IP Hatch-Waxman Team Scores Patent Invalidity Trial Victory on Behalf of Azurity Pharmaceuticals
Windels Marx’s Hatch-Waxman Team won a patent invalidity trial on behalf of Azurity Pharmaceuticals, Inc. (“Azurity”) and its subsidiary against Heron Therapeutics, Inc. (“Heron”) concerning Azurity’s proposed version of CINVANTI® (aprepitant) injectable emulsion.
On June 1, 2026, the Delaware district court held that certain of Heron’s asserted patents were invalid due to a lack of written description. The Court held that Azurity had shown by clear and convincing evidence that the specifications of the patent families had not shown that the inventors had possession of the invention commensurate with the full scope of the claims asserted at trial. Pursuant to a stipulation between the parties, a judgment of non-infringement was also entered in favor of Azurity on the remaining asserted patents for the CINVANTI® product. Heron had asserted 13 patents against Azurity.
“The Court's ruling affirms the strength of Azurity’s scientific, intellectual property, and regulatory work, and we are proud to have defended that work successfully,” said Hanok George, Chief Legal & Compliance Officer at Azurity. “The outcome reaffirms our strategy of using the 505(b)(2) pathway to bring innovative, patient-centric medications to market.”
This win is particularly meaningful, as it comes at the heels of a trial loss and settlements of other cases brought by sponsors of proposed generics of CINVANTI®.
“Windels Marx is a valuable partner to Azurity in its IP litigation matters,” said Lena Cavallo, VP, Global Litigation and IP Enablement. “The team brought the precision and tenacity this case demanded. Across two years of litigation and a complex multi-day trial, their team never wavered — and that consistency made all the difference.”
The full trial team consisted of Constance Huttner, Elham Steiner, Robyn Ast-Gmoser and Colby Davis, as well as Eddie Rivera (paralegal) and Thomas Han (IT Professional). They were led and supported by Ajay Kayal and Andrew Miller.
