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March 25, 2020

Galderma Wins Federal Circuit Appeal Against Amneal, Affirming “Doctrine of Equivalents” Infringement Ruling for Key Oracea® Patents


King & Spalding, on behalf of Galderma Laboratories (Fort Worth, TX), won Federal Circuit affirmance of its 2018 trial win against Amneal Pharmaceuticals, protecting Galderma’s flagship Oracea® product from generic competition until December 24, 2025.  In a March 25, 2020 opinion, the Federal Circuit unanimously affirmed D. Del. Chief Judge Stark’s trial ruling that Amneal’s generic copy of Oracea® infringed Galderma’s Chang patents under the “doctrine of equivalents,” despite Amneal’s claim that it had “designed around” the Chang patents.  The Federal Circuit also rejected Amneal’s assertion of “prosecution history estoppel” – agreeing with Galderma that the record of prior inter partes review proceedings did not clearly and unmistakably exclude Amneal’s product from infringing the Chang patents.  King & Spalding’s trial win for Galderma against Amneal has been awarded “Hatch-Waxman Case of the Year” by LMG Life Sciences, recognized by Law360 in awarding King & Spalding “Life Sciences Group of the Year,” and commended by Financial Times in the Litigation and Disputes category for the 2019 Innovative Lawyers North America Awards.