DCT
3:13-cv-00832
Ameritox Ltd v. Millennium Health LLC
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Ameritox, Ltd. (Texas)
- Defendant: Millennium Laboratories, Inc. (California)
- Plaintiff’s Counsel: Kramon & Graham, P.A.; Bartlit Beck Herman Palenchar & Scott LLP; K&L Gates LLP
- Case Identification: 3:13-cv-00832, D. Md., 06/23/2011
- Venue Allegations: Plaintiff alleges venue is proper in the District of Maryland because Defendant transacts business in the state and operates products and services that allegedly infringe the patents-in-suit within the district.
- Core Dispute: Plaintiff, an exclusive licensee, alleges that Defendant’s drug monitoring services and associated patient reports infringe two patents related to methods for monitoring medication usage by analyzing drug metabolites in biological samples.
- Technical Context: The technology addresses the field of clinical urine testing, aiming to improve the accuracy of monitoring patient adherence to prescribed medications, particularly for pain management and addiction treatment.
- Key Procedural History: Plaintiff Ameritox asserts its rights as the exclusive licensee of the patents-in-suit from Marshfield Medical Research and Education Foundation, based on a license agreement dated March 15, 2010. The complaint does not mention any prior litigation or administrative proceedings involving the patents.
Case Timeline
| Date | Event |
|---|---|
| 2003-08-28 | Earliest Priority Date for ’680 and ’895 Patents |
| 2009-09-08 | ’680 Patent Issued |
| 2010-03-15 | Ameritox and Marshfield License Agreement |
| 2010-08-31 | ’895 Patent Issued |
| 2011-06-01 | Ameritox alleges it became aware of infringing Millennium report (approximate) |
| 2011-06-23 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,585,680 - "Method and Device for Monitoring Medication Usage," issued September 8, 2009
The Invention Explained
- Problem Addressed: The patent’s background section identifies a major problem in urine-based drug testing: significant variance in drug metabolite concentrations due to a patient's hydration level. A well-hydrated patient may show low metabolite levels, while a poorly hydrated patient may show high levels, making it difficult for clinicians to determine true compliance with a prescribed dosage from a simple positive or negative result (’680 Patent, col. 1:50-58).
- The Patented Solution: The invention proposes a method to correct for this variability. It involves measuring the concentration of a "test metabolite" (from a prescribed drug) and a "reference metabolite" (creatinine, which is excreted at a relatively constant rate) in a urine sample. By calculating the ratio of the test metabolite to creatinine, the result is normalized for urine dilution. This normalized ratio can then be compared against a "normative data set" to assess whether the patient's medication use is consistent with their prescription, thereby enabling more accurate detection of overuse, underuse, or diversion (’680 Patent, Abstract; col. 2:2-7; col. 3:15-26).
- Technical Importance: The method provided a quantitative framework for interpreting urine drug tests that went beyond simple detection, offering clinicians a tool to potentially assess adherence to a specific dosage regimen by accounting for a key physiological variable (’680 Patent, col. 2:54-68).
Key Claims at a Glance
- The complaint does not specify which claims are asserted but alleges infringement of "one or more claims" (Compl. ¶12). Independent claim 1 is representative of the core method.
- Independent Claim 1 Elements:
- Providing a biological sample (urine) from a patient on a prescribed medication regimen.
- Providing a set of known normative data specific to a reference metabolite.
- Contacting the biological sample with an analytical device.
- Detecting the presence of at least one test metabolite.
- Normalizing the biological sample to adjust for hydration by determining the metabolite/creatinine ratio.
- Quantifying the concentration of the test metabolite by comparing the determined ratio to the set of known normative data.
- The complaint does not explicitly reserve the right to assert dependent claims, but such a reservation is standard practice.
U.S. Patent No. 7,785,895 - "Method and Device for Monitoring Medication Usage," issued August 31, 2010
The Invention Explained
- Problem Addressed: As a continuation of the application that led to the ’680 Patent, the ’895 Patent addresses the identical technical problem: the variability in urine drug testing results caused by patient hydration levels, which complicates the assessment of medication compliance (’895 Patent, col. 1:52-58).
- The Patented Solution: The ’895 Patent discloses the same solution as its parent patent: using a metabolite-to-creatinine ratio to normalize test results for urinary dilution. This normalized value is then compared to a normative data set to determine if medication usage is consistent with the prescribed regimen, with the goal of identifying non-adherence such as overuse or underuse (’895 Patent, Abstract; col. 2:2-7; col. 4:46-54).
- Technical Importance: The technical importance is identical to that of the ’680 Patent, as it seeks to provide a more reliable and quantitative method for monitoring patient adherence to prescribed drugs.
Key Claims at a Glance
- The complaint alleges infringement of "one or more claims" (Compl. ¶18). Independent claim 1 is representative.
- Independent Claim 1 Elements:
- Providing a biological sample from a patient on a prescribed medication regimen.
- Providing a set of known normative data specific to a reference metabolite.
- Contacting the biological sample with an analytical device.
- Detecting the presence of at least one test metabolite.
- Normalizing the sample by determining the metabolite/creatinine ratio.
- Quantifying the concentration of the test metabolite by comparing the ratio to the normative data.
- The complaint does not explicitly reserve the right to assert dependent claims.
III. The Accused Instrumentality
Product Identification
- The accused instrumentalities are Defendant Millennium's "drug monitoring services," specifically including its "methods to arrive at its new reports" (Compl. ¶¶ 10, 12).
Functionality and Market Context
- The complaint alleges that Millennium, a direct competitor to Ameritox, provides services to monitor drug levels in patients being treated for chronic pain and addiction (Compl. ¶¶ 5, 6). The specific functionality accused of infringement is embodied in a "new Millennium urine test sample report" that Ameritox became aware of around June 2011 (Compl. ¶10). According to the complaint, this report "provides physicians with comparative results, comparing the subject patient to others patients that have also taken the same drug(s) as the subject patient" (Compl. ¶10). The complaint references a sample of this report as Exhibit C, but the exhibit was not filed with the public complaint. No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint does not specify which claims are asserted or provide a detailed mapping of claim elements to the accused services. The infringement theory must be inferred from the general allegations and the description of the accused report. The following table summarizes the likely infringement theory for claim 1 of the ’680 Patent based on the complaint's description of Millennium's services.
’680 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| (a) providing one biological sample obtained from a patient on a prescribed medication regimen, wherein the sample comprises at least one test metabolite, wherein in the sample is urine; | Millennium receives and tests urine specimens from patients prescribed medications for chronic pain and addiction. | ¶¶ 6, 10 | col. 21:10-14 |
| (b) providing one set of known normative data specific to a reference metabolite... | Millennium’s report compares the subject patient to "others patients that have also taken the same drug(s)," which allegedly constitutes providing a set of normative data. | ¶10 | col. 21:15-19 |
| (c) contacting the biological sample with an analytical device; | Millennium operates as a clinical laboratory that tests specimens. | ¶¶ 5, 6 | col. 21:20-21 |
| (d) detecting the presence of at least one test metabolite in the biological sample with the device... | Millennium's services include "monitoring drug levels in patients," which necessitates detecting metabolites. | ¶6 | col. 21:22-26 |
| (e) normalizing the biological sample to adjust for changes in the patient's hydration status by determining the metabolite/creatinine ratio of the patient; and | The complaint does not explicitly state that Millennium calculates a metabolite/creatinine ratio, but alleges its methods infringe the patent, which requires this step. | ¶10 | col. 21:27-30 |
| (f) quantifying the concentration of at least one test metabolite... by comparing a ratio... to the set of known normative data... | Millennium’s report provides "comparative results" by comparing a patient to others, which allegedly constitutes the claimed quantification step. | ¶10 | col. 21:31-35 |
- Identified Points of Contention:
- Scope Questions: A central dispute may be whether Millennium's alleged comparison of a patient to "others patients" (Compl. ¶10) meets the "set of known normative data" limitation. The patent specification describes developing this data through statistical models and confidence intervals (’680 Patent, col. 2:11-13, col. 3:20-26), raising the question of whether a simple population comparison without such statistical rigor falls within the claim scope.
- Technical Questions: The complaint provides no direct evidence that Millennium's methods perform the specific step of "normalizing the biological sample... by determining the metabolite/creatinine ratio" (’680 Patent, col. 21:27-30). A key factual question will be whether Millennium’s accused process actually calculates and uses this specific ratio as required by the claims, or if it uses a different method for its "comparative results."
V. Key Claim Terms for Construction
The Term: "a set of known normative data" (Claim 1)
- Context and Importance: This term is at the core of the patented method. Its construction will likely determine whether Millennium's alleged practice of comparing a patient to "other patients" infringes. Practitioners may focus on this term because it is not explicitly defined with a precise boundary, creating ambiguity.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim language itself is broad, not explicitly requiring statistical models or regression analysis. A party could argue "normative data" simply means data from a reference population used for comparison.
- Evidence for a Narrower Interpretation: The specification repeatedly discusses this data in the context of creating "dose related normal distribution curves or confidence intervals" and "regression analyses" (’680 Patent, col. 2:11-13, col. 3:20-26). This suggests "normative data" implies a more sophisticated, statistically-processed dataset, not just raw data from other patients.
The Term: "normalizing the biological sample to adjust for changes in the patient's hydration status by determining the metabolite/creatinine ratio" (Claim 1)
- Context and Importance: This is the key technical step for solving the problem of dilution identified in the patent. Infringement hinges on whether the accused method performs this specific type of normalization.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The term "normalizing" could be argued to encompass various methods of adjusting data, although the claim itself specifies the means for doing so.
- Evidence for a Narrower Interpretation: The claim explicitly defines the means of normalization: "by determining the metabolite/creatinine ratio." The specification's background and detailed description are focused entirely on this ratio as the solution to the hydration problem, strongly suggesting that this exact calculation is a required step, not merely an example of normalization (’680 Patent, col. 2:2-7).
VI. Other Allegations
- Indirect Infringement: The complaint makes conclusory allegations of contributory and induced infringement for both patents (Compl. ¶¶ 12, 18). It does not, however, plead specific facts to support these claims, such as identifying a specific component sold for a direct infringer's use or specific instructions provided by Millennium that would encourage infringement.
- Willful Infringement: The complaint alleges that Millennium has "actual knowledge" of both patents and that its infringement "has been deliberate, willful and wanton" (Compl. ¶¶ 14, 20). These allegations are made on "information and belief" and form the basis for seeking enhanced damages.
VII. Analyst’s Conclusion: Key Questions for the Case
Definitional Scope: The case may turn on claim construction, specifically whether the term "a set of known normative data" can be interpreted broadly enough to read on Millennium's alleged practice of providing "comparative results" by comparing a patient to "others patients," or if the term requires the more rigorous statistical models and confidence intervals described in the patent specification.
Evidentiary Proof of Infringement: Given the lack of technical detail in the complaint, a central factual question will be what evidence Plaintiff can produce to demonstrate that Millennium's proprietary methods actually perform the claimed step of "normalizing... by determining the metabolite/creatinine ratio." The dispute will likely focus on whether this specific calculation is part of Millennium's process or if there is a fundamental mismatch in technical operation.