Quick background for readers who are new to brazil patent scenario: In brazil, the pharmaceutical product and related patents’ grant (it is not much clear here; what kind of patent application are linked) is linked to its regulatory agency ANVISA (Brazilian National Health Surveillance Agency). The Brazilian Patent Office (INPI) will send the patent application files to ANVISA in order to obtain official approval, which will state reasons for giving or denying its approval. Related reading click here
In a recent decision, Attorney general of union defines the role of ANVISA and INPI. According to AGU’s opinion, INPI will analyze the patentability requirement and ANVISA’s role will be restricted to evaluating safety and efficacy.
Nearly 145 pharmaceutical patent applications are pending due to the disagreement.