US Patent 8,870,827: Automatic Injector Claim Scope, Patent Landscape, and Generic Entry Risk

US Patent 8,870,827 protects a mechanical automatic-injector platform centered on a retractable, lockable needle cover, an internally protected locking system, cartridge and needle-length adjustability, and containment of residual actuation energy. The patent is directed to device architecture rather than a specific drug formulation. Its principal commercial relevance is to epinephrine and diazepam autoinjectors.

The strongest infringement risk lies in an injector that combines all of the following: a cartridge-based stored-energy drive, a needle cover that is locked in a retracted position before use, automatic activation by pressing the cover against the injection site, and a locked extended position after injection. Claims 2, 3, 6, 7, 18, and 20 add detailed mechanical limitations that may narrow literal infringement but also identify the patent's principal design-around boundaries.

What does US Patent 8,870,827 cover?

US 8,870,827 covers an automatic injector and a separate needle-cover component.

Item	Description
Patent	US 8,870,827
Title	Automatic injector
Patent type	Utility patent
Grant date	October 28, 2014
Core technology	Cartridge-based automatic injector with retractable and lockable needle cover
Exemplary medicaments	Epinephrine and diazepam
Main device categories	Epinephrine autoinjectors, rescue-medication injectors, cartridge-based disposable injectors
Independent claims	Claims 1 and 22
Principal subject matter	Injector architecture and needle-cover construction
Orange Book relevance	Generally limited because the claims are directed to a delivery device, not a drug composition

The patent is not a conventional drug patent. It does not claim epinephrine, diazepam, a formulation, a salt, a dosage regimen, or a manufacturing process for either active ingredient. Claim 21 identifies epinephrine and diazepam as medicaments used in the device, but the patent's enforceable value remains tied to the injector structure.

How is claim 1 constructed?

Claim 1 is the principal system claim. It requires the accused product to include each of the following limitations:

A housing.
A cartridge container inside the housing.
A cartridge received in the container.
A medicament in the cartridge.
A needle assembly containing a needle.
An actuation assembly with a stored-energy source.
A drive that pushes medicament through the needle after release of stored energy.
A needle cover received in the housing.
An opening in the needle cover through which at least part of the cartridge container passes.
A locked retracted position before dispensing.
A needle-cover surface that contacts the injection site before dispensing.

The claim does not require a particular spring, gas source, cartridge material, drug concentration, injection volume, needle gauge, or delivery rate. The stored-energy source could therefore encompass several mechanical configurations, subject to the claim's construction and the patent's specification.

The claim does require a specific spatial relationship between the housing, cartridge container, cartridge, needle assembly, and needle cover. A device using a needle shield that is not received in the housing, or a device in which the shield does not surround or cooperate with the cartridge container as claimed, may present a lower literal-infringement risk.

Which dependent claims create the greatest infringement risk?

Claims 2 through 21 add mechanical features that divide the patent into several enforcement positions.

Claims	Added limitation	Commercial significance
2-4	Internal locking mechanism and locking tooth	Protects pre-use retention of the cover and shields the lock from tampering and dirt
3	Spring-action extension that adjusts locking-tooth position	Targets accommodation of different cartridge and needle dimensions
5-7	Locked extended position after use	Protects post-injection needle shielding
6	Locking arm connected to cartridge container	Creates a defined post-use lock architecture
7	Thick and thin curved strut portions	Narrow mechanical geometry likely aimed at a particular molded locking-arm design
8	Enclosed front cover with an opening sized only for the needle	Limits access to the needle and supports post-use protection
9	Cover pressure initiates dispensing	Covers a skin-contact, push-against-the-body activation mechanism
10-12	Cover extends beyond housing; housing does not contact the injection site	Defines the external operating geometry
13	Oval housing	Protects a particular ergonomic cross-section
14	Non-removable needle sheath	Adds needle protection before use
15	One-piece molded collet coupled to the plunger	Protects the drive-to-plunger connection
16	Actuation energy is not transferred to the needle cover	Separates drive energy from shield movement
17	Residual energy is contained to prevent injector kickback	Addresses user safety and recoil control
18	Spring between needle cover and cartridge container	Protects a specific shield-return or shield-positioning arrangement
19	Closed cartridge-container front end with a needle-only opening	Adds an internal barrier around the needle
20	Multiple axle slots for adjustable locking-tooth placement	Protects size-adjustable cartridge and needle accommodation
21	Epinephrine or diazepam medicament	Narrows the system to two expressly identified rescue drugs

Claims 2 and 4 are alternative locking-mechanism pathways. Claim 2 requires a locking tooth that engages the cover. Claim 4 requires a locking mechanism inside the housing but does not require the locking tooth language. A product could avoid claim 2 while still implicating claim 4 if it uses a different internal locking structure.

Claims 5 through 7 focus on post-use safety. They are potentially important for products with a permanently extended needle shield after injection. A product that retracts the shield after use, uses a removable cap, or relies on a different post-use lock may reduce exposure to these claims.

What does claim 22 protect?

Claim 22 is an independent component claim covering a needle cover itself. It requires:

an elongated hollow body;
an enclosed end surface;
an opening through which only the needle passes;
two longitudinal slots on opposite sides;
multiple inwardly extending locking projections in each slot.

Claims 23 through 25 add:

paired openings and laterally extending edge surfaces;
internal grooves aligned with the longitudinal slots; and
cross slots extending across the longitudinal slots.

Claim 22 is important because it can be asserted against a needle-cover component even if the complete injector does not satisfy every limitation of claim 1. A manufacturer that sources the needle cover from a third party may face contributory-infringement or induced-infringement exposure if the component is made for a patented-use configuration.

The claim is still structurally constrained. A cover without two opposed longitudinal slots, without inward locking projections, or without an enclosed front end with a needle-only opening may fall outside its literal scope.

What formulations and dosage forms are protected?

The patent does not claim a formulation. Claim 21 identifies epinephrine or diazepam as the medicament, but it does not specify:

concentration;
pH;
preservative system;
excipients;
liquid or lyophilized form;
dose volume;
injection route;
stability profile; or
release profile.

The patent therefore does not create formulation exclusivity for epinephrine or diazepam. A competing manufacturer could use a different formulation and still face infringement if its injector practices the claimed device architecture. Conversely, a formulation that avoids the claimed injector structure would not infringe merely because it contains epinephrine or diazepam.

When does US 8,870,827 lose exclusivity?

The patent was granted on October 28, 2014. Its term is governed by the twenty-year term measured from the earliest effective nonprovisional priority filing, subject to patent-term adjustment and any applicable terminal disclaimer. The record should be reviewed for the controlling priority date and USPTO term-adjustment calculation before relying on a specific expiration day.

Based on the patent's early-2010s priority period, the nominal term is expected to fall in the early 2030s, subject to the official USPTO adjustment. Patent expiry does not eliminate other patent risks involving the same injector, including continuation patents, related foreign patents, design patents, or drug-product patents owned by a separate rights holder.

Exclusivity category	Relevance to US 8,870,827
Utility-patent term	Expected to extend into the early 2030s, subject to the official term calculation
Pediatric exclusivity	Not established by the claim set
Orphan-drug exclusivity	Not established by the claim set
New chemical entity exclusivity	Not applicable to this device patent
Biologic exclusivity	Not applicable
Formulation exclusivity	Not claimed
Method-of-use exclusivity	Not claimed in the conventional drug-patent sense
Device patent exclusivity	Primary protection

What is the Orange Book status of US 8,870,827?

US 8,870,827 should not be treated as an Orange Book drug-patent listing merely because claim 21 identifies epinephrine or diazepam. The Orange Book lists patents submitted for approved drug products under the statutory drug-patent listing framework. A standalone mechanical injector patent is not automatically listed against every drug product used in that injector. FDA Orange Book treatment depends on the NDA holder's submission and the agency's listing determinations. (U.S. Food and Drug Administration, 2024a)

The practical result is that a generic applicant generally would not address this patent through a Paragraph IV certification solely because it seeks approval for epinephrine or diazepam. A Paragraph IV certification is directed to a listed patent associated with the relevant reference-listed drug. Device-patent disputes can instead arise through separate patent litigation, contract claims, regulatory-device issues, or product-launch disputes.

Does the patent create biosimilar risk?

No meaningful biosimilar risk arises from this patent. Epinephrine and diazepam are small-molecule active ingredients, not biologic reference products. The Biologics Price Competition and Innovation Act and the Purple Book framework do not govern this patent's principal technology. (U.S. Food and Drug Administration, 2024b)

The relevant competitive threat is generic or authorized-generic entry using a different injector, not biosimilar substitution.

Which competing products create the greatest overlap?

The principal overlap is with cartridge-based rescue-medication autoinjectors that use a front-end needle cover or shield.

Product or platform type	Likely overlap	Principal distinction
Conventional EpiPen-type injector	Cartridge, stored energy, needle protection	Many configurations use a removable safety cap and a different activation architecture
Auvi-Q-type injector	Automatic needle deployment and retractable needle	Electronic controls, voice guidance, and different shield mechanics may avoid some limitations
Prefilled epinephrine syringe systems	Medicament and needle delivery	May lack the claimed automatic stored-energy injector architecture
Diazepam rescue autoinjector	Expressly identified medicament	Product-specific cartridge and shield design determine claim exposure
Generic epinephrine autoinjector	Potential direct competitor	Risk depends on cover geometry, internal lock, activation method, and post-use lock
Reusable or manually actuated injector	Lower overlap	May lack automatic stored-energy release or the claimed cover sequence

The patent does not monopolize all epinephrine autoinjectors. It targets a particular combination of mechanical functions. Product-by-product claim mapping is required.

How strong is the patent estate?

The patent has moderate structural breadth but substantial combination specificity.

Strengths

Claim 1 covers the complete operating sequence, not merely an isolated spring or shield.
The claims address both pre-use and post-use needle-cover locking.
Claims 3 and 20 address dimensional variation among cartridges and needles.
Claim 22 provides a separate component claim directed to the needle cover.
Claims 16 and 17 address energy transfer and recoil, which may be relevant to safety-focused designs.

Weaknesses

Claim 1 contains numerous spatial and functional limitations.
Several dependent claims require highly specific molded geometries.
Claim 21 does not create meaningful drug exclusivity.
A competitor may redesign the shield, locking system, activation trigger, or cartridge support without changing the active ingredient.
Prior-art vulnerability may be significant because automatic injectors, spring-driven plungers, needle shields, and cartridge holders were established technologies before the priority period.

The most commercially durable protection is likely the combination of a pressure-activated needle cover, an internally protected pre-use lock, and a permanently locked post-use position. The individual features are easier to design around when separated from the claimed combination.

What generic launch scenarios exist?

Scenario 1: Same architecture, same cover sequence

A competitor launches an epinephrine or diazepam injector with the same retractable cover, internal locking tooth, pressure activation, and post-use lock. This presents the highest infringement risk under claims 1, 2, 5, and 9, with possible additional exposure under claims 3, 6, 18, and 20.

Scenario 2: Same cartridge concept, different needle-cover system

A competitor retains the cartridge and stored-energy drive but uses a removable cap or a shield that is not locked in the claimed retracted position. This could avoid claim 1 if the required cover relationship and locked retracted position are absent.

Scenario 3: Different activation mechanism

A competitor uses a manual button or electronic trigger rather than pressing the needle cover against the injection site. This may avoid claim 9 and could affect claim 1 if the claimed pre-dispensing cover operation is not present.

Scenario 4: Different post-use protection

A competitor uses automatic needle retraction into the housing rather than locking the needle cover in an extended position. This may reduce exposure to claims 5 through 7, although claim 1 remains relevant.

Scenario 5: Different needle-cover component

A competitor uses a cover without opposed longitudinal slots and inward locking projections. This is the principal design-around route for claim 22.

What litigation and settlement issues matter?

The claim text alone does not establish whether US 8,870,827 has been asserted, licensed, challenged, or resolved in a particular court proceeding. A complete diligence review should distinguish:

infringement litigation involving the patent;
inter partes review or post-grant review;
ownership and inventorship disputes;
license agreements covering the injector platform;
settlements that impose launch dates or field restrictions;
continuation patents with overlapping claims; and
foreign counterparts with different claim scope.

A freedom-to-operate opinion should not rely on the expiration of US 8,870,827 alone. Device manufacturers may hold parallel patents on cartridge positioning, needle deployment, automatic activation, safety caps, voice electronics, dose delivery, and manufacturing methods.

What manufacturing and geographic barriers exist?

The patent's practical manufacturing relevance is concentrated in injection-molded parts and assembly tolerances. Potentially sensitive components include:

the hollow needle cover;
locking projections;
longitudinal slots and cross slots;
spring-action locking teeth;
cartridge-container axle slots;
the one-piece molded collet;
the locking arm's thick and thin strut portions; and
the enclosed cartridge-container front end.

Foreign counterparts may create additional exposure in Europe, Canada, Japan, Australia, and other markets, but US 8,870,827 itself has no extraterritorial effect. Importation of an infringing injector into the United States can create US infringement exposure under 35 U.S.C. § 271. Manufacturing outside the United States does not, by itself, eliminate risk if the product is imported, sold, or used in the US market. (U.S. Patent and Trademark Office, 2024)

Key Takeaways

US 8,870,827 is a mechanical injector patent, not a formulation patent.
Claims 1 and 22 are the principal independent claims.
The core combination is a cartridge-based stored-energy injector with a pressure-activated, retractable, lockable needle cover.
Claims 2 through 4 protect internal pre-use locking structures.
Claims 5 through 7 protect post-use needle-cover locking.
Claims 16 and 17 address energy isolation and prevention of injector kickback.
Claim 22 independently targets a needle-cover component with opposed longitudinal slots and inward locking projections.
Epinephrine and diazepam are identified uses, not protected drug compositions.
The patent does not create biosimilar exclusivity and is not, by itself, a conventional Orange Book drug patent.
The highest generic-launch risk comes from a product that copies the cover-locking sequence and cartridge-container geometry.
The strongest design-around options are a different activation mechanism, a different post-use shield strategy, or a needle cover lacking the claimed slot-and-projection structure.
The patent's expected term reaches into the early 2030s, subject to the official USPTO term calculation and any related patent rights.

FAQs

Does US 8,870,827 cover all epinephrine autoinjectors?

No. It covers only products that satisfy the limitations of at least one asserted claim, including the claimed housing, cartridge, stored-energy drive, needle cover, and locking relationships.

Can a generic use epinephrine and avoid US 8,870,827?

Yes. Drug identity alone does not determine infringement. A generic may reduce risk by using a different cover, activation mechanism, cartridge support, or post-use locking system.

Is the needle cover itself separately patented?

Claim 22 independently claims a needle cover with an enclosed end, needle-only opening, opposed longitudinal slots, and inward locking projections. Claims 23 through 25 add further structural limitations.

Does a Paragraph IV challenge automatically apply to this patent?

No. Paragraph IV applies to an applicable listed patent for the relevant reference-listed drug. A mechanical injector patent is not automatically subject to a Paragraph IV certification for every epinephrine or diazepam product.

Does the patent block a biosimilar or interchangeable biologic?

No. Epinephrine and diazepam are small-molecule drugs, and this patent does not claim a biologic product or a biosimilar-relevant manufacturing process.

References

U.S. Food and Drug Administration. (2024a). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book
U.S. Food and Drug Administration. (2024b). Purple Book: Database of licensed biological products. https://purplebooksearch.fda.gov/
U.S. Patent No. 8,870,827. (2014). Automatic injector. United States Patent and Trademark Office.
U.S. Patent and Trademark Office. (2024). Patent term adjustment and patent term information. https://www.uspto.gov/patents/laws/patent-term-calculator
35 U.S.C. §§ 154, 271, 321, and 355. United States Code.

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2005271355	⤷ Start Trial
Australia	2010201665	⤷ Start Trial
Australia	2013222015	⤷ Start Trial
Canada	2576776	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 8,870,827

Summary for Patent: 8,870,827