On November 19th ANVISA (Brazilian Health Surveillance Agency) published four manuals on the examination of patent applications for pharmaceutical products and processes under prior consent. With the manuals, the Agency complies with Decision 1199/2020 of the Federal Court of Auditors (TCU) of May this year, which determined the publication, within 180 days, of the analysis criteria of the Agency’s analysts within the scope of the prior consent, foreseen in art. 229-C of Law 9.279/1996 (Industrial Property Law), meeting the obligation to make this information transparent to society, according to the provisions of the Federal Constitution and Law 9.784/99.
Manual 1 – Identification of Patent Applications for Pharmaceutical Products and Processes under Prior Consent
Manual 2 – Health Risk Analysis in Patent Applications for Pharmaceutical Products and Processes under Prior Consent
Manual 3 – Identification and Analysis of Patent Applications for Pharmaceutical Products and Processes under Prior Consent Subject to the Offering of Subsidies to the Patentability Examination of the Brazilian Patent and Trademark Office (BPTO)
Manual 4 – Examination of Patentability in Prior Consent of Patent Applications for Pharmaceutical Products and Processes
You can access the full publications on the ANVISA’s website:
