In 2021, the Brazilian legislature revoked a controversial article (Article 229-C) in the Brazilian IP Law, ending the participation of ANVISA (the Brazilian FDA) in examining Brazilian patent applications.

As discussed below, the revocation of this article was a big step in the battle to reduce the backlog in the examination of Brazilian patent applications.

Previously, patent applications in the pharmaceutical area were required to seek “prior approval” from the ANVISA before they could move on to examination in the Brazilian PTO. Pharmaceutical and biotechnological patent applications were subjected to extensive delay due to the time it took for ANVISA to evaluate the publication for prior approval.

For nearly 20 years, the law created the unsatisfactory situation of having a dual examination system through 2 different Brazilian state agencies (ANVISA and the Brazilian PTO). This often led to inconsistent interpretations, excessive delay, as well as significant litigation.

Some months after the change, we can already see positive impacts on the Brazilian patent system.

Shortly after the new law came into force, the Brazilian PTO received over 1,000 pending patent applications directly from ANVISA and was able to proceed with examination on the basis that either the applications had already received the required authorisation, or indeed that no such authorisation is required going forward.

Today we can already see that about 74% of the cases that were sent to the Brazilian PTO from ANVISA already had their examination started through the publication of a preliminary office action.

Based on this important change to Brazilian law, we are also seeing changes within specific areas related to health and life sciences. One such example is the therapeutic use of substances such as Cannabis sativa L., tetrahydrocannabinol (THC), and structural classes of synthetic cannabinoids, the use of which was prohibited in Brazil (Ordinance SVS/MS # 344/1998).

Until recently, ANVISA had the power to limit the scope of patent protection and even refuse to give prior approval to such applications. Now, with the change in the law by Brazil’s legislature, such applications are no longer required to seek prior approval from ANVISA and, as a result, there has been a significant increase in filings for cannabis-based medicines in Brazil.

Looking at the big picture, the recent changes by the Brazilian legislature have made the patent process considerably less bureaucratic for applicants in the pharmaceuticals area and have paved a way for increased patent filings for new health products and medicines in Brazil.

 

FICPI’s view and involvement

Independent IP attorneys bring insights and counsel from a wider external perspective and a commitment to high quality work, complying with all relevant regulations. FICPI is the only worldwide organisation exclusively for independent IP attorneys and is driven by a strong shared interest to promote common solutions and advocacy for private practice.

Next steps

Consider joining FICPI’s Study & Work Committee (CET 5) on Biotechnology and Pharmaceuticals. Find out more at: https://ficpi.org/cetcommissions/cet-5-biotechnology-and-pharmaceuticals

 

 

 

 

 

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