Auto Injection Tech LLC v. Novo Nordisk AS

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Auto Injection Technologies LLC (Texas)
  • Defendant: Novo Nordisk A/S (Denmark)
  • Plaintiff’s Counsel: Fabricant LLP
• Case Identification: 2:25-cv-00376, E.D. Tex., 04/09/2025
• Venue Allegations: Plaintiff alleges that venue is proper because Defendant is a foreign corporation, which may be sued in any U.S. judicial district.
• Core Dispute: Plaintiff alleges that Defendant’s medicament injection devices, specifically the NovoPen Echo and Ozempic products, infringe patents related to drug delivery device mechanisms.
• Technical Context: The technology concerns handheld, pen-style injection devices, which are widely used for self-administration of medications like insulin and GLP-1 agonists for diabetes management.
• Key Procedural History: The complaint alleges the patents-in-suit originated with inventors at Sanofi-Aventis Deutschland GmbH. It further alleges that Defendant Novo Nordisk, as a direct competitor, had knowledge of the patents, citing prior patent litigation between Novo Nordisk and Sanofi-Aventis.

Case Timeline

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

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

The Invention Explained

• Problem Addressed: The patent describes the need for a drug delivery device that enables "a reliable setting and dispensing of a dose of a medicament" ('294 Patent, col. 2:20-22).
• The Patented Solution: The invention proposes a mechanism centered on a drive member that has "stable and unstable states" relative to the device's longitudinal axis. When the mechanism is in an unstable state (e.g., between set dosage increments), a biasing means exerts a force or torque to move the drive member into a stable state ('294 Patent, Abstract). This system is designed to ensure that dose setting is precise and the device consistently returns to a defined state, enhancing reliability ('294 Patent, col. 8:14-24).
• Technical Importance: This approach aims to improve the accuracy and user-friendliness of pen-type injectors, which is critical for patient safety in self-administered therapies where precise dosing is required ('294 Patent, col. 2:20-22).

Key Claims at a Glance

• The complaint asserts at least independent claim 3 (Compl. ¶20).
• The essential elements of independent claim 3 include:
  • A drug delivery device for setting and dispensing a drug dose, comprising a drive member for driving a piston rod and a dose member for actuating the drive member.
  • The dose member is constrained to an axial movement along the device's longitudinal axis.
  • The drive member has stable and unstable states relative to the longitudinal axis.
  • In an unstable state, the drive member is biased by a biasing means towards a stable state.
• Plaintiff reserves the right to assert additional claims (Compl. ¶19).

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

The Invention Explained

• Problem Addressed: The patent notes that injection devices often require a "priming step" where a user dispenses a small amount of drug before the first real dose. This is done to close any potential gap between the piston rod and the drug cartridge's bung (stopper) that may result from manufacturing tolerances, which if not closed could lead to an underdose on the first injection ('662 Patent, col. 7:30-38).
• The Patented Solution: The invention is a device designed to be ready-to-use without priming. This is achieved by ensuring that in the device's "unused delivery state" (i.e., as delivered to the customer), the bearing on the distal end of the piston rod already "abuts the bung" ('662 Patent, Abstract; col. 7:61-67). This pre-set contact eliminates the gap, making the priming step unnecessary.
• Technical Importance: By eliminating the need for priming, the invention aims to improve user-friendliness and reduce the risk of dosing errors, particularly for patients without formal medical training ('662 Patent, col. 7:46-50).

Key Claims at a Glance

• The complaint asserts at least independent claim 1 (Compl. ¶34).
• The essential elements of independent claim 1 include:
  • An injection device with a housing containing a cartridge with a medicament and a movable bung, where the housing has an inner thread.
  • A piston rod with an outer thread that engages the housing's inner thread.
  • A bearing positioned at the distal end of the piston rod.
  • In an "unused delivery state," the bearing abuts the bung.
  • A driver coupled to the piston rod for dose dispensing.
• Plaintiff reserves the right to assert additional claims (Compl. ¶33).

III. The Accused Instrumentality

Product Identification

The complaint names the NovoPen Echo and Ozempic injection pens as the Accused Products (Compl. ¶14).

Functionality and Market Context

• The complaint describes the NovoPen Echo as a reusable pen injector for insulin, providing screenshots from its user manual to illustrate its features (Compl. ¶21). One such screenshot describes how the pen "allows the user to dial required doses from 0.5 to 30 units in 0.5-unit increments" (Compl. p.7 visual).
• Ozempic is identified as a pre-filled injection pen containing semaglutide for the treatment of type 2 diabetes (Compl. ¶35, p.15 visual).
• The complaint alleges the products are part of widely publicized R&D programs from a direct competitor to the patents' original assignee (Compl. ¶12). A visual from the Ozempic website identifies it as an "injectable prescription medicine" (Compl. p.15 visual).

IV. Analysis of Infringement Allegations

'294 Patent Infringement Allegations

'662 Patent Infringement Allegations

Identified Points of Contention

• Scope Questions: A question for the '294 patent is whether the accused devices' dose-setting mechanism, which provides audible and tactile "clicks" at discrete increments, falls within the patent's definition of a system with "stable and unstable states" that is "biased by biasing means," or if it operates on a different technical principle.
• Technical Questions: A key factual question for the '662 patent is whether the accused Ozempic device, as manufactured and delivered in its "unused delivery state," consistently features a bearing that "abuts the bung." Evidence will be required to show that this contact is a deliberate design feature that reliably eliminates any gap across all manufactured units.

V. Key Claim Terms for Construction

For the '294 Patent

• The Term: "stable and unstable states"
• Context and Importance: This phrase is central to the claimed invention's mechanism. The outcome of the infringement analysis for claim 3 will likely depend on how this term is construed, as it must be mapped onto the operation of the accused devices.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The patent defines these states functionally: an unstable state exists when the "drive member is biased by a biasing means towards a stable state" ('294 Patent, col. 8:18-21). This functional language could be argued to encompass a wide range of detent or click-stop mechanisms.
  • Evidence for a Narrower Interpretation: The specification heavily features embodiments with a "bias track" having specific physical recesses and peaks that define the stable and unstable states ('294 Patent, Figs. 1, 5E, 5F; col. 5:10-33). A party could argue the term should be limited by these specific structural examples.

For the '662 Patent

• The Term: "in an unused delivery state, the bearing abuts the bung"
• Context and Importance: This limitation defines the "no-priming" feature that is the core of the asserted claim. Proving this condition is met in the accused devices is critical for the Plaintiff's infringement case.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The patent defines "unused delivery state" as "the state of the device as it is sold and delivered to customers" ('662 Patent, col. 3:1-4). The stated object is to "eliminate" a "potential gap" ('662 Patent, col. 3:28-32), suggesting "abuts" means physical contact sufficient to close such a gap.
  • Evidence for a Narrower Interpretation: The specification also states it is "desirable to apply a small force to the bung" ('662 Patent, col. 7:63-65). A defendant might argue that "abuts" requires not just incidental contact but a specific, designed pre-load force to be applied to the bung, and that without it, the claim is not met.

VI. Other Allegations

• Indirect Infringement: The complaint alleges induced infringement for both patents, asserting that Defendant provides product manuals and online instructions that guide end-users to operate the Accused Products in an infringing manner (Compl. ¶25, ¶39). It also pleads contributory infringement, alleging the accused components are not staple articles of commerce and are specially adapted for use in the infringing devices (Compl. ¶26, ¶40).
• Willful Infringement: The complaint alleges willful infringement based on pre-suit knowledge. It claims Defendant was a direct competitor of the original assignee (Sanofi-Aventis), monitored its patent activities, and had been involved in "previous patent litigations" with Sanofi-Aventis. It further alleges willful blindness, claiming Defendant has a policy of not reviewing patents of others to avoid knowledge of infringement (Compl. ¶12).

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

• A central issue for the '662 patent will be one of evidentiary proof: what evidence will establish that the Ozempic device's internal components, as manufactured and sold in an "unused delivery state," are consistently configured so the piston rod's bearing "abuts the bung," thereby meeting the patent's anti-priming limitation?
• A key question for the '294 patent will be one of claim construction and technical operation: does the accused NovoPen Echo's click-based dose-setting mechanism function as a system of "stable and unstable states" where a "biasing means" actively resolves the mechanism into a stable position, as required by the claim, or does it represent a distinct and non-infringing technical approach to dose selection?