Notícias
ANVISA published four handbooks containing guidelines about its examination proceedings of pharmaceutical patent applications

Desculpe-nos, mas este texto está apenas disponível em Inglês Americano. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.

ANVISA recently published four handbooks containing guidelines about its examination proceedings, in attention to a order issued by the federal audition bodies to be more transparent regarding the examination of pharmaceutical patent applications (see: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2020/anvisa-publica-manuais-com-orientacoes-sobre-pedidos-de-patentes). Their content are the following:

1st Handbook: Identification of patent applications related to pharmaceutical products and processes under analysis (checking the admissibility, i.e., if the patent application falls within the provisions of article 229-C of the Brazilian IP Law);

2nd Handbook: Analysis of public health risk of patent applications related to pharmaceutical products and processes under analysis (if the claimed subject matter falls within the list of proscribed substances established by ANVISA);

3th Handbook: Identification and analysis of patent applications related to pharmaceutical products and processes under analysis subject to the offer of third parties technical subsides to the Brazilian PTO (checking if the patent application comprises subject matter considered of interest for the heath assistance policies by the SUS (Brazilian Unified Healthcare Program); and

4th Handbook: Patentability examination requirements in prior consent of patent applications related to pharmaceutical products and processes (guidelines for the offer of technical subsides by third parties).

After ANVISA’s decision, the patent application will be sent back to the Brazilian PTO under two scenarios: (i) prior consent granted by ANVISA (application will follow the normal flow of technical examination) or (b) prior consent denied (the application will be definitely extinguished).