BRAZIL Law and Practice Contributed by: Ana Paula Affonso Brito and Maria Eduarda de O Borrelli Junqueira, Montaury Pimenta, Machado & Vieira de Mello
4. Patent Term Extensions for Pharmaceutical Products 4.1 Supplementary Protection Certificates Initially, it is important to highlight that patent term adjustments (PTAs) or supplementary pro - tection certificates (SPCs) are not available in Brazil, nor are they the subject of any formal legal provision. However, in view of a Supreme Court decision issued in May 2021 (lawsuit ADI No 5529/DF), stating the unconstitutionality of the sole para - graph of Article 40 of the Industrial Property Act and abolishing the ten-year minimum validity term for patents for inventions and the seven- year minimum validity term for utility models, patentees are filing lawsuits in Brazil request - ing PTAs based on the unjustified delay of the BPTO in the analysis of patent applications, on a case-by-case basis. Therefore, it is not up to the BPTO to decide a possible patent term adjust - ment. Rather, this discussion is being addressed in the federal courts, with the BPTO figuring as a defendant. Such lawsuits are new and, for now, it is not possible to predict how they are going to evolve, what their outcome will be, and how long it will take to reach a final decision. It is also not pos - sible to answer questions regarding eligibility criteria and/or provide information regarding the calculation of the duration of adjustments. At present, there are approximately 60 lawsuits requesting a PTA before the Brasília Federal Court, and most of these have the same goal: seeking a PTA, based on an excerpt from a decision by the Honourable Judge Dias Toffoli, who quoted the PTA expression as an institute
of other countries, which, in theory, allows the extension of the patent validity term. Most of the decisions already issued are pre - liminary injunction decisions that do not have the purpose of effectively extending the patent term in a definitive way, but rather, that have the purpose of suspending the patent expiry date, until a decision is made on the merits of the mat - ter (all of them still pending). The movement to file lawsuits seeking patent validity adjustment began in the second half of 2021. All patents subject to these lawsuits refer to technologies in the pharmaceutical area. Up until April 2024, a total of 62 lawsuits had been filed seeking compensation for the term, due to unjustified delays on the part of the BPTO. These lawsuits have been filed before the fed - eral courts, in the court of the Judicial Section of Brasília, the federal capital. The unanimous choice of the Brasília court implies a significant impact on case law regard - ing PTAs, since all first-instance decisions will emanate from the Brasília court and the respective appeals will be heard by the Federal Regional Court of the First Circuit (TRF-1). By concentrating such lawsuits in a single court, the expected effect is the consolidation of the TRF- 1 as a paradigmatic instance in which Brazilian precedents on the subject will be issued, at least for now. Among the 62 actions filed, several bring claims for preliminary relief in the first instance (either with the initial brief or incidentally), that is, it is requested that the final provision (compensa - tion for the patent term) be granted provisionally, based on Article 300, caput, of the current Code of Civil Procedure.
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