DCT

1:22-cv-00605

Dexcom Inc v. Abbott Diabetes Care Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:21-cv-01699, D. Del., 12/22/2022
  • Venue Allegations: Venue is asserted based on a mandatory forum selection clause in a 2014 Settlement and License Agreement between the parties, which allegedly grants exclusive jurisdiction to the U.S. District Court for the District of Delaware for any related disputes. Venue is also asserted on the basis that Defendant is incorporated in Delaware.
  • Core Dispute: Plaintiff seeks a declaratory judgment that it does not infringe Defendant's patents covering continuous glucose monitoring (CGM) technology because those patents are licensed under a 2014 settlement agreement, and alleges Defendant breached that agreement by filing infringement suits in other jurisdictions.
  • Technical Context: The dispute is centered on continuous glucose monitoring (CGM) technology, a significant and highly competitive market segment for diabetes management devices.
  • Key Procedural History: The complaint alleges that the parties have a long history of litigation that was resolved by a July 2014 Settlement and License Agreement (SLA). The present action was initiated after Defendant filed patent infringement lawsuits against Plaintiff on June 30, 2021, in the Western District of Texas and in Europe. Plaintiff alleges these lawsuits violate the license grant, mandatory dispute resolution procedures, and exclusive forum selection clause of the 2014 SLA.

Case Timeline

Date Event
2005-03-10 Earliest Priority Date for U.S. Patent No. 10,993,642
2005-04-15 Earliest Priority Date for U.S. Patent Nos. 10,980,452; 10,702,215; 10,702,193
2005-08 Initial patent litigation between Abbott and DexCom began
2014-07 Parties entered into the Settlement and License Agreement (SLA)
2020-07-07 U.S. Patent No. 10,702,193 Issued
2020-07-07 U.S. Patent No. 10,702,215 Issued
2021-04-20 U.S. Patent No. 10,980,452 Issued
2021-05-04 U.S. Patent No. 10,993,642 Issued
2021-06-30 DexCom filed patent infringement suit against Abbott in W.D. Texas
2021-09-20 Abbott sent notice letter to DexCom alleging breach of the SLA
2022-12-22 Amended Complaint filed in D. Delaware

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

This analysis focuses on the patents asserted by DexCom against Abbott that are the subject of the license dispute.

U.S. Patent No. 10,980,452 - "Analyte Sensor"

  • Issued: April 20, 2021

The Invention Explained

  • Problem Addressed: The patent's background describes the challenge of maintaining a reliable, moisture-proof electrical connection between the portion of a transcutaneous analyte sensor that is implanted in a host (the in vivo portion) and the external electronics (the ex vivo portion) (U.S. Patent No. 10,980,452, col. 1:49-59).
  • The Patented Solution: The invention provides a sensor system that includes a sealing member designed to secure the electrical contact between the sensor and the electronics unit. This sealing member is constructed from materials with specific hardness properties (durometer) to create a robust seal that resists moisture ingress and maintains electrical integrity, even with patient movement ('452 Patent, Abstract; col. 2:56-62).
  • Technical Importance: For wearable medical devices like CGMs, a stable and environmentally sealed connection between the sensor and its electronics is critical for ensuring accurate data transmission and long-term operational reliability.

Key Claims at a Glance

  • The complaint does not specify which claims are asserted in the related litigation. Independent claim 1 is representative of the patented system.
  • Essential elements of independent claim 1 include:
    • A transcutaneous glucose sensor comprising an in vivo and an ex vivo portion.
    • Sensor electronics configured to connect to the sensor.
    • An electrical contact for connecting the sensor electronics and the sensor.
    • A sealing member comprising at least a first material with a first durometer hardness and a second material with a second durometer hardness.
  • The complaint does not reserve the right to assert dependent claims.

U.S. Patent No. 10,702,215 - "Systems and methods for dynamically and intelligently monitoring a host's glycemic condition after an alert is triggered"

  • Issued: July 7, 2020

The Invention Explained

  • Problem Addressed: Continuous glucose monitors can produce frequent alarms for high or low glucose levels. This can lead to "alarm fatigue," where a user becomes desensitized and may ignore critical alerts, particularly if their glucose level hovers near a threshold, causing repeated nuisance alarms (U.S. Patent No. 10,702,215, col. 1:63-2:12).
  • The Patented Solution: The patent discloses a system that intelligently manages alerts after an initial trigger. It defines operational "states" such as "active," "acknowledged," and "inactive." The system transitions between these states based on criteria beyond a simple threshold crossing, such as the user acknowledging an alert or sensor data indicating a trend toward a safe glucose range. This logic is designed to suppress redundant alarms while re-alerting the user if their condition genuinely worsens ('215 Patent, Abstract; Fig. 11).
  • Technical Importance: This technology aims to improve the usability and safety of CGM systems by making alerts more clinically relevant, reducing the burden of nuisance alarms and thereby potentially increasing patient compliance.

Key Claims at a Glance

  • The complaint does not specify which claims are asserted in the related litigation. Independent claim 1 is representative of the patented method.
  • Essential elements of independent claim 1 include:
    • Evaluating sensor data using a first function to determine if a real-time glucose value meets one or more user-settable first criteria.
    • Evaluating sensor data using a second function to determine if a predicted glucose value meets one or more non-user-settable second criteria.
    • Activating a hypoglycemic indicator if either the first or second criteria are met.
    • Providing an output based on the activated indicator.
  • The complaint does not reserve the right to assert dependent claims.

III. The Accused Instrumentality

Product Identification

The products accused by DexCom in the underlying litigations are identified as Abbott’s FreeStyle Libre line of continuous glucose monitors and associated products and accessories (“FSL Products”) (Compl. ¶16, ¶44).

Functionality and Market Context

The complaint describes the FSL Products as continuous glucose monitors but does not provide further technical detail on their specific functionality or market position (Compl. ¶16).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint does not allege infringement but instead seeks a declaratory judgment of non-infringement based on a license defense. Abbott alleges that the patents DexCom asserted against it in the Western District of Texas are licensed under the terms of the parties' 2014 SLA (Compl. ¶36). The complaint references claim chart exhibits, which were not provided, that purport to show how the asserted patent claims meet the SLA’s definition of a licensed patent (Compl. ¶¶ 39-43).

Abbott’s central theory is that the asserted patents, while filed after 2005, are licensed because they claim priority to pre-2005 patent applications covered by the SLA (Compl. ¶28, ¶37). The SLA is alleged to define “DexCom Licensed Patents” in three categories under Paragraph A.13, subsections (a), (b), and (c) (Compl. ¶28). The complaint alleges that the asserted patents fall into categories (b) and/or (c) based on their prosecution history and relationship to earlier patents and provisional applications (Compl. ¶¶ 39-43). The specific technical and legal basis for these contentions is heavily redacted in the public version of the complaint (Compl. ¶¶ 39-43).

  • Identified Points of Contention:
    • Scope Questions: The primary dispute is one of contract interpretation: do the asserted claims of the W.D. Tex. Asserted Patents fall within the definition of a "DexCom Licensed Patent" as defined by Paragraph A.13 of the SLA?
    • Technical Questions: A key factual question for the court will be whether the asserted patents, as a technical matter, satisfy the specific priority and subject matter criteria laid out in Subsections A.13(b) and (c) of the SLA. This analysis may require a detailed review of the patents’ prosecution histories and the technical disclosures of their parent and provisional applications.

V. Key Claim Terms for Construction

The central dispute revolves around the interpretation of terms within the 2014 SLA, not the patent claims themselves. The construction of these contractual terms will likely determine whether the asserted patents are licensed.

  • The Term: "claim, priority (in whole or in part) to any of the Pre-2005 Patents and Applications" (from SLA Paragraph A.13(b)) (Compl. ¶28).

    • Context and Importance: This term defines a key category of licensed patents. Its interpretation is critical because the asserted patents were filed after 2005 and are only alleged to be licensed through their priority relationship to older, pre-2005 applications (Compl. ¶37). Practitioners may focus on this term because it directly addresses whether the license grant extends to later-issued patents in a continuing patent family.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The plain language "in whole or in part" cited in the complaint could support an expansive reading, suggesting that any valid link in the priority chain is sufficient to bring a later patent under the license (Compl. ¶28).
      • Evidence for a Narrower Interpretation: The complaint does not articulate a potential basis for a narrower interpretation of this term. A narrower interpretation could, for example, require that the specific asserted claims, not just the patent generally, trace their subject matter directly to a pre-2005 application without the introduction of new matter.

  • The Term: The conditions of SLA Paragraph A.13(c) (Compl. ¶28).

    • Context and Importance: This paragraph is alleged to define another category of licensed patents that are central to the dispute (Compl. ¶38).
    • Intrinsic Evidence for Interpretation: The specific requirements of this subsection are heavily redacted in the public version of the complaint, which precludes a detailed analysis of its potential interpretation (Compl. ¶10, ¶28).

VI. Other Allegations

  • Breach of Contract: Abbott alleges DexCom materially breached the SLA in several ways:
    • Breach of License Grant: By suing Abbott for infringement of patents that are allegedly licensed (Compl. ¶47, ¶80(2)).
    • Breach of Forum Selection Clause: By filing suit in the Western District of Texas and in Europe when the SLA allegedly mandates that all disputes be heard exclusively in the District of Delaware (Compl. ¶48, ¶80(3)).
    • Breach of Dispute Resolution Clause: By initiating litigation without first engaging in the mandatory dispute resolution process outlined in the SLA, despite Abbott's alleged attempts to trigger that process (Compl. ¶48, ¶¶ 61-76, ¶80(4)-(5)).
  • Breach of Implied Covenant of Good Faith and Fair Dealing: Abbott alleges that even if DexCom's actions did not breach the express terms of the SLA, suing Abbott's affiliates on the asserted patents frustrates the purpose of the worldwide license grant and thus violates the implied covenant of good faith and fair dealing inherent in the agreement (Compl. ¶¶ 92-98).

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

  • A central issue will be one of contractual scope: can the definition of "DexCom Licensed Patents" in the 2014 SLA, which focuses on patents filed before January 1, 2005, or claiming priority thereto, be construed to cover the asserted patents, which issued after 2020? The outcome will likely depend on a detailed analysis of the patents' prosecution histories juxtaposed with the specific contractual language governing priority claims.
  • A key procedural question will be one of enforceability: did DexCom's filing of infringement lawsuits in Texas and Europe constitute a breach of the SLA’s mandatory dispute resolution and forum selection clauses? The court's decision on this point could impact the viability of the parallel litigations.