Article 229 of the Brazilian Industrial Property Law #9.279/96 was amended with the publication of Brazilian Law 10.196 on February 14, 2001, to add Section 229-C which provides that “The grant of patents for pharmaceutical products and processes shall depend upon the prior consent from the National Sanitary Vigilance Agency”.  Thus, as a result of the addition of this provision, any patent application related to a pharmaceutical product or process became subject to the “prior consent” of the National Sanitary Vigilance Agency (ANVISA), whose mandate is to protect the public by preventing “the production and commercialization of products and services that are potentially harmful to human health”.  Therefore, in effect, Section 229-C provides for a two-tier examination process for pharmaceutical products and processes in Brazil.

In view of the inherent conflict between ANVISA and the Brazilian Patent Office (the National Institute of Industrial Property (INPI)) regarding the review of the patentability requirements (namely, novelty, inventive step, enablement of the claims, clarity, etc.) of patent applications directed to pharmaceutical products and processes, an administrative proceeding was conducted before the Attorney General’s Office (AGU) on July 22, 2008.  The result of the proceeding was the issuance of Opinion No. 210/PGF/AE/2009 on October 16, 2009 (Federal Opinion), which was subsequently approved by the Attorney General.  The Federal Opinion held that ANVISA’s statutory duty to review pharmaceutical patent applications for prior consent should be limited to the examination of issues closely related to its institutional purposes, namely, issues related to public health.  Unhappy with the Federal Opinion, ANVISA filed a request for reconsideration with the AGU.  On July 1, 2011, the AGU issued Opinion No. 337/PGF/EA/2010 (Second Opinion), which was subsequently approved by the Attorney General, reaffirming the conclusions stated in the Federal Opinion.  Specifically, the Second Opinion ratified that ANVISA was required to limit its examination of patent applications only to issues of public health for purposes of granting or denying prior consent.

On August 19, 2013, a civil pro-ANVISA action was brought by a Federal Public Prosecutor in Brazil seeking to: 

(1) declare null and void the Federal Opinion;

(2) declare and recognize the legal authority of ANVISA to analyze the patentability requirements for pharmaceutical product and process patent applications; and

(3) declare the full applicability of the provisions of Article 229-C concerning ANVISA’s granting of prior consent.

A preliminary injunction request was also sought to immediately declare null and void the Federal Opinion until a decision on the merits was issued.  The trial judge denied this request and an appeal was made to the Federal Circuit.  The Circuit court decided not to rule on this appeal until a final decision on the merits was issued by the lower court.

A decision by the trial judge was issued on September 12, 2013, summarily dismissing the claims of the Federal Public Prosecutor.  Essentially, the judge held that it did not make sense to assign to ANVISA, the institutional purpose of which is to protect the health of the population, the additional role of reviewing the patentability requirements of pharmaceutical product and process applications for which INPI was charged with the same responsibility.  The judge concluded that a fair interpretation of the law was to avoid this sort of “double” patentability analysis. 

It is expected that ANVISA will appeal the trial judge’s decision to the Federal Court of Appeals.  Please watch the BRIC Wall for future updates on any such appeal.

Gustavo de Freitas Morais of Danneman Siemsen also contributed to this post.