Siegler v. Sorrento Therapeutics, Inc.
| Decision Date | 02 August 2019 |
| Docket Number | Case No. 3:18-cv-01681-GPC-NLS |
| Parties | SARA ELIZABETH SIEGLER and Sara Elizabeth Siegler, Plaintiffs, v. SORRENTO THERAPEUTICS, INC., TNK THERAPEUTICS, INC., BDL PRODUCTS, INC., CARGENIX HOLDINGS LLC, TUFTS MEDICAL CENTER, PROSPECT CHARTERCARE ROGER WILLIAMS MEDICAL CENTER LLC, HENRY JI, RICHARD PAUL JUNGHANS, STEVEN C. KATZ, and THE BOARD OF DIRECTORS OF SORRENTO THERAPEUTICS, INC., Defendants. |
| Court | U.S. District Court — Southern District of California |
Before the Court are four motions. The first is a motion to dismiss the Second Amended Complaint brought by defendants BDL Products, Inc., Cargenix Holdings LLC, Henry Ji, Sorrento Therapeutics, Inc., TNK Therapeutics, Inc. (hereinafter, the "Sorrento Defendants"), on May 17, 2019.1 (ECF No. 90.) This motion has been fully briefed. (ECF Nos. 113, 117.) The second is a motion to dismiss for failure to state a claim and lack of personal jurisdiction by defendant Tufts Medical Center ("Tufts"), dated May 17, 2019. (ECF No. 91.) This motion has also received the benefit of full briefing. (See ECF Nos. 114, 118.) The third and final motion is pro se Plaintiff Sara Elizabeth Siegler's ("Plaintiff's") motion for reconsideration, dated June 30, 2019 (ECF No. 111), which the parties have fully briefed. (ECF Nos. 113, 122.) The final motion is Plaintiff's motion "to introduce newly discovered evidence," filed July 31, 2019 (ECF No. 124), which was opposed on August 1, 2019. (ECF No. 125.)
Pursuant to Civil Local Rule 7.1(d)(1), the Court finds the matter suitable for adjudication without oral argument. For the reasons set forth below, the Court GRANTS the Sorrento Defendants' motion to dismiss, DENIES as moot Tufts's motion to dismiss, DENIES Plaintiff's motion for reconsideration, and GRANTS Plaintiff's motion to introduce newly discovered evidence.
The Court takes as true the factual allegations stated in Plaintiff's Second Amended Complaint ("SAC"). (ECF No. 86.) Since the SAC incorporates many of the same allegations raised previously in Plaintiff's First Amended Complaint ("FAC"), (ECF No. 3), the Court will rely on its prior recitation of the allegationscontained in the FAC (see ECF No. 75), and supplement with newly-pleaded allegations where applicable and relevant.2
Plaintiff Sara Elizabeth Siegler is a resident of Ohio. Plaintiff established an Ohio-based sole-proprietorship in her own name in April of 2011. Plaintiff's sole-proprietorship is "an early stage micro-entity without any marketed pharmaceutical products to date." (ECF No. 3, at 46.) Plaintiff's work through her sole-proprietorship has made her a "potential participant in the CAR T cell pharmaceutical market both domestically and abroad." (Id.)
In 2013, Plaintiff began corresponding with defendant Richard Junghans ("Dr. Junghans"). As a result of this correspondence, Plaintiff began to work on a planned collaboration with Dr. Junghans to develop new chimeric antigen receptor ("CAR") T cell-based therapeutics for virology and oncology indications, which had been previously invented by Dr. Junghans. (ECF No. 86, at 4.) According to Plaintiff, Dr. Junghans previously filed patent application No. 10/006,711 in 2002 for a "second generation CAR T cell construct with a humanized single chain variable fragment . . . binding domain targeting the carcinoembryonic antigen ("CEA") on tumor cells," but abandoned that application as of February 17, 2006. (Id. at 4, 95.)
Beginning in late 2013 through August 2015, Plaintiff created two "work products" through the collaboration with Dr. Junghans. (Id. at 3.) During this period, Plaintiff sent Dr. Junghans several "drafts" of the work products. (Id. at 46.) Those work products encompass two text-based scientific articles (hereinafterthe "Copyrighted Articles") which were registered with the United States Copyright Office on September 8, 2015. (ECF No. 3, at 85, 91.) They include a work entitled "In Vivo Testing of 3rd Generation Anti-CEA Designer CAR T Cells with Bcl-xL in Pancreatic Cancer," registered as TXu 1-998-310 (the "'310 Copyright") and a work entitled "Phase 1b/2 Study of [2nd Generation] Anti-CEA Designer CAR T Cells in Breast Cancer," registered as TXu 1-998-311 (the "'311 Copyright"). (Id.)
To develop this research, Plaintiff made plans to utilize the current Good Manufacturing Practice ("cGMP") facility at defendant Prospect Chartercare Roger Williams Medical Center LLC ("RWMC"), a for-profit medical institution in Rhode Island.
In May of 2014, after Plaintiff's initial contact with Dr. Junghans, Dr. Junghans took employment on a part-time basis with Tufts, a not-for-profit medical institution with its principal place of business in Massachusetts. (ECF No. 3, at 11). Dr. Junghans was initially employed as an Investigator in the Department of Medicine, Division of Hematology and Oncology, and later served as a member of the Special and Scientific Staff. (ECF No. 19-2 (Decl. of Susan Blanchard, dated Sept. 26, 2018).)
Thereafter, on March 4, 2015, Dr. Junghans executed a nondisclosure agreement with defendant Sorrento Therapeutics, Inc. ("SRNE"). Plaintiff alleges that this nondisclosure agreement was intended to scuttle Plaintiff out of the planned collaboration and to deprive her of her right to first refusal on Dr. Junghans's inventions. (ECF No. 68, at 6.)
On or about July 16, 2015, Dr. Junghans registered in Massachusetts a company, i.e., defendant BDL Products, Inc. ("BDL"). Plaintiff alleges that BDLwas created for the sole purpose of facilitating Dr. Junghans's theft of Plaintiff's intellectual property. (ECF No. 3, at 5.) According to Plaintiff, Dr. Junghans passed off her work as his own, and violated her right to first refusal on other CAR T cell constructs for which Plaintiff had not yet registered copyrights, including the "anti-c-KIT CAR, the anti-GD3 CAR, the anti-PSMA CAR, and the anti-IL13Rα2 CAR." (ECF No. 3, at 11.) After its establishment, BDL was acquired by SRNE via its wholly-owned subsidiary, TNK Therapeutics, Inc. ("TNK"). (Id.) Henry Ji, the Chairman, President, and CEO of SRNE, and the individual members of SRNE's Board of Directors, have been named as defendants to this suit.
On August 7, 2015, Dr. Junghans and BDL executed a Stock Purchase Agreement ("SPA") with TNK. The SPA was allegedly contingent upon the closing of a Membership Interest Purchase Agreement ("MPA") between TNK and CARgenix Holdings LLC ("Cargenix"), a Rhode Island corporation that has as one of its equity owners defendant Steven C. Katz ("Dr. Katz"). (Id. at 6, 11.) The MPA includes a section titled "Execution of Exclusive License Agreements," which provides for the exclusive licensing of the "IL13 CAR, the c-KIT CAR, and the HIV CAR." (Id. at 20.) According to Plaintiff, also in either the MPA or the SPA was a "restrictive covenant" provision that prohibited Dr. Junghans and his affiliated research institution, i.e., Tufts, from working with her as part of the originally-planned collaboration. (Id.) It is further alleged that SRNE and TNK enticed Dr. Junghans to misappropriate and infringe Plaintiff's intellectual property in exchange for a $6,000,000 stock payment as part of the SPA. (Id. at 16.)
Plaintiff became privy to the SPA and MPA in August of 2015. Around August 24, 2015, she received email correspondence from Susan Blanchard, Vice President for Research Administration at Tufts. The email exchange apparentlysignaled to Plaintiff that her planned collaboration with Dr. Junghans was in potential peril. (Id. at 17.) A few days later, on August 27, 2015, Dr. Junghans sent Plaintiff an email advising that "i/tufts can not help a competitor" and "i/tufts can continue to do my own 'research' including collaborations." (Id.) Plaintiff believes that the contents of those emails derive from the restrictive covenants found in either the MPA or the SPA. Communications between Dr. Junghans and Plaintiff about further collaboration were unsuccessful, and Plaintiff ultimately terminated her relationship with Dr. Junghans after discovering that it was Dr. Junghans' company, i.e., BDL, which had precipitated the restrictive covenant. (Id. at 18.)
In April 2016, SRNE and TNK entered into an Immunotherapy Research Collaboration Agreement ("IRCA") with RWMC, whose cGMP facility Plaintiff had hoped to utilize. Although it is not entirely clear based on Plaintiff's pleadings whether the IRCA contained an exclusivity clause, Plaintiff indicates that as a result of the IRCA, she was effectively precluded from using the cGMP facility. As a consequence, Plaintiff avers that she is bereft of a "cGMP facility to manufacture clinical grade investigational products for use in the pre-approval phases of the product development lifecycle." (Id. at 21.) Later, in January of 2018, the initial IRCA was extended. That extension unambiguously contained an "exclusive agreement to operate the 'Cellular Immunotherapy and Gene Therapy Facility' at Roger Williams Medical Care Center . . . under Sorrento management." (Id. at 22.)
On July 14, 2016, a clinical trial referred to as "HITM-SURE" was registered to clinicaltrials.gov with a National Library of Medicine identifier NCT02850536. The HITM-SURE trial is a study of a U.S. Food and Drug Administration ("FDA") regulated product—i.e., CAR T cells—and lists RWMC as its sponsor. The currenttitle for the trial is "CAR-T Hepatic Artery Infusions or Pancreatic Venous...
To continue reading
Request your trial