On August 31, 2021, the Brazilian Patent and Trademark Office (BPTO) published information on its website concerning the prosecution of pharmaceutical patent applications after extinction of the Brazilian Health Surveillance Agency (ANVISA)’s prior approval. We would like to point out the following:
i. the exchange of patent applications between both institutions was ended on August 27, 2021;
ii. patent applications with examination already concluded by ANVISA and forwarded to the BPTO before the enactment of Law No. 14,195/2021 were published in the Official Gazette No. 2643, having received the decision of prior approval or inadequacy with Article 229-C of the Brazilian Industrial Property Law;
iii. patent applications already approved by ANVISA, but that have not been forwarded to the BPTO until the enactment of Law No. 14,195/2021, will receive the decision of prior approval in the next editions of the Official Gazette;
iv. patent applications still waiting for ANVISA’s prior approval have already been transferred to the BPTO and will follow ordinary prosecution after publication of decision informing of Article 229-C’s revocation;
v. patent applications with pending office actions or rejected by ANVISA will be sent to the BPTO, and will also follow ordinary prosecution after publication of decision informing of Article 229-C’s revocation; and
vi. patent applications filed until December 31, 2016, included in the Combat Plan Against Backlog, will follow to examination and receive the preliminary office action decisions.
For more information, please contact us at email@example.com.