Auto Injection Tech LLC v. GSK PLC

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Auto Injection Technologies LLC (Texas)
  • Defendant: GSK plc (Great Britain)
  • Plaintiff’s Counsel: Fabricant LLP
• Case Identification: 2:25-cv-00373, E.D. Tex., 04/09/2025
• Venue Allegations: Venue is alleged to be proper because the Defendant is a foreign corporation, which may be sued in any judicial district, and because Defendant allegedly has sufficient minimum contacts with the Eastern District of Texas through the sale of the accused products.
• Core Dispute: Plaintiff alleges that Defendant’s Trelegy brand inhaler, which includes a dose-counting mechanism, infringes a patent related to mechanical counters for inhaler devices.
• Technical Context: The technology concerns mechanical dose counters integrated into dry powder inhalers, which are important for patient safety by providing a clear indication of the number of remaining doses.
• Key Procedural History: The complaint notes that the asserted patent was invented during the inventors' time at Sanofi-Aventis Deutschland GmbH, which is identified as a direct competitor to Defendant GSK, suggesting a potential competitive context for the dispute.

Case Timeline

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

U.S. Patent No. 8,083,127 - "Slave Wheel Counter Mechanism Useable With An Inhaler," issued December 27, 2011

The Invention Explained

• Problem Addressed: The patent's background section identifies the risk of patients unknowingly using an inhaler beyond its intended number of doses, which could result in receiving an incorrect or sub-therapeutic dose with "possibly dangerous consequences" (’127 Patent, col. 1:43-49).
• The Patented Solution: The invention is a mechanical counter for an inhaler that displays the number of doses remaining. It uses multiple indicator members, such as a "unit wheel" and a "tens wheel," that are rotatable about a central axis (’127 Patent, col. 2:6-14). The core of the described embodiment is a "slave wheel" that rotates on an offset axis and functions as a rotatory intermittent drive transfer mechanism. This mechanism ensures that after a full rotation of the unit wheel (e.g., ten doses), the tens wheel is advanced by a single increment (’127 Patent, Abstract; col. 2:57-67).
• Technical Importance: The described mechanism provides a compact and reliable method for integrating a multi-digit dose counter into an inhaler, giving patients a clear warning when the device is running low and needs replacement (’127 Patent, col. 1:49-57).

Key Claims at a Glance

• The complaint asserts infringement of at least independent claim 9 (Compl. ¶20).
• The essential elements of independent claim 9 are:
  • An inhaler, comprising:
  • an air channel for delivering a medicament;
  • a counter indicating a number of doses of the medicament that have been dispensed or that remain,
  • wherein the counter comprises a first indicator member which moves one increment for each dose of the medicament that is delivered
  • and a second indicator member which moves one increment for every n doses of medicament that are delivered, where n is greater than 1.
• The complaint reserves the right to assert other claims of the ’127 Patent (Compl. ¶18).

III. The Accused Instrumentality

Product Identification

The complaint identifies the accused products as GSK's "inhaler devices," specifically naming the "Trelegy" inhaler (Compl. ¶11). The complaint also references "the shape of the ELLIPTA inhaler" as a GSK trademark (Compl. p. 4).

Functionality and Market Context

• The accused product is described as a dry powder inhaler that comprises an "air channel to dispense the medicament" to the user (Compl. ¶22). A cited screenshot provides user instructions to "Take one long, steady, deep breath in through your mouth" (Compl. p. 6).
• A central feature is its dose counter, which allegedly "tracks the remaining doses of medicament the user has, and decrements the remaining doses" (Compl. ¶23). The complaint alleges that to accomplish this, the device uses "two counters, a tens counter and a ones counter" (Compl. ¶23). A diagram from a third-party publication shows the counter displaying "30," then "9" (implying 29), and finally "0" (Compl. p. 7). This diagram is presented as evidence of a two-part counter that decrements with use.
• The complaint alleges the product has significant market importance, citing a GSK financial report that lauds Trelegy as the "number one brand in COPD and asthma globally" (Compl. ¶14).

IV. Analysis of Infringement Allegations

'127 Patent Infringement Allegations

Identified Points of Contention

• Scope Questions: Claim 9 is written broadly and does not explicitly recite the "slave wheel" mechanism that is the focus of the patent's title, abstract, and detailed description. A central legal question will be whether the scope of the term "counter" in claim 9 is implicitly limited to the specific "slave wheel" embodiment described in the specification, or if it covers any two-part counter mechanism meeting the functional requirements of the claim.
• Technical Questions: The complaint relies on high-level functional descriptions and third-party materials to allege infringement. It does not provide evidence on the specific internal mechanics of the Trelegy counter. A key factual question will be whether the accused device's internal gear and wheel assembly operates in a manner that falls within the scope of the claim, particularly how the "tens" and "ones" indicators are mechanically linked.

V. Key Claim Terms for Construction

• The Term: "counter"
• Context and Importance: The definition of "counter" will be dispositive. The patent is titled "Slave Wheel Counter Mechanism," and the specification heavily details this specific embodiment. However, asserted claim 9 does not mention a "slave wheel." Practitioners may focus on this term because if it is construed broadly to mean any mechanism with two functionally-linked indicator members, the Plaintiff's infringement case may be strengthened. If it is construed narrowly to require the "slave wheel" architecture, the Plaintiff would face a higher burden to prove infringement.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: Claim 9 itself recites the elements of the counter functionally, without structural limitations like a "slave wheel" or an "offset axis" (’127 Patent, col. 12:35-50). The language in the "Summary and Objects of the Invention" also initially describes the counter in broader, functional terms before detailing the preferred slave wheel embodiment (’127 Patent, col. 2:4-23).
  • Evidence for a Narrower Interpretation: The patent's Abstract explicitly describes a "slave wheel, rotatable about an axis offset from the central axis" as a key feature. The Detailed Description consistently and repeatedly explains the operation of this specific slave wheel mechanism, potentially suggesting this structure is not merely a preferred embodiment but is central to the invention as a whole (’127 Patent, Abstract; col. 3:60-67).

VI. Other Allegations

• Indirect Infringement: The complaint alleges induced infringement, stating that GSK provides "instructions, documentation, and other information to customers and end-users suggesting that they use the Accused Products in an infringing manner" (Compl. ¶24). It also pleads contributory infringement, alleging the accused components are material to the invention, not staple articles of commerce, and are known by GSK to be especially adapted for infringement (Compl. ¶25).
• Willful Infringement: Willfulness is alleged based on GSK's status as a direct competitor to Sanofi-Aventis (where the patent was developed), which the complaint asserts gave GSK knowledge of the patent since its issuance. The complaint further alleges that GSK was "willfully blind" and maintains a "policy or practice of not reviewing the patents of others" (Compl. ¶10).

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

The resolution of this case will likely depend on the answers to two central questions:

1. A core issue will be one of claim scope: Can the term "counter" in claim 9, which is functionally defined, be construed broadly to read on any two-part dose-counting mechanism, or will the court limit its meaning to the specific "slave wheel" architecture that is heavily emphasized throughout the patent's specification?
2. A key evidentiary question will be one of technical proof: Assuming a broad construction of the claim, what evidence will discovery reveal about the actual internal mechanism of the Trelegy inhaler's counter? The case will move from the high-level allegations in the complaint to a detailed, gear-level comparison of the accused device and the patent's claims.