Backlog of drug patents in Brazil

Generics/Research | Posted 25/06/2021 post-comment0 Post your comment

In an article on ‘How much does the backlog on drug patents cost for health in Brazil?’, Jannuzzi et al. in 2017 [1] 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.

Patent 1 V13E17

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 [2].

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 [3].

The following series of articles discuss the legal requirements for equivalence studies; packaging, substitution and prescription laws; and the generics market in Brazil.

Editor’s comment
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:

First biosimilar of infliximab approved in Brazil: response from the Brazilian IBD society

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The generics market in Brazil

Laws on packaging, substitution and prescription of generics in Brazil

Legal requirements on equivalence studies for generics in Brazil

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References
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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