One of the most contentious issues in the Brazilian pharmaceutical landscape is role of National Sanitary Vigilance Agency (ANVISA) during the prior approval/consent analysis of patent applications claiming pharmaceutical inventions. Article 229-C of Brazil’s Patent Statute (Statute) provides that ANVISA shall have the right to provide approval of patent applications claiming pharmaceutical inventions (often referred to as “prior approval” or “prior consent”). Specifically, Article 229-C provides that: “The grant of patents for pharmaceutical products and processes shall depend upon the prior approval from the National Sanitary Vigilance Agency”.

During the past few years, the courts in Brazil have issued decisions holding that Article 229-C did not grant ANVISA the power to examine patent applications for compliance with the patentability requirements under the Statute. Moreover, these cases held that ANVISA was solely limited to determining whether or not a patent application was against public health according to Article 18, I of the Statute and nothing more.

The most favorable decisions for patent owners were issued by District Courts sitting in Brasilia. Specifically, several Courts issued preliminary injunctions ordering ANVISA to grant prior approval of patent applications claiming pharmaceutical inventions holding that the examination of patentability requirements by ANVISA was illegal (for example, in May 2015, the 15^th Federal District Court granted a preliminary injunction requested by Novartis on a writ of mandamus filed against ANVISA).

However, on June 11, 2015, the Honorable Marcia Nunes de Barros of the 13^th Federal District Court sitting in Rio de Janeiro denied a preliminary injunction and held that ANVISA was permitted to examine a patent application claiming pharmaceutical inventions for compliance with the patentability requirements. The case was filed by Abbvie, Inc. and related to two patent applications involving Kaletra® (lopinavir/ritonavir).

In a 30-page decision, the Judge described the importance of Article 229-C and ANVISA’s ability to examination patent applications for compliance with the patentability requirements under the Statute in order to avoid the patenting of inventions to merely “incremental innovations”. Specifically, the Judge stated that: “…taking into consideration the systematic element, it seems clear, as already exposed, that the goal of the rule that included ANVISA in the proceeding of deciding about pharmaceutical patents, was clearly to include a vision over public health during examination, in a way to avoid the granting of undue patents, with highlights to the incremental ones”.

Unfortunately, but not surprisingly, this unfavorable decision will be used by ANVISA with respect to currently pending and future filed patent applications. However, it is too soon to assess how this decision will impact the current framework relating to Article 229-C and ANVISA with respect to patent prosecution. This decision should be carefully analyzed and rebutted by patent owners in order to avoid what could be a potential game changer in the pharmaceutical sector that might negatively impact innovator companies in Brazil.

Patent owners should keep in mind that the Federal Courts sitting in Brasilia have traditionally been more inclined to hold that ANVISA cannot examine patent applications for compliance with patentability requirements. Hopefully, this decision will not impact Judges sitting in Brasilia.

Roberto Rodrigues is co-author of this article.