Brazil clarifies approval system for pharma patents

Brazil’s President Michel Temer has revealed measures aimed at improving the IP system in the country.

On Wednesday, April 12, Temer announced plans to streamline analysis for pharmaceutical patents, simplify technology transfer and employ more examiners.

As part of the new measures, the Brazilian Patent and Trademark Office (INPI) and the National Health Surveillance Agency (ANVISA) signed an agreement clarifying the role of each institution in granting patents for pharmaceutical products and processes.

The agreement has resolved a deadlock over the need for ANVISA to provide prior consent for the safety of pharmaceutical applications.

This caused a double-tier examination procedure, with both authorities analysing the patentability requirements of the same application, and led to a backlog of unexamined applications.

According to the INPI the agreement will streamline the patent process, as well as facilitating the arrival of new generics to the market and ensuring legal certainty for investors.

The new measures clarify that ANVISA will only analyse the impact on public health, while the INPI will analyse patentability criteria—novelty, inventive activity and industrial application.

According to the INPI, there are around 23,000 pending applications in the pharmaceutical area.

Another 70 people will be hired as examiners, bringing the total to more than 210, to help fight against the backlog of patents (243,820 last year).

The Brazilian National Confederation of Industry, representative of Brazilian industry, said the regulation puts an end to the uncertainty in the pharmaceutical sector.

“In addition to the domestic benefit, the change will have a positive impact on Brazil’s reputation. Because it is a peculiarity of the Brazilian system—the prior consent of a health agency for the granting of patents—the lack of definition about the attribution of each institution is often the object of international criticism,” it said.