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 alleged to be proper in the District of Delaware because Defendant DexCom, Inc. is a Delaware corporation and therefore resides in the district.
• Core Dispute: Plaintiff alleges that Defendant’s G7 continuous glucose monitoring (CGM) system infringes four U.S. patents related to integrated sensor/transmitter units, device applicators, and data processing methods for CGM systems.
• Technical Context: The technology involves continuous glucose monitoring systems, which provide real-time glucose readings for diabetes management, largely replacing traditional, painful fingerstick blood tests.
• Key Procedural History: The complaint notes that a prior covenant-not-to-sue agreement between the parties expired in March 2021. Plaintiff subsequently filed suit against Defendant’s previous-generation G6 product in July 2021, asserting one of the same patents-in-suit as the present case (the ’954 patent). These allegations may be relevant to Plaintiff's claims of pre-suit knowledge and willful infringement.

Case Timeline

Date	Event
2009-02-03	U.S. Patent No. 11,202,591 Priority Date
2009-04-29	U.S. Patent No. 11,298,056 Priority Date
2009-07-23	U.S. Patent No. 10,827,954 Priority Date
2010-02-01	U.S. Patent No. 11,266,335 Priority Date
2014-01-01	Abbott FreeStyle Libre launched
2018-01-01	DexCom G6 launched
2018-01-01	Abbott FreeStyle Libre 2 launched
2020-01-01	Abbott FreeStyle Libre 3 launched
2020-11-10	U.S. Patent No. 10,827,954 Issued
2021-03-31	Covenant-not-to-sue agreement between Abbott and DexCom expired
2021-07-01	Abbott filed G6 Action against DexCom
2021-12-21	U.S. Patent No. 11,202,591 Issued
2022-03-01	DexCom G7 received CE mark approval in Europe
2022-03-08	U.S. Patent No. 11,266,335 Issued
2022-04-12	U.S. Patent No. 11,298,056 Issued
2022-04-28	DexCom G7 limited launch initiated in Europe
2023-02-17	DexCom G7 began selling in the United States (on or before this date)
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

The Invention Explained

• Problem Addressed: The patent's background section describes the inconvenience of traditional "finger stick" glucose tests and notes that early implantable continuous monitors suffered from transient, low sensor readings, a phenomenon referred to as "early signal attenuation" (ESA) or "night time drop outs" that could lead to clinically significant errors (ʼ954 Patent, col. 3:1-17).
• The Patented Solution: The invention claims to address these issues through systems that feature factory-based calibration, eliminating the need for frequent and inconvenient user calibrations via finger sticks. This is achieved by programming the system with a predictable "drift profile" that allows the device to apply a correction factor to sensor readings over time, maintaining accuracy throughout the sensor's wear life (ʼ954 Patent, col. 5:19-30). The system comprises a sensor, a data processing unit, and a receiver unit (ʼ954 Patent, FIG. 1).
• Technical Importance: The development of reliable, factory-calibrated CGM systems that do not require user fingerstick calibration was a significant step in making the technology more convenient and accessible for a broad population of people with diabetes (Compl. ¶6).

Key Claims at a Glance

• The complaint asserts at least independent claim 1 (Compl. ¶83).
• The essential elements of independent claim 1 include:
  • A glucose monitoring system configured to determine an analyte level using a drift correction factor associated with the analyte sensor.
  • The drift correction factor is determined by an algorithm using a drift profile.
  • The drift profile is programmed into the memory of the system prior to insertion of the sensor.
• The complaint does not explicitly reserve the right to assert dependent claims for this patent.

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

The Invention Explained

• Problem Addressed: The patent's background section identifies a need for an "easy-to-use, simple, insertion assembly which is reliable, minimizes pain, and is easy to use" for self-implanting continuous glucose sensors (ʼ591 Patent, col. 2:6-10).
• The Patented Solution: The invention describes an apparatus and system for inserting an analyte sensor. The system includes an "on-body unit" comprising a housing, a glucose sensor, and sensor electronics, which is delivered by an "inserter" (ʼ591 Patent, Claim 1). The inserter includes a sharp that pierces the skin, and the system is configured to advance the on-body unit from a first position to a second position where the housing is secured to the skin. The inserter then automatically retracts the sharp, leaving a portion of the sensor in place (ʼ591 Patent, Claim 1).
• Technical Importance: This technology simplifies the sensor application process, which previously could be complex and intimidating, into a more streamlined, automated action, thereby improving the user experience and reducing barriers to adoption (Compl. ¶7).

Key Claims at a Glance

• The complaint asserts at least independent claim 1 (Compl. ¶95).
• The essential elements of independent claim 1, which claims an insertion assembly, include:
  • An on-body unit containing a housing, a glucose sensor, and sensor electronics.
  • An inserter with a sharp, where the on-body unit is disposed within the inserter.
  • The inserter is configured to advance the on-body unit and sharp from a first to a second position to pierce the skin and secure the housing.
  • The inserter is further configured to automatically retract the sharp, leaving a part of the sensor in the skin.
• The complaint does not explicitly reserve the right to assert dependent claims for this patent.

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• Multi-Patent Capsule: U.S. Patent No. 11,266,335

  • Patent Identification: U.S. Patent No. 11,266,335, Medical Device Inserters and Processes of Inserting and Using Medical Devices, issued March 8, 2022.
  • Technology Synopsis: This patent relates to medical device inserters designed for simple, one-step application. It addresses the need for user-friendly applicators by describing a device with a handle and a sharp that automatically retracts after deploying a sensor onto the skin, enhancing both safety and ease of use.
  • Asserted Claims: At least claim 1 (Compl. ¶106).
  • Accused Features: The G7's integrated, single-use applicator, which deploys the all-in-one sensor and transmitter unit onto the user's body in a single action (Compl. ¶¶68-70).

• Multi-Patent Capsule: U.S. Patent No. 11,298,056

  • Patent Identification: U.S. Patent No. 11,298,056, Methods and Systems for Early Signal Attenuation Detection and Processing, issued April 12, 2022.
  • Technology Synopsis: The patent addresses the problem of data gaps in CGM readings caused by events like failed calibrations or signal loss. The patented solution is a system that stores sensor data during such an "adverse condition" and then processes the stored data after the condition is corrected to "backfill" the gap in the user's glucose history, providing a more complete and accurate record.
  • Asserted Claims: At least claim 1 (Compl. ¶141).
  • Accused Features: The DexCom G7 system's alleged "Quality of Service" feature, which the complaint states assures users that if the connection is lost, missed data packets from up to 24 hours will be transmitted upon reconnection, thereby backfilling data gaps (Compl. ¶139).

III. The Accused Instrumentality

• Product Identification: The DexCom G7 continuous glucose monitoring (CGM) system (Compl. ¶1).
• Functionality and Market Context: The complaint describes the DexCom G7 as a "streamlined all-in-one sensor with built in disposable transmitter" that is "60% smaller" than its predecessor (Compl. ¶¶23, 26). A central feature is its application via a new, single-use inserter that deploys the integrated sensor and transmitter unit in one step, a process the complaint alleges was copied from Abbott's technology (Compl. ¶¶24, 69). An image in the complaint from a DexCom G7 guide depicts this one-step application process, instructing the user to "Press and hold applicator firmly against skin and then push button" (Compl. p. 30). The G7 system is also promoted as not requiring fingerstick calibration, another key feature allegedly copied from Abbott (Compl. ¶63). The complaint positions the G7 as DexCom's direct competitor to Abbott's FreeStyle Libre systems, alleging it incorporates Abbott's innovations to better compete (Compl. ¶54).

IV. Analysis of Infringement Allegations

The complaint references claim chart exhibits (Exhibits E-H) that were not provided with the complaint document. The infringement allegations are therefore summarized below in prose based on the complaint's narrative.

• U.S. Patent No. 10,827,954 Infringement Narrative:
  The complaint alleges that the DexCom G7 system infringes the ’954 patent by implementing a factory-calibrated system that provides accurate glucose measurements throughout its wear life without requiring user calibration via fingersticks (Compl. ¶¶55, 63). This theory is based on the G7 continuing an allegedly infringing feature from DexCom's prior G6 product, which was the subject of an earlier lawsuit by Abbott involving the ’954 patent (Compl. ¶62). The core of the alleged infringement is the G7's ability to correct for sensor drift over time without user input, which Plaintiff contends practices the claimed invention of using a pre-programmed "drift profile."

• U.S. Patent No. 11,202,591 Infringement Narrative:
  The complaint alleges that the DexCom G7's "all-in-one on-body unit with an integrated sensor and electronics" and its associated single-step applicator infringe the ’591 patent (Compl. ¶24). The complaint repeatedly draws parallels between the G7's design and Abbott's FreeStyle Libre systems, which embody the patented technology (Compl. ¶¶74-75). The complaint includes a visual timeline suggesting DexCom's applicator designs have converged over time toward Abbott's designs (Compl. p. 2). The infringement theory focuses on the G7's mechanical structure, which combines the sensor and transmitter into a single disposable unit deployed by a simple inserter, allegedly mapping onto the elements of the asserted claims.

• Identified Points of Contention:

  • Scope Questions: For the ’954 patent, a key question will be whether DexCom's method for achieving a no-calibration system falls within the scope of the term "drift profile programmed into the memory." The dispute may center on whether DexCom's specific algorithms for managing sensor sensitivity over time are equivalent to the claimed "drift profile."
  • Technical Questions: For the ’591 patent, the analysis will likely focus on a structural comparison. A central question for the court will be whether the specific mechanical components of the G7 inserter and the integrated on-body unit it deploys contain every structural element recited in the asserted apparatus claims, or if there are material differences in their construction and operation.

V. Key Claim Terms for Construction

• The Term: "drift profile" (from Claim 1 of the ’954 Patent)

• Context and Importance: This term is central to the ’954 patent's invention of a factory-calibrated CGM. The construction of "drift profile" will likely determine whether DexCom's method of compensating for changes in sensor sensitivity over time infringes. Practitioners may focus on this term because its definition could encompass a wide range of algorithmic solutions or be limited to more specific implementations.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The patent describes the invention as providing "a predictable sensitivity drift" and using a "drift profile to apply a correction factor" (ʼ954 Patent, col. 5:22-29). This language could support a construction covering any pre-programmed method that algorithmically corrects for known sensor sensitivity changes over the life of the sensor.
  • Evidence for a Narrower Interpretation: The specification may describe particular methods for determining or applying the drift profile. A defendant may argue that the term should be construed more narrowly to be limited to the specific methodologies or mathematical models disclosed in the patent's embodiments.

• The Term: "an inserter" and its relationship with the "on-body unit" (from Claim 1 of the ’591 Patent)

• Context and Importance: Claim 1 of the ’591 patent is an apparatus claim reciting a specific combination of components: an "on-body unit" (housing, sensor, electronics) and an "inserter" (with a sharp) that deploys it. The infringement analysis will depend on whether the DexCom G7's single, disposable applicator-and-sensor device can be mapped onto this claimed two-part "inserter" and "on-body unit" structure.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The patent describes the general goal of a simple insertion assembly ('591 Patent, col. 2:6-10). This purpose could support a construction where the claimed terms read on various integrated or multi-part applicator designs that achieve that goal.
  • Evidence for a Narrower Interpretation: The detailed description and figures (e.g., ’591 Patent, FIG. 10, FIG. 23) depict specific, distinct components for the inserter and the on-body unit. A defendant may argue these depictions limit the claim terms to an assembly where the inserter and on-body unit are more clearly separable components than in the accused all-in-one G7 device.

VI. Other Allegations

• Indirect Infringement: The complaint alleges both induced and contributory infringement for all asserted patents. It alleges that DexCom provides materials, such as user guides and instructions, that instruct customers on how to use the G7 system in an infringing manner (Compl. ¶¶86, 98, 108, 143).
• Willful Infringement: The complaint alleges that DexCom's infringement is willful and deliberate. This allegation is primarily based on DexCom's alleged pre-suit knowledge of the ’954 patent from the prior G6 Action filed in July 2021, which concerned a similar product (Compl. ¶50). It is also based on allegations that DexCom attempted to extend a prior covenant-not-to-sue, which allegedly demonstrates knowledge of Abbott's patent portfolio (Compl. ¶21).

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

• A core issue will be one of technological convergence versus copying: The complaint frames DexCom's product evolution as deliberate imitation of Abbott's successful FreeStyle Libre features. The court will need to examine whether the accused G7 system represents independent development toward a similar technical solution or constitutes infringement of Abbott's patented methods for no-calibration CGMs ('954 patent) and integrated, single-step applicators ('591 and '335 patents).
• A key evidentiary question will be one of functional and structural mapping: Does the G7's software-based method for maintaining accuracy without user calibration operate in a manner that falls within the scope of the claimed "drift profile" ('954 patent)? Similarly, do the mechanical components of the G7's all-in-one applicator and sensor unit contain each structural element recited in the apparatus claims of the '591 and '335 patents?
• A central dispute will likely concern data processing equivalence: Can the '056 patent's claims for "backfilling" data gaps by processing stored, unprocessed sensor data be read to cover the G7's described feature of re-transmitting "missed packets" of already-processed data upon reconnection, or is there a fundamental mismatch in technical operation?