DCT
1:19-cv-00374
Roche Diabetes Care Inc v. Valeritas Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Roche Diabetes Care, Inc. (Delaware)
- Defendant: Valeritas, Inc. and Valeritas Holdings, Inc. (Delaware)
- Plaintiff’s Counsel: Fish & Richardson P.C.
- Case Identification: 1:19-cv-00374, D. Del., 02/22/2019
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because both Defendant entities are incorporated in Delaware.
- Core Dispute: Plaintiff alleges that Defendants’ V-Go wearable insulin delivery device infringes a patent related to a hydraulic system for administering injectable products at a controlled rate.
- Technical Context: The technology concerns wearable infusion pumps, a key component in the management of diabetes that enables continuous, long-term drug delivery.
- Key Procedural History: Plaintiff alleges sending a letter to Defendant on April 20, 2018, offering a license to the patent-in-suit, which may be used to support allegations of willful infringement. Public records indicate that on April 23, 2019, subsequent to the filing of this complaint, the inventor filed a disclaimer for claims 1-3, 5-8, and 16-21 of the patent-in-suit. As the complaint asserts claims 2 and 4, which are dependent on the now-disclaimed Claim 1, this subsequent procedural event raises a threshold question regarding the viability of the asserted claims.
Case Timeline
| Date | Event |
|---|---|
| 1999-08-18 | ’795 Patent Priority Date |
| 2004-05-18 | ’795 Patent Issue Date |
| 2018-04-20 | Roche sends license offer letter to Valeritas |
| 2019-02-22 | Complaint Filing Date |
| 2019-04-23 | Disclaimer of Claims 1-3, 5-8, 16-21 of '795 Patent filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 6,736,795 - “Device for Administering an Injectable Product,” issued May 18, 2004.
The Invention Explained
- Problem Addressed: The patent describes a problem with prior art injection devices, such as those using drive springs, where the drive force changes over the course of delivery, resulting in an "undesirable variable delivery rate" (Compl. ¶16; ’795 Patent, col. 2:31-39).
- The Patented Solution: The invention proposes a device that uses a "transmission link" between the drive mechanism and the delivery mechanism. This link contains a "fluid space for an incompressible fluid" and a "pressure reducing means" ('795 Patent, Abstract; col. 2:13-17). This hydraulic coupling attenuates the force from the drive means (e.g., a spring), allowing for a stronger, more stable energy source to be used while ensuring the product is "evenly delivered" over the course of an infusion (Compl. ¶17; ’795 Patent, col. 2:35-43).
- Technical Importance: This design allows an infusion device to use a high-energy drive source, like a powerful spring, but smooth out its force delivery, which is critical for providing consistent, low-volume drug administration over extended periods (Compl. ¶17; ’795 Patent, col. 2:35-51).
Key Claims at a Glance
- The complaint asserts claims 2 and 4, which depend on independent claim 1 (Compl. ¶27).
- Independent Claim 1, now disclaimed, recites the following essential elements:
- a) a casing;
- b) a container for the product accommodated by said casing;
- c) a delivering means for delivering product out of said container;
- d) a drive means; and
- e) a transmission link via which said drive means drives said delivering means, said transmission link comprising a fluid space for an incompressible fluid and a pressure reducing means, wherein said fluid space can be impinged on a drive side by pressure from said drive means and said pressure reducing means reduces a fluid pressure generated by said drive means toward a driven side of said fluid space.
- The complaint does not explicitly reserve the right to assert other claims but notes its infringement examples are "non-limiting" (Compl. ¶28).
III. The Accused Instrumentality
Product Identification
The V-Go, a wearable and disposable insulin delivery device (Compl. ¶4).
Functionality and Market Context
- The V-Go is marketed for "continuous subcutaneous infusion of insulin over 24 hours and on-demand bolus dosing" for adult patients (Compl. ¶22).
- The complaint alleges the device operates via a "spring driven" mechanism that pushes a "viscous fluid" through a "basal rate flow restrictor" (Compl. ¶30, ¶34). This fluid movement, in turn, acts on a piston to dispense insulin from a separate container at a preset basal rate (Compl. ¶32). A schematic in the complaint illustrates the device's internal components, including separate compartments for a viscous fluid and insulin. (Compl. ¶30, schematic).
IV. Analysis of Infringement Allegations
'795 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a) a casing | The Accused Product includes a casing. A schematic in the complaint shows the external housing of the V-Go device. | ¶30 | col. 4:4-6 |
| b) a container for the product accommodated by said casing | The Accused Product incorporates a container for insulin, which is identified in a provided schematic. | ¶31 | col. 4:7-10 |
| c) a delivering means for delivering product out of said container | The Accused Product uses a piston that is pushed to dispense insulin through a needle into the patient's subcutaneous tissue. | ¶32 | col. 4:11-15 |
| d) a drive means | The Accused Product uses a spring to place a viscous fluid under pressure, which drives the system. The complaint includes a visual highlighting this spring. | ¶33 | col. 4:56-59 |
| e) a transmission link ... comprising a fluid space for an incompressible fluid and a pressure reducing means ... | The Accused Product uses a "viscous fluid" in a separate compartment as the transmission link. This fluid is placed under pressure by the spring and passes through a "basal rate flow restrictor" which allegedly acts as the "pressure reducing means" to reduce the fluid pressure toward the driven side. | ¶33, ¶34 | col. 4:13-17 |
Identified Points of Contention
- Procedural Question: The primary issue is the legal effect of the post-complaint disclaimer of Claim 1, upon which all asserted claims (2 and 4) depend. This action may render the infringement allegations moot as pleaded.
- Scope Questions: A central question for claim construction would have been whether the accused "basal rate flow restrictor," depicted as a single component, falls within the scope of the claimed "pressure reducing means." The patent specification heavily details this means as a system of long, spiral capillaries ('795 Patent, col. 5:29-47, Fig. 2).
- Technical Questions: A factual dispute may arise over whether the "viscous fluid" used in the V-Go device functions as an "incompressible fluid" as required by the claim. The complaint provides a schematic showing how a "basal rate flow restrictor" reduces pressure generated by the drive means. (Compl. ¶34, schematic). Another schematic illustrates how the drive means' working stroke is allegedly transmitted through the fluid space. (Compl. ¶35, schematic).
V. Key Claim Terms for Construction
The Term: "pressure reducing means"
Context and Importance
This term is central to the invention's purported novelty of smoothing out the delivery force. The infringement analysis depends on whether the accused "basal rate flow restrictor" is covered by this term. Practitioners may focus on this term to dispute whether a simple restrictor performs the function of the detailed capillary system described in the patent.
Intrinsic Evidence for Interpretation
- Evidence for a Broader Interpretation: The patent states that the pressure reducing means "creates a fluid connection which only allows a delayed flow of the fluid" ('795 Patent, col. 2:27-29), suggesting a functional definition not tied to a specific structure. The claim language itself uses the "means" format, which can imply a broader functional scope.
- Evidence for a Narrower Interpretation: The specification's preferred embodiment describes the "pressure reducing means" as being formed by a "capillary body" and an outer sleeve, creating a "spiral" fluid channel ('795 Patent, col. 5:29-37, col. 6:36-42). An argument could be made that the scope of the "means" is limited to the corresponding structure disclosed in the specification and its equivalents.
The Term: "incompressible fluid"
Context and Importance
This term defines a required physical property of the hydraulic medium in the "transmission link." The validity of the infringement allegation hinges on the V-Go's "viscous fluid" meeting this limitation.
Intrinsic Evidence for Interpretation
- Evidence for a Broader Interpretation: The patent does not provide a special definition for "incompressible fluid," suggesting it should be given its plain and ordinary meaning in the relevant art, which typically accounts for substantial, rather than perfect, incompressibility.
- Evidence for a Narrower Interpretation: The specification discloses that "A highly viscous oil is preferably used as the working fluid" ('795 Patent, col. 5:24-25). A party could argue that this preference, combined with the technical requirements of the hydraulic system, implicitly narrows the scope of "incompressible fluid" to fluids with specific properties, like high viscosity oil.
VI. Other Allegations
Indirect Infringement
The complaint alleges induced infringement, stating that Valeritas "encourages and intends" infringement by providing marketing materials, a website, and user instructions that teach customers to use the V-Go in an infringing manner (Compl. ¶23, ¶38, ¶40).
Willful Infringement
The complaint alleges willfulness based on pre-suit knowledge of the ’795 Patent. This allegation is supported by reference to a license offer letter Roche sent to Valeritas on April 20, 2018, nearly ten months before the complaint was filed (Compl. ¶3, ¶28, ¶41-42).
VII. Analyst’s Conclusion: Key Questions for the Case
- A dispositive threshold question will be one of procedural viability: what is the legal consequence of the Plaintiff asserting claims (2 and 4) that are dependent on a claim (Claim 1) that was statutorily disclaimed after the complaint was filed? This post-filing event may render the entire action moot.
- Assuming the case proceeds, a core issue would be one of claim scope: can the term "pressure reducing means," which the patent describes as a complex capillary system, be construed to cover the accused V-Go's "basal rate flow restrictor"? The outcome of this construction would likely determine infringement.
- A key evidentiary question would be one of technical operation: does the "viscous fluid" in the accused device function as an "incompressible fluid" in a manner consistent with the patent's hydraulic transmission mechanism, or is there a fundamental mismatch in how the two systems operate?