Brazilian law # 14,195/21 revoking Article 229-C of the Brazilian IP Law was recently sanctioned by the Presidency, leading to intense debate on how this will affect the examination of patent applications in future. Based on the provisions of said article, any patent application related to the pharmaceutical area (including biotechnology cases) would have to be submitted to the National Health Surveillance Agency – ANVISA (the Brazilian FDA) for its prior approval instead of being exclusively prosecuted at the Brazilian PTO.
Prior to this surprising change in Brazilian legislation, ANVISA’s attribution was to analyze whether the subject matter of a patent application represents a risk to health, is understood as a pharma product comprising, or a pharma process resulting in, a substance whose use is prohibited in Brazil, as provided for in Ordinance SVS/MS # 344/1998.
ANVISA’s assessment was mainly based on Lists E and F of Ordinance SVS/MS # 344/1998, which define the plants and substances prohibited for use in Brazil. In this context, substances such as Cannabis sativa L., tetrahydrocannabinol (THC), and structural classes of synthetic cannabinoids were included in these Lists. It is true that said Ordinance provides some exceptions for the use of these substances in terms of their concentrations in medicines. However, ANVISA used to require the removal of the above-mentioned substances from the claim set as a condition to receive the prior approval. Thus, ANVISA had the right to formulate requirements that resulted in limitations on the scope of protection of patent applications, or even deny the prior approval, ending the applicant’s chances of obtaining a patent in Brazil.
With the revocation of Article 229-C, patent applications will no longer need to receive ANVISA’s prior approval, and an even greater stimulus is expected for the patent protection of therapeutic use of cannabinoids in Brazil.
The filing of patent applications relating to cannabinoid-associated technologies with the Brazilian PTO has increased significantly in recent years, which can be interpreted as a reflection of changes in the regulation on the import and sale of cannabis-based medicines. It is expected that this reduction of bureaucracy in the examination of patent applications in the pharmaceutical area will encourage applicants to seek protection in Brazil for their technologies.