Law extinguishes prior consent from Anvisa for pharmaceuticals

On August 27th, the Presidency of the Republic approved (with vetoes) and published Law 14,195, which extinguished the need for prior consent from the National Health and Surveillance Agency (Anvisa) for patents on pharmaceutical products and processes. Art. 57, item XXVI, of the new Law revoked art. 229-C of Law 9,279/1996. Based on the new legislation, the BPTO informs:

• Applications returned by ANVISA will proceed normally at the BPTO after the publication of order 7.7, with a specific text regarding the revocation of art. 299-C

• The applications concluded by ANVISA and sent to the BPTO before the revocation of the article were published in the Industrial Property Journal (Revista da Propriedade Industrial – RPI) No. 2763 (such requests are related to Official Letters 335 to 346/2021 COOPI/GGMED/ANVISA, of August 23rd). These publications were of consent (dispatch code 7.5) or non-compliance with art. 229-C (dispatch code 7.7).

• The applications that were in charge of ANVISA were returned to the BPTO through Official Letters 347 to 358/2021 on August 30th, 2021. The institute received a total of 1,284 applications. Of these, 54 already had the consent published by ANVISA before the revocation of art. 229-C and will have the publication of order 7.5 in the RPI. One application remained for rectification of the Official Letter;

• The BPTO is awaiting the return of 19 patent applications that were pending or that already had a denial decision;

• Applications deposited until 12/31/2016, integrated with the Fight against Backlog Plan, will continue for examination and receive publications 6.21 or 6.22.