Vanda Pharmaceuticals Inc. v. Apotex Inc.

CourtDistrict Court, D. Delaware
DecidedFebruary 10, 2023
Docket1:23-cv-00153
StatusUnknown

This text of Vanda Pharmaceuticals Inc. v. Apotex Inc. (Vanda Pharmaceuticals Inc. v. Apotex Inc.) is published on Counsel Stack Legal Research, covering District Court, D. Delaware primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Vanda Pharmaceuticals Inc. v. Apotex Inc., (D. Del. 2023).

Opinion

NOT FOR PUBLICATION UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY VANDA PHARMACEUTICALS INC., Civil Action Nos.: 22-7528; 22-7529 Plaintiff, v. OPINION TEVA PHARMACEUTICALS USA, INC., Defendant. VANDA PHARMACEUTICALS INC., Plaintiff, v. APOTEX INC. et al, Defendants. CECCHI, District Judge. I. INTRODUCTION Plaintiff Vanda Pharmaceuticals Inc. (“Vanda” or “Plaintiff”) filed actions for patent infringement against defendants Teva Pharmaceuticals USA, Inc. (“Teva”), Apotex Inc., and Apotex Corp. (collectively, “Defendants”). Presently before the Court are Defendants’ cross- motions to transfer pursuant to 28 U.S.C. § 1404. See, e.g., ECF No. 23.1 Plaintiff opposed the 1 Although these actions were filed under separate dockets, see Civ. Nos. 22-7528, 22-7529, Defendants filed joint memoranda of law, and the cross-motions (as well as Plaintiff’s submissions and pleadings) are substantially identical across each case. Therefore, the Court need not address each case separately for the purpose of its analysis here. Accordingly, all ECF numbers referenced in this Opinion refer to No. 22-7528 unless stated otherwise. The cross-motions were submitted in response to Plaintiff’s motions for a temporary restraining order. See ECF No. 7; see also Civ. No. 22-7529, ECF No. 5. 1 motions. See ECF No. 40. For the reasons set forth below, Defendants’ motions are GRANTED, and the Court transfers these cases to the United States District Court for the District of Delaware. II. BACKGROUND Vanda is a pharmaceutical company incorporated in Delaware with its principal place of

business in Washington, D.C. See ECF No. 1 (“Compl.”) at ¶ 1. Vanda asserts that its business model generally consists of acquiring compounds that failed in development by other drug companies, developing them into FDA-approved products, and then commercializing them. Id. ¶ 20. As relevant here, Vanda acquired the drug tasimelteon, now marketed as HETLIOZ®, which was subsequently approved by the FDA to treat rare sleep disorders, including “a debilitating condition that principally affects totally blind people called Non-24-Hour Sleep-Wake Disorder (“Non-24”).” Id. ¶¶ 20-23, 25-26; ECF No. 7-1 at 5. Vanda holds multiple patents relating to tasimelteon. The suit for patent infringement underlying the instant motion to transfer concerns U.S. Patent No. 11,285,129 (the ’129 patent), which issued on March 29, 2022 and relates to a method of administering tasimelteon to a patient and the interaction between tasimelteon and beta

blockers. Id. ¶¶ 13-14; see also ECF No. 7-1 at 5. Prior to this action, the parties engaged in lengthy litigation concerning multiple patents related to tasimelteon in the United States District Court for the District of Delaware. Id. at 12-13. In 2018, upon Defendants’ submissions of Abbreviated New Drug Applications (ANDAs) to obtain FDA approval to manufacture and sell generic versions of HETLIOZ®, Vanda filed suit in the District of Delaware, asserting multiple related patents.2 See Compl. ¶¶ 22-39, Vanda Pharms.

2 Vanda originally asserted six patents but added others through the course of litigation. See, e.g., Stipulation to Amend Compl., Vanda Pharms. Inc. v. Teva Pharms. USA, Inc., No. 18-cv-651 (D. Del. Dec. 7, 2018) (adding U.S. Patent No. 10,071,977); see Def. Br. at 5 (noting 15 patents asserted in total). Through “forced narrowing of the asserted patents and claims by the district court” in Delaware, Vanda ultimately limited its assertions to four patents. Pl. Br. at 12. Relatedly, 2 Inc. v. Teva Pharms. USA, Inc., No. 18-651, ECF No. 1. The Delaware Action culminated in a four-day bench trial before Chief Judge Colm F. Connolly in March 2022, who found in favor of Defendants. Specifically, in his December 13, 2022 decision, Chief Judge Connolly found that each claim of the four asserted patents which ultimately went to trial either was not infringed or

was invalid. See Opinion at 71, Vanda Pharms. Inc. v. Teva Pharms. USA, Inc., No. 18-651 (D. Del. Dec. 13, 2022) [hereinafter Vanda I], ECF No. 336. Notably, the Delaware litigation involved—in addition to the same parties and products at issue here—the same ANDAs, the same product labels, the same patent specification, and similar prior art. It also concerned drug-drug interactions with tasimelteon (like here) as well as methods of use of tasimelteon for treating Non- 24 (the sleep disorder treated by tasimelteon). See generally id.; see also Def . Br. at 11-14. After the unfavorable ruling in Delaware, Vanda immediately appealed Chief Judge Connolly’s decision to the Federal Circuit. See ECF No. 7-1 at 13. Because Teva’s ANDA had been approved just a day before Chief Judge Connolly’s ruling (and Teva was apparently prepared to go to market imminently), Vanda also petitioned the Federal Circuit to immediately enjoin

Defendants from commercial marketing and sale of their generics pending appeal. Id. After a brief stay to properly consider Vanda’s application for an injunction, the Federal Circuit concluded that “Vanda ha[d] not established that an injunction pending appeal is warranted,” denying its request for an injunction and lifting the temporary stay. Vanda Pharms. Inc. v. Teva Pharms. USA, Inc,

Defendants assert that Vanda “expressly committed to the district court in Delaware that, in exchange for securing a later trial date and adding other later-issued patents to the Delaware litigation, Vanda would not assert any additional patents against Teva’s and Apotex’s tasimelteon products.” Def. Br. at 14 n.3; see, e.g., ECF No. 23-2, Ex. 2 at 29 (“[THE COURT]: … Mr. Groombridge, what you have to tell your client is that means they should not plan on ever getting to litigate in another case patents associated with these products. Fair enough? MR. GROOMBRIDGE: Yes, we understand, Your Honor.”). Vanda, for its part, asserts that any agreement with the District of Delaware could not have extended to a patent that had not yet issued. See Pl. Br. at 16 n.5. 3 No. 23-1247 (Fed. Cir. Dec. 28, 2022), ECF No. 27 at 2. Having been denied the relief it sought from the District of Delaware and the Federal Circuit, Vanda then sought a temporary injunction from this Court to prevent Defendants from going to market with their generics. See ECF No. 7; see also Vanda I, Final Judgment at 3, ECF No. 338.3

After conferencing with the parties and hearing argument on December 29, 2022, during which the Court was made aware that Defendants intended to immediately move to transfer this action to the District of Delaware, this Court provided a schedule for the parties to address the multiple issues before it. See ECF Nos. 13, 14; see also ECF No. 15 (Ltr. from Vanda in response to Dec. 29, 2022 hearing). Defendants filed their cross-motion to transfer shortly thereafter (ECF No. 23; see also ECF No. 21 (“Def. Br.”)), which Vanda opposed, ECF No. 40 (“Pl. Br.”). These submissions included various declarations and exhibits, which the Court has also considered. See, e.g., ECF Nos. 23-1, 23-2, 23-3, 24, 40-1, 40-2, 40-3, 40-4, 40-5, 40-6. III. LEGAL STANDARD Section 1404(a) permits transfer “[f]or the convenience of parties and witnesses, [and] in

the interest of justice.” 28 U.S.C. § 1404(a). “The purpose of section 1404(a) is to protect litigants, witnesses, and the public against unnecessary inconvenience and expense.” Teva Pharms. USA, Inc. v. Sandoz Inc., No. 17-275, 2017 WL 2269979, at *4 (D.N.J. May 23, 2017) [hereinafter Teva Pharms.] (citing Liggett Grp. Inc. v. R.J. Reynolds Tobacco Co., 102 F. Supp. 2d 518, 525-26 (D.N.J. 2000)).

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