DCT

1:25-cv-00591

Becton Dickinson Co v. Baxter Intl Inc

Log In

I. Executive Summary and Procedural Information

Case Timeline

Date Event
2011-01-10 Earliest Priority Date for ’703 Patent
2011-10-17 Earliest Priority Date for ’180 and ’058 Patents
2013-03-13 Earliest Priority Date for ’880 Patent
2014-01-13 Earliest Priority Date for ’868 and ’414 Patents
2022-03-29 ’180 Patent Issued
2022-05-10 ’880 Patent Issued
2022-08-30 Accused Novum IQ Syringe Pump FDA Clearance
2024-02-13 ’058 Patent Issued
2024-03-29 Accused Novum IQ LVP FDA Clearance
2024-07-02 ’414 Patent Issued
2025-01-21 ’703 Patent Issued
2025-04-15 ’868 Patent Issued
2025-05-12 Complaint Filing Date

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

U.S. Patent No. 11,289,180 - Medical Device with Information Reader

Issued March 29, 2022

The Invention Explained

  • Problem Addressed: The patent’s background section describes inefficiencies in medical environments where barcode scanners are either permanently attached to a single medical device, limiting flexibility, or are "floating" scanners that send data to a centralized system without the ability to direct information to a specific device for programming. (Compl. ¶20; ’180 Patent, col. 1:26-42).
  • The Patented Solution: The invention is an infusion pump that generates and displays a unique "scannable tag" (e.g., a barcode) on its own screen. A single, separate information reader can scan the pump's tag to establish an association and then scan a medication barcode. The pump then receives the corresponding medication information, which streamlines the programming workflow by ensuring the correct data is routed to the correct pump using less hardware. (Compl. ¶20; ’180 Patent, Abstract; col. 2:38-44).
  • Technical Importance: This approach is designed to improve safety and efficiency in clinical workflows by creating a direct, verifiable link between a specific pump and a medication order using a single scanning device. (Compl. ¶20).

Key Claims at a Glance

  • The complaint asserts independent claim 1. (Compl. ¶21).
  • The essential elements of claim 1 include:
    • An infusion pump comprising a display, data processor, and memory.
    • The pump is caused to: render a scannable tag on its display, with the tag configured to provide information uniquely identifying the infusion pump.
    • The pump is caused to: receive medication information (e.g., an infusion parameter, medication name, or order identifier).
    • The pump is configured to receive this medication information after an information reader scans both the pump's on-screen tag and a separate medication barcode.
  • The complaint explicitly asserts dependent claims 8, 9, 13, and 15, which add limitations related to routing information, network connectivity, and parenteral infusions. (Compl. ¶23-27).

U.S. Patent No. 11,901,058 - Associating An Information Reader And A Medical Device

Issued February 13, 2024

The Invention Explained

  • Problem Addressed: As a member of the same patent family as the ’180 Patent, this patent addresses the same problems of inefficient and error-prone association between medical devices and programming information in a clinical setting. (Compl. ¶29; ’058 Patent, col. 1:22-42).
  • The Patented Solution: The invention is an infusion pump with a wireless module that renders a barcode on its display. After a barcode reader scans the pump's on-screen barcode and an infusion barcode, the pump wirelessly receives infusion information and operates to cause administration of the infusion. This provides a wireless-enabled method for the streamlined, device-specific programming workflow. (Compl. ¶29-30; ’058 Patent, col. 5:16-24).
  • Technical Importance: This solution provides a method for reducing hardware and programming steps while ensuring correct pump-medication association in a modern, wirelessly connected hospital environment. (Compl. ¶29).

Key Claims at a Glance

  • The complaint asserts independent claim 1. (Compl. ¶30).
  • The essential elements of claim 1 include:
    • An infusion pump comprising a display, a wireless module, a data processor, and memory.
    • The pump is caused to: render a barcode on its display.
    • The pump is caused to: configure itself for receiving infusion information.
    • The pump is caused to: receive, via the wireless module, infusion information after a barcode reader scans both the on-screen barcode and an infusion barcode.
    • The pump is caused to: operate, based on the received information, to cause administration of the infusion.
  • The complaint asserts dependent claims 5 and 6, which add limitations directed to routing information contained within the barcode. (Compl. ¶32).

U.S. Patent No. 11,324,880 - Infusion Monitoring System

Issued May 10, 2022

  • Technology Synopsis: The patent describes a system where an infusion pump communicates with a separate remote device (e.g., a server). The remote device processes infusion data and transmits the status to a mobile communication device, which displays the information as an interactive timeline, allowing a clinician to drill down into infusion events and parameters. (Compl. ¶34-35).
  • Asserted Claims: Independent claim 1 is asserted. (Compl. ¶37).
  • Accused Features: The "Infusion Story" feature of Defendant's IQ Enterprise Connectivity Suite, which allegedly provides an interactive, chronological depiction of infusion events on a mobile device. (Compl. ¶64).

U.S. Patent No. 12,278,868 - Remote Flashing During Infusion

Issued April 15, 2025

  • Technology Synopsis: The patent relates to an infusion pump that can wirelessly receive configuration updates (e.g., for dose error reduction software) from a remote server. The pump itself identifies its current state (e.g., pre-infusion, during infusion, post-infusion, after power-up) and determines a "clinically appropriate time" to activate the update, thereby preventing interruptions to patient treatment. (Compl. ¶41-43).
  • Asserted Claims: Independent claim 1 is asserted. (Compl. ¶44).
  • Accused Features: The "Over-the-air updates" feature of the Novum IQ platform, which allows for remote updates to firmware and drug libraries. (Compl. ¶66).

U.S. Patent No. 12,028,414 - Remote Flashing During Infusion

Issued July 2, 2024

  • Technology Synopsis: Belonging to the same family as the ’868 Patent, this patent also describes an infusion pump that receives configuration information from a remote server and determines a clinically appropriate time to activate the update based on its operational state. (Compl. ¶48).
  • Asserted Claims: Independent claim 1 is asserted. (Compl. ¶49).
  • Accused Features: The "Over-the-air updates" feature of the Novum IQ platform. (Compl. ¶66).

U.S. Patent No. 12,205,703 - Displaying Visual Elements On A Medical Device

Issued January 21, 2025

  • Technology Synopsis: The patent describes an infusion pump with a multi-color display that activates different "visual profiles" (e.g., color schemes, layouts) based on the pump's operational state or treatment parameters, determined by a rules-based process. The pump also includes an ambient light sensor to automatically adjust the display's brightness. (Compl. ¶53).
  • Asserted Claims: Independent claim 1 is asserted. (Compl. ¶54).
  • Accused Features: The Novum IQ pumps' "multi-color display" that allegedly shows different configurations depending on the pump's state, and its "Ambient Light Sensor" for automatically adjusting screen brightness. (Compl. ¶67-68).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is Baxter's "Novum IQ Infusion Platform," which includes the Novum IQ LVP (large volume pump), the Novum IQ Syringe Pump, and associated software products such as the IQ Enterprise Connectivity Suite and Dose IQ Safety Software (collectively, the "Accused Infusion Systems"). (Compl. ¶1, 59).

Functionality and Market Context

The complaint alleges the Accused Infusion Systems provide a comprehensive platform for managing medication delivery. Key accused technical functionalities include:

  • On-Screen Barcodes: The pumps display on-screen scannable barcodes to ensure correct pump identification and facilitate "auto-programming." (Compl. ¶62). A screenshot provided in the complaint shows a QR code on the pump's screen with the prompt "Scan this barcode, or program manually." (Compl. p. 22).
  • Remote Monitoring: The IQ Enterprise Connectivity Suite includes a feature called "Infusion Story" that provides an interactive, "chronological depiction" of infusion events, enabling "data drilldown into every individual infusion on every individual pump." (Compl. ¶64).
  • Remote Updates: The platform supports "over-the-air firmware and drug library updates," which allegedly allows pumps to remain in clinical use while receiving updates. (Compl. ¶66).
  • Adaptive Display: The pumps feature a multi-color LCD display that presents information in different visual configurations and incorporates an "Ambient Light Sensor" to "[a]utomatically adjust[] screen brightness to the room." (Compl. ¶67-68). A marketing image shows this feature highlighted on the pump. (Compl. p. 26).

IV. Analysis of Infringement Allegations

’180 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
render a scannable tag on the display of the infusion pump, wherein the scannable tag is configured to be readable by an information reader and is configured to provide medical device information uniquely identifying the infusion pump... The Accused Infusion Systems feature "on-screen barcodes with scan prompts" that are used to ensure the pumps are correctly identified. ¶62 col. 3:19-24
receive medication information about medication to be administered to a patient by the infusion pump... The on-screen barcode is part of an "auto-programming workflow" that enables "seamless interoperability" with a hospital's EMR system to program infusions. ¶62-63 col. 4:6-14
wherein the infusion pump is configured to receive the medication information after the information reader scans a medication barcode on the medication to be administered to the patient. The alleged "auto-programming workflow" involves scanning the on-screen barcode and then a medication barcode to program the pump with the correct parameters from the EMR system. ¶63 col. 4:9-14

’058 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a wireless module configured to communicate with a wireless network; The Novum IQ pumps support "over-the-air" updates and are "communicatively coupled with a server," which necessitates wireless communication capabilities. ¶63, 66 col. 5:11-15
render a barcode on the display of the infusion pump, wherein the barcode is configured to be scanned by a barcode reader; The Novum IQ pumps are marketed as having "on-screen barcodes" for pump identification. A screenshot shows a QR code displayed on the pump screen. ¶62; p. 22 col. 5:55-61
receive, via the wireless module, infusion information... after the barcode reader scans the barcode on the display of the infusion pump and an infusion barcode... The "auto-programming workflow" allegedly involves scanning the on-screen and medication barcodes to enable interoperability with an EMR system, from which the pump receives infusion information. ¶63 col. 6:15-24
operate, based at least on the received infusion information, to cause administration of the infusion. The fundamental purpose of the Accused Infusion Systems is to administer infusions based on programmed parameters. ¶59 col. 6:2-4

Identified Points of Contention

  • Scope Questions: The complaint alleges an "auto-programming workflow" but does not detail the specific hardware or sequence of steps. A potential issue is whether the term "information reader" in the patents, which the specification describes as a device that becomes associated with the pump, reads on the potentially more integrated scanning systems used with modern EMRs.
  • Technical Questions: What specific "medical device information" is encoded in the accused on-screen barcode? The analysis may turn on whether this barcode performs the function of "uniquely identifying the infusion pump" in a manner that facilitates the specific data-routing and association process described in the patents' specifications.

V. Key Claim Terms for Construction

  • The Term: "scannable tag" (’180 Patent, Claim 1)

  • Context and Importance: This term is the central element of the asserted workflow. The dispute may focus on whether the accused "on-screen barcode" is encompassed by this term, particularly regarding the type and function of the information it must convey to meet the claim limitation.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification states that an information device can be a "barcode (static or dynamic) or an RFID tag," suggesting the term is not limited to a specific format. (’180 Patent, col. 3:9-10).
    • Evidence for a Narrower Interpretation: The specification describes the tag as containing "association information" that facilitates "communicative coupling" and routing of subsequent information to that specific device. (’180 Patent, col. 2:22-26, 4:5-8). An argument could be made that a tag merely containing a serial number, without information to establish a routing path, might not meet the functional requirements implied by the specification.

  • The Term: "clinically appropriate time" (’868 Patent, Claim 1)

  • Context and Importance: This term is key to the non-obviousness and infringement arguments for the remote update patents. Practitioners may focus on this term because its definition will determine whether Defendant’s update process, which the complaint alleges occurs at appropriate times, infringes.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The claim itself provides a list of potential states that define the time: "prior to administering the infusion..., while administering..., after administering..., after receiving a power-up command..., or after receiving a power-down command." (’868 Patent, col. 15:5-12). This list, using "or," suggests flexibility.
    • Evidence for a Narrower Interpretation: The specification emphasizes that the purpose is to ensure the update "does not interfere with patient treatment." (’868 Patent, col. 14:42-43). This purpose could be used to argue that the determination of an "appropriate time" must be based on an active assessment of patient safety risk, rather than simply occurring during any non-infusion state.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendant induces infringement by supplying the Accused Infusion Systems with the knowledge and intent that its customers (e.g., healthcare providers) will use them in an infringing manner, and by providing instructions, brochures, and marketing materials that direct users to perform the patented methods. (Compl. ¶82, 90, 98, 106, 114, 122).
  • Willful Infringement: The complaint alleges willful infringement based on Defendant's alleged knowledge of the Asserted Patents since at least the launch of the accused products. (Compl. ¶84, 92, 100, 108, 116, 124). The factual basis includes the parties' status as direct competitors, their extensive history of patent litigation against one another, Defendant's alleged monitoring of Plaintiff's patent portfolio, and the citation of a parent patent to the '180 and '058 patents during the prosecution of Defendant's own patent application. (Compl. ¶72-75).

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

  • A core issue will be one of functional specificity: For the patents on remote updates ('868 and '414), does Defendant's "over-the-air" update feature operate by having the pump autonomously identify its own state and determine a "clinically appropriate time" to activate, as claimed, or is the timing of updates controlled primarily by a central server or a user prompt in a manner that differs from the claimed invention?
  • A second central question will be one of workflow equivalence: For the patents on device programming ('180 and '058), does the accused "auto-programming" workflow function in substantially the same way as the claimed method, which requires an "information reader" to scan an on-screen tag to create a specific communicative association for routing medication data? Discovery will likely focus on the precise data flow and hardware interactions in Defendant's system.
  • Finally, a key question for damages will be one of scienter: Given the extensive history and competitive relationship alleged in the complaint, what was the extent of Defendant’s knowledge of Plaintiff’s specific patented technologies prior to the suit, and did its actions constitute the objective recklessness required to support a finding of willfulness?