DCT

2:26-cv-01797

TSK Laboratory Europe BV v. Kabushikigaisha Tasuku

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:26-cv-01797, D. Nev., 06/11/2026
  • Venue Allegations: Venue is asserted on the basis that the defendant is not a resident of the United States but is subject to the court's personal jurisdiction within the District of Nevada.
  • Core Dispute: Plaintiff alleges that Defendant's needle and syringe products infringe a patent related to a low-dead-space needle hub assembly designed to minimize residual fluid.
  • Technical Context: The technology resides in the field of medical hypodermic devices, where minimizing the waste of expensive injectable drugs, such as botulinum toxin, is a significant commercial and clinical concern.
  • Key Procedural History: The complaint alleges a prior business relationship where the Defendant acted as a contract manufacturer for the Plaintiff. It also alleges that Plaintiff provided Defendant with written notice of infringement approximately two and a half months before filing the suit, which may form the basis for a willfulness claim.

Case Timeline

Date Event
2013-10-29 '949 Patent Priority Date
2018-03-13 '949 Patent Issue Date
2025-08-01 Defendant allegedly approached Plaintiff's distributor to promote accused products (approximate date)
2026-03-31 Plaintiff allegedly sent written notice of infringement to Defendant
2026-04-09 Defendant allegedly marketed accused products at AMSPA trade show in Las Vegas
2026-06-11 Complaint Filing Date

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

U.S. Patent No. 9,913,949 - "Needle Hub Assembly for a Syringe and a Syringe Comprising such Needle Hub Assembly"

The Invention Explained

  • Problem Addressed: The patent's background section describes the problem of wasting expensive medications, specifically botulinum toxin, which can remain as residual fluid within the "dead space" of a standard syringe and needle hub connection after an injection is administered ʼ949 Patent, col. 1:59-66
  • The Patented Solution: The invention proposes a needle hub assembly with a specifically dimensioned syringe connector. The key feature is a "substantially conical receiving opening" with a length between 3-7 mm, a dimension that intentionally deviates from certain ISO standards to create a tighter connection that minimizes the volume of this dead space '949 Patent, abstract '949 Patent, col. 2:12-16 This configuration is designed to ensure that "substantially no, or at least as little as possible, toxin is left in the syringe and/or needle hub assembly" after use '949 Patent, col. 2:38-41
  • Technical Importance: By minimizing the dead space, the design directly addresses the economic problem of drug waste, which can lead to "substantial cost savings" for clinicians using high-cost injectable products '949 Patent, col. 2:41-43

Key Claims at a Glance

  • The complaint asserts independent Claim 1 of the '949 Patent Compl. ¶51 Compl. ¶56
  • The essential elements of Claim 1 are:
    • A needle hub assembly for a syringe, said assembly having a longitudinal axis comprising:
    • a needle hub body having a syringe connector for receiving an attachment member of a syringe at a first end of the body and a needle receiving portion at a second opposing end of the body,
    • a needle extending from the needle receiving portion,
    • wherein the syringe connector comprises a substantially conical receiving opening for receiving a syringe attachment member, at least a distal end thereof,
    • wherein a length of said opening, measured along the longitudinal axis, is between 3-7 mm.

III. The Accused Instrumentality

Product Identification

The complaint identifies the "TSK SELECT Needles" and "TSK Syringes" as the "Accused Products" Compl. ¶28 Compl. ¶50

Functionality and Market Context

The complaint alleges these are hypodermic needle and syringe products marketed and sold for medical use Compl. ¶¶28, 33-35 A key feature highlighted in Defendant's alleged marketing materials is a "Low dead space design" intended to "minimize[] residual chemical solution" left in the needle hub after injection Compl. ¶52 An image from the Defendant's datasheet describes how the hub of the TSK SELECT™ Needle is designed to minimize residual solution, thereby maximizing the use of solutions Compl. p. 12 The complaint alleges that Defendant is marketing these products to the same consumers as Plaintiff, creating direct competition and market confusion Compl. ¶33 Compl. ¶35

IV. Analysis of Infringement Allegations

'949 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A needle hub assembly for a syringe, said assembly having a longitudinal axis... The Accused Product is the "TSK SELECT™ Needle," which is a needle hub assembly for a syringe. ¶52 col. 2:5-6
a needle hub body having a syringe connector... and a needle receiving portion at a second opposing end of the body, The Accused Product's hub body has a connector for a syringe and a portion for receiving the needle. ¶52 col. 4:49-54
a needle extending from the needle receiving portion, The Accused Product includes a needle extending from its hub. ¶52 col. 4:54-55
wherein the syringe connector comprises a substantially conical receiving opening for receiving a syringe attachment member, at least a distal end thereof, The complaint alleges the Accused Product's syringe connector includes a substantially conical receiving opening. ¶52 col. 4:7-11
wherein a length of said opening, measured along the longitudinal axis, is between 3-7 mm. The complaint alleges, without providing specific measurements, that the Accused Product meets this dimensional limitation. ¶52 col. 6:14-16
  • Identified Points of Contention:
    • Evidentiary Question: A central issue will be whether the Plaintiff can provide evidence that the internal geometry of the accused "TSK SELECT Needle" hub meets the specific dimensional limitation of Claim 1. The complaint alleges infringement of this element but does not present measurements or reverse engineering data to show that the "length of said opening" is, in fact, "between 3-7 mm" Compl. ¶51 Compl. ¶52
    • Technical Question: It may become a point of contention whether the accused product's connector opening is "substantially conical" as required by the claim, should its geometry deviate from a perfect cone.

V. Key Claim Terms for Construction

  • The Term: "a length of said opening... is between 3-7 mm"
  • Context and Importance: This numerical range is the central feature distinguishing the invention from prior art and is the basis for the claimed "low dead space" benefit. The infringement analysis for Claim 1 will likely hinge on whether the accused product's physical dimensions fall within this precise range. Practitioners may focus on this term because it is a clear, potentially dispositive limitation.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The parties may dispute the proper methodology for measuring the "length of said opening." However, the patent specification does not appear to provide significant flexibility, as the term defines a specific, bounded numerical range.
    • Evidence for a Narrower Interpretation: The patent explicitly states that the invention "does not strictly comply with the relevant ISO standard" regarding the opening's length, indicating the patentee's intent to define the invention by this specific, non-standard dimension '949 Patent, col. 2:17-21 This emphasis on a precise dimensional range suggests the numbers should be strictly construed. The patent also provides a preferred embodiment of "approximately 6.1 +- 0.05 mm," reinforcing the importance of a specific, measurable length '949 Patent, col. 2:15-16

VI. Other Allegations

  • Indirect Infringement: The complaint's patent count focuses on direct infringement under 35 U.S.C. § 271(a) and § 271(g) (importation) Compl. ¶56 It does not contain separate allegations for induced or contributory infringement.
  • Willful Infringement: The complaint alleges willful infringement based on Defendant's alleged pre-suit knowledge of the '949 patent. Specifically, it claims that Plaintiff, through counsel, "advised JAPAN in writing that the Accused Products infringe '949 patent" on March 31, 2026, and that Defendant continued to import, use, and offer the products for sale thereafter Compl. ¶53

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

  1. A primary issue will be one of evidentiary proof: Can the Plaintiff, through discovery and expert analysis, produce factual evidence demonstrating that the internal "length of said opening" in the accused "TSK SELECT Needle" hub measures between the 3-7 mm range required by Claim 1? The current complaint makes a conclusory allegation on this critical point without providing supporting data.
  2. A second key question will relate to willfulness and damages: How will the alleged prior business relationship, where Defendant purportedly served as a contract manufacturer for Plaintiff, influence the court's assessment of knowledge and intent? The resolution of this issue could significantly impact potential damages, particularly concerning the claim for willfulness based on alleged pre-suit notice.
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