Innovation & Technology

Brazil Announces Changes in Pharmaceutical Patenting

The country aims to make the process more efficient and modern

The country aims to make the process more efficient and modern

On April 12th the Brazilian National Health Surveillance Agency (ANVISA) signed an ordinance with the National Institute of Industrial Property (INPI) to increase the agility of the review process of patents for pharmaceutical products and processes. The deal aims to modernize and reduce the bureaucracy facing new generic medications entering  the Brazilian market.


The document was signed by the President of ANVISA, Jarbas Barbosa, and by the President of INPI, Luiz Otavio Pimentel, in a ceremony in Brasilia, Brazil.


The President of Brazil, Michel Temer, admitted that the former process was confusing. “Each entity was uncertain regarding their tasks and that caused the processes to become stagnant. More than 20 thousand patent requests were halted.”


In 2001, article 229-C was included in the Law of Industrial Property, determining that the granting of medical patents in Brazil needed to be approved by ANVISA. From 2001 to 2013, all the patent requests in the pharmaceutical field were sent to ANVISA after the review and decision of INPI, which determines whether a request meets the criteria to become a patent, which are: novelty, inventive activity and industrial application.


In 2013, however, the ANVISA resolution RDC 21/2013 determined that the review of patent requests should be done through ANVISA, prior to the technical examination of INPI. If the request was denied, it would be archived at INPI.


The problem, however, was a lack of communication. The roles of each institution were not clear, leading both entities to perform the same procedure to review a patent, making it be examined twice. This led to a significant loss of time, as well as an increase in the backlog.


The lack of efficiency in the process hurt the market of generic medications, which are cheaper, because the time required for a patent to expire and allow for the commercialization of generic medicine only starts once the patent is granted.


During the ceremony, the secretary of Science, Technology and Pharmaceutical Ingredients of the Health Ministry, Marco Fireman, spoke about the future scenario for medical patents in Brazil: “This agreement will reduce costs in Brazil, which will allow to increase the base of production in generic medications, whilst ensuring the law is followed in regard to patents”, claimed.


The intention of the agreement is to streamline the process of patent reviewing, in order to make sure each entity complies with its role. ANVISA will review the public impact of the medicine submitted for a patent, whilst INPI will analyze the criteria required for a patent.


The Brazilian National Confederation of Industry said that the agreement ends the uncertainty in regard to patents in the medical sector and will facilitate the arrival of new generic medication to the Brazilian market, on top of ensuring legal certainty for investors. Additionally, INPI has hired 210 new technologists and reviewers of patents, industrial drawings and trademarks, in order to increase the efficiency of the patenting process in Brazil.




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