DCT

1:21-cv-00977

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: 1:21-cv-00977, D. Del., 10/04/2021
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 continuous glucose monitoring (CGM) technology, including systems for handling data gaps and methods for implanting and mounting on-skin medical devices.
Technical Context: The technology at issue is continuous glucose monitoring, a critical tool for diabetes management that provides real-time glucose readings without the need for routine fingersticks.
Key Procedural History: The complaint notes that U.S. Patent No. 10,952,653 is a continuation of U.S. Patent No. 10,820,842, indicating a shared technical disclosure which may streamline aspects of claim construction and validity analysis for those patents.

Case Timeline

Date	Event
2009-04-29	Priority Date for ’842 and ’653 Patents
2009-07-23	Priority Date for ’954, ’647, and ’443 Patents
2010-03-24	Priority Date for ’341, ’649, ’654, ’216, and ’440 Patents
2010-06-29	Priority Date for ’338 and ’644 Patents
2014-01-01	Abbott launches FreeStyle Libre in Europe
2017-01-01	Abbott launches FreeStyle Libre in the United States
2018-01-01	Abbott launches FreeStyle Libre 2 in Europe
2018-01-01	Dexcom launches G6 continuous glucose monitoring product
2020-01-01	Dexcom launches G6 Pro product
2020-01-01	Abbott launches FreeStyle Libre 2 in the United States
2020-01-01	Abbott launches FreeStyle Libre 3 in Europe
2020-11-03	’842 Patent Issued
2020-11-10	’954 Patent Issued
2020-12-29	’338 Patent Issued
2021-01-05	’341 Patent Issued
2021-03-16	’647 Patent Issued
2021-03-16	’649 Patent Issued
2021-03-23	’653 Patent Issued
2021-03-30	’654 Patent Issued
2021-04-06	’644 Patent Issued
2021-04-13	’443 Patent Issued
2021-05-11	’216 Patent Issued
2021-05-25	’440 Patent Issued
2021-10-04	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 addresses the problem of data gaps in continuous glucose monitoring (CGM) systems that occur when a "failure mode condition" arises, such as an inability to calibrate the sensor (Compl. ¶¶66-67). These gaps deprive patients of a complete and accurate record of their glucose levels, which is critical for managing diabetes (Compl. ¶65; ’842 Patent, col. 11:6-8).
The Patented Solution: The invention solves this problem by storing the raw, unprocessed sensor data during the failure period. After the failure is corrected (e.g., through a successful calibration), the system retrieves the stored raw data and processes it using the new, valid calibration parameters. This allows the system to "backfill" the data gap, creating a more continuous and complete glucose history for the user (Compl. ¶69; ’842 Patent, col. 12:47-61). Figure 7B of the patent, reproduced in the complaint, illustrates a glucose graph with a previously empty period filled in (Compl. p. 20).
Technical Importance: This technology improves the safety and functionality of CGM systems by recovering data that would otherwise be lost, providing users and healthcare providers with more robust information for making therapy and health management decisions (Compl. ¶¶69, 79).

Key Claims at a Glance

The complaint asserts at least claim 14 and also discusses dependent claims 2, 3, 4, 7, 13, 15, 16, and 22 (Compl. ¶¶75-77, 80-81).
Independent Claim 14 requires:
- an analyte sensor;
- one or more processors; and
- a memory device storing instructions that, when executed, cause the processor(s) to:
  - detect a failure mode condition that causes sensor data gaps to be outputted to a display;
  - store sensor data received from the sensor during the time period of the failure mode condition;
  - process that stored sensor data; and
  - in response to a correction of the failure mode condition, output the processed stored data to the display so the 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 background describes conventional "finger stick" glucose tests as inconvenient and painful, leading to poor patient compliance, while existing continuous monitoring systems also presented challenges ('954 Patent, col. 1:15-col. 2:68). The invention aims to provide a less invasive and more comfortable continuous monitoring system to improve usability ('954 Patent, col. 3:10-17).
The Patented Solution: The patent describes a low-profile, skin-mounted analyte monitoring system featuring a small, partially implantable sensor. A key aspect of the solution is a "double-sided" sensor design, where electrodes are placed on both sides of the sensor's substrate, which reduces the required surface area and allows for a smaller, less invasive implantable portion ('954 Patent, Abstract; col. 3:41-59). The system also claims a method of using a pre-programmed "drift profile" to correct for changes in sensor sensitivity over time, potentially reducing the need for user-initiated calibrations ('954 Patent, col. 4:5-10).
Technical Importance: The smaller, less invasive sensor design is intended to reduce the likelihood of bleeding and thrombus formation upon implantation, which can improve sensor accuracy, reduce pain, and increase patient comfort ('954 Patent, col. 3:25-34).

Key Claims at a Glance

The complaint asserts at least claim 1 (Compl. ¶85).
Independent Claim 1 requires:
- a memory;
- a base unit for mounting on a skin surface;
- an analyte sensor with a proximal portion for positioning within the base unit and a distal portion for insertion through the skin;
- a conductive member within the base unit for electrical contact with the sensor;
- the system is configured to determine the analyte level using at least a "drift correction factor" associated with the sensor, which is determined by an algorithm using a "drift profile"; and
- the "drift profile" is programmed into the memory prior to insertion of the sensor's distal portion through the skin.

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 a mounting unit for an on-skin medical device. The mounting unit includes a feature, such as a breakable or bendable portion, that allows a user to more easily release the medical device from the mount after its period of use.
Asserted Claims: At least claim 23 (Compl. ¶89).
Accused Features: The complaint alleges that the Dexcom G6 system infringes, but does not specify which features of the G6 mounting or applicator system are accused of infringing this patent, instead referencing a claim chart in Exhibit O that is not provided with the complaint (Compl. ¶89).

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 a medical device inserter for implanting a sensor. The technology involves mechanical assemblies, such as those using springs and rotatable members, to automate the process of inserting a sensor into the skin and subsequently retracting the insertion needle.
Asserted Claims: At least claim 1 (Compl. ¶93).
Accused Features: The complaint alleges that the Dexcom G6 system infringes, but does not specify which features of the G6 applicator are accused of infringing this patent, instead referencing a claim chart in Exhibit P that is not provided with the complaint (Compl. ¶93).

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 focuses on the configuration of a transmitter unit for an analyte sensor. It describes features for aligning and retaining the sensor to ensure a reliable electrical connection with the transmitter, including the use of contact pins with metal components to improve conductivity.
Asserted Claims: At least claim 1 (Compl. ¶97).
Accused Features: The complaint alleges that the Dexcom G6 system infringes, but does not specify which features of the G6 transmitter are accused of infringing this patent, instead referencing a claim chart in Exhibit Q that is not provided with the complaint (Compl. ¶97).

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, like the '341 patent, describes a medical device inserter. The technology involves mechanical assemblies for automating the process of inserting a sensor into the skin and retracting the needle.
Asserted Claims: At least claim 1 (Compl. ¶101).
Accused Features: The complaint alleges that the Dexcom G6 system infringes, but does not specify which features of the G6 applicator are accused of infringing this patent, instead referencing a claim chart in Exhibit R that is not provided with the complaint (Compl. ¶101).

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

Issued: March 23, 2021.
Technology Synopsis: As a continuation of the '842 patent, this patent also describes technology for addressing data gaps in CGM systems. It claims a system where an on-body unit stores sensor data during a failure mode condition and wirelessly transmits it to a receiver unit after the condition is corrected, allowing the data gap to be filled.
Asserted Claims: At least claim 1 (Compl. ¶108).
Accused Features: The complaint alleges the Dexcom G6's backfilling technology infringes, referencing a claim chart in Exhibit S that is not provided (Compl. ¶108).

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, similar to others in the suit, describes a medical device inserter with mechanisms for automated sensor insertion and needle retraction.
Asserted Claims: At least claim 1 (Compl. ¶112).
Accused Features: The complaint alleges that the Dexcom G6 system infringes, but does not specify which features of the G6 applicator are accused of infringing this patent, instead referencing a claim chart in Exhibit T that is not provided with the complaint (Compl. ¶112).

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, similar to the '338 patent, describes a mounting unit for an on-body medical device that includes a breakable or bendable portion to facilitate release of the medical device from the mount.
Asserted Claims: At least claim 1 (Compl. ¶116).
Accused Features: The complaint alleges that the Dexcom G6 system infringes, but does not specify which features of the G6 mounting system are accused of infringing this patent, instead referencing a claim chart in Exhibit U that is not provided with the complaint (Compl. ¶116).

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

Issued: April 13, 2021.
Technology Synopsis: This patent describes an assembly for inserting a sensor, focusing on the mechanical components of the inserter that facilitate the subcutaneous implantation of the sensor.
Asserted Claims: At least claim 13 (Compl. ¶120).
Accused Features: The complaint alleges that the Dexcom G6 system infringes, but does not specify which features of the G6 applicator are accused of infringing this patent, instead referencing a claim chart in Exhibit V that is not provided with the complaint (Compl. ¶120).

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, similar to others in the suit, describes a medical device inserter with automated mechanisms for sensor insertion and needle retraction.
Asserted Claims: At least claim 1 (Compl. ¶124).
Accused Features: The complaint alleges that the Dexcom G6 system infringes, but does not specify which features of the G6 applicator are accused of infringing this patent, instead referencing a claim chart in Exhibit W that is not provided with the complaint (Compl. ¶124).

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 also describes a medical device inserter with automated mechanisms for sensor insertion and needle retraction.
Asserted Claims: At least claim 1 (Compl. ¶128).
Accused Features: The complaint alleges that the Dexcom G6 system infringes, but does not specify which features of the G6 applicator are accused of infringing this patent, instead referencing a claim chart in Exhibit X that is not provided with the complaint (Compl. ¶128).

III. The Accused Instrumentality

Product Identification

Dexcom’s G6 and G6 Pro continuous glucose monitoring (CGM) systems (collectively, "G6") (Compl. ¶29).

Functionality and Market Context

The G6 system is comprised of three primary components: an applicator with a built-in sensor, a transmitter, and a display device, which can be a dedicated receiver or a smart device running the G6 App (Compl. ¶30). An image from the G6 User Guide shows these components and their functions (Compl. ¶30, p. 12). The applicator is a single-use device that inserts a portion of the sensor under the user's skin and attaches a transmitter holder via an adhesive patch (Compl. ¶31). An illustration from the G6 User Guide depicts this single-step application process (Compl. ¶31, p. 13).
The complaint alleges that the G6 system incorporates several of Abbott's patented technologies that represent a "substantial departure" from Dexcom's prior G5 product (Compl. ¶29). Key accused functionalities include the adoption of factory calibration, which eliminates the need for user-initiated fingerstick calibrations, and the use of drift correction to allow for a longer sensor wear period of 10 days (Compl. ¶33). The complaint also highlights the G6's "Simple auto-applicator" as an allegedly infringing feature (Compl. ¶34).

IV. Analysis of Infringement Allegations

The complaint references infringement claim charts in Exhibits M through X for each of the twelve asserted patents, but these exhibits were not filed with the First Amended Complaint.

’842 Patent Infringement Allegations: The complaint provides a detailed narrative infringement theory for at least claim 14 of the ’842 patent, which is directed to "backfilling" technology (Compl. ¶¶61-81). The complaint alleges that prior CGM systems, including Dexcom's own earlier products, suffered from "data gaps" when errors such as calibration failures occurred (Compl. ¶¶67-68). It alleges the ’842 Patent solved this problem by storing raw sensor data during the error and retrospectively processing it to fill the gap once the system recovered (Compl. ¶69). The complaint alleges that Dexcom incorporated this patented "backfilling" technology into its G6 product, thereby infringing at least claim 14 (Compl. ¶81).
’954 Patent Infringement Allegations: The complaint alleges that the Dexcom G6 meets every limitation of at least claim 1 of the ’954 patent (Compl. ¶85). It references a claim chart in Exhibit N, which is not provided, but does not offer a detailed narrative infringement theory for this patent in the body of the complaint.

V. Key Claim Terms for Construction

The Term: "failure mode condition" (’842 Patent, Claim 14)
Context and Importance: The scope of this term is central to the infringement analysis for the ’842 patent. The infringement question may turn on whether routine, transient data interruptions in the G6 system (e.g., temporary signal loss) qualify as a "failure mode condition," or if the term is limited to more significant system errors like a failed calibration.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent specification provides a non-exhaustive list of examples, including "an inability to promptly calibrate the sensor, system malfunction, sensor dislodging, signal errors associated with the sensor, transmitter unit, receiver unit, and the like" ('842 Patent, col. 13:19-27). The open-ended phrase "and the like" may support a construction that encompasses a wide range of events causing data gaps.
- Evidence for a Narrower Interpretation: The detailed description of the invention and the provided figures (e.g., FIG. 7A) heavily emphasize "a failed calibration event" as the primary problem being solved ('842 Patent, col. 11:6-8; col. 12:32-34). A party may argue the term should be construed in light of these more specific examples, rather than covering any transient data loss.
The Term: "drift profile programmed into the memory... prior to insertion" (’954 Patent, Claim 1)
Context and Importance: The temporal element of this term is critical. Infringement of claim 1 of the ’954 patent may depend on whether the G6 system's "drift correction" (Compl. ¶33) relies on a predetermined profile that is loaded into the system's memory before the sensor is implanted in the user, as the claim language requires.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The complaint's allegation that the G6 uses "factory calibration" may suggest that sensor performance characteristics, including drift, are determined and programmed at the time of manufacture, which is "prior to insertion" (Compl. ¶33). The patent specification discusses using "pre-set or pre-programmed" data ('954 Patent, col. 4:9-10).
- Evidence for a Narrower Interpretation: The claim requires the "drift profile" itself to be programmed prior to insertion. If the accused G6 system instead uses a generic algorithm that dynamically calculates and applies drift correction based on data gathered after the sensor is inserted, a party could argue that this does not meet the claim's specific temporal limitation.

VI. Other Allegations

Indirect Infringement: The complaint does not include separate counts for induced or contributory infringement.
Willful Infringement: The complaint does not explicitly use the word "willful." However, it alleges that Dexcom is "deliberately using Abbott's patented technology" and that the G6 represents a "substantial departure" from Dexcom's prior products, which could form the basis for a later claim of willfulness (Compl. ¶¶29, 35). The prayer for relief also requests a finding that the case is "exceptional under 35 U.S.C. § 285," which is often associated with findings of willful infringement or litigation misconduct (Compl. p. 34, ¶e).

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

A central issue will be one of technical operation: Does the Dexcom G6's method for handling temporary data unavailability function in the same way as the "backfilling" of data from a "failure mode condition" as claimed by the ’842 patent, or is there a fundamental operational difference?
The case will also turn on a key claim construction dispute: Can the term "drift profile programmed into the memory... prior to insertion" from the ’954 patent be construed to cover a system that may use factory-set parameters to dynamically calculate drift correction after sensor insertion?
A third core issue will be one of infringement across a large patent set: Given the assertion of ten additional patents related to mechanical aspects of CGM applicators and mounts without detailed allegations in the complaint body, a significant question will be how Plaintiff intends to prove infringement of these claims and whether the accused G6 applicator and mounting mechanisms practice the specific configurations claimed in each of those patents.