Through Ordinance #2,466/2020, published on October 15, 2020, two (2) Intellectual Property advisory groups were created with the objective of assisting the Ministry of Health in IP issues, including examining patent applications selected as strategic, among other actions and initiatives. The groups were named as Commission of Intellectual Property for Health (COMPIS) and Intellectual Property and Health Articulation Group (GAPIS) and will be composed by different representatives, including member of the Brazilian National Agency for Sanitary Surveillance (ANVISA).
In Brazil, the patent system is not linear for the pharmaceutical field. Based on Article 229-C of the Brazilian IP Law, any pharmaceutical patent application must be submitted for prior approval by ANVISA, instead of being processed exclusively at the Brazilian PTO.
The Brazilian PTO is responsible for analyzing the patentability requirements for granting patents, whereas ANVISA should analyze whether the Applicant intends to protect substances considered to be forbidden in the country. Such step by ANVISA in the patent prosecution goes beyond its role of analyzing issues of prior approval when the subject matter of the application is of interest to the Brazilian Public Health System (SUS), where prior approval is usually published accompanied by a technical opinion on patentability. ANVISA’s opinion is not binding and is considered by the Brazilian PTO as documents for aiding examination, such as third-party observations.
The Ministry of Health is on the same page as ANVISA and has interfered with the processing of patent applications, requesting priority examination of some cases, for example. To find out more about the Ministry of Health’s requests to expedite patent applications in Brazil, see: PDF or Website.
COMPIS and GAPIS will provide information and support to the Ministry of Health to select strategic pharmaceutical patent applications for public health policies. Thus, a greater interference in the patent examination procedure is expected, by the Ministry of Health and ANVISA.