VANDA PHARMACEUTICALS INC. v. TEVA PHARMACEUTICALS USA, INC.

District Court, D. New Jersey·Decided December 26, 2023·No. 2:23-cv-00511·Unknown

Opinion

NOT FOR PUBLICATION

UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY

VANDA PHARMACEUTICALS, INC., Civil Action No. 23-511 (MEF) (JSA) Plaintiff,

v.

TEVA PHARMACEUTICALS, INC.,

Defendant. OPINION JESSICA S. ALLEN, U.S.M.J. This is a Lanham Act case brought by Plaintiff, Vanda Pharmaceuticals, Inc. (“Vanda”), against Defendant, Teva Pharmaceuticals, Inc. (“Teva”), alleging that Teva has engaged in false advertising through its generic version of Vanda’s drug HETLIOZ®. Before the Court is Teva’s motion to transfer the case to the United States District Court for the District of Delaware, pursuant to 28 U.S.C. § 1404(a), or in the alternative, to dismiss the complaint for failure to state a claim, pursuant to Federal Rule of Civil Procedure 12(b)(6). (ECF Nos. 9, 17). Vanda opposes the motion. (ECF No. 13). No oral argument was heard, pursuant to Fed. R. Civ. P. 78(b). For the reasons set forth below, and for good cause shown, Teva’s motion to transfer is GRANTED.1

1 In light of its transfer decision, the Court does not reach Teva’s alternative request to dismiss the complaint. See Siemens Fin. Servs. Inc. v. Open Advantage MRI II, 2008 WL 564707, at *2 (D.N.J. Feb. 29, 2008) (stating that a motion to transfer, pursuant to Section 1404(a), is a non-dispositive motion); see also LifeCell Corp. v. Lifenet Health, 2016 WL 54489, at *1 n.1 (D.N.J. Feb. 9, 2016) (issuing opinion on request for Section 1404(a) transfer and not reaching Rule 12 motion), aff’d 2016 WL 3545752 (D.N.J. June 28, 2016). I. RELEVANT BACKGROUND AND PROCEDURAL HISTORY2 This case is the latest round in an ongoing dispute between Vanda and Teva related to Teva’s generic version of Vanda’s branded drug product HETLIOZ®. As is described below, the Complaint alleges that Teva has falsely advertised its generic product for uses beyond the labeling

that the FDA approved in violation of the Lanham Act. (Compl., ¶ 5; ECF No. 1). A brief discussion about the parties’ other lawsuits involving HETLIOZ® is necessary to address the instant motion. Vanda is a pharmaceutical company incorporated in Delaware with its principal place of business in Washington, D.C. (Compl., ¶ 8). Vanda’s business model generally consists of acquiring compounds that other companies failed to develop, identifying uses for them, and then developing these compounds into FDA-approved products and marketing them. (Id., ¶ 2). In that vein, Vanda acquired the drug tasimelteon, which it developed into HETLIOZ®, an FDA- approved treatment for two rare sleep disorders: Non-24-Hour Sleep-Wake Disorder (“Non-24”) and nighttime sleep disturbances in Smith-Magenis Syndrome (“SMS”). (Id., ¶ 3). Vanda holds

several patents that cover, among other things, the method for using and the process for making tasimelteon. (Id., ¶ 39). Teva is a pharmaceutical company incorporated in Delaware with its principal place of business in New Jersey. (Id., ¶ 9). In January 2018, Teva submitted an Abbreviated New Drug Application (“ANDA”) to the FDA, seeking approval to manufacture and sell a generic version of HETLIOZ®. (Id., ¶ 59). On April 30, 2018, Vanda sued Teva in the United States District Court for the District of Delaware, Vanda Pharms. Inc. v. Teva Pharms. USA, Inc., et al., 18-651 (D.

2 Portions of this section are drawn from the Opinion dated February 10, 2023, issued by the Honorable Claire C. Cecchi, U.S.D.J. in Vanda Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., et al., 22-7528 (CCC) and Vanda Pharmaceuticals, Inc. v. Apotex Inc., et al., 22-7529 (CCC) (herein “Vanda II”). (See 22-7528, ECF No. 53). The parties cite Judge Cecchi’s Opinion in their briefs using the Westlaw citation. This Court does the same. Del.) (herein “Vanda I”), alleging that Teva’s filing of an ANDA with the FDA infringed several patents covering tasimelteon. See Vanda Pharms. Inc v. Teva Pharms. USA, Inc., 2023 WL 1883357, at *1 (D.N.J. Feb. 10, 2023). Vanda I was assigned to the Honorable Colm F. Connolly, Chief U.S.D.J. for the District of Delaware. Id.

On December 12, 2022, the FDA approved Teva’s generic version of HETLIOZ® to treat Non-24. (Compl., ¶¶ 66, 69-70). On December 13, 2022, following the completion of a bench trial, Chief Judge Connolly ruled in favor of Teva, finding that the claims of the patents asserted at trial were either not infringed or invalid. See Vanda, 2023 WL 1883357, at *1. On or about December 14, 2022, Vanda (i) appealed Chief Judge Connolly’s decision to the United States Court of the Appeals for the Federal Circuit; (ii) sought a stay; and (iii) petitioned the Federal Circuit to enjoin Teva from commercial marketing and the sale of its generic product. Id. While the appeal in Vanda I was pending, on December 27, 2022, Vanda filed two patent infringement actions, including one against Teva, in this District. Both cases were assigned to the Honorable Claire C. Cecchi, U.S.D.J.: Vanda Pharms. Inc. v. Teva Pharmaceuticals USA, Inc., et

al., 22-7528 (CCC) (JSA) and Vanda Pharmaceuticals, Inc. v. Apotex Inc., et al., 22-7529 (CCC) (JSA) (“Vanda II”).3 Vanda II arose out of the same Teva ANDA at issue in Vanda I. See Vanda, 2023 WL 1883357, at *1-2. However, the Vanda II complaints alleged infringement of different patents covering tasimelteon than were asserted in Vanda I. See id. On December 28, 2022, the Federal Circuit denied Vanda’s petition for a stay of Chief Judge Connolly’s decision in Vanda I. See Vanda, 2023 WL 1883357, at *2. On December 29, 2022, following the Federal Circuit’s decision, Vanda filed an application for a temporary restraining order in Vanda II, seeking to prevent Teva from going to market with its generic. Id.

3 For ease of reference, the Court will refer to the defendants in Vanda II collectively as “Teva,” unless otherwise indicated. at *2. On the same date, Judge Cecchi heard argument, in Vanda II, on Vanda’s request for an injunction, during which time Teva advised Judge Cecchi that it intended to immediately move to transfer Vanda II to the District of Delaware. Id. Additionally, on December 29th, Teva launched its product and began publicly marketing and advertising it as a generic alternative to HETLIOZ®.

(Compl., ¶ 72). On January 6, 2023, Teva moved to transfer Vanda II to the District of Delaware, pursuant to Section 1404(a), ostensibly so that it could be consolidated before Chief Judge Connolly. (Vanda II Docket, ECF No. 23).4 On January 17, 2023, Vanda opposed Teva’s motion to transfer. (Id., ECF No. 40). On January 29, 2023, Vanda filed the current action against Teva, alleging false advertising regarding Teva’s generic product, in violation of the Lanham Act, 15 U.S.C. § 1125(a)(1)(B) (herein, “this case” or “Vanda III”). When filing Vanda III, Vanda specifically identified, in the Civil Cover Sheet, that this case is “related” to Vanda II. (See ECF No. 1-9) (emphasis added). Likewise, in Vanda’s Local Civil Rule 11.2 statement, filed with the Vanda III complaint, while

stating that the legal theories were different, Vanda acknowledged “this case is related to No. 22- 7528- CCC-JSA [Vanda II], currently pending in this district before Judge Cecchi.” (ECF No. 1-10) (emphasis added). The Clerk assigned Vanda III to Judge Cecchi. (See ECF Entry dated 1/29/23). On February 10, 2023, Judge Cecchi granted Teva’s motion to transfer Vanda II to the District of Delaware, pursuant to Section 1404(a). See Vanda, 2023 WL 1883357, at *1.

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VANDA PHARMACEUTICALS INC. v. TEVA PHARMACEUTICALS USA, INC., (D.N.J. 2023).

VANDA PHARMACEUTICALS INC. v. TEVA PHARMACEUTICALS USA, INC. (VANDA PHARMACEUTICALS INC. v. TEVA PHARMACEUTICALS USA, INC.) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.

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