ALLERGAN, INC., et al., Plaintiffs, v. REVANCE THERAPEUTICS, INC., Defendant Case No. 3:23-cv-00431 United States District Court, M.D. Tennessee, Nashville Division Filed April 19, 2024 Counsel P. Anthony Sammi, Melanie R. Rupert, Matthew S. Aibel, Eric W. Dittmann, Carl J. Minniti III, Amanda Lane Pober, Paul Hastings LLP, New York, NY, Andrea Pallios Roberts, Paul Hastings LLP, Palo Alto, CA, Brenda L. Danek, Latham & Watkins LLP, Chicago, IL, Cecilia Peniza, Latham & Watkins LLP, Washington, DC, Gabrielle LaHatte, Latham & Watkins LLP, San Francisco, CA, Jeffrey A. Pade, James V. Razick, Richard Rothman, Paul Hastings LLP, Washington, DC, Jennifer S. Baldocchi, Lindsey C. Jackson, Paul Hastings LLP, Los Angeles, CA, Jessica Eve Mendelson, Paul Hastings LLP, San Francisco, CA, William A. Blue Jr., Constangy, Brooks, Smith & Prophete, LLP., Brentwood, TN, for Plaintiffs. Catherine H. Molloy, Greenberg Traurig LLP, Tampa, FL, Diana A. Balluku, Gregory S. Bombard, Greenberg Traurig, P.A., Boston, MA, Jacob R. Dean, Justin K. Victor, Greenberg Traurig, P.A., Atlanta, GA, James N. Boudreau, Greenberg Traurig, LLP, Philadelphia, PA, for Defendant. Frensley, Jeffery S., United States Magistrate Judge ORDER I. INTRODUCTION *1 Plaintiffs Allergan, Inc.; Allergan Pharmaceuticals Ireland Unlimited Company; Allergan USA, Inc.; and Allergan Sales, LLC (collectively, “Allergan”) brought this suit against Defendant Revance Therapeutics, Inc. (“Revance”) alleging misappropriation of trade secrets under the Defend Trade Secrets Act of 2016 (“DTSA”) (18 U.S.C. § 1836) and the Tennessee Uniform Trade Secrets Act (“TUTSA”) (Tenn. Code Ann. § 47-25-1701, et seq.) related to Allergan's botulinum neurotoxin injectable products and dermal fillers, including its “flagship products,” collectively known as Botox. Docket No. 1 (Complaint). Revance has denied the substantive allegations and asserted affirmative defenses. Docket No. 87. This matter is now before the Court upon a Motion to Compel Discovery filed by Allergan. Docket No. 82. Allergan has also filed a Supporting Memorandum and other supporting documents. Docket Nos. 82-1 through 82-28, 77, 78, 79, 80. Revance has filed a Response in Opposition and supporting documents. Docket Nos. 88, 88-1 through 88-3. Allergan has filed a Reply. Docket No. 91. With the Court's permission, Revance has filed a Surreply. Docket No. 136. The Parties have also filed a Joint Statement of Issues Pursuant to Local Rule 37.01. Docket No. 81. For the reasons set forth below, Allergan's Motion (Docket No. 82) is GRANTED. Therefore, Allergan's Motion seeking a case management conference to discuss this dispute (or other unspecified and unbriefed issues) (Docket No. 92) is DENIED. II. LAW AND ANALYSIS A. Discovery Requests and Motions to Compel Discovery in federal court is governed by the Federal Rules of Civil Procedure, which provide that a party may request production of documents or other tangible items as long as the information sought is within the scope of discovery. Fed. R. Civ. P. 34(a); see also Fed. R. Civ. P. 26(b)(1). Interrogatories are covered by Rule 33, which provides that “[e]ach interrogatory must, to the extent it is not objected to, be answered separately and fully in writing under oath.” Fed. R. Civ. P. 33(b)(3). In general, the scope of discovery extends to nonprivileged information that is relevant to any party's claim or defense, regardless of whether the information sought is admissible, that is “proportional to the needs of the case.” Fed. R. Civ. P. 26(b)(1). The Rules were amended, effective December 1, 2015, in part to address the alleged costs and abuses attendant to discovery. Under Rule 26, “[t]here is now a specific duty for the court and the parties to consider discovery in the light of its ‘proportional[ity] to the needs of the case ....’ ” Turner v. Chrysler Grp. LLC, No. 3:14-1747, 2016 U.S. Dist. LEXIS 11133, at *2, (M.D. Tenn. Jan. 27, 2016), quoting Fed. R. Civ. P. 26(b)(1). The following factors are relevant to a consideration of whether the scope of discovery is proportional: (1) the importance of the issues at stake in the action, (2) the amount in controversy, (3) the parties' relative access to relevant information, (4) the parties' resources, *2 (5) the importance of the discovery in resolving the issues, and (6) whether the burden or expense of the proposed discovery outweighs its likely benefit. Fed. R. Civ. P. 26(b)(1) (numbering added). “Nevertheless, the scope of discovery is, of course, within the broad discretion of the trial court.” United States v. Carell, No. 3:09-0445, 2011 U.S. Dist. LEXIS 57435 at *5 (M.D. Tenn. May 26, 2011), quoting Lewis v. ACB Bus. Servs., Inc., 135 F.3d 389, 402 (6th Cir. 1998) (internal quotation marks omitted). After making a good faith effort to resolve a dispute, a party may move for an order compelling discovery. Fed. R. Civ. P. 37(a)(1). The moving party “must demonstrate that the requests are relevant to the claims or defenses in the pending action.” Carell, 2011 U.S. Dist. LEXIS 57435 at *5, quoting Anderson v. Dillard's, Inc., 251 F.R.D. 307, 309-10 (W.D. Tenn. 2008) (internal quotation marks omitted). “Relevance for purposes of discovery is broadly construed and the information sought need not be admissible to be discoverable.” T.C. ex rel S.C. v. Metro Gov't of Nashville & Davidson Cty., No. 3:17-01098, 2018 WL 3348728, 2018 U.S. Dist. LEXIS 113517, at *17 (M.D. Tenn. July 9, 2018). “If relevancy is shown, the party resisting discovery bears the burden of demonstrating why the request is unduly burdensome or otherwise not discoverable under the Federal Rules.” Carrell, 2011 U.S. Dist. LEXIS 57435, at *5 (internal quotation marks and citation omitted). Further, for purposes of a motion to compel, “an evasive or incomplete disclosure, answer, or response must be treated as a failure to disclose, answer, or respond.” Fed. R. Civ. P. 37(a)(4). B. Allergan's Motion to Compel Allergan provides the following “relevant factual overview”:[1] Through decades of research and large-scale clinical trials, Allergan pioneered the use of botulinum neurotoxin (“BoNT”) in effective, FDA-approved biologic therapies. Allergan currently markets its BoNT products under the well-known Botox brand. ... Allergan alleges that Revance—a company that competes with Allergan in the BoNT market—has engaged in a concerted poaching scheme of 100+ employees to misappropriate Allergan's valuable trade secrets. The FDA [Food and Drug Administration] Documents that Allergan seeks to compel concern (i) Revance's Daxxify product approved by the FDA pursuant to BLA [Biologics License Application] No. 761127, and (ii) Revance's forthcoming proposed Botox Biosimilar. ... Revance submitted BLA No. 7611127 to the FDA seeking Daxxify approval in November 2019. The FDA approved Daxxify in September 2022. ... A BLA is a collection of documents concerning, inter alia, the development, manufacture, formulation, and clinical work that an applicant (such as Revance) submits to the FDA to justify its request for approval. ... Similar to a legal treatise that is supplemented over time with additional information, a BLA is a living compendium that continues to incorporate additional submissions or amendments that reference sections of the BLA that have already been submitted. ... Since approval of Daxxify in September 2022, Revance has announced that it made additional requests of the FDA through supplemental applications that would be further incorporated into BLA No. 761127. *3 Revance is also developing a “biosimilar” product with a third-party collaborator (Viatris, Inc.) through an FDA application that would seek approval based on the FDA's prior approval of Allergan's Botox product. ... Allergan alleges that Revance's misappropriation of Allergan's trade secrets has played a key role in accelerating the development of Revance's proposed Botox Biosimilar. ... Allergan has already produced documents and served detailed interrogatory responses in this case showing that its trade secrets (e.g., highly confidential and valuable manufacturing and regulatory documents) were improperly accessed, downloaded, and/or printed by multiple former Allergan employees poached by Revance, including Jennifer Aggabao and Derek Chan. Docket No. 82-1, p. 9-12 (citations omitted). Allergan brings this Motion to compel further responses to three of its Requests for Production of Documents (“RFP”): RFP Nos. 31, 35, and 36.[2] Docket No. 82, p. 1. Request for Production No. 31 All documents concerning Revance's IND and BLA application(s) for DaxibotulinumtoxinA for Injection submitted to the FDA and any supplements or amendments thereto, including but not limited to, any documents comprising or concerning any communication between Revance and the FDA concerning Revance's IND(s), Revance's BLA(s), or any applications for marketing authorization outside the United States or documents from which the examples, tables, and data appearing in Revance's IND(s), Revance's BLA(s), or applications for marketing authorization outside the United States were taken. ... Request for Production No. 35 All documents concerning the factors that Revance considered in connection with its February 2019 “Biosimilar Initial Advisory Meeting” with the FDA regarding a forthcoming Botox Biosimilar product, including, but not limited to, the characterization and elucidation-related documents to the forthcoming Botox Biosimilar's characterization, such as the molecular structure and potency of a Botox biosimilar product. ... Request for Production No. 36 All communications between Revance and the FDA concerning Revance's proposed Botox Biosimilar product. Docket No. 82-3, p. 3, 5-7 (reformatted). Revance objected to all three RFP. Id. Allergan contends that the following categories of documents are responsive to RFP Nos. 31, 35, and 36 but are being improperly withheld by Revance: Category 1 (RFP Nos. 31 and 35): Biologics License Application (“BLA”) No. 761127 concerning Revance's Daxxify product, including any post-approval supplemental submissions Category 2 (RFP No. 36): Any communications with the FDA concerning Revance's proposed Botox Biosimilar Docket No. 82-1, p. 5. As set forth above, the Court's first inquiry is whether the information requested is relevant to the claims and defenses in this matter. Carell, 2011 U.S. Dist. LEXIS 57435 at *5. As the moving party, Allergan bears the burden of demonstrating relevance. Id. If Allergan carries its burden, Revance must then demonstrate that production of the information sought would impose an undue burden or that the information is otherwise not discoverable under the Federal Rules of Civil Procedure. Id. 1. Relevance *4 Allergan maintains that the “FDA Documents would reveal the extent of the misappropriation that infected Revance's development of its Daxxify and proposed Botox Biosimilar products present in FDA filings.” Docket No. 82-1, p. 6. Allergan also points to Revance's Rule 26(a)(1) Initial Disclosures, which “expressly identified, inter alia, the following document categories as ‘relevant to the parties' claims or defenses’ ”: “Revance's communications with the Food and Drug Administration (FDA) concerning BoNT products” “Documents concerning Revance's research and development of Daxxify” “Documents concerning Revance's research and development concerning a Botox biosimilar” Docket No. 82-1, p. 17-18, quoting Docket No. 82-20, p. 6-7 (emphasis added by Allergan). Allergan argues that “Revance cannot withhold production of the FDA Documents on the basis of relevance after identifying those same documents in its Rule 26(a)(1) Initial Disclosures.” Id. at 18. But, Allergan asserts, “Revance refuses to produce the complete files of the FDA Documents. Rather, Revance claims that it is only required to produce a small subset of the FDA Documents, namely piecemeal portions and excerpts dated after August 2022 for ‘which Jennifer Aggabao participated.’ ” Id. at 9, quoting Docket No. 82-26. Allergan maintains that “[a] BLA is a compilation that builds on itself over time with supplements and updates, so any production should maintain the integrity of the file from the time it was submitted through the present, and continue on a rolling basis ahead of trial.” Id. at 19. Additionally, Allergan argues that “production of the full BLA is necessary to gauge the contribution by Ms. Aggabao to the Daxxify regulatory submissions by comparing submissions before and after she joined Revance.” Id. Allergan also contends that “Allergan's initial disclosures, interrogatory responses, and document productions concerning Mr. Chan's conduct evidence Revance misappropriation in the timeframe before BLA No. 761127 was filed in November 2019 and before Ms. Aggabao joined Revance in August 2022.” Id. at 20 (emphasis in original; footnote omitted). Revance responds that “Revance has not put its FDA-related documents at issue, and [Allergan] cannot reasonably argue the entirety of those filings is relevant to their claim.”[3] Docket No. 88, p. 18. Revance asserts that it “has already committed to producing portions of its FDA filings – those in which Ms. Aggabao has participated.” Id. Revance also argues that because “[Allergan] premise[s] [its] misappropriation allegations on Revance's hiring of [Allergan's] former employees,” “[t]his liability theory gives the specific chronology of these hirings special importance.” Id. at 19-20. Citing the timeline of Ms. Aggabao's and Mr. Chan's departure from Allergan and hiring at Revance, Revance argues that “the requested documents are irrelevant and not proportional to the needs of the case.” Id. at 20. *5 Allergan replies that “[t]he BLA, in its entirety (as well as other documents in Revance's files), will likely show misappropriations over time, as Revance leveraged additional former Allergan employees to build it.” Docket No. 91, p. 3. Allergan asserts that “Revance had to submit and update its BLA to secure approval for Daxxify,” that “[t]he sections of the BLA are updated periodically through the present,” and that “[o]nly the full BLA production will track Revance's misappropriation over time.” Id. As to Revance's statement that it will produce the portion of the BLA that post-dates Ms. Aggabao's hiring, Allergan maintains that “[t]he BLA was submitted using the FDA's eCTD format, which requires modules be arranged by topic, not chronological order.” Id. at 4, citing Docket Nos. 88-2, 82-21 (emphasis in original). Allergan argues that it “needs the entire BLA to compare its contents before and after employees like Chan, Aggabao, and others contributed” and that “[t]his is relevant to both misappropriation and Revance's independent development defense.” Id., citing Docket No. 87, p. 23 (emphasis in original). As stated above, in the instant Motion, Allergan is specifically seeking to compel production of “Biologics License Application (‘BLA’) No. 761127 concerning Revance's Daxxify product, including any post-approval supplemental submissions” and “[a]ny communications with the FDA concerning Revance's proposed Botox Biosimilar.”[4] Docket No. 82-1, p. 5. The Court finds that these documents are relevant to the claims and defenses in this case, including Allergan's claim that: Revance's unlawful scheme to misappropriate Allergan Trade Secrets is yielding, inter alia, the benefits of accelerated efforts to obtain FDA approval for an alternative CBPA, approval for an additional manufacturing site, and worldwide expansion, as well as a more rapid commercial entry for Daxxify and the RHA Collection.[5] Furthermore, Revance's efforts to obtain approval for its Botox biosimilar are benefiting from Revance's misappropriation of highly confidential information concerning Botox characterization, potency determination strategy, and other regulatory-related efforts. The potency-determination strategies, including through the post-approval supplement to obtain approval of an alternative CPBA, that Revance is pursuing with respect to Daxxify will also be used to seek approval for Revance's Botox biosimilar. Docket No. 1 (Complaint), p. 31, ¶ 127. The documents are also relevant to Revance's affirmative defense that “Allergan's claims of trade secret misappropriation fail because Revance developed its products as a result of its own labor and efforts.” Docket No. 87, p. 23. 2. Unduly Burdensome or Otherwise Not Discoverable Under the Federal Rules a) Undue Burden Revance does not contend that production of the requested information would impose an undue burden. See Docket Nos. 88, 136. The closest Revance comes to making a burden argument is its statement that “[a]s context, [Allergan's] BLA submission (which [Allergan] claim[s] is a misappropriated trade secret) approximates 45,895 documents spanning 1,735,081 pages.” Docket No. 88, p. 5. Revance provides no information as to the time or expense that would be associated with production. Accordingly, the Court finds that Revance has not established that production of the requested information would impose an undue burden. b) Identification and Validity of Claimed Trade Secrets *6 Revance argues that the information sought by Allergan need not be produced because “trade secret plaintiffs must identify their trade secrets with reasonable particularity before compelling production of their competitor's documents,” which Revance contends Allergan has not done. Docket No. 88, p. 7 (internal quotation marks omitted). Revance maintains that “[t]rade secret plaintiffs cannot, as [Allergan does] here, justify access to a defendant's most valuable information simply by claiming everything is a trade secret.” Id. (emphasis in original). Revance asserts that “many courts across the country recognize the growing consensus in favor of requiring those plaintiffs bringing claims of trade secret misappropriation to identify, with reasonable particularity, the alleged trade secrets at issue.” Id., quoting A&P Tech., Inc. v. Lariviere, No. 1:17-cv-534, 2017 U.S. Dist. LEXIS 211822, 2017 WL 6606961, at *7 (S.D. Ohio Dec. 27, 2017) (internal quotation marks and citation omitted). But Judge Richardson has already rejected Revance's assertion that “the Complaint fails to identify the purportedly misappropriated trade secrets with reasonable particularity,” finding that “despite being the party that bears the burden for purposes of the instant Motion [to Dismiss], [Revance] cites to no legal authority that would serve to distinguish [Allergan's] alleged business-related trade secrets [ ] from other items that have qualified (under such legal authority) for trade-secret protection in this district or others.” Docket No. 69, p. 29, 34. Judge Richardson noted that: The DTSA and TUTSA define trade secrets broadly. Under DTSA, “trade secrets are ‘all forms and types of financial, business, scientific, technical, economic, or engineering information, including patterns, plans, compilations, program devices, formulas, designs, prototypes, methods, techniques, processes, procedures, programs, or codes,’ which the owner has taken reasonable measures to keep secret, and which derive[ ] independent economic value from that secrecy.” B&P Littleford, LLC v. Prescott Mach., LLC, No. 20-1449, 2021 WL 3732313, at *5 (6th Cir. Aug. 24, 2021) (quoting 18 U.S.C. § 1839(3)). Similarly, under TUTSA, trade secrets are “information, without regard to form, including, but not limited to, technical, nontechnical or financial data, a formula, pattern, compilation, program, device, method, technique, process or plan,” which the owner has made reasonable efforts to keep secret, and which derive independent economic value from that secrecy. Tenn. Code Ann. § 47-25-1702(4). Consistent with these broad definitions, courts in this district have found that seemingly general descriptions in the plaintiff's complaint of items alleged to be trade secrets qualify for trade-secret protection. For example, in Great Am. Opportunities, Inc. v. Cherry Bros., LLC, No. 3:17-CV-1022, 2018 WL 418567 (M.D. Tenn. Jan. 16, 2018), Judge Trauger was satisfied that the following “confidential business information” sufficiently identified the misappropriated trade secrets: “[B]usiness plans, marketing and promotional strategies, financial data, sales training materials, actual and potential customer lists and related information, past and current fundraising programs, sales representative contact and performance information, pricing information and strategies, competitive business information, and industry know-how.” Id. at *1, *4. [Allergan's] business-related trade secrets as described in ¶ 34(vi)-(ix) of the Complaint are at least as specific as those mentioned in Great America. Accordingly, the Court is satisfied that the business-related trade secrets are properly alleged as trade secrets and are adequate to put [Revance] on notice of what was allegedly misappropriated. The Court therefore declines to dismiss [Allergan's] claims on the basis that the Complaint fails to identify the purportedly misappropriated trade secrets with reasonable particularity. *7 Id. at 34-35 (internal block quote reformatted). The undersigned finds that the same reasoning applies here, possibly with even more force given the low bar for relevance in discovery. T.C. ex rel S.C., 2018 U.S. Dist. LEXIS 113517, at *17. Revance also appears to argue that the requested information should not be produced in discovery because “[i]t is [Allergan's] burden to show information warrants trade secrets status,” and Allergan has not done so. Docket No. 88, p. 12-17, 19. This argument overlaps with Revance's contention that Allergan has not identified its alleged trade secrets with sufficient particularity. See id. To the extent it is a separate argument, it is one that belongs to the dispositive motion or trial stage, not to discovery. The scope of relevance in discovery is broad and does not depend upon the establishment of facts that a party must seek to prove at trial. Even if Revance's assertion is true, Allergan's failure to carry an evidentiary burden at this point is not a bar to receiving discovery of documents that are relevant to the Parties' claims and defenses. c) Temporal Limitations Relatedly, Revance argues that Allergan's requests are overbroad because they contain no temporal limitations, citing the dates of employment for Ms. Aggabao and Mr. Chan and “the operative three-year statute of limitations.” Docket No. 88, p. 9; see p. 20-21. Judge Richardson has found that “contrary to [Revance's] characterization of the Complaint, [Allergan] has based its misappropriation claim on more than the mere fact that [Revance] hired one of its former employees,” noting that Allergan alleges that “these advancements [in obtaining FDA approval for an alternative CBPA and rapidly entering the market with Daxxify and products in the RHA Collection] occurred only after [Revance] hired away from [Allergan] multiple individuals (including Aggabao, Chastain, and Shepherd) ....” Docket No. 69, p. 24-25. The Complaint alleges that Revance hired multiple former Allergan employees over the course of years in an effort to gain secret information from Allergan. Docket No. 1. Given these findings and allegations, it would be premature to place a temporal limit on otherwise relevant documents when it is not clear at this point exactly when the alleged trade secret theft occurred or was or should have been discovered. See 18 U.S.C. § 1836(d); Tenn. Code Ann. § 47-25-1707. Like the burden to establish whether certain material warrants trade secret status, this is an issue to be resolved at a later stage in the litigation, particularly as Revance has made no argument that production would impose an undue burden. d) Proportionality The Court has also considered all of the proportionality factors set forth in Rule 26, particularly the amount in controversy, the importance of the discovery in resolving the issues, and the Parties' resources. Fed. R. Civ. P. 26(b)(1). The requested information is alleged to be (and appears to the Court to be) pivotal to the claims and defenses in this matter. The amount in controversy is substantial, and the Parties are both sophisticated and seemingly well-resourced. Given the high level of relevance and the lack of any asserted burden, the Court finds that the requested discovery is proportional to the needs of the case. III. CONCLUSION *8 Because the requested information is relevant to the claims and defenses in this matter, Revance has not demonstrated (or even articulated) any burden associated with producing the information, and Revance has not established that the information is otherwise not discoverable under the Federal Rules, it must be produced. Therefore, Allergan's Motion (Docket No. 82) is GRANTED. No later than May 13, 2024, Revance must produce Biologics License Application No. 761127 concerning Revance's Daxxify product, including any post-approval supplemental submissions, and any communications with the FDA concerning Revance's proposed Botox Biosimilar. In keeping with the mandate of Rule 26(e)(1)(A), Revance must supplement its production as necessary between now and the disposition of this matter. Consequently, Allergan's Motion seeking a case management conference to discuss this dispute (or other unspecified and unbriefed issues) (Docket No. 92) is DENIED. IT IS SO ORDERED. Footnotes [1] The Court includes this “factual overview” for the purpose of providing necessary background, identifying key issues and individuals, and explaining the meaning of technical terms. Its inclusion here is not intended as an endorsement of any disputed facts. [2] Although Allergan states that “Revance's stonewalling is not limited to the key requests for production at issue here,” Allergan does not identify any other specific RFP in the instant Motion. Docket No. 82-1, p. 6, n.1. [3] Revance cites Steven Bengelsdorf MD, Pllc v. Lumenis, Inc. for the proposition that a request for “all data” supplied to the FDA is overbroad. Docket No. 88, p. 18, quoting No. 3:09-0911, 2011 WL 577344, at *10 (M.D. Tenn. Feb. 9, 2011). But Bengelsdorf is distinguishable on the basis that there, not all “technical data” was found to be relevant because not all components of the technology at issue were “challenged or questioned” in the Complaint. Bengelsdorf, 2011 WL 577344, at *10. Here, Allergan alleges that Revance has based its entire product or products on trade secrets stolen from Allergan. Docket No. 1. Even if this were not the case, the Court finds that in this matter, the requested information is relevant and proportional for the reasons set forth herein. [4] While Revance argues that Allergan has not demonstrated the relevance or proportionality of “internal deliberations within Revance,” Allergan is not seeking to compel such communications in the instant Motion. See Docket No. 82-1, p. 5 (“Allergan is therefore moving ... to compel Revance's production of the following categories of documents ...”). [5] The Complaint defines “CBPA” as “cell-based potency assay,” and “the RHA Collection” as “a line of dermal filler products.” Docket No. 1, p. 8, 17.