The First Chamber of the Supreme Federal Court (STF) unanimously ruled against extending the patent for the anticoagulant medication beyond the 20-year period in a case involving the EMS laboratory and the pharmaceutical company Bayer. The Court denied Bayer’s appeal and upheld the decision that EMS could import and produce a generic version of the anticoagulant rivaroxaban even before the publication of the judgment minutes of the Direct Action of Unconstitutionality (ADI) 5529, which limited the patent term to 20 years from the filing date of the application.

The ADI deemed unconstitutional the unique paragraph of the Industrial Property Law, which stated that the patent term could not be less than 10 years from the decision of the National Institute of Industrial Property (INPI) approving the grant. The decision was published in May 2021, with retroactive effects for medications. Shortly after, the generic version of rivaroxaban was launched in the market. According to the criteria set by the ADI, the patent for the medication expired in December 2020.

In its legal arguments, Bayer maintained that preparatory actions, such as importing batches of products needed to manufacture the medication and filing registrations with ANVISA, could only have been undertaken following the ADI.

The dispute began in the 3rd Civil Court of Hortolândia. There, the decision was in favor of Bayer. EMS was ordered to destroy the batches produced before the ADI and to pay compensation for losses and damages. The first-instance judgment made it clear that the medication was produced in April 2021, after the patent had expired but before the publication of the ADI.

The case reached the Supreme Court, and Minister Luiz Fux ruled in favor of EMS. Bayer appealed. Now, in the chamber, 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 8th and reached a majority before its conclusion on March 15th.

“Let it be repeated: the validity of the patent beyond the 20-year term set forth in the main provision of Article 40 of Law 9.279/1996 is unconstitutional, and the Full Court of the STF did not modulate the effects of this declaration of unconstitutionality for pharmaceutical products. The specific effects were reserved to avoid litigation, not to allow it in the exact terms it would be possible if the patent privilege were in force,” wrote Fux in his vote.

The discussion took place in Rcl 59091.