Comprimidos de liberação modificada: análise dos pedidos de patente depositados no Brasil e da utilização destes na prática do evergreening

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Main Author: Zalfa, Viviane Mega de Andrade
Other Authors: Marin, Victor Augusto
Published: 2014
Subjects:
Online Access:https://www.arca.fiocruz.br/handle/icict/9256
id ndltd-IBICT-oai-www.arca.fiocruz.br-icict-9256
record_format oai_dc
collection NDLTD
sources NDLTD
topic comprimidos de liberação modificada
Preparações Farmacêuticas
patentes farmaceuticas
Vigilância Sanitária
spellingShingle comprimidos de liberação modificada
Preparações Farmacêuticas
patentes farmaceuticas
Vigilância Sanitária
Zalfa, Viviane Mega de Andrade
Comprimidos de liberação modificada: análise dos pedidos de patente depositados no Brasil e da utilização destes na prática do evergreening
description Made available in DSpace on 2014-07-28T18:10:45Z (GMT). No. of bitstreams: 2 license.txt: 1748 bytes, checksum: 8a4605be74aa9ea9d79846c1fba20a33 (MD5) 87.pdf: 692507 bytes, checksum: e3a37710da30b2110d2adef882a97ca9 (MD5) Previous issue date: 2008 === Made available in DSpace on 2014-12-22T16:56:33Z (GMT). No. of bitstreams: 2 87.pdf: 692507 bytes, checksum: e3a37710da30b2110d2adef882a97ca9 (MD5) license.txt: 1748 bytes, checksum: 8a4605be74aa9ea9d79846c1fba20a33 (MD5) Previous issue date: 2008 === Fundação Oswaldo Cruz. Instituto Nacional de Controle de Qualidade em Saúde === Since 1945, Brazil did not issue pharmaceutical patents. This situation has change following the new Industrial Property Law (LPI nº. 9279/96) enactment in 14/05/1996, according to TRIPS Agreement disposal on patentability of all technological sectors. By one hand, pharmaceutical patents are an important mechanism to encourage innovation. By the other, they create monopolies, ensuring pharmaceutical companies the power to establish high prices during the protection period. Also, they delay the introduction of generic competitors into the market, which could enhance access to medicines. Brazilian National Health Surveillance Agency (ANVISA) participates in the examination of pharmaceutical patent applications by means of a legal mechanism of “prior consent”. This examination is aimed at a more restrictive interpretation of patentability criteria. The goal is not to enact undue patents, which do not aggregate any technological or therapeutic advance, but generally contributes to improperly extend market exclusivity of pharmaceutical products. Secondary patents on new pharmaceutical dosage forms are one kind of market exclusivity extension, as may be the case for modified release tablets. This work analyzes the profile of patent applications filed in Brazil for modified release tablets from 01/01/95 to 31/12/07. Applications were searched in the European Patent Office and in the Brazilian National Institute of Indústrial Property databases. Analysis was aimed at investigating whether the development of these formulations would be justifiable by a therapeutic advance point of view or would only serve as strategies of market dominance. Results showed that the United States, along with European countries, were responsible for 80% of the applications, while only 1% were carried out by Brazilians. Most of applications for modified release tablets were directed for active ingredients acting in the nervous system (33.3%), in the alimentary treat and metabolism (16.4%), and in the cardiovascular system (15.5%). Detailed analysis of patent applications identified cases where this kind of formulation is useful, even crucial, as is the case of proton pump inhibitors. Nevertheless, it was also observed that in most situations this kind of incremental modification does not represent a real advance, being only a patent extension strategy.
author2 Marin, Victor Augusto
author_facet Marin, Victor Augusto
Zalfa, Viviane Mega de Andrade
author Zalfa, Viviane Mega de Andrade
author_sort Zalfa, Viviane Mega de Andrade
title Comprimidos de liberação modificada: análise dos pedidos de patente depositados no Brasil e da utilização destes na prática do evergreening
title_short Comprimidos de liberação modificada: análise dos pedidos de patente depositados no Brasil e da utilização destes na prática do evergreening
title_full Comprimidos de liberação modificada: análise dos pedidos de patente depositados no Brasil e da utilização destes na prática do evergreening
title_fullStr Comprimidos de liberação modificada: análise dos pedidos de patente depositados no Brasil e da utilização destes na prática do evergreening
title_full_unstemmed Comprimidos de liberação modificada: análise dos pedidos de patente depositados no Brasil e da utilização destes na prática do evergreening
title_sort comprimidos de liberação modificada: análise dos pedidos de patente depositados no brasil e da utilização destes na prática do evergreening
publishDate 2014
url https://www.arca.fiocruz.br/handle/icict/9256
work_keys_str_mv AT zalfavivianemegadeandrade comprimidosdeliberacaomodificadaanalisedospedidosdepatentedepositadosnobrasiledautilizacaodestesnapraticadoevergreening
AT zalfavivianemegadeandrade modifiedreleasetabletsanalysisofpatentapplicationsfiledinbrazilandtheiruseintheevergreeningofpharmaceuticalpatents
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spelling ndltd-IBICT-oai-www.arca.fiocruz.br-icict-92562019-01-21T16:53:13Z Comprimidos de liberação modificada: análise dos pedidos de patente depositados no Brasil e da utilização destes na prática do evergreening Modified release tablets: analysis of patent applications filed in Brazil and their use in the evergreening of pharmaceutical patents Zalfa, Viviane Mega de Andrade Marin, Victor Augusto Quental, Cristiane Machado Caetano, Mônica Fontes Gemal, Andre Luis Reis, André Luis de Almeida dos Gemal, Andre Luis Reis, André Luis de Almeida dos comprimidos de liberação modificada Preparações Farmacêuticas patentes farmaceuticas Vigilância Sanitária Made available in DSpace on 2014-07-28T18:10:45Z (GMT). No. of bitstreams: 2 license.txt: 1748 bytes, checksum: 8a4605be74aa9ea9d79846c1fba20a33 (MD5) 87.pdf: 692507 bytes, checksum: e3a37710da30b2110d2adef882a97ca9 (MD5) Previous issue date: 2008 Made available in DSpace on 2014-12-22T16:56:33Z (GMT). No. of bitstreams: 2 87.pdf: 692507 bytes, checksum: e3a37710da30b2110d2adef882a97ca9 (MD5) license.txt: 1748 bytes, checksum: 8a4605be74aa9ea9d79846c1fba20a33 (MD5) Previous issue date: 2008 Fundação Oswaldo Cruz. Instituto Nacional de Controle de Qualidade em Saúde Since 1945, Brazil did not issue pharmaceutical patents. This situation has change following the new Industrial Property Law (LPI nº. 9279/96) enactment in 14/05/1996, according to TRIPS Agreement disposal on patentability of all technological sectors. By one hand, pharmaceutical patents are an important mechanism to encourage innovation. By the other, they create monopolies, ensuring pharmaceutical companies the power to establish high prices during the protection period. Also, they delay the introduction of generic competitors into the market, which could enhance access to medicines. Brazilian National Health Surveillance Agency (ANVISA) participates in the examination of pharmaceutical patent applications by means of a legal mechanism of “prior consent”. This examination is aimed at a more restrictive interpretation of patentability criteria. The goal is not to enact undue patents, which do not aggregate any technological or therapeutic advance, but generally contributes to improperly extend market exclusivity of pharmaceutical products. Secondary patents on new pharmaceutical dosage forms are one kind of market exclusivity extension, as may be the case for modified release tablets. This work analyzes the profile of patent applications filed in Brazil for modified release tablets from 01/01/95 to 31/12/07. Applications were searched in the European Patent Office and in the Brazilian National Institute of Indústrial Property databases. Analysis was aimed at investigating whether the development of these formulations would be justifiable by a therapeutic advance point of view or would only serve as strategies of market dominance. Results showed that the United States, along with European countries, were responsible for 80% of the applications, while only 1% were carried out by Brazilians. Most of applications for modified release tablets were directed for active ingredients acting in the nervous system (33.3%), in the alimentary treat and metabolism (16.4%), and in the cardiovascular system (15.5%). Detailed analysis of patent applications identified cases where this kind of formulation is useful, even crucial, as is the case of proton pump inhibitors. Nevertheless, it was also observed that in most situations this kind of incremental modification does not represent a real advance, being only a patent extension strategy. 2014-07-28T18:10:45Z 2014-12-22T16:56:33Z 2014-07-28T18:10:45Z 2014-12-22T16:56:33Z 2008 info:eu-repo/semantics/publishedVersion info:eu-repo/semantics/masterThesis ZALFA, V. M. A. Comprimidos de liberação modificada: análise dos pedidos de patente depositados no Brasil e da utilização destes na prática do evergreening. 2008. 137 f. Dissertação (Mestrado em Vigilância Sanitária)- Instituto Nacional de Controle de Qualidade em Saúde, Fundação Oswaldo Cruz, Rio de Janeiro, 2008. https://www.arca.fiocruz.br/handle/icict/9256 info:eu-repo/semantics/openAccess reponame:Repositório Institucional da FIOCRUZ instname:Fundação Oswaldo Cruz instacron:FIOCRUZ