Last Updated: August 13, 2026

Details for Patent: 9,108,002


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Which drugs does patent 9,108,002 protect, and when does it expire?

Patent 9,108,002 protects OZEMPIC and is included in one NDA.

This patent has fourteen patent family members in eleven countries.

Summary for Patent: 9,108,002
Title:Automatic injection device with a top release mechanism
Abstract:The present invention relates to a handheld mechanical injection device by which set doses of a liquid medicament can be injected from a medical reservoir. The medicament is expelled through an injection needle by release of a power reservoir in the device, the power reservoir being fully or partially released by actuation of a user operable release member being positioned at or near an upper end of the injection device, the upper end being that end of the injection device which is opposite the injection needle.
Inventor(s):Tom Hede Markussen
Assignee: Novo Nordisk AS
Application Number:US13/326,738
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,108,002
Patent Claim Types:
see list of patent claims
Device;
Patent landscape, scope, and claims:

United States Patent 9,108,002 Scope and Claims for Handheld Torsion-Spring Injection Devices With Proximal Planar Release Button

US 9,108,002 is directed to a handheld, spring-powered injection device that couples a torsion spring energy reservoir with a mechanical release triggered at the most proximal end by a release member having a generally planar surface perpendicular to the piston-rod longitudinal axis. The claims narrow the device architecture through (i) a rotatable dose setting member, (ii) a rotatably arranged multi-component driver that engages a drive track of the piston rod and has an axially movable part that moves into a disconnected position to release stored energy, and (iii) a proximal planar-surface release button/member used by user force applied to that planar surface.

Actionable landscape bottom line: The estate is likely to be most defensible for spring-motor injection pens/syringe-like devices that (1) use torsion springs as the energy source, (2) implement rotary-to-linear conversion via a multi-part driver engaging a piston-rod track, and (3) provide a user-release interface at the proximal end using a planar surface oriented perpendicular to the piston axis to trigger energy release.


What does US 9,108,002 claim for torsion-spring handheld injection devices?

Core claim theme: a torsion spring stores energy to drive a piston rod to expel a dose, and a mechanical release system is actuated by the user at the proximal end using a planar release surface oriented perpendicular to the piston-rod axis. In claim 1, the release action is tied to axial movement of a multi-component driver that shifts into a disconnected position to release stored energy.

Claim 1 scope: dose setting + multi-component rotatable driver + planar proximal release

Claim 1 contains the following required elements:

  1. Handheld injection device with a housing.
  2. Rotatable dose setting member rotatable about a longitudinal axis of the housing.
  3. Power reservoir comprising a torsion spring for storing energy to expel the dose.
  4. Piston rod (axially driven).
  5. Release member at the most proximal portion of the device, opposite the needle-end mounting portion.
  6. Rotatably arranged multi-component driver with at least part(s) that:
    • at least partly engages a drive track of an associated piston rod, and
    • a further part is axially movable into a position disconnected from the housing, releasing accumulated energy in the torsion spring.
  7. Axial movement of the further part by the user applying force onto a generally planar surface of the release member.
  8. The planar surface is generally perpendicular to a longitudinal direction of the piston rod.

Interpretation that drives infringement/validity analysis:

  • The claim is not merely “torsion spring injection.” It requires a specific release geometry and kinematics: the user actuation is via force on a proximal planar surface oriented perpendicular to piston motion, and this actuation causes an axially movable driver component to move into a disconnected position releasing stored energy.
  • The claim also adds a dose-setting rotary feature (rotatable dose setting member about the housing axis), so a device lacking a rotatable dose setting dial/knob is outside the literal claim.

Claim 2 scope: planar proximal release button + rotary-to-axial conversion

Claim 2 is broader in some respects and narrower in others, replacing the multi-component driver detail of claim 1 with a more general drive mechanism:

  1. Injection device with housing and drive member.
  2. Piston rod having a longitudinal direction.
  3. Torsion spring storing energy to drive a dose.
  4. Drive mechanism converting relative rotational motion into axial movement of the piston rod.
  5. Release button at the most proximal end, opposite the needle mounting end.
  6. Release button has a generally planar surface perpendicular to the piston rod’s longitudinal direction.

Interpretation:

  • Claim 2 is less specific on the “multi-component driver” and the “disconnected from the housing” feature, but still requires:
    • torsion spring
    • rotational-to-axial conversion
    • proximal release button interface with planar perpendicular orientation.

Claim dependency signal

Even without the printed dependency structure, the language indicates:

  • Claim 1 is a device architecture claim with detailed internal mechanism and release-kinematics.
  • Claim 2 is a simplified mechanism claim focusing on the planar perpendicular proximal release button and the presence of a rotational-to-axial conversion drive mechanism.

How is US 9,108,002 likely to be enforced against competing injection pen designs?

Most likely infringement targets are devices that match all (or most) of these “lock-in” limitations.

1) Torsion spring energy reservoir

If a competitor uses a compression spring, gas, motor, or other energy source, literal coverage is materially weakened for both claims.

High-risk design features for competitors:

  • A torsion spring acting on a driving component to store energy between cocking and firing.

2) Rotary dose setting about housing longitudinal axis

Claim 1 requires the dose-setting interface to be rotatable about the housing axis.

Low-risk for competitors:

  • Dose setting that is not rotary about the housing longitudinal axis, e.g., linear increments or non-rotary dose selection, can avoid the claim 1 limitation.

3) Rotatably arranged multi-component driver engaging piston-rod drive track

Claim 1 requires:

  • a rotatably arranged multi-component driver
  • with at least part engaging at least part of a piston-rod drive track

This maps to internal ratchet/track and driver architectures common in mechanical pens.

4) Axially movable driver part into “disconnected from housing” position to release stored energy

This is the highest-specificity trigger in claim 1.

Enforcement will hinge on whether competitor mechanisms:

  • hold energy while a driver component is engaged in a coupling state, then
  • transition to a disconnected condition by axial movement of a driver component into a state not coupled to the housing,
  • resulting in release of the torsion spring energy.

5) Proximal release member/button planar surface perpendicular to piston axis

Both claims require this human-interface geometry.

This is a recurring differentiator across device families:

  • A firing button whose contact surface is oriented perpendicular to piston movement direction at the proximal end.

Design-around observation: Shifting to a release actuation that is not planar-perpendicular (for example, angled surfaces, non-planar geometry, actuated linkage distributed away from a single planar surface aligned perpendicular to piston axis) can reduce literal fit, though depends on claim construction of “generally planar” and “generally perpendicular.”


What patents are adjacent to US 9,108,002 in handheld torsion-spring injection technology?

A complete “adjacent patent map” requires bibliographic retrieval of:

  • application number,
  • assignee,
  • cited references,
  • prosecution history,
  • family members.

You provided only the claim text for US 9,108,002, not assignee, publication history, or priority chain, so a legally usable cross-patent landscape cannot be produced from the provided information alone.


How strong is the patent estate for device mechanics versus interface geometry?

Based on claim language alone:

Claim strength signals

  • High specificity for claim 1: multi-component rotatable driver, drive-track engagement, axially movable part disconnected from housing, torsion spring reservoir, rotatable dose setting member, and proximal planar perpendicular release actuation.
  • Moderate specificity for claim 2: retains torsion spring and rotational-to-axial conversion, but does not require the detailed disconnected driver geometry.

Practical conclusion for enforceability

  • Claim 1 is stronger for asserting against “same mechanical architecture” devices.
  • Claim 2 can reach a broader set of designs sharing the proximal planar-perpendicular release button and torsion/rotary-to-axial conversion.

Where do potential validity challenges likely cluster for US 9,108,002?

Without the prosecution record and cited prior art list, only claim-limitation based vulnerability can be identified from typical prior art structures in injection devices:

Likely obviousness clusters

  1. Torsion-spring handheld pens with dose setting and piston drive are well-established in the art.
  2. The combination with a proximal planar release interface perpendicular to piston axis could be argued as an obvious ergonomic/kinematic design choice if prior art shows similar actuation surfaces and orientations.
  3. For claim 1, the internal “multi-component driver,” “drive track engagement,” and “axially movable disconnected position release” are mechanical features that prior art often discloses in varying form.

Likely novelty clusters

The highest novelty burden (if any) is likely the precise coupling of:

  • axial movement into a disconnected from housing position,
  • triggered by user force on a planar surface at the proximal end oriented perpendicular to the piston axis.

This is a narrow technical mechanism and may be less commonly duplicated.


What would a generic “design-around” strategy look like against claims 1 and 2?

Avoiding claim 2 fastest

To avoid claim 2, a designer can focus on:

  • eliminating a torsion spring energy reservoir, or
  • removing the “generally planar surface generally perpendicular” limitation at the proximal release interface, or
  • replacing rotational-to-axial conversion with a non-matching drive mechanism.

Avoiding claim 1 while keeping claim 2 risk

To avoid claim 1, a designer can focus on:

  • removing the required rotatable dose setting member about the housing longitudinal axis, and/or
  • altering the release mechanism so the energy release is not achieved through an axially movable rotatably arranged multi-component driver part into a disconnected-from-housing condition, and/or
  • altering the drive-track engagement architecture so it is not “multi-component driver” engaging a piston-rod drive track in the claimed way.

Key Takeaways

  • US 9,108,002 claim 1 covers handheld torsion-spring injection devices with rotatable dose setting about the housing axis, a rotatably arranged multi-component driver engaging a piston-rod drive track, and an energy release triggered by user force on a proximal planar release surface perpendicular to the piston axis, causing an axially movable driver component to move into a disconnected-from-housing position.
  • Claim 2 covers torsion-spring injection devices with rotational-to-axial piston drive and a proximal release button whose contact surface is planar and perpendicular to piston longitudinal direction.
  • The enforceability and design-around leverage concentrate on the proximal planar perpendicular release interface and the specific release kinematics (claim 1) around the “disconnected from housing” driver transition.

FAQs

  1. Does US 9,108,002 require a needle-mounting structure to be present in the asserted device?
    The claims describe an injection device where a needle may be mounted at the distal end opposite the proximal release member, making the needle-end context part of the device arrangement.

  2. Can a device with a torsion spring and a proximal button still infringe if the button face is angled rather than “generally planar”?
    Literal risk depends on whether the surface still reads as “generally planar” and whether it remains “generally perpendicular” to the piston rod longitudinal direction.

  3. What is the biggest differentiator between claim 1 and claim 2?
    Claim 1 requires the rotatably arranged multi-component driver, including drive-track engagement and an axially movable part moving into a disconnected from the housing release state; claim 2 omits those internal specifics.

  4. Do these claims cover motor-driven pens?
    The claims require a torsion spring power reservoir and the specified mechanical coupling; motor-only drive architectures without the claimed torsion-spring/mechanical conversion elements are less likely to fit.

  5. Is dose setting required in claim 2?
    Claim 2 does not expressly recite a “rotatable dose setting member,” unlike claim 1.


References (APA)

  1. United States Patent No. 9,108,002.

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Drugs Protected by US Patent 9,108,002

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-001 Dec 5, 2017 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y Y ⤷  Start Trial
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-004 Oct 6, 2022 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y Y ⤷  Start Trial
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-002 Apr 9, 2019 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y Y ⤷  Start Trial
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-003 Mar 28, 2022 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 9,108,002

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Denmark2005 00113Jan 21, 2005

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