Abbott Diabetes Care Inc v. Dexcom Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Abbott Diabetes Care Inc. (Delaware) and Abbott Diabetes Care Limited (United Kingdom)
  • Defendant: DexCom, Inc. (Delaware)
  • Plaintiff's Counsel: Morris, Nichols, Arsht & Tunnell LLP
• Case Identification: 1:23-cv-00239, D. Del., 03/03/2023
• Venue Allegations: Venue is asserted 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 G7 continuous glucose monitoring (CGM) system infringes four U.S. patents related to factory-calibrated sensors, integrated sensor-inserter assemblies, and data gap backfilling technology.
• Technical Context: The technology at issue involves continuous glucose monitors, which are critical medical devices for diabetes management that reduce or eliminate the need for painful and frequent fingerstick blood tests.
• Key Procedural History: The parties have a history of litigation, including a 2005 lawsuit that was settled in 2014 by an agreement that included a covenant-not-to-sue, which expired in March 2021. Plaintiff subsequently filed suit against Defendant's G6 product in July 2021 (the "G6 Action"), which Plaintiff alleges put Defendant on notice of infringement by its CGM products, including the '954 patent asserted in this case.

Case Timeline

Date	Event
2005-XX-XX	Prior litigation initiated by Abbott against DexCom
2009-02-03	Priority Date for U.S. Patent No. 11,202,591
2009-04-29	Priority Date for U.S. Patent No. 11,298,056
2009-07-23	Priority Date for U.S. Patent No. 10,827,954
2010-03-24	Priority Date for U.S. Patent No. 11,266,335
2014-07-XX	Settlement and License Agreement ("SLA") including covenant-not-to-sue
2020-11-10	U.S. Patent No. 10,827,954 Issues
2021-03-31	Covenant-not-to-sue expires
2021-07-02	Abbott files "G6 Action"; DexCom allegedly put on notice of '954 patent
2021-12-21	U.S. Patent No. 11,202,591 Issues
2022-03-XX	DexCom G7 receives CE mark approval in Europe
2022-03-08	U.S. Patent No. 11,266,335 Issues
2022-04-12	U.S. Patent No. 11,298,056 Issues
2022-04-28	DexCom initiates limited launch of G7 in the United Kingdom
2023-02-17	DexCom begins selling and/or offering for sale the G7 in the United States
2023-03-03	Complaint Filed

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

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

• Patent Identification: U.S. Patent No. 10,827,954, "Continuous Analyte Measurement Systems and Systems and Methods for Implanting Them," issued November 10, 2020. Compl. ¶38 '954 Patent, cover

The Invention Explained

• Problem Addressed: The patent's background describes the inconvenience and pain of traditional "finger stick" glucose testing and the shortcomings of early continuous glucose monitoring (CGM) systems, which required frequent user calibration to account for sensor inaccuracies and drift Compl. ¶¶4-5 '954 Patent, col. 2:1-20
• The Patented Solution: The patent discloses a CGM system that eliminates the need for user calibration by using a pre-programmed "drift profile" stored in the device's memory prior to sensor insertion. This profile is used by an algorithm to apply a "drift correction factor" to the raw sensor data, thereby converting it into a calibrated glucose measurement throughout the sensor's wear life '954 Patent, claim 1 '954 Patent, col. 5:21-34
• Technical Importance: This "factory calibration" approach was a significant step toward making CGMs more user-friendly and accessible by removing the burden of frequent and painful fingerstick calibrations Compl. ¶¶10-11

Key Claims at a Glance

• The complaint asserts infringement of at least independent claim 1 Compl. ¶83
• The essential elements of independent claim 1 include:
  • a memory;
  • a base unit configured for mounting on a skin surface;
  • an analyte sensor with a portion for insertion through the skin;
  • a conductive member for electrical contact with the sensor;
  • wherein the system is configured to determine the analyte level using a "drift correction factor" determined by an algorithm using a "drift profile"; and
  • wherein the "drift profile" is programmed into the memory prior to sensor insertion.

U.S. Patent No. 11,202,591 - "Analyte Sensor and Apparatus for Insertion of the Sensor"

• Patent Identification: U.S. Patent No. 11,202,591, "Analyte Sensor and Apparatus for Insertion of the Sensor," issued December 21, 2021 Compl. ¶40 '591 Patent, cover

The Invention Explained

• Problem Addressed: The complaint describes earlier CGM insertion devices as complicated, multi-step, and intimidating, with one CEO calling them "kind of scary" Compl. ¶17 Compl. ¶66 The patent addresses the need for a simple, reliable, and less painful insertion assembly Compl. ¶68 '591 Patent, col. 2:1-10
• The Patented Solution: The patent discloses an integrated insertion assembly where an on-body unit (containing the sensor and electronics) and an insertion sharp are entirely disposed within an inserter. The inserter is configured to advance both components in a linear motion to pierce the skin, and then automatically retract the sharp, leaving the on-body unit secured to the user's skin. This simplifies the application process to a single step '591 Patent, claim 1 Compl. ¶69 The design is illustrated in a complaint figure showing the one-step application process Compl. p. 30
• Technical Importance: This technology represents a significant shift towards user-centric design, replacing complex, error-prone applicators with a simple, "one-step" process that improves ease-of-use and patient comfort Compl. ¶68 Compl. ¶69

Key Claims at a Glance

• The complaint asserts infringement of at least independent claim 1 Compl. ¶95
• The essential elements of independent claim 1 include:
  • An on-body unit comprising a housing, a glucose sensor, and sensor electronics.
  • An inserter comprising a proximal end, a distal end, an interior, and a sharp.
  • The on-body unit and sharp are entirely disposed in the inserter's interior.
  • At least a portion of the glucose sensor is disposed in the sharp.
  • The inserter is configured to advance the on-body unit and sharp in a linear direction from a first to a second position to pierce the skin.
  • The inserter is further configured to automatically retract the sharp from the user.
  • The inserter's distal end is configured to be removed from the skin after the sharp is retracted.

U.S. Patent No. 11,266,335 - "Medical Device Inserters and Processes of Inserting and Using Medical Devices"

• Patent Identification: U.S. Patent No. 11,266,335, "Medical Device Inserters and Processes of Inserting and Using Medical Devices," issued March 8, 2022 Compl. ¶42
• Technology Synopsis: The patent describes a glucose monitoring assembly that includes an inserter and an on-body electronics unit. The problem addressed is creating a secure yet detachable engagement between the inserter and the on-body unit. The patented solution involves an on-body unit housing with a "plurality of recesses disposed on a periphery" that detachably engages with the inserter '335 Patent, claim 1
• Asserted Claims: At least independent claim 1 is asserted Compl. ¶105
• Accused Features: The G7's integrated applicator and on-body sensor unit design, which allows for a single-step application, is alleged to infringe Compl. ¶¶68-69

U.S. Patent No. 11,298,056 - "Methods and Systems for Early Signal Attenuation Detection and Processing"

• Patent Identification: U.S. Patent No. 11,298,056, "Methods and Systems for Early Signal Attenuation Detection and Processing," issued April 12, 2022 Compl. ¶44
• Technology Synopsis: The patent addresses the problem of "data gaps" in CGM systems, where sensor readings are not displayed due to adverse conditions like calibration failures or signal loss Compl. ¶¶119-122 The patented solution is a system that detects an adverse condition, stores the sensor data during the resulting data gap, and then, after the condition is corrected, processes the stored data to "backfill" the gap in the user's display, creating a more complete glucose history '056 Patent, claim 1 An image in the complaint from a prior DexCom user guide illustrates such a data gap, showing an alert for "No glucose data" Compl. p. 45
• Asserted Claims: At least independent claim 1 is asserted Compl. ¶140
• Accused Features: The G7's "Quality of Service" feature is accused of infringing. This feature is alleged to transmit missed data packets (up to 24 hours) to the display device upon reconnection, which Abbott contends is a form of the claimed "backfilling" Compl. ¶139

III. The Accused Instrumentality

Product Identification

The accused instrumentality is the DexCom G7 Continuous Glucose Monitoring (CGM) System (the "G7") Compl. ¶1

Functionality and Market Context

The G7 is a CGM system designed for diabetes management Compl. ¶3 The complaint alleges the G7 is an "all-in-one sensor unit with a sensor pre-connected to electronics and loaded in an applicator," allowing for application in a "single step" Compl. ¶¶2, 24 This design is presented as a "substantial departure" from DexCom's previous G5 and G6 devices, which required users to manually attach a reusable transmitter to a sensor pod Compl. ¶¶2, 18 The complaint highlights that the G7 is promoted as being "60% smaller" than the G6 and as a "1-piece sensor application" that does not require the user to save a separate transmitter Compl. ¶26 The complaint also alleges the G7 incorporates "factory calibration" that eliminates the need for fingerstick calibrations, a feature touted in G7 marketing as "No fingersticks" Compl. ¶¶63-64 A key accused function is the G7's ability to "backfill" up to 24 hours of missed sensor readings upon re-establishing a lost connection between the transmitter and display device Compl. ¶139 The complaint provides a visual timeline comparing the evolution of Abbott's and Dexcom's applicators and sensor units, suggesting Dexcom's G7 design converged on Abbott's pre-existing all-in-one model Compl. pp. 2-3

IV. Analysis of Infringement Allegations

'954 Patent Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
a memory;	The G7 system includes memory in its transmitter and/or display device.	¶83; Ex. E, pp. 1, 3-5	col. 29:43-45
a base unit configured for mounting on a skin surface;	The G7 comprises a base unit that is mounted on the user's skin.	¶83; Ex. E, p. 7	col. 27:51-53
an analyte sensor comprising a proximal portion configured for positioning within the base unit and a distal portion configured for insertion through the skin surface,	The G7 comprises an analyte sensor with a proximal portion positioned within the base unit and a distal portion inserted through the skin.	¶83; Ex. E, p. 8	col. 28:5-9
wherein the analyte sensor is configured to generate one or more signals related to an analyte level;	The G7 analyte sensor generates electrical current signals related to the user's glucose level.	¶83; Ex. E, p. 10	col. 31:4-10
a conductive member positionable within the base unit and in electrical contact with the analyte sensor;	The G7 comprises a conductive member that makes electrical contact with the analyte sensor.	¶83; Ex. E, p. 11	col. 28:10-15
wherein the continuous analyte measurement system is configured to determine the analyte level using at least a drift correction factor associated with the analyte sensor, the drift correction factor determined by an algorithm of the continuous analyte measurement system using a drift profile;	The G7 system determines the analyte level using a drift correction factor. For example, the G7 is factory calibrated and uses a calibration function that corrects for sensor drift over the 10-day wear period.	¶83; Ex. E, p. 12	col. 5:25-34
and wherein the drift profile is programmed into the memory of the continuous analyte measurement system prior to insertion of the distal portion of the sensor through the skin surface.	The G7's drift profile is programmed into its memory prior to sensor insertion.	¶83; Ex. E, p. 15	col. 5:25-29

'591 Patent Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
(a) an on-body unit, comprising: a housing comprising a top surface and a bottom surface... a glucose sensor; and sensor electronics...	The G7 insertion assembly comprises an on-body unit, which includes a housing, a glucose sensor, and sensor electronics.	¶95; Ex. F, pp. 1-4	col. 2:20-22
(b) an inserter, comprising: a proximal end, a distal end, and an interior; and a sharp,	The G7 insertion assembly comprises an inserter with a proximal end, distal end, interior, and a sharp.	¶95; Ex. F, p. 5	col. 4:10-13
wherein the on-body unit and the sharp are entirely disposed in the interior of the inserter,	The G7 on-body unit and sharp are entirely disposed in the interior of the G7 inserter.	¶95; Ex. F, p. 8	col. 4:26-28
wherein at least a portion of the glucose sensor is disposed in the sharp,	At least a portion of the G7 glucose sensor is disposed in the sharp.	¶95; Ex. F, p. 8	col. 4:29-30
wherein the sharp extends through the opening of the top surface and the opening of the bottom surface along the longitudinal axis when the on-body unit is in a first position,	The G7 sharp extends through the top and bottom openings of the on-body unit housing when in a first position.	¶95; Ex. F, p. 9	col. 4:31-35
wherein the inserter is configured to advance the on-body unit and the sharp in a linear direction from the first position to a second position such that the sharp pierces skin of a user and the housing of the on-body unit is secured to the skin of the user in the second position,	The G7 inserter is configured to advance the on-body unit and sharp in a linear direction to pierce a user's skin and secure the on-body unit housing to the skin.	¶95; Ex. F, p. 10	col. 4:36-43
wherein the distal end of the inserter is configured to be positioned on the skin of the user before advancement of the on-body unit and the sharp,	The distal end of the G7 inserter is configured to be positioned on the user's skin before advancement.	¶95; Ex. F, p. 13	col. 4:44-47
wherein the inserter is further configured to automatically retract the sharp from within the user and entirely into the interior of the inserter and leave a part of the glucose sensor in the skin of the user, and	The G7 inserter is configured to automatically retract the sharp from the user and leave a part of the glucose sensor in the skin.	¶95; Ex. F, p. 14	col. 4:48-53
wherein the distal end of the inserter is further configured to be removed from the skin of the user after automatic retraction of the sharp from within the user.	The distal end of the G7 inserter is configured to be removed from the user's skin after the sharp is automatically retracted.	¶95; Ex. F, p. 16	col. 4:54-57

• Identified Points of Contention:
  • '954 Patent (Factory Calibration): A primary point of contention may involve the scope of the term "drift profile." The complaint alleges the G7's factory calibration infringes (Compl. ¶¶60-62), but a court will need to determine if Dexcom's calibration algorithm, which accounts for sensor drift, is technically equivalent to the specific "drift profile" methodology claimed in the '954 patent. The question is whether Dexcom's method of ensuring accuracy over the wear life falls within the patent's claims, which describe programming a "drift profile" into memory prior to insertion.
  • '591 Patent (Inserter): The infringement analysis may focus on whether the G7's fully disposable, single-piece design can be mapped onto the claim language of the '591 patent, which recites a distinct "on-body unit" and an "inserter." The complaint alleges the G7 is an all-in-one system that performs the claimed functions (Compl. ¶24, Compl. ¶69). A central question is whether a single, integrated disposable product can simultaneously meet the claim limitations for both an "inserter" and an "on-body unit" that are described and depicted in the patent as more discrete components. The G7's single-step insertion process is shown in a complaint diagram (Compl. p. 17).

V. Key Claim Terms for Construction

• For the '954 Patent:

  • The Term: "drift profile"
  • Context and Importance: This term is central to the '954 patent's invention of a factory-calibrated sensor. The construction of this term will be critical to determining whether Dexcom's method for ensuring sensor accuracy over its lifespan, which Abbott alleges is a "drift profile" (Compl. ¶60), falls within the scope of the claims. Practitioners may focus on this term because its definition will likely resolve the core infringement question for this patent.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent states the system is configured to determine the analyte level using a "drift correction factor" determined by an algorithm using a "drift profile" '954 Patent, claim 1 This general, functional language may support an interpretation that covers any pre-programmed method for correcting sensor drift.
    • Evidence for a Narrower Interpretation: The specification may describe specific methods or data sets that constitute a "drift profile," potentially limiting the term to those examples. For instance, the complaint itself cites an article suggesting the similar G6 system corrects drift by "keeping track of the day since insertion" (Compl. ¶61), which could be argued as a specific embodiment distinct from other potential drift correction methods.

• For the '591 Patent:

  • The Term: "on-body unit" and "inserter"
  • Context and Importance: Claim 1 of the '591 patent recites both an "on-body unit" and an "inserter" where the former is "entirely disposed in the interior of the" latter before use. The G7 is described as an "all-in-one" disposable device (Compl. ¶24). The key question is whether this integrated G7 product can be conceptually separated to meet the limitations for two distinct components.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claim functionally defines the "inserter" as the component that advances the sharp and the "on-body unit" as the component that is secured to the skin '591 Patent, claim 1 Abbott may argue that the outer shell of the G7 device functions as the "inserter" and the internal sensor/transmitter that remains on the skin is the "on-body unit."
    • Evidence for a Narrower Interpretation: The patent's figures (e.g., FIG. 10, FIG. 23) depict a visually distinct "inserter" (100) and a separate "sensor housing" (122) being assembled. A party might argue that the term "on-body unit" should be construed in light of these embodiments to mean a component that is structurally separate from the inserter prior to the insertion process, which may not describe the G7's integrated design.

VI. Other Allegations

• Indirect Infringement: The complaint alleges that Dexcom induces infringement by providing user guides and instructions that direct customers to use the G7 system in an infringing manner (Compl. ¶¶86, 98, 108, 143). It also alleges infringement for sales outside of the United States under 35 U.S.C. § 271(f) by supplying components of the patented inventions from the U.S. with the intent that they be combined abroad (Compl. ¶¶85, 97, 107, 142).
• Willful Infringement: Willfulness is alleged for all asserted patents. The allegations are based on Dexcom's alleged pre-suit knowledge of Abbott's technology, stemming from a prior litigation and a covenant-not-to-sue agreement that expired in 2021 (Compl. ¶¶20-22, 77-81). The complaint specifically alleges Dexcom knew of the '954 patent from the "G6 Action" filed in July 2021, and that the filing of the present complaint provides "indisputable notice" as to all asserted patents (Compl. ¶¶50-51).

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

• A core issue will be one of structural interpretation: can the claim elements for a multi-component "inserter" and "on-body unit," as described in the '591 and '335 patents, be construed to read on the single-piece, all-in-one disposable design of the Dexcom G7?
• A second central question will be one of algorithmic scope: does Dexcom's method of "factory calibration" in the G7 system, which corrects for sensor inaccuracies over time, fall within the '954 patent's claimed "drift profile," or is the patent's scope limited to a more specific method of drift correction?
• A key evidentiary question will be one of functional equivalence: does the Dexcom G7's feature of transmitting "missed packets" of data upon reconnection perform substantially the same function in substantially the same way to achieve the same result as the '056 patent's claimed system for "backfilling" data gaps by retrieving and processing previously unprocessed data?