I. Executive Summary and Procedural Information
- Parties & Counsel:
- Case Identification: 1:22-cv-01120, E.D. Va., 10/05/2022
- Venue Allegations: Plaintiff alleges venue is proper in the Eastern District of Virginia because Defendant maintains a regular and established business presence in the district, including an office in Glen Allen, Virginia.
- Core Dispute: Plaintiff alleges that Defendant’s electronic health record (EHR) platforms and related healthcare management software infringe two patents related to the centralized processing of healthcare information and the automated generation of insurance claims.
- Technical Context: The technology concerns networked computer systems for managing electronic health records, intended to improve the accuracy, efficiency, and interoperability of patient data across different providers and payers.
- Key Procedural History: Both patents-in-suit are expired. The complaint seeks damages for past infringement within the six-year statutory limitation period. The complaint alleges that Defendant’s willfulness period begins upon service of the complaint.
Case Timeline
| Date |
Event |
| 1999-12-18 |
U.S. Patent No. 7,464,040 Priority Date |
| 2001-04-25 |
U.S. Patent No. 7,490,048 Priority Date |
| 2008-12-09 |
U.S. Patent No. 7,464,040 Issued |
| 2009-02-10 |
U.S. Patent No. 7,490,048 Issued |
| 2021-05-06 |
Date of Plaintiff's review of Defendant's webpages |
| 2022-10-05 |
Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,464,040 - “APPARATUS AND METHOD FOR PROCESSING AND/OR FOR PROVIDING HEALTHCARE INFORMATION AND/OR HEALTHCARE-RELATED INFORMATION”
The Invention Explained
- Problem Addressed: The patent’s background section describes the healthcare system at the time of invention as inefficient and error-prone due to its reliance on fragmented, often paper-based, patient information. This system led to inaccurate data, delays in treatment, and rising costs associated with processing insurance claims (’040 Patent, col. 1:27-51, col. 2:4-15).
- The Patented Solution: The invention proposes a computer-implemented system featuring a central processing computer that connects communication devices used by patients, healthcare providers, and healthcare payers (insurers) (’040 Patent, Fig. 1). In a key embodiment, a provider transmits patient information (e.g., diagnosis, treatment) to the central computer, which updates the patient's electronic record and then automatically generates and transmits a corresponding insurance claim to the payer’s computer system (’040 Patent, Abstract; col. 28:57-66, col. 29:1-10).
- Technical Importance: This approach sought to create a unified, efficient electronic ecosystem for healthcare data, aiming to improve diagnostic accuracy and streamline the traditionally cumbersome insurance claims submission and reconciliation process (’040 Patent, col. 2:48-56).
Key Claims at a Glance
- The complaint asserts independent claims 1 and 46 (Compl. ¶57).
- Essential elements of independent claim 1 include:
- A receiver for receiving information regarding an individual from a healthcare provider's computer over a network like the Internet.
- A database located remotely from the provider's computer that stores information for a plurality of individuals, providers, and payers.
- A processing device that processes the individual's information by storing it or updating their healthcare record.
- The processing device automatically generates an insurance claim in response to the storing or updating of the record.
- The processing device transmits the insurance claim to a second computer associated with the healthcare payer.
U.S. Patent No. 7,490,048 - “APPARATUS AND METHOD FOR PROCESSING AND/OR FOR PROVIDING HEALTHCARE INFORMATION AND/OR HEALTHCARE-RELATED INFORMATION”
The Invention Explained
- Problem Addressed: The patent identifies problems in maintaining the privacy of patient healthcare records, safeguarding them, and providing notification to patients when others have accessed or modified their files (’048 Patent, col. 2:19-30).
- The Patented Solution: The invention discloses a computer-implemented method for managing access to a patient's electronic healthcare file. The system processes a request from a person or entity to access or modify a record, determines if the access is authorized based on pre-set restrictions, and, critically, generates and transmits a notification message to the patient's personal communication device. This message contains details about the request and any actual change made, and it is transmitted concurrently with or prior to the completion of the access or modification (’048 Patent, Abstract; Fig. 17A-17B).
- Technical Importance: This technology addressed the need for patient-centric privacy controls and auditable access logs in digital health systems, providing patients with near real-time transparency into how their personal health information is being handled (’048 Patent, col. 7:31-36).
Key Claims at a Glance
- The complaint asserts claims 1, 2, 10, 20, and 22-40, with claim 20 identified as exemplary (Compl. ¶37).
- Essential elements of independent claim 20 include:
- Receiving and storing information regarding a restriction or limitation on the ability of a person or entity to access or modify a patient's healthcare record.
- Processing a request from a person or entity to access or modify that record.
- Determining, based on the stored restriction, whether the access is authorized.
- Generating a message that contains information about the requesting entity and any actual change, alteration, or modification made to the record.
- Transmitting that message to the patient's communication device over a network.
III. The Accused Instrumentality
Product Identification
The complaint names a wide array of Allscripts software platforms and services, collectively termed the “Accused Instrumentalities” (Compl. ¶¶31, 32). These include, among others, 2bPrecise, Allscripts Practice Management, Care Director, dbMotion, CarePort, SunRise, and FollowMyHealth (Compl. ¶31.i-xx).
Functionality and Market Context
The accused products are described as a comprehensive suite of Electronic Health Record (EHR), practice management, and patient engagement solutions (Compl. ¶31). Their alleged functionality includes consuming and integrating patient data from various clinical and lab sources into a unified, longitudinal patient record (Compl. ¶31.i, ¶31.iv). A screenshot from the Defendant's webpage for its dbMotion solution shows a user interface for a consolidated and actionable patient record (Compl. ¶31.iv, Fig. 5-6). The platforms also manage patient scheduling, billing, insurance verification, and care coordination across different healthcare settings (Compl. ¶31.ii, ¶31.v, ¶31.ix). The complaint alleges these systems form a cloud-based framework allowing providers and patients to access, send, and manage patient health information (Compl. ¶46).
IV. Analysis of Infringement Allegations
7,464,040 Infringement Allegations
| Claim Element (from Independent Claim 1) |
Alleged Infringing Functionality |
Complaint Citation |
Patent Citation |
| a receiver, wherein the receiver receives information regarding an individual, wherein the information regarding an individual is transmitted from a first computer or from a first communication device, wherein the first computer or the first communication device is associated with a healthcare provider... |
The Accused Instrumentalities receive patient information transmitted from a healthcare provider's computer or communication device over the Internet. |
¶59 |
col. 40:40-48 |
| a database or a memory device... wherein the database or the memory device stores information regarding a plurality of individuals, a plurality of healthcare providers, and a plurality of healthcare insurers or healthcare payers. |
The Accused Instrumentalities utilize a database that stores information for multiple individuals, providers, and payers, including healthcare records and insurance data. |
¶¶59, 60 |
col. 40:49-57 |
| a processing device, wherein the processing device processes the information regarding an individual... for at least one of storing the information regarding an individual in the database or the memory device and updating the healthcare record... |
The Accused Instrumentalities include a processing device that stores and updates an individual's information in the database or healthcare record. |
¶61 |
col. 40:58-66 |
| and further wherein the processing device automatically generates an insurance claim in response to the storing of the information regarding an individual in the database or the memory device or the updating of the healthcare record... |
The processing device automatically generates an insurance claim in response to the storing or updating of the individual's healthcare information. |
¶61 |
col. 40:66-70 |
| and further wherein the processing device transmits the insurance claim to the second computer or to the second communication device. |
The processing device transmits the generated insurance claim to a second computer associated with the healthcare insurer or payer. |
¶61 |
col. 40:70-73 |
- Identified Points of Contention:
- Scope Questions: A central question may concern the scope of "automatically generates an insurance claim in response to" the updating of a healthcare record. The analysis may focus on whether the accused systems create claims as a direct, programmatic result of a clinical data entry event, or if claim generation is a distinct, user-initiated workflow that occurs subsequent to, and separate from, the act of updating a patient's clinical file.
7,490,048 Infringement Allegations
| Claim Element (from Independent Claim 20) |
Alleged Infringing Functionality |
Complaint Citation |
Patent Citation |
| receiving information regarding a restriction or limitation regarding an ability of a person or an entity to at least one of access, obtain, change, alter, and modify, information contained in an individuals or patients healthcare record... |
The Accused Instrumentalities are configured to receive and contain information regarding restrictions on a person's ability to access or modify a patient's healthcare record. |
¶¶39, 41 |
col. 60:54-61 |
| storing the information regarding the restriction or limitation... |
The Accused Instrumentalities store the information regarding the access restriction or limitation. |
¶42 |
col. 60:62-63 |
| processing, with a processor, a request by a person or an entity to at least one of access, obtain, change, alter, and modify, the information contained in an individuals or patient's healthcare record... |
The Accused Instrumentalities use a processor to process requests from users to access or modify information within a patient's healthcare record. |
¶42 |
col. 60:64-68 |
| determining, using the information regarding the restriction or limitation, whether the person or the entity is allowed or authorized to at least one of access, obtain, change, alter, and modify, the information... |
The system determines, based on the stored restriction information, whether the requesting person or entity is authorized to perform the requested action on the record. |
¶42 |
col. 61:1-6 |
| generating a message containing... information regarding the person or the entity making the request... and further wherein the message contains an actual change, alteration, or modification, made to the information... |
The system generates a message containing information identifying the requestor and detailing the actual change or modification made to the record's information. |
¶42 |
col. 61:7-14 |
| and transmitting the message to a communication device of the individual or patient via, on, or over, a communication network. |
The system transmits the generated message to the communication device of the patient over a network. |
¶42 |
col. 61:15-18 |
- Identified Points of Contention:
- Technical Questions: The infringement analysis may turn on the specific operational details of the accused notification feature. A key question is whether the accused system generates and transmits the required message with the "actual change" to the patient's device in near real-time, as suggested by separate allegations (Compl. ¶43), or if it performs a more conventional post-event audit logging function that records changes after they have been completed.
V. Key Claim Terms for Construction
- Patent: U.S. Patent No. 7,464,040
- The Term: “automatically generates an insurance claim in response to the storing of the information... or the updating of the healthcare record” (Claim 1)
- Context and Importance: This phrase establishes a specific causal and automated link between a clinical record-keeping action and a financial/administrative action. The dispute may center on whether this requires a direct, system-initiated process without intervening user commands, or if it can cover a semi-automated workflow where a user initiates a "generate claim" function that pulls from the newly updated record.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes a high-level goal of facilitating "efficient information collection, processing and dissemination" and "cost efficiency," which a streamlined, even if not fully autonomous, process could support (’040 Patent, col. 2:50-52).
- Evidence for a Narrower Interpretation: The flowchart in Figure 14B depicts "UPDATE PATIENT'S RECORDS" (1408) and "GENERATE CLAIM FORM" (1409) as distinct, sequential steps. This could suggest that claim generation follows a record update but is not necessarily an immediate and automatic consequence of it, potentially requiring a separate trigger.
- Patent: U.S. Patent No. 7,490,048
- The Term: "a message containing... an actual change, alteration, or modification, made to the information" (Claim 20)
- Context and Importance: This term defines the required content of the notification sent to the patient. Practitioners may focus on whether the "message" must contain the substantive content of the change itself (e.g., "Diagnosis changed from X to Y") or if a more generic notification that a change occurred (e.g., "Your record was modified by Dr. Smith") is sufficient to meet the limitation.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The term "containing... an actual change" could be interpreted to mean the message must include the substance of the modification, providing the patient with full transparency.
- Evidence for a Narrower Interpretation: The specification does not provide an explicit definition or example of the message content, which may leave room for an interpretation that a notification describing the fact of the change, without detailing its substance, satisfies the "containing" requirement.
VI. Other Allegations
- Indirect Infringement: The complaint alleges inducement of infringement for both patents. It asserts that Defendant's advertising and offering for sale of the Accused Instrumentalities, which enable providers and patients to access health information, constitutes active steps to encourage infringing uses (Compl. ¶¶45-48, 64-67).
- Willful Infringement: Willfulness allegations are based on both pre- and post-suit conduct. The complaint alleges Defendant has a practice of "willfully blind" disregard for patent rights by not performing clearance reviews before launching products (Compl. ¶¶49, 68). It further states that infringement will be willful from the date of service of the complaint, establishing post-suit knowledge (Compl. ¶¶44, 63).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of process automation: For the ’040 Patent, does the accused systems' functionality for creating insurance claims meet the claim requirement of being "automatically generate[d]... in response to" the updating of a clinical record, or is it a distinct, user-driven workflow that is separate from the act of updating a patient's chart?
- A key evidentiary question will be one of functional specificity: For the ’048 Patent, does the accused system's notification or logging feature generate and transmit a message to the patient that contains the "actual change" to their record, and does it do so with the near real-time characteristics implied by other allegations, or does it perform a more conventional post-event audit logging function that may differ in content and timing from what the claim requires?