DCT

1:22-cv-01648

Mallinckrodt Pharma Ireland Ltd v. Airgas Therap LLC

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:22-cv-01648, D. Del., 02/12/2024
  • Venue Allegations: Venue is alleged in the District of Delaware based on Defendants Airgas Therapeutics LLC and Airgas USA LLC being organized under the laws of Delaware and thus residing in the district. Venue over French parent company Air Liquide S.A. is alleged based on its products being prescribed and used within Delaware.
  • Core Dispute: Plaintiff alleges that Defendant’s generic inhaled nitric oxide drug (Ulspira) and its associated delivery system (Ulspira TS), for which Defendant sought and received FDA approval, infringe six patents related to nitric oxide treatment methods and delivery device technology.
  • Technical Context: The technology concerns systems and methods for delivering inhaled nitric oxide, a critical therapy for neonates with hypoxic respiratory failure, a life-threatening condition associated with pulmonary hypertension.
  • Key Procedural History: The complaint notes that several of the asserted patents were subject to prior litigation against a different defendant (Mallinckrodt v. Praxair). In that case, certain claims of U.S. Patent No. 8,795,741—different from those asserted here—were found invalid. Plaintiff asserts the current claims of that patent are valid and enforceable as they were not subject to the prior judgment and include an affirmative treatment step.

Case Timeline

Date Event
2009-06-30 U.S. Patent No. 8,795,741 Priority Date
2011-01-06 U.S. Patent Nos. 8,776,794 & 8,776,795 Priority Date
2011-11-07 U.S. Patent No. 10,773,046 Priority Date
2014-02-19 U.S. Patent Nos. 9,279,794 & 9,919,118 Priority Date
2014-07-15 U.S. Patent No. 8,776,794 Issued
2014-07-15 U.S. Patent No. 8,776,795 Issued
2014-08-05 U.S. Patent No. 8,795,741 Issued
2016-03-08 U.S. Patent No. 9,279,794 Issued
2018-03-20 U.S. Patent No. 9,919,118 Issued
2020-09-15 U.S. Patent No. 10,773,046 Issued
2022-11-18 Plaintiff receives Defendant’s Paragraph IV Notice Letter
2023-07-27 FDA approves Defendant's ANDA No. 203144
2023-07-27 Defendant allegedly begins commercial activity
2023-11-05 Defendant displays and markets accused products at AARC Congress
2024-02-12 Amended Complaint Filed

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 8,776,794 - "Nitric oxide delivery device", Issued July 15, 2014

The Invention Explained

  • Problem Addressed: The patent addresses the need for a gas delivery device that can accurately and safely administer therapy gas, such as nitric oxide, by ensuring that the correct gas is being used and that its properties are known (Compl. ¶47; U.S. Patent No. 9,408,993, col. 1:24-41).
  • The Patented Solution: The invention is a gas delivery device featuring a valve attachable to a gas cylinder. This valve contains a circuit with a memory to store data about the gas (e.g., its identification, expiration date, and concentration) and a processor with a transceiver to communicate this data to a main control module. This communication allows the control module to verify the gas data before and during administration, ensuring the correct therapy is delivered (Compl. ¶47; U.S. Patent No. 9,408,993, col. 2:15-34).
  • Technical Importance: This "smart valve" approach enhances patient safety by automating the verification of critical gas parameters, reducing the risk of human error in a clinical setting where incorrect gas administration can have severe consequences (U.S. Patent No. 9,408,993, col. 2:25-34).

Key Claims at a Glance

  • The complaint asserts infringement of at least Claim 1 (Compl. ¶¶47, 140).
  • Independent Claim 1 recites:
    • A gas delivery device comprising a gas source with nitric oxide.
    • A valve attachable to the gas source, with an inlet, outlet, and actuator to control gas flow to a control module.
    • A circuit including a memory to store gas data (identification, expiration date, concentration).
    • The circuit also includes a processor and transceiver to communicate the gas data to the control module to verify the gas identification, concentration, and expiration status.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 8,776,795 - "Gas delivery device and system", Issued July 15, 2014

The Invention Explained

  • Problem Addressed: Similar to the ’6,794 patent, this invention addresses the need for a safe and reliable system for administering therapy gas from a source by verifying the gas's properties (Compl. ¶51; U.S. Patent No. 8,776,794, col. 1:19-47).
  • The Patented Solution: The patent describes a gas delivery device, distinct from the gas source itself, that comprises a valve and an integrated circuit. The circuit includes memory storing gas data and a processor/transceiver to communicate that data to a control module for verification. This system architecture separates the device from the gas source, focusing on the "smart" components that enable safe administration (Compl. ¶51; U.S. Patent No. 8,776,794, col. 2:10-31).
  • Technical Importance: This technology provides a modular safety system where the verification intelligence resides in the delivery device, allowing it to be used with various compatible gas sources while maintaining a consistent safety-check protocol (U.S. Patent No. 8,776,794, col. 2:21-31).

Key Claims at a Glance

  • The complaint asserts infringement of at least Claim 1 (Compl. ¶¶51, 165).
  • Independent Claim 1 recites:
    • A gas delivery device to administer therapy gas from a gas source.
    • The device comprises a valve attachable to the gas source with an inlet, outlet, and actuator.
    • The device also comprises a circuit with a memory to store gas data (identification, expiration date, concentration).
    • The circuit further includes a processor and transceiver to communicate this gas data to a control module for verification.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 9,279,794 - "Systems and methods for compensating long term sensitivity drift of electrochemical gas sensors exposed to nitric oxide", Issued March 8, 2016

  • Technology Synopsis: This patent describes a method for maintaining the accuracy of electrochemical gas sensors used in nitric oxide delivery systems. The invention compensates for sensor "drift" by implementing a dynamic recalibration schedule that is triggered by changes in the therapeutic dosage setting and can be postponed if a clinical alarm is active, thereby balancing accuracy with patient safety (Compl. ¶55; ’9,794 Patent, Abstract).
  • Asserted Claims: Claim 1 is asserted (Compl. ¶55).
  • Accused Features: The complaint alleges that the Ulspira TS device embodies this method by using a system controller to establish dosage, deliver gas, identify changes in dosage settings, and implement a sensor recalibration schedule that postpones calibration if an alarm is active (Compl. ¶¶95-101).

U.S. Patent No. 8,795,741 - "Methods for treating patients who are candidates for inhaled nitric oxide treatment", Issued August 5, 2014

  • Technology Synopsis: This patent claims a method of treatment that reduces the risk of pulmonary edema in neonatal patients receiving inhaled nitric oxide. The method involves identifying patients who have pre-existing left ventricular dysfunction (LVD) and administering a different, modified treatment regimen to them compared to patients without LVD (Compl. ¶42; ’741 Patent, Abstract).
  • Asserted Claims: Claim 24 is asserted (Compl. ¶42).
  • Accused Features: The complaint alleges that Defendants induce infringement of this method patent through the FDA-approved labeling for Ulspira, which allegedly instructs medical practitioners to identify patients with LVD and adjust the nitric oxide treatment regimen accordingly (Compl. ¶¶79-80).

U.S. Patent No. 10,773,046 - "Apparatus and method for monitoring nitric oxide delivery", Issued September 15, 2020

  • Technology Synopsis: The patent describes a therapeutic gas delivery apparatus that includes a display and a control circuit. The control circuit is operable to calculate the delivered concentration of nitric oxide and send data to the display to produce an indicator that informs the user whether the concentration is within a target range, an under-delivery region, or an over-delivery region (Compl. ¶58; U.S. Patent No. 9,770,570, Abstract).
  • Asserted Claims: Claim 1 is asserted (Compl. ¶58).
  • Accused Features: The Ulspira TS device is alleged to contain a display and control circuit that produces an indicator showing whether the delivered nitric oxide concentration is in a target, under-delivery, or over-delivery region (Compl. ¶¶92-93).

U.S. Patent No. 9,919,118 - "Systems and methods for compensating long term sensitivity drift of electrochemical gas sensors exposed to nitric oxide", Issued March 20, 2018

  • Technology Synopsis: This patent discloses a method for notifying a user about a sensor's calibration status. The method involves storing calibration data, performing a calibration, notifying the user that measurement is "off-line" during the process, and then using the new calibration data to determine an actual gas concentration that compensates for sensor drift (Compl. ¶61; U.S. Patent No. 9,919,118, Abstract).
  • Asserted Claims: Claim 1 is asserted (Compl. ¶61).
  • Accused Features: The complaint alleges the Ulspira TS device performs this method by storing calibration values, monitoring patient intake, performing calibrations, and notifying the user that measurement is off-line during the calibration process (Compl. ¶¶105-113).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are Defendants' Ulspira, a nitric oxide gas for inhalation drug product, and the Ulspira TS, a nitric oxide delivery system (Compl. ¶1).

Functionality and Market Context

  • The Ulspira drug and Ulspira TS delivery system are intended for use together to provide inhaled nitric oxide therapy to neonates with hypoxic respiratory failure (Compl. ¶¶81, 127). The complaint alleges that the Ulspira TS system contains a control module and connects to nitric oxide gas cylinders via a valve that allows gas to flow to the patient (Compl. ¶88). Functionalities alleged to be central to the dispute include a circuit within the valve assembly that stores and communicates gas data for verification (Compl. ¶91), a system for dynamically scheduling and performing sensor calibrations (Compl. ¶¶97-101), and a display that indicates whether the delivered gas concentration is in a target, under-, or over-delivery region (Compl. ¶93). The products are positioned as a generic version of Plaintiff's INOmax® therapy system (Compl. ¶1, ¶62). A marketing brochure for the Ulspira TS device highlights features such as "automatic cylinder switch and purge, with detailed cylinder management" and "precise dosing" (Compl. p. 25, Exhibit 8).

IV. Analysis of Infringement Allegations

U.S. Patent No. 8,776,794 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A gas delivery device comprising: a gas source to provide therapy gas comprising nitric oxide; The Ulspira TS device is used with Airgas' iNO gas cylinders, which serve as the gas source. ¶88 U.S. Patent No. 9,408,993, col. 3:56-58
a valve attachable to the gas source, the valve including an inlet and an outlet in fluid communication and a valve actuator to open or close the valve... The Ulspira TS system connects to the gas cylinders via a valve, which allows the gas to flow to a control module that delivers a desired dose to the patient. ¶88 U.S. Patent No. 9,408,993, col. 4:10-18
a circuit including: a memory to store gas data comprising one or more of gas identification, gas expiration date and gas concentration; and The Ulspira TS contains a circuit with memory to store gas concentration data. ¶91 U.S. Patent No. 9,408,993, col. 2:20-24
a processor and a transceiver in communication with the memory to send and receive signals to communicate the gas data to the control module that controls gas delivery to a subject and to verify one or more of the gas identification, the gas concentration and that the gas is not expired. The Ulspira TS contains a circuit that communicates gas concentration data to the control module to verify the data and enable proper titration of the gas. ¶91 U.S. Patent No. 9,408,993, col. 2:24-31

U.S. Patent No. 8,776,795 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A gas delivery device to administer therapy gas from a gas source, the gas delivery device comprising: The Ulspira TS is a device used to administer therapy gas from Airgas' iNO gas cylinders. ¶88 U.S. Patent No. 8,776,794, col. 1:19-21
a valve attachable to the gas source, the valve including an inlet and an outlet in fluid communication and a valve actuator to open or close the valve... The Ulspira TS device includes a valve that connects to the gas cylinders and allows gas to flow to a control module. ¶88 U.S. Patent No. 8,776,794, col. 4:10-18
a circuit including: a memory to store gas data comprising one or more of gas identification, gas expiration date and gas concentration; and The Ulspira TS device contains a circuit with memory to store gas concentration data. ¶91 U.S. Patent No. 8,776,794, col. 2:21-25
a processor and a transceiver in communication with the memory to send and receive signals to communicate the gas data to a control module that controls gas delivery to a subject and to verify one or more of the gas identification, the gas concentration and that the gas is not expired. The Ulspira TS device contains a circuit that communicates gas data to a control module for verification and titration. ¶91 U.S. Patent No. 8,776,794, col. 2:25-31

Identified Points of Contention

  • Scope Questions: For the ’6,794 and ’795 patents, a central question may be the interpretation of "verify." Does the complaint provide sufficient factual basis to show that the Ulspira TS device performs an active verification step as required by the claims, or does it merely transmit data for the control module to process? The complaint's allegations are based on private "source code inspection," suggesting the evidence is not public and will be a key area of discovery (Compl. ¶91).
  • Technical Questions: For the ’9,794 and ’118 patents, the dispute may focus on whether the accused device’s sensor calibration software operates in the specific manner claimed. For example, does the Ulspira TS system's calibration schedule respond to a "change in the setting" of the dosage, and does it postpone calibration upon detecting an "active alarm," as recited in claim 1 of the ’9,794 patent? (Compl. ¶¶97, 100). The complaint alleges these functionalities exist, but the specific operational details will be a matter for expert testimony and further discovery.

V. Key Claim Terms for Construction

  • The Term: "verify" (from Claim 1 of the ’6,794 and ’795 patents)
  • Context and Importance: This term is critical because it defines the action performed by the claimed "processor and a transceiver" in relation to the gas data. The infringement analysis will likely turn on whether the Ulspira TS system's communication protocol between the valve and the control module meets the specific functional requirement of "verifying" the gas properties, as opposed to merely transmitting them. Practitioners may focus on this term because its definition could distinguish a simple data-pass-through system from a "smart" system that performs a safety check as claimed.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification of the parent '993 patent states that the transceiver communicates "to send the gas data to the control module... to permit the user to enter the gas data into the memory" (U.S. Patent No. 9,408,993, col. 2:32-37). This language could suggest that "verify" encompasses the overall process of ensuring the correct data is in the system, which could be a broad function.
    • Evidence for a Narrower Interpretation: The claim language recites that the processor and transceiver "verify one or more of the gas identification, the gas concentration and that the gas is not expired" (Compl. ¶47). This structure suggests an active checking or confirmation function, which could be interpreted more narrowly than simply communicating data for a separate component to check.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement for all asserted patents, stating Defendants know and intend that physicians and healthcare providers will use Ulspira and Ulspira TS according to the provided instructions and labeling, thereby directly infringing the claims (Compl. ¶¶144, 156, 169, 181, 194, 206, 220, 232, 243, 255, 266, 278). The complaint also alleges contributory infringement for the device patents on the basis that the Ulspira TS is a material part of the invention and not a staple article of commerce suitable for substantial noninfringing use (Compl. ¶¶145, 157, 170, 182, 195, 207, 221, 233, 244, 256, 267, 279).
  • Willful Infringement: Willfulness is alleged based on Defendants having actual and/or constructive notice of the patents since their publication dates and actual notice of infringement allegations as of the filing date of the original complaint in the action (Compl. ¶¶146, 171, 196, 222, 245, 268). The complaint alleges that Defendants' continued commercial activities despite this knowledge constitute willful infringement.

VII. Analyst’s Conclusion: Key Questions for the Case

  • A central issue will be one of evidentiary proof: The complaint’s infringement allegations for the device patents rely heavily on information obtained from a private "source code inspection." A key question will be what this non-public evidence actually shows about the functionality of the Ulspira TS device and whether it is sufficient to prove that the device performs the specific verification and calibration steps required by the asserted claims.
  • A second core issue will be one of claim scope, particularly for the device patents (’6,794 and ’795). Can the term "verify" be construed to cover the data communication protocol used by the Ulspira TS system, or does the claim require a more specific, self-contained validation process within the valve's circuit that is absent from the accused device?
  • A third question will relate to induced infringement of the method patents (’741, ’9,794, and ’118). Does the FDA-approved label for Ulspira, in conjunction with Defendants' marketing materials, provide sufficient instruction and encouragement to clinicians to practice every step of the claimed methods, thereby establishing Defendants' specific intent to induce infringement?