Auto Injection Tech LLC v. Medtronic PLC

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Auto Injection Technologies LLC (Texas)
  • Defendant: Medtronic Public Limited Company (Ireland)
  • Plaintiff’s Counsel: Fabricant LLP
• Case Identification: 2:25-cv-00375, E.D. Tex., 10/09/2025
• Venue Allegations: Plaintiff alleges that venue is proper because Defendant is a foreign company subject to personal jurisdiction in the Eastern District of Texas and may therefore be sued in any judicial district.
• Core Dispute: Plaintiff alleges that Defendant’s Medtronic InPen smart insulin pen infringes seven patents related to the mechanical drive, dosing, and feedback mechanisms of drug delivery devices.
• Technical Context: The technology at issue involves mechanical components within pen-type injection devices used for self-administration of medication, a field critical to patients with chronic conditions like diabetes.
• Key Procedural History: The complaint alleges that Defendant, as a direct competitor to the patents' original assignee, Sanofi-Aventis Deutschland GmbH, was aware of or willfully blind to the asserted patents since their issuance.

Case Timeline

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

U.S. Patent No. 10,780,231 - "Drive Mechanism for a Drug Delivery Device and Drug Delivery Device," Issued Sep. 22, 2020

The Invention Explained

• Problem Addressed: The patent background describes a need for improved, non-visual user feedback in drug delivery devices, noting that such feedback is particularly important for users with poor eyesight (US 10,780,231 Patent, col. 1:31-35). Existing mechanisms may only provide feedback after an operation is complete, which is insufficient.
• The Patented Solution: The invention provides a drive mechanism with two interacting "feedback elements" that generate tactile and/or audible feedback (e.g., clicks) during a dose setting or dispensing operation ('231 Patent, Abstract). One element moves axially and has a helical structure with protrusions that interact with a second feedback element, thereby informing the user about the progress of the operation ('231 Patent, col. 2:40-50).
• Technical Importance: This approach provides real-time, non-visual confirmation of the device's operation, which can enhance user confidence and the safety of self-administered dosing ('231 Patent, col. 1:31-35).

Key Claims at a Glance

• The complaint asserts at least independent Claim 1 (Compl. ¶31).
• Claim 1 requires:
  • A drive mechanism with a housing having a longitudinal axis.
  • A first feedback element movable along the longitudinal axis, which comprises a helical structure.
  • A second feedback element.
  • The elements are adapted to interact to provide tactile and/or audible feedback during a dose setting operation.
  • The first feedback element comprises a first surface with first protrusions and a second surface with second protrusions.
  • The first and second protrusions are arranged opposite one another to result in feedback when interacting with the second feedback element.
  • The second protrusions are configured to interact with the second feedback element during at least one of dose setting and dose dispensing.
• The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 9,289,560 - "Drive Assembly for a Drug Delivery Device and Drug Delivery Device," Issued Mar. 22, 2016

The Invention Explained

• Problem Addressed: The patent background addresses the general need for drug delivery devices that are simple to use and enable precise delivery of a drug ('560 Patent, col. 1:21-25). This implies a need for robust and intuitive mechanical designs.
• The Patented Solution: The invention describes a drive assembly where a piston rod's movement is controlled by a rotatable "rotation sleeve." Critically, rotating the sleeve in a first direction causes the piston rod to move distally (to dispense a dose), while rotating it in the opposite second direction allows for dose selection without moving the piston rod axially ('560 Patent, Abstract). This mechanically decouples the dose-setting action from the dose-dispensing action ('560 Patent, col. 3:42-56).
• Technical Importance: This design can improve dose accuracy and ease of use by allowing a user to set a dose without working against the force of the dispensing mechanism.

Key Claims at a Glance

• The complaint asserts at least independent Claim 1 (Compl. ¶47).
• Claim 1 requires:
  • A drive assembly with a housing having proximal and distal ends and a longitudinal axis.
  • A rotation sleeve rotatable relative to the housing.
  • A drive member that is axially moveable relative to the housing.
  • A piston rod that is axially moveable relative to the housing.
  • The piston rod is in mechanical cooperation with the rotation sleeve to be moveable in the distal direction when the sleeve rotates in a first direction (D1) and to be stationary in axial direction when the sleeve rotates in a second, opposite direction (D2).
  • The rotation sleeve is in mechanical cooperation with the drive member to be rotatable when the drive member is displaced axially.
• The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 8,585,656 - "Dose Setting Mechanism for Priming a Drug Delivery Device," Issued Nov. 19, 2013

• Technology Synopsis: This patent addresses the problem of ensuring dose accuracy by requiring a "priming" step before the first use (US 8,585,656 Patent, col. 1:40-52). The invention is a dose setting mechanism with a dial sleeve that follows a purely rotational path during priming and then transitions to a helical path for subsequent dose setting, thereby forcing the user to prime the device to remove any internal air gaps before a dose can be set ('656 Patent, Abstract).
• Asserted Claims: Independent Claim 1 (Compl. ¶62).
• Accused Features: The complaint alleges that the InPen's dose setting mechanism, including its dial sleeve and internal housing, performs this two-stage motion, rotating for priming and translating helically for dose setting (Compl. ¶¶63-68).

U.S. Patent No. 9,387,294 - "Drug Delivery Device," Issued Jul. 12, 2016

• Technology Synopsis: This patent describes a drug delivery device mechanism where a drive member has "stable and unstable states" relative to its longitudinal axis (US 9,387,294 Patent, Abstract). In an unstable state (e.g., between dose increments), a biasing mechanism pushes the drive member towards a stable state, providing tactile feedback and preventing the user from setting an imprecise, "in-between" dose.
• Asserted Claims: Independent Claim 3 (Compl. ¶78).
• Accused Features: The complaint alleges the InPen's dose knob provides doses in 0.5 unit increments and that if a user attempts to set an unstable dose (e.g., 0.6 units), the knob "tends move towards the nearest stable state" (Compl. ¶82).

U.S. Patent No. 10,201,662 - "Injection Device and Assembly Method," Issued Feb. 12, 2019

• Technology Synopsis: This patent addresses the problem of an initial gap between the piston rod and the cartridge bung, which can lead to an underdose on the first use (US 10,201,662 Patent, col. 2:28-34). The invention is an injection device where, in its "unused delivery state," a bearing on the distal end of the piston rod already "abuts the bung," eliminating the need for a user to perform a priming step to close this gap ('662 Patent, Abstract).
• Asserted Claims: Independent Claim 1 (Compl. ¶92).
• Accused Features: The complaint alleges the InPen's piston rod has a bearing that, when the device is ready for use, is already in contact with the cartridge bung before the injection process begins (Compl. ¶95).

U.S. Patent No. 11,135,376 - "Dosing Mechanism for Multi-Shot Injection Device Comprising Flexible Ratchet Element," Issued Oct. 5, 2021

• Technology Synopsis: This patent describes a ratchet mechanism for a dose-setting handle that uses a "movable flexible ratchet element" with at least two teethed portions (US 11,135,376 Patent, Abstract). Applying torque to the handle causes cams to deform the flexible element, releasing its engagement with a fixed circumferential teething and allowing for controlled dose adjustment.
• Asserted Claims: Independent Claim 1 (Compl. ¶106).
• Accused Features: The complaint alleges, through teardown images, that the InPen contains a fixed ratchet element with circumferential teething and a movable flexible ratchet element (a "white ring") that interact as claimed (Compl. ¶¶108-111).

U.S. Patent No. 9,457,150 - "Biasing Mechanism for a Drug Delivery Device," Issued Oct. 4, 2016

• Technology Synopsis: This patent discloses a non-plastic, non-coil spring biasing element for holding a drug cartridge securely within its housing (US 9,457,150 Patent, Abstract). The element comprises two flexible "connection side loops" that allow it to be self-retained within the device housing and apply a compressive force to the cartridge, preventing unwanted movement.
• Asserted Claims: Independent Claim 1 (Compl. ¶121).
• Accused Features: The complaint identifies a "biasing element" within the InPen teardown that allegedly has first and second connection side loops and resides in a compressed state when a cartridge is installed, biasing the cartridge within its housing (Compl. ¶¶122-127).

III. The Accused Instrumentality

• Product Identification: The Medtronic "InPen," described as a reusable smart insulin pen (Compl. ¶¶23, 93).
• Functionality and Market Context: The InPen is a drug delivery device for insulin that uses Bluetooth to connect to a mobile application for dose calculations and tracking (Compl. ¶93). The complaint alleges it is part of Defendant's "Diabetes Operating Unit," which generates substantial revenue, and that Defendant continues to develop the product, as evidenced by a 2024 announcement of FDA clearance for a new InPen app (Compl. ¶¶24-26). The infringement allegations focus on the internal mechanical components of the pen, including its dose knob, dialing clicker and ratchet mechanisms, drive sleeve, piston rod, and cartridge biasing element, which are identified through teardown photographs (Compl. ¶¶33, 49, 107, 122). A teardown image shows the InPen's internal "First feedback element with Dialing clicker ratchet" (Compl. p. 11, ¶33).

IV. Analysis of Infringement Allegations

U.S. Patent No. 10,780,231 Infringement Allegations

Identified Points of Contention (’231 Patent)

• Scope Questions: The analysis may turn on whether the components identified in teardown images of the InPen meet the specific structural definitions of the claim. A question for the court could be whether the accused "dialing clicker ratchet" (Compl. p. 11, ¶33) constitutes a single "first feedback element" that is both "movable along the longitudinal axis" and comprises a "helical structure" as required by Claim 1.
• Technical Questions: A factual question may arise regarding the arrangement of the alleged protrusions. The complaint alleges the "first and second protrusions are arranged opposite one another" (Compl. ¶36). Evidence will be needed to substantiate this specific spatial and functional arrangement within the accused device.

U.S. Patent No. 9,289,560 Infringement Allegations

Identified Points of Contention (’560 Patent)

• Technical Questions: A central evidentiary question will be whether the InPen's mechanism operates in the specific dual mode required by the claim. What evidence does the complaint provide that the piston rod is truly "stationary in axial direction" when the rotation sleeve is turned for dose setting, as opposed to experiencing some incidental or minor axial movement?
• Scope Questions: The analysis may raise the question of whether the priming operation of the InPen, which involves axial piston rod movement upon rotation (Compl. ¶51), corresponds to the claimed function of moving the piston rod "in the distal direction relative to the housing" for purposes of drug delivery, or if it is a distinct, non-infringing function.

V. Key Claim Terms for Construction

• For the ’231 Patent:

  • The Term: "helical structure"
  • Context and Importance: This term defines a key feature of the "first feedback element." The infringement allegation hinges on the accused "dialing clicker ratchet" possessing this structure (Compl. ¶33). Practitioners may focus on this term because its construction will determine whether a component with discrete, angled teeth that follows a helical path can be considered a "helical structure," or if the term is limited to a more continuous form, like a thread.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification states the helical structure "may be helpful to transform a longitudinal movement... into a rotational movement," suggesting a functional rather than purely structural definition ('231 Patent, col. 3:13-17).
    • Evidence for a Narrower Interpretation: The embodiments described consistently refer to a "helical groove" ('231 Patent, col. 3:19, 3:21), and the figures (e.g., Fig. 2) depict a distinct groove. This could support an argument that the "helical structure" must be a groove, not merely a helical arrangement of protrusions.

• For the ’560 Patent:

  • The Term: "stationary in axial direction"
  • Context and Importance: This limitation is critical to the non-infringement analysis for the dose-setting operation. Defendant will likely argue that some de minimis axial play or movement exists in its device during dose setting, raising the question of whether "stationary" means absolutely motionless or merely not actively driven in an axial direction.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent's overall context contrasts the active distal movement for dispensing with the non-dispensing state during dose setting. This context may support a construction where "stationary" means not being driven to dispense, rather than a complete absence of any physical motion.
    • Evidence for a Narrower Interpretation: The claim uses the term "stationary" in direct opposition to "moveable in the distal direction," which suggests the patentee intended a clear and absolute distinction between the two operational states ('560 Patent, col. 13:51-54). The plain meaning of "stationary" implies a lack of movement.

VI. Other Allegations

• Indirect Infringement: The complaint alleges both induced and contributory infringement for all asserted patents. Inducement is based on Defendant allegedly providing instructions, marketing materials, and product manuals that direct customers and end-users to operate the InPen in an infringing manner (Compl. ¶¶38, 53). Contributory infringement is based on allegations that the accused components are not staple articles of commerce, have no substantial non-infringing uses, and are known by Defendant to be especially adapted for infringement (Compl. ¶¶39, 54).
• Willful Infringement: The complaint alleges that Defendant has had knowledge of the patents since their issuance, based on its status as a "direct competitor" to the original assignee, Sanofi-Aventis, and its alleged practice of monitoring Sanofi-Aventis's patent portfolio (Compl. ¶22). Alternatively, it alleges willful blindness, claiming Defendant adopted a policy of not reviewing the patents of others to deliberately avoid knowledge of infringement (Compl. ¶22).

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

• A central issue will be one of structural mapping: for several of the patents, the case will likely depend on whether the physical components of the accused InPen, as revealed in teardown photographs, can be mapped onto the specific structural limitations recited in the claims (e.g., the "helical structure" of the '231 patent or the "flexible ratchet element" of the '376 patent).
• A key question will be one of operational equivalence: does the accused InPen's drive mechanism perform the specific, multi-part functions required by claims such as Claim 1 of the '560 patent, which requires the piston rod to be "moveable" during rotation in one direction but "stationary" during rotation in the opposite direction?
• A third core issue will concern knowledge and intent: given the allegations that Defendant was a direct competitor of the original patent owner, the court will likely examine what evidence supports the claim that Defendant knew of, or was willfully blind to, the asserted patents, which is critical for the willfulness and indirect infringement claims.