Patent: 9,108,002

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):	Markussen; Tom Hede (Bagsv.ae butted.rd, DK)
Assignee:	Novo Nordisk A/S (Bagsvaerd, DK)
Application Number:	13/326,738
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,108,002
Patent Claims:	see list of patent claims

Comprehensive Claim and U.S. Patent Landscape Analysis for United States Patent 9,108,002 (Handheld Injection Device With Torsion Spring and Planar-Release Button)

United States Patent 9,108,002 protects a specific handheld injection architecture: (1) torsion-spring energy storage driving a piston rod, and (2) an axially movable release element actuated by user force applied to a planar surface that is perpendicular to the piston rod axis, including a rotatably arranged multi-component driver engaging a piston-rod drive track. The patent’s enforceable scope turns on whether accused devices include the planar-release geometry, the perpendicular actuator-to-piston relationship, the axial movement of a release component from a connected state to a disconnected state, and the specific torsion-spring-to-piston energy path plus the multi-component rotational driver/track engagement.

What does US 9,108,002 claim, and what elements are most limiting?

Core claimed components (independent claim structure) US 9,108,002 has claims that, as provided, focus on a handheld injection device with:

• Rotatable dose setting member about the device longitudinal axis.
• Power reservoir using a torsion spring to store energy that expels a dose.
• Piston rod driven by the torsion spring energy.
• Release member located at the proximal end (opposite the needle end).
• Planar release surface geometry: the generally planar surface is perpendicular to the longitudinal direction of the piston rod.
• Axially movable release component that moves into a disconnected position from the housing to release accumulated energy.
• Rotatably arranged multi-component driver with components that:
  • include at least one part that engages a drive track of an associated piston rod; and
  • include another part that is axially movable by user-applied force onto the planar release member surface.
• Drive mechanism converting motion (relative rotational motion to axial movement of piston rod) consistent with the multi-component driver architecture.

Most limiting claim hooks From claim 1 and claim 2 as supplied, the most infringement-sensitive limitations are:

1. Planar actuator surface perpendicular to piston-rod axis

   • The claim language ties the “generally planar surface” to a spatial relationship: perpendicular to the longitudinal direction of the piston rod.
   • Many injection pens use push buttons aligned with the longitudinal axis or foot/lever geometries. Those may fall outside literal scope if the surface is not perpendicular in the claimed way.

2. Axially movable release element from a connected to a disconnected state

   • The release component’s function is not merely “press a button to trigger.” It specifically moves axially into a position disconnected from the housing to release torsion spring energy.

3. Torsion spring as the stored-energy power reservoir

   • Spring-driven injectors often use compression springs or leaf springs. The independent claim framing is explicitly torsion-spring energy storage.

4. Rotatably arranged multi-component driver with drive-track engagement

   • Claim 1 adds a mechanical specificity: a rotatably arranged multi-component driver with part(s) engaging a piston-rod drive track, plus an axially movable part.

5. Proximal end release location opposite needle end

   • This may be satisfied by many pen designs, but in close cases it can be relevant if the trigger is at a different end or via a different layout.

How does claim 1 narrow the architecture relative to claim 2?

Claim 1 is structurally richer than claim 2.

• Claim 1 explicitly requires:

  • a rotatably arranged multi-component driver with at least part engaging a drive track of an associated piston rod, and
  • another part axially movable into a disconnected position to release energy stored in the torsion spring.
  • user force applied onto a planar release member surface, with the planar surface perpendicular to the piston rod axis.

• Claim 2 is more generalized, listing:

  • housing, drive member, piston rod longitudinal direction, torsion spring,
  • drive mechanism converting relative rotational motion into axial movement,
  • release button at proximal end with planar surface perpendicular to piston rod axis.

In litigation, claim 1 provides stronger defenses against broad “torsion spring + button” arguments because it adds the multi-component driver/track engagement limitations.

Is the “planar surface perpendicular to the piston rod” a likely infringement or validity battleground?

This geometry is a high-value claim element because it creates a measurable structural constraint. Accused devices often vary:

• button surfaces that are curved, angled, recessed, or partially cylindrical,
• activators that apply force through a molded rib or protrusion,
• release actuators that are rotational, not axial,
• planar surfaces that are parallel (or angled) relative to the piston rod axis rather than perpendicular.

Patent scope implication If a competitor’s injector uses a planar trigger surface whose face is not perpendicular to the piston rod axis (as in the claim), that competitor has a cleaner non-infringement path. If the competitor uses an actuator that is functionally equivalent but geometrically different, courts often treat geometry as a literal limitation if it is recited as such and not framed as “wherein” language that can be satisfied by an equivalent arrangement.

Claim construction risk “Generally planar” adds flexibility for slight curvature or manufacturing tolerance, but the perpendicular relationship remains a clear boundary condition.

How strong is US 9,108,002’s patent estate for torsion-spring handheld injectors?

A critical assessment of strength depends on prior art, file history, and prosecution amendments, none of which are included in the prompt. Since those are required to evaluate novelty/non-obviousness, claim charts, and doctrine-of-equivalents posture with precision, this analysis focuses on structural strength: which claim elements are distinctive and which are likely to be common in the field.

Structurally distinctive elements (stronger anchors)

• Combination of torsion spring energy storage with:
  • an axially movable release component disconnected from the housing, and
  • a user-actuated release element with planar surface perpendicular to piston-rod axis,
  • plus the rotatably arranged multi-component driver and drive-track engagement (claim 1).

These elements together are narrower than a generic “torsion spring injector with a proximal trigger.”

Potentially common sub-features (weak anchors)

• Handheld injection devices with proximal release mechanisms.
• Dose setting members rotatable about the longitudinal axis.
• Converting rotational input into axial piston movement.
• Torsion spring power reservoirs (torsion springs are present in multiple injector families).

If those common sub-features are widely disclosed in earlier injector designs, they reduce novelty unless the planar-perpendicular and axially-disconnect release mechanism are genuinely unique in combination.

Litigation posture implication The most plausible infringement arguments center on demonstrating:

• the release member’s axial movement into a disconnected housing state, and
• the actuator surface perpendicular relationship,
• with torsion spring energy storage and piston-rod drive-track engagement consistent with claim 1 (or at least the rotational-to-axial conversion consistent with claim 2).

Which competitors’ injectors are most at risk under the claim limitations (high-probability risk pattern)?

Without prosecution history and without a list of target devices, the practical risk pattern is still clear:

Higher risk design pattern

• Pen-type or auto-injector where:
  • energy is stored in a torsion spring,
  • dose setting is done via rotation about the device axis,
  • user activation occurs at proximal end by pressing a face-like planar surface,
  • that press drives an axially moving release member (or a part) that transitions from a connected state to a disconnected state relative to housing,
  • piston rod moves axially from the stored torsion energy through a conversion mechanism with track/driver engagement (claim 1).

Lower risk design pattern

• Compression-spring energy storage instead of torsion springs.
• Release actuators whose face is not perpendicular to piston rod axis.
• Triggers that actuate via rotational movement rather than axial movement into a disconnected configuration.
• Designs where piston rod motion is driven by mechanisms not involving a drive track engaged by a rotatably arranged multi-component driver.

What patents likely cluster around US 9,108,002 (same design space) and how do they affect enforcement?

This question requires access to the patent family of US 9,108,002, its citations, and continuation/divisional practice. Those data are not provided in the prompt, so an “identified competitor patent list” cannot be produced without risking fabrication.

What can be concluded without external records is the types of nearby patents that typically compete in this design space:

• Torsion-spring auto-injector families with dose-setting and energy storage.
• Rotational-to-axial conversion mechanism patents for dose delivery.
• Trigger/release mechanism patents including planar button geometry and axial release element disengagement.
• Drive-track and piston-rod coupling patents where multi-part drivers engage grooves/tracks.
• User interface mechanism patents (dose setting ring, proximal release button).

Enforcement impact usually comes from:

• overlapping claims that cover different subsets of the mechanism, and
• earlier priority filings that attack novelty of one element (for example, axial disconnect release or planar trigger geometry).

Without the actual patent citations of US 9,108,002, it is not possible to state which specific patents protect which specific sub-features in this architecture.

When does US 9,108,002 expire, and how does that affect generic entry or device competition?

Patent term for U.S. utility patents typically runs from earliest non-provisional filing date with adjustments; term can also be affected by PTA and terminal disclaimers. The prompt does not provide:

• the earliest effective filing date for US 9,108,002,
• whether it has patent term adjustment (PTA),
• whether any terminal disclaimers exist.

Therefore, this cannot be computed accurately from the provided information.

How would a Paragraph IV-style challenge map to an injector patent, and is it relevant?

Paragraph IV is an FDA Hatch-Waxman pathway concept for drug products, not medical devices. US 9,108,002 is a patent on a handheld injection device. In practice, competitive “entry risk” comes through:

• device design-around rather than drug Paragraph IV litigation,
• possible state-law or federal patent infringement suits if a competitor ships an injector product,
• licensing for use of specific mechanical features.

A “generic entry risk scenario” is better framed as:

• whether a competing injector can avoid torsion spring, the planar perpendicular release geometry, the axial disconnect release mechanism, and the drive-track/multi-component driver coupling.

How does claim 1 vs claim 2 change infringement risk for differently engineered devices?

Claim 1 (device architecture specificities)

• If an accused device has a torsion spring and a proximal release button but lacks a multi-component rotatable driver that engages a drive track of the piston rod, it is less likely to infringe claim 1.
• If the release element is not axially movable into a disconnected position, claim 1 is likely harder to reach.

Claim 2 (broader functional conversion with planar perpendicular release button)

• Claim 2 can be easier for plaintiffs if the competitor’s mechanism converts relative rotational motion into axial piston movement and uses a torsion spring, even if it does not have the exact multi-component driver/track engagement.
• But claim 2 still requires the planar release button surface perpendicular to piston rod axis and the proximal release location.

What design-arounds are most likely to avoid literal infringement?

Based on the claim elements as written:

1. Change energy storage type

   • Move from torsion spring to compression spring or another energy storage architecture.

2. Change planar-perpendicular actuator geometry

   • Keep a proximal trigger but make the trigger contact surface not perpendicular to the piston rod axis, or implement a non-planar or angled activation interface such that the “generally planar surface” requirement and the perpendicular relationship are not met.

3. Avoid an axial release element disconnected from the housing

   • Use a release mechanism that triggers while remaining connected to housing, or trigger through a different motion path (e.g., rotational latch release).

4. Avoid the drive-track engaged by the rotatably arranged multi-component driver (claim 1)

   • Use a different rotational-to-axial conversion approach that does not rely on a multi-component rotatable driver engaging a drive track on the piston rod.

5. Reconfigure the dose-setting member function

   • If the claim is enforced as requiring a specific “rotatable dose setting member rotatable about the longitudinal axis,” then using a different dose-setting scheme could help.

Key Takeaways

• US 9,108,002’s enforceable core is the mechanical combination of torsion spring power storage with a proximal release member/button having a planar surface perpendicular to the piston rod axis, plus (in claim 1) an axially movable release component that disconnects from the housing and a rotatably arranged multi-component driver engaging a piston-rod drive track.
• The planar-perpendicular actuator relationship and the axially disconnect release are the most litigation-relevant limitations because they create measurable structural boundaries that design-arounds can target.
• Without family/citation/PTA data, this analysis cannot provide exact expiration dates, identify specific licensing competitors, or map known patent clusters by number.
• In infringement risk assessments, devices that substitute compression springs, change trigger geometry so it is not perpendicular to the piston rod axis, or use a different release motion path are positioned to avoid literal scope.
• For claim coverage mapping, focus claim charts on: release motion direction and disconnection state, actuator surface orientation, torsion spring presence, and (claim 1) track-coupled multi-component driver engagement.

FAQs

1. Can an injector infringe claim 2 if its release button is not perfectly planar?
   “Generally planar” gives some tolerance, but the surface must still be arranged so its face is generally perpendicular to the piston rod’s longitudinal direction.

2. Does a torsion spring alone establish infringement of US 9,108,002?
   No. The claims also require the planar perpendicular release button geometry and, for claim 1, the specific axially movable disconnected release and rotatable multi-component driver engaging a piston-rod drive track.

3. What is the main difference between claim 1 and claim 2 for infringement purposes?
   Claim 1 requires a more specific rotatable multi-component driver/drive-track engagement and a disconnected axial release part; claim 2 is broader but still requires the planar perpendicular proximal release button.

4. Are Paragraph IV challenges relevant to this type of patent?
   Not in the Hatch-Waxman sense. Risk is primarily patent infringement exposure in device competition, not Paragraph IV drug challenges.

5. What design changes most effectively reduce risk under these claims?
   Switching away from torsion spring energy storage, changing the trigger surface orientation so it is not perpendicular to the piston rod axis, and using a release mechanism that does not move axially into a disconnected state.

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References

1. US Patent 9,108,002 (claims provided in prompt).

Details for Patent 9,108,002

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536	June 16, 2005		2031-12-15
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536	October 31, 2013		2031-12-15
Novo Nordisk Inc.	NOVOLOG MIX 50/50	insulin aspart protamine and insulin aspart	Injectable Suspension	021810	August 26, 2008		2031-12-15
Seqirus Inc.	FLUAD	influenza vaccine, adjuvanted	Injection	125510	November 24, 2015		2031-12-15
Seqirus Inc.	FLUAD,FLUAD QUADRIVALENT	influenza vaccine, adjuvanted	Injection	125510	February 21, 2020		2031-12-15

International Patent Family for US Patent 9,108,002

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2006076921
United States of America	9616180
United States of America	8096978
United States of America	2024366880
United States of America	2022249780