Pleading Use of Trade Secrets Concerning a Biological Product by Showing Product-Related Similarities: Allergan,Inc. v. Revance Therapeutics,Inc.

Abstract

This article analyzes Allergan, Inc. v. Revance Therapeutics, Inc., 711 F. Supp. 3d 873 (M.D. Tenn. 2024), a decision enhancing trade secret protection on biological product innovations. Here, the district court determined that the complaint plausibly alleged the defendant’s unauthorized use of some of the plaintiff’s trade secrets. This holding relied on comparison between the alleged trade secrets and the development or testing of the defendant’s biological drugs. The Allergan approach extends the Sixth Circuit’s Stratienko rule that compares the plaintiff’s trade secret(s) and the defendant’s product as a way to prove unauthorized use of the plaintiff’s trade secret(s). Under the Allergan approach, the trade secret protection of pioneer biologics expands its peripheral boundary to cover the pioneer company’s proprietary information of stability and potency testing of its pioneer biological. In addition, the Allergan decision will provide advanced protection on the pioneer company’s trade secrets before the biosimilar company starts to file a biosimilar application.

I. INTRODUCTION

Botulinum neurotoxin (“BoNT”) type A, a toxin produced by the bacterium Clostridium botulinum, is used to make an injectable product for therapeutic or cosmetic purposes.¹ For example, BOTOX® and BOTOX® Cosmetic are BoNT injectable products manufactured and marketed by Allergan, Inc.²

In 2004, the U.S. Food and Drug Administration (“FDA”) approved Botox for use in temporarily reducing the appearance of moderate-to-severe glabellar lines.³ Since then, Botox has become a successful cosmetic product.⁴ Allergan, Inc. also manufactures and sells Juvéderm®, a dermal filler used to correct moderate-to-severe facial folds.⁵ Botox is expected to be paired with Juvéderm for achieving a desired facial rejuvenation look.⁶

On April 28, 2023, Allergan, Inc. and its family companies (collectively, “Allergan”) sued Revance Therapeutics, Inc. (“Revance”) for trade secret misappropriation under both the federal Defend Trade Secrets Act (“DTSA”) and the Tennessee Uniform Trade Secrets Act (“TUTSA”).⁷ The alleged trade secrets involved two Allergan’s products, Botox and Juvéderm.⁸ The asserted misappropriation resulted in accelerated FDA approvals for Revance’s two products, Daxxify® and RHA® Collection, competing with Botox and Juvéderm, respectively.⁹

The definition of “misappropriation” under the TUTSA is almost the same as its DTSA counterpart.¹⁰ The DTSA divides “misappropriation” into two categories.¹¹ The first category is “acquisition of a trade secret of another by a person who knows or has reason to know that the trade secret was acquired by improper means[.]”¹² The second category is “disclosure or use of a trade secret of another without express or implied consent by a person”:

Who “used improper means to acquire knowledge of the trade secret[.]”¹³

Who “at the time of disclosure or use, knew or had reason to know that his knowledge of the trade secret was” (a) “derived from or through a person who had used improper means to acquire it[,]” (b) “acquired under circumstances giving rise to a duty to maintain its secrecy or limit its use[,]” or (c) “derived from or through a person who owed a duty to the person seeking relief to maintain the secrecy of the trade secret or limit the use of the trade secret[.]”¹⁴

Who “before a material change of the position of the person, knew or had reason to know” that “the trade secret was a trade secret” and that “knowledge of the trade secret had been acquired by accident or mistake[.]”¹⁵

On January 3, 2024, the United States District Court for the Middle District of Tennessee denied Revance’s motion to dismiss under Rule 12(b)(6) of the Federal Rules of Civil Procedure (hereinafter, “Allergan decision”).¹⁶ The district court found that Allergan plausibly alleged sufficient facts to support its misappropriation claim.¹⁷ Among other things, the district court determined that the complaint plausibly alleged Revance’s unauthorized use of some of Allergan’s trade secrets.¹⁸ This holding relied on comparison between Allergan’s trade secrets and the development or testing of Revance’s biological drugs.¹⁹

This article is intended to explain why the Allergan decision may enhance trade secret protection on biological innovations. Part II introduces the background of the Allergan decision, including the alleged trade secrets, the incidents of trade secret misappropriation, and the district court’s denial of Revance’s motion to dismiss. Part III analyzes the Allergan court’s reasoning on Revance’s use of Allergan’s trade secrets. Finally, Part IV discusses practical implications drawn from the Allergan decision that may level up trade secret protection on innovative biological drugs.

II. BACKGROUND OF ALLERGAN, INC. v. REVANCE THERAPEUTICS, INC.

A. Alleged trade secrets

In the complaint, the alleged trade secrets were categorized into nine items:

“Characterization data concerning the Botox drug substance”;

“The Botox Reference Standard”;

“The critical reagents [used in an assay], standard operating procedures, protocols, and data associated with Allergan’s [cell-based potency assay (“CBPA”)] technologies”;

“Allergan’s strategies and techniques to manufacture Botox, such as those described in confidential Botox regulatory filings relating to cell banks, upstream and downstream processes, storage conditions, finish-and-fill steps, and related data”;

“Regulatory strategies and best practices”;

“Data regarding Allergan’s customers for Botox and/or Juvéderm, including market data, preferences, contacts, buying history, confidential sales representative success rates, territories, identities, and related information”;

“Marketing strategies for Botox and Juvéderm”;

“Allergan’s past, current, and future commercial and regulatory plans concerning Botox and/or Juvéderm”; and

“Strategies to compete in the marketplace, including against Revance’s Daxxify and RHA products.”²⁰

Specifically, the “Botox Reference Standard” includes Allergan’s “own unique potency reference standard to determine whether manufactured Botox falls within the acceptable potency levels” and “all associated procedures, protocols, and data[.]”²¹

Allergan’s unique CBPA technologies which measure potency in vitro at the cellular level were created to satisfy the FDA’s requirement of an assay testing technique used for assessing the stability and potency of BoNT products.²² In addition, Allergan was the first company to receive FDA approval for the use of a CBPA for measuring the potency of a BoNT product.²³

B. Alleged misappropriation

Allergan’s misappropriation allegations were grounded primarily on Revance’s recruitment of three former Allergan high-level employees, Cara Chastain, Jennifer Aggabao, and Wendy Shepherd.²⁴

Chastain was Allergan’s Executive Director of Facial Aesthetics Marketing when she resigned from Allergan in August 2021.²⁵ A few days before her resignation, she pretended to perform her job duties to seek access to Allergan’s confidential information, including competitive strategies in response to Revance’s then-FDA-pending Daxxify product.²⁶ Upon her resignation, she hid her acceptance of Revance’s job offer by falsely stating that she had no job lined up.²⁷ Right after her false statement, she attended Revance’s financial strategy meeting.²⁸

Aggabao was Allergan’s Director of Global Regulatory Affairs for Chemistry Manufacturing and Controls (“CMC”) Biologics when she departed to a new position with Revance.²⁹ She resigned on August 26, 2022, but she had discussed her potential job with Revance about in July 2022.³⁰ On August 28, 2022, she started to work for Revance.³¹

Aggabao’s role in Allergan allowed her to access Allergan’s trade secrets, including the Botox Reference Standard and CBPA technology.³² Near her resignation date, she accessed and downloaded electronic documents at a rate beyond her job responsibilities, which documents contained Allergan’s trade secrets characterized as “confidential information on internal best practices used by Allergan regulatory professionals to ensure consistency with manufacturing[-]related submissions to agencies, manufacturing information, and Botox drug substance characterization analysis and potency information related to, inter alia, reference standard protocols, CBPA procedures and critical reagents, validation techniques, and stability data.”³³

Shepherd was Allergan’s Senior Business Development Manager when Revance was recruiting her.³⁴ She was responsible for Botox and Juvéderm sales efforts and was able to access Allergan’s highly confidential customer lists and internal sales data.³⁵ To prepare for her job interview with Revance, she used Allergan’s trade secrets to create a PowerPoint presentation.³⁶ The presentation file included a list of Allergan’s top salespeople, with their associated sales figures and geographic locations (e.g., 2022 sales figures for Botox and Juvéderm), and a “30-60-90 Day Business Plan.”³⁷

Shepherd stored the presentation file on her work computer and sent it to her personal email address.³⁸ After her interview with Revance, she sent to her email address more of Allergan’s confidential documents covering internal sales tracking, customer lists, action plans, strategies for responding to frequently asked questions, pricing calculators for Botox and Juvéderm sales, business strategy templates, performance reports, and a customer email distribution list.³⁹ Then, she deleted numerous files and folders from her work computer.⁴⁰

Revance intentionally filled its ranks with Chastain, Aggabao, and Shepherd and gave them responsibilities consistent with the duties they had, respectively, in Allergan’s positions.⁴¹ Revance also hired other former Allergan employees to fill its positions in order to gain the benefits from Allergan’s trade secrets.⁴²

Revance’s alleged misappropriation was specifically assisted by Aggabao, who intentionally hid from her superior and team in Allergan her future employment with Revance.⁴³ Aggabao started to work for Revance just a few days after accessing and downloading those Allergan’s confidential documents, while Revance still possessed, held, or controlled some or all of the stolen information until this lawsuit was initiated.⁴⁴ In return, Revance offered Aggabao a 50 percent wage increase, title promotion, bonus pay, and company stock.⁴⁵

Overall, these alleged misappropriating activities contributed to Revance’s accelerated efforts to obtain FDA approval for an alternative CBPA and more rapid commercial entry for Daxxify and the RHA Collection.⁴⁶ They also improved Revance’s chances to acquire FDA approval for its Botox biosimilar.⁴⁷

C. Motion to dismiss

In reviewing Revance’s motion to dismiss concerning the misappropriation claim, the district court in Allergan Inc. took a three-step approach.⁴⁸ First, the district court “analyze[d] whether [Allergan] has pled facts sufficient to state a claim that [Revance] acquired [Allergan’s] trade secrets.”⁴⁹ The district court found Allergan’s factual allegations sufficient in terms of establishing Revance’s acquisition of Allergan’s trade secrets from Aggabao and Shepherd.⁵⁰

Second, the district court “evaluate[d] whether [Allergan] has pled facts sufficient to state a claim that [Revance] used [Allergan’s] trade secret(s).”⁵¹ The district court found that the complaint provided sufficient circumstantial evidence showing that Revance used the trade secrets it acquired from Aggabao.⁵² But, with respect to the trade secrets acquired from Shepherd (namely, sales figures and geographic locations of customers), the district court opined that the complaint did not sufficiently allege they were used by Revance.⁵³

Finally, the district court asked “whether [Revance] acquired or used (as the case may be) [Allergan’s] trade secret(s) with the requisite knowledge to be liable for misappropriating [Allergan’s] trade secrets.”⁵⁴ Because the use of Allergan’s trade secrets acquired from Aggabao was sufficiently alleged, the district court required proof of the requisite knowledge by showing that at the time of that unauthorized use, the defendant “knew or had reason to know that the trade secret was ‘derived from or through a person who owed a duty to the person seeking relief to maintain the secrecy or limit the use of the trade secret.’”⁵⁵ The district court held that Allergan sufficiently alleged Revance’s knowledge of Aggabao’s duty to maintain the secrecy of [Allergan’s] trade secrets or limit their use.⁵⁶ On the other hand, since the complaint merely supported Revance’s acquisition of Allergan’s trade secrets from Shepherd, not the use of those trade secrets, the district court required the requisite knowledge to be proved by showing that “the acquisition occurred by improper means[.]”⁵⁷ But, the district court found that Allergan failed to do so.⁵⁸

Ultimately, the district court concluded that Allergan’s misappropriation claim had been “adequately stated under applicable pleading standards[.]”⁵⁹ Therefore, the district court denied Revance’s motion to dismiss.⁶⁰

III. DISTRICT COURT’S DECISION ON UNAUTHORIZED USE OF THE ALLEGED TRADE SECRETS

A. Governing law

To find Revance’s use of the alleged trade secrets, the district court in Allergan Inc. relied on Stratienko v. Cordis Corp., a Sixth Circuit decision which dealt with a lawsuit brought under the TUTSA.⁶¹ In Stratienko, the Sixth Circuit declared that “[c]aselaw from other circuits thus suggests that Tennessee law would most likely permit circumstantial evidence of use in trade-secret cases.”⁶²

Under Stratienko, “[s]ufficient circumstantial evidence of use in trade-secret cases must demonstrate that (1) the misappropriating party had access to the secret and (2) the secret and the defendant’s design share similar features.”⁶³ Regarding the similarity requirement, Stratienko specifies that the plaintiff “must demonstrate similarity between his secret idea (not his product in general) and [the defendant’s] device.”⁶⁴

Drawing from Stratienko, the district court in Allergan Inc. further noted that “the relevant inquiry with respect to similarity is not whether the plaintiff’s and the defendant’s products are similar.”⁶⁵ Rather, the district court held that “the Stratienko-suggested inquiry regarding similarity of design boils down to whether the plaintiff can show sufficient similarity between (i) the ‘innovative aspect’ of the plaintiff’s ‘secret idea’ (i.e., trade secret) to which the defendant had access and (ii) the defendant’s product[.]”⁶⁶

To resolve the present case, the district court “evaluate[d] the similarity between the features of [Daxxify and Revance’s Botox biosimilar] and the trade secrets to which [Revance] had access.”⁶⁷ For this comparison, the district court considered “features not only of [Revance’s] product itself, but also of the development and/or testing of [Revance’s] products.”⁶⁸

B. Issue I: Access requirement

Regarding the access requirement, the district court found that Allergan’s factual allegations clearly established that Revance “had access to (and acquired) its trade secrets from the conduct of Aggabao and Shepherd.”⁶⁹ For instance, the complaint alleged that Allergan’s trade-secret information Aggabao had accessed and downloaded was still in Revance’s possession, custody, or control and that Shepherd shared Allergan’s trade secrets concerning sales figures and geographic locations with Revance during her interview with Revance.⁷⁰

C. Issue II: Similarities between Botox and Daxxify

In determining that similarities existed between Botox and Daxxify, the district court focused on “the changes [Revance sought] to make to its method for determining the potency of Daxxify” with the FDA.⁷¹ The district court noted that Revance originally acquired its FDA approval for Daxxify based on a traditional in vivo LD₅₀ mouse lethality test to determine potency but later requested approval for a change to a CBPA testing method comparable to what Allergan used for Botox.⁷² Thus, considering that information related to Allergan’s CBPA procedures was among those Allergan’s trade secrets to which Revance had access through Aggabao’s conduct, the district court found Revance’s use of Allergan’s trade secrets.⁷³

D. Issue III: Similarities between Botox and Revance’s Botox biosimilar

In examining whether similarities existed between Botox and Revance’s Botox biosimilar, the district court first recognized that when this lawsuit was initiated, the fact that “[Revance’s] biosimilar had not yet been approved or released” made it difficult for Allergan to assert “how the features of [Revance’s] biosimilar are similar to the trade secrets to which [Revance] had access.”⁷⁴ However, the district court found that Allergan’s complaint “certainly [went] beyond pointing to facts comparing [Botox] to [Revance’s Botox biosimilar].”⁷⁵

The district court specified three factual allegations:

“[W]ithout access to [Allergan’s] trade secrets concerning structural characterization and elucidation studies, the Botox reference standard, and strategies for determining potency[,]” “it would be extremely difficult, ‘if not impossible,’ for anyone to produce a Botox biosimilar[.]”⁷⁶

Revance “had access to these exact trade secrets” through Aggabao.⁷⁷

“[T]his [trade secret] information is precisely the type of information that an applicant would typically submit to the FDA about a particular biologic product to obtain biosimilar approval for that product.”⁷⁸

Drawing from these allegations, the district court characterized the complaint as “indicating that it would be extremely difficult, ‘if not impossible,’ for anyone to produce the biosimilar for which [Revance] plans to seek approval without using the precise trade secrets to which [Revance] had access.”⁷⁹

Although acknowledging that Allergan did not make a direct comparison, the district court opined that the complaint “demonstrate[ed] similarity between [Allergan’s] trade secrets (to which [Revance] had access) and the information that [Revance] almost certainly would have needed to develop and obtain approval for its Botox biosimilar.”⁸⁰ Therefore, the district court held that the complaint “ha[d] presented enough circumstantial evidence from which one could plausibly infer that [Revance] used [Allergan’s] trade secrets in creating and obtaining approval for its Botox biosimilar.”⁸¹

IV. PRACTICAL IMPLICATIONS: STRATIENKO RULE EXTENSION

Stratienko is the first decision of the Sixth Circuit which applies the access-and-similarity test to determining trade secret misappropriation.⁸² Around three months after the Allergan decision, the Sixth Circuit in Professional Investigating and Consulting Agency, Inc. v. SOS Security, LLC reaffirmed that Stratienko requires “that to support the inference of misappropriation, defendant’s product or process must bear substantial similarities to plaintiff’s secret, not plaintiff’s product or process more generally.”⁸³

While Stratienko focuses on the trade secret features of the plaintiff’s product, the Allergan decision extends the Stratienko rule to looking into those used for testing or developing the defendant’s product. This rule extension is necessary for strengthening trade secret protection on pharmaceutical or medical products.

A. Similarities based on product testing

Without the extension of the Stratienko rule, comparing Revance’s Daxxify and Allergan’s Botox would not lead to a conclusion of trade secret misappropriation. Daxxify is technologically different from Botox because Daxxify contains a purified form of botulinum neurotoxin A, earning the title “vegan BOTOX.”⁸⁴ In addition, Daxxify uses a peptide to stabilize the neurotoxin, while Botox’s stabilizer is human serum albumin.⁸⁵

However, in determining the similarities between Botox and Daxxify, the Allergan court considered Allergan’s CBPA testing method.⁸⁶ This CBPA testing method was approved by the FDA in 2011 for use in the stability and potency testing of BOTOX® and BOTOX® Cosmetic.⁸⁷ Allergan developed its CBPA test to replace the traditional in vivo LD₅₀ mouse lethality test.⁸⁸

Due to the severe toxicity concern of botulinum neurotoxin, the FDA requires an applicant for BoNT product approval to submit stability and potency testing data.⁸⁹ Using the LD₅₀ mouse lethality test to prepare such data is expected because the test has long been recognized as the “gold standard” method for assessing the toxicity level of manufactured botulinum neurotoxin batches.⁹⁰ Nonetheless, the desire to replace the LD₅₀ mouse lethality test has existed for years.⁹¹ The critical issue is animal cruelty.⁹² The LD₅₀ mouse lethality test includes “dosing mice with dilutions of the sample being tested and calculating the dilution at which 50% of the mice would be expected to die.”⁹³

Before its CBPA test was approved, Allergan also adopted the LD₅₀ mouse lethality test for the FDA approval of BOTOX® and BOTOX® Cosmetic.⁹⁴ But, on a mission to develop animal-free stability and potency testing, Allergan spent a decade of research and development and invested approximately U.S. $65 million.⁹⁵ These endeavors led to Allergan’s unique “Botox Reference Standard” which ultimately made Allergan the first company to receive FDA approval for use of CBPA testing in connection with release of BoNT products for sale.⁹⁶

Because of the lack of international consensus on a reference potency standard for a BoNT product, an applicant for BoNT product approval has to create and submit a unique reference standard specifically for its own BoNT products.⁹⁷ Therefore, the FDA’s approval of a BoNT product actually covers not only the BoNT product itself but also the associated testing measures for ensuring product safety. Those testing measures are reasonably part of proprietary features of a BoNT product and can be used to compare with the infringer’s product under the Stratienko rule.

In addition, such a unique reference standard can be kept as a trade secret even though it is handed to the FDA. Information or data submitted to the FDA generally enjoys nondisclosure protection.⁹⁸ Although the Freedom of Information Act (“FOIA”) gives the public a right to access government information, 5 U.S.C. § 552(b)(4) (“Exemption 4”) exempts from disclosure “trade secrets and commercial or financial information obtained from a person and privileged or confidential.”⁹⁹ Clinical study procedures, clinical study results, exploratory endpoints, and unrelated adverse events have been recognized as examples of Exemption 4.¹⁰⁰ Likewise, product testing information is expected to be exempted from the FOIA. A testing method such as Allergan’s Botox Reference Standard and CBPA technologies remain confidential even though they have been submitted to the FDA.

Hence, as long as a testing method for potency of a BoNT product satisfies the statutory definition of “trade secret,” it is protectable under both the federal DTSA and the state UTSAs. The Allergan court’s approach extends the Stratienko rule by comparing the testing methods used by a trade secret owner and one that misappropriates the trade secret, so as to improve the peripheral boundary of trade secret protection on biological innovation.

B. Similarity analysis for a biological and its biosimilars

BOTOX® and BOTOX® Cosmetic are toxin-based biological products under 42U.S.C. § 262(i) and authorized by the FDA through the same “Biologics License Application” (“BLA”) submitted by Allergan.¹⁰¹ Since the FDA’s approval, these two products have been subject to the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) which permits others to use a short pathway under 42 U.S.C. § 262(k) to acquire approval of a “biosimilar,” a biological product “biosimilar to an already licensed biological product (reference product).”¹⁰²

42 U.S.C. § 262(i)(2) provides that for purposes of biosimilar applications, “biosimilar” or “biosimilarity” means “that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components” and that “there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.”¹⁰³ Under the FDA’s Guidance on Scientific Considerations in Demonstrating Biosimilarity to a Reference Product, demonstrating biosimilarity requires submission of sufficient data and information, while the “type and amount of analyses and testing that will be sufficient to demonstrate biosimilarity will be determined on a product-specific basis.”¹⁰⁴

BoNT products are generally not interchangeable.¹⁰⁵ For instance, due to the nature of a BoNT as a protein, the size and chemical composition of BoNT proteins affect how they form their structures contributed to their overall biological activity.¹⁰⁶ This phenomenon causes manufacturing difficulty of BoNT products, such that a small process modification may end up with a different clinical profile.¹⁰⁷ Thus, it is understandable that Revance had a motive to recruit Allergan’s sensitive employees to learn Allergan’s proprietary information about Botox product manufacture. Without that information, as the Allergan court acknowledged, it is impossible for Revance to replicate Botox biosimilars.¹⁰⁸

In determining the similarities between Botox and Revance’s Botox biosimilar, the Allergan court noted that “[b]y definition, a biosimilar shares features with the product that it seeks to imitate.”¹⁰⁹ Nonetheless, under the Stratienko rule, the Allergan court refrained from considering “evidence of similarities between two products “as “an inference of use, even where the plaintiff can show that the defendant had access to the plaintiff’s trade secrets.”¹¹⁰ However, unlike the Stratienko rule comparing “[the plaintiff’s] secret idea (not his product in general) and [the defendant’s] device[,]”¹¹¹ the Allergan court adopted an inquiry asking “whether there is sufficient similarity between [Revance’s] product and the trade secrets to which [Revance] had access.”¹¹²

Additionally, in finding Revance’s unlawful use of Allergan’s trade secrets, the Allergan court embraced a notion that “it would be extremely difficult, ‘if not impossible,’ for anyone to produce the biosimilar for which [Revance] plans to seek approval without using the precise trade secrets to which [Revance] had access.”¹¹³ Those precise trade secrets were what Aggabao took from Allergan, and they covered the information essential to manufacturing and testing of Botox products and regulatory submissions concerning manufacturing consistency.¹¹⁴

Therefore, in the context of biosimilar applications under the BPCIA, the Allergan approach extends the Stratienko rule to focus on the plaintiff’s trade secrets that had been accessed by the defendant. The Allergan approach also examines whether the accessed information was necessary for manufacturing and testing biological products and for submitting to the FDA required information concerning consistency, safety, and potency of such products.

Under the Allergan approach, a biological pioneer can sue a biosimilar company for trade secret misappropriation even though the biosimilar company like Revance only “has repeatedly claimed that it will soon file regulatory papers seeking approval for a copycat biosimilar[.]”¹¹⁵ But, a plausible factual scenario must include that the biosimilar company recruits the pioneer’s former employees who has taken or copied the pioneer’s proprietary information concerning manufacturing or testing of its biological product.

V. CONCLUSION

The complex nature of a biological product may motivate a biosimilar company to recruit ex-employees of a pioneer company so as to use the confidential information taken or stolen by those employees to manufacture the pioneer biological and acquire FDA approval. However, the DTSA and UTSA provide a cause of action for the pioneer company to sue the biosimilar company for trade secret misappropriation.

One type of misappropriation is the unauthorized use of other’s trade secrets with knowledge that the secrets were acquired or disclosed without the owner’s consent. Under the Sixth Circuit’s Stratienko decision, comparing the plaintiff’s trade secret(s) and the defendant’s product is a way to prove unauthorized use of the plaintiff’s trade secret(s).

In the context of biological or biosimilar products, the Allergan decision further extends the Stratienko rule to permitting comparison between the plaintiff’s trade secret(s) and the development or testing of the defendant’s biological product. Under the Allergan approach, the trade secret protection of pioneer biologics expands its peripheral boundary to cover the pioneer company’s proprietary information of stability and potency testing of its pioneer biological. In addition, the Allergan decision will provide advanced protection on the pioneer company’s trade secrets before the biosimilar company starts to file a biosimilar application.

Footnotes

1

See Bagus Komang Satriyasa, Botulinum Toxin (Botox) A for Reducing the Appearance of Facial Wrinkles: a Literature Review of Clinical Use and Pharmacological Aspect, 12 Clinical, Cosmetic and Investigational Dermatology 223, 223 (2019), available at (last visited Mar. 14, 2024).

2

See Alan B. Scott, Dennis Honeychurch, & Mitchell F. Brin, Early Development History of Botox (OnabotulinumtoxinA), 102(Suppl) Medicine S3, S6 (2023), available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10374179/pdf/medi-102-e32371.pdf (last visited Mar. 14, 2024). BOTOX® was named by Allergan in 1991 after Allergan acquired the relevant technology from Oculinum, Inc. See Lauren L Spiegel, Jill L Ostrem & Ian O Bledsoe, FDA Approvals and Consensus Guidelines for Botulinum Toxins in the Treatment of Dystonia, 12(5) Toxins 332, at 2 (2020), available at (last visited Jan. 15, 2025).

3

See Katherine Cohen Cooper, Injecting Caution: A Need for Enhanced State-Level Enforcement Tactics Targeting the Cosmetic Use of Liquid Silicone Products, 30 J. Contemp. Health L. & Pol’y 249, 256–57 (2014).

4

See Ben Adams, AbbVie Taps 25 Real Consumers of Botox Cosmetic in ‘See Yourself’ Campaign As Rivals Stack Up, FIERCE Pharma, Sep. 22, 2022, (last visited Dec. 31, 2024) (“The Big Pharma’s latest campaign comes amid an upsurge in Botox marketing and a growing list of rivals that want to take a bite out of this market, which Botox currently leads. It made $5.3 billion in sales last year, though Botox also has several medical approvals.”).

5

See Allergan, Inc. v. Merz Pharms., LLC, No. SACV 11–446 AG (EX), 2012 WL 13134616, at *1 (C.D. Cal. Feb. 1, 2012); see also Allergan USA, Inc. v. Prollenium US Inc., No. CV 19–126-CFC-SRF, 2019 WL 7298569, at *1 (D. Del. Dec. 30, 2019).

6

See Allergan Inc. Announces FDA Approval Of Juvederm(R), BioSpace, June 5, 2006, (last visited Dec. 31, 2024).

7

See Allergan, Inc. v. Revance Therapeutics, Inc., 711 F. Supp. 3d 873, 878, 883 (M.D. Tenn. 2024); see also Mike Scarcella, Allergan Accuses Botox Rival Revance of Employee Raiding in US Lawsuit, Reuters, May 3, 2023, (last visited Jan. 28, 2025). After the DTSA was enacted, a trade secret misappropriation claim may be brought under both federal and state statutes. See Pei-Chen Tu, Shih-Wei Wu & Ping-Hsun Chen, Reasonable Measures to Protect Software’s Functionality as a Trade Secret in Software Licensing: a Lesson from Turret Labs USA, Inc. v CargoSprint, LLC, 14 Queen Mary J. Intell. Prop. 477, 477–78 (2024).

8

See Allergan, Inc., 711 F. Supp. 3d at 878, 880.

9

See id. at 878–79.

10

See Tenn. Code Ann. § 47–25-1702(2) (West 2025); see also Allergan, Inc., 711 F. Supp. 3d at 885.

11

See Mark Edward Blankenship Jr., Gastrophysics and Intellectual Property Law: Analyzing the Legal and Market Effects of A Reimagined Form of Culinary Art and Science, 75 S.C. L. Rev. 471, 484 (2023).

12

18 U.S.C. § 1839(5)(A).

13

18 U.S.C. § 1839(5)(B)(i).

14

18 U.S.C. § 1839(5)(B)(ii).

15

18 U.S.C. § 1839(5)(B)(iii).

16

See Allergan, Inc., 711 F. Supp. 3d at 883, 899.

17

See Allergan, Inc., 711 F. Supp. 3d at 899; see also Mike Scarcella, Botox Rival Revance Loses Bid to Dismiss Allergan Trade Secrets Lawsuit, Reuters, Jan. 5, 2024, (last visited Jan. 29, 2025).

18

See Allergan, Inc., 711 F. Supp. 3d at 889–92.

19

See id. at 890–91.

20

Id. at 880.

21

Id. at 879.

22

See id. at 879–80.

23

See Allergan, Inc., 711 F. Supp. 3d at 879.

24

See id. at 880–83.

25

See id. at 882.

26

See id.

27

See id.

28

See Allergan, Inc., 711 F. Supp. 3d at 882.

29

See id. at 881.

30

See id.

31

See id.

32

See id.

33

Allergan, Inc., 711 F. Supp. 3d at 881.

34

See id. at 882.

35

See id.

36

See id.

37

See id.

38

See Allergan, Inc., 711 F. Supp. 3d at 882.

39

See id.

40

See id. at 883.

41

See id.

42

See id.

43

See Allergan, Inc., 711 F. Supp. 3d at 882.

44

See id. at 881–82.

45

See id. at 882.

46

See id. at 883.

47

See id.

48

See Allergan, Inc., 711 F. Supp. 3d at 885–86.

49

Id. at 885–86.

50

See id. at 888.

51

Id. at 886.

52

See id. at 889–93.

53

See Allergan, Inc., 711 F. Supp. 3d at 892–93.

54

Id. at 886.

55

Id. at 894.

56

See id.

57

Id.

58

See Allergan, Inc., 711 F. Supp. 3d at 895.

59

Id. at 899.

60

See id.

61

See Allergan, Inc., 711 F. Supp. 3d at 889–90; see also Stratienko v. Cordis Corp., 429 F.3d 592, 596 (6th Cir. 2005).

62

Stratienko, 429 F.3d at 601.

63

Id. at 600.

64

Id. at 602 (emphasis in original).

65

Allergan, Inc., 711 F. Supp. 3d at 890.

66

Id.

67

Id. at 890–91.

68

Id. at 891.

69

Id. at 890.

70

See Allergan, Inc., 711 F. Supp. 3d at 890.

71

See id. at 891.

72

See Allergan, Inc., 711 F. Supp. 3d at 891; see also Yasushi Torii et al., Establishment of Alternative Potency Test for Botulinum Toxin Type A Using Compound Muscle Action Potential (CMAP) in Rats, 90 Toxicon 97, 98 (2014) (“The standard method to determine the biological activities of botulinum toxin products has been the lethal dose 50% (LD₅₀) test, involving intraperitoneal (ip) injections of mice[.]”), available at https://www-sciencedirect-com-443.web.bisu.edu.cn/science/article/pii/S0041010114002098/pdfft?md5=3aac97038dd6153f8310cfca8f5b658f&pid=1-s2.0-S0041010114002098-main.pdf (last visited Jan. 14, 2025).

73

See Allergan, Inc., 711 F. Supp. 3d at 891.

74

See id.

75

Id.

76

Id. at 891–92.

77

See id. at 892.

78

Allergan, Inc., 711 F. Supp. 3d at 892.

79

Id.

80

Id.

81

Id.

82

See Ping-Hsun Chen, Trade Secret Protection Against Misappropriation Committed by Your Foreign Distributor-A Lesson from Atricure, Inc. v. Jian Meng, 102 J. Pat. & Trademark Off. Soc’y 252, 262 (2022).

83

Pro. Investigating & Consulting Agency, Inc. v. SOS Sec., LLC, No. 23–3344, 2024 WL 2106223, at *3 (6th Cir. May 10, 2024) (emphasis in original).

84

See DAXXIFY® vs BOTOX® & Other Alternatives: INFOGRAPHIC Comparison, (last visited Jan. 14, 2025).

85

See id.

86

See Allergan, Inc., 711 F. Supp. 3d at 891.

87

See Allergan, Inc., Allergan Receives FDA Approval for First-of-Its-Kind, Fully in vitro, Cell-Based Assay for BOTOX® and BOTOX® Cosmetic (onabotulinumtoxinA), businesswire, June 24, 2011, (last visited Jan. 18, 2025).

88

See Ester Fernández-Salas et al., Botulinum Neurotoxin Serotype a Specific Cell-Based Potency Assay to Replace the Mouse Bioassay, 7(11) PLoS ONE e49516, at 8 (2012) (“For over 25 years there has been a strong desire to replace the mouse bioassay with a fully in vitro assay that enables sensitive evaluation of all key steps in BoNT/A action[.]”), available at https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0049516&type=printable (last visited Jan. 15, 2025).

89

See Christine Rasetti-Escargueil & Michel R Popoff, Recent Developments in Botulinum Neurotoxins Detection, 10(5) Microorganisms 1001, at 3 (2022), available at (last visited Jan. 17, 2025).

90

See Eric A. Johnson, Manufacture of Commercial Botulinum Neurotoxins for Human Treatment, in Treatment of Dystonia 120, 122 (Dirk Dressler, Eckart Altenmüller & Joachim K. Krauss eds., Cambridge University Press 2018), available at (last visited Jan. 18, 2025).

91

See Fernández-Salas et al., supra note 88, at 8; see also Interagency Coordinating Committee on the Validation of Alternative Methods [hereinafter, ICCVAM], Report on the ICCVAM-NICEATM/ECVAM Scientific Workshop on Alternative Methods to Refine, Reduce or Replace the Mouse LD50 Assay for Botulinum Toxin Testing (NIH Publication Number 08–6416) 1 (National Institutes of Health 2008), available at (last visited Jan. 19, 2025).

92

See The Humane Society of the United States, Close Up Reports No. 26: LD50: A Cruel Waste of Animals, at 1–3 (1983), available at https://www.wellbeingintlstudiesrepository.org/cu_reps/26 (last visited Jan. 19, 2025); see also Michael Balls, Replacing the Animal Testing of Botulinum Toxin: Time to Smooth Out the Wrinkles, 38 ATLA 1, 1–2 (2010), available at (last visited Jan. 19, 2025).

93

See ICCVAM, supra note 91, at 1.

94

See Mitchell F Brin, Charmaine James & John Maltman, Botulinum Toxin Type A Products Are Not Interchangeable: A Review of the Evidence, 8 Biologics 227, 230 (2014), available at (last visited Jan. 19, 2025).

95

See Allergan, Inc., supra note 87.

96

See Allergan, Inc., supra note 87; see also Complaint at 7–9, Allergan, Inc. v. Revance Therapeutics, Inc., 711 F. Supp. 3d 873 (M.D. Tenn. 2024) [hereinafter, Allergan Complaint], available at (last visited Jan. 14, 2025).

97

See Allergan, Inc., 711 F. Supp. 3d at 879.

98

Ping-Hsun Chen, Trade Secret Protection on Technical Information in a Premarket Notification Submission for a Medical Device After TaiDoc Tech. Corp. v. OK Biotech Co., 36 Biotechnology Law Report 93, 96–103 (2017).

99

5 U.S.C. § 552(b)(4); see also Karen Czapanskiy, Comment, Time Limits Under the Freedom of Information Act: Another Problematic New Property Reform, 44 Md. L. Rev. 38, 42 (1985); Deepa Varadarajan, Business Secrecy Expansion and FOIA, 68 UCLA L. Rev. 462, 486 (2021). 21 C.F.R. § 20.61(c) further provides that “[d]ata and information submitted or divulged to the Food and Drug Administration which fall within the definitions of a trade secret or confidential commercial or financial information are not available for public disclosure.” 21 C.F.R. § 20.61(c) (2022) (emphasis added). 21 C.F.R. § 20.61(a) defines “trade secret” as what “may consist of any commercially valuable plan, formula, process, or device that is used for the making, preparing, compounding, or processing of trade commodities and that can be said to be the end product of either innovation or substantial effort.” 21 C.F.R. § 20.61(a) (2022).

100

See Seife v. Food & Drug Admin., 492 F. Supp. 3d 269, 274 (S.D.N.Y. 2020).

101

See Ray v. Allergan, Inc., 863 F. Supp. 2d 552, 558 (E.D. Va. 2012); see also Allergan, Inc. v. Burwell, No. CV 13–00264 (RJL), 2016 WL 1298960, at *1, *5 (D.D.C. Mar. 31, 2016).

102

Sandoz Inc. v. Amgen Inc., 582 U.S. 1, 1 (2017).

103

42 U.S.C. § 262(i)(2).

104

U.S. Food & Drug Admin., Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Guidance for Industry 9 (Apr. 2015), available at [hereinafter FDA, Demonstrating Biosimilarity to a Reference Product].

105

See Brin, James & Maltman, supra note 94, at 227.

106

See id. at 228.

107

See id.

108

See Allergan, Inc., 711 F. Supp. 3d at 892.

109

Id. at 891.

110

Id. (emphasis in original) (citing Stratienko, 429 F.3d at 602).

111

Stratienko, 429 F.3d at 602 (emphasis in original).

112

Allergan, Inc., 711 F. Supp. 3d at 891.

113

Id. at 892.

114

See id. at 881, 892.

115

Id. at 891 (internal quotation marks omiited).