Notes

1 Database of REDBIO, membership listing of the Argentine Forum on Biotechnology (FAB) [Foro Argentino de Biotecnología] and the Directory of Biotechnology Institutions [Diretório de Instituições Biotecnológicas], Fiocruz Foundation website: http://www.procc.fiocruz.br.

2 Diagnósticos Vegetales SRL, Garbi Biotecnología Vegetal, Laboratorio de Cultivo in vitro Proarpa S.A., Propagar and Tecnoplant S.A., members of REDBIO.

3 Between June 1999 and June 2000, the Argentine pharmaceutical industry sold US$ 3.840 billion in products, of which US$ 3.3 billion was for products sold by prescription and US$ 540 million was for OTC products.

4 The industry suffered a setback in its production capacity as a result of the status achieved (and now lost) by Argentina, as a country free of foot-and-mouth disease without vaccination.

5 Data corresponding to the companies organized in CAPROVE for the year 2000, representing approximately 70% of the domestic market.

6 Conducted by Leonardo Vaccarezza, from the Institute for Social Studies of Science & Technology [Instituto de Estudios Sociales de la CyT], at the National University of Quilmes, hired by the Argentine Focal Point of CamBioTec, among 100 directors of companies in the food industry. It was published in April 2000.

7 FONTAR was created in 1993 under the Department of Economic Programming [Secretaría de Programación Económica] of the Ministry of Economy [Ministerio de Economía]. In 1996 it was incorporated into the Department of Science and Technology [Secretaría de Ciencia y Tecnología] to form, with the Fund for Scientific and Technological Research (FONCyT) [Fondo para la Investigación Científica y Tecnológica], the National Agency for the Promotion of Science and Technology (ANPCyT) [Agencia Nacional de Promoción Científica y Tecnológica].

8 The survey was conducted during 2000, by the Incubators and Science Parks Program of the National University of La Plata.

9 According to information from the Biotechnology Program of the Multi-Year National Science and Technology Plan (PNPCyT) [Plan Nacional Plurianual de Ciencia y Tecnología] (1999-2001).

10 http://www.porquebiotecnologia.com.ar

11 Martín Piñeiro and Eduardo Trigo, directors of the CEO Group [Grupo CEO], Campo 21, November 8, 2000.

12 This point was based on the work of Alvarez, Edgar: La Biotecnología en Paraguay, Caacupé, Paraguay, 2000.

13 Information obtained from the website of PROCISUR: http://www.procisur.org.uy

14 The seminar was organized by the Argentine No Till Farmers Association (Aapresid) [Asociación Argentina de Productores en Siembra Directa] and the David Rockefeller Center for Latin American Studies, of Harvard University (DRCLAS), and was held in Mar del Plata, Uruguay.

15 Diario Noticias, July 24, 2001, http://www.diarionoticias.com.py

16 The origins of this lab date from 1992-93, at the initiative of a group of researchers from the Clemente Estable Institute of Biological Research (IIBCE) [Instituto de Investigaciónes Biológicas Clemente Estable]. Today, it works in a strategic alliance with a medical analysis laboratory, Fertilab.

17 For this purpose, a project was presented to the National Development Corporation, which is a public funding agency for venture capital projects.

18 The entrepreneurs feel that the production of biological materials has been disabled in the region and that this loss of capacity affects the production of vaccines, the ability of countries to deal with health emergencies and the capability to develop other associated products such as vaccines against rabies, among others.

19 The government supports the development of the fruits and vegetables sector, subsidizing 50% of the reconversion costs for the productive sector. Santa Rosa won an international tender to supply the materials required by the program, covering 100% of national market demand in this area.

20 On the basis of this activity, there is a collaborative program with the company Vinos Finos Juan Carrau.

21 This indicates that the market in Brazil is important; however, there are many customs barriers that hinder the entry and sale of these products.

22 They are opening the Mexican market and intend to enter the South African market.

23 The mechanism used is the acquisition of a percentage of the share package, which in the period of 4 years must be reacquired by the company or sold in the market.

24 Biotechnology was chosen as the field to develop the first experiment in establishing priorities.

25 Some experts take into account the existence of about 50 biotechnologists who are pursuing their own lines of work, and the more than 300 people trained or in training for these activities.

26 To date, this issue has not gained prominence in the debate of political parties in Uruguay; there are supporters and opponents of the application of biotechnology in most political parties represented in Parliament.

27 The thrust of the campaign was to try to install a contradiction between the primary external image of the country, i.e., “Uruguay, a natural country,” and the application of technological knowledge in various fields of production, particularly in the agricultural sector.

28 The main parties involved in this new process are organized around the National Outlook Observation Committee [Observatorio Nacional de Prospectiva], an institution linked to the Presidency.

29 The President at the time, Tabaré Vásquez, was a leading proponent of the policy of innovation and support for the development of biotechnology.

30 http://www.biodiv.org

31 This topic was based on the work of Neffa (2000).

32 This point was based on the work of Kors, Jorge: La propiedad intelectual y la Ley de Confidencialidad. 2nd Congress on Intellectual Property, University of Buenos Aires, Department of Science and Technology, Science and Technology Series of the UBA, Buenos Aires, August 24-25, 1998.

33 This point has been elaborated based on the work of Correa et al. (1996).

34 The literature often refers to this as TRIPS.

35 A sui generis system is one developed for a special purpose. See European Federation of Biotechnology (1996), Patenting in Biotechnology, Bulletin of the EFB, Number 1, September 1996.

36 Building upon the work of Correa et al. (1996), and Correa (1998).

37 Currently, most litigation occurs in the field of plant biotechnology, an area which, being in strong expansion, triggers frequent disputes. The average cost of a lawsuit in Argentina for a patent for a crop of some importance, according to one study, is on the order of US$ 3 million for each company involved. These disputes have affected the main products of biotechnology. For example, in the pharmaceutical field, there have been some lawsuits in the areas of interferon B, tissue plasminogen activator (tPA), human growth hormone and erythropoietin (CORREA, 1998).

38 Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, (EUROPEAN COMMISSION, 1998).

39 Judgment of the Court of Justice of European Communities of 9 October 2001, in Case C-377/98 Netherlands v European Parliament and Council.

40 European Commission: Report of the Commission to the European Parliament and Council, COM (2002) 2 final, Brussels, January 14, 2002.

41 Developed based on work by Correa (1996).

42 Developed based on work by the European Biotechnology Foundation (1996).

43 Text based on work by Correa et al. (1996).

44 National Executive of Argentina: Ley No. 28.360/96, de Patentes de Invención y Modelos de Utilidad (Decreto 260/96), Boletín Oficial de la República Argentina, Buenos Aires, March 22, 1996.

45 Senate and Chamber of Deputies of Argentina: Ley No. 20.247/73, de Semillas y Creaciones Fitogenéticas, Buenos Aires, March 30, 1973.

46 Senate and Chamber of Deputies of Argentina: Ley No. 24.376/94, Aprobación del Convenio Internacional para la Protección de las Obtenciones Vegetales, Buenos Aires, 1994.

47 Senate and Chamber of Deputies of Argentina: Ley No. 20.247/73, de Semillas y Creaciones Fitogenéticas, Buenos Aires, March 30, 1973.

48 National Congress of Paraguay: Ley No. 1.630, de Patentes de Invenciones, Asunción, November 29, 2000.

49 National Congress of Paraguay: Ley No. 1.294, de Marcas, Asunción, August 6, 1998.

50 National Congress of Paraguay: Ley No. 385, de semillas y Protección de Cultivares, Asunción, August 11, 1994.

51 National Congress of Paraguay: Ley No. 1.630, de Patentes de Invenciones, Asunción, November 29, 2000.

52 National Congress of Paraguay: Ley No. 1.294, de Marcas, Asunción, August 6, 1998.

53 See the website of the Directorate of Intellectual Property (DGPI) [Dirección General de Propiedad Intelectual] of Paraguay’s Ministry of Industry and Commerce (MIC) [Ministerio de Industria y Comercio]: http://www.mic.gov.py/v1/node/43.

54 Senate and House of Representatives of the Oriental Republic of Uruguay: Ley No. 17.164, regula los derechos y obligaciones relativos a las patentes de invención, los modelos de utilidad y los diseños industriales, Montevideo, September 2, 1999.

55 Senate and House of Representatives of the Oriental Republic of Uruguay: Ley No. 16.076, Centro Nacional de la Propiedad Industrial, sustitúyese disposición de la Ley No. 9.956, Marcas de fábrica, comercio y agricultura, Montevideo, November 13, 1989.

56 Senate and House of Representatives of the Oriental Republic of Uruguay: Ley No. 16.811, Instituto Nacional de Semillas. créase y declárase de interés nacional, Montevideo, February 22, 1997.

57 Senate and House of Representatives of the Oriental Republic of Uruguay: Ley No. 16.580, Protección de las Obtenciones Vegetales. Convenio Internacional Suscrito en París, República de Francia, Montevideo, October 4, 1994.

58 Department of Sustainable Development and Environmental Policy of the Ministry of Social Development and Environment (MDSyMA). Convention on Biological Diversity, the Second National Report of the Parties, Buenos Aires, May 2001. Website of the Convention on Biological Diversity (CBD).

59 Argentine Chamber of Deputies: Proyecto de ley de Bioseguridad en la Aplicación de la Biotecnología Agropecuaria, Buenos Aires, 2001.

60 Argentine Chamber of Deputies, op. cit.

61 To date, the institutional framework to which that Committee belonged to has been established. Provision has been made for it to be located within SENASA, but there are proposals to raise the its status to the level of the Enforcement Authority Committee.

62 National Congress of Paraguay: Ley No. 385, ee Semillas y Protección de Cultivares, Asunción, August 11, 1994.

63 National Congress of Paraguay. Ley No. 123/91, que adoptan nuevas formas de protección fitosanitaria, Asunción, 1991.

64 Presidency of the Republic of Paraguay: Decreto No. 18.481/97, por el cual se crea la Comisión de Bioseguridad, Asunción, 1997.

65 National Congress of Paraguay: Law No. 294/93 de Evaluación de Impacto Ambiental, Asunción, 1993.

66 National Congress of Paraguay: Law No. 253/93, que aprueba el Convenio sobre Diversidad Biológica, adoptado durante la Conferencia de las Naciones Unidas sobre el Medio Ambiente y Desarrollo, Asunción, 1993.

67 Ministry of Agriculture and Livestock of Paraguay: Resolución MAG No. 397/2000, Noticias, October 3, 2000.

68 This point was elaborated based on the work of Zalduendo, La Propiedad lntelectual en el Mercosur, 2nd Congress on Intellectual Property, University of Buenos Aires (UBA), Department of Science and Technology, Science and Technology Series, UBA, Buenos Aires, August 24-25, 1998.

69 Argenntina’s Ministry of Agriculture, Livestock, Fisheries and Food (SAGPyA): Bioseguridad Agropecuaria: hacia la comercialización de vegetales y vacunas genéticamente modificados, SAGPyA, Buenos Aires, September 1997.

70 President of the Republic of Uruguay: Decreto No. 249/00, de la creación de la Comisión de Evaluación de Riesgo de Vegetales Genéticamente Modificados, Montevideo, August 30, 2000.

71 In accordance with the provisions of Law No. 16,466 dated January 19, 1994, and its regulations.

72 Presidency of the Republic of Uruguay: Decreto No. 80/86, de la creación del Comité Nacional de Biotecnología de Uruguay, Montevideo, 1986.

73 This point was developed based on the work of Zalduendo, La Propiedad lntelectual en el Mercosur, 2nd Congress on Intellectual Property, University of Buenos Aires (UBA), Department of Science and Technology, Science and Technology Series, UBA, Buenos Aires, August 24-25, 1998.

74 MERCOSUR/CMC/DEC. No. 08/95: Protocolo de Armonización de Normas sobre Propiedad Intelectual en el MERCOSUR, en materia de Marcas, Indicaciones de Procedencia y Denominaciones de Orígen.

75 MERCOSUR/CMC/DEC No. 01/99: Acuerdo de Cooperación y Facilitación sobre la Protección de las Obtenciones Vegetales, based on Recommendation No. 2/98 of Work Subgroup No. 8 (SGT-8): “Agriculture.”

76 MERCOSUR/CMC/DEC No. 16/98: Protocolo de Armonización de Normas en Materia de Diseños Industriales, approved based on Recommendation No. 7/94 of Work Subgroup No. 7 (SGT-7): “Industry.”

77 Information taken from the website of the National Advisory Commission on Agricultural Biotechnology (CONABIA) [Comisión Nacional Asesora de Biotecnología Agropecuaria] http://www.mecon.gov.ar/conabia

78 MERCOSUR/CMC/DEC No. 2/01: Acuerdo Marco sobre Medio Ambiente del MERCOSUR, based on Recommendation No. 1/01 from Work Subgroup No. 6 (SGT-6): “Environment.”

79 MERCOSUR/GMC/RES No. 46/96: Marco Regulatorio para el Tratamiento de la Genética Animal de Bovinos, Caprinos, Ovinos, Equinos y Porcinos en el MERCOSUR, based on Recommendation No. 2/96 of Work Subgroup No. 8 (SGT-8): “Agriculture.”

80 MERCOSUR/GMC/RES No. 11/93: Marco Regulatorio para Productos Veterinarios, based on Recommendation No. 2/93 of Work Subgroup No. 3 (SGT-3): “Technical Regulations.”

81 MERCOSUR/GMC/RES No. 04/92: Reglas sobre Prácticas Adecuadas para la Fabricación y la Inspección de la Calidad de los Medicamentos, based on Recommendation No. 5 of Work Subgroup No. 3 (SGT-3): “Technical Regulations.”

82 MERCOSUR/GMC/RES No. 70/98: Estándar Mercosur de Terminología de Semillas, based on Recommendation No. 20/98 from Work Subgroup No. 8 (SGT-8): “Agriculture.”

83 Agreement on Trade-Related Aspects of Intellectual Property Rights, established in the framework of the Uruguay Round of the World Trade Organization.

84 Executive Branch of Argentina: Ley No. 24.481, modificada por la Ley 24.572, T.O. 1996, de Patentes de Invención y Modelos de Utilidad, in Boletín Oficial de la República de Argentina, No. 28,360, Buenos Aires, March 22, 1996.

85 President of the Republic of Brazil: Lei No. 9.279, Regula direitos e obrigações relativos à propriedade industrial, Brasília, May 14, 1996.

86 National Congress of Paraguay: Ley No. 1.630, de Patentes de Invenciones, Asunción, November 29, 2000.

87 President of Brazil: Lei No. 10.196, Altera e acresce dispositivos à lei nº 9.279, de 14 de maio de 1996, que regula direitos e obrigações relativos à propriedade industrial, e dá outras providências, Brasília, February 14, 2001.

88 INPI recognizes, for receiving deposits of microorganisms, the depositary institutions recognized by the World Intellectual Property Organization (WIPO), or those which meet the following conditions: they must be permanent; they must not be dependent on the control of the depositors; they must have staff and adequate facilities to verify the relevance of the deposit and ensure its preservation and storage without risk of contamination; and they must provide necessary security measures to minimize the risk of loss of the deposited material.

89 Senate and Chamber of Deputies of Argentina: Ley No. 20.247, Ley de semillas y creaciones fitogenéticas, Buenos Aires, March 30, 1973.

90 National Congress of Paraguay: Ley No. 123/91, “que adoptan nuevas formas de protección fitosanitarias,” Asunción, 1991.

91 Senate and House of Representatives of the Oriental Republic of Uruguay: Ley No. 16.811 Instituto Nacional de Semillas: Créase y declárase de interés nacional, Montevideo, February 22, 1997.

92 President of Brazil: Lei No. 9.456, Institui a Lei de Proteção de Cultivares e dá outras providências, Brazil’s Federal Official Gazette [Diário Oficial da União (D.O.U.)], April 28, 1997.

93 Senate and Chamber of Deputies of Argentina: Ley No. 24.376/94, Aprovación del Convenio Internacional para la Protección de las Obtenciones Vegetales, Buenos Aires, 1994.

94 President of Brazil: Lei No. 9.456, Institui a Lei de Proteção de Cultivares e dá outras providências, Brazil’s Federal Official Gazette [Diário Oficial da União (D.O.U.)], April 28, 1997.

95 Senate and House of Representatives of the Oriental Republic of Uruguay: Ley No. 16.580, Protección de las Obtenciones Vegetales; Convenio Internacional Suscrito en París, República de Francia, Montevideo, October 4, 1994.

96 Senate and House of Representatives of the Oriental Republic of Uruguay: Ley No. 16.811, Instituto Nacional de Semillas: Créase y declárase de interés nacional, Montevideo, February 22, 1997.

97 In the case of Argentina, INASE was dissolved by decree of the Executive branch, but continues to serve as INASE, while discussing a new institutional status.

98 Argentina’s Ministry of Agriculture, Livestock, Fisheries and Food (SAGPyA): Resolución 124/91, Creación de la Comisión Nacional Asesora de Biotecnología Agropecuaria (CONABIA), Buenos Aires, 1992.

99 Argentina’s National Service for Agrifood Health and Quality (SENASA): Resolucón 1.265/99, Creación del Comité Técnico Asesor sobre Uso de Organismos Genéticamente Modificados, Buenos Aires, 1999.

100 Argentina’s Department of Health and Social Action: Resolución de creación de la Comisión Nacional de Biotecnología y Salud (CONBYSA), Buenos Aires, 1994.

101 Paraguay’s Advisory Committee for Biotechnology (CAB) includes representatives from the Network of Environmental Organizations of Paraguay (ROAM) [Red de Organizaciones Ambientalistas del Paraguay].

102 In the case of living matter, when not used for commercial multiplication or propagation.

103 This must be a permanent institution, must not depend on the applicant, must have adequate facilities and staff and must have security measures that ensure no escape or losses.

104 The term “variety,” when used to indicate a cultivated variety, is equivalent to the term “cultivar”.

105 Except for the cultivation of sugarcane, which requires the authorization of the breeder with or without payment of fees for exploitations that exceed the minimum established by law.

106 Free Trade Area of the Americas (FTAA): FTAA Draft Agreement, FTAA Ministerial Meeting, Buenos Aires, July 3, 2001, http://www.vi-fema-abf.org.ar

107 Brazilian Association of Industries of Fine Chemistry, Biotechnology and their Specialties (ABIFINA) (2001): Necesaria vinculación entre el régimen de la competencia y la propiedad intelectual, Taller sobre Propriedad Intelectual, VI Foro Empresarial de las Américas, Buenos Aires, June 21, 2001, http://www.vi-fema-abf.org.ar

108 Argentine Industrial Union: Taller sobre Propriedad Intelectual, VI Foro Empresarial de las Américas, Buenos Aires, June 21, 2001, http://www.vi-fema-abf.org.ar

109 Mercosur Industrial Council: Taller sobre Propriedad Intelectual, VI Foro Empresarial de las Américas, Buenos Aires, June 21, 2001, http://www.vi-fema-abf.org.ar

110 Free Trade Area of the Americas (FTAA): Conclusiones, VI Foro Empresarial de las Américas, Buenos Aires, June 21, 2001, http://www.vi-fema-abf.org.ar

111 One of the officially organized forums to develop the organizational process of the FTAA.