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Prior consent by ANVISA in patent applications is no longer necessary

  • 02 September 2021
  • New legislation

A new Law issued on August 27, 2021 aiming to reduce bureaucracy in the business environment in Brazil, simplifies the process of granting patents on pharmaceutical products and processes, that no longer depends on prior approval from the National Agency for Sanitary Surveillance (ANVISA).

Among the effects over several laws in our legal framework, the new Law, No. 14,195, of August 26, 2021, revokes Article 229-C of the Industrial Property Law no. 9,279/1996, enabling faster examination of this type of patent of invention.

The BRPTO published on August 31 the new procedure after the extinction of article 229-C:

  • The flow of patent applications from BRPTO to ANVISA has ended with the publication of the new law (on August 27, 2021);
  • 1,284 patent applications that were awaiting examination at ANVISA returned to BRPTO on August 30th. These applications will follow the normal procedure at the BRPTO after the publication of the cited return in the Industrial Property Gazette (IPG).
  • Applications filed until 12/31/2016, which are part of the BPTO’s Patent Backlog Reduction Plan, will have preliminary office actions (codes 6.21 or 6.22) issued.

Considering that ANVISA is no longer an additional step in the examination of patents for pharmaceutical products and processes, it is expected that these cases will be prosecuted in a faster way.

Anyway, for cases not included in the Patent Backlog Reduction Plan, there is still the possibility of accelerating the examination through some of the acceleration programs currently available in BPTO, for example, (i) Patent Prosecution Highway (PPH), (ii) technologies already available in the market, (iii) treatments of specific diseases such as AIDS , Cancer and Neglected Diseases and (iv) processes for treatment of Covid-19.

We remain at your disposal for any necessary clarifications.

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Prior consent by ANVISA in patent applications is no longer necessaryPrior consent by ANVISA in patent applications is no longer necessary