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character. Article 240, for instance, which establishes the purpose of the Brazilian Patent
Office, and Article 241, authorizing the creation of special intellectual property courts,
are not mere transitional provisions, despite being included under this title.
In order to avoid biased interpretation, we propose a legislative alteration aimed at making
evident that ANVISA’s prior consent is applicable to all types of patent applications in
the pharmaceutical field and not just those filed under the pipeline mechanism.
8.3 ANVISA’s prior consent and its
relevance to public health
In this section we deal with ANVISA’s participation on applications for the grant of
pharmaceutical patents in order to make evident the importance of this participation
for the protection of public health.
An important study conducted by ANVISA makes a qualitative analysis of the decisions
issued in the exercise of prior consent for the period between 2001 and 2009 225 and
shows how the participation of the Agency in patent grant procedures has been proving
relevant not only to avoid the grant of inappropriate patents but also to increase the
quality of granted patents. It is important to remember that ANVISA only analyzed
patent applications after examination by the Brazilian Patent Office and only when the
latter considered the application ready for granting – as the Inter-ministerial Working
Group had not yet gathered to deliberate about the procedures.
Between 2001 and 2009 (until October), ANVISA analyzed 1,346 patent applications.
Out of those applications: i) 988 were granted consent; ii) 119 were denied consent; iii)
90 were barred by the Brazilian Patent Office after ANVISA’s examination and iv) 149
were in other situations as of the conclusion of the study (such as waiting for ANVISA’s
examination or for the fulfillment of requirements by the applicant). The main reasons
for denial of consent by ANVISA are shown in the following table.
225 Coordenação de Propriedade Intelectual – COOPI/GGMED/ANVISA. Technical opinion concerning Bill
No. 3.709/2008. November 25, 2009. Available at:: http://www2.camara.gov.br/atividade-legislativa/
comissoes/comissoes-permanentes/cdeic/audiencias/audiencia-publica-24-11-2009/Parecer%20
Tecnico%20relativo%20ao%20PL3709-2008.pdf/at_download/file.