DCT

1:21-cv-00977

Abbott Diabetes Care Inc v. Dexcom Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:21-cv-00977, D. Del., 07/01/2021
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Dexcom, Inc. is incorporated in Delaware and thus resides in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s G6 and G6 Pro continuous glucose monitoring products infringe twelve patents related to analyte monitoring systems, sensor design, and data processing.
  • Technical Context: The technology concerns continuous glucose monitoring (CGM) systems, which allow individuals with diabetes to track blood glucose levels without frequent, painful fingerstick tests.
  • Key Procedural History: The complaint does not mention any prior litigation, Inter Partes Review (IPR) proceedings, or licensing history between the parties concerning the asserted patents.

Case Timeline

Date Event
2009-04-29 Priority Date for U.S. Patent No. 10,820,842
2009-07-23 Priority Date for U.S. Patent No. 10,827,954
2014-01-01 Abbott FreeStyle Libre first approved in Europe
2017-01-01 Abbott FreeStyle Libre first approved in the United States
2018-01-01 Dexcom G6 introduced
2018-01-01 Abbott FreeStyle Libre 2 approved in Europe
2020-01-01 Abbott FreeStyle Libre 2 approved in the United States
2020-01-01 Abbott FreeStyle Libre 3 approved in Europe
2020-01-01 Dexcom G6 Pro introduced
2020-11-03 U.S. Patent No. 10,820,842 Issued
2020-11-10 U.S. Patent No. 10,827,954 Issued
2020-12-29 U.S. Patent No. 10,874,338 Issued
2021-01-05 U.S. Patent No. 10,881,341 Issued
2021-03-16 U.S. Patent No. 10,945,647 Issued
2021-03-16 U.S. Patent No. 10,945,649 Issued
2021-03-23 U.S. Patent No. 10,952,653 Issued
2021-03-30 U.S. Patent No. 10,959,654 Issued
2021-04-06 U.S. Patent No. 10,966,644 Issued
2021-04-13 U.S. Patent No. 10,973,443 Issued
2021-05-11 U.S. Patent No. 11,000,216 Issued
2021-05-25 U.S. Patent No. 11,013,440 Issued
2021-07-01 Complaint Filing Date

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

U.S. Patent No. 10,820,842 - Methods and Systems for Early Signal Attenuation Detection and Processing

Issued November 3, 2020

The Invention Explained

  • Problem Addressed: The patent describes time periods when a continuous analyte sensor's characteristics or a user's physiological condition may be "unsuitable for a sensor calibration event" (’842 Patent, col. 11:6-9). During such periods, a system may be unable to display accurate glucose information, creating gaps in the data record available to the user (Compl. ¶3).
  • The Patented Solution: The invention provides a method for handling these data gaps. When an "adverse condition" is detected (such as a failed calibration), the system disables the data output but continues to receive and store the raw sensor data (’842 Patent, col. 12:10-15). Once a successful calibration occurs, the system retrieves the stored raw data from the gap period, processes it using the new, valid calibration parameters, and "backfills" the previously missing information for display, creating a more continuous data record (’842 Patent, FIG. 6, col. 12:40-62).
  • Technical Importance: This data backfilling technique addresses the problem of data gaps caused by transient sensor errors or missed calibrations, which could otherwise force users to rely on less convenient monitoring methods. (Compl. ¶18, 22).

Key Claims at a Glance

  • The complaint asserts at least independent claim 14. (Compl. ¶62).
  • The essential elements of Claim 14, a method claim, are:
    • Detecting a failure mode condition, causing one or more sensor data gaps to be outputted to a display.
    • Storing sensor data received from the analyte sensor for at least a portion of the time period associated with the failure mode.
    • Processing the stored sensor data for that time period.
    • In response to a correction of the failure mode, outputting the processed stored sensor data to the display such that the gaps are at least partially filled.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 10,827,954 - Continuous Analyte Measurement Systems and Systems and Methods for Implanting Them

Issued November 10, 2020

The Invention Explained

  • Problem Addressed: The patent's background describes that early continuous glucose monitoring systems were often invasive, cumbersome, and created discomfort for the user, which could lead to low compliance with testing protocols. (’954 Patent, col. 2:8-16; Compl. ¶3, 18).
  • The Patented Solution: The patent discloses a low-profile continuous analyte measurement system that includes a skin-mounted portion and an implantable sensor. The invention focuses on the physical design of the system, including an "on-skin sensor control unit" with a housing and a sensor with a portion configured to be implanted in vivo, to create a system that is less invasive and more comfortable for the patient. (’954 Patent, Abstract; FIG. 1).
  • Technical Importance: By creating smaller, more user-friendly physical designs, such systems aim to improve patient comfort and compliance with continuous glucose monitoring, which is critical for diabetes management. (Compl. ¶4, 23).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1. (Compl. ¶66).
  • The essential elements of Claim 1, a system claim, are:
    • An on-skin sensor control unit configured for mounting on a skin surface, including a housing.
    • An analyte sensor comprising a portion configured to be positioned in vivo and an external portion.
    • A retention portion of the sensor configured for positioning within the housing.
    • A battery disposed within the housing.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 10,874,338 - Devices, Systems and Methods for On-Skin or On-Body Mounting of Medical Devices

Issued December 29, 2020

  • Technology Synopsis: This patent relates to mounting structures for on-body medical devices. The invention describes a mounting unit with a main portion and a moveable release portion, which can be altered (e.g., bent or broken) to release the medical device from the mount. (’338 Patent, Abstract).
  • Asserted Claims: At least claim 23. (Compl. ¶70).
  • Accused Features: The complaint alleges infringement by Dexcom's G6 products. (Compl. ¶70).

U.S. Patent No. 10,881,341 - Medical Device Inserters and Processes of Inserting and Using Medical Devices

Issued January 5, 2021

  • Technology Synopsis: This patent describes an apparatus for inserting a medical device into the skin. The invention includes a first subassembly with a sharp and a first driver, and a second subassembly with a housing and a second driver for advancing the sharp. (’341 Patent, Abstract).
  • Asserted Claims: At least claim 1. (Compl. ¶74).
  • Accused Features: The complaint alleges infringement by Dexcom's G6 products, which are promoted as having a "simple auto-applicator." (Compl. ¶34, fn. 25; ¶74).

U.S. Patent No. 10,945,647 - Analyte Sensor Transmitter Unit Configuration for a Data Monitoring and Management System

Issued March 16, 2021

  • Technology Synopsis: This patent discloses methods and systems for sensor alignment and retention to improve connectivity between an analyte sensor and a transmitter unit. The invention includes transmitter unit contact pins with metal components to improve electrical conductivity. (’647 Patent, Abstract).
  • Asserted Claims: At least claim 1. (Compl. ¶78).
  • Accused Features: The complaint alleges infringement by Dexcom's G6 products. (Compl. ¶78).

U.S. Patent No. 10,945,649 - Medical Device Inserters and Processes of Inserting and Using Medical Devices

Issued March 16, 2021

  • Technology Synopsis: This patent describes a medical device inserter with a housing, a rotor, a torsion spring, and multiple slidable bodies. The mechanism is designed to insert a sensor coupled with a needle into the skin. (’649 Patent, Abstract).
  • Asserted Claims: At least claim 1. (Compl. ¶82).
  • Accused Features: The complaint alleges infringement by the applicator of the Dexcom G6 product. (Compl. ¶31, 82).

U.S. Patent No. 10,952,653 - Methods and Systems for Early Signal Attenuation Detection and Processing

Issued March 23, 2021

  • Technology Synopsis: This patent is related to the ’842 Patent and describes methods for handling adverse conditions in an analyte monitoring system. It discloses detecting such conditions, disabling data output, storing the data, and then processing and outputting the stored data after the condition is resolved. (’653 Patent, Abstract).
  • Asserted Claims: At least claim 1. (Compl. ¶86).
  • Accused Features: The complaint alleges infringement by Dexcom's G6 products, which allegedly incorporate factory calibration and drift correction. (Compl. ¶33, 86).

U.S. Patent No. 10,959,654 - Medical Device Inserters and Processes of Inserting and Using Medical Devices

Issued March 30, 2021

  • Technology Synopsis: This patent discloses a device inserter with an interior assembly including springs, a sliding member, and an actuator. The mechanism is configured to advance a sharp and a glucose sensor into the skin and then retract the sharp. (’654 Patent, Abstract).
  • Asserted Claims: At least claim 1. (Compl. ¶90).
  • Accused Features: The complaint alleges infringement by the applicator of the Dexcom G6 product. (Compl. ¶31, 90).

U.S. Patent No. 10,966,644 - Devices, Systems and Methods for On-Skin or On-Body Mounting of Medical Devices

Issued April 6, 2021

  • Technology Synopsis: This patent, related to the ’338 Patent, describes a mounting structure for retaining a medical device on the skin. The structure includes a breakable portion that, when altered, releases the medical device. (’644 Patent, Abstract).
  • Asserted Claims: At least claim 1. (Compl. ¶94).
  • Accused Features: The complaint alleges infringement by Dexcom's G6 products. (Compl. ¶94).

U.S. Patent No. 10,973,443 - Sensor Inserter Assembly

Issued April 13, 2021

  • Technology Synopsis: This patent describes a sensor inserter assembly that includes a sensor, sensor control unit, and display. A key feature is a retractable introducer for subcutaneously implanting the sensor. (’443 Patent, Abstract).
  • Asserted Claims: At least claim 13. (Compl. ¶98).
  • Accused Features: The complaint alleges infringement by the applicator of the Dexcom G6 product. (Compl. ¶31, 98).

U.S. Patent No. 11,000,216 - Medical Device Inserters and Processes of Inserting and Using Medical Devices

Issued May 11, 2021

  • Technology Synopsis: This patent discloses a glucose monitoring system with an inserter that includes a housing, a rotor, a torsion spring, and multiple slidable bodies. The mechanism is designed to insert a sensor coupled with a needle into the skin. (’216 Patent, Abstract).
  • Asserted Claims: At least claim 1. (Compl. ¶102).
  • Accused Features: The complaint alleges infringement by the applicator of the Dexcom G6 product. (Compl. ¶31, 102).

U.S. Patent No. 11,013,440 - Medical Device Inserters and Processes of Inserting and Using Medical Devices

Issued May 25, 2021

  • Technology Synopsis: This patent discloses a glucose monitoring system with an inserter that includes a housing, a rotor, a torsion spring, and multiple slidable bodies. The invention is designed for inserting a sensor disposed within the inserter housing into the skin. (’440 Patent, Abstract).
  • Asserted Claims: At least claim 1. (Compl. ¶106).
  • Accused Features: The complaint alleges infringement by the applicator of the Dexcom G6 product. (Compl. ¶31, 106).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are the Dexcom G6 and G6 Pro continuous glucose monitoring systems, collectively referred to as the "G6". (Compl. ¶29).

Functionality and Market Context

  • The G6 system is described as comprising three main components: an applicator with a built-in sensor, a transmitter, and a display device such as a receiver or smart device with associated software (e.g., G6 App). (Compl. ¶30). A visual from the G6 user guide shows these three components and describes their functions. (Compl. p. 12).
  • The complaint alleges that the G6 applicator is used in a single step to insert a portion of the sensor under the skin and apply a transmitter holder. (Compl. ¶31). Another visual from the G6 user guide illustrates this single-step application process. (Compl. p. 13).
  • Key accused features of the G6 system include its use of factory calibration, which avoids the need for user-initiated fingerstick calibrations, and an applicator design that Abbott alleges is a departure from Dexcom's earlier, more "intimidating" products like the G5. (Compl. ¶33-34). Dexcom is alleged to heavily promote the "without fingersticks" feature of its G6 products. (Compl. ¶33).

IV. Analysis of Infringement Allegations

The complaint references, but does not include, claim chart exhibits (Exhibits M-X) that purportedly detail the infringement of each asserted patent. (Compl. ¶62, 66, 70, 74, 78, 82, 86, 90, 94, 98, 102, 106). In the absence of these exhibits, the infringement analysis is based on the narrative allegations in the complaint.

'842 Patent Infringement Allegations

  • The complaint alleges that the Dexcom G6 system infringes at least claim 14 of the ’842 patent. (Compl. ¶62). The core of the allegation appears to be that the G6 system, like the patented method, handles periods of potential data inaccuracy. The complaint states that the G6 "adopts factory calibration, including drift correction to allow for a longer wear period." (Compl. ¶33). This suggests Abbott's infringement theory may be that the G6 system identifies periods where sensor drift or other factors could render data inaccurate (a "failure mode condition"), stores the raw data from that period, and then retrospectively processes it to provide an accurate reading to the user, thereby filling a potential data gap.

Identified Points of Contention ('842 Patent)

  • Scope Questions: A central question may be the definition of "failure mode condition" under claim 14. The court may need to determine if this term, as defined by the patent, covers routine events like sensor drift correction, or if it is limited to more significant, detectable errors.
  • Technical Questions: A key factual question will be how the G6 system actually handles sensor drift and factory calibration. The analysis may turn on whether the G6 system performs the claimed steps of storing raw data during a period of potential inaccuracy, waiting for a "correction" (e.g., applying a drift correction factor), and then retrospectively processing the stored data to "fill" a gap, as opposed to simply applying a continuous, real-time correction algorithm to the data stream.

'954 Patent Infringement Allegations

  • The complaint alleges that the G6 system infringes at least claim 1 of the ’954 patent. (Compl. ¶66). The allegations focus on the physical design and operation of the G6, characterizing it as a "substantial departure" from Dexcom's prior products that "incorporates many of Abbott's patented innovations." (Compl. ¶29). The complaint specifically highlights the G6's "simple auto-applicator" and its ease of insertion, contrasting it with the "intimidating' and complicated G5 applicator design." (Compl. ¶34). The infringement theory appears to be that the physical components of the G6 system—including its on-skin unit, implantable sensor, and applicator—map onto the elements of the patented system.

Identified Points of Contention ('954 Patent)

  • Scope Questions: The dispute may center on the scope of terms describing the physical structure, such as "on-skin sensor control unit" and "retention portion." The court may need to construe these terms to determine if the specific mechanical design of the Dexcom G6 components falls within the scope claimed by the ’954 patent.
  • Technical Questions: The factual analysis will likely involve a direct physical comparison of the accused G6 components against the limitations of claim 1. This could involve examining how the G6 sensor is retained within its on-body housing and whether this mechanism is equivalent to the claimed "retention portion."

V. Key Claim Terms for Construction

'842 Patent: "failure mode condition" (from Claim 14)

  • Context and Importance: The definition of this term is critical because infringement depends on whether the routine operation of the G6's factory calibration and drift correction features constitutes the detection of a "failure mode condition" as required by the claim. Practitioners may focus on this term to distinguish between routine algorithmic adjustments and the detection of a specific, defined error state.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent specification states that conditions unsuitable for calibration can include "sensor data values being outside a predetermined range" or "rate of change of sensor data values being above a predetermined threshold," which could be interpreted to include periods of sensor drift. (’842 Patent, col. 11:20-24).
    • Evidence for a Narrower Interpretation: The claim language recites "detecting...a failure mode condition." This phrasing, combined with other listed examples like "detection of a failure mode of a sensor," may suggest the term is limited to specific, identifiable error events rather than continuous, algorithm-based drift compensation. (’842 Patent, col. 11:20-21, 15:31).

'954 Patent: "on-skin sensor control unit" (from Claim 1)

  • Context and Importance: The scope of this term will be central to determining whether the Dexcom G6's on-body components (the transmitter and the sensor holder/adhesive patch) collectively constitute the claimed "unit." The complaint alleges the G6 incorporates Abbott's innovations in design, making the comparison of these physical structures a key point of the dispute. (Compl. ¶29).
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification describes the "on-skin sensor control unit" broadly as including a "housing which is configured to mount on the skin," which could potentially read on the combined G6 transmitter and its holder. (’954 Patent, col. 8:46-47).
    • Evidence for a Narrower Interpretation: Claim 1 requires the "battery" to be "disposed within the housing" of the "on-skin sensor control unit." The Dexcom G6 transmitter, which contains the battery, is a separate component that snaps into a holder applied to the skin. (Compl. p. 13). This physical separation may support an argument that the G6 does not have a single "on-skin sensor control unit" containing a battery as claimed.

VI. Other Allegations

The complaint does not provide sufficient detail for analysis of indirect or willful infringement.

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

  • A core issue will be one of functional operation: Does the Dexcom G6's alleged "drift correction" functionality operate by detecting a "failure mode condition," storing data, and retrospectively processing it to fill a data gap, as claimed in the '842 patent? Or does it use a different, real-time method that falls outside the claim scope?
  • A second central issue will be one of structural scope: Do the physically separate components of the Dexcom G6 on-body system (transmitter with battery, sensor holder, adhesive patch) combine to form a single "on-skin sensor control unit" as that term is defined in the '954 patent, or does their separability place the accused product outside the claim's structural limitations?
  • A broader question will be one of technological succession: The complaint frames Dexcom's G6 as a "substantial departure" from its prior products that "adopted Abbott's patented technologies." (Compl. ¶5, 33-34). The case may therefore turn on whether Dexcom's product evolution constitutes independent development or the infringement of the numerous design, data processing, and application patents asserted by Abbott.