Credit: Archive/Agência Brasil
The 1st Panel of the Federal Supreme Court (STF), by unanimous vote, rejected the extension of drug patents beyond the 20-year period in a discussion involving the EMS laboratory and the pharmaceutical company Bayer. The Court denied Bayer’s appeal and maintained the decision that EMS could import and produce the generic version of the anticoagulant rivaroxaban even before the publication of the trial minutes of the Direct Unconstitutionality Action (ADI) 5529 — which limited the patent term to 20 years, counting from the filing of the application.
The ADI considered unconstitutional the sole paragraph of the Industrial Property Law, which determined that the patent term could not be less than 10 years from the INPI decision approving the grant. The decision was published in May 2021, with retroactive effect for medicines. Days later, the generic version of rivaroxaban was released on the market. According to the criteria established by the ADI, the medicine’s patent expired in December 2020.
In its statements in court, Bayer maintained that the preparatory actions, such as importing batches of products necessary to make the medicine and registration requests from Anvisa, could only have been adopted through the ADI.
The discussion began at the 3rd Civil Court of Hortolândia. There, the decision was in favor of Bayer. EMS was ordered to destroy the batches produced before ADI and to pay compensation for losses and damages. In the first instance ruling, it is clear that the medicine was produced in April 2021 — therefore, after the end of the patent, but before the publication of the ADI.
The discussion reached the Supreme Court and Minister Luiz Fux judged the issue in favor of EMS. Bayer appealed. Now, in the group, Fux’s vote prevailed with the support of ministers Cristiano Zanin, Alexandre de Moraes, Cármen Lúcia and Flávio Dino. The trial has been in virtual plenary since March 8 and formed a majority before the end, on March 15.
“Repeat: the validity of the patent beyond the period of 20 (twenty) years provided for in the caput of art. 40 of Law 9,279/1996 is unconstitutional and the STF Plenary did not modulate the effects of this declaration of unconstitutionality for pharmaceutical products. The reservation of concrete effects was made to avoid judicialization and not to allow it in the exact terms in which it would be possible if the patent privilege were in force”, Fux wrote in his vote.
The discussion took place at Rcl 59091.