A Delaware federal judge has dismissed two Allergan entities from ongoing litigation concerning alleged patent infringement related to Botox products. This ruling narrows the plaintiff group in the high-profile Allergan Botox patent suit Delaware case.

U.S. District Judge Richard Andrews ruled that Allergan Ireland lacked standing in the suit, as the company failed to prove exclusive licensing rights to the disputed Botox patents. Additionally, Allergan USA Inc. voluntarily agreed to be dismissed, leaving Allergan Inc. as the sole plaintiff.

The case centers on a 2021 lawsuit filed by Allergan Inc. against biotechnology firms Revance Therapeutics Inc. and Ajinomoto Bio-Pharma Services, accusing them of infringing six patents tied to Botox-related pharmaceutical compositions and methods. Revance’s botulinum toxin product, DaxibotulinumtoxinA for Injection, marketed as DAXXIFY, was approved by the FDA for treatment of frown lines and cervical dystonia in 2022 and 2023, respectively.

Judge Andrews highlighted contractual complexities involving multiple Allergan entities and licensing agreements dating back to 2001, noting that ownership and rights transfers were not clearly established. The court emphasized that the burden of demonstrating standing rested with Allergan.

Despite delays in FDA approval due to the COVID-19 pandemic and inspection deficiencies, the court rejected arguments that potential non-commercialization of the product negated infringement claims.

The litigation continues with Allergan Inc. pursuing patent rights against Revance and Ajinomoto in the U.S. District Court for the District of Delaware under case number 1:21-cv-01411.

Legal Representation:

• Allergan Inc.: Morris Nichols Arsht & Tunnell LLP; Paul Hastings LLP

• Revance Therapeutics Inc. and Ajinomoto Bio-Pharma Services: Young Conaway Stargatt & Taylor LLP; Sterne Kessler Goldstein & Fox PLLC