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The Federal Circuit on Friday upheld a district court ruling that cleared the way for Indian generic-drug maker Lupin Inc. to sell a treatment for a chronic skin condition, rejecting an appeal from Swiss skincare giant Galderma.

The case centers around Galderma's Oracea brand, a doxycycline capsule used to treat rosacea, and Lupin’s plans to launch a generic version of the drug. Galderma sued Lupin in 2021, alleging patent infringement in an effort to block the launch of the generic. However, following a three-day bench trial earlier this year, U.S. Circuit Judge Stephanos Bibas of the Third Circuit ruled in favor of Lupin, concluding that Galderma failed to prove its infringement claims.

Chief U.S. Circuit Judge Kimberly Moore, writing the precedential opinion, affirmed the district court's findings, stating that there was "no clear error" in the trial court's decision. The Federal Circuit agreed with Judge Bibas’ assessment that Galderma did not substantiate its infringement allegations with sufficient evidence, relying instead on "conclusory conjecture."

"The district court did not clearly err in finding Galderma did not prove the two-stage dissolution test represented in Lupin’s product," Judge Moore wrote. The Federal Circuit also sided with Judge Bibas’ choice to credit Lupin’s expert testimony over Galderma's.

Following the court's ruling, Lupin announced the launch of what it described as the “first generic version of Oracea,” marking a significant victory for the Indian pharmaceutical company in the competitive generic drug market.

The patents in question are U.S. Patent Nos. 7,749,532 and 8,206,740, covering aspects of the Oracea formulation. Galderma, a former subsidiary of Nestlé and L'Oréal, had sought to protect its product from generic competition. However, the Federal Circuit's ruling now opens the door for Lupin to market its generic version.

Representatives for both companies declined to comment on the ruling. The case is Galderma Laboratories L.P. v. Lupin Inc., case number 24-1664, in the U.S. Court of Appeals for the Federal Circuit.

The Federal Circuit panel included Judges Kimberly A. Moore, Richard Linn, and Sharon Prost. Galderma was represented by Gerald J. Flattmann Jr. and Andrew Cochran of Cahill Gordon & Reindel LLP, while Lupin was represented by William A. Rakoczy, Katie Boda, Joseph Thomas Jaros, and Adrianne C. Rose of Rakoczy Molino Mazzochi Siwik LLP.