Direct Biologics v. McQueen

63 F.4th 1015
CourtCourt of Appeals for the Fifth Circuit
DecidedApril 3, 2023
Docket22-50442
StatusPublished
Cited by2 cases

This text of 63 F.4th 1015 (Direct Biologics v. McQueen) is published on Counsel Stack Legal Research, covering Court of Appeals for the Fifth Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Direct Biologics v. McQueen, 63 F.4th 1015 (5th Cir. 2023).

Opinion

Case: 22-50442 Document: 00516698574 Page: 1 Date Filed: 04/03/2023

United States Court of Appeals for the Fifth Circuit United States Court of Appeals Fifth Circuit

FILED April 3, 2023 No. 22-50442 Lyle W. Cayce Clerk Direct Biologics, L.L.C.,

Plaintiff—Appellant,

versus

Adam McQueen; Vivex Biologics, Incorporated; Vivex Biologics Group, Incorporated,

Defendants—Appellees.

Appeal from the United States District Court for the Western District of Texas USDC 1:22-CV-381

Before Davis, Dennis, and Higginson, Circuit Judges. James L. Dennis, Circuit Judge: Direct Biologics, LLC (“DB”) brought claims for breach of covenant to not compete and misappropriation of trade secrets against Adam McQueen, DB’s former employee, and Vivex Biologics, Inc. (“Vivex”), McQueen’s new employer. After granting DB a temporary restraining order based on its trade secret claims, the district court denied DB’s application for a preliminary injunction. Finding that DB’s claims were subject to arbitration, the district court also dismissed DB’s claims against McQueen and Vivex and entered final judgment. For the following reasons, we Case: 22-50442 Document: 00516698574 Page: 2 Date Filed: 04/03/2023

No. 22-50442

VACATE the district court’s orders denying DB’s motion for a preliminary injunction and dismissing DB’s claims, and REMAND for further proceedings consistent with this opinion. I. A. DB is a biotechnology company in the field of regenerative medicine, which develops and manufactures pharmaceutical products derived from biological sources. It offers two main product lines. The first, AmnioWrap, is an allograft skin substitute used for tissue repair and regeneration, with applications for slow-healing wounds, burn injury, and general surgery. The second, ExoFlo, is a proprietary extracellular vesicle (“EV”) product similar to stem cell therapy, with applications in the treatment of severe COVID-19. Understanding how to navigate Food and Drug Administration (“FDA”) regulatory channels is an important aspect of DB’s business. In 2021, DB had to withdraw ExoFlo from the market after the FDA announced that EV products had to undergo formal approval as “drugs and biological products” under section 351 of the Public Health Service Act (“PHSA”). This spurred a race among DB and its competitors to secure FDA approval for their products. At the time this appeal was briefed, DB’s product was undergoing the final phase of clinical trials to become the first purely biologic EV drug to receive commercial approval for use in the United States. DB hired McQueen as its third employee in 2018. During his four years at DB, McQueen held various senior titles and became an equity member of DB. McQueen served as an Executive Vice President at DB from April 30, 2018, until March 28, 2022, when he resigned from DB.1 His

1 McQueen’s employment with DB was formally terminated for cause on March 29, 2022.

2 Case: 22-50442 Document: 00516698574 Page: 3 Date Filed: 04/03/2023

responsibilities included participating in intellectual property and product development, sales initiatives, operations, regulatory and compliance as well as clinical aspects of DB’s business. McQueen’s wide-ranging responsibilities and equity member status allowed him access to DB’s confidential and trade secret information. DB alleges that McQueen, as a high-level executive, was one of only a handful of individuals at the company intimately involved with both the AmnioWrap and ExoFlo product lines, and who knows the company’s most closely guarded secret: the formula and production specifications for its flagship technology, ExoFlo. B. McQueen and DB are party to two key agreements: an Employment Agreement, governed by Texas law, and an Operating Agreement, governed by Wyoming law. Each agreement contains: (i) a non-competition covenant temporarily prohibiting McQueen from accepting certain employment with enterprises that compete with DB, and (ii) a confidentiality covenant prohibiting McQueen from using or disclosing confidential information he acquired from DB. The Employment Agreement’s non-compete provision is narrower than that of the Operating Agreement. While the Employment Agreement only prohibits McQueen from providing “services . . . similar to that which [he] provided to [DB],” the Operating Agreement more broadly prohibits any employment with a competitor. The Employment Agreement also includes an arbitration provision requiring McQueen and DB to arbitrate any “controversy or claim” arising from the agreement, their employment relationship, or the termination of such a relationship. While the provision requires arbitration of “all issues of final relief,” it also includes a carve-out allowing either of the parties to seek preliminary injunctive relief in federal court.

3 Case: 22-50442 Document: 00516698574 Page: 4 Date Filed: 04/03/2023

C. Following his resignation from DB in March 2022, McQueen joined Vivex as Vice President of Product Strategy. Vivex is a direct competitor of DB that sells and markets allograft products and develops EV products. DB contends that Vivex is one of only a few companies with the “resources, infrastructure, and commercial motive in place to immediately and wrongfully exploit” the confidential DB information that McQueen carried over with him to Vivex. In addition, DB alleges that as a senior manager at Vivex, McQueen is well-positioned to help Vivex compete with DB’s AmnioWrap product line and guide Vivex through accelerated development and FDA approval of new EV products. DB further alleges that after McQueen began working for Vivex, DB discovered that while McQueen was still working for DB, he had linked his personal Dropbox2 account to DB’s online accounts. DB contends that McQueen, using Dropbox, deliberately misappropriated to his personal control numerous documents containing DB’s confidential information and trade secrets, including some of the company’s most sensitive proprietary information. DB asserts that it never authorized McQueen to link his personal Dropbox account to its cloud-based corporate accounts or place company documents or information on his personal cloud storage account, and that conduct violates express company policy. DB further alleges that McQueen has shared this confidential trade secret information with Vivex to

2 “Dropbox is a company that hosts an off-site virtual storage application . . . [a]fter creating an account, users may place items in a Dropbox folder and then access them remotely through the application[.]” United States v. Rivenbark, 748 F. App’x 948, 950 (11th Cir. 2018).

4 Case: 22-50442 Document: 00516698574 Page: 5 Date Filed: 04/03/2023

“destroy [DB’s] hard-earned competitive advantage” in the allograft and EV technology spaces. McQueen contends that he has complied with his contractually agreed covenants and works for Vivex in a non-competitive role. McQueen also denies that he has used or disclosed DB’s confidential information and asserts that he has “repeatedly sought to return all information and documents to Plaintiff.” McQueen further claims that he began using a personal Dropbox account when he first started working for DB because DB had not yet given him a company-owned computer or access to a company- controlled filesharing or storage platform. McQueen states that he has not modified any DB document linked between his personal and company Dropbox accounts since July 2, 2021. While Vivex’s Vice President for Research and Development testified that McQueen does not work on any “area[s] of competition” between DB and Vivex, McQueen testified that the responsibilities of his new job included helping with the launch of “an allograph tissue product” at Vivex. D.

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Bluebook (online)
63 F.4th 1015, Counsel Stack Legal Research, https://law.counselstack.com/opinion/direct-biologics-v-mcqueen-ca5-2023.