, and due to abuse by the patent owner. Argentina uses similar conditions, but defines more precisely the conduct that is abusive, specifying types actions that can be considered anti-competitive practices, without prejudice to other behaviors defined in the law on protecting competition. Paraguay and Uruguay also incorporate this concept.

Brazil requires the patent owner to manufacture the product or use the process in the country, except in case of economic unfeasibility. Argentina does not have a similar regulation to provide for compulsory licenses due to lack of exploitation or insufficient exploitation. This criterion is not included in the legislation of Paraguay and Uruguay.

Reversing the burden of proof

All countries have introduced, in their legislation, an article that allows a judge to reverse the burden of proof in disputes regarding new products or processes, although not all countries have extended this to cover the same things: Brazil, Argentina and Paraguay have authorized this for products, while Uruguay has authorized this for processes.

Pharmaceutical patents

Pharmaceutical inventions are patentable in Argentina after the lapse of five years from publication of the law. The extension period of five years applied to pharmaceutical products has not been expanded to cover chemical, non-pharmaceutical or non-veterinary products, such as pesticides, fertilizers, dyes, etc. The situation of such products has not changed with regard to their protection and exploitation under the new law. Argentina has honored the commitments made with the ratification of the GATT-TRIPS Agreement regarding the protection of pharmaceutical products.

Uruguay has established a similar system, which lasted until November 2001. Brazil recognizes patenting of pharmaceutical products with retroactivity, allowing their protection if they are not traded on any market and where the applicant has obtained a patent in the country where the first application was filed. Argentina has adopted a transitional period of 5 years in accordance with TRIPS, and the same was done by Uruguay. Meanwhile, Paraguay has adopted a transition by January 1, 2003. This is an important issue that may be brought up again in a subsequent comparative analysis of the consequences of specific strategies on the development of biotechnology in the pharmaceutical industry in the Mercosur countries.

The Pharmaceutical Research and Manufacturers of America (PhRMA) requested the inclusion of Argentina among the countries that allegedly infringe upon intellectual property rights. In the same list and in the category of “Priority Foreign Country,” are Brazil, South Africa and India. The US entity accused the Argentine government of “allowing local copying of pharmaceutical innovations” and “making it easier for local companies to appropriate intellectual property rights” from the entity’s companies, and recommended application of trade sanctions as provided for in section 301 of the US Trade Act of 1974.

Criticisms by US industry of Argentine legislation on intellectual property included claims that it “does not present sufficient guarantees” and that the Argentine government refuses to sign an “agreement” within the framework of the World Trade Organization (WTO), an organization that attempted a mediation between the two countries. The United States positioned itself against Brazil in the WTO due to its local manufacturing clause and denounced Argentine law for its use of compulsory licenses.

Acts in good faith

The laws of Brazil, Paraguay and Uruguay agree that rights of the patent owner may be restricted, provided that the product or the process to which the patent is directed has been introduced into commerce in the country prior to the filing date of the patent being applied for, which would constitute an act performed in good faith. Argentina’s legislation also acknowledges the limitation of the right of the patent owner where consistent preparations have already been made for the introduction of the product into the market.

Development of the institutional system

The institutional system has been developed within Mercosur. All countries have institutional areas responsible for managing industrial property issues. In Argentina and Brazil, they were organized in the form of the National Institutes of Industrial Property (INPI). In Paraguay, regulation depends on the Directorate of Industrial Property (DGPI) [Dirección General de la Propiedad Intelectual] of the Ministry of Trade and Industry and in Uruguay, it depends on the National Directorate of Industrial Property (DNPI) [Dirección Nacional de la Propiedad Industrial], of the Ministry of Industry, Energy and Minerals.

As already discussed, Argentina and Brazil have adopted a structure involving national institutes, which enjoy an important institutional autonomy. This is the structure of choice in international experience. Paraguay and Uruguay have entrusted this responsibility under the direction of public bodies, belonging to national government ministries, which have less autonomy from the legal-functional point of view.

National development strategies

The industrial property laws of Brazil, Paraguay and Uruguay have exceptions to the rights of the patent owner, giving a third, unauthorized party, the power to perform acts or experiments conducted solely in order to obtain information in order to process a registration, or preparations for future commercial exploitation, before a patent’s expiration date. Uruguay authorizes this from one year prior to expiration, Paraguay authorizes this from 30 days prior, while Brazil does not provide any date. In Brazil, this modification was introduced by a recently enacted law87 which extends the scope of the country’s industrial property law in this area. In Argentina, legislation has made no provisions regarding this issue.

It is also worth noting that in Brazil, patent law includes a topic on applying for a patent and establishes a special procedure for products or processes related to national defense. The other Mercosur countries still have not introduced a corresponding consideration to their respective laws.

Patents in the field of biotechnology

Patenting of plants and animals

In the four Mercosur countries, patenting in biotechnology has been dealt with and incorporated into their laws governing intellectual property. In Argentina, the patent law was approved after a complex proceeding. Law No. 24,481 was revised one month after its approval, with the Executive branch vetoing several articles. Finally, in 1996 the consolidated text [Texto Ordenado (T.O.)] of Law No. 24,481 was published, amended by Law No. 24,572, which is in effect to this day. Some important issues were introduced later by Decree No. 260/96, which regulates the articles of that law (CORREA, 1996).

Article 6 (g) states that “all kinds of living matter and substances pre-existing in nature,” do not result in patent, because they are not inventions, a decision intended to exclude the patentability of substances existing in nature. Article 7 (b) established as unpatentable “the totality of the biological and genetic material existing in nature or its replica in biological processes implicit in animal plant and human reproduction, including processes related to genetic material capable of conducting its own replication in normal and free conditions, as occurs in nature.” Finally, Decree No. 260/96, regulating Article 6, incorporated the idea that “plants, animals and essentially biological procedures for their reproduction” are not patentable

According to some experts (CORREA, 1996), Article 7 (b) partially overlaps with Article 6 (g) by strengthening the concept of non-patentability of substances existing in nature and biological processes, but does not refer to “essentially biological” processes, leaving it open to be discussed whether they do or do not need to be included in the area of patenting. In summary, the situation in Argentina would be as follows (CORREA, 1996):

Decree No. 260/96, which regulates the Law, renewed the prohibition on patenting plants and animals. The Law and Decree contradict each other, as the Decree prohibits patenting and the Law permits it. Of course, the one that should prevail is the Law.

In the case of Brazil, Law No. 9,279/96 excludes from patenting, due to the fact they do not constitute an invention, all or part of natural living beings and biological materials found in nature or isolated from it, including the genome or germplasm of any natural living thing and natural biological processes. Under this law, whole or parts of living beings are not patentable, except transgenic microorganisms that meet the general requirements of patentability – novelty, inventive step and capability of industrial application – and which do not represent a mere discovery.

Paraguay does not consider as patentable plants and animals other than microorganisms and essentially biological procedures for the production of plants and animals, provided they are not non-biological or microbiological.

For Uruguay, plants and animals do not constitute an invention. But microorganisms and essentially biological procedures for the production of plants or animals are patentable, except for non-biological or microbiological procedures.

In summary, the situation in the Mercosur countries is as follows: essentially biological processes are not patentable in Brazil, Paraguay and Uruguay; however, they are patentable, by omission, under Argentine legislation. Plants and animals are not patentable in any of those countries, with the only possible exclusion being animals in Argentina.

Patents on microorganisms

The legislative systems of Argentina, Brazil, Paraguay and Uruguay have incorporated patenting microorganisms, although some doubts remain about Argentine legislation. In practice, this country does grant patents for microorganisms. The law in Brazil is the only one that includes a definition of genetically modified microorganisms, understanding them to be organisms, other than whole or part of plants or animals, which express, through direct human intervention in their genetic composition, a trait not normally attainable by the species under natural conditions.

All four countries have introduced, as a condition for granting this patent, the deposit of biological material in authorized banks. These banks must be accredited by the World Intellectual Property Organization (WIPO), so that they can participate in international agreements. The law of Argentina requires certain requirements to be fulfilled for this purpose88. Paraguayan law does not require the deposit of the microorganism strain, if this procedure has already been performed in a WTO country. Uruguay has established the requirement for authorization by its National Directorate of Industrial Property (DNPI) [Dirección Nacional de la Propiedad Industrial], under the Ministry of Industry, Energy and Minerals, until the country ratifies international agreements on the matter.

The laws of Argentina and Brazil incorporate the requirements of accessibility to the public of the microorganism from the date of publication of the patent application. Paraguay and Uruguay did not have regulations on the matter. Argentina adds the possibility that such persons may obtain a sample if they meet the conditions established by regulation. In practice, these considerations do not have immediate consequences, since there is no accredited database of microorganisms in the Mercosur countries.

Breeder’s rights

The only type of protection of intellectual property rights for plant varieties that is enforced by Mercosur countries is legislation regarding Plant Breeder’s Rights (PBR). All countries have such legislation, which allows protected varieties to be available to develop new varieties without prior consent from the breeder of the original variety (“breeder’s exception”), and allows farmers to re-use the propagating material of a variety protected by DOV for its continuous planting (“farmer’s privilege”). The four countries that make up Mercosur have joined, at various times, the International Union for the Protection of New Varieties of Plants (UPOV).

The oldest law of plant varieties protection is from Argentina89, approved in 1973. Paraguay adopted its law in 199190, while Uruguay adopted its law in 199791. The most modern law is that of Brazil92, adopted in 2000. On December 25, 1994, Argentina signed the UPOV Act of 197893, and it was signed by Brazil on May 23, 199994. Paraguay approved its accession to UPOV 78 with Law No. 988/96 dated November 14, 1996, and Uruguay acceded to UPOV 78 on November 13, 199495, and in 1997 it passed Law No. 16,811, which regulates Property Rights for Plant Varieties under UPOV 7896.

Unlike what happens in the field of industrial property rights, national laws on breeder’s rights in the Mercosur countries have converged to establish a strong foundation of uniformity, based on their relation to the same international organization, i.e., UPOV. National laws show only insignificant differences, such as the duration of protection, which in Brazil is 2 years less than in the other Mercosur countries, or in the treatment of farmers based outside the country. The biggest difference is seen in the Brazilian legislation, which has incorporated the concept of “essentially derived variety,” in conformance with UPOV 91.

Institutional organization in this area follows its own pattern, also distinct from that described for the regulation of industrial property. Argentina and Uruguay each created a National Seeds Institute (INASE) [Instituto Nacional de Semillas], which reports to the Ministry of Agriculture, Livestock, Fisheries and Food (SAGPyA) [Secretaría de Agricultura, Ganadería, Pesca y Alimentos] and the Ministry of Agriculture, Livestock and Fisheries (MGAP) [Ministerio de Ganadería, Agricultura y Pesca], respectively97. Meanwhile, Brazil established a National Plant Variety Protection Service (SNPC) [Serviço Nacional de Proteção de Cultivares] under the Ministry of Agriculture, Livestock and Food Supply (MAPA) [Ministério da Agricultura, Pecuária e Abastecimento]. In Paraguay, this function is handled by the Directorate of Seeds (DISE) [Dirección de Semillas] under the Ministry of Agriculture and Livestock (MAG) [Ministerio de Agricultura y Ganadería].

Chapter 2
Biosafety regulations

Principles, models and institutional organization

All Mercosur member countries have developed institutional structures responsible for dealing with biosafety of GMO products. The mechanism used is basically the creation of an Advisory Committee composed of experts, responsible for issuing assessments and producing non-binding opinions and findings, to support decision-making by state ministries and/or departments responsible for adopting administrative decisions.

These Advisory Committees have distinct functions, such as specific responsibility per productive area where GMOs occur, and institutional location and status. The major differences are, however, in the principles adopted by each country, the level of complexity of national systems and the degree of experience in regulation.

Fields of application and technical and institutional areas of coverage

In Brazil, technical responsibility for regulation of biosafety lies with the National Technical Commission on Biosafety (CTNBio) [Comissão Técnica Nacional de Biossegurança], under the Ministry of Science and Technology. CTNBio operates in the field prescribed by Law No. 11,105/2005 and has technical expertise on activities related to GMOs in all areas. It operates in conjunction with the Ministries of Environment, Health and Agriculture, which, through technical findings issued by CTNBio, process decisions through their own agencies, and in accordance with their respective duties.

Argentina has a more complex regulatory system, in which several advisory committees participate, linked to various bodies. The National Advisory Commission on Agricultural Biotechnology (CONABIA) [Comisión Nacional Asesora de Biotecnología Agropecuaria] is responsible for the field of genetically modified plants98, while the National Service for Agrifood Health and Quality (SENASA) [Servicio Nacional de Sanidad y Calidad Agroalimentaria] (SENASA, 1999)99 is oriented towards food, transgenic microorganisms and genetically modified animals. Both institutions present their recommendations to the Ministry of Agriculture, Livestock, Fisheries and Food (SAGPyA). The National Commission on Biotechnology and Health (CONBYSA) [Comisión Nacional de Biotecnología y Salud] (CONBYSA, 1994)100 is responsible for the area of human health, and submits its recommendations to the Ministry of Health.

In the Argentine system, analyzing the impact of GMOs on the environment is the responsibility of CONABIA, and its findings on the matter are adopted by SAGPyA. In the case of genetically modified plants, the Argentine system includes the National Directorate of Agrifood Markets (DNMA) [Dirección Nacional de Mercados Agroalimentarios] under SAGPyA, which is responsible for assessing the impact of GMO releases on the country’s international trade.

In Paraguay, the Advisory Committee for Biotechnology (CAB) is responsible for technical issues related to GMOs in agriculture, and its recommendations are submitted to the Ministries of Agriculture (MAG) and Public Health and Welfare (MSPBS). Finally, Uruguay’s Commission on Risk Assessment of Genetically Modified Plants (CERVGM) [Comisión de Evaluación de Riesgo de Vegetales Genéticamente Modificados] has technical responsibility for the impact of genetically modified plants on health and the environment, and its findings serve as input to the decisions of the Ministries of Livestock, Agriculture and Fisheries (MGAP), and Housing, Environment and Land Use Planning (MVMAOT).

Precautionary principle versus substantial equivalence

The Mercosur countries focus on the regulation of biosafety of GMOs using different principles. Argentina and Uruguay use a similar approach, essentially in the tradition of the American and Canadian systems, based on the principles of “risk assessment and management” for the consideration of environmental problems, and “substantial equivalence” for risk assessment of food.

Brazil and Paraguay use principles inspired by the European system, which focuses on the “precautionary principle,” incorporated into the Conference on Biological Diversity and, more recently, the Cartagena Protocol on Biosafety. Environmentally, this principle presupposes that potentially hazardous effects deriving from a phenomenon, product or process can be identified, but scientific assessment does not permit determining the risk with sufficient certainty. The regulatory system based on this principle also assumes that genetically modified foods are not equivalent to common foods, which is why they must meet different safety requirements.

Accumulated regulatory experiences

The most prominent regional experience in the field of regulation is that of Argentina. Its success can be seen in agriculture, following the explosive development of the cultivation of genetically modified crops, which made Argentina one of the countries with the largest area planted with genetically modified varieties and the second largest world exporter of GMOs. The performance of the Argentine regulatory system extends to other crops such as corn, cotton, rapeseed (canola) and some smaller varieties. CONABIA evaluates, supervises and controls more than 650 events, from laboratory trails to commercial releases, and recently approved and released six genetically modified crops for commercial exploitation.

In Brazil, regulatory activity has been severely hampered by political barriers to the development of GMOs in the country. The strong dynamic of research and development, particularly in the public sector, has not translated into a significant impact on innovation. Resistance from environmental groups and sectors of the political structure, coupled with decisions by federal and state courts, have prevented the commercial use of crops that had received favorable technical findings from CTNBio and favorable political and administrative decisions from the ministry responsible for the releases. Brazil has two crops released: herbicide-tolerant soybeans and insect-resistant cotton, but the aforementioned barriers are impeding their entry into the market and their extensive use in agriculture.

In Paraguay, the Agriculture Biosafety Commission (CBA) believes that preliminary studies carried out on varieties of genetically modified soy and corn have given results which discourage the introduction of these crops into the country. Because of this, the Subsecretariat of Natural Resources and Environment (SSERNMA) of the Ministry of Agriculture and Livestock (MAG) has established successive bans on the use of GMO seeds in the last two seasons in the country. In the case of Uruguay, the current Commission on Risk Assessment of Genetically Modified Plants (CERV) issued a favorable finding, and the Ministry of Livestock, Agriculture and Fisheries (MGAP) approved the introduction of a variety of genetically modified soya, which is grown in small areas in a demarcated region in the country.

In the context of a relatively small regulatory activity, the regulatory system of Uruguay, based on the scientific capacity of the National Institute of Agricultural Research (INIA) and other biotechnology research institutions in the country, has scientific prestige that supports its decisions. Its equivalent in Paraguay, in contrast, is based on a reduced internal scientific capacity, which is why there is concern that technical decisions are influenced by political motives101. In the latter country, there exists a semi-official discourse about a GMO-free country, which is contrary to the intentions of agricultural producers.

Mechanisms for public participation

The countries in the Mercosur bloc give different treatment to issues of public perception and acceptance of biotechnology. In Argentina and Brazil, there are no mechanisms for public participation in the authorization process for products or processes based on GMOs. In Uruguay, legislation provides that before adopting any resolution, the competent authority must make available in their offices the authorization application, the results of the evaluation of its risk assessment and other relevant documentation, so that the public can obtain knowledge and make assessments. In the case of Paraguay, the Agriculture Biosafety Commission (CBA) includes a representative from the Network of Environmental Organizations of Paraguay (ROAM) [Red de Organizaciones Ambientalistas del Paraguay].

Product labelling

Commercial labelling of products based on GMOs has not been widely disseminated among the Mercosur countries. Argentina and Paraguay have established systems, and Uruguay has a project that is under study by the National Parliament. In the case of Brazil, there is a law passed by Congress and Ordinance No. 2,658 dated December 22, 2003, which defines the symbol designating the labelling described in Decree No. 4,680.

Comparative tables of regulations on biosafety

Table 5. Features and institutional capacities of countries.

Regulation

Argentina

Brazil

Paraguay

Uruguay

Laws supporting development of biotechnology

No

Yes

No

Yes

National biotechnology committees

No

Yes

Yes

Yes

Regulation of production areas in which GMOs are used

Human health

MS

MS / CNS

MSPBS

MSP

Agriculture and livestock

SAGPyA

MAPA

MAG / MSPBS

MGAP

Foods

SAGPyA / MS

MS / Interinstitutional commission

MS

MSP

Environment

MBS

MMA / CONAMA / IBAMA

SRN and MAM

MVMAOT

Laws or ordinances establishing the general regulatory framework

Decree-Law No. 6,704/66

Law No. 20,247/73

Law No. 13,636/49

Food Code Decree No. 811/99

Law No. 11,105/2005

Law No. 18,481/97

Law No. 385/94

Law No. 16,466/94

Regulations specific to GMOs

Human health

No

Regulatory Rulings (INs) [Instruções Normativas]
No. 8, 9

No

Agriculture and livestock

SAGPyA Resolutions No. 656/92, 837/93, 289/97 and 131/98 226

INs No. 2, 3, 4, 5, 6, 10, 11, 12, 13, 18

Law No. 82/99

DGSA Resolutions No. 8/7/95, 8/12/95 and 13/1/96

Foods

SAGPyA Resolutions No. 289/97 Annexes and 511/98

Law No. 10,467/99

Decree No. 3,871/01

Law No. 836/80 on the Health Code

Environment

No

Laws No. 6,938/81

and 9,605/98

Provisional Measure No. 1,710-1/98

No

Entities with direct responsibility for regulations on biotechnology

Drugs and medicines

Entity

CONBYSA

CTNBio

No

Does not exist.

Functions

Advisory commission

Consultative body

-

-

Regulation creating the entity

ANMAT Resolution No. 413/93

Law No. 11,105/2005

-

-

Plants

Entity

CONABIA

CTNBio

CBA

CERV

Functions

Advisory commission

Consultative body

Advisory commission

Advisory commission

Regulation creating the entity

SAGPyA Resolution No. 124/91

Decree No. 18,481/97

Executive Decree No. 249/2000

Animals

Entity

CTAUOGM

CTNBio

No

Does not exist.

Functions

Advisory commission

Consultative body

-

-

Regulation creating the entity

SENASA Resolution No. 1,265/99

Law No. 11,105/2005

-

-

Simplified procedures

No

No

No

Under study

The Cartagena Protocol

Yes

Yes

-

No

Enforcement agency

Under discussion

No

Yes

No

Focal point

SAGPyA (for Clearinghouse)

No

(no data)

No

Table 6. Release of GMOs in the agricultural sector.

Regulatory attributes

Argentina

Brazil

Paraguay

Uruguay

Agency responsible for regulating release of GMOs in agriculture

SAGPyA

CTNBio (consultative); MAPA or MMA or MS (executive)

CBA

MGAP

Agency responsible for overseeing release of GMOs

Risk assessment

CONABIA

CNTBio (along with MAPA, MMA and MS)

Yes

CERVGM

Crop inspections

SENASA / INASE

CNTBio and MAPA

No crops authorized

Yes

Registration of cultivars

INASE

SNPC

DISE

INASE

Commercial release

SAGPyA

CNTBio, may also be assessed by CNBS

No

MGAP and MEF

Interinstitutional coordination

Link between biosafety and registration of cultivars

Yes

Yes

Yes

Partial

Types of authorization for environmental release

Greenhouse laboratory trial

Yes

Yes

Yes

Yes

Field trial

Yes

No

No

Yes

Pre-commercial multiplication

Yes

No

No

Yes

Commercial multiplication

Yes

No

No

Yes

Number of GMO crops released for marketing

6

2

0

2

Considerations for authorizing environmental release of GMOs

Characteristics of the material / organism subject control / donor-recipient-vector system

Yes

Yes

Yes

Purpose of the experiment and schedule of operations

Yes

Yes

-

Yes

Biosafety methods and procedures to be employed

Yes

Yes

Yes

Final disposal of the GMO

Yes

Yes

Yes

Proposed method of transfer

Yes

Yes

Yes

Commercial approval of GMOs

Yes

No

No

Yes

Non-regulatory mechanisms of marketing of GMOs

Perception and public acceptance

No

Yes

Resolution No. 554/99

Public hearing

Labelling

Under study

Yes

Under study

Draft law before Parliament

Evaluation of the impact on international trade

Yes

Yes

Yes

Yes

Difference between GMOs and traditional genetics

Registration and certification

No

Yes

No

Crop trials

No

Yes

No

Abbreviations used in Tables 5 and 6

Argentina

ME: Ministry of Economy [Ministerio de Economía]

MP: Ministry of Production [Ministerio de la Producción]

MS: Ministry of Health [Ministerio de Salud]

MDSyMA: Ministry of Social Development and the Environment [Ministerio de Desarrollo Social y Medio Ambiente]

SI: Department of Industry [Secretaría de Industria], under ME

SAGPyA: Ministry of Agriculture, Livestock, Fisheries and Food [Secretaría de Agricultura, Ganadería, Pesca y Alimentación], under ME

SEDSyPA: Ministry of Sustainable Development and Environmental Policy [Secretaria de Desarrollo Sustentable y Política Ambiental], under MDSyMA

SPyRS: Ministry of Health Policy and Regulatory [Secretaría de Política y Regulación Sanitaria], under MS

ANMAT: National Administration of Food, Drug and Medical Technology [Administración Nacional de Medicamentos, Alimentos y Tecnología Médica], under MS

INAL: National Institute of Food [Instituto Nacional de Alimentos], under ANMAT

INAME: National Institute of Drugs [Instituto Nacional de Medicamentos], under ANMAT

SENASA: National Service of Agrifood Health and Quality [Servicio Nacional de Sanidad y Calidad Agroalimentaria], under SAGPyA

INASE: National Seeds Institute [Instituto Nacional de Semillas], under SAGPyA

CTAUOGM: Technical Advisory Committee on the Use of GMOs [Comité Técnico Asesor para el Uso de OGM], under SENASA

CONABIA: National Commission on Agricultural Biotechnology [Comisión Nacional Asesora de Biotecnología Agropecuaria], under SAGPyA

CONBYSA: National Commission on Biotechnology and Health [Comisión Nacional de Biotecnología y Salud], under ANMAT

DNMA: National Directorate of Agrifood Markets [Dirección Nacional de Mercados Agroalimentarios], under SAGPyA

Brazil

ANVISA: National Health Surveillance Agency [Agência Nacional de Vigilância Sanitária]

CNBS: National Biosafety Council [Conselho Nacional de Biossegurança]

CNS: National Health Council [Conselho Nacional de Saúde]

CONAMA: National Council for the Environment [Conselho Nacional do Meio Ambiente]

CTNBio: National Technical Commission on Biosafety [Comissão Técnica Nacional de Biossegurança]

IBAMA: Brazilian Institute of Environment and Natural Resources [Instituto Brasileiro do Meio Ambiente e dos Recursos Naturais Renováveis]

MAPA: Ministry of Agriculture, Livestock and Supply [Ministério da Agricultura, Pecuária e Abastecimento]

MMA: Ministry of the Environment, Water Resources and the Legal Amazon [Ministério do Meio Ambiente, dos Recursos Hídricos e da Amazônia Legal]

MS: Ministry of Health [Ministério da Saúde]

SISNAMA: National System of the Environment [Sistema Nacional do Meio Ambiente]

SNPC: National Plant Varieties Protection Service [Serviço Nacional de Proteção de Cultivares], under MAPA

Paraguay

CBA: Biosafety Commission [Comisión de Bioseguridad Agropecuaria], under MAG and MSPBS

MAG: Ministry of Agriculture and Livestock [Ministerio de Agricultura y Ganadería]

MSPBS: Ministry of Public Health and Welfare [Ministerio de Salud Pública y Bienestar Social]

SSERNMA: Subsecretariat of Natural Resources and Environment [Subsecretaría de Estado de Recursos Naturales y Medio Ambiente], under MAG

Uruguay

MGAP: Ministry of Livestock, Agriculture and Fisheries [Ministerio de Ganadería, Agricultura y Pesca]

MVMAOT: Ministry of Housing, Spatial Planning and Environment [Ministerio de Vivienda, Medio Ambiente y Ordenamiento Territorial]

MEC: Department of Education and Culture [Ministerio de Educación y Cultura]

CNB: National Committee for Biotechnology [Comité Nacional de Biotecnología]

INASE: National Seeds Institute [Instituto Nacional de Semillas], under MGAP

INIA: National Institute of Agricultural Research [Instituto Nacional de Investigación Agropecuaria]

DGSA: General Directorate of Agricultural Services [Dirección General de Servicios Agrícolas], under MGAP

CERVGM: Commission on Risk Assessment of Genetically Modified Plants [Comisión de Evaluación de Riesgo de Vegetales Genéticamente Modificados], under MGAP

Comparative tables of regulations on intellectual property

Table 7. Intellectual property protection.

Regulation

Argentina

Brazil

Paraguay

Uruguay

Industrial property

Invention patents

Law No. 24,481, modified by Law No. 24,572 (T.O. 1996)

Decree No. 260/96

Law No. 9,279/96, Decree 2,553/98 and Law No. 10,196/2001

Law No. 1,630

Law No. 17,164

Utility Models

Law No. 24,481, modified by Law No. 24,572 (T.O. 1996)

Decree No. 260/96

Law No. 9,279/96

Law No. 1,630

Law No. 17,164

Industrial model and designs

Decree-Law No. 6,673/63

Law No. 9,279/96

Law No. 17,164

Trademarks

Law No. 22,362

Law No. 9,279/96

Law No. 1,294/98

Law No. 17,011

Technology transfer

Law No. 22,426

Law No. 9,279/96

Law No. 17,164

Enforcement agency

INPI

INPI

DGPI

DNPI

Breeder’s Rights

Seeds law

Law No. 20,247 and Decree No. 2,183/91

Law No. 9,456/97

Law No. 385

Law No. 16,811

Accession to UPOV

Law No. 24,376

Legislative Decree No. 28/99

Law No. 988/96

Law No. 16,580

Enforcement agency

INASE

SNPC

DISE

INASE

Confidentiality

Law 24,776

Law No. 17,164

Table 8. Invention patents.

 Rights holder

Argentina inventor

Brazil inventor

Paraguay inventor

Uruguay inventor

Inventions developed during the employment relationship

Total or partial right of the employer.

Additional remuneration or compensation (50% of benefits)

Total right of the employer, unless agreed in contract

Total right of the employer

Total or partial right of the employer

Additional remuneration or compensation (50% of benefits)

Validity of advance waiver of rights worker

Null and void

Not applicable

Not applicable

Any provision less favorable to the inventor is null and void

Conditions for protection

Novelty

Absolute novelty

Absolute novelty

Absolute novelty

Absolute novelty

Disclosure

Does not affect the novelty that year

Does not affect the novelty that year

Does not affect the novelty that year

Does not affect the novelty that year

Duration of invention patent

Twenty years

Twenty years

Twenty years

Twenty years

Regulatory body

INPI

INPI

DGPI

DNPI

Transitional arrangements

Pharmaceutical and chemical-agricultural industry (until March 31, 2001)

No

No

Pharmaceutical
and chemical-agricultural industry (until November 30, 2001)

Patents of addition

Yes

Yes

No

No

Patents of interest to national defense

No

Yes

No

No

Patents for foreign individuals or legal entities

Persons with established legal domicile in the country

Persons protected by international agreements or domiciled in the country

Accepted without requirements

Accepted without requirements

Unpatentable materials

Because they are not inventions

All types of living matter and substances existing in nature. Plants, animals and essentially biological procedures for reproduction

All or part of natural living beings and biological materials found in nature or isolated from it, including the genome or germplasm of any natural living being and natural biological processes

Plants and animals, other than microorganisms and essentially biological procedures for the production of plants or animals, except for non-biological or microbiological procedures. Biological and genetic material as it exists in nature

Not patentable

The totality of biological and genetic material existing in nature or its replica, in biological processes implicit in animal, plant and human breeding, including processes related to genetic material capable of conducting its own replication in normal and free conditions as occurring in nature

All or part of living beings, except transgenic microorganisms meeting the three patentability requirements – novelty, inventive step and capability of industrial application – provided for in Art. 8 and which are not a mere discovery

Plants and animals other than microorganisms and essentially biological procedures for the production of plants and animals that are not non-biological or microbiological processes

Rights conferred

Exclusive right to exploit

Yes

Yes

Yes

Yes

Sanctions against fraud

Criminal and civil

Criminal and civil

Criminal and civil

Criminal and civil

Reversing the burden of proof

For process patents

For process patents

For process patents

For process patents

Limitations on rights conferred

Exception for activities of R&D, testing or teaching

Yes

Yes

Yes

Yes

Experimentation, including preparation of a future commercial exploitation

No

Yes

30 days before expiration

During the year prior to expiration

Inventions in state-authorized monopolies

No

No

No

Exploitation authorized by the owner of the monopoly, or by its suspension

Introductions into trade prior to filing and based on acts of good faith

No

Yes

Yes

Yes

Products lawfully placed into trade

Yes

Yes102

Yes

Yes

Exceptions

Monopolistic or anti-competitive conduct

Yes

Yes

Yes

Yes

License due to dependent patents

Yes

Yes

Yes

Yes

Lack of exploitation

After three years from the granting of the patent, or after four years from filing the application

After three years from the granting of the patent

After three years from the granting of the patent, or after four years from filing the application

After three years from the granting of the patent, or after four years from filing the application

Lack of sufficient exploitation or production in the country

No

Yes

No

No

Reasons of public interest

Yes

Yes

Yes

Yes

Table 9. Patenting of microorganisms.

Patenting

Argentina

Brazil

Paraguay

Uruguay

Patentability of microorganisms

Yes

Yes

Yes

Yes

Obligation to deposit the strain

Yes

Yes

Yes

Yes

Requirements of depositary institutions

Accepted by WIPO or meeting determined requirements103

Accepted by INPI or specified in an international agreement

It is not necessary to perform deposit if it has already been done in a WTO country

Authorized by DNPI, pending ratification of international agreements on this matter

Accessibility of microorganism

Access from the time of publication

The public can obtain samples

Access from the time of publication

No

No

Existence of accredited depositaries in the country

No

No

No

No

Table 10. Plant variety property.

Property

Argentina

Brazil

Paraguay

Uruguay

Material eligible for protection

Plant breeding creations or plant varieties

Yes

Yes

Yes

Yes

Essentially derived plant varieties

No

Yes

No

No

Definition of plant breeding creations

The plant variety obtained by discovery or application of scientific knowledge to hereditary breeding of plants

A variety of any genus or species of higher plant species that is clearly distinguishable from other plant varieties, known by a minimum margin of descriptors, by its own denomination, which is homogeneous and stable and is a species capable of use by the agroforestry complex, as described in specialized publications, available and accessible to public, or equal to component lineages of the hybrids

A cultivar or variety, whatever its genetic nature, obtained by discovering or incorporating or transferring and/or applying scientific knowledge of hereditary plant breeding

A set of cultivated plants which is distinguished from rest of its species by any trait and which maintains its own traits under sexual or asexual reproduction104

Rights holder

Property right on the obtained plant

Breeder

Breeder

Breeder

Creator

Scope of property right

Cannot be used without the express authorization of the creator

Exclusivity in exploitation

Exclusivity in exploitation

Exclusivity in exploitation

Conditions for plant variety protection

Differentiation

Yes

Yes

Yes

Yes

Uniformity or homogeneity

Yes

Yes

Yes

Yes

Stability

Yes

Yes

Yes

Yes

Novelty of the cultivar

Yes

Yes

Yes

Yes

Mechanisms of reproduction or propagation of the cultivar

No

Yes

Yes

Yes

Declaration of limited public use

For a period greater than 2 years

Yes

Scope of protection

Protection of varieties of plant species

Yes

Yes

Yes

Yes

Protection of new varieties “discovered” for spots affecting fruit tree varieties

Yes

No

No

No

Protection of species found in nature

No

No

No

No

Accession to UPOV

UPOV 1978 Act

Yes

Yes

Yes

Yes

Other UPOV Acts

No

Yes

No

No

Essentially derived variety

No

Yes

No

No

Farmer’s privilege

Yes

Yes105

Yes

Yes

Term of the title to property

Between 10 and 20 years, depending on the species

Between 15 and 18 years, depending on the species

Between 15 and 20 years, depending on the species

Between 15 and 20 years, depending on the species

Regulators

INASE

SNPC

DISE

INASE

Can be used to create a new plant variety

Yes

Yes

Registration of cultivars for farmers domiciled abroad

If there is reciprocity with the foreign country and the person has legal domicile in Argentina

Yes

Yes, if the representative has legal domicile in the country

If a representative has established a domicile in the country

Abbreviations used in Tables 7, 8, 9 and 10

Argentina:

INASE: National Seeds Institute [Instituto Nacional de Semillas], under SAGPyA

INPI: National Industrial Property Institute [Instituto Nacional de la Propiedad Industrial], under ME

ME: Ministry of Economy [Ministerio de Economía]

SAGPyA: Ministry of Agriculture, Livestock, Fisheries and Food [Secretaría de Agricultura, Ganadería, Pesca y Alimentación], under ME

Brazil:

INPI: National Institute of Industrial Property [Instituto Nacional da Propriedade Industrial], under MCT

Ministry of Agriculture, Livestock and Food Supply (MAPA) [Ministério da Agricultura, Pecuária e Abastecimento]

SNPC: National Plant Varieties Protection Service [Serviço Nacional de Proteção de Cultivares], under MAPA

Paraguay:

DISE: Directorate of Seeds [Dirección de Semillas], under MAG

DGPI: Directorate of Industrial Property [Dirección General de la Propiedad Intelectual], under MIC

MAG: Ministry of Agriculture and Livestock [Ministerio de Agricultura y Ganadería]

MIC: Ministry of Industry and Trade [Ministerio de Industria y Comercio]

Uruguay:

DNPI: National Directorate of Industrial Property [Dirección Nacional de la Propiedad Industrial], under MIEM

INASE: National Seeds Institute [Instituto Nacional de Semillas], under MGAP

MGAP: Ministry of Livestock, Agriculture and Fisheries [Ministerio de Ganadería, Agricultura y Pesca]

MIEM: Ministry of Industry, Energy and Mining [Ministerio de Industria, Energía y Minería]

International:

OECD: Organisation for Economic Cooperation and Development

WIPO: World Intellectual Property Organization

UPOV: International Union for the Protection of New Varieties of Plants