DCT

1:21-cv-00977

Abbott Diabetes Care Inc v. Dexcom Inc

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Key Events
Amended Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:21-cv-00977, D. Del., 05/20/2022
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Dexcom, Inc. is a Delaware corporation and thus resides in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s G6 line of continuous glucose monitoring (CGM) systems infringes twelve patents related to CGM technology, including methods for factory calibration to eliminate user fingersticks and simplified sensor applicator designs.
  • Technical Context: The technology involves continuous glucose monitoring systems for diabetes management, a significant market that has largely replaced traditional, painful fingerstick-based blood glucose measurements.
  • Key Procedural History: The complaint notes that the parties engaged in prior litigation that concluded with a Settlement and License Agreement in July 2014. This agreement included a covenant-not-to-sue that expired on March 31, 2021. Plaintiff alleges that Defendant used the covenant period to incorporate Plaintiff's patented technology into its products and continued infringing after the covenant's expiration, which forms a basis for the willfulness allegations.

Case Timeline

Date Event
2009-04-29 U.S. Patent No. 10,820,842 Priority Date
2009-07-23 U.S. Patent No. 10,827,954 Priority Date
2014-07-01 Parties enter into Settlement and License Agreement (SLA)
2014-01-01 Abbott's FreeStyle Libre first approved for use in Europe
2017-01-01 Abbott's FreeStyle Libre first approved for use in the U.S.
2018-01-01 Dexcom introduces the Accused G6 Product
2020-01-01 Dexcom introduces the G6 Pro product
2020-11-03 U.S. Patent No. 10,820,842 Issues
2020-11-10 U.S. Patent No. 10,827,954 Issues
2021-03-31 Covenant-not-to-sue from 2014 SLA expires
2021-07-02 Original Complaint served on Dexcom
2022-05-20 Second Amended Complaint Filed

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 addresses the problem of "data gaps" in continuous glucose monitoring systems, which occur when a system cannot accurately report a patient's glucose levels due to events like a failed sensor calibration (Compl. ¶¶130-131; ’842 Patent, col. 11:6-8). These gaps result in an incomplete data record for the user, which can compromise therapy management (Compl. ¶¶131, 139). An image from a prior art Dexcom STS-7 User Guide illustrates this "No glucose data" problem (Compl. p. 40).
  • The Patented Solution: The invention provides a method and system to retrospectively "backfill" these data gaps. The system stores the unprocessed sensor data during a failure mode condition. Once the condition is corrected (e.g., through a successful calibration), the system retrieves the stored data, processes it using the new, valid calibration parameters, and outputs the processed data to the display, thereby closing the gap in the user's glucose history (’842 Patent, col. 12:47-61; Compl. ¶137).
  • Technical Importance: This technology provides patients with a more complete and accurate record of their glucose levels, which "advantageously" provides "additional robustness . . . to the user and/or healthcare provider to improve therapy or health management decisions" (’842 Patent, col. 13:39-42; Compl. ¶147).

Key Claims at a Glance

  • The complaint asserts independent claims 1 and 14, along with several dependent claims (Compl. ¶61).
  • Independent claim 14 is directed to an analyte monitoring system comprising:
    • An analyte sensor
    • One or more processors
    • A memory device storing instructions which, when executed, cause the processor(s) to:
      • detect a failure mode condition, wherein the failure mode condition causes one or more sensor data gaps to be outputted to a display
      • store sensor data received from the analyte sensor for at least a portion of a time period associated with the failure mode condition
      • process the sensor data for that time period
      • in response to a correction of the failure mode condition, output the processed stored sensor data to the display such that the one or more sensor data gaps are at least partially filled.

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 addresses the drawbacks of traditional diabetes monitoring, which required frequent, painful "fingerstick" measurements for both discrete glucose checks and for calibrating early-generation CGM devices (Compl. ¶¶2-3; ’954 Patent, col. 2:10-21). This frequent calibration burden was a significant barrier to CGM adoption (Compl. ¶76). A screenshot from Dexcom's earlier G5 User Guide highlights the requirement to "Calibrate the Dexcom G5 Mobile at least once every 12 hours" (Compl. p. 21).
  • The Patented Solution: The invention describes a continuous analyte measurement system that avoids the need for user-initiated calibration by employing a "predetermined sensitivity drift profile" stored in memory (’954 Patent, Claim 1). This profile allows the system's processor to adjust the raw sensor data to account for the sensor's expected changes in sensitivity over its wear life, thereby providing accurate glucose readings without requiring periodic fingerstick calibrations by the user (’954 Patent, col. 16:15-30; Compl. ¶¶79-81).
  • Technical Importance: This "factory calibration" approach was a key innovation that made CGM technology significantly more convenient and less painful, thereby increasing patient access and compliance (Compl. ¶¶4, 79).

Key Claims at a Glance

  • The complaint asserts independent claim 1 and dependent claims 7 and 15-17 (Compl. ¶61).
  • Independent claim 1 is directed to a continuous analyte measurement system comprising:
    • An on-skin data processing unit including a housing and configured to be positioned on the skin
    • A memory device disposed in the housing and storing a predetermined sensitivity drift profile
    • A processor disposed in the housing and configured to:
      • receive sensor data from a sensor
      • determine a glucose level based on the received sensor data and the predetermined sensitivity drift profile.

Multi-Patent Capsule: U.S. Patent No. 10,874,338

  • Patent Identification: 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 (Compl. ¶41).
  • Technology Synopsis: The technology relates to on-body mounting units for medical devices. It describes a mounting structure with a breakable portion that, when altered, facilitates the release of a medical device, such as a reusable transmitter, from a disposable sensor mount (Compl. ¶¶106, 193).
  • Asserted Claims: 1, 3, 5, 10-11, 14-15, 17, 22-23, 26 (Compl. ¶61).
  • Accused Features: The "Streamlined Transmitter Holder" of the Dexcom G6, which allegedly incorporates a "new breakaway feature" that allows the transmitter to "snap out for easy removal," is accused of infringement (Compl. ¶¶109, 193; G6 User Guide at 46).

Multi-Patent Capsule: U.S. Patent No. 10,881,341

  • Patent Identification: U.S. Patent No. 10,881,341, “Medical Device Inserters and Processes of Inserting and Using Medical Devices,” issued January 5, 2021 (Compl. ¶43).
  • Technology Synopsis: The technology relates to medical device inserters, describing a compact, automated system with components that move along multiple axes to handle and insert a CGM system (Compl. ¶89). This design aims to make the insertion process easier and more compact for the user.
  • Asserted Claims: 1, 4, 13, 16, 18, 26-27, 29 (Compl. ¶61).
  • Accused Features: The Dexcom G6's "simple auto-applicator" is accused of infringing. The complaint alleges that Dexcom copied this technology to move away from its prior "intimidating" and complex G5 applicator design (Compl. ¶¶34, 95).

Multi-Patent Capsule: U.S. Patent No. 10,945,647

  • Patent Identification: U.S. Patent No. 10,945,647, “Analyte Sensor Transmitter Unit Configuration for a Data Monitoring and Management System,” issued March 16, 2021 (Compl. ¶45).
  • Technology Synopsis: The technology relates to the configuration of a transmitter and its mount, including a base and a locking mechanism, to improve sensor insertion, placement, and connectivity (Compl. ¶¶231, 234).
  • Asserted Claims: 1-3, 11-14 (Compl. ¶61).
  • Accused Features: The Dexcom G6 transmitter mount, which includes a base and locking mechanism that engages a sensor subassembly, is accused of infringement (Compl. ¶¶234-235).

Multi-Patent Capsule: U.S. Patent No. 10,945,649

  • Patent Identification: U.S. Patent No. 10,945,649, “Medical Device Inserters and Processes of Inserting and Using Medical Devices,” issued March 16, 2021 (Compl. ¶47).
  • Technology Synopsis: The technology relates to a convenient and compact automated CGM inserter assembly that includes a torsion spring to provide consistent, rapid, and less painful needle insertion (Compl. ¶90).
  • Asserted Claims: 1, 6, 8, 10, 17-18, 25, 28 (Compl. ¶61).
  • Accused Features: The Dexcom G6's automated inserter is accused of incorporating this patented technology, which Abbott alleges was copied from its own innovations (Compl. ¶95).

Multi-Patent Capsule: U.S. Patent No. 10,952,653

  • Patent Identification: U.S. Patent No. 10,952,653, “Methods and Systems for Early Signal Attenuation Detection and Processing,” issued March 23, 2021 (Compl. ¶49).
  • Technology Synopsis: As a continuation of the ’842 patent, this patent relates to technological solutions for the problem of sensor data gaps that result from failure mode conditions in CGM systems, enabling the recovery of otherwise lost glucose data (Compl. ¶270).
  • Asserted Claims: 1, 3, 5-8, 11, 15, 18 (Compl. ¶61).
  • Accused Features: Dexcom's G6 system, which includes a data "backfill" feature to fill in data gaps caused by temporary shutdowns or signal loss, is accused of infringing (Compl. ¶¶110, 278-279).

Multi-Patent Capsule: U.S. Patent No. 10,959,654

  • Patent Identification: U.S. Patent No. 10,959,654, “Medical Device Inserters and Processes of Inserting and Using Medical Devices,” issued March 30, 2021 (Compl. ¶51).
  • Technology Synopsis: This technology concerns a compact, automated CGM system and inserter assembly designed to be easier for a user to handle, featuring insertion assembly components that move along multiple different axes (Compl. ¶89).
  • Asserted Claims: 1, 8, 10, 15, 20, 22, 26 (Compl. ¶61).
  • Accused Features: The Dexcom G6 auto-applicator is accused of infringing, with the complaint alleging Dexcom incorporated these inventions to compete with Abbott's FreeStyle Libre products (Compl. ¶95).

Multi-Patent Capsule: U.S. Patent No. 10,966,644

  • Patent Identification: 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 (Compl. ¶53).
  • Technology Synopsis: This patent relates to on-body mounting units for medical devices, specifically a mount with a "breakaway feature" that allows for easier and safer removal of a reusable transmitter from a used sensor component (Compl. ¶¶109, 318).
  • Asserted Claims: 1-3, 5, 8-11, 15 (Compl. ¶61).
  • Accused Features: The Dexcom G6 transmitter holder and its "breakaway feature" for transmitter removal are accused of infringement (Compl. ¶¶109, 318).

Multi-Patent Capsule: U.S. Patent No. 10,973,443

  • Patent Identification: U.S. Patent No. 10,973,443, “Sensor Inserter Assembly,” issued April 13, 2021 (Compl. ¶55).
  • Technology Synopsis: The invention relates to an easier-to-use and safer CGM insertion assembly. Key features include coupling the mount to the end of the inserter to reduce the number of components the user handles and automated insertion/retraction via a simple push of a button (Compl. ¶¶87-88).
  • Asserted Claims: 1, 13-14, 18, 20-21, 23 (Compl. ¶61).
  • Accused Features: The Dexcom G6 "1-button simplified insertion" auto-applicator is accused of infringing these claims (Compl. ¶¶95-96).

Multi-Patent Capsule: U.S. Patent No. 11,000,216

  • Patent Identification: U.S. Patent No. 11,000,216, “Medical Device Inserters and Processes of Inserting and Using Medical Devices,” issued May 11, 2021 (Compl. ¶57).
  • Technology Synopsis: This patent covers a compact, automated CGM inserter assembly. The design allows for various components to move along multiple different axes, making the device easier for a user to handle and carry (Compl. ¶89).
  • Asserted Claims: 1-4, 6, 11, 13, 16-17, 19, 23-26, 28-29 (Compl. ¶61).
  • Accused Features: The Dexcom G6 auto-applicator is accused of infringing by incorporating these patented designs (Compl. ¶95).

Multi-Patent Capsule: U.S. Patent No. 11,013,440

  • Patent Identification: U.S. Patent No. 11,013,440, “Medical Device Inserters and Processes of Inserting and Using Medical Devices,” issued May 25, 2021 (Compl. ¶59).
  • Technology Synopsis: This invention relates to an easy-to-use, compact, and automated CGM inserter assembly that utilizes a torsion spring to provide consistent, rapid, and less painful needle insertion (Compl. ¶90).
  • Asserted Claims: 1, 7, 10-11, 17, 24-25 (Compl. ¶61).
  • Accused Features: The automated inserter for the Dexcom G6 is accused of incorporating these inventions (Compl. ¶95).

III. The Accused Instrumentality

  • Product Identification: The accused products are the Dexcom G6 Continuous Glucose Monitoring System and its variations, including the Dexcom Pro Q, Dexcom G6 Pro, Dexcom G6 Glucose Program, and Dexcom ONE systems (collectively, the "Accused Products") (Compl. ¶62).
  • Functionality and Market Context: The Accused Products are sixth-generation CGM systems that include an applicator with a sensor, a transmitter, and a display device such as a receiver or a smart device running a compatible software application (Compl. ¶30). The complaint alleges that the G6 system represents a "substantial departure" from Dexcom's prior G5 product by incorporating two key features allegedly patented by Abbott: (1) factory calibration that eliminates the need for routine user fingerstick calibrations, and (2) a "simple auto-applicator" for easier, one-touch sensor insertion (Compl. ¶¶29, 33-34, 74). The complaint provides a table from Dexcom's G6 User Guide identifying the system's main components (Compl. p. 12). Dexcom allegedly designed and markets the G6 to compete directly with Abbott's FreeStyle Libre products (Compl. ¶74). Marketing materials are cited which highlight the G6's "0 fingerpricks" and "1-button simplified insertion" in comparison to the older G5 system (Compl. pp. 23, 29).

IV. Analysis of Infringement Allegations

10,820,842 Patent Infringement Allegations

Claim Element (from Independent Claim 14) Alleged Infringing Functionality Complaint Citation Patent Citation
an analyte monitoring system comprising: an analyte sensor; one or more processors; and a memory device storing instructions which, when executed...cause the one or more processors to: The Dexcom G6 system, which includes a sensor, a transmitter with a processor, and a display device with a processor and memory (Compl. ¶30). ¶30, ¶143 col. 16:29-32
detect a failure mode condition, wherein the failure mode condition causes one or more sensor data gaps to be outputted to a display... The G6 system detects when a connection is lost between the transmitter and display device due to "a temporary shutdown, Signal Loss, or similar issue," which causes a gap in the glucose graph (Compl. ¶154). ¶154 col. 16:35-38
store sensor data received from the analyte sensor for at least a portion of a time period associated with the failure mode condition... The G6 transmitter stores up to 3 hours of missed glucose readings (packets) when the connection to the display device is lost (Compl. ¶149). ¶149 col. 16:39-42
...in response to a correction of the failure mode condition, output the processed stored sensor data...such that the one or more sensor data gaps are at least partially filled... Upon re-connection, a transmitter sends the missed packets to the display device, which then processes the data and backfills the gap on the graph (Compl. ¶155). ¶155 col. 16:45-49
  • Identified Points of Contention:
    • Scope Questions: A central question may be whether a temporary wireless "Signal Loss" between a transmitter and receiver, as described for the G6 (Compl. ¶154), constitutes a "failure mode condition" within the meaning of the ’842 Patent. The patent specification provides a non-exhaustive list including "system malfunction" and "signal errors associated with the...transmitter unit, [or] receiver unit" ('842 Patent, col. 13:19-27), which may support the plaintiff's interpretation.
    • Technical Questions: The analysis may focus on the sequence of operations. What evidence does the complaint provide that the G6 system's processing and outputting of stored data occurs "in response to a correction of the failure mode condition," as required by the claim, versus simply upon re-establishment of a standard communication link?

10,827,954 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a continuous analyte measurement system, comprising: an on-skin data processing unit including a housing configured to be positioned on the skin of a user; The Dexcom G6 system includes a transmitter that is worn on the skin and contains a processor (Compl. ¶30). ¶30 col. 15:28-31
a memory device disposed in the housing of the on-skin data processing unit and storing a predetermined sensitivity drift profile; The G6 transmitter memory allegedly stores a "drift profile" or "calibration function" that corrects for sensor drift over its 10-day wear period (Compl. ¶¶80-81). ¶80, ¶81 col. 15:32-35
a processor disposed in the housing of the on-skin data processing unit and configured to...determine a glucose level based on the received sensor data and the predetermined sensitivity drift profile. The G6 processor allegedly uses the stored drift profile to convert interstitial current to glucose values without requiring fingerstick calibrations from the user (Compl. ¶81). A user guide image shows users are instructed to "enter a sensor code" to enable this functionality (Compl. p. 52). ¶81, ¶174 col. 15:36-40
  • Identified Points of Contention:
    • Scope Questions: A primary dispute will likely involve the construction of "predetermined sensitivity drift profile." The question for the court will be whether this term, as defined by the intrinsic evidence, reads on the G6's alleged system of using a "sensor code" to select a corresponding "calibration function" based on an "average" sensor's drift (Compl. ¶¶81, 174).
    • Technical Questions: What evidence demonstrates that the G6's "sensor code" and internal algorithm function as a "sensitivity drift profile" as claimed, rather than a different form of factory calibration or signal processing? The actual operation of the G6 software will be a central factual issue.

V. Key Claim Terms for Construction

  • The Term: "failure mode condition" (from ’842 Patent, Claim 14)

    • Context and Importance: Infringement of the ’842 Patent hinges on whether the G6's temporary signal loss between its transmitter and receiver constitutes a "failure mode condition." A narrow definition limited to sensor-specific errors could be non-infringement, while a broader definition covering communication interruptions may support infringement.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification provides a broad, exemplary list: "...an inability to promptly calibrate the sensor, system malfunction, sensor dislodging, signal errors associated with the sensor, transmitter unit, receiver unit, and the like, or other variables or parameters that result in the inability of the...system to display or output the real-time monitored...level" ('842 Patent, col. 13:19-27). This language suggests the term is not limited to the specific examples provided.
      • Evidence for a Narrower Interpretation: A party might argue that the primary examples in the specification relate to calibration events and sensor performance issues ('842 Patent, col. 11:6-8). The context could suggest that routine, temporary communication dropouts that are an expected part of wireless operation are distinct from the types of system "failures" contemplated by the patent.

  • The Term: "predetermined sensitivity drift profile" (from ’954 Patent, Claim 1)

    • Context and Importance: This term is the crux of the infringement allegation for the ’954 Patent. Its construction will determine whether the G6's method of using a "sensor code" to apply a factory-set correction algorithm falls within the scope of the claims. Practitioners may focus on this term because it distinguishes the invention from prior art systems requiring ongoing user calibration.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The plain language of the claim suggests any profile of expected sensitivity changes, determined in advance of use and stored in memory to adjust readings, could be covered. The context of the patent family is avoiding user-initiated fingerstick calibrations.
      • Evidence for a Narrower Interpretation: A party could argue the term should be limited to specific methods of creating or applying such a profile if disclosed in the specification or prosecution history. The defense may argue that a system that selects one of several profiles based on a code is different from a system that stores and applies a single, universal profile as might be described in a specific embodiment.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement of infringement based on Dexcom providing product documentation and educational materials, such as user guides, that instruct and encourage patients and physicians to use the Accused Products in an infringing manner (Compl. ¶118). Specific examples include instructions on using the "no fingersticks" calibration feature (Compl. ¶174) and the single-push auto-applicator (Compl. ¶213).
  • Willful Infringement: The complaint alleges willful infringement based on both pre- and post-suit knowledge. It asserts Dexcom knew of the Asserted Patents on or shortly after their issue dates (Compl. ¶69) and that, as a "fierce rival," it actively monitors Abbott's patent activity (Compl. ¶70). Crucially, the complaint alleges Dexcom developed and launched the G6 during the term of a covenant-not-to-sue between the parties, continued selling the products after the covenant expired on March 31, 2021, and did so despite Abbott's refusal to grant an extension (Compl. ¶¶113-115). Service of the original complaint on July 2, 2021, is cited as further notice (Compl. ¶72).

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

  • A central evidentiary question will be one of technical copying and equivalence: Does the evidence show that Dexcom's G6 system, in its move away from fingerstick calibrations and complex applicators, incorporates the specific technological solutions claimed in Abbott's patents, or did it independently develop a functionally distinct, non-infringing alternative to compete with Abbott's FreeStyle Libre?
  • A core legal issue will be one of definitional scope: Can the term "failure mode condition" be construed to cover temporary wireless signal loss, and can "predetermined sensitivity drift profile" be construed to cover the G6's use of a sensor code to apply a factory-set calibration algorithm? The outcome of claim construction will be critical to the infringement analysis.
  • A key issue for willfulness and damages will be the impact of the parties' commercial history: How will the court interpret Dexcom's decision to launch the G6 with the accused features during a covenant-not-to-sue period with its primary competitor and to continue its conduct after that covenant's explicit expiration?