In an article on ‘How much does the backlog on drug patents cost for health in Brazil?’, Jannuzzi et al. in 2017  showed backlogs in the analysis of patent applications in Brazil. These delays, known as ‘backlogs‘, extend the term of patents granted on medicines and delay the entry of generics into the market.
Backlog of drug patents in Brazil
Generics/Research | Posted 25/06/2021 0 Post your comment
After analysing data on three formulations of antiretrovirals (etravirine 100 mg tablet, fosamprenavir 100 mg and raltegravir 400 mg coated tablets), the authors showed that the Federal Government unnecessarily spends over US$14 million per year due to the patent duration of these drugs. In another article in 2013, Jannuzzi et al. showed that patent extension applications for original medicines have become commonplace in Brazil, which should be rare: 38% of patent applications granted and filed in 1997, 85.5% in 1998 and almost 100% of patents granted for medicines after 1999 .
While the National Institute of Industrial Property (Instituto Nacional de la Propiedad Industrial, INPI) makes a decision on the patentability of the subject matter of patent applications in question, generics companies are prevented from launching their products on the market, hindering access to cheaper medicines .
The following series of articles discuss the legal requirements for equivalence studies; packaging, substitution and prescription laws; and the generics market in Brazil.
Readers interested to learn more about biosimilars in Brazil are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:
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Readers interested in contributing a research or perspective paper relating to generics or biosimilars development in Latin American countries in English or Spanish to GaBI Journal – an independent, peer reviewed academic journal – please submit your manuscript here.
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The generics market in Brazil
LATIN AMERICAN FORUM
The brand-new section the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.
View this week’s headline article: Un nuevo decreto modifica varios aspectos del sistema de aprobación regulatoria de biosimilares en México
Browse the news in the Latin American Forum!
LATIN AMERICAN FORUM
Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.
Vea el artículo principal de esta semana: Un nuevo decreto modifica varios aspectos del sistema de aprobación regulatoria de biosimilares en México
Explore las noticias en el Foro Latinoamericano!
1. Jannuzzi AHL, Vasconcellos AG. How much does the backlog on drug patents cost for health in Brazil? Cad Saúde Pública. 2017;33(8):1-6.
2. Jannuzzi AHL, Vasconcellos AG. A study of drug patents in Brazil and its implications in Generic Drug Policy success. 2013.
3. Nardi EP, Silva ARA. A closer look at generic drugs: the Brazilian case. In: Lowell T. Duncan (Ed). Advances in Health and Disease. Volume 21. Nova Science Publishers; 2020. Chapter 2. ISBN: 978-1-53617-783-1.
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