In August 2017, the Brazilian Health Surveillance Agency (ANVISA) published Resolution No. 168/2017, which establishes the administrative procedures related to ANVISA´s “prior consent” for the granting of pharmaceutical patent applications, regulated by Joint Ordinance No. 1/2017.
As previously reported in our blog, earlier this year the Brazilian National Institute of Industrial Property (INPI) and ANVISA reached an agreement regarding the legal provision of “prior consent,” which establishes that ANVISA needs to approve the grant of patent applications in the pharmaceutical field.
Consequently, Joint Ordinance No. 1 on examination of pharmaceutical patent applications was signed in April 2017. It is aimed at solving the long-lasting and controversial conflict regarding the double examination of pharmaceutical patent applications that the two entities have been performing for years.
Resolution No. 168/2017 establishes that, after ANVISA receives a patent application from the INPI, its assessment will be limited to the analysis of public health issues. An application will be considered to be contrary to public health if it involves a health risk, i.e. it refers to a substance whose use has been prohibited in the country.
The resolution also establishes that when ANVISA issues either a preliminary opinion against the consent of a patent application, or any other request, applicants will be notified and granted a period of up to 60 days to fileany arguments or documents to support the approval. In case this deadline is not met, ANVISA will not grant consent to the patent application.
There will be a period of 30 days to appeal the denial decision before ANVISA´s Board of Directors and, after ANVISA´s final decision on the health risk assessment, the application will be sent back to the INPI for the conclusion of the administrative procedure.
Further, the resolution establishes that in case ANVISA considers thata patent application is of interest regarding national drug policies, the agency may issue an opinion based on patentability requirements. This analysis will be sent to the INPI, which will examine it as a third-party observation. This means that, regardless of ANVISA’s patentability opinion on an application,the INPI will make the final decision about its grant or denial.
Click here to read Resolution No. 168/2017 (only in Portuguese).
We will keep you updated about how these regulations will be implemented in practice by ANVISA and the INPI.
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