DCT

4:22-cv-03062

Well Cell Global LLC v. Calvit

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 4:22-cv-03062, S.D. Tex., 10/27/2022
  • Venue Allegations: Plaintiff alleges venue is proper in the Southern District of Texas because a substantial part of the events giving rise to the claims occurred there, and because certain defendants signed licensing agreements expressly consenting to venue in the district.
  • Core Dispute: Plaintiff alleges that Defendants’ "Insulinic" clinics infringe patents related to individualized diabetes treatment methods and kits, following the termination of a prior licensing relationship between the parties.
  • Technical Context: The technology concerns systems and methods for improving insulin sensitivity and managing diabetes through intravenous, pulsatile insulin administration based on personalized patient data.
  • Key Procedural History: The complaint alleges that certain Defendants were former licensees of the patents-in-suit. Plaintiff alleges that after it terminated the license agreements due to alleged breaches, Defendants continued to use the patented technology, forming the basis for allegations of knowing and willful infringement.

Case Timeline

Date Event
2015-02-17 Earliest Priority Date for ’595 and ’990 Patents
2017-05-16 U.S. Patent No. 9,652,595 Issued
2020-01-14 U.S. Patent No. 10,533,990 Issued
2020-07-24 Plaintiff Well Cell acquires rights to the patents-in-suit
2021-09-13 License Agreement issued to Defendant Insulinic LA
2021-11-01 License Agreement issued to Defendant Insulinic FL
2022-06-09 Plaintiff sends notice of default letter regarding License Agreements
2022-07-19 Plaintiff terminates License Agreements with Defendants
2022-09-07 Plaintiff sends cease-and-desist letter to Defendants
2022-10-27 Complaint Filed

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

U.S. Patent No. 9,652,595 - "Kit that improves impaired hepatic glucose processing in subjects"

  • Patent Identification: U.S. Patent No. 9,652,595, "Kit that improves impaired hepatic glucose processing in subjects", issued May 16, 2017.

The Invention Explained

  • Problem Addressed: The patent's background section describes the significant health and economic costs of Diabetes Mellitus and notes the insufficiency of prior glucose control methods, including earlier forms of "Pulsed Insulin Therapy," in preventing long-term complications (’595 Patent, col. 1:22-2:15).
  • The Patented Solution: The invention is a kit for administering individualized insulin therapy. It comprises physical components like a blood glucose meter and intravenous catheters, combined with a "portable data storage" device. This data storage is the core of the system, containing computer instructions, databases of metabolic factors, treatment models, and libraries of care plan templates to create a personalized, data-driven treatment regimen for a patient (’595 Patent, Abstract; col. 3:13-4:65).
  • Technical Importance: The invention represents a shift toward a systematized and computer-assisted approach for personalizing diabetes treatment, moving beyond simple insulin administration to a comprehensive, data-driven management protocol.

Key Claims at a Glance

  • The complaint does not identify specific asserted claims. Based on the infringement allegations, analysis of independent claim 1 is representative.
    • A kit for individualized intravenous exogenous insulin-based therapy comprising:
      • a blood glucose meter for measuring metabolic factors;
      • an intravenous catheter to deliver insulin bolus volume dosage amounts;
      • a portable data storage configured with an administrative processor to create a subject profile;
      • a database of metabolic factors on the portable data storage;
      • a library of weight management protocols on the portable data storage;
      • a diabetic treatment model on the portable data storage; and
      • a library of care plan templates on the portable data storage.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 10,533,990 - "Physiologic insulin-sensitivity improvement"

  • Patent Identification: U.S. Patent No. 10,533,990, "Physiologic insulin-sensitivity improvement", issued January 14, 2020.

The Invention Explained

  • Problem Addressed: The patent addresses the same general problem as its parent ’595 Patent: the inadequacy of prior art methods for treating impaired hepatic glucose processing and the need for a more optimized therapy to produce superior results (’990 Patent, col. 1:22-2:38).
  • The Patented Solution: The invention is a method for individualized insulin therapy that focuses on the timing of insulin administration. The method involves creating a patient-specific care plan that dictates a schedule for introducing multiple insulin boluses intravenously. A key feature is that this schedule must have "at least one unequal time period" between at least one pair of boluses, meaning the infusions are not administered at perfectly regular intervals (’990 Patent, Abstract; col. 7:10-19). This is intended to better mimic the body's natural metabolic processes.
  • Technical Importance: This technology suggests that the therapeutic efficacy of insulin administration depends not just on the dosage, but on the rhythm and timing of its delivery, proposing that irregular, pulsatile delivery can improve patient outcomes.

Key Claims at a Glance

  • The complaint does not identify specific asserted claims. Based on the infringement allegations, analysis of independent claim 1 is representative.
    • A method for individualized intravenous exogenous insulin-based treatment, comprising the steps of:
      • creating a subject profile for a subject;
      • assessing metabolic factors of the subject and storing them;
      • creating a care plan with treatment sessions, a plan goal, and a schedule of bolus introductions with at least one unequal time period;
      • introducing glucose to the subject to stimulate hormone production;
      • testing the subject for blood glucose levels and comparing them to therapeutic ranges.
  • The complaint does not explicitly reserve the right to assert dependent claims.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are the "insulin infusion pumps, kits, and/or IV tubing infusion cassettes" and the associated diabetes treatment services offered at Defendants' "Insulinic" clinics (Compl. ¶79).

Functionality and Market Context

  • The complaint alleges that Defendants use the accused products and services to deliver "individualized intravenous exogenous insulin-based therapy" to patients to improve impaired hepatic glucose processing (Compl. ¶79). This therapy is alleged to utilize software that includes "portable data storage in communication with a client device processor" containing various databases and treatment models (Compl. ¶79). The Defendants' website and press releases are cited as evidence of marketing these services for diabetes management (Compl. ¶80).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

’595 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A kit for individualized intravenous exogenous insulin-based therapy... Defendants use, sell, or offer for sale "insulin infusion pumps, kits, and/or IV tubing infusion cassettes." ¶79 col. 1:17-21
a blood glucose meter for measuring metabolic factors of a subject... The accused kits allegedly contain a blood glucose meter. ¶79 col. 4:32-35
an intravenous catheter to deliver a plurality of insulin bolus volume dosage amounts... The accused kits allegedly include a plurality of intravenous catheters fluidly engageable with a fluid source. ¶79 col. 4:36-39
a portable data storage configured with an administrative processor to create a subject profile... Defendants allegedly utilize software that includes portable data storage in communication with a client device processor. ¶79 col. 3:39-45
a database of metabolic factors...a library of weight management protocols...a diabetic treatment model...and a library of care plan templates... The accused software allegedly includes a database of metabolic factors, a library of weight management protocols, a diabetic treatment model, and a library of care plan templates. ¶79 col. 3:13-38

’990 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for individualized intravenous exogenous insulin-based treatment... Defendants' clinics deliver "individualized intravenous exogenous insulin-based therapy for infusing insulin intravenously to a subject or a patient to improve impaired hepatic glucose processing." ¶79 col. 1:17-21
creating a subject profile for a subject... The complaint does not provide sufficient detail for analysis of this specific element. col. 7:42-67
creating a care plan with...a schedule of bolus introductions with at least one unequal time period... The complaint does not provide sufficient detail for analysis of this specific element, beyond the general allegation that Defendants use the inventions claimed in the patent. ¶79 col. 7:10-19

Identified Points of Contention

  • Evidentiary Questions: The complaint makes high-level, conclusory allegations that the accused instrumentalities practice the claims. A central issue will be whether Plaintiff can produce evidence that Defendants’ system actually includes a "portable data storage" containing all the specific software modules required by the ’595 Patent claims, and whether their treatment method actually employs the specific "unequal time period" schedule required by the ’990 Patent claims.
  • Scope Questions: The dispute may turn on the construction of key terms. For the ’595 Patent, the scope of "kit" and "portable data storage" will be at issue. For the ’990 Patent, the precise meaning of an "unequal time period" will be critical to determining infringement.

V. Key Claim Terms for Construction

The Term: "portable data storage" (’595 Patent)

  • Context and Importance: This term is central to the ’595 Patent's kit claim. The infringement question will depend on whether the system used by Defendants qualifies as a "kit" containing such "portable data storage." Practitioners may focus on this term because its scope could determine whether a cloud-based or distributed software system meets the limitation, or if a specific, self-contained physical device is required.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claims state the storage is "in communication with client device processor," which could suggest a networked or cloud configuration rather than a single, integrated device (’595 Patent, Abstract).
    • Evidence for a Narrower Interpretation: The specification provides examples of "non-transitory computer readable medium, such as a hard disk drive, solid state drive, flash drive, tape drive, and the like," which could be used to argue for a more limited interpretation tied to physical media (’595 Patent, col. 5:47-50).

The Term: "at least one unequal time period" (’990 Patent)

  • Context and Importance: This term appears to be the primary point of novelty for the method claims of the ’990 Patent. Infringement will hinge on whether the Defendants' treatment protocol uses infusion intervals that meet this definition. The question is whether any deviation from perfect regularity suffices, or if a specific, algorithmically determined variation is required.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The term is defined simply as "a unit of time between a pair of bolus in a treatment session that is different in length from a time period between another pair of bolus," which suggests any non-uniform timing could infringe (’990 Patent, col. 7:10-15).
    • Evidence for a Narrower Interpretation: The patent provides a specific example where three boluses are separated by 4-minute intervals, and a fourth is delivered after a 6.5-minute interval. This example of a distinct, irregular interval following a series of regular ones could be argued to limit the scope of the claim to similarly structured schedules (’990 Patent, col. 7:20-28).

VI. Other Allegations

Indirect Infringement

  • The complaint alleges inducement by Defendants "marketing to practitioners that they can utilize their insulin infusion pumps, kits, and/or IV tubing infusion cassettes for diabetes testing and management" (Compl. ¶80). Contributory infringement is alleged on the basis that the accused products are "especially made or especially adapted for practicing the invention" and are not staple articles of commerce (Compl. ¶81).

Willful Infringement

  • The willfulness allegation is predicated on Defendants' alleged knowledge of the patents from their prior licensing agreements (Compl. ¶81). The complaint asserts that Defendants continued to infringe after the licenses were terminated on July 19, 2022, and after receiving a cease-and-desist letter on September 7, 2022, which may support a finding of post-suit willfulness (Compl. ¶81, ¶83).

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

  • A central issue will be one of factual proof versus claim scope: Can the Plaintiff demonstrate that the specific treatment protocols and systems used by the Defendants post-license-termination actually practice the patented inventions? This will require detailed evidence comparing the accused methods to the ’990 Patent's specific requirement for an "unequal time period" between insulin boluses.
  • A key question of claim construction will be determinative for the ’595 Patent: Does the term "kit" comprising a "portable data storage" require a tangible, co-packaged set of physical components, or can it be construed more broadly to cover a system where software, potentially cloud-based, is used in conjunction with separate physical devices like pumps and catheters?
  • The case also presents a significant question regarding intent and damages, arising from the parties' prior business relationship: Given that Defendants were former licensees, the court will have to determine whether their post-termination activities constitute willful infringement, which could expose them to enhanced damages.