Recently, ANVISA published Resolution No. 168/2017, which sets protocols for the analysis of pharmaceutical patent applications. This Resolution allows applicants that deal with those types of patent applications to have a better understanding of the procedure within the regulatory agency.
After ANVISA receives the patent application from the BPTO, it will analyze the application in the light of public health and make a determination regarding its consent. The application will be considered contrary to public health if the product or process presents a health risk; that is, when the pharmaceutical product or process generates a substance for use that been prohibited in the country.
The Resolution further establishes that when the regulatory agency issues a preliminary opinion against the consent of the patent application, or when it issues any request, applicants will have up to 60 days to present their arguments and documents to encourage the agency to provide consent in case the deadline is not met, ANVISA will not consent to the patent application. Applicants may supplement their application with support documentation at any time during the process.
In case ANVISA determines that the patent application is relevant to public health, the agency will issue an opinion based on patentability standards. This analysis will be sent to the BPTO, which will examine the report as a third-party observation; that is, ANVISA’s opinion does not bind the BPTO in terms of their ultimate decision to grant or deny the patent application.
The Resolution complements the joint ordinance issued earlier this year by ANVISA and the BPTO. For more information regarding the joint ordinance, please click here.
For further information, please feel free to contact us.
Read it in pdf Newsletter August 31st, 2017