Advertisement

Knowledge Generation and Laboratory Capacity Building in the Fight Against HIV/AIDS in Brazil: Experiences on the Development of a Heat-Stable Formulation Comprising Ritonavir

  • Cristina Mello R d’Almeida
Chapter

Abstract

This chapter explores the design of an original generic medicine formulation technology in Brazil, which consists in producing heat-stable capsules of a molecule used in AIDS tritherapy to increase its effectiveness. As Abbott had originally developed and patented this technology to prevent competition from generics, Brazil decided to form a national consortium to develop a competing technology. The Brazilian consortium benefited from an international cooperation network on HIV/AIDS involving Brazil and seven developing countries. The Chinese partner provided raw material for R&D. The author of this chapter participated in the consortium supervised by the Ministry of Health, which, in the mid-2000s, was comprised of public and private pharmaceutical laboratories and the National Technological Institute, which specialized in the polymer industry. She was thus able to gather detailed observations of technological exchanges and R&D operations. The chapter documents the local production of a hybrid technology, between pharmaceutical chemistry and polymer chemistry, using the concepts and methods of the knowledge economy to describe the know-how of laboratories, and the sources and appropriation of information (codified and uncodified) by the various actors, both public and private. It envisages international technological cooperation between developing countries.

Bibliography

  1. Abbott. (2005). WO2005039551: Solid pharmaceutical dosage form comprising and HIV protease inhibitor solid dispersion. WIPO (Publication date: 06.05. 2005).Google Scholar
  2. Abbott Laboratories. (2008). Solid pharmaceutical dosage formulations. Patent application Nr. WO 2008/067164. International publication date: 5 June 2008.Google Scholar
  3. Abbott Laboratories. (2011). Solid pharmaceutical dosage form. Patent application Nr. US 2011/0008430. Publication date: 13 January 2011.Google Scholar
  4. Busino, G. (1998). Sociologie des Sciences et des Techniques. Paris: Presses Universitaires de France.Google Scholar
  5. Capasso, M., Cefis, E., & Frenken, K. (2011). Spatial differentiation in industrial dynamics: A core-periphery analysis based on the Pavitt-Miozzo-Soete Taxonomy (No. 2011/02). LEM working paper series. Available at: https://www.econstor.eu/dspace/bitstream/10419/89265/1/655202617.pdf
  6. Cassier M. (1998). L’émergence de nouvelles formes d’invention collective: réseaux et consortia de recherche dans le domaine des biotechnologies, Réalités Industrielles – Annales des Mines: Les nouvelles formes d’organisation de la recherche. Février 1998.Google Scholar
  7. Cassier, M., & Correa, M. (2003). Patents, innovation and public health: Brazilian public sector laboratories’ experience in copying AIDS drugs. In J.-P. Moatti, B. Coriat, Y. Souterand, T. Barret, J. Dumoulin, & Y.-A. Flori (Eds.), Economics of AIDS and access to HIV/AIDS care in developing countries. Issues and challenges (pp. 89–108). Paris: ANRS, Collection Sciences Sociales et Sida.Google Scholar
  8. Castellacci, F. (2008). Technological paradigms, regimes and trajectories: Manufacturing and service industries in a new taxonomy of sectoral patterns of innovation. Research Policy, 37(6), 978–994. Available at: http://www2.druid.dk/conferences/viewpaper.php?id=1319&cf=9CrossRefGoogle Scholar
  9. Cimoli, M., & Porcile, G. (2009). Sources of learning paths and technological capabilities: An introductory roadmap of development processes. Economics of Innovation and New Technology, 18(7), 675–694.CrossRefGoogle Scholar
  10. Claude, D. (1994). La Coopération technologique internationale : les transferts de technologie. Bruxelles: De Boeck (406p, Chap.15).Google Scholar
  11. Correa, C. M. (2002). Protection of data submitted for the registration of pharmaceuticals: Implementing the standards of the TRIPS agreement, South Center. Available at: http://www.who.int/medicines/areas/policy/protection_of_data.pdf
  12. d’Almeida, C., Hasenclever, L., Krikorian, G., Orsi, F., Sweet, C., & Coriat, B. (2008). New antiretroviral treatments post-2005 TRIPS constraints: First moves towards IP flexibilization in developing countries. In The political economy of HIV/AIDS in southern countries. Northampton: Edward Elgar Publisher.Google Scholar
  13. Dionisio, D., Racalbuto, V., & Messeri, D. (2010). Designing ARVs patent pool up to trade & policy evolutionary dynamics. The Open Aids Journal, 4, 70–75.CrossRefGoogle Scholar
  14. Donato, E. M. (2008). Perfil de Dissolução in vitro baseado nos dados in vivo, estudos de estabilidade térmica e metodologia analítica. Tese de Doutorado. Porto Alegre: UFRGS.Google Scholar
  15. Dubois, M. (2001). La Nouvelle Sociologie des Sciences. Paris: Presses Universitaires de France.Google Scholar
  16. Essential Inventions. (2004a). Petition to use authority under Bayh-Dole Act to promote access to ritonavir, supported by National Institute of Allergy and Infections Diseases Contract No. AI27220. Available at: www.essentialinventions.org/legal/norvir/norvir-29jan04petition.pdf
  17. Essential Inventions. (2004b). How much has the public invested in ritonavir, and how much has Abbott? Available at: www.essentialinventions.org/drug/ei06032004.html
  18. Fundação de Apoio ao Desenvolvimento da Computaçao Cientfica (FACC). (2010). LORITME – Formulação e testes clinicos de comprimidos revestidos termo-estaveis de ritonavir (produto 1) e da associaçao de ritonavir com lopinavir (produto 2). Project proposal submitted to FINEP.Google Scholar
  19. Gadelha, C. A. G. (2001). Politica Industrial: Uma Visao Neo-Schumpeteriana Sistemica e Estrutural. Revista de Economia Politica, 21(n 4 (84)), 149–170.Google Scholar
  20. Gadelha, C. A. G. (2003). O Complexo Industrial da Saude e a Necessidade de um Enfoque Dinamico na Economia da Saude. Ciencia e Saude Coletiva, 8(2), 521–535.CrossRefGoogle Scholar
  21. Guennif, S., & Ramani, S. V. (2012). Explaining divergence in catching-up in pharma between India and Brazil using the NSI framework. Research Policy, 41(2), 430–441.CrossRefGoogle Scholar
  22. Guimaraes, R. (2004). Bases para uma Politica Nacional de Ciencia, Tecnologia e Inovaçao em Saude. Ciencia e Saude Coletiva, 9(2), 375–387. Available at: www.scielosp.org/pdf/csc/v9n2/20392.pdf.CrossRefGoogle Scholar
  23. Hasenclever, L., & Paranhos, J. (2009). The development of the pharmaceutical industry in Brazil and India: Technological capability and industrial development. Available at: https://www.researchgate.net/profile/Lia_Hasenclever/publication/228859162_The_development_of_the_pharmaceutical_industry_in_Brazil_and_India_technological_capability_and_industri
  24. Hernandez, V. A. (2001). Laboratoire: Mode d’Emploi. Sciences, hiérarchies et pouvoirs. Paris: L’Harmattan.Google Scholar
  25. I-MAK (Initiative for Medicines, Access & Knowledge). (2011). Patents and HIV medications: An overview, January 2011.Google Scholar
  26. Kitson, A. (2009). Knowledge translation and guidelines: A transfer, translation or transformation process? International Journal of Evidence-Based Healthcare, 7, 124–139.CrossRefGoogle Scholar
  27. Losego, P., & Arvanitis, R. (2008). La Science dans les Pays Non Hégémoniques. Revue d’Anthropologie des Connaissances, 2(3), 334–342.CrossRefGoogle Scholar
  28. Médecins Sans Frontières (MSF). (2010, January). Untangling the web of antiretroviral price reductions: 12th edition. Available at: http://www.msfaccess.org/content/untangling-web-antiretroviral-price-reductions-12th-edition-january-2010
  29. Médecins Sans Frontières (MSF). (2014, July). Untangling the web of antiretroviral price reductions: 17th edition. Available at: http://www.msfaccess.org/content/untangling-web-antiretroviral-price-reductions-17th-edition-–-july-2014
  30. Montobbio, F., & Sterzi, V. (2013). The globalization of technology in emerging markets: A gravity model on the determinants of international technological collaborations. World Development, 44, 281–299.CrossRefGoogle Scholar
  31. Pavitt, K. (1984). Sectoral patterns of technical change: Towards a taxonomy and a theory. Research Policy, 13(6), 343–373.CrossRefGoogle Scholar
  32. Sherman, E. M., & Steinberg, J. G. (2011). Heat-stable ritonavir tablets: A new formulation of a pharmacokinetic enhancer for HIV. Expert Opinion on Pharmacotherapy, 12(1), 141–148.CrossRefGoogle Scholar
  33. Spicy IP India. (2011). Patent office rejects Abbott’s application on HIV drug. Available at: http://spicyipindia.blogspot.com/2011/01/patent-office-rejects-abbotts.html
  34. Suzigan, W., & Furtado, J. (2010). Instituições e Políticas Industriais e Tecnológicas: Reflexões a Partir da Experiência Brasileira. Estudos em Economia, 40(1), 7–41.CrossRefGoogle Scholar
  35. Treatment Access: Indian Generic Heat-Stable Ritonavir. (2006). HIV treatment bulettin, I-Base Published. Available at: http://www.i-base.info/htb/v7/htb7-12/indian.html
  36. US Pharmacopoeia. (2008). USP NF 2008 (United States pharmacopeia/national formulary).Google Scholar
  37. Vinck, D. (2007). Retour sur le Laboratoire comme Espace de Production de Connaissances. Revue d’Anthropologie des Connaissances, 2, 159–165.CrossRefGoogle Scholar
  38. WHO. (2008) The international pharmacopoeia fourth edition – First supplement. WHO.Google Scholar

Copyright information

© The Author(s) 2019

Authors and Affiliations

  1. 1.Assistance Publique-Hôpitaux de ParisParisFrance

Personalised recommendations