Law No. 14,195 of 08.26 has been revoked, with immediate effect, article 229-C of the Industrial Property Law (LPI), which made the granting of patents related to pharmaceutical products and processes subject to prior consent by ANVISA (Brazil's National Health Regulatory Agency).


Previously, in practice, patent applications in the pharmaceutical field, and also in food and biotechnology areas, when in some way related to the pharmaceutical area and/or promoting health benefits, were submitted prior to the meris examination by the Brazilian PTO (INPI), to ANVISA for compliance with article 229-C of the LPI.

ANVISA, until mid-2017, assuming the role of INPI, issued opinions on the patentability of the invention, granting or not prior consent based on patentability criteria - instead of sticking to public health issues, as would be ANVISA’s expected competence on this matter. As a result, many of the applications not allowed by ANVISA were in limbo when returning to the INPI, which did not accept ANVISA's interference in the examination of these applications.

Needless to say, the proceedings, on this basis, was unduly delayed. The discussion, not infrequently, ended up in court. As a way to resolve this issue, in mid-2017, by means of a Joint Ordinance, ANVISA started to grant - or not - prior consent to applications in the light of public health, any opinion on the patentability of the invention being considered merely third parties' observations by the INPI. This improved the processing of applications, which were no longer in limbo. However, it did not solve the issue of delay.


Finally, a few days ago, ANVISA's history of interference in the processing of patent applications came to an end, with the revocation of Article 229-C. ANVISA and INPI are yet to comment on the matter. However, it is expected that this measure, in line with INPI's plans to combat the examination backlog, will further benefit applicants, and encourage new filings of patent applications in Brazil.


FICPI’s view and involvement

FICPI is the only organisation exclusively for independent IP attorneys and makes the world a little bit smaller, bringing independent IP attorneys from around the world together to connect, share knowledge and grow through news, blogs, events and committees.

Next steps
Previous Post
Eurasian Patent Office launches its pharmaceutical register