Improved IP-situation in Brazil for pharmaceutical patent applications

Last week, the President of Brazil, Michel Temer, revealed measures aimed at improving the IP-system in the country. One measure is to employ more patent examiners, while the overall aim is to ensure more efficient processing of patent applications, especially those in the pharmaceutical sector.

As part of the new measures, the Brazilian Patent Office (INPI) and the National Health Surveillance Agency (ANVISA) have signed an agreement to clarify the roles of these two institutions in granting patent applications for pharmaceutical products and processes.

A few years ago Brazil introduced significant changes to the pharmaceutical patent examination, which resulted in a new workflow for pharmaceutical patent applications. According to this workflow, pharmaceutical cases are sent directly to ANVISA for examination of factors related to public health issues. ANVISA determines whether a pharmaceutical patent application poses risks to public health, which will result in either grant or denial of “prior consent” in respect of the application. Patent cases which receive prior consent are then returned to the INPI for further prosecution. However, the original workflow required that ANVISA also examines the patentability criteria. This time-consuming workflow has created a tremendous backlog of patent applications within the pharmaceutical field.

According to INPI, the new agreement will streamline the patent process for pharmaceutical patent applications and facilitate new generics on the market. The new agreement clarifies that ANVISA only has to analyze the impact on public health, while INPI will analyze the patentability criteria, such as novelty, inventive step and industrial applicability.

Thus, it is good to know that even though it historically has been difficult to obtain pharmaceutical patents in Brazil, the situation is now hopefully changing. However, a long period is expected before the processing of patent applications for pharmaceutical products and processes is at a normal level.

// Karolina Wiktorson