New law revokes certain patent-related clauses in Brazil’s Industrial Property Law

​On August 27, 2021, Law No. 14,195 (the ‘Business Environment Law’) was published in the Official Federal Gazette after President Jair Bolsonaro signed the law into effect, although certain clauses were vetoed.

This new law provides for important changes across different sectors of the Brazilian legal system, including the Civil Code, Code of Civil Procedure, Corporations Law, Commercial Representation Law and the Industrial Property Law. It also introduces new rules concerning commercial papers, the facilitation of foreign trade, and the Integrated Asset Recovery System (Sira).

Arising from Provisional Measure No. 1,040/2021 (approved by the House of Representatives in June 2021), the Business Environment Law was approved by the National Congress in early August. Irajá Silvestre Filho, the rapporteur of the Bill in the Senate, suggested some specific amendments during the approval process, however these were then rejected in the House of Representatives.

Amendments to the Industrial Property Law

Article 57, item XXVI of the Business Environment Law revokes Article 229-C and the sole paragraph of Article 40 of the Industrial Property Law (LPI).

Included in the LPI in 2001, Article 229-C determined that patents for pharmaceutical products and processes could not be granted without the Brazilian Health Regulatory Agency’s (Anvisa) prior consent. Anvisa’s jurisdiction and role in the Brazilian patent system had been the subject of debate ever since.

With Article 229-C now revoked, obtaining patents for pharmaceutical products and processes no longer requires Anvisa’s approval, which aims to speed up the patent application process. According to the new legislation, the National Institute of Industrial Property (INPI) will be solely responsible for analyzing and granting applications for these patents.

Article 40, sole paragraph of the LPI had established minimum 10-year and 7-year terms, respectively, for invention and utility model patents, counted from the date they were granted. This provision was already declared unconstitutional on May 6, 2021 in an en banc session before the Supreme Federal Court concerning Direct Action for the Declaration of Unconstitutionality (ADI) No. 5,529, filed in 2016.

The Court’s decision was issued with retroactive effects on patents:

• Granted based on Article 40, sole paragraph of the LPI;
• Subject to lawsuits filed on or before April 7, 2021; and
• Related to pharmaceutical products and health equipment.

However, an exception applies to patents in effect by virtue of Article 40, sole paragraph prior to the judgment of ADI No. 5,529, safeguarding them from any potential effects.

With the Business Environment Law now in effect, all invention and utility model patents will be valid for a period of 20 and 15 years from the date of filing, respectively, as provided for in the head of Article 40 of the LPI.

For further information about this subject, please contact Mattos Filho’s Intellectual Property practice area.

*In collaboration with Lorena Sampaio Pereira.

*The summary of this article is available in French, Japanese and Italian at this link.