Brazil – First Instance Decision Grants Patent Term Adjustment in Gilead Case

Federal court grants case-specific compensation, signaling a potential shift in PTA strategy post-Article 40.

On February 10, the 4th Federal Court of the Federal District granted a patent term adjustment (PTA) for patent PI 0112646-6, owned by Gilead Sciences Inc., recognizing that excessive and unjustified delay by the Brazilian Patent and Trademark Office (BRPTO) during prosecution warranted compensation.

The application, filed in 2001, was granted only in 2017 after more than 16 years of examination. Following the Brazilian Supreme Court’s 2021 decision in ADI #5,529, which invalidated the 10-year-from-grant rule under Article 40 of the Patent Statute, the patent term was significantly reduced. Gilead did not seek to revive the invalidated rule but instead requested a case-specific adjustment based on identifiable delays in the prosecution record.

Although the lawsuit was initially dismissed, the judge reversed the decision after a motion for clarification and held that the BRPTO’s unjustified delay triggered state liability under Article 37, Paragraph 6, of the Constitution. The Court ordered the issuance of a new letters patent publication with a proportionally extended term.

While prior PTA decisions in Brazil have generally been unfavorable, this ruling stands out for relying on an individualized assessment of delay, potentially opening the door for similar claims—subject to appellate review.