On 8 May 2018, the Brazilian Patent Office (INPI in Portuguese) issued Resolution 217/2018, which modifies Resolution 80 of 2013 and introduces changes in the fast or fast-track examination of patent applications related to pharmaceutical products and processes.
Now -and apart from patent applications related to cancer, HIV and neglected diseases- patent applications related to rare diseases are eligible for the fast-track exam. Additionally, the resolution also incorporates Chikungunya and Zika into the list of neglected / rare diseases that can benefit from the new procedure.
The fast-track procedure does not prevent the intervention of the Brazilian Regulatory Authority (ANVISA in Portuguese) in the practice of the substantive examination, which is mandatory in pharmaceutical applications according to Resolution 736 of 2 May 2014. In fact, ANVISA assumes that the application is a priority and accelerate its intervention.