For the first time, a Brazilian court has analyzed the merits of a Patent Term Adjustment (PTA) request and recognized the patent holder’s right to an extension of the patent term due to excessive and unjustified delays by the Brazilian Patent and Trademark Office (INPI). This decision was issued on May 12, 2025, by the 4th Federal Civil Court of the Federal District. The case involves Genzyme Corporation and The Regents of the University of Michigan, under case number 1088996-39.2021.4.01.3400.
This represents a landmark ruling in the context of PTA-related litigation in Brazil. Since the Brazilian Supreme Federal Court (STF) declared the sole paragraph of Article 40 of the Industrial Property Law (IPL) unconstitutional on May 12, 2021, patents granted by INPI are no longer entitled to the automatic 10-year protection from the grant date when the examination exceeds half of the standard 20-year term from the filing date (or 15 years in the case of utility models).
Companies holding patents affected by this ruling have been turning to the judiciary to request specific and individualized extensions through court orders, arguing that they are entitled to adjustments due to delays not attributable to the patent holder.
The ruling in the Genzyme case, however, appears to go further by concluding that the company is entitled to a 10-year term counted from the grant date, similar to what was previously provided under the now-repealed sole paragraph of Article 40 of the IPL. The decision has not yet been officially published, and INPI is expected to file an appeal with suspensive effect before the Federal Regional Court of the 1st Region (TRF-1).
Our attorneys, Paulo Armando and Isabelle Ilicciev, highlight the importance of closely monitoring ongoing PTA cases, as the uniformity of interpretation regarding the application of the Supreme Court ruling in the constitutional review will ultimately be resolved by the STF. “There is cautious optimism regarding the impacts of the decision in ADI 5.529 going forward. However, for patents affected by this binding decision, or for market players looking to launch products based on this (or similar) technology, achieving clarity through the judiciary or via new legal provisions will be productive for ensuring legal certainty and predictability in the market — whether by validating or closing the judicial pathway for PTAs,” they noted.
