Allergan Wins $56M in Botox Patent Fight with Revance

Background

Allergan, Inc., Allergan Pharmaceuticals Ireland Unlimited Company, and Allergan USA, Inc.—all subsidiaries of AbbVie Inc.—filed a patent infringement suit against Revance Therapeutics, Inc. and Ajinomoto Althea, Inc. (doing business as Ajinomoto Bio-Pharma Services or ABPS). The suit, filed in federal court, concerns nine U.S. patents: Nos. 11,033,625; 11,147,878; 11,285,216; 7,354,740; 8,409,828; 11,124,786; 11,203,748; 11,326,155; and 7,332,567. These patents relate to the formulation, manufacturing processes, and testing (particularly potency assays) for botulinum toxin-based therapeutics.

Revance, based in Nashville, Tennessee, developed Daxxify (formerly known as DaxibotulinumtoxinA for Injection), a botulinum toxin product positioned as a competitor to Allergan’s Botox. Ajinomoto, based in San Diego, California, served as a contract manufacturer.

Cause

The lawsuit stemmed from Revance’s activities in connection with Daxxify leading up to and following its Biologics License Application (BLA) submission to the FDA. While certain pre-approval manufacturing activities can be shielded under the FDA “safe harbor” (35 U.S.C. § 271(e)(1)), Allergan argued that the Defendants’ actions—including large-scale manufacturing, stockpiling, and quality testing—went beyond protected development efforts.

Plaintiffs also cited public statements and conduct indicating Revance’s intent to commercialize Daxxify immediately after FDA approval, further suggesting infringement. At the heart of the claim were cell-based potency assays and production methods that allegedly used Allergan’s patented botulinum toxin substrate technology and formulations.

Injury

Allergan claimed ongoing and imminent harm to its competitive position in the botulinum toxin market due to the unauthorized use of its patented innovations. The alleged infringement threatened to erode Allergan’s market share and investment in its intellectual property portfolio, which underpins Botox—a flagship therapeutic and cosmetic product.

Damages

Plaintiffs sought damages for:

Past, present, and future acts of infringement
Loss of exclusivity and competitive edge
Prejudgment and post-judgment interest
Attorneys’ fees and legal costs

They also sought injunctive relief to prevent further infringement by Revance and Ajinomoto.

Key Arguments and Proceedings

Legal Representation

Plaintiffs: Allergan, Inc. | Allergan Pharmaceuticals Ireland Unlimited Company | Allergan USA, Inc.
Counsel for Plaintiff: Anthony David Raucci | Jeremy A. Tigan | Eric W. Dittmann | Krystina L. Ho | Ashley N. Mays-Williams | Bruce M. Wexler | Carl J. Minniti III | Chad J. Peterman | David Valente | Isaac S. Ashkenazi | Karthik R. Kasaraneni | Melanie R. Rupert |
Defendants: Revance Therapeutics, Inc. | PCI San Diego, Inc. d/b/a Ajinomoto Bio-Pharma Services
Counsel for Defendants: Anne Shea Gaza | Samantha G. Wilson | Daniel G. Mackrides | Adam C. LaRock | Adil B. Moghal | Andrew Solomon | Anna G. Phillips | Byron L. Pickard | Christopher M. Gallo | Deirdre M. Wells | Dennies Varughese | Louis P. Panzica Jr. | Marsha Rose Gillentine | Nirav N. Desai | Peter J. Armenio | Ryan E. Conkin | Sasha S. Rao | Tyler C. Liu

Claims

The complaint included:

Direct Infringement under 35 U.S.C. § 271(a) for all nine asserted patents
Declaratory Judgment of infringement under 28 U.S.C. §§ 2201–2202 and 35 U.S.C. § 271
A jury trial demand on all issues so triable

The lawsuit reflects rising tension in the neurotoxin therapeutics market, with Revance emerging as a significant competitor to AbbVie/Allergan’s Botox dominance.

Defense

Revance Therapeutics, Inc. and Ajinomoto Bio-Pharma Services denied all allegations of patent infringement and challenged the validity and enforceability of Allergan’s asserted patents. They filed counterclaims seeking declaratory judgments of non-infringement for U.S. Patent Nos. 7,354,740, 8,409,828, and 7,332,567. Among their primary defenses, the defendants argued that Allergan failed to state a viable claim and that their activities fell within the safe harbor provision under 35 U.S.C. § 271(e)(1), which protects actions reasonably related to seeking FDA approval.

Additionally, the defendants asserted that the asserted patents were invalid and that there was no exceptional case warranting fees or enhanced damages. They also invoked equitable doctrines such as estoppel, waiver, and unclean hands to bar or limit Allergan’s relief. Revance contended that any alleged infringement was protected and that the plaintiffs were not entitled to damages or injunctive relief.

Jury Verdict

On July 18, 2025, the jury returned a verdict in favor of the plaintiffs, awarding Allergan, Inc., Allergan Pharmaceuticals Ireland Unlimited Company, and Allergan USA, Inc. $56,000,000 in damages. The jury found that Revance Therapeutics, Inc. and Ajinomoto Bio-Pharma Services had willfully infringed multiple patents related to botulinum toxin formulations, and concluded that the infringement caused significant financial harm to Allergan’s competitive position in the market.

Court Documents

Court documents are available for purchase upon request at Jurimatic@exlitem.com