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

District Court, E.D. Tennessee·Decided July 11, 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 Neil J. Beaton [Doc. 336]. Defendant responded in opposition to the motion [Doc. 398], and Plaintiff filed a reply [Doc. 480-5]. 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. 336]. 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 Neil J. Beaton, a certified public accountant, as its damages expert [Doc. 503-6 ¶ 2]. Specifically, Defendant asked Mr. Beaton “to evaluate what, if any damages, [Plaintiff] has incurred in this case and to evaluate the conclusions

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]. set forth in set forth in [DeForest] McDuff[’]s Report” [Id. ¶ 5].3 Mr. Beaton summarizes his opinions as follows: 9. My review of the record did not show any evidence that Caelum directly obtained, much less misappropriated, any confidential or proprietary information directly from UT or UTRF, or any of its employees.

10. Based upon my review of the allegations and evidentiary record, the UTRF Assets were allegedly provided to Columbia University (“Columbia”) on September 9, 2013, when the University of Tennessee’s (“UT”) Dr. Alan Solomon caused the transfer of Investigational New Drug (“IND”) 117,316, including underlying preclinical studies and information that UTRF now claims to be proprietary, to Columbia’s Dr. Suzanne Lentzsch; and on June 9, 2016, when Dr. Solomon caused the transfer of orphan-drug designations (“ODD”) #09-2903 (use of monoclonal antibody 11-1F4 as a therapeutic agent in amyloidosis) and #09-2937 (use of monoclonal antibody 11-1F4 as a radioimmunoimaging agent for amyloidosis) to Dr. Lentzsch.

11. It is further alleged that on December 16, 2013, Columbia and UTRF subsequently entered into an inter-institutional agreement (“IIA”), and then an amendment terminating such IIA on June 12, 2017.

12. It appears that UTRF alleges that such UTRF Assets were provided to, or made available to, Caelum, by virtue of an Exclusive License Agreement (the “Exclusive Agreement”) between Caelum and the Trustees of Columbia University, dated January 1, 2017.

13. Thus, if UTRF is successful in proving that the UTRF Assets were misappropriated, the time of misappropriation should be measured as of 2013, when UT’s Dr. Solomon caused the transfer of such UTRF Assets to Columbia, allegedly without UTRF’s authorization or without compensation.

14.

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

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