Previous consent of the National Health Surveillance Agency – Anvisa for granting of patents revoked

2 September 2021

New Brazilian law revokes the prior consent of the National Health Surveillance Agency (Anvisa) for the granting of patent applications for pharmaceutical products and processes.

2 September 2021

Proposed Bill that aims to improve the business environment in Brazil was approved on August 26, 2021 and transformed into Ordinary Law 14195/2021. The proposal that revoked a series of legal provisions in order to reduce bureaucracy and simplify the functioning of the economy approved, among them, the revocation of article 229-C of the Brazilian Industrial Property Law no. 9,279 of May 1996, that is, the idea of ​​ending the requirement of prior consent from the National Health Surveillance Agency (Anvisa) for the registration of drug patents in the country – an initiative that pleased the pharmaceutical industry.

The reporting congressman of the Bill, Marco Bertaiolli, recalled that the change does not eliminate the need for Anvisa to approve or not the marketing of a drug, regardless of whether there is a patent registered for it.

Since 2001, the legislation determines that the granting of patents for pharmaceutical products and processes requires the approval of the regulatory agency, which delayed the analysis of a patent application. However, Anvisa’s analysis only assesses whether the formula contains or could result in a substance prohibited for use in Brazil, which will need to be analyzed again when authorization for the sale of the product is requested.

In practice, Anvisa’s role is not to assess the patentability of medicines, but their safety. The revocation of the article thus promotes the reduction of bureaucracy in the examination of a patent application, giving the BPTO back the power to decide on the merits of inventiveness and innovation of an application.

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Rafaela Mattos



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