On November 19, 2020, ANVISA (the Brazilian Health Agency) published four important documents related to the examination of patent applications for pharmaceutical products and processes that depend on the prior consent of that agency, in accordance with article 229-C of the Industrial Property Law (Law 9279/96). They are the following:

“Manual 1 – Identification of Patent Applications for Pharmaceutical Products and Processes subject to Prior Consent”;

“Manual 2 – Health Risk Analysis in Patent Applications for Pharmaceutical Products and Processes subject to Prior Consent”;

“Manual 3 – Identification and Analysis of Patent Applications for Pharmaceutical Products and Processes subject to Prior Consent and to the Offering of Subsidies for the Patentability Examination of the National Institute of Industrial Property (INPI)”; and

“Manual 4 – Examination of Patentability in the Prior Consent of Patent Applications for Pharmaceutical Products and Processes”.

The preparation and publication of these documents were determined by the Decision 1199/2020 of the Federal Court of Auditors (TCU), in order to enhance transparency concerning the criteria to be applied by ANVISA professionals when evaluating the cases subject to prior consent in accordance with the legal provision.

Click here to find out more (in Portuguese).

 

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