United States Patent 8,313,466 (US 8,313,466): Scope, Claim Map, and US Patent Landscape for Needle-Actuated, Spring/Gas Powered Auto-Injector Apparatus

US 8,313,466 centers on an auto-injector style apparatus in which an energy storage member (typically a spring and in some claims a pressurized gas container) is actuated by a release member when an external actuation member is moved, driving a medicament container and coupled needle to an injection position, with safety lock and needle guard interaction.

What is US 8,313,466 claiming in plain terms?

Core claim theme (claims 1 and 7): an injection device architecture with (i) a housing defining an internal volume, (ii) a medicament container coupled to a needle, (iii) an internal energy storage member that provides force to move the medicament container to an injection position, (iv) a release member actuated by movement of an external actuation member, and (v) optional safety lock/needle guard features that limit actuation travel.

Mechanism claim theme (claims 5, 11, 20): relative motion where the internal container moves toward injection while the external actuator moves in an opposite direction when actuated.

Feature-extension theme (claims 8, 9, 10, 13, 15, 16, 17, 22):

geometric offset between the medicament container axis and the energy storage member axis
spring vs gas container energy storage
puncturer for penetrating a gas container when gas-based storage is actuated
safety lock limiting actuation member travel
distal-end opening arrangement controlling where portions of needle and actuator exit
medicament identified as epinephrine

Where are the claim boundaries: apparatus elements vs functional language?

US 8,313,466 is apparatus-broad with functional actuation hooks. The claims are drafted to capture different internal architectures so long as the device includes the structural elements and functional relationships:

Structural elements explicitly required

Housing defining a volume (plus distal end portion and proximal end portion in claim 7)
Medicinal container movably disposed within the volume (or movably disposed between two positions)
Needle coupled to the medicament container
Energy storage member disposed within the volume, producing force to move the medicament container to an injection position
Release member disposed within the volume
Actuation member having at least two portions: one engaged with the release member and one outside the distal end surface/passageway for user manipulation

Functional relationships that delimit scope

The release member is configured to actuate the energy storage member.
The actuation member movement triggers the release member actuation: “when the actuation member is moved” (claims 1 and 7) and through recited positions (claims 7 and 18).
Motion is constrained by the safety lock in dependent claims: it “engage[s]” a portion of the actuation member to limit movement.
In gas-based dependent claims: the energy storage is “a gas container configured to contain a pressurized gas,” and a puncturer penetrates the gas container when actuated (claim 9).

What patents likely cover the same device class (US auto-injector architecture)?

US 8,313,466’s claims track a common auto-injector technology stack: internal energy storage, trigger/release, dose delivery needle drive, and safety interlocks.

High-probability adjacent patent families (by technical feature cluster, not by assignee because no bibliographic data is provided here):

Auto-injector needle-drive mechanisms
- spring-powered plunger/needle actuation
- gas-powered stored energy (including puncture valves/breakers)
Trigger/release mechanisms
- release member linking external actuator motion to internal energy release
- deformation-enabled release members that collapse or yield upon actuation
Safety lock and needle guard integration
- movement-limiting safety lock coupled to the actuator
- needle guard portions that engage the safety lock
Geometric packaging offsets
- offset longitudinal axes between energy storage member and medicament container
- multi-part housing volume segmentation

In litigation and licensing practice, these clusters often map to different patent estates: one estate on energy storage, another on triggering, another on safety interlocks and needle guards, and another on dose delivery geometry.

How broad are the independent claims (claim 1 vs claim 7 vs claim 18)?

Claim 1 (independent apparatus)

Claim 1 requires:

housing volume
medicament container movably disposed within volume coupled to needle
energy storage member produces force to move medicament container to injection position where needle portion is disposed through distal end surface of housing
release member inside volume actuates energy storage member
actuation member with first portion engaged with release member, second portion through distal end surface enabling manipulation

Breadth strength: it does not limit the energy storage member type in claim 1; it only requires it “is configured to produce a force” for needle injection. Spring and gas appear only in dependents (claims 6 and 9).

Critical limiting feature: coupling through the distal end surface and actuator portion outside the distal end surface. Designs that move needle via a concealed axial drive but do not use an external actuation member portion through a distal surface could fall outside.

Claim 7 (independent apparatus)

Claim 7 adds:

housing with distal and proximal end portions
medicament container movable between first and second positions, with needle disposed within housing at first position and extending at second position
actuator moved from first actuator position to second actuator position
explicit arrangement: “second portion of the actuation member disposed outside of the distal end portion of the housing”

Breadth strength: still broad on the energy storage type (spring or gas in dependents), but it adds positional language and actuator travel positions.

Claim 18 (independent apparatus)

Claim 18 adds a multi-zone packaging structure:

volume split into first portion (offset from second portion)
distal end portion defines a first passageway and a second passageway
medicament container in first portion; energy storage member in second portion
actuation member with first portion within volume and second portion through second passageway when the actuation member is in the first position (note: “disposed through the second passageway when the actuation member is in the first position”)

Breadth strength: captures split-chamber and dual-passage architectures. This can be a strong differentiator if competitors use a single continuous interior volume.

What patent scope is created by each dependent claim?

Spring vs gas energy storage: claims 6, 9, 10

Claim 6: energy storage member is a spring producing force when actuated by release member.
Claim 9: energy storage member is a gas container with pressurized gas; includes puncturer to penetrate the gas container when the gas container is actuated.
Claim 10: energy storage member is a spring (in the claim 7/related independent context).

Landscape implication: many auto-injectors in commercial use are spring-driven, while gas-powered designs often use puncture/valve structures. A competitor using gas valves without a puncturer penetrating a gas container could try to design around claim 9 while still potentially landing in the broader spring-like trigger concept only if their energy store is not a gas container.

Safety lock and needle guard interaction: claims 2, 3, 16, 3

Claim 2: safety lock engaged with the second portion of actuation member to limit movement.
Claim 3: safety lock includes protrusion engaging the second portion to limit movement, and adds a needle guard with first and second portions, where the second portion engages the safety lock.
Claim 16: safety lock movably coupled to distal end portion; engages second portion of actuator to limit movement.

Scope leverage: safety features tend to be highly design-specific. Claim 3 is more specific due to needle guard portioning and engagement with the safety lock.

Release member deformation: claim 12, 21

Claim 12: portion of release member configured to deform when actuation member moved.
Claim 21: same concept, in the claim 18 set.

Design-around vector: using an actuation-release linkage without a deformable release member element can avoid these dependents while still meeting base trigger/release relationships in the independent claims.

Axis offset packaging: claims 8, 19

Claim 8: longitudinal axis of medicament container offset from longitudinal axis of energy storage member.
Claim 19: same in claim 18 context.

Landscape implication: offset packaging is common for space management in single-shot devices. If a competitor uses coaxial alignment, it may avoid these dependents but not necessarily claim 1/7.

Two-direction motion: claims 5, 11, 20

Claim 5: external actuation member moves in one direction; medicament container moves in opposite direction when moving toward injection position.
Claim 11: similar oppositely directed motion.
Claim 20: similar oppositely directed motion in claim 18.

Design-around vector: some devices use cams/links that decouple user lever motion direction from internal injection direction. If the motion relationship is not “substantially opposite,” these dependents narrow.

Housing split with wall partition: claim 13

side wall divides volume into portion 1 and portion 2
medicament container in portion 1; energy storage member in portion 2

Claim 13 overlaps with claim 18’s offset volume split but is drafted as a sidewall partition.

Distal end opening and actuator/needle routing: claim 15

distal end surface defines first opening and second opening
portion of needle through first opening when medicament container in injection position
third portion of actuator through second opening

Landscape implication: this is a structural routing claim. Devices that use a single opening, or place actuator through a different end feature, can avoid claim 15.

Epinephrine: claims 14, 17, 22

Claim 14: medicament container includes epinephrine.
Claim 17: medicament container includes epinephrine.
Claim 22: same.

Scope impact: these are content-limiting claims tied to an epinephrine formulation. If a competitor’s device is for another medicament (not epinephrine), these epinephrine dependents may not apply. Independent apparatus claims remain potentially relevant to epinephrine-branded products, but enforcement on the epinephrine dependents would require that the medicament includes epinephrine.

What does the claim set cover in practice: delivery form and device architecture?

Covered device type: an injection device where a needle is driven into an injection position through a distal end surface of a housing. The structure is consistent with single-use auto-injector or similar.

Covered components:

internal needle drive by stored energy (spring or pressurized gas with puncturer)
trigger/release mechanism linking user actuation to internal energy release
safety lock preventing hazardous actuation movement
optional needle guard integrated with safety lock
epinephrine medicament as an optional limitation

Not required in all claims:

puncturer (only in claim 9)
needle guard (only in claim 3)
deformable release member (only in claims 12 and 21)
split volume wall partition (only in claim 13)
axis offset (only in claims 8 and 19)
dual openings (only in claim 15)
epinephrine limitation (only in claims 14, 17, 22)

When does US 8,313,466 lose exclusivity for generic/similar devices?

No bibliographic elements are provided in the prompt (filing date, priority date, term adjustments, or patent expiration data). Without those, an exclusivity timeline cannot be stated accurately.

What generic entry risks exist for near-design substitutes?

Because this is an apparatus patent, “generic entry” is not the same as FDA small molecule generics. The risk is design-around difficulty and infringement exposure for alternative auto-injector mechanisms.

Where competitors are most exposed

Any design that uses:
- internal energy storage member that drives a medicament container/needle to an injection position
- a release member inside the housing
- an external actuation member with a portion outside the distal end surface that actuates the release member
- safety lock limiting the actuation member travel

This is the common “core scaffold” of claim 1.

Where competitors can mitigate risk

Replace the architecture so that actuation member engagement/release actuation is not performed through the claimed relationship.
Eliminate the distal surface routing or dual-passage routing features targeted by claim 15.
Avoid the deformable release member structure of claims 12/21.
Use a different energy-store architecture that does not match gas container + puncturer (claim 9), while still potentially satisfying the general spring/generic energy store element.

What is the Orange Book status of US 8,313,466?

No FDA product listing information or Orange Book mapping information is provided in the prompt. This cannot be determined from the claim text alone.

What FDA regulatory pathway affects this patent?

The claims are apparatus claims for an auto-injector style delivery system. FDA regulatory pathways can impact market entry timing, but the prompt provides no sponsor name, NDA/BLA reference product, device classification, or PMA/510(k) linkage.

Key claim-to-feature matrix for infringement triage

Feature	Claim(s) where required	Risk for competitors using similar design
Housing with internal volume	1, 7, 18	High if any auto-injector housing is used
Medicament container movably disposed + needle coupled	1, 7, 18	High
Energy storage member drives medicament to injection position	1, 7, 18	High
Release member inside housing actuated by actuator movement	1, 7, 18	High
Actuation member has first engaged portion and second external portion through distal end surface/passageways	1, 7, 18	High
Safety lock engages actuator portion to limit travel	2, 3, 16	Medium-high depending on safety interlock design
Needle guard engages safety lock	3	Medium
Spring energy storage	6, 10	Medium
Gas container energy storage + puncturer penetrating gas container	9	Medium if using gas store
Deformable release member portion	12, 21	Medium
Offset axis geometry	8, 19	Medium
Opposite-direction motion relationship	5, 11, 20	Medium
Split volume by side wall partition	13	Medium
Distal end surface dual opening routing	15	Medium
Medicament includes epinephrine	14, 17, 22	Only relevant for epinephrine products

Which design variables most likely determine freedom-to-operate?

Trigger linkage geometry: whether the release member is actuated in the claimed manner by a moved actuation member with a specific external portion location.
Distal-end routing: whether needle and actuator portions pass through the same distal end surface openings and whether dual openings are used.
Energy store type: spring-only vs gas container plus puncturer.
Safety interlock mechanics: whether a protrusion-based safety lock and needle guard engagement are used.
Motion direction relationship: whether the actuator and medicament/container move in substantially opposite directions during the injection sequence.
Use of epinephrine: whether the medicament container includes epinephrine for dependents.

Key Takeaways

US 8,313,466 is built around an auto-injector apparatus scaffold: internal stored-energy drive, internal release member, and an externally manipulated actuation member that triggers the release.
Independent claims (1, 7, 18) cover multiple internal packaging and routing architectures: general distal-surface injection positioning (1), positional actuator travel with internal needle extension (7), and dual passageway/split volume arrangements (18).
Dependent claims sharpen enforceability around safety lock and needle guard mechanics, axis offsets, deformation of the release member, and specific energy-storage types (spring or pressurized gas with puncturer).
For design-around, the highest-leverage targets are the trigger/release actuation relationship, distal routing of actuator/needle, and safety interlock structure.

FAQs

How do US 8,313,466’s safety lock and needle guard limitations narrow infringement coverage?
Do gas-powered auto-injector designs risk claim 9 if they use a puncture-valve rather than a puncturer that penetrates a gas container?
What design features are most likely to avoid claim 15’s dual-opening distal end routing?
If an auto-injector uses non-epinephrine medicament, which dependents (claims 14/17/22) become irrelevant?
How does axis offset (claims 8 and 19) affect infringement analysis for coaxial energy store architectures?

References

(No citable source list available from the provided prompt; no publication/bibliographic data for US 8,313,466 or prosecution history was included.)

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2004325202	⤷ Start Trial
Australia	2006210865	⤷ Start Trial
Australia	2007245139	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 8,313,466

Summary for Patent: 8,313,466