Last Updated: May 11, 2026

Details for Patent: 8,814,834


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Which drugs does patent 8,814,834 protect, and when does it expire?

Patent 8,814,834 protects OTREXUP and is included in one NDA.

This patent has nine patent family members in five countries.

Summary for Patent: 8,814,834
Title:Injector safety device
Abstract:A safety member for use with an injection device is disclosed. The safety member includes a blocking ring extending into a housing of the injection device in blocking association with a latch member associated with a trigger mechanism of the injector, in which the blocking ring blocks movement of a portion of the trigger mechanism into a firing position. The safety member further includes a manipulable portion disposed outside the housing and configured for hand-manipulation by a user to remove the safety member from the housing to unblock the firing mechanism to enable firing of the injector.
Inventor(s):Julius Sund, Eric Lagman, Peter Hoeft, Paul R. Lesch, Jr., Tom Kramer
Assignee: Antares Pharma Inc
Application Number:US12/921,940
Patent Claim Types:
see list of patent claims
Use; Dosage form;
Patent landscape, scope, and claims:

United States Patent 8,814,834 (Injector with Guard, Trigger Interlock, and Safety Blocking Through Housing Opening): Claims, Scope, and U.S. Landscape

What does US 8,814,834 claim, in technology terms?

US 8,814,834 claims a disposable or re-usable medicament injector that combines: (i) a plunger-driven firing mechanism, (ii) a latch/trigger system that releases a ram, and (iii) a retractable guard that can move into an “actuating” position. The key novelty is the safety member that physically blocks the trigger from entering the firing position by preventing guard retraction to the actuating position, while the safety member includes a blocking member that extends through a housing opening and abuts a portion of the trigger, with the safety member having an external body portion.

This is not a generic safety-guard. The claim language forces a specific mechanical chain:

  • Guard retraction to actuating position drives the trigger toward firing position.
  • A safety member blocks that trigger movement by limiting guard travel and/or by directly abutting the trigger via a blocking member that passes through a housing opening.
  • The safety member’s blocking member has an end disposed within the housing to abut the trigger.
  • The blocking member extends through an opening in the housing and attaches to a body portion outside the housing.
  • Specific force relationships and structural latch/ram features appear in dependent claims.

Core independent claim (Claim 1) scope: required elements and functional constraints

Claim 1 recites an injector comprising the following mandatory components and interactions:

A. Reservoir and firing stack

  1. Housing
  2. Container portion disposed within the housing forming a fluid chamber containing medicament and including:
    • Plunger moveably disposed in the container portion defining a portion of the fluid chamber.
  3. Firing mechanism
    • Ram affixed to the plunger, extending axially from the plunger.
  4. Latch
    • Moveably disposed within the housing
    • Configured to engage a portion of the ram.
  5. Trigger
    • Moveably disposed within the housing between:
      • Ready position: latch is held in engagement with the ram.
      • Firing position: latch releases, permitting movement of ram.
  6. Safety member
    • Positionable relative to the housing to restrict movement of the trigger into the firing position.
  7. Guard
    • Extending distally of the housing.
    • Retractable from a protecting position to an actuating position.
    • Retraction causes a portion of the guard to move the trigger into the firing position.
    • Safety member restricts movement of the trigger by preventing movement of the guard into the actuating position.

B. Blocking member through a housing opening (structural interlock)

  1. Housing includes an opening formed therein.
  2. Safety member includes a blocking member
    • Has an end disposed within the housing that abuts a portion of the trigger.
    • Blocking member extends through the housing opening
    • Attaches to a body portion disposed outside the housing.

Implication for claim scope: An accused injector must have (i) a safety member that restricts trigger movement into firing position, (ii) a retractable guard that normally drives trigger motion, and (iii) a specific physical blocking architecture using a blocking member through a housing opening into internal abutment of the trigger, attached to an external body portion.

C. Guard-trigger relationship is not optional

Claim 1 ties guard retraction mechanically to firing:

  • Guard in protecting position prevents firing.
  • Guard retraction to actuating position moves the trigger into firing.
  • Safety member blocks guard movement into actuating position so trigger cannot reach firing.

A design that blocks the trigger without using guard travel limitation and/or without the explicit safety member-blocking member architecture would fall outside Claim 1’s literal recitation.


Dependent claim features that narrow scope (Claims 2–11)

Below, each dependent claim adds a specific structural/functional limitation that narrows the covered embodiments.

Claim 2 (snap-fit removable blocking member)

  • Blocking member retained in housing opening by snap fit.
  • User can remove it to permit trigger movement into firing.

Narrowing effect: requires a snap-fit retention and user-removal functionality for the internal blocking member.

Claim 3 (quantified force relationships on trigger)

  • Trigger moves from ready to firing position using a first amount of force.
  • There is frictional relationship between trigger and latch creating retaining force (second amount).
  • Safety member provides safety force on trigger (third amount).
  • Numeric constraint: first amount is greater than second amount by about 2.5 lbs.

Narrowing effect: requires a definable force stack with about a 2.5 lb differential between specified force measurements, plus the frictional retaining force between trigger and latch.

Claim 4 (flexible arm latch with projection/indentation)

  • Latch includes:
    • Flexible arm
    • Projection
  • Ram includes:
    • Indentation
  • Projection receivable in indentation.
  • Projection held in indentation when trigger abuts latch in ready position.

Narrowing effect: specific latch flexure/projection-in-indentation architecture.

Claim 5 (disengagement upon firing)

  • Indentation/projection configured so:
    • latch restricts ram movement when projection held in indentation by trigger.
    • moving trigger to firing position allows projection and indentation to disengage.
    • ram moves axially relative to latch.

Narrowing effect: ties structural engagement to release timing at firing position.

Claim 6 (needle and guard positional relationship)

  • Includes needle with tip penetrating skin.
  • Guard distal end positioning:
    • Protecting position: distal end of guard is distally of needle tip.
    • Retracted position: distal end of guard is proximally of needle tip.

Narrowing effect: requires specified relative axial positions between needle tip and guard in guarding vs retracted state.

Claim 7 (alternative safety member arrangement: blocking member abuts guard)

  • Housing opening + safety member includes:
    • blocking member
    • body portion
  • Blocking member end disposed within housing to abut portion of the guard.
  • Blocking member extends through housing opening and into connection with external body portion.

Narrowing effect: safety member blocks by abutting the guard internally, rather than (or in addition to) directly abutting trigger as in Claim 1’s internal abutment. Still requires through-opening connection to external body portion.

Claim 8 (axial ordering: blocking member between guard and trigger)

  • Guard proximal end and trigger distal end define distance.
  • In guarding position:
    • guard proximal end is axially remote from trigger distal end.
  • Blocking member disposed axially between guard proximal end and trigger distal end.

Narrowing effect: requires specific axial layout that supports guard/trigger spacing while blocking.

Claim 9 (safety member locking element slidably associated with sleeve)

  • Injector includes sleeve affixed within housing for retaining container.
  • Safety member includes locking element slidably associated with sleeve.
  • Locking element movable:
    • first position: guard retractable to actuating position
    • second position: locking element fixed relative to sleeve and blocks movement of guard into actuating position.

Narrowing effect: adds sleeve-based slidably guided locking element and defined positions that change guard ability.

Claim 10 (spring bias causes locking element shift after retraction)

  • Spring within housing biases guard to protecting position.
  • After guard retracts to actuating position, guard returns to protecting position.
  • Guard retraction engages guard with locking member.
  • Guard’s return moves locking element into second position.

Narrowing effect: requires spring-biased return cycle that repositions locking element after actuation.

Claim 11 (safety member as a cap with snap-fit to guard)

  • Safety member in form of a cap covering open end of the guard and surrounding guard.
  • Guard includes a flange.
  • Cap includes a projection to achieve snap-fit between guard and cap.
  • Cap abuts housing to restrict retraction into actuating position.

Narrowing effect: adds cap-and-flange snap-fit structure and cap-to-housing abutment as the blocking mechanism.


Practical claim boundaries: what designs are clearly outside?

Based on the literal limitations in Claim 1 and its narrowing dependent claims, the main “outside” buckets are:

  1. No housing opening with an internal blocking member that extends through and attaches to an external body portion.
  2. No blocking interaction with trigger movement into firing position.
  3. No retractable guard that moves the trigger into firing position upon retraction.
  4. No latch that holds ram in ready position and releases it at firing position.
  5. No axial ram-plunger coupling.
  6. If force quantification is required by asserted dependent claims, designs lacking the specified ~2.5 lb differential or lacking the frictional retaining force relationship would not meet those dependent claim limitations.

Patent landscape analysis (U.S.): how to read the competitive field

Given the claim structure, US 8,814,834 targets a specific defensive posture common in auto-injector safety mechanisms: preventing actuation until safety conditions are satisfied, often with removable or positionable safeties and guard interlocks.

What US 8,814,834 likely competes against

The dominant U.S. auto-injector ecosystems generally cluster into three mechanisms:

  • Needle guard/needle shield actuation interlock (mechanical sequencing so needle cannot expose early).
  • Trigger latch and ram release architecture (snap-latch engagement and release timing).
  • External safety removers/caps (user removes cap or removes barrier to enable actuation).

US 8,814,834 uniquely blends:

  • a guard that retracts and physically moves the trigger to firing, and
  • a safety member that blocks guard retraction to the actuating position, and
  • a through-housing blocking member that abuts internal trigger portions, tethered to an external body.

Where the patent is likely strongest

  • In enforcement scenarios where an accused injector uses:
    • guard retraction to drive trigger movement,
    • a separate safety member preventing guard travel,
    • and a physically interposed blocking member that enters the housing through an opening to abut the trigger.
  • In design-arounds, it discourages substitutes that use only electronic interlocks or only external caps that do not create an internal blocking member through a housing opening.

Where the patent may be easier to avoid

  • If an injector blocks trigger motion indirectly without a blocking member extending through a housing opening and attaching to an external body portion, it reduces literal match likelihood for Claim 1.
  • If the injector’s safety mechanism only covers the needle guard externally without limiting guard travel into an “actuating position” while also driving trigger motion, it may avoid the core functional chain in Claim 1.

Claim-by-claim “design-around” pressure map

Design-around vectors aimed at Claim 1

Claim 1 element that drives scope Design-around approach in practice
Safety member blocks trigger into firing by preventing guard from entering actuating position Use a safety that blocks firing via a separate inhibitor not tied to guard travel into an actuating position
Housing opening + internal blocking member end abutting trigger Replace with a safety that does not insert an internal blocking member through a housing opening to abut the trigger
Guard retraction moves trigger into firing position Make guard movement only cover or uncover the needle, not directly move the trigger into firing
Latch engages ram in ready and releases at firing Use a different release architecture (e.g., direct plunger release, different latch topology)

Design-around vectors aimed at dependent claims

  • Snap-fit removable internal blocking member (Claim 2): avoid snap-fit or avoid user-removal.
  • Force relationship requirement (Claim 3): alter frictional retaining forces or safety force magnitudes; avoid measurable dependency.
  • Flexible arm latch with projection/indentation (Claims 4-5): shift latch geometry and engagement style.
  • Needle tip vs guard distal/proximal positioning (Claim 6): change guard travel endpoints.
  • Safety member blocking guard internally (Claim 7) and axial ordering (Claim 8): alter axial placement or the abutment target.
  • Sleeve-guided locking element (Claim 9) and spring-biased return cycle (Claim 10): implement a safety that does not lock via sleeve-associated sliding locking element or remove spring return sequence.
  • Cap with flange snap-fit (Claim 11): avoid cap-projection snap-fit to guard flange; use different covers.

What to infer for freedom-to-operate (FTO) posture

Without external file wrapper citations and without citing specific family members or cited references, the actionable FTO conclusion is constrained to claim-structure risk: US 8,814,834 is a mechanical interlock patent that is most relevant to products using:

  • a movable trigger/latch/ram firing train,
  • a retractable needle guard that drives the trigger,
  • and a safety mechanism that prevents guard travel and includes an internal through-housing blocking member attached to an external body.

The higher the degree of overlap in that mechanical chain, the higher the infringement risk. The lower the overlap in any one of those three anchor features (guard-to-trigger actuation, through-opening trigger blocking member, and safety preventing guard to actuating position), the lower the risk for literal infringement.


Key Takeaways

  • US 8,814,834 Claim 1 is defined by a specific mechanical sequence: retractable guard drives trigger motion toward firing, while a separate safety member blocks that motion by preventing guard travel into an actuating position.
  • The patent’s most enforceable structural element is the through-housing blocking member: a blocking member extends through a housing opening into the housing to abut the trigger and attaches to an external body portion.
  • Dependent claims narrow to concrete sub-features including snap-fit removable blocking parts, quantified force relationships (~2.5 lb differential), flexible-arm latch engagement with ram indentation, and guard/needle endpoint positioning.
  • FTO risk is highest for devices replicating the guard-to-trigger actuation chain plus the through-opening trigger blocking member. Designs that decouple guard motion from trigger actuation or that replace internal through-opening blocking are less likely to map to Claim 1.

FAQs

1) What is the single most important limitation in Claim 1 for infringement?
The safety member must include a blocking member that extends through a housing opening into the housing to abut the trigger, while the safety member restricts trigger movement by preventing guard retraction to an actuating position.

2) Does Claim 1 require the needle to be present?
No. Needle inclusion and specific positional relationships appear in Claim 6, not Claim 1.

3) Can a product infringe through a different trigger-latch-release mechanism?
It can only infringe if the product still includes a latch engaged with a ram in ready position and releases the ram when the trigger reaches firing position, with the guard and safety interlocks matching Claim 1’s constraints.

4) What do Claims 2 and 11 have in common?
Both describe particular safety member implementations: Claim 2 focuses on a snap-fit blocking member removable by a user, while Claim 11 covers a cap with flange snap-fit and housing abutment to restrict guard retraction.

5) How do the force-specific provisions affect strategy?
Claim 3 adds quantified force relationships. A product that avoids those measured constraints may avoid dependent-claim coverage even if it matches the broader guard-trigger safety chain.


References

  1. United States Patent No. 8,814,834.

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Drugs Protected by US Patent 8,814,834

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Assertio Speclty OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-005 Nov 7, 2014 DISCN Yes No 8,814,834 ⤷  Start Trial Y ⤷  Start Trial
Assertio Speclty OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-001 Oct 11, 2013 DISCN Yes No 8,814,834 ⤷  Start Trial Y ⤷  Start Trial
Assertio Speclty OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-006 Mar 24, 2016 DISCN Yes No 8,814,834 ⤷  Start Trial 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: 8,814,834

PCT Information
PCT FiledMarch 10, 2009PCT Application Number:PCT/US2009/036682
PCT Publication Date:September 17, 2009PCT Publication Number: WO2009/114542

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