Allergan, Inc. v. Revance Therapeutics, Inc.

CourtDistrict Court, M.D. Tennessee
DecidedJanuary 3, 2024
Docket3:23-cv-00431
StatusUnknown

This text of Allergan, Inc. v. Revance Therapeutics, Inc. (Allergan, Inc. v. Revance Therapeutics, Inc.) is published on Counsel Stack Legal Research, covering District Court, M.D. Tennessee primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Allergan, Inc. v. Revance Therapeutics, Inc., (M.D. Tenn. 2024).

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF TENNESSEE NASHVILLE DIVISION

ALLERGAN, INC. et al., ) ) Plaintiffs, ) ) NO. 3:23-cv-00431 v. ) ) JUDGE RICHARDSON REVANCE THERAPEUTICS, INC. ) ) Defendant. )

MEMORANDUM OPINION

Allergan, Inc., Allergan Pharmaceuticals Ireland Unlimited Company, Allergan USA, Inc., and Allergan Sales, LLC (collectively, “Plaintiff”) brought this action against Defendant, Revance Therapeutics, Inc., via a two-count complaint. Plaintiff asserted therein claims for misappropriation of trade secrets in violation of the federal Defend Trade Secrets Act (DTSA) (Count I) and the Tennessee Uniform Trade Secrets Act (TUTSA) (Count II). Plaintiff seeks damages as well as declaratory and injunctive relief. Now pending before the Court is Defendant’s Motion to Dismiss (Doc. No. 33, “Motion”) seeking the dismissal of Counts I and II. The Motion is supported by a memorandum of law (Doc. No. 34, “Memorandum”). Plaintiff filed a Response in opposition to the Motion (Doc. No. 43, “Response”), and Defendant filed a Reply. (Doc. No. 46). BACKGROUND I. Facts1 A. Regulatory Landscape Surrounding Competing Drugs Plaintiff is a pharmaceutical company that manufactures and sells, among other drugs, botulinum neurotoxin (BoNT) injectable products and dermal fillers. (Doc. No. 1 at ¶¶ 1-2). At issue here are Plaintiff’s injectable BoNT product, Botox, and a line of dermal filler products under

the trade name Juvéderm. (Id. at ¶¶ 23-24). Defendant is a competitor in the BoNT and dermal filler space, and it developed an injectable BoNT product, with the trade name “Daxxify,”2 to compete directly with Botox. (Id. at ¶ 4). Defendant obtained FDA approval for Daxxify in September 2022. (Id. at ¶ 50). Shortly thereafter, Defendant began seeking approval to use Daxxify internationally and to expand its regulatory filing to cover new indications.3 (Id.). Moreover, in 2020, Defendant also launched a line of dermal filler products, referred to as the “RHA Collection,” which compete directly with Plaintiff’s Juvéderm products. (Id. at ¶ 66). Defendant also is seeking FDA approval of a Botox biosimilar4 on which Defendant has collaborated with

1 All (alleged) facts in this section are taken from the Complaint at Doc. No. 1 and, as discussed below, are taken as true for purposes of resolving the pending Motion. Notably, in some places in this section, reference is made not to alleged facts, but to a party’s assertions; unlike alleged facts, such assertions are not accepted at true but are included to place the alleged facts in context with the party’s competing assertions.

2 Daxxify is referred to in the Complaint also as “RT002.” (Doc. No. 1 at ¶ 4). For the sake of simplicity, the Court uses the term “Daxxify” throughout this memorandum.

3 Without purporting to state exactly what Plaintiff means when it refers to “indication,” the Court understands that generally, an “indication” for a medication is “a valid reason—most often for medical issues such as signs/symptoms or diseases/disorders—to use [the] medication.” Sohn S, Liu H., Analysis of Medication and Indication Occurrences in Clinical Notes, AMIA Annu Symp Proc. (Nov. 14, 2014).

4 According to the FDA, a biosimilar is a medication very similar, but not identical, to an original biological medication. https://www.fda.gov/drugs/biosimilars/biosimilar-basics-patients. Biosimilars are made from the same types of sources (e.g., living cells or microorganisms) and are just as safe and effective as the original biologic medication to which they are highly similar. Id. To obtain approval through the abbreviated approval process set forth by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), “a biosimilar manufacturer must show that its proposed product is ‘highly similar’ to the

Veatris, Inc. and plans to launch in 2026. (Id. at ¶¶ 54, 56). Like Daxxify, Defendant’s Botox biosimilar would compete directly with Plaintiff’s Botox products. (Id. at ¶ 76). As relevant to its trade secret claims, Plaintiff asserts that its development of confidential know-how concerning BoNT regulatory, technical, and manufacturing efforts has been critical to Botox’s success. (Id. at ¶ 26). For example, obtaining approval for a BoNT product requires a

demonstration of acceptable potency levels of the drug and the drug product. (Id. at ¶ 30). In the absence of any international consensus as to a reference potency standard, each manufacturer uses a unique reference standard specific to its own product. (Id.). Plaintiff uses its own unique potency reference standard to determine whether manufactured Botox falls within the acceptable potency levels. (Id.). This unique reference standard, and all associated procedures, protocols, and data (collectively, the “Botox Reference Standard”) are trade secrets.5 (Id.). The FDA also requires applicants to use a testing-technique (referred to as an “assay”) to assess the potency of BoNT products. (Id. at ¶¶ 26, 31). Plaintiff was the first company to receive FDA approval for the use of a cell-based potency assay (“CBPA”) which measures potency in

already-licensed biologic product and that there are no ‘clinically meaningful differences’ between the two products in terms of ‘safety, purity, and potency.’” (Doc. No. 1 at ¶ 57 (quoting 42 U.S.C. § 262)).

5 The Sixth Circuit has stated that “what constitutes a trade secret is a question of fact.” ECIMOS, LLC v. Carrier Corp., 971 F.3d 616, 643 (6th Cir. 2020); Caudill Seed & Warehouse Co. v. Jarrow Formulas, Inc., 53 F.4th 368, 381 (6th Cir. 2022) (“Whether a particular type of information constitutes a trade secret is a question of fact.”). Even for questions of fact, a court is not required to accept as true “bare assertions,” formulaic recitation of the elements, or “conclusory” allegations. Ashcroft v. Iqbal, 556 U.S. 662, 681 (2009). In other words, although a question of fact, the Court is not required to accept as true that what Plaintiff calls “Allergan Trade Secrets” indeed qualify as trade secrets in whole or in part under relevant law from a mere assertion by Plaintiff that these items are “trade secrets.” However, where a complaint asserts that certain items qualify as trade secrets and supports that assertion with factual matter relating to the criteria used to define trade secrets under the DTSA and TUTSA (as the Complaint does here) the Court must accept that assertion as true. Therefore, for present purposes the Court accepts as true Plaintiff’s allegation that the Allergan Trade Secrets, as defined in ¶ 34 of the Complaint, qualify for trade-secret protection under DTSA and TUTSA. vitro at the cellular level. (Id.). Plaintiff’s CBPA technologies, including the critical reagents used in the assay, procedures, protocols, and data also are trade secrets. Botox and Juvéderm’s success are largely attributable to sales and marketing strategies, including, but not limited to, customer lists and market analysis, which Plaintiff keep highly confidential. (Id. at ¶ 27). In full, Plaintiff’s trade secrets include:

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Bluebook (online)
Allergan, Inc. v. Revance Therapeutics, Inc., Counsel Stack Legal Research, https://law.counselstack.com/opinion/allergan-inc-v-revance-therapeutics-inc-tnmd-2024.