The impacts of ending ANVISA’S participation in the examination of Brazilian patent applications

04/10/2021

The impacts of ending ANVISA’S participation in the examination of Brazilian patent applications

About a month after the publication of Law # 14,195/21, which revoked Article 229-C of the Brazilian IP Law, it is already possible to observe significant impacts in the examination of patent applications that were pending at ANVISA (the Brazilian FDA) awaiting review prior approval.

Soon after the publication of this Law, the Brazilian PTO received more than a thousand patent applications from ANVISA and proceeded immediately with the publication of notifications in the Industrial Property Journal regarding these cases, stating that (i) the patent application no longer requires ANVISA’s prior approval in view of the revocation of Article 229-C of Brazilian IP Law or (ii) the patent application was already approved by ANVISA before the new Law, thus leaving the way clear for the Brazilian PTO to act with regard to the examination of these applications

Since one of the main issues regarding the beginning of the examination of pharmaceutical and biotechnological patent applications was the time it took for ANVISA to evaluate the publication of the prior approval and, therefore, the time in which the application was stuck in this Agency, positive effects are already being observed because about 74% of the cases that returned to the Brazilian PTO have already had their examination started with the publication of a preliminary office action.

The revocation of Article 229-C of Brazilian IP Law was a relevant step in the battle to reduce the backlog in the examination of Brazilian patent applications.

We will keep you duly posted on this matter and should you have any questions, please feel free to contact us.











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