DCT

4:22-cv-03062

Well Cell Global LLC v. Calvit

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Key Events
Amended Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 4:22-cv-03062, S.D. Tex., 10/25/2024
  • Venue Allegations: Venue is alleged to be 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 that expressly consented to venue in the district for any related disputes.
  • Core Dispute: Plaintiffs allege that Defendants’ diabetes treatment clinics and associated services infringe a patent related to individualized, intravenous insulin-based therapy methods.
  • Technical Context: The technology concerns advanced therapeutic protocols for treating diabetes and other metabolic disorders by improving a patient's physiologic insulin sensitivity.
  • Key Procedural History: The complaint, a Fourth Amended Complaint, alleges a prior business relationship where Plaintiffs licensed the patented technology to certain Defendants. Plaintiffs allege they terminated these licenses due to breach of contract and subsequently sent cease-and-desist letters, which Defendants allegedly ignored, leading to the current litigation.

Case Timeline

Date Event
2015-02-17 U.S. Patent No. 10,533,990 earliest priority date
2020-01-14 U.S. Patent No. 10,533,990 issues
2020-07-24 Well Cell Global acquires intellectual property from Diabetes Relief
2021-09-13 License issued to Defendant Insulinic LA
2021-11-01 License issued to Defendant Insulinic FL
2022-01-31 Certain Defendants sign Non-Disclosure Agreements in Texas
2022-06-09 Plaintiffs issue letter warning of license termination
2022-07-19 License Agreements with Insulinic LA and FL terminated
2022-09-07 Plaintiff Well Cell sends cease-and-desist letter to Defendants
2022-11-29 Plaintiff Diabetes Relief sends cease-and-desist letter
2024-10-25 Plaintiffs' Fourth Amended Complaint filed

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

U.S. Patent No. 10,533,990 - "Physiologic Insulin-Sensitivity Improvement"

  • Issued: January 14, 2020

The Invention Explained

  • Problem Addressed: The patent's background section notes that conventional methods for managing diabetes, while controlling blood glucose, are often insufficient to prevent long-term complications such as neuropathy (nerve disease) and retinopathy (eye disease) (’990 Patent, col. 2:7-13). It further notes that while "Pulsed Insulin Therapy" has shown promise, the known treatment parameters were insufficient to produce optimal results ('990 Patent, col. 2:29-33).
  • The Patented Solution: The invention is a highly individualized method for intravenous insulin therapy. The method involves assessing a patient's specific "metabolic factors" (e.g., respiratory quotient, C-peptide levels) to create a subject profile, then using a "diabetic treatment model" to generate a customized care plan ('990 Patent, Abstract; col. 3:13-25). A key feature of this plan is the sequential introduction of insulin boluses at irregular or "unequal time periods" to improve the body's natural glucose processing capabilities ('990 Patent, col. 3:41-45). The patent provides detailed look-up tables as an example of the "diabetic treatment model" that correlates patient weight with specific dosages and infusion timings ('990 Patent, Figs. 1A-1B).
  • Technical Importance: The claimed method purports to offer superior results over prior art insulin therapies by systematically optimizing and individualizing treatment parameters based on a patient's unique metabolic profile ('990 Patent, col. 2:33-36).

Key Claims at a Glance

  • The complaint does not identify specific claims but alleges infringement of the "inventions claimed in the Patent-in-Suit" (Compl. ¶52). Representative independent method claim 1 is analyzed below.
  • The essential elements of independent claim 1 include:
    • Creating a subject profile for a subject.
    • Assessing metabolic factors of the subject and storing them.
    • Creating a care plan with treatment sessions and a plan goal, which indicates a schedule of bolus introductions with at least one unequal time period.
    • Introducing glucose to the subject to stimulate gastrointestinal 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 other claims, but this is standard practice.

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are the diabetes treatment services provided at Defendants' "Insulinic" clinics, which allegedly utilize Plaintiffs' patented methods (Compl. ¶¶ 5, 48). These services are delivered using "insulin infusion pumps and/or IV tubing infusion cassettes" (Compl. ¶52).

Functionality and Market Context

The complaint alleges that Defendants operate clinics that provide an "individualized intravenous exogenous insulin-based therapy for infusing insulin intravenously to a subject or a patient to improve impaired hepatic glucose processing" (Compl. ¶52). This is the same language used to describe the patented invention. The complaint further alleges that Defendants market these infringing services and associated training through websites, such as "Insulinic.com" (Compl. ¶¶ 6, 53). Exhibit 4 provides printouts of the insulinic.com website, which the complaint alleges markets the infringing diabetes treatment services (Compl. ¶122, Ex. 4). Defendants' clinics are alleged to operate in Louisiana, Florida, Hawaii, and Georgia, directly competing with Plaintiffs' business (Compl. ¶5).

IV. Analysis of Infringement Allegations

U.S. Patent No. 10,533,990 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
creating a care plan with a plurality of treatment sessions for the subject and a plan goal, wherein the care plan uses the assessed metabolic factors and indicates a schedule of bolus introductions with at least one unequal time period...for sequential intravenous introduction to the subject The complaint alleges that Defendants' therapy involves "treatment sessions involving the assessment of metabolic factors, forming a subject profile, and matching the subject profile to a diabetic treatment model," which is then used to calculate the "quantity and frequency of intravenous insulin bolus." ¶48, ¶52 col. 27:6-21
introducing glucose to the subject to stimulate gastrointestinal hormone production that results in a release of enzymes from the subject's liver and causing blood glucose levels of the subject to be in a therapeutic range The complaint alleges that Defendants' therapy is an "individualized intravenous exogenous insulin-based therapy" designed to "improve impaired hepatic glucose processing," which the patent teaches is achieved by introducing glucose. ¶48, ¶52 col. 27:22-29
testing the subject for blood glucose levels, comparing tested blood glucose levels to a plurality of therapeutic ranges, and verifying that the subject is in at least one of the plurality of therapeutic ranges The complaint alleges that the accused therapy involves using a "diabetic treatment model" to calculate insulin bolus and dosage amounts, which is a process the patent describes as being based on monitoring and adjusting to the patient's blood glucose levels in real time. ¶48, ¶52 col. 27:30-37

Identified Points of Contention

  • Technical Questions: The complaint's infringement theory relies on its assertion that Defendants' services mirror the patented method (Compl. ¶¶ 48, 52). A central evidentiary question will be whether Plaintiffs can prove that Defendants' actual clinical practices include every step of the asserted claim. For example, the complaint does not provide specific facts showing that Defendants perform the step of "introducing glucose to the subject to stimulate gastrointestinal hormone production," which is a specific mechanism recited in claim 1.
  • Scope Questions: Claim 1 requires using a "diabetic treatment model" to create a care plan. The patent specification provides highly detailed tables as an embodiment of this model ('990 Patent, Figs. 1A-1B). A key legal dispute may arise over whether the protocols or guidelines used by Defendants meet the definition of this term, or whether the term should be construed more narrowly to require the specific inputs and outputs shown in the patent's exemplary figures.

V. Key Claim Terms for Construction

  • The Term: "diabetic treatment model"

    • Context and Importance: This term appears in independent claim 1 and is central to the patented method. The infringement analysis will depend heavily on whether the charts, software, or clinical protocols used by Defendants fall within the scope of this term. Practitioners may focus on this term because it is not a standard term of art and its construction could be case-dispositive.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification describes the term as referring to "a plurality of look up tables" that reflect various dosing protocols and patient parameters ('990 Patent, col. 4:53-65). Plaintiffs may argue this supports a broad construction covering any system of tables or rules used to guide treatment.
      • Evidence for a Narrower Interpretation: The patent provides very specific examples in Figures 1A and 1B, which depict detailed tables with columns for patient weight, dosages of insulin, potassium, and magnesium, and specific time intervals for bolus introductions ('990 Patent, Figs. 1A-1B). Defendants may argue these detailed embodiments limit the term to a comprehensive, multi-factor computational model, not just general clinical guidelines.

  • The Term: "unequal time period"

    • Context and Importance: This feature is presented as a key aspect of the invention's method for delivering insulin boluses. Proving that Defendants' therapies use "unequal" time periods will be critical for infringement.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification provides a definition: "a unit of time between a pair of bolus... that is different in length from a time period between another pair of bolus" ('990 Patent, col. 8:10-14). This suggests any non-uniform timing between bolus administrations could meet the limitation.
      • Evidence for a Narrower Interpretation: The patent states that the time intervals can be a "random sequence" and provides examples ranging from 2 to 10 minutes ('990 Patent, col. 5:12-16). A defendant could argue that this context implies more than just a simple difference in timing, but perhaps a calculated or randomized irregularity that its own, more structured protocol does not possess.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement. It alleges inducement on the basis that Defendants market their services and equipment to practitioners with instructions on how to perform the infringing diabetes treatment (Compl. ¶53). It alleges contributory infringement by asserting that Defendants offer for sale training services and infusion equipment that are "especially made or especially adapted for practicing the invention" and are not staple articles of commerce (Compl. ¶54).
  • Willful Infringement: The complaint alleges that Defendants' infringement has been willful, asserting that Defendants had actual knowledge of the '990 Patent because it was included in the license agreements they previously held with Plaintiffs (Compl. ¶56). The pleading cites the termination of these licenses and subsequent cease-and-desist letters as further evidence of knowing and intentional infringement (Compl. ¶54, ¶56).

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

  • A central issue will be one of definitional scope: how will the court construe the term "diabetic treatment model"? Will it be interpreted broadly to encompass any set of clinical protocols for individualized insulin therapy, or will it be narrowed to the complex, multi-variable look-up tables shown in the patent's figures? The outcome of this question will significantly impact the infringement analysis.
  • A key evidentiary question will be one of process mapping: can Plaintiffs produce discovery evidence demonstrating that Defendants’ clinical practices perform every recited step of the asserted method claim? The complaint's allegations track the patent's language, but the case will turn on factual proof of what happens in Defendants' clinics, especially regarding nuanced steps like using "unequal time periods" and "introducing glucose to stimulate gastrointestinal hormone production."