CREATION OF THE INTER-INSTITUTIONAL ARTICULATION GROUP (GAI) BETWEEN THE BRAZILIAN PATENT AND TRADEMARK OFFICE (INPI) AND THE NATIONAL AGENCY OF SANITARY SURVEILLANCE (ANVISA)
INPI and ANVISA published joint ordinance no. 2 on November 9th 2017, establishing the creation of the Inter-Institutional Articulation Group (GAI) between both entities to harmonize the patentability criteria.
According to joint ordinance No. 1 which was previously published by the two bodies, they were seeking to avoid carrying out a double patentability exam. Therefore, ANVISA must now limit itself to analyze public health issues and grant previous approval except for prohibited substances in Brazil.
If ANVISA determines that the object of the pharmaceutical patent application is strategic for the Brazilian health system, it may also analyze its merits and its report must be studied by INPI as an opposition filed by an interested third party.
The group will be composed by thee members of each entity which may invite experts of the private and public sectors, if necessary. Its purpose is to suggest formal procedures and issue substantive opinions aiming to seek a consensus on patentability criteria and technical understandings of patents applications considered as strategic to the health system.