University of Tennessee Research Foundation v. Caelum Biosciences, Inc.

District Court, E.D. Tennessee·Decided July 1, 2024·No. 3:19-cv-00508·Unknown

Opinion

UNITED STATES DISTRICT COURT EASTERN DISTRICT OF TENNESSEE AT KNOXVILLE

UNIVERSITY OF TENNESSEE RESEARCH ) FOUNDATION, ) ) Plaintiff, ) ) v. ) No. 3:19-CV-508-CEA-DCP ) CAELUM BIOSCIENCES, INC., ) ) Defendant. )

MEMORANDUM AND ORDER

This case is before the undersigned pursuant to 28 U.S.C. § 636, the Rules of this Court, and Standing Order 13-02. Now before the Court is Plaintiff’s Daubert Motion to Exclude the Testimony of Kurt R. Gehlsen [Doc. 339]. Defendant responded in opposition to the motion [Doc. 395], and Plaintiff filed a reply [Doc. 480-2]. The motion is ripe for adjudication. See E.D. Tenn. L.R. 7.1(a). For the reasons stated below, the Court GRANTS IN PART AND DENIES IN PART the motion [Doc. 339]. I. BACKGROUND “This case largely concerns the ownership and development of the 11-1F4 antibody and related research materials” [Doc. 259 pp. 2–3 (citing Doc. 61 p. 1)]. According to the allegations in the Second Amended Complaint (“Amended Complaint”), Dr. Alan Solomon (“Dr. Solomon”) with the University of Tennessee (“UT”) developed the 11-1F4 antibody (“Antibody”), and the “ownership of the [A]ntibody materials and associated materials are held by [Plaintiff]” [Doc. 61 ¶ 1]. The Antibody is effective in treating amyloidosis [Id. ¶ 3]. “In 2009, Dr. Solomon applied for and received two different orphan drug designations for two indications of the 11-1F4 [A]ntibody (‘the 11-1F4 Orphan Drug Designations’)” [Id. ¶ 72]. According to the allegations, Defendant Caelum Biosciences, Inc. (“Defendant” or “Caelum”) “was founded to advance the clinical development research from [Dr.] Solomon” [Id. ¶ 1]. Plaintiff University of Tennessee Research Foundation (“Plaintiff” or “UTRF”) alleges that Defendant’s “sole focus and mission . . . is to commercialize the [Antibody] technology, which it has renamed to CAEL-101” [Id. ¶ 31].

Plaintiff entered into several different agreements relating to the Antibody [Id. ¶ 28]. “In 2011, [UT] and the National Cancer Institute (‘NCI’) entered into a Material Transfer Agreement pursuant to the NCI’s Experimental Therapeutics Program (“NExT”)” [Id. ¶ 79]. In 2013, Plaintiff entered an Inter-Institutional Agreement (“IIA”) with former party, The Trustees of Columbia University in the City of New York (“Columbia” or “Columbia University”), allowing it to work on clinical trials with respect to the Antibody [Id. ¶¶ 47–48, 85–86]. On March 14, 2017, Defendant “entered into a Confidentiality Agreement with [Plaintiff] and [UT] so that the parties could exchange information in connection with a potential sponsored research agreement involving [Plaintiff’s] 11-1F4 technology” [Id. ¶ 104]. These agreements, Plaintiff alleges, did not transfer certain rights, including the know-how of the Antibody [Id. ¶¶ 79, 86, 110].1

According to Plaintiff, in 2017, Defendant “began publishing press releases containing false statements regarding the ownership of the 11-1F4 technology, [made] false disclosures on its website, and . . . [made] false disclosures with the U.S. Food and Drug Administration claiming that it had licensed the 11-14F4 technology from Columbia University and that [Defendant] was now the owner of the 11-14F4 Orphan Drug Designations” [Id. ¶ 102]. Plaintiff concludes: On information and belief, [Defendant] has used and continues to utilize 11-1F4 materials that are the property of [Plaintiff], including but not limited to: murine 11-1F4 materials; chimeric 11-1F4 materials; cell clones utilized in the production of chimeric 11-1F4

1 Plaintiff explains that the “know-how” is the “the physical antibody materials, protein sequences, or research data regarding the 11-1F4 antibodies” [Doc. 61 ¶ 86]. antibodies, and ELISA reagents. On information and belief, [Defendant] has also used and continues to utilize [Plaintiff’s] research data, clinical trial and laboratory testing protocols, and documentation incorporated into the Investigational New Drug applications for therapies incorporating the 11-1F4 monoclonal antibody. [Defendant’s] use of the 11-1F4 property rights and know- how is without written authorization from [Plaintiff][,] and [Defendant] has not compensated [Plaintiff] for its use of these materials.

[Id. ¶ 116]. Based on the above, Plaintiff alleges that Defendant breached the Confidentiality Agreement [id. at ¶¶ 125–37]; converted Plaintiff’s property [id. ¶¶ 138–60]; committed slander of title [id. ¶¶ 161–86];2 interfered with its business relationship with Columbia [id. ¶¶ 187–207]; interfered with its business relationship with industry partners [id. ¶¶ 208–27]; became unjustly enriched [id. ¶¶ 228–37]; and misappropriated trade secrets under the Tennessee Uniform Trade Secrets Act (“TUTSA”), Tenn. Code Ann. § 47-25-1701 et seq. [id. ¶¶ 238–53]. Plaintiff also seeks declaratory judgments. First, it seeks a declaratory judgment that it owns “all right, title, and interest in [certain] tangible materials, know-how, and confidential research data originating or obtained from a laboratory of [UT]” [Id. ¶ 255]. In addition, Plaintiff seeks a declaration that it “owns the exclusive rights to utilize for commercial, for-profit purposes [certain] materials and information generated by the [NCI]” [Id. ¶ 262]. Further, it seeks a declaratory judgment that it owns the 11-1F4 Orphan Drug Designations [Id. ¶¶ 270–77]. Relevant to the instant matter, Defendant retained Kurt R. Gehlsen, Ph.D. (“Dr. Gehlsen”) as an expert in this matter [Doc. 340-2 ¶ 1]. Specifically, Defendant retained him to provide an opinion on “(1) whether [Plaintiff’s] Purported Trade Secrets are generally known in the industry

2 Plaintiff defines the slandered property as “(1) the chimeric 11-1F4 antibody, (2) cell clones utilized in production of the chimeric 11-1F4 antibody, and (3) the 11-1F4 Orphan Drug Designations (collectively, the ‘11-1F4 Slandered Property’)” [Doc. 61 ¶ 162]. or readily ascertainable by proper means; and (2) whether [Plaintiff] made reasonable efforts consistent with industry standards to keep its Purported Trade Secrets confidential” [Id. ¶ 4]. Dr. Gehlsen outlines his opinions as follows: 16. The material, information, and/or data alleged by UTRF to constitute “trade secrets” are generally known in the industry and/or are readily ascertainable from publications, presentations, ATCC deposits, patents, and/or other proper means such that no real economic value would be obtained from their disclosure.

17. UTRF failed to undertake reasonable efforts to keep any of UTRF’s claimed “trade secrets” confidential and, instead, their actions or omissions reflect that they understood at the time that such information was not proprietary.

18. Dr. Solomon’s transfer of the IND effectively transferred all rights to access, use, and rely on all previous submissions to the FDA in connection with IND 117,316.

19. Mr. Day’s opinion that it was consistent with customary practices in the technology transfer industry for Dr. Solomon to transfer all his ownership, rights, and interest in the IND to Dr. Lentzsch without any agreement in place containing restrictions or confidentiality protections is wrong. In my 35 years in this industry, I have never seen such an IND transfer, or transfer of any proprietary information without a predecessor agreement in place.

20. Dr. Stevens’ opinion that Michael Spector failed to conduct adequate due diligence on ch11-1F4 prior to executing the Columbia License Agreement is not consistent with industry practice. Even by Dr. Stevens’ own standards, Caelum conducted adequate diligence in its negotiations with Columbia. Dr.

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University of Tennessee Research Foundation v. Caelum Biosciences, Inc., (E.D. Tenn. 2024).

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