DCT
1:13-cv-02071
IMS Health Inc v. Symphony Health Solutions Corp
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: IMS Health Incorporated (Delaware)
- Defendant: Symphony Health Solutions Corporation (Delaware), Source Healthcare Analytics, LLC (Delaware), and ImpactRx, Inc. (Delaware)
- Plaintiff’s Counsel: Fish & Richardson P.C.
- Case Identification: 1:13-cv-02071, D. Del., 12/20/2013
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because the defendants are organized under the laws of Delaware and conduct substantial business in the district.
- Core Dispute: Plaintiff alleges that Defendants’ healthcare data analytics products and services infringe three patents related to de-identifying and longitudinally linking patient data, and to modeling the post-launch market performance of pharmaceutical products.
- Technical Context: The technology at issue involves methods for processing large-scale, sensitive healthcare data to generate anonymized, longitudinal patient records and predictive market analytics, which are valuable tools in the pharmaceutical and healthcare research industries.
- Key Procedural History: The complaint alleges that Defendants Symphony and Source had actual knowledge of the ’224 patent as of 2010, stemming from due diligence performed during discussions of a potential merger. Additionally, public records indicate that claim 2 of the asserted ’578 patent and claims 4, 8, 9, and 12 of the asserted ’452 patent have been disclaimed. These events may be relevant to questions of willfulness and the scope of the asserted claims.
Case Timeline
| Date | Event |
|---|---|
| 1999-09-20 | Earliest Priority Date for U.S. Patent No. 8,473,452 |
| 1999-12-10 | Earliest Priority Date for U.S. Patent No. 6,397,224 |
| 2001-12-05 | Earliest Priority Date for U.S. Patent No. 7,577,578 |
| 2002-05-28 | U.S. Patent No. 6,397,224 Issues |
| 2009-08-18 | U.S. Patent No. 7,577,578 Issues |
| 2010-01-01 | Alleged Pre-Suit Knowledge of ’224 Patent by Defendants |
| 2013-06-25 | U.S. Patent No. 8,473,452 Issues |
| 2013-12-20 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,473,452 - “System and Method for Analyzing De-identified Health Care Data,” issued June 25, 2013
The Invention Explained
- Problem Addressed: The patent addresses the need to gather and analyze sensitive healthcare data for research while complying with privacy legislation like the Health Insurance Portability and Accountability Act (HIPAA), which prohibits the transmission of personally identifiable information (U.S. US8473452B1, col. 2:45-54).
- The Patented Solution: The invention describes a method for creating a unique, de-identified alias for an individual. This is achieved by selecting a subset of a person’s identification fields from a healthcare record (e.g., last name, birth date, gender), concatenating them, and then encrypting the result to create a unique patient identifier. This identifier is stored with the non-personal health data, while the original identifying information is removed, allowing for privacy-compliant longitudinal analysis ('452 Patent, Abstract; col. 2:55-68).
- Technical Importance: This approach provided a method to create persistent, anonymous identifiers for individuals across different data sources, enabling valuable longitudinal studies without compromising patient privacy ('452 Patent, col. 3:20-24).
Key Claims at a Glance
- The complaint alleges infringement of one or more claims, with the allegations closely tracking the language of method claims (Compl. ¶16). Independent method claim 2 is representative.
- Claim 2, broken down:
- selecting, by one or more processors, a patient record from at least one health care database
- extracting alphanumeric information from a plurality of the identification fields included in the patient record, the extracted alphanumeric information uniquely identifying the patient
- generating an encrypted unique patient identifier by encrypting the extracted alphanumeric information
- generating a de-identified patient record... [which] includes the at least one health care field... and the encrypted unique patient identifier
- wherein the de-identified patient record does not include any information that identifies the patient other than the encrypted unique patient identifier
- transmitting the de-identified patient record to a second database
- The complaint does not explicitly reserve the right to assert dependent claims.
U.S. Patent No. 6,397,224 - “Anonymously Linking a Plurality of Data Records,” issued May 28, 2002
The Invention Explained
- Problem Addressed: The patent identifies the difficulty of linking multiple records for a single individual when those records come from different data sources that use different, non-universal identification schemes. This problem is compounded by the fact that personal identifiers (like names or addresses) can change over time ('224 Patent, col. 1:40-54).
- The Patented Solution: The invention proposes a system that generates at least two different "encoded identity references" (EIRs) for an individual from two different subsets of their identifying information (e.g., EIR1 from name+DOB+ZIP, and EIR2 from healthcare ID+DOB). It then assigns a single, identical "anonymization code" (AC) to both EIRs. This allows the system to link records for the same person even if only one of the underlying identifiers is present, without needing to reverse the encoding ('224 Patent, Abstract; col. 2:55-col. 3:27; Fig. 2).
- Technical Importance: This method creates a robust, self-maintaining "anonymous index" that can link disparate data sets over time, even as a person's identifying information evolves, a critical function for longitudinal health studies ('224 Patent, col. 15:10-21).
Key Claims at a Glance
- The complaint asserts infringement of one or more claims, with allegations reflecting the language of method claims (Compl. ¶26). Independent method claim 1 is representative.
- Claim 1, broken down:
- encoding a first encoded identity reference from a first subset of the identifying elements of a data record
- encoding a second encoded identity reference from a second subset of the identifying elements of the data record
- assigning to each of the first and second encoded identity references an identical anonymization code for anonymously representing the individual
- inserting the assigned anonymization code into the data record
- The complaint does not explicitly reserve the right to assert dependent claims.
U.S. Patent No. 7,577,578 - “Method for Determining the Post-Launch Performance of a Product on a Market,” issued August 18, 2009
Technology Synopsis
The patent describes a method for forecasting the future market share of a product, such as a pharmaceutical drug. The method involves collecting and storing data in three specific categories: key success factors (e.g., marketing efforts), unmet needs in the market, and the propensity of decision-makers (e.g., physicians) to choose the product. A computer then uses a simulation model with this data to calculate the product's future performance ('578 Patent, Abstract; col. 2:38-55).
Asserted Claims
The complaint asserts infringement of one or more claims (Compl. ¶36). Independent claim 1 is a method claim.
Accused Features
The complaint accuses Defendants' "LaunchAdvantage" product, which allegedly "employs a computer simulation model to determine a future market share of a product" based on data related to success factors, unmet needs, and decision-maker propensity (Compl. ¶36).
III. The Accused Instrumentality
Product Identification
The accused instrumentalities are Defendants’ products and services, identified as "Patient Analytics Suite," "Market Profiler," and "LaunchAdvantage" (Compl. ¶12).
Functionality and Market Context
- The complaint alleges that Symphony and Source, through products like Patient Analytics Suite and Market Profiler, are in the business of "de-identifying healthcare records" and generating revenue by "aggregating, longitudinally linking, and performing analytics on such de-identified records" (Compl. ¶12). These activities form the basis for the infringement allegations regarding the '452 and '224 patents.
- The complaint alleges that Symphony and ImpactRx, through services like LaunchAdvantage, "generate revenue by collecting product-related healthcare data and performing analytics on such data" (Compl. ¶12). This service is specifically alleged to employ a "computer simulation model to determine a future market share of a product" (Compl. ¶36), forming the basis for the infringement allegations regarding the '578 patent.
- Plaintiff IMS Health positions itself as a "leader in healthcare analytics," suggesting the market for these services is established and commercially significant (Compl. ¶10).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
'452 Patent Infringement Allegations
| Claim Element (from Independent Claim 2) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| selecting, by one or more processors, a patient record from at least one health care database... | The complaint alleges Defendants perform de-identification of patient records selected from at least one health care database (Compl. ¶16). | ¶16 | col. 14:40-42 |
| extracting alphanumeric information from a plurality of the identification fields included in the patient record, the extracted alphanumeric information uniquely identifying the patient; | The complaint alleges Defendants' solution includes "extracting alphanumeric information from a plurality of identification fields... the extracted alphanumeric information uniquely identifying the patient" (Compl. ¶16). | ¶16 | col. 14:50-54 |
| generating an encrypted unique patient identifier by encrypting the extracted alphanumeric information; | The complaint alleges Defendants' solution includes "generating an encrypted unique patient identifier by encrypting the extracted alphanumeric information" (Compl. ¶16). | ¶16 | col. 14:55-57 |
| generating a de-identified patient record, wherein the de-identified patient record includes the at least one health care field that is included in the selected patient record and the encrypted unique patient identifier... | The complaint alleges Defendants' solution includes "generating a de-identified patient record, wherein the de-identified patient record includes at least one health care field... and the encrypted unique patient identifier" (Compl. ¶16). | ¶16 | col. 14:58-63 |
| and wherein the de-identified patient record does not include any information that identifies the patient other than the encrypted unique patient identifier... | The complaint alleges that "the de-identified patient record does not include any information that identifies the patient other than the encrypted unique patient identifier" (Compl. ¶16). | ¶16 | col. 14:63-66 |
Identified Points of Contention
- Technical Questions: The complaint's allegations are conclusory and mirror the claim language. A central question for the court will be one of evidence: what proof demonstrates that the accused "Patient Analytics Suite" and "Market Profiler" actually perform each specific step of the claimed method? For instance, does the process generate an "encrypted" identifier, and is information identifying the patient truly removed as the claim requires?
'224 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| encoding a first encoded identity reference from a first subset of the identifying elements of a data record; | The complaint alleges Defendants' de-identification and linking includes "encoding a first... encoded identity reference from a first... subset of the identifying elements of a data record" (Compl. ¶26). | ¶26 | col. 16:62-64 |
| encoding a second encoded identity reference from a second subset of the identifying elements of the data record; | The complaint alleges Defendants' de-identification and linking includes "encoding a... second encoded identity reference from a... second, respectively, subset of the identifying elements of a data record" (Compl. ¶26). | ¶26 | col. 16:65-col. 17:2 |
| assigning to each of the first and second encoded identity references an identical anonymization code for anonymously representing the individual associated with the data record; and | The complaint alleges Defendants' de-identification and linking includes "assigning to each of the first and second encoded identity references an identical anonymization code for anonymously representing the individual associated with the data record" (Compl. ¶26). | ¶26 | col. 16:3-6 |
| inserting the assigned anonymization code into the data record. | The complaint alleges Defendants' de-identification and linking includes "inserting the assigned anonymization code into the data record" (Compl. ¶26). | ¶26 | col. 16:7-8 |
Identified Points of Contention
- Scope Questions: Does the defendants' process for "longitudinally linking" (Compl. ¶12) data use the specific architecture required by claim 1? The invention's core is the use of two different encoded references linked by a single anonymization code. The infringement analysis will turn on whether the accused systems actually implement this two-reference-to-one-code linking mechanism, or if they use a different method to link records.
V. Key Claim Terms for Construction
For the ’452 Patent
- The Term: "encrypted unique patient identifier" (Claim 2)
- Context and Importance: The definition of "encrypted" is critical to the scope of the claim. The dispute may focus on whether this term requires a specific type of cryptographic process (e.g., reversible encryption) or can be read more broadly to include other techniques like one-way hashing, which also serve the patent's goal of de-identification.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent's overall goal is to "de-identify" data to maintain privacy ('452 Patent, col. 1:18-21). A party could argue that any method that renders the identifier non-personal, including irreversible hashing, falls within the spirit and purpose of the invention.
- Evidence for a Narrower Interpretation: The term "encrypting" is used repeatedly and distinctly ('452 Patent, col. 14:55-57). A party could argue that in the context of cryptography, "encryption" implies a process that can be reversed with a key, distinguishing it from "hashing."
For the ’224 Patent
- The Term: "an identical anonymization code" (Claim 1)
- Context and Importance: This term is the lynchpin of the '224 invention, as it is the element that links the two otherwise separate encoded identity references. Practitioners may focus on this term because the entire inventive concept of linking disparate records anonymously rests on the function of this code. The infringement question will likely depend on whether the accused system employs a single token or code that performs this specific linking function.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent describes the code as potentially being a "unique serial number" ('224 Patent, col. 3:3-4), which could suggest that its form is not as important as its function of linking references.
- Evidence for a Narrower Interpretation: The specification and figures consistently depict the "anonymization code" (AC) as a distinct data element stored in a database (the "anonymous index") for the express purpose of associating two or more different encoded identity references ('224 Patent, col. 6:67-68; Fig. 2). This suggests a specific structural role that a defendant's system must replicate.
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement for all three patents. The allegations state that Defendants provide software to third parties (such as "data suppliers" or "customers") and encourage them to use it to perform the patented methods (Compl. ¶¶17, 27, 37). The complaint further alleges that the software is "especially made for use in infringement" and is "not a staple article of commerce suitable for substantial non-infringing use," which are key elements for a contributory infringement claim (Compl. ¶¶18, 28, 38).
- Willful Infringement: The complaint alleges willful infringement for all three patents. For the ’452 and ’578 patents, knowledge is alleged based on the filing of the complaint, supporting a claim for post-suit willfulness (Compl. ¶¶15, 20, 35, 40). For the ’224 patent, the complaint alleges pre-suit knowledge dating back to 2010, arising from due diligence related to a potential merger, which may support a claim for pre-suit willfulness and enhanced damages (Compl. ¶¶25, 30).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue for the ’452 and ’224 patents will be one of evidentiary support: given the conclusory nature of the allegations, can the plaintiff provide technical evidence that the accused "Patient Analytics Suite" and "Market Profiler" actually perform the specific, multi-step data processing and linking methodologies recited in the independent claims, or is there a fundamental mismatch in technical operation?
- A key question for damages will be the substantiation of pre-suit knowledge: can the plaintiff prove its allegation that Defendants knew of the ’224 patent in 2010? The resolution of this factual question will be critical to the determination of willfulness and the potential for enhanced damages.
- The dispute over the ’578 patent may turn on a question of functional scope: does the accused "LaunchAdvantage" service, in practice, use a simulation model that incorporates the three specific types of data required by claim 1—key success factors, unmet product needs, and the propensity of a decision-maker—or does it rely on a different set of inputs for its market forecasting?