DCT
1:24-cv-00668
Roche Diabetes Care Inc v. Trividia Health Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Roche Diabetes Care, Inc. (Delaware)
- Defendant: Trividia Health, Inc. (Delaware)
- Plaintiff’s Counsel: McCarter & English, LLP; Wilmer Cutler Pickering Hale and Dorr LLP
- Case Identification: 1:24-cv-00668, D. Del., 06/04/2024
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because Trividia is a Delaware corporation and conducts business in the district.
- Core Dispute: Plaintiff alleges that Defendant’s TRUE METRIX brand of blood glucose test strips, and the methods used to produce them, infringe patents related to the specific layered structure of the test strip and a mass-manufacturing process for creating it.
- Technical Context: The technology concerns disposable electrochemical biosensors, commonly known as test strips, used by individuals for self-monitoring of blood glucose levels, a critical component of diabetes management.
- Key Procedural History: The complaint alleges that Defendant had pre-suit knowledge of the patents through various channels, including its own patents citing Roche’s patents, direct competition with Roche’s marked products, and a predecessor’s patent application citing the application for one of the patents-in-suit. Plaintiff also alleges it provided direct notice via a letter on April 28, 2023, and a detailed presentation on June 27, 2023, which form the basis for its willfulness allegations.
Case Timeline
| Date | Event |
|---|---|
| 2003-06-20 | Priority Date for ’467 and ’849 Patents |
| 2010-06-01 | Issue Date for U.S. Patent No. 7,727,467 |
| 2011-02-22 | Issue Date for U.S. Patent No. 7,892,849 |
| 2014-08-24 | FDA Clearance for Accused TRUE METRIX Products Announced |
| 2023-04-28 | Plaintiff sent notice letter to Defendant identifying the ’467 Patent |
| 2023-06-27 | Plaintiff gave presentation to Defendant alleging infringement of both patents |
| 2024-06-04 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,727,467 - Reagent Stripe for Test Strip
- Patent Identification: U.S. Patent No. 7727467, “Reagent Stripe for Test Strip,” issued June 1, 2010.
The Invention Explained
- Problem Addressed: The patent describes challenges in manufacturing accurate test strips that require very small sample volumes. Specifically, when applying liquid reagent into a pre-formed test strip chamber, phenomena like the "meniscus effect" can cause the reagent layer to be uneven, leading to inconsistent and inaccurate test results (’467 Patent, col. 1:49-2:10).
- The Patented Solution: The invention is a test strip with a specific layered structure designed for mass production. A key feature is that the reagent layer is applied as a thin, uniform stripe onto the base substrate before the spacing layer (which forms the walls of the sample chamber) is laminated on top. This process results in a structure where the reagent layer is "sandwiched" between the base and spacing layers and extends all the way to the side edges of the strip, creating a smooth, consistent floor for the sample chamber (’467 Patent, Abstract; col. 3:1-6).
- Technical Importance: This structural approach allows for the creation of a very thin and uniform reagent layer, which improves the reproducibility and accuracy of tests that use sub-microliter sample volumes (’467 Patent, Abstract).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶26).
- Claim 1 of the ’467 Patent requires:
- A base substrate having a working electrode and a counter electrode formed thereon and having two opposite side edges and an end edge;
- A spacing layer overlying the base substrate and having a void that at least partially defines a sample-receiving chamber;
- A covering layer overlying the spacing layer; and
- A reagent layer disposed in the sample-receiving chamber, covering a portion of the base substrate and at least one electrode, where the reagent layer extends under the spacing layer to the two side edges and is sandwiched between the spacing layer and the base substrate.
- The complaint reserves the right to assert additional claims (Compl. ¶25).
U.S. Patent No. 7,892,849 - Reagent Stripe for Test Strip
- Patent Identification: U.S. Patent No. 7892849, “Reagent Stripe for Test Strip,” issued February 22, 2011.
The Invention Explained
- Problem Addressed: The patent addresses the same manufacturing challenge as its parent ’467 patent: how to mass-produce test strips with small sample chambers and highly uniform reagent layers to ensure test accuracy (’849 Patent, col. 1:24-2:38).
- The Patented Solution: The ’849 patent claims the method of manufacturing the test strip structure described in the ’467 patent. The claimed process involves starting with a continuous "web" of base material, forming electrodes on it, applying a continuous "stripe" of reagent parallel to the web's edge, laminating the spacing and covering layers on top, and finally, cutting individual test strips from the laminated web. This final cutting step simultaneously defines the sides of the test strip and the side edges of the reagent layer, ensuring they are coextensive (’849 Patent, Abstract; col. 3:42-4:23).
- Technical Importance: This reel-to-reel manufacturing method enables the cost-effective mass production of test strips with the novel structure that improves accuracy for small sample volumes (’849 Patent, Abstract).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶44).
- Claim 1 of the ’849 Patent requires the method steps of:
- (a) providing a web of base substrate material;
- (b) forming an electrode set on the web;
- (c) applying a stripe of reagent material to the web, parallel to the web edge;
- (d) laminating a web of spacing material on top;
- (e) aligning and laminating a web of covering layer material over the other layers; and
- (f) cutting a test strip from the laminated web, where the cut defines the sides of the strip and results in a reagent layer extending to the sides under the spacing layer.
- The complaint reserves the right to assert additional claims (Compl. ¶43).
III. The Accused Instrumentality
Product Identification
- The accused products are the TRUE METRIX® Test Strips and TRUE METRIX® PRO Test Strips (Compl. ¶13). For the ’849 patent, the accused instrumentality is the method Trividia performs in the United States to manufacture these products (the "Infringing Method") (Compl. ¶¶15, 45).
Functionality and Market Context
- The accused products are disposable plastic strips used with a corresponding meter to measure blood glucose levels (Compl. ¶29). The complaint alleges they are composed of multiple layers, including a base substrate with electrodes, a spacing layer, a covering layer, and a reagent layer (Compl. ¶¶28-37). According to product documentation cited in the complaint, when blood enters the strip, glucose reacts with chemicals and electrodes to produce a measurable electrical current (Compl. ¶29). Trividia allegedly manufactures these products in the United States (Compl. ¶45). An image from the Defendant’s marketing materials shows the products advertised with “TRIPLE SENSE TECHNOLOGY” and a “MADE IN USA” emblem (Compl. p. 5).
IV. Analysis of Infringement Allegations
Infringement Allegations: U.S. Patent No. 7,727,467
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a base substrate having a working electrode and a counter electrode formed thereon and having two opposite side edges and an end edge; | The accused strips have a bottom base substrate with a working and counter electrode formed on it. An image shows the base substrate with its electrodes after other layers have been removed. | ¶¶28-30 | col. 8:21-40 |
| a spacing layer overlying the base substrate and having a void that at least partially defines a sample-receiving chamber; | The accused strips have a spacing layer on top of the base substrate, which contains a void that defines the sample-receiving chamber. | ¶¶31-34 | col. 11:59-12:4 |
| a covering layer overlying the spacing layer; and | The accused strips have a top covering layer placed over the spacing layer. | ¶35 | col. 12:20-24 |
| a reagent layer disposed in the sample-receiving chamber and covering a portion of the base substrate and at least one of the electrodes, the reagent layer extending under the spacing layer to the two side edges of the base substrate and being sandwiched between the spacing layer and the base substrate. | The accused strips contain a reagent layer (annotated in yellow in an image) that is disposed in the chamber, covers the electrodes, extends to the two side edges of the substrate, and is sandwiched between the spacing and base layers. | ¶¶36-37 | col. 17:50-18:9 |
Identified Points of Contention (’467 Patent)
- Scope Questions: The analysis may focus on the precise meaning of the reagent layer being "sandwiched" between the spacing layer and base substrate while also "extending under the spacing layer to the two side edges." The dispute could turn on whether the accused product's architecture meets this specific structural relationship, or if its reagent is configured in a materially different way.
- Technical Questions: The complaint provides annotated images of a disassembled test strip to show the reagent layer extending to the side edges (Compl. p. 16). A key evidentiary question will be whether discovery confirms that this structure exists in the final, assembled product and is a result of the claimed manufacturing legacy, rather than an artifact of disassembly.
Infringement Allegations: U.S. Patent No. 7,892,849
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| (a) providing a web of base substrate material having first and second web edges; | Based on a video allegedly showing the manufacturing process of Trividia's predecessor, the process begins with a "web" of rigid plastic backing. | ¶¶49, 50 | col. 3:44-46 |
| (b) forming an electrode set on the web comprising a working electrode and a counter electrode; | The process allegedly uses "precision lasers that ablate electrodes on the test strips" to form the electrode set on the web. | ¶50 | col. 3:47-48 |
| (c) applying a stripe of reagent material to the web and covering at least one electrode... the stripe being oriented substantially parallel to the first web edge; | Based on analysis of the final product, the complaint alleges the manufacturing method applies the reagent layer as a stripe parallel to the first web edge. | ¶51 | col. 3:49-53 |
| (d) laminating a web of spacing material on top of the base substrate material and providing a cavity... that at least partially defines a sample receiving chamber; | The video allegedly shows that material is added "to protect the electrodes and create a space where chemistry is applied." | ¶52 | col. 3:54-59 |
| (e) aligning and then laminating a web of covering layer material over the web of base substrate and spacing material; and | The video allegedly shows that a "final layer protects the chemistry and helps draw the blood into the test strip." | ¶53 | col. 4:1-3 |
| (f) cutting a test strip from the laminated web... the cutting defining the first and second sides of the test strip, wherein the test strip comprises a reagent layer extending to the first and second sides of the test strip under the spacing layer. | The video allegedly explains that "the strips are cut with high speed rotary blades into individual strips," with the video showing that this cutting defines the sides of each strip. | ¶54 | col. 4:4-10 |
Identified Points of Contention (’849 Patent)
- Technical Questions: A screenshot from a promotional video shows an employee wearing a shirt with the "Nipro" logo, the name of Trividia's predecessor (Compl. p. 20). The infringement allegations for this method patent rely heavily on this video and on inferences drawn from the final product's structure. A central question will be whether Plaintiff can prove through discovery that Trividia’s current U.S. manufacturing process is the same or materially the same as the one depicted.
- Scope Questions: The dispute may involve whether Trividia's alleged use of lasers to "ablate" electrodes meets the claim limitation of "forming" an electrode set. Similarly, questions may arise as to whether the application of reagent in Trividia's process meets the specific limitations of an applied "stripe" that is "substantially parallel" to a web edge.
V. Key Claim Terms for Construction
For the ’467 Patent
- The Term: "reagent layer extending under the spacing layer to the two side edges of the base substrate and being sandwiched between the spacing layer and the base substrate"
- Context and Importance: This phrase describes the core structural novelty of the claimed test strip. Proving infringement requires showing that the accused products embody this specific three-dimensional arrangement, making its construction central to the dispute.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent's "Summary of the Invention" states the reagent layer "is sandwiched between the spacing layer and the base substrate and extends to the first and second sides of the base substrate" (’467 Patent, col. 1:57-61), which could be read to cover any structure with this general configuration.
- Evidence for a Narrower Interpretation: The detailed description links this structure to a specific manufacturing process where the reagent is applied before other layers and then cut, creating coextensive edges (’467 Patent, col. 18:1-9). This may support a narrower construction where the structure must bear the hallmarks of that specific process.
For the ’849 Patent
- The Term: "cutting a test strip from the laminated web produced from steps (a)-(e), the cutting defining the first and second sides of the test strip, wherein the test strip comprises a reagent layer extending to the first and second sides of the test strip under the spacing layer."
- Context and Importance: This final step defines how the manufacturing process creates the novel product structure. The infringement analysis for this process claim will depend on how this "cutting" step is defined and what it must achieve.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim language is functional, describing what the cutting "defines" and what the resulting strip "comprises." This could support an interpretation that covers any cutting technique that produces the specified outcome.
- Evidence for a Narrower Interpretation: The specification emphasizes that this cutting process is what allows the reagent layer edges to be "aligned with the side and dose receiving edges of the test strip" (’849 Patent, Abstract), suggesting the cutting step must be the direct cause of this alignment.
VI. Other Allegations
Indirect Infringement
- The complaint alleges inducement of infringement of the ’467 patent, stating Trividia provides customers and end users with instructions for using the infringing test strips, such as the "TRUE METRIX® Self-Monitoring Test Strips Instructions for Use" (Compl. ¶38).
Willful Infringement
- The complaint alleges willful infringement of both patents based on pre- and post-suit knowledge. The alleged bases for knowledge include: Trividia hiring former Roche employees; Trividia's own patents citing Roche patents, including one sharing an inventor with the patents-in-suit; a predecessor's patent application search report citing the application that became the ’467 patent; Roche's marking of its competing products; and direct notice via a letter dated April 28, 2023, and a subsequent presentation on June 27, 2023, that detailed the alleged infringement (Compl. ¶¶17-22).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of structural verification: can Plaintiff prove through discovery that the accused test strips, in their final assembled form, possess the precise layered architecture required by the ’467 patent, specifically a reagent layer that is "sandwiched" and extends "under the spacing layer to the two side edges"?
- A second central dispute will be one of process confirmation: does the evidence, which the complaint bases on a predecessor's promotional video and reverse-engineering of the final product, accurately reflect Trividia's current U.S. manufacturing method as claimed in the ’849 patent, particularly the steps of applying a reagent stripe parallel to a web edge and then cutting the web to define the strip's sides?
- Given the extensive allegations of pre-suit notice, a significant question will be one of scienter and intent: did Defendant's alleged knowledge of the patents, culminating in direct notice from Plaintiff in April and June 2023, establish an objectively high likelihood of infringement such that its continued manufacturing and sales constitute willful infringement?