Mallinckrodt plc v. Airgas Therapeutics LLC

INOmax® (nitric oxide)

March 22, 2024

GENERICally Speaking: A Hatch-Waxman Bulletin

Case Name: Mallinckrodt plc v. Airgas Therapeutics LLC, Civ No. 22-1648-RGA, 2024 WL 1251260 (D. Del. Mar. 22, 2024) (Andrews, J.)

Drug Product and Patent(s)-in-Suit: INOmax® (nitric oxide); U.S. Patents Nos. 9,770,570 (“the ’570 patent”), 8,282,966 (“the ’966 patent”), 8,293,284 (“the ’284 patent”), 8,431,163 (“the ’163 patent”), 8,795,741 (“the ’741 patent”), 8,291,904 (“the ’904 patent”), 8,573,209 (“the ’209 patent”), 8,573,210 (“the ’210 patent), 8,776,794 (“the ’6794 patent”), 8,776,795 (“the ’795 patent”), 9,265,911 (“the ’911 patent”), 9,279,794 (“the ’9794 patent”), 9,295,802 (“the ’802 patent”), and 9,408,993 (“the ’993 patent”)

Nature of the Case and Issue(s) Presented: On December 30, 2022, Plaintiffs sued Defendants for patent infringement related to Defendants’ ANDA, which seeks approval to market a generic version of INOmax. Defendants Airgas Therapeutics LLC and Airgas USA LLC are incorporated in Delaware. Defendant Air Liquide S.A. (“ALSA”) is a French company. While the complaint alleged that Airgas Therapeutics LLC is a wholly-owned subsidiary of Airgas USA LLC and Airgas USA LLC and Airgas Therapeutics LLC are wholly-owned subsidiaries of ALSA, ALSA contended that Airgas USA LLC and Airgas Therapeutics LLC are wholly-owned subsidiaries of Airgas, Inc., and that ALSA “is separated by at least five degrees of corporate structure from the other two defendants in this matter.” Defendants Airgas Therapeutics LLC and Airgas USA LLC filed an answer. ALSA, instead, filed this motion, asserting a lack of personal jurisdiction over it, which the court granted.

Why Defendants Prevailed: ALSA argued in its motion that the complaint’s conclusory allegations of jurisdiction—ALSA’s submissions of ANDAs to the FDA and its selling/distributing of medical gases and other equipment through the US—lack factual support. In response, Plaintiffs rely on (i) statements on ALSA’s website indicating its purposefully directing activities at the US; (ii) an agency relationship between ALSA and the other defendants; and (iii) ALSA “directed regulatory activities for the accused ANDA in the United States” and active efforts to grow its US presence.

The court found that Plaintiffs did not meet their burden of pleading that ALSA purposefully directed its activities at U.S. residents. The group of Air Liquide companies includes various entities other than ALSA, Airgas Therapeutics LLC, and Airgas USA LLC. The evidence Plaintiffs cited did not suggest that ALSA, rather than another company in the Air Liquide group, had contacts with the US. Plaintiffs’ reliance on ALSA’s website fails because it describes the Air Liquide group generally and there was no evidence that ALSA itself had contacts with the United States. Additionally, the complaint and Plaintiffs’ supporting exhibits are insufficient to meet Plaintiffs’ burden of pleading an agency relationship. There is nothing in the record to suggest that ALSA is involved in the day-to-day management of the other Defendants, or that it has substantial authority over the other Defendants.

The court went on to deny Plaintiff’s request for jurisdictional discovery as well. “Plaintiffs’ vague assertions about the information they hope to find in jurisdictional discovery—details about ‘ALSA's control over the Airgas defendants, contacts with the United States, and involvement in filing and commercializing the ANDA’—place their request in the realm of a ‘fishing expedition.’”

Related Publications

First Quarter
GENERICally Speaking: A Hatch-Waxman Litigation Bulletin
Oren Langer, Christopher Pinahs, Emily Tremblay, and Christine May
March 25, 2024
Endo Ventures Unlimited Co. v. Nexus Pharms. Inc.
GENERICally Speaking Hatch Waxman Bulletin
March 8, 2024
UCB, Inc. v. Mylan Techs. Inc.
GENERICally Speaking Hatch Waxman Bulletin
March 5, 2024
Genentech, Inc. v. Sandoz, Inc.
GENERICally Speaking Hatch Waxman Bulletin
February 26, 2024
Janssen Pharms., Inc. v. Tolmar, Inc.
GENERICally Speaking Hatch Waxman Bulletin
Back to Top