DCT

2:26-cv-01797

TSK Laboratory Europe BV v. Kabushikigaisha Tasuku

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Amended Complaint
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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:26-cv-01797, D. Nev., 09/04/2026
  • Venue Allegations: Venue is asserted on the basis that the Defendant is a foreign corporation not resident in the United States but is subject to personal jurisdiction in the District of Nevada through its alleged acts of infringement, marketing, and offers for sale directed at the district.
  • 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 medication waste.
  • Technical Context: The technology concerns single-use medical injection devices, specifically the interface between a syringe and a needle hub, which is critical for minimizing the residual volume of expensive medications left in the device after administration, particularly in fields like aesthetic medicine.
  • Key Procedural History: The complaint alleges a prior business relationship between the parties, during which Defendant allegedly became aware of the patent-in-suit. Plaintiff also alleges it provided Defendant with formal written notice of infringement approximately five months before filing the complaint.

Case Timeline

Date Event
2013-10-29 '949 Patent Priority Date
2018-03-13 '949 Patent Issue Date
2025-08-01 Defendant allegedly begins marketing Accused Products
2026-03-31 Plaintiff provides written notice of infringement to Defendant
2026-04-09 Defendant allegedly markets Accused Products at trade show in Las Vegas, NV
2026-09-04 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"

  • Patent Identification: U.S. Patent No. 9,913,949, "Needle Hub Assembly for a Syringe and a Syringe Comprising Such Needle Hub Assembly", issued March 13, 2018 (the "'949 Patent"). Compl. ¶10

The Invention Explained

  • Problem Addressed: The patent's background section describes the problem of medication waste in standard syringe and needle hub assemblies. Due to the physical space within the connection point (the "dead space"), a small but significant amount of fluid, such as expensive botulinum toxin, remains in the device after an injection is completed. '949 Patent, col. 1:50-68
  • The Patented Solution: The invention is a needle hub assembly with a specifically dimensioned syringe connector. The connector features a "substantially conical receiving opening" with a claimed length of "between 3-7 mm" '949 Patent, col. 6:15-17 As detailed in the specification and illustrated in figures, this specific geometry is designed to closely mate with a syringe tip, minimizing the enclosed volume and creating a "substantially zero dead space dosage device" to reduce waste. '949 Patent, col. 5:30-34 '949 Patent, Fig. 2
  • Technical Importance: For expensive medications administered in very small quantities, minimizing waste through optimized hub design can result in substantial cost savings and enable more accurate patient dosing. '949 Patent, col. 2:41-43

Key Claims at a Glance

  • The complaint's infringement allegations focus on independent Claim 1. Compl. ¶51
  • The essential elements of Claim 1 are:
    • A needle hub assembly for a syringe with a longitudinal axis.
    • A needle hub body with a syringe connector at a first end and a needle receiving portion at a second end.
    • A needle extending from the needle receiving portion.
    • The syringe connector comprising a substantially conical receiving opening with a length between 3-7 mm along the longitudinal axis.

III. The Accused Instrumentality

Product Identification

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

Functionality and Market Context

  • The Accused Products are presented as a medical needle and syringe system. Compl. ¶28 The complaint alleges that the "TSK SELECT Needle" is a needle hub assembly that includes a "luer compatible syringe connector" and a "needle receiving portion" at opposing ends. Compl. ¶57 Compl. p. 13 An image from the Defendant's marketing materials, included in the complaint, highlights a "Low dead space design" intended to "minimize residual chemical solution." Compl. p. 14
  • The complaint alleges that the Defendant is marketing the Accused Products to the same customers and distributors as the Plaintiff, including those in the aesthetic medicine field, creating direct competition. Compl. ¶33 Compl. ¶35

IV. Analysis of Infringement Allegations

The complaint alleges that the Accused Products infringe at least Claim 1 of the '949 Patent, both literally and under the doctrine of equivalents. Compl. ¶52 The core infringement allegations from the complaint are summarized below.

'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 comprising: The Accused Products are alleged to "comprise a needle hub assembly for a syringe." ¶56 col. 5:4-5
a. 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, The Accused Products are alleged to comprise a needle hub body with a syringe connector at one end and a needle receiving portion at the other, as shown in a product image. Compl. p. 13 ¶57 col. 5:6-11
b. a needle extending from the needle receiving portion, The Accused Products are alleged to "comprise a needle extending from the needle receiving portion." ¶58 col. 5:12-13
c. wherein the syringe connector comprises a substantially conical receiving opening for receiving a syringe attachment member... wherein a length of said opening, measured along the longitudinal axis, is between 3-7 mm The Accused Products are alleged to include a syringe connector with a receiving opening that meets this limitation, "either literally or under the doctrine of equivalents." ¶59 col. 6:12-17

Identified Points of Contention

  • Scope Questions: The complaint explicitly anticipates a dispute over the "between 3-7 mm" length limitation by pleading infringement under the doctrine of equivalents. Compl. ¶59 Compl. ¶60 This raises the question of whether the accused device's opening, if found to be outside the 3-7 mm range, can be considered equivalent under the function-way-result test.
  • Technical Questions: A central factual question will be the precise, as-manufactured length of the receiving opening in the accused "TSK SELECT Needle." The complaint does not provide a specific measurement, making this a matter for discovery and expert testimony.

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 primary feature that purports to distinguish the invention from prior art and enable the low-dead-space benefit. The infringement analysis will likely hinge on whether the accused product's dimensions fall within this range literally, or alternatively, if they are equivalent. Practitioners may focus on this term because the complaint preemptively raises a doctrine of equivalents argument, signaling that the literal measurement may be a point of dispute. Compl. ¶60
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A party arguing for a broader scope may point to the plain language of Claim 1, which explicitly defines the invention using the "3-7 mm" range, suggesting that any dimension within this range is covered. '949 Patent, col. 6:15-17 The general description of the problem in the background does not tie the solution to a more specific dimension. '949 Patent, col. 1:50-68
    • Evidence for a Narrower Interpretation: A party arguing for a narrower scope may highlight that the abstract and a preferred embodiment in the detailed description both disclose a much more specific length of "approximately 6.1 +0.05 mm." '949 Patent, abstract '949 Patent, col. 2:15-16 This could be used to argue that the true inventive concept is narrower than the full 3-7 mm range, potentially limiting the scope of equivalents.

VI. Other Allegations

  • Willful Infringement: The complaint alleges willful infringement based on both pre-suit and post-suit knowledge. Compl. ¶53 It alleges Defendant was aware of the '949 Patent "since it issued" because of a prior business relationship between the parties. Compl. ¶22 It further alleges that the Plaintiff, through counsel, provided Defendant with written notice of infringement on March 31, 2026, and that Defendant's allegedly infringing activities continued thereafter. Compl. ¶53

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

This case appears to center on a well-defined technical feature in a competitive market. The key questions for the court will likely be:

  1. A central factual question will be one of measurement and scope: Does the accused "TSK SELECT Needle" hub have a receiving opening with a length that falls within the literally claimed "between 3-7 mm" range specified in Claim 1 of the '949 Patent?

  2. Should the accused product's dimensions fall outside the literal range, a key legal question will be one of equivalence: As alleged by the plaintiff, does the accused hub's opening perform substantially the same function (enabling a low-dead-space connection) in substantially the same way (via its specific conical interface) to achieve substantially the same result (minimized medication waste), thereby infringing under the doctrine of equivalents?

  3. A critical question for damages will be willfulness: Does the evidence support the allegation of pre-suit knowledge based on the parties' prior relationship, or did knowledge only attach after the formal notice letter? Furthermore, did the defendant's conduct after receiving notice rise to the level of objective recklessness required to support enhanced damages?