Brazil: BRPTO Stands Up To ANVISA For Pharmaceuticals

Last Updated: 17 May 2016
Article by Luisa Rezende Castro

As you already know, for the allowance of pharmaceutical patents, the Brazilian IP Law currently requires the prior consent from ANVISA (Brazilian Health Surveillance Agency – equivalent to American FDA) along with the usual examination from the BRPTO. It has been a while that both federal authorities dispute for the role of examining patents, which led to a double tier examination procedure.

The current flow established by Ordinance 1065 of May 25, 2012 developed by a Working Group formed by several Brazilian Ministries states that a pharmaceutical application should be sent to ANVISA for prior consent before being evaluated by BRPTO and, in case ANVISA denies the prior consent, that this application should be returned to the BRPTO in order to be shelved.

Although the BRPTO and most of the Pharmaceutical companies always claimed that ANVISA's role is just evaluating what is contrary/unsafe to health, ANVISA has been evaluating patentability requirements for several years without clear guidelines and usually with a point of view much more related to political reasons than to technical or safety reasons.

On January 13, 2016, the BRPTO filed a petition in a Lawsuit that Abbvie INC filed against ANVISA (in which Abbvie questions ANVISA's role to analyze patentability requirements). Although the relationship between the BRPTO and ANVISA has been troubled since ANVISA started the double tier examination, this petition seems to be the clearest and strongest assertion ever made by the BRPTO against ANVISA. In such petition, the BRPTO really stands up to ANVISA's patentability analysis. The most relevant BRPTO's assertions, in our view, were:

  1. that the BRPTO feels discredited by ANVISA's patentability analysis.
  2. that there are no legal basis assigning to ANVISA the responsibility of analyzing the patentability requirements.
  3. that ANVISA itself issued a Resolution assigning such responsibility to the own Agency when there is an IP Law that states that such responsibility is of the BRPTO, thus contravening the Principle of Legality.
  4. that in case the BRPTO is obliged to publish the definitive shelving of a patent application in consequence of an ANVISA's decision of denying the prior consent, such procedure would not allow the submission of an appeal (since the BRPTO would not be entitled to review ANVISA's Technical Report) and, thus, this would contravene Brazilian IP Law.
It is remarkable to see the BRPTO standing up to ANVISA and claiming for a clearer IP framework in Brazil. More than that, if this BRPTO's positioning consolidates and if the Federal Court takes it into consideration for the final decision, although we may not guarantee, we believe it may raise the chances of success of similar Lawsuits filed against ANVISA.

Now, both Abbvie and ANVISA will have a chance to file replies about such BRPTO's petition. We will keep you posted!

In case you have any doubt about this or any other pharma topic in Latin America, Spain or Portugal, please contact Ms. Luisa Rezende Castro (lcastro@clarkemodet.com.br).

Originally published March 15, 2016


Clarke, Modet & Co - BRAZIL

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Av. Marechal Câmara, 160, 12º andar (Ed. Le Bourget), RJ 20020-080
Tel: +(55-21) 3223-9500
Email: brj@clarkemodet.com.br


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