The participation of the National Health Surveillance Agency (ANVISA) in the granting of patents ... more The participation of the National Health Surveillance Agency (ANVISA) in the granting of patents for pharmaceutical products and processes in Brazil took place since 2001, giving this sector of the Ministry of Health unprecedented legal competence, until then exclusive to the entity of the National Institute of Industrial Property (INPI). This chapter proposes to analyze the technical and legal aspects inherent to patenting combined with the ability to make political decisions in favor of implementing flexibilities in the patent examination of medicines that may be favorable to public health. John Kingdon's Multiple Flows Model was the methodology chosen to understand the most relevant factors that influenced the government's agenda for the creation of Anvisa's prior consent. The results allowed to outline the political window that materialized the formulation of the public policy in question, as well as to call attention to the fundamental importance for the protection of the current needs of humanity and of its future generations inserted in the concept of One Health.
DOAJ (DOAJ: Directory of Open Access Journals), Jun 1, 2010
The aim of this article is to show how the National Institute of Industrial Property (INPI) is ex... more The aim of this article is to show how the National Institute of Industrial Property (INPI) is examining the patent applications related to the polymorphic forms in the pharmaceutical field. In order to do so, there was a survey regarding the number of patent applications in this field. Such applications had already been examined by the INPI from January 2008 to March 2009. Results show that most of the patent applications neither meet some of the patentability requirements, nor some of the descriptive sufficiency condition requirements, in accordance with the legal provisions of Law 9279/96 (LPI) and the exam draft guidelines developed by the Institute.
The chapter, written by Marilena Correa, Maurice Cassier and Maria Andrea Loyola, shows the forma... more The chapter, written by Marilena Correa, Maurice Cassier and Maria Andrea Loyola, shows the formation, expansion and regulation of the similar and generic medicines’ markets since the 1990s. In particular, it explores the diffusion of bio-equivalence tests for the copy of both similar and generic medicines. The bio-equivalence tests carried out in centres authorized by ANVISA measure the quality of copies to guarantee their interchangeability with first medicines. The growth of the bio-equivalence test market and the extension of the network of bio-equivalence centres approved by the Health Surveillance Agency is a keystone in the construction of the pharmaceutical innovation system. In 2000, the national bio-equivalence centres performed only 27 percent of all bio-equivalence tests, whereas in 2010 they performed 87 percent of them. The process of standardizing Brazilian copies has until now been oriented primarily towards the needs of the domestic and regional markets. Obtaining the WHO prequalification standard could represent a new frontier of this standardization, aimed at international donor markets such as those of the Global Fund. To date, no Brazilian firm has acquired WHO prequalification, in contrast to Indian firms which make substantial use of them to conquer global generics markets.
The participation of the National Health Surveillance Agency (ANVISA) in the granting of patents ... more The participation of the National Health Surveillance Agency (ANVISA) in the granting of patents for pharmaceutical products and processes in Brazil took place since 2001, giving this sector of the Ministry of Health unprecedented legal competence, until then exclusive to the entity of the National Institute of Industrial Property (INPI). This chapter proposes to analyze the technical and legal aspects inherent to patenting combined with the ability to make political decisions in favor of implementing flexibilities in the patent examination of medicines that may be favorable to public health. John Kingdon's Multiple Flows Model was the methodology chosen to understand the most relevant factors that influenced the government's agenda for the creation of Anvisa's prior consent. The results allowed to outline the political window that materialized the formulation of the public policy in question, as well as to call attention to the fundamental importance for the protection of the current needs of humanity and of its future generations inserted in the concept of One Health.
DOAJ (DOAJ: Directory of Open Access Journals), Jun 1, 2010
The aim of this article is to show how the National Institute of Industrial Property (INPI) is ex... more The aim of this article is to show how the National Institute of Industrial Property (INPI) is examining the patent applications related to the polymorphic forms in the pharmaceutical field. In order to do so, there was a survey regarding the number of patent applications in this field. Such applications had already been examined by the INPI from January 2008 to March 2009. Results show that most of the patent applications neither meet some of the patentability requirements, nor some of the descriptive sufficiency condition requirements, in accordance with the legal provisions of Law 9279/96 (LPI) and the exam draft guidelines developed by the Institute.
The chapter, written by Marilena Correa, Maurice Cassier and Maria Andrea Loyola, shows the forma... more The chapter, written by Marilena Correa, Maurice Cassier and Maria Andrea Loyola, shows the formation, expansion and regulation of the similar and generic medicines’ markets since the 1990s. In particular, it explores the diffusion of bio-equivalence tests for the copy of both similar and generic medicines. The bio-equivalence tests carried out in centres authorized by ANVISA measure the quality of copies to guarantee their interchangeability with first medicines. The growth of the bio-equivalence test market and the extension of the network of bio-equivalence centres approved by the Health Surveillance Agency is a keystone in the construction of the pharmaceutical innovation system. In 2000, the national bio-equivalence centres performed only 27 percent of all bio-equivalence tests, whereas in 2010 they performed 87 percent of them. The process of standardizing Brazilian copies has until now been oriented primarily towards the needs of the domestic and regional markets. Obtaining the WHO prequalification standard could represent a new frontier of this standardization, aimed at international donor markets such as those of the Global Fund. To date, no Brazilian firm has acquired WHO prequalification, in contrast to Indian firms which make substantial use of them to conquer global generics markets.
Uploads
Papers by Marilena C D Villela Correa