Brazilian Congress Approves a Project on Temporary Patent Suspension on Vaccines and Medicines - COVID-19


Brazilian Congress Approves a Project on Temporary Patent Suspension on Vaccines and Medicines - COVID-19


The Senate approved last week (August 11), the Bill No. 12/2021 ("PL 12/2021"), which aims to facilitate the compulsory licensing of patents in Brazil, in cases of emergency or public interest, such as in the current coronavirus pandemic. Said bill, authored by the Senator Paulo Paim, in the form of the substitute text approved in the Chamber, with amendments by the rapporteur in the Senate, is pending presidential sanction.

In short, PL 12/2021 amends the text of Law No. 9,279/96 (Industrial Property Law), authorizing the Executive Branch to grant, ex officio, a compulsory license, "temporary and non-exclusive, for the exploitation of the patent or request of patent”. Nevertheless, the approved text establishes the necessary guarantees to the patent holder regarding the temporary nature of the compulsory licensing, to the protection against undue exploitation, and to the determination of minimum parameters for the establishment of a remuneration compatible with market standards.

If the President sanctions the PL 12/2021 in the form approved by the Senate, the Executive Branch will have to prepare a list of patents / patent requests subject to compulsory licensing after the publication date of the statement of emergency or public interest, or the recognition of the public calamity. In any case, patents that are the object of production technology transfer or voluntary licensing agreements are excluded from the compulsory licensing.

Even though the Senate announces the PL 12/2021 as "vanguard", since the beginning of the debate on the subject, the Government has shown reluctance to support this type of measure (see: https://www.migalhas.com.br/depeso/346522/suspensao-temporaria-de-patentes-de-vacinas-da-covid-19). Thus, at the moment, it is not possible to guarantee that PL 12/2021 will be sanctioned by the President, without any restrictions.

For more information, access https://www25.senado.leg.br/web/atividade/materias/-/materia/149310 and contact us.


Ricardo Barretto Ferreira da Silva - Senior partner and coordinator of the area of TMT - Technology, Media and Telecommunications, and Data Protection of Azevedo Sette Advogados. Juliana Gebara Sene Santos Ikeda - Coordinator of Intellectual Property & Life Sciences of the TMT team of Azevedo Sette Advogados. Gabriela Soares Mussallam - Collaborator of the TMT team of Azevedo Sette Advogados.