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Double examination of pharmaceutical patent applications in Brazil

The Brazilian Industrial Property Law (Law No. 9279/96) was altered by Law No. 10196/01, which introduced a new step in the prosecution of patent applications for pharmaceuticals in Brazil. Now, the granting of patents for pharmaceuticals requires the previous consent of ANVISA, the Brazilian food and drug authority.
Now, the granting of patents for pharmaceuticals requires the previous consent of ANVISA, the Brazilian food and drug authority. Actually, this kind of patent application is examined twice: by the Brazilian PTO and by ANVISA under highly subjective criteria.

“Article 229 – C – The grant of patents for pharmaceutical products and processes shall depend on prior consent from the National Agency of Sanitary Surveillance (Agência Nacional de Vigilância Sanitária – ANVISA).” (Article included by Law n° 10.196 of 14.02.2001)”

In our view, the legal competency for issuing written opinions (on the examination of the applications) falls within the scope of the PTO. In this sense, we believe that ANVISA does not hold legal competence to perform prior art analysis or to require corrections or changes in the application since it is not the official authority in charge of the examination of patent applications in Brazil. The scopes of authority of both ANVISA and the PTO are defined in federal laws.

Although the written opinions issued by ANVISA may be contested, what we see as a result is a delay in the final decision of grant or rejection of the patent application.

In 2009, the Unions Attorney General (AGU) issued an opinion stating that ANVISAs action should be limited to the

analysis of the issues closely related to its institutional purposes, i.e. public health issues. ANVISA filed a request for reconsideration before the AGU. On January 2011, the AGU ratified its position and determined that ANVISA should limit its examination to public health purposes.

Despite those opinions, ANVISA has issued a press release stating that, in its view, the new AGU’s opinion simply maintains the previous understanding that ANVISA and the PTO have different activities regarding patent analysis, thus requiring a synergy between both institutions.

Nowadays, ANVISA analyses patent applications in the same way as it used to do before the issuance of the AGU’s opinions.

We will watch carefully the AGU’s reaction and the new developments of the situation.

Carmen Sánchez-Puelles