Endo Ventures Unlimited v. Nexus Pharmaceuticals Inc

CourtDistrict Court, E.D. Wisconsin
DecidedMarch 25, 2024
Docket2:23-cv-00299
StatusUnknown

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

Bluebook
Endo Ventures Unlimited v. Nexus Pharmaceuticals Inc, (E.D. Wis. 2024).

Opinion

UNITED STATES DISTRICT COURT EASTERN DISTRICT OF WISCONSIN

ENDO VENTURES UNLIMITED COMPANY, OPERAND PHARMACEUTICALS III LIMITED, and PAR STERILE PRODUCTS LLC,

Plaintiffs, Case No. 23-cv-0299-bhl v.

NEXUS PHARMACEUTICALS INC,

Defendant. ______________________________________________________________________________

ORDER GRANTING MOTION TO DISMISS ______________________________________________________________________________

On March 5, 2023, Plaintiffs Endo Ventures Limited (Endo) and Par Sterile Products, LLC (Par Sterile) filed this lawsuit against Defendant Nexus Pharmaceuticals, Inc. (Nexus), alleging that Nexus infringed their rights under two patents related to the administration of a drug, ephedrine sulfate, to patients under anesthesia. (ECF No. 1.) After Nexus moved to dismiss for lack of jurisdiction under Federal Rule of Civil Procedure 12(b)(2), and, in the alternative, for improper venue under Rule 12(b)(3), Plaintiffs responded by filing an amended complaint in which they corrected Endo’s name, added a third plaintiff—Operand Pharmaceuticals III Limited (Operand)—and attempted to address the jurisdictional issues raised by Nexus. (ECF Nos. 18 & 25.) Nexus again moved to dismiss. (ECF No. 30.) Because the Court agrees that personal jurisdiction is lacking, Nexus’s Rule 12(b)(2) motion will be granted. Given this ruling, the Court will not address Nexus’s venue arguments. FACTUAL BACKGROUND1 Plaintiff Endo is an Irish company with offices in Dublin, Ireland. (ECF No. 25 ¶3.) On May 31, 2023, Endo transferred part of its business to Plaintiff Operand, which is also an Irish

1 This Background is derived from Plaintiffs’ amended complaint, (ECF No. 25), the allegations in which are presumed true for purposes of the motion to dismiss. See Bell Atl. Corp. v. Twombly, 550 U.S. 544, 554–56 (2007). It is also derived from the jurisdictional affidavits and exhibits filed by Plaintiffs and Nexus in their motion to dismiss filings. company. (Id. ¶¶4–5.) Plaintiff Par Sterile is a limited liability company organized and existing under Delaware laws with its place of business in New Jersey. (Id. ¶6.) Par Sterile is an affiliate and sublicensee of Operand. (Id. ¶¶14, 16.) Operand owns a New Drug Application (NDA) for ephedrine sulfate injection in glass vials. (Id. ¶17.) The Federal Drug Administration (FDA) approved this NDA on October 16, 2020 and Par Sterile began marketing the vials in March 2022. (Id.) Operand is also beneficial owner of a supplement to the NDA, covering ephedrine sulfate injection in prefilled syringes. (Id. ¶18.) The FDA approved Operand’s supplement to the NDA on April 22, 2022. (Id.) The vials and syringes produced pursuant to the NDA and its supplement consist of ready-to-use formulations of ephedrine sulfate without the need for further dilution which are employed to treat hypotension occurring in connection with anesthesia. (Id. ¶19.) Operand is also the exclusive licensee of two patents, U.S. Patent Nos. 10,869,845 (’845 Patent), issued in December 2020, and 11,491,121 (’121 Patent), issued in November 2022. (Id. ¶¶1, 13–16.) Plaintiffs’ ephedrine products were not commercially available until the effective filing date of these two patents. (Id. ¶20.) Defendant Nexus is a corporation organized and existing under Illinois law with its principal place of business in Lincolnshire, Illinois. (Id. ¶7.) Nexus is in the business of developing, manufacturing, marketing, and distributing pharmaceutical products around the United States, including in the Eastern District of Wisconsin. (Id. ¶8.) In addition to its Illinois operations, Nexus has a facility in Pleasant Prairie, Wisconsin. (Id. ¶10.) Nexus manufactures the products at issue in this lawsuit solely in Italy. (Id. ¶30.) In April 2020, the FDA approved Nexus for an NDA that also relates to ephedrine sulfate injections in glass vials. (Id. ¶22.) On August 17, 2021, Nexus filed a complaint in the District of New Jersey seeking a declaration that its ephedrine sulfate products do not infringe the ’845 patent. (Id. ¶23.) The parties ultimately settled that dispute. (Id.) After the settlement, Nexus filed a supplement to its NDA, seeking approval to market ephedrine sulfate injections in pre-filled syringes. (Id. ¶24.) On March 1, 2023, the FDA approved the supplement to Nexus’s NDA. (Id.) When Nexus later declined to provide confidential information about its ephedrine sulfate products to them, Plaintiffs filed this lawsuit. (Id. ¶25.) Plaintiffs bring two patent infringement claims against Nexus for infringement of the ’845 and ’121 Patents. (Id. ¶¶31–55.) They also seek a declaratory judgment, permanent injunction, and monetary damages. (Id. at 11.) In August 2019, Nexus began a ten-year project that included building a manufacturing facility in Pleasant Prairie, Wisconsin. (ECF No. 33-5 ¶8.) As of June 30, 2023, however, Nexus has not manufactured any drug products for commercial distribution in the Pleasant Prairie facility and has not derived any revenue from operations at that site. (Id. ¶¶9–11.) Nexus also leases a warehouse in Pleasant Prairie but does not store products in the warehouse and does not derive income from activities there. (Id. ¶12.) All “activities related to the preparation and submission of Nexus’s” NDA were performed in Illinois and all products produced under the NDA are manufactured in Italy. (Id. ¶¶18, 19.) No Nexus ephedrine products were imported into or sold in the United States before March 5, 2023. (Id. ¶¶26, 28.) LEGAL STANDARD Nexus seeks dismissal under Federal Rules of Civil Procedure 12(b)(2) and 12(b)(3). Rule 12(b)(2) governs a defendant’s challenge to a federal court’s personal jurisdiction. Apple Inc. v. Zipit Wireless, Inc., 30 F.4th 1368, 1374 (Fed. Cir. 2022). Rule 12(b)(3) relates to venue challenges. In re Micron Tech., Inc., 875 F.3d 1091, 1096 (Fed. Cir. 2017). Although this Court is ordinarily guided by precedents of the Seventh Circuit, in the patent context it must look to Federal Circuit law “because the jurisdictional issue is intimately involved with the substance of the patent laws.” Autogenomics, Inc. v. Oxford Gene Tech. Ltd., 566 F.3d 1012, 1016 (Fed. Cir. 2009) (internal quotations marks omitted) (quoting Avocent Hunstville Corp. v. Aten Int’l Co., 552 F.3d 1324, 1328 (Fed. Cir. 2008)). Where “the district court’s disposition as to the personal jurisdictional question is based on affidavits and other written materials . . . a plaintiff need only to make a prima facie showing that defendants are subject to personal jurisdiction.” Xilinx, Inc. v. Papst Licensing GmbH & Co. KG, 848 F.3d 1346, 1352 (Fed. Cir. 2017) (quoting Avocent, 552 F.3d at 1329). As such, pleadings and affidavits are to be construed in the light most favorable to the plaintiff. Autogenomics, 566 F.3d at 1017. That said, “[a]lthough we must resolve factual conflicts in [Plaintiffs’] favor, [Plaintiffs are] entitled to only those inferences that are reasonable.” Id. at 1018 (citing Pennington Seed, Inc. v. Produce Exch. No. 299, 457 F.3d 1334, 1338 (Fed. Cir. 2006)). ANALYSIS Nexus moves to dismiss Plaintiffs’ amended complaint under both Federal Rules of Civil Procedure

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Bluebook (online)
Endo Ventures Unlimited v. Nexus Pharmaceuticals Inc, Counsel Stack Legal Research, https://law.counselstack.com/opinion/endo-ventures-unlimited-v-nexus-pharmaceuticals-inc-wied-2024.