Landmark ruling: brazilian federal judge grants patent term adjustment

In a landmark decision with strategic implications for innovators in Brazil, a Federal Trial Judge has ruled in favor of Novo Nordisk, adjusting the term of a pharmaceutical patent to compensate for the Brazilian Patent and Trademark Office (BPTO) unreasonable examination delays. The ruling confirms that patent holders can secure a judicial remedy to recover time lost to administrative inefficiency, thereby preserving the full economic value of their innovations.

The case centered on Brazilian patent PI0410972-4, which is related to the medicines Victoza® and Saxenda®. The BPTO took almost 14 years to grant the patent. The Dannemann patent litigation team, representing Novo Nordisk, successfully argued that this delay was disproportionate and attributable exclusively to the BPTO’s operational failures. The federal court unequivocally rejected the BPTO’s defense of a chronic workload backlog, establishing that administrative inefficiency cannot be used as a shield to justify the violation of a patent holder’s rights.

This victory marks a pivotal development in the Brazilian patent system, particularly following the Brazilian Supreme Court’s 2021 decision in a constitutional challenge. In that case, the Supreme Court declared the automatic extension of patent terms unconstitutional, a mechanism that had previously guaranteed a minimum of 10 years of validity from the date of grant.

However, the Brazilian Supreme Court’s decision left the door open for a more precise and just solution: a case-by-case adjustment of a patent’s term – analogous to the Patent Term Adjustment (PTA) in U.S. law – for proven instances of unreasonable and unjustified administrative delay.

The legal strategy architected by the Dannemann patent litigation team was built upon this crucial distinction. Novo Nordisk did not seek to revive the old, automatic rule. Instead, they sought a specific, tailored remedy grounded in fundamental constitutional principles, namely the right to a reasonable duration of proceedings and the state’s duty of efficiency. The trial judge fully endorsed this interpretation.

Crucially, the trial judge’s ruling recognized that monetary damages are an insufficient remedy for the harm caused. The very essence of a patent is the grant of temporary exclusivity, a right whose value is eroded with each passing day of bureaucratic delay. The ruling affirmed that the most effective and appropriate measure to repair the damage caused by state inefficiency is to restore that lost time through a direct adjustment of the patent’s term.

This decision is more than a single victory; it is a clear signal from the Judiciary that the rights of innovators will be protected against BPTO’s inertia. It confirms a viable legal pathway for companies across all sectors to reclaim patent term lost due to the BPTO’s historical delays.

Patent holders whose patents underwent prolonged and unjustified examination periods should seize this moment to reevaluate their portfolios and identify candidates for similar legal action. This ruling transforms the burdens of bureaucratic delays into remarkable opportunities to reclaim valuable market exclusivity.