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 conduc