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Signed a New Agreement for the Examination of Pharmaceutical Patent Applications in Brazil

Yesterday (04/12/2017), in a formal ceremony held in Palácio do Planalto, in the capital Brasília, it was signed the much anticipated agreement between the Brazilian Patent and Trademark Office (BPTO) and the National Health Surveillance Agency (ANVISA) regarding the examination of pharmaceutical patent applications.

In addition to expediting the processing and examination of patents in the pharmaceutical field, this will put an end to many lawsuits that exists over this issue. This will convert in benefits to Brazil, since this new found stability can attract investors to the field. Also, a final decision over certain patent applications can encourage companies to increase the production of certain products, generating more offers of pharmaceutical products in the Brazilian market.

The agreement signed yesterday was published also yesterday as a Joint Ordinance No. 1, with full effect on both entities proceedings. The main aspects of such agreement is summarized below.

As currently required by Article 229-C, ANVISA will continue to issue prior consent over patent application for pharmaceutical product or process (article 1 of the Joint Ordinance). However, article 4 of the Joint Ordinance prescribes that ANVISA will limit its analysis to the risk of the product or process to the public health. The risk is characterized by prohibited substances in Brazil. 

This procedure will be performed soon after the filing of examination request presented to the BPTO  (article 2 of the Joint Ordinance).

For those cases that may have great effect or consequences on public policies for health (related, for example, on the access of certain medications), ANVISA will be capable to offer subsidies for BPTO Examination. Therefore, ANVISA cannot interfere in the analysis of patentability requirements.

The BPTO, in turn, will evaluate the patentability requirements.  This Joint Ordinance is already in effect and, by force of its article 8, will affect all current patent application still pending, even the ones already examined by ANVISA.

Our office and our attorneys act before the BPTO and the ANVISA. We will be able to enforce the new Join Ordinance on benefit of your clients.

If you are interested in finding more about this Join Ordinance or the measures that can be taken to expedite your client’s patent applications in the pharmaceutical field in Brazil, please contact us at info@tavaresoffice.com.br

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