Change in the Industrial Property Law: ANVISA no longer participates in the processing of patent applications

30 . August . 2021 |

Law No. 14,195 of 08.26 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.

Until then, in practice, patent applications in the pharmaceutical area, and also in food and biotechnology areas, when they could have some relationship with the pharmaceutical area and/or could promote health benefits, were submitted prior to the meris examination by the Brazilian PTO (INPI), to ANVISA for purposes of 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. As a result, many of the applications not allowed by ANVISA were in limbo at 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 rarely, ended up in court. As a way to resolve this imbroglio, in mid-2017, through 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, 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 the filing of patent applications in Brazil.

For further information, contact:

Ana Paula Celidonio

Isabella Katz Migliori

Time de Propriedade Intelectual

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