Endo Ventures Unlimited Co. v. Nexus Pharms. Inc.

ephedrine sulfate

March 25, 2024

GENERICally Speaking: A Hatch-Waxman Bulletin

Case Name: Endo Ventures Unlimited Co. v. Nexus Pharms. Inc., Civ. No. 23-cv-299-BHL, 2024 WL 1254358 (E.D. Wis. Mar. 25, 2024) (Ludwig, J.) 

Drug Product and Patent(s)-in-Suit: ephedrine sulfate; U.S. Patents Nos. 10,869,845 (“the ’845 patent”) and 11,491,121 (“the ’121 patent”)

Nature of the Case and Issue(s) Presented: Endo sued Nexus in the Eastern District of Wisconsin, alleging infringement of the patents-in-suit, after Nexus filed a supplement to its NDA seeking approval to market ephedrine sulfate injections in pre-filled syringes (the parties had settled a previous suit on Nexus’s initial NDA).

Nexus had built a manufacturing facility in Pleasant Prairie, Wisconsin, and it planned to market and sell the accused product in Wisconsin. But as of the date of Endo’s complaint, Nexus had not manufactured any drug products for commercial distribution in that facility. It had not derived revenue from operations at that site. And it had not stored product in its warehouse in the district. Thus, Nexus moved to dismiss for lack of personal jurisdiction. The court granted the motion.

Why Nexus Prevailed: The court granted Nexus’s Rule 12(b)(2) motion because it could not exercise personal jurisdiction (general or specific) over Nexus. Nexus’s principal place of business and state of incorporation were in Illinois, not Wisconsin. And Nexus’s investments in a Wisconsin-based facility were insufficient to establish general jurisdiction, in part because the facts did not show that Nexus used Wisconsin as its primary manufacturing location. The court could not find that Nexus was “at home” in Wisconsin.

The court also declined to exercise specific personal jurisdiction over Nexus. Endo relied on Nexus’s intentions for its Wisconsin facility—a fatal flaw in Endo’s arguments. Actions after Endo initiated suit are not relevant to the personal jurisdiction analysis. And as of the date of the complaint, Nexus’s plans for the Wisconsin facility had yet to come to fruition.

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