A federal judge in Delaware has set the stage for a high-stakes patent infringement trial between pharmaceutical giants Allergan and Revance Therapeutics, scheduled to proceed in July following the denial of summary judgment motions from both parties. The case represents a significant legal battle over botulinum toxin formulation patents that could impact the competitive landscape for aesthetic and therapeutic neurotoxin products.
Court Rejects Summary Judgment Motions
U.S. District Judge Richard G. Andrews issued a 30-page opinion on Monday largely rejecting summary judgment motions from both Allergan and Revance, clearing the path for trial. The court found that Allergan failed to provide sufficient evidence to support its claim to an earlier conception date for one of its formulation patents involving animal protein-free formulations.
"Allergan cannot point to one document that proves the conception of the three-month storage buffered claim," Judge Andrews noted in his ruling, highlighting deficiencies in Allergan's evidence regarding patent conception dates.
The court also denied Revance's request to dismiss claims for lost profits and declined to grant Allergan's motion to find infringement based on Revance's stipulations, stating that such a ruling could complicate the jury process and reduce incentives for future legal stipulations.
Patent Infringement Allegations
The lawsuit, originally filed in 2021, alleges that Revance's botulinum toxin product Daxxify (DaxibotulinumtoxinA-lanm) infringes six U.S. patents related to Botox formulations and stabilization methods. The disputed patents include Nos. 11,033,625; 11,147,878; 7,354,740; 8,409,828; 11,124,786; and 7,332,567, covering pharmaceutical compositions and methods tied to Botox-related products.
Revance's Daxxify product received FDA approval for treatment of frown lines in 2022 and cervical dystonia in 2023, positioning it as a direct competitor to Allergan's established Botox franchise. The court maintained that intent to sell is not a prerequisite for potential patent infringement, rejecting Revance's previous motion to dismiss based on potential non-commercialization.
Plaintiff Group Narrowed
In a separate ruling, Judge Andrews dismissed two Allergan entities from the litigation, significantly narrowing the plaintiff group. Allergan Ireland was dismissed after the court ruled it 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.
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 Allergan Ireland now holding rights to the Botox-related intellectual property following a series of transfers from other Allergan entities between 2001 and 2020.
Market Impact and Legal Representation
The case has proceeded despite delays in FDA approval processes due to the COVID-19 pandemic and inspection deficiencies that affected Revance's product development timeline. The court rejected arguments that potential non-commercialization of the product negated infringement claims, maintaining the validity of the patent dispute.
Allergan is represented by Morris Nichols Arsht & Tunnell LLP and Paul Hastings LLP, while Revance and co-defendant Ajinomoto Bio-Pharma Services are represented by Young Conaway Stargatt & Taylor LLP and Sterne Kessler Goldstein & Fox PLLC. The litigation continues in the U.S. District Court for the District of Delaware under case number 1:21-cv-01411.
