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

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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.