On July 18, 2025, after a five-day trial, the jury in Allergan v. Revance Case No. 1:21-cv-01411 (D. Del.) entered a verdict finding claim 8 of Allergan’s U.S. Patent No. 7,354,740 (“the ’740 patent”), claim 6 of U.S. Patent No. 11,147,878 (“the ’878 patent”), and claim 8 of U.S. Patent No. 11,203,748 (“the ’748 patent”) not invalid for obviousness.  The patents relate to Allergan’s Botox^® (onabotulinumtoxinA).  The jury also entered damages in the form of a reasonable royalty for infringement of the patents by Revance’s Daxxify^® (daxibotulinumtoixnA-lanm) in the amount of $56 million.  Revance had previously stipulated to infringement of the claims if they were determined to be valid.

The damages award was calculated using a 15% royalty for formulation claim 6 of the ’878 patent and a combined 12% for manufacturing claims 8 of the ’740 and ’748 patents until the September 2023 expiration of the ’740 patent.  After the ’740 patent expired, the royalty was dropped to 4% for claim 8 of the ’748 patent through its expiration.

There are no additional ongoing patent disputes related to Botox^® or Daxxify^®.

In 2024, AbbVie reported $2.718 billion in U.S. sales for Botox^® therapeutic and an additional $1.682 billion for Botox^® cosmetic.  Revance reported $79 million in Daxxify^® sales for the first three quarters of 2024.

For more information about these and other biosimilar and biologic drug patent disputes, please visit BiologicsHQ.

 

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The author would like to thank April Breyer Menon for her contributions to this article.