Compulsory license: patent owners in Brazil are under no obligation to provide know-how and raw materials

Good news for patent owners in Brazil: the National Congress has upheld the President’s veto n° 48/2021, which prevented those who had their patent compulsorily licensed in the country from being required to provide all the information for the subject matter protected by the patent to be reproduced, as well as biological material and test data provided to the National Health Surveillance Agency (ANVISA).

The decision taken in a Congress Joint Session on July 5th, 2022 was the result of intense negotiation between Government and Opposition and closed an important chapter in the discussion regarding the limits of compulsory license in the country.

The regulation originally proposed as Bill 12/2021 was hostile to patent owners and in the opposite direction of the expected movement to stimulate innovation in the country.

The bill was proposed by Senator Paulo Paim (PT/RS) aiming to amend the Brazilian Industrial Property Law (Law nº 9.279/96) regarding patent compulsory license or patent applications, specifically in cases of declaration of national or international emergency or public interest, or recognition of national public calamity.

Bill 12/2021 without the vetoed passages was converted into Law 14.200/2021, which amended Law 9.279/96 to increase the legal hypotheses of compulsory licensing and provide more robustness to the rules already stated in the Brazilian Industrial Property Law.

Besides the obligation to provide know-how, technical studies, test data and inputs, the possibility of granting a compulsory license by law was also vetoed. The President’s Office ratified the need of a formal act by the President for granting a compulsory license in Brazil also in this hypothesis.

For more details regarding the vetoed passages by the President of the Republic and the reasons for this, check here the study of the Veto released by the Senate.

If you would like more information on the subject, please do not hesitate to contact us at mail@kasznarleonardos.com.