Alere, Inc. v. Church & Dwight Co., Inc.

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Inverness Medical Innovations, Inc. (Delaware), Inverness Medical Switzerland GMBH (Switzerland), and SPD Swiss Precision Diagnostics GMBH (Switzerland)
  • Defendant: Church & Dwight Company, Inc. (Delaware)
  • Plaintiff’s Counsel: Hogan Lovells U.S. LLP; Clements & Pineault, LLP
• Case Identification: 1:10-cv-10027, D. Mass., 07/20/2010
• Venue Allegations: Venue is alleged to be proper under 28 U.S.C. §§ 1391(b) & (c) and 1400(b), although the complaint does not specify the factual basis for venue in the District of Massachusetts.
• Core Dispute: Plaintiffs allege that Defendant’s FIRST RESPONSE®GOLD™ Digital pregnancy test products infringe three patents related to the internal operation of electronic lateral flow assay readers.
• Technical Context: The lawsuit concerns the technology inside digital diagnostic devices, such as at-home pregnancy tests, which electronically interpret the results of a chemical assay to improve accuracy and provide user-friendly features.
• Key Procedural History: The complaint alleges that Plaintiffs' own CLEARBLUE®Easy™ digital pregnancy test device practices claims of the patents-in-suit, which may be raised later to support arguments for commercial success and non-obviousness. No other significant procedural events are mentioned.

Case Timeline

Date	Event
2003-06-04	Earliest Priority Date for ’532, ’394, and ’378 Patents
2007-07-03	U.S. Patent No. 7,239,394 Issued
2008-01-01	U.S. Patent No. 7,315,378 Issued
2008-01-08	U.S. Patent No. 7,317,532 Issued
2010-07-20	Complaint Filed

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

U.S. Patent No. 7,317,532 - Flow Sensing for Determination of Assay Results, Issued January 8, 2008

The Invention Explained

• Problem Addressed: The patent identifies that in lateral flow assays (the technology behind test strips), the rate at which a liquid sample travels along the porous carrier can vary significantly from test to test (’532 Patent, col. 2:36-44). An abnormally fast or slow flow rate, caused by "flooding" or "blocking," can lead to inaccurate results (’532 Patent, col. 2:30-44).
• The Patented Solution: The invention is an electronic assay reader that actively monitors the sample's flow rate. It uses an optical system to detect when the fluid front reaches at least two different points on the test strip and a processor to calculate the time elapsed between these detections (’532 Patent, Abstract). If this calculated flow rate falls outside a predetermined acceptable range, the device can reject the assay result as invalid, thereby preventing an erroneous reading (’532 Patent, col. 3:5-11).
• Technical Importance: This technology introduces a procedural control check into a disposable diagnostic device, aiming to increase the reliability and accuracy of results by identifying and rejecting tests compromised by fluid flow abnormalities.

Key Claims at a Glance

• The complaint asserts claims including dependent claim 26, which relies on independent claim 24 (Compl. ¶14).
• Independent Claim 24 requires:
  • A housing and a porous test strip with a sample receiving zone external to the housing and first and second zones internal to the housing.
  • A light source system to illuminate the first and second zones.
  • A light detection system to detect light from those zones.
  • A processor configured to receive signals from the detection system and "determine a result indicative of a time required for a liquid... to flow from the first zone along the flow path to the second zone."

U.S. Patent No. 7,239,394 - Early Determination of Assay Results, Issued July 3, 2007

The Invention Explained

• Problem Addressed: Conventional assay tests require users to wait for a preset period before reading the result to ensure accuracy (’394 Patent, col. 2:10-14). This waiting period can be inconvenient or, in urgent medical situations, critically slow, and reading the test too early risks a false-negative result (’394 Patent, col. 1:57-60).
• The Patented Solution: The patent describes a device that can declare a result before the full assay time has elapsed. The device's processor measures the accumulating signal (e.g., the darkness of a test line) and compares it against two predefined thresholds: an upper threshold and a lower threshold (’394 Patent, Abstract). If the signal rapidly exceeds the upper threshold (indicating a strong positive), or if it remains below the lower threshold after a certain interval (indicating a clear negative), the device can "terminate the assay" and display the result early (’394 Patent, col. 2:35-47).
• Technical Importance: This method provides a faster result for users in cases of very high or very low analyte concentrations, enhancing user experience without sacrificing the reliability of waiting a full period for intermediate results.

Key Claims at a Glance

• The complaint asserts claims including dependent claim 23, which relies on independent claim 1 (Compl. ¶23).
• Independent Claim 1 requires:
  • A computation circuit responsive to a signal representing analyte accumulation.
  • The circuit compares the signal to a first (upper) threshold.
  • The circuit compares the signal to a second (lower) threshold.
  • The circuit generates an output signal indicative of a first result if the signal exceeds the first threshold or a second result if it is less than the second threshold.
  • The circuit terminates the assay if the signal crosses either threshold under the defined conditions.

Multi-Patent Capsule

• Patent Identification: U.S. Patent No. 7,315,378, Optical Arrangement For Assay Reading Device, Issued January 1, 2008.
• Technology Synopsis: The patent addresses the challenge of ensuring accurate optical readings in an assay device where the disposable test strip may not be perfectly aligned with the internal optics (’378 Patent, col. 2:1-12). The invention describes specific optical layouts, such as using a single photodetector to receive light from multiple zones ("shared photodetector") or multiple photodetectors to receive light from a single zone ("commonly read zone"), to create an inherent signal compensation for minor physical misalignments (’378 Patent, col. 3:26-50, Abstract).
• Asserted Claims: The complaint asserts claims including dependent claim 18, which relies on independent claim 12 (Compl. ¶32).
• Accused Features: The complaint alleges that the internal optical arrangement of the FIRST RESPONSE®GOLD™ Digital product infringes the patent (Compl. ¶32).

III. The Accused Instrumentality

Product Identification

• The accused instrumentality is Defendant's "FIRST RESPONSE®GOLD™ Digital" pregnancy test (Compl. ¶14, ¶23, ¶32).

Functionality and Market Context

• The product is an at-home digital pregnancy test that electronically reads a test strip and displays the result to the user. The complaint alleges that this product competes directly with the Plaintiffs' CLEARBLUE®Easy™ digital pregnancy tests (Compl. ¶13, ¶22, ¶31). No further technical details regarding the internal operation of the accused product are provided in the complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide sufficient detail for a full claim chart analysis. It makes general allegations of infringement without mapping specific features of the accused product to the elements of the asserted claims. No probative visual evidence provided in complaint.

• ’532 Patent Infringement Allegations: The complaint alleges that the accused product is covered by one or more claims of the ’532 Patent, such as claim 26 (Compl. ¶14). The underlying infringement theory would be that the accused device contains a processor and optical system that measures the time it takes for a fluid sample to travel between two points on the test strip to perform a flow-rate validity check, as recited in independent claim 24.
• ’394 Patent Infringement Allegations: The complaint alleges that the accused product is covered by one or more claims of the ’394 Patent, such as claim 23 (Compl. ¶23). The implied infringement theory is that the accused device's software logic compares a developing test signal against both an upper and a lower threshold to determine if a result can be displayed before a maximum test time has elapsed, as recited in independent claim 1.
• Identified Points of Contention:
  • Technical Questions: A primary factual dispute will concern the actual method of operation of the accused device's software and hardware. A key question for the ’532 Patent is whether the device actually calculates a "time required for... flow" between two distinct zones as a control function, or if it uses a simpler, non-flow-based timer. For the ’394 Patent, a key question is whether the device’s logic for displaying a result uses the specific dual-threshold comparison claimed, or if it relies on a different method, such as a single threshold crossing or a fixed-time reading.

V. Key Claim Terms for Construction

Term from the ’532 Patent: "determine a result indicative of a time required for a liquid... to flow from the first zone... to the second zone" (Claim 24)

• Context and Importance: The construction of this term is critical to define what constitutes infringing "flow sensing." The dispute will center on whether this requires an explicit calculation and validation of flow rate, or if it could be read more broadly to cover any system that simply times the arrival of the fluid front at a location.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The claim language "indicative of a time" could be argued to not require a formal rate calculation (distance/time), but merely a timing check.
  • Evidence for a Narrower Interpretation: The patent specification repeatedly discusses calculating a "flow rate" and rejecting the assay if that rate is "outside the upper and lower limits" (’532 Patent, col. 3:9-11), suggesting the "determining" step is part of a specific validation process, not just a simple timer.

Term from the ’394 Patent: "terminate the assay" (Claim 1)

• Context and Importance: This term is central to the "early determination" feature. Whether the accused device "terminates the assay" will depend on the definition of that action. Practitioners may focus on this term because it dictates the point at which the claimed early-result logic must take effect.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The specification states that upon crossing a threshold, "an early... result is then displayed" (’394 Patent, col. 3:34-35). This could support a view that "terminate" simply means the conclusion of the decision-making process, allowing a result to be shown.
  • Evidence for a Narrower Interpretation: The abstract states the device will "terminate the assay if the signal exceeds the first threshold or... is less than the second threshold." This could be argued to imply a definitive stop to all further measurement or data processing, a more stringent requirement than simply displaying an interim finding.

VI. Other Allegations

• Indirect Infringement: The complaint alleges contributory and induced infringement for all three patents (Compl. ¶14, ¶23, ¶32). The complaint does not plead specific facts, but the basis for inducement would likely be Defendant's sale of the product with user instructions that allegedly direct consumers to use the device in an infringing manner.
• Willful Infringement: The complaint alleges that Defendant "is willfully infringing" (Compl. ¶15, ¶24, ¶33). No specific facts supporting pre-suit knowledge of the patents are alleged. The claim may be intended to apply primarily to post-filing conduct, where continued sales after notice via the lawsuit could be argued to be willful.

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

1. A core issue will be one of operational equivalence: does reverse-engineering of the accused FIRST RESPONSE® product reveal that it actually practices the specific methods recited in the claims? Specifically, does its control logic (a) calculate fluid flow rate for test validation (’532 Patent) and (b) employ a dual-threshold comparison to terminate the assay early (’394 Patent), or does it achieve its results through technically distinct, non-infringing means?
2. The case will also turn on a question of definitional scope: how will the court construe key claim terms such as "determine a result indicative of a time required for... flow" (’532 Patent) and "terminate the assay" (’394 Patent)? A narrow construction tied closely to the patent’s specific embodiments would make infringement harder to prove, while a broader construction would expand the scope of infringing activity.
3. An evidentiary question will be whether Plaintiffs can demonstrate that the internal optical architecture of the accused device infringes the claims of the ’378 patent, which relate to specific arrangements of light sources and detectors designed to compensate for physical misalignment of the test strip.