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ANVISA’s prior approval on pharmaceutical patent applications is no longer required.

On August 26, 2021, Law No. 14,195 was published and revoked the sole paragraph of Article 40 and Article 229-C of Law No. 9,279/1996 (the Brazilian Industrial Property Law – BIPL).

The sole paragraph of Article 40, which was recently declared unconstitutional by the Supreme Federal Court, extended the term of validity of patents of invention whose applications took more than 10 years to be examined by the Brazilian Patent and Trademark Office (BPTO) (or more than 7 years for utility model applications). More information can be obtained at this link.

Article 229-C from BIPL (now revoked) conditioned the grant of pharmaceutical products/processes-related patents to the Brazilian Health Surveillance Agency (ANVISA)’s prior approval.

Until the enactment of BIPL in 1996, there was no protection of pharmaceutical patents in Brazil. Over decades there was a conflict between BPTO and ANVISA as to the wording of Article 229-C, and both Institutions questioned each other’s legal jurisdiction to examine pharmaceutical products/processes-related patent applications. Such discussions enhanced the delay in granting patents for the aforementioned sector.

After several lawsuits questioning ANVISA’s jurisdiction to assess patentability requirements, a Joint Ordinance of the two bodies was issued in 2017, defining that ANVISA would carry out an analysis of patent applications limited to the point of view of public health, while the BPTO would assess the patentability requirements. However, delays in granting patents persisted.

Now, with the enactment of Law No. 14,195/2021, ANVISA’s participation in the prosecution of pharmaceutical patent applications is no longer required, although it may still submit arguments during examination, as any interested third party. In this way, the BPTO is once again the only governmental agency responsible for examining and granting patents in the pharmaceutical field.

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