Details for Patent: 9,737,669

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Summary for Patent: 9,737,669

Title:	Devices, systems and methods for medicament delivery
Abstract:	Apparatuses for automatic medicament injection and methods for manufacturing automatic medicament injectors are described herein. In some embodiments, an apparatus includes a housing, a needle, an energy storage member, an actuator, a locking member, and a needle guard. The needle is configured to move between a first position and a second position. In its first position, the needle is contained within the housing. In its second position, at least a portion of the needle extends from the housing. The energy storage member has a first configuration and a second configuration and is configured to produce a force when moving between its first configuration and its second configuration to move the needle from its first position to its second position. The actuator is configured to move the energy storage member from its first configuration to its second configuration. The locking member is movably coupled to the distal end portion of the housing such that the locking member can be moved between a first position and a second position. In its first position, the locking member is configured to engage the actuator to prevent the actuator from moving the energy storage member to the second configuration. The needle guard is removably coupled to at least one of the distal end portion of the housing or a base movably coupled to the distal end portion of the housing.
Inventor(s):	Eric S. Edwards, Evan T. Edwards, Mark J. Licata, Paul F. Meyers
Assignee:	kaleo Inc
Application Number:	US14/731,048
Patent Claim Types: see list of patent claims	Use; Device;

United States Patent 9,737,669: Scope, Claims, Expiration, and Autoinjector Patent Landscape

U.S. Patent No. 9,737,669 protects a spring-driven autoinjector architecture with a removable, laterally operated safety lock positioned between housing and base shoulders. The patent is directed primarily to device mechanics, not to epinephrine chemistry. Its strongest limitation is the combination of a transverse removable safety lock, a movable base that actuates the injection mechanism, and a needle or medicament container that advances along the device axis.

The claims cover three overlapping apparatus configurations. Independent claims 1, 11, and 19 each require a housing, medicament-delivery mechanism, movable base, and safety lock. Claims 9, 18, and 25 narrow the devices to epinephrine-containing injectors. The patent therefore has potential relevance to epinephrine autoinjectors and other spring-powered injection systems using the same safety architecture.

What does U.S. Patent 9,737,669 protect?

The patent protects a disposable or single-use autoinjector in which a safety component blocks activation until the user removes or laterally shifts it.

The core elements are:

Claim element	Technical requirement
Housing	Has proximal and distal end portions
Injection mechanism	Needle moves from a contained position to an extended position, or the medicament container moves to an injection position
Energy storage member	Produces force for needle or container movement
Base	Moves relative to the housing and actuates the energy storage member
Needle opening	Base has an opening through which the needle extends
Safety lock	Moves relative to the distal housing
Lock direction	Moves nonparallel, and in several claims normal, to the needle axis
Blocking function	Prevents base movement in the locked position
Release function	Is removed from the blocking position, or removed from the housing, before activation
User interface	May include arrows or numerals showing removal direction
Cover	May surround the distal housing, safety lock, and base
Drug	May be epinephrine

The patent does not require every embodiment to use a fixed needle that advances independently. Claims 11 through 18 instead cover an arrangement in which the medicament container itself moves to an injection position and the needle becomes fluidically coupled to the container.

How do the independent claims differ?

Claim 1: Needle-position architecture

Claim 1 is the broadest mechanical formulation of the three independent claims. It requires:

1. A housing.
2. A needle movable between an internal first position and an externally projecting second position.
3. An energy storage member that drives needle movement.
4. A movable base that actuates the energy storage member.
5. A safety lock that blocks base movement.
6. A safety lock that moves in a direction nonparallel to the needle axis.

The claim does not expressly require a medicament container or epinephrine. A device that uses the claimed needle and activation structure could potentially fall within claim 1 even if its drug, dose, or therapeutic use differs.

The phrase “nonparallel to a longitudinal axis of the needle” is broader than “normal.” A lock moving diagonally or along another nonparallel path could satisfy the literal directional language of claim 1, subject to the full claim construction and device geometry.

Claim 11: Container-position architecture

Claim 11 requires:

• A medicament container inside the housing.
• An energy storage member that moves the container to an injection position.
• A needle fluidically coupled to the container in that position.
• A distal needle end extending from the housing.
• A base with a needle opening.
• An elongated safety-lock portion between a housing shoulder and base shoulder.

This claim is narrower than claim 1 because it requires a moving medicament container and a shoulder-to-shoulder blocking relationship. It is potentially stronger against devices that reproduce the claimed structural arrangement, because the lock is not merely a generic trigger inhibitor. It occupies a defined location between the housing and base shoulders.

Claim 19: Contact and spacing architecture

Claim 19 requires:

• A medicament container.
• A moving container driven by an energy storage member.
• A needle coupled to the container in the second container position.
• A movable base.
• A safety lock that contacts the base in the first position.
• A safety lock spaced from the base in the second position.
• A removable cover surrounding the safety lock and base.

Claim 19 is distinct from claim 11. Claim 11 emphasizes an elongated lock portion disposed between shoulders. Claim 19 emphasizes the transition from contact with the base to spacing from the base, plus the cover surrounding the distal assembly.

What limitations create the main infringement risk?

The most important claim limitations are not the presence of a spring or needle alone. They are the interaction among the base, safety lock, housing shoulder, and distal cover.

Transverse or nonaxial safety-lock movement

Claims 1, 3, 11, 14, 19, and 21 require movement of the safety lock in a direction nonparallel or normal to the needle axis. A conventional pull-off safety cap that moves axially along the needle axis may avoid the literal scope of these limitations.

A device can face greater risk if its safety component:

• Slides sideways across the distal housing.
• Is pulled laterally or radially away from the needle axis.
• Is removed from a track running transverse to the device.
• Uses a laterally movable tab that clears the base only after transverse travel.

The claim language does not require a particular angle, handle shape, color, or user grip.

Blocking the movable base

The safety lock must prevent movement of the base in the first position. This limitation distinguishes the patent from devices in which a safety component blocks only a trigger, actuator button, plunger, or needle shield.

A competing device is more exposed where the base itself cannot move because the safety lock occupies the space between the base and housing or because the lock directly bears against the base.

Shoulder-to-shoulder placement

Claims 7, 11, 19, and 20 require or reinforce placement between a housing shoulder and a base shoulder. The shoulders may be annular, radial, ledge-like, or otherwise configured to restrain axial base movement. The claim analysis will turn on the ordinary meaning of “shoulder” and the patent’s specification.

A design that blocks the base at a different location, such as by a pin, latch, hinged arm, or internal trigger, may avoid these limitations. That result depends on whether the alternative structure performs the same claimed function in substantially the same way.

Removal from the housing

Claims 2 and 15 require the safety lock to be removed from the housing in the second position. Other claims do not necessarily require complete removal. A lock that remains captive but shifts clear of the base may implicate claims 1, 11, or 19 while avoiding claims 2 and 15.

The distinction is commercially important. A tear-off tab, loose shipping piece, or fully detachable collar presents a different claim profile from an integrated sliding lock.

Which dependent claims materially narrow the patent?

Claims	Added limitation	Commercial significance
2, 15	Lock removed from housing	Targets detachable safety pieces
3, 14, 21	Lock moves normal to needle axis	Narrows direction to transverse movement
4, 12, 23	Protrusion engages housing	Covers retention or snap-fit structure
5, 13, 24	Two extended portions and two protrusions	Covers bilateral lock retention
6, 16	Arrow or numeral on outer lock surface	Covers user instructions molded or printed on lock
7, 20	Lock between housing and base shoulders	Defines axial blocking location
8, 17, 19	Distal cover surrounds lock and base	Covers protected shipping configuration
9, 18, 25	Medicament is epinephrine	Narrows to epinephrine autoinjectors
10, 22	Needle and spring axes are noncoaxial	Covers offset internal layouts
26	Noncoaxial status window	Covers visual drug or device-status inspection

Claims 9, 18, and 25 are particularly relevant to an epinephrine product, but they are narrower than the corresponding independent claims. A product can potentially infringe an independent claim without containing epinephrine if all mechanical elements are present.

Claim 26 adds a noncoaxial status window. It is a specialized limitation requiring the housing to show at least part of the medicament container through a window whose centerline is not coaxial with the housing’s longitudinal centerline. This claim may be useful against devices with offset viewing windows, but it is unlikely to cover a conventional centered inspection window.

What is the likely patent term and expiration timing?

U.S. Patent No. 9,737,669 issued on August 22, 2017. Its enforceable term is generally governed by 35 U.S.C. § 154 and runs for 20 years from the relevant nonprovisional application filing date, subject to patent-term adjustment, terminal disclaimers, and any applicable patent-term extension.

The issue date alone does not establish the expiration date. The controlling analysis requires the patent’s continuity data, earliest effective nonprovisional filing date, patent-term adjustment, and any terminal disclaimer recorded by the USPTO. Those details are available in the USPTO Patent Center record and the patent’s front page. The provisional priority date does not itself start the 20-year term.[1][2]

For commercial diligence, the patent should be treated as an issued device patent with a term extending into the 2030s unless the prosecution record shows a terminal disclaimer or other term restriction. Patent expiration should not be assumed from the 2017 issue date.

What is the Orange Book status of U.S. Patent 9,737,669?

The Orange Book lists patents associated with approved drug products, including patents submitted by an NDA holder for drug substance, drug product, or method-of-use protection.[3] A mechanical autoinjector patent may be submitted for listing when it is properly tied to an approved drug product and satisfies FDA listing requirements.

The relevant questions are:

1. Whether the patent was submitted for the applicable epinephrine NDA.
2. Whether FDA accepted the patent for Orange Book listing.
3. Which claims were identified as drug-product or method-of-use claims.
4. Whether the listed patent is subject to a Paragraph IV certification.
5. Whether a 30-month stay or litigation event affected generic approval timing.

The claims supplied are apparatus claims. They are not method-of-treatment claims and do not claim epinephrine as a chemical compound. Any Orange Book relevance would therefore depend on the patent’s relationship to the approved delivery system and the NDA holder’s listing submission, rather than on the drug substance itself.

A patent’s absence from the Orange Book would not eliminate ordinary infringement risk. A device patent may remain enforceable under patent law even if it is not listed for Hatch-Waxman purposes. Conversely, Orange Book listing does not establish validity or infringement.[3]

What Paragraph IV challenges and generic-entry risks exist?

An ANDA applicant seeking approval for an epinephrine autoinjector may address a listed patent through:

• Paragraph I certification, if no patent information is listed.
• Paragraph II certification, if the patent has expired.
• Paragraph III certification, if the applicant will wait until expiration.
• Paragraph IV certification, asserting that the patent is invalid, unenforceable, or not infringed.

If a Paragraph IV notice is served for a listed patent, the NDA holder may file an infringement action within 45 days. A timely action can trigger a statutory stay of FDA approval, generally up to 30 months, subject to statutory exceptions and court decisions.[4]

The central Paragraph IV arguments against this patent would likely focus on:

• No transverse lock movement.
• No movable base that actuates the energy storage member.
• No lock positioned between housing and base shoulders.
• No complete removal of the lock.
• No claimed protrusions engaging the housing.
• No noncoaxial spring and needle axes.
• No covered distal cap surrounding the lock and base.

The strongest noninfringement design would use an axial cap, an internal trigger block, or a safety mechanism that prevents firing without blocking movement of the claimed base.

Which products and companies are commercially relevant?

The patent landscape is centered on epinephrine autoinjectors and competing delivery platforms rather than on ordinary syringes.

Product or platform	Company	Device relevance
Auvi-Q	kaléo, Inc.	Compact epinephrine autoinjector platform; likely relevant to the patent’s commercial context
EpiPen	Viatris/Mylan; originally Meridian Medical Technologies	Established spring-loaded autoinjector with a different legacy device architecture
Authorized generic EpiPen	Viatris/Mylan	Commercially aligned with EpiPen device design
Symjepi	Adamis Pharmaceuticals, later acquired by Sandoz	Prefilled syringe format rather than the same autoinjector architecture
Neffy	ARS Pharmaceuticals	Intranasal epinephrine; does not use the claimed needle, base, or spring architecture
Generic epinephrine autoinjectors	Various ANDA sponsors	Potential Hatch-Waxman and device-patent exposure

Auvi-Q is the most commercially relevant comparator because the claimed structure is associated with compact, user-operated epinephrine autoinjector designs. EpiPen is an important competitive reference but does not automatically fall within this patent. Infringement depends on the specific internal geometry and operation of the accused device, not on the product category.

Neffy and other non-injectable products generally avoid the claims because they do not use a needle, movable injection base, or needle-directed energy storage system.

How strong is the patent estate for an epinephrine autoinjector?

The patent has moderate structural strength and narrower product-specific breadth.

Strengths

• Three independent claims cover related but distinct injection architectures.
• The claims focus on a concrete mechanical interaction rather than a purely functional result.
• The transverse lock and shoulder-blocking relationship may be difficult to avoid in a compact device using the same user workflow.
• Epinephrine claims provide direct product relevance.
• Noncoaxial axis limitations may capture compact internal layouts not covered by conventional axial designs.

Weaknesses

• The claims are limited to particular safety-lock and base relationships.
• A conventional axial safety cap may avoid the directional limitations.
• Claims 9, 18, and 25 are narrower because they require epinephrine.
• Claim 26 is highly specific.
• Mechanical claim validity may be vulnerable to prior-art combinations involving autoinjector safety caps, removable shipping locks, movable bases, and spring-driven needle mechanisms.

The principal validity issues would be anticipation under 35 U.S.C. § 102 and obviousness under 35 U.S.C. § 103. Relevant prior art would include earlier autoinjectors with:

• Removable safety keys.
• Laterally sliding or transverse locks.
• Base-blocking tabs.
• Spring-driven needle deployment.
• Movable cartridge or syringe assemblies.
• Visual status windows.
• Noncoaxial spring and needle arrangements.

What licensing and litigation issues matter?

A license covering the drug product or brand does not necessarily cover the device patent unless the patent is expressly included. Due diligence should distinguish among:

1. Drug substance licenses.
2. Device-platform licenses.
3. Manufacturing and assembly licenses.
4. NDA or ANDA settlement agreements.
5. Cross-licenses covering patent families.
6. Supply agreements with indemnification provisions.

For an ANDA or 505(b)(2) entrant, the critical documents are the Orange Book patent listing, Paragraph IV notice, infringement complaint, claim construction record, settlement agreement, and any consent judgment. A settlement may permit a launch date before patent expiration while preserving restrictions on product design, supplier changes, or authorized-generic competition.

The patent’s device claims can also affect contract manufacturers. A manufacturer that builds a covered autoinjector may face direct infringement exposure under 35 U.S.C. § 271(a), while an entity supplying components or encouraging manufacture may face contributory or induced-infringement theories under §§ 271(b) and 271(c).[5]

What design-arounds are most plausible?

Potential design-around strategies include:

• Replace the transverse safety lock with an axial removable cap.
• Block a trigger or plunger rather than the movable base.
• Use a hinged safety arm rather than a removable elongated lock.
• Keep the safety lock captive and move it rotationally, if the resulting geometry avoids the claimed directional limitation.
• Eliminate the housing and base shoulder interface.
• Use a fixed syringe with a separate needle shield.
• Align the spring and needle axes to avoid claims 10 and 22.
• Use a centered or differently configured status window to avoid claim 26.
• Move the medicament container without using the claimed base-actuation sequence.

A design-around must be evaluated against every limitation of each asserted claim. Changing only the safety-lock shape may not avoid infringement if the lock still moves transversely, blocks the base, engages housing shoulders, and is surrounded by a distal cover.

How does this patent compare with competing epinephrine-device patents?

Issue	U.S. 9,737,669	Conventional EpiPen-type design	Nasal epinephrine product
Needle	Required by independent claims	Yes	No
Spring-driven injection	Required	Usually yes	No
Movable base	Required	Product-specific	No
Transverse safety lock	Central limitation	Product-specific	No
Movable medicament container	Required in claims 11 and 19	Product-specific	No
Epinephrine	Dependent claims only	Usually yes	Usually yes
Orange Book relevance	Depends on NDA listing	Product-specific	Separate product estate
Main risk	Device-architecture infringement	Depends on internal structure	Generally outside scope

Key Takeaways

• U.S. Patent 9,737,669 is a device patent covering a spring-driven autoinjector with a movable base and transverse or nonaxial safety lock.
• Claims 1, 11, and 19 are the principal enforcement claims.
• The most important limitations are the safety lock’s direction of movement, its ability to block the base, and its position between housing and base shoulders.
• Claims 9, 18, and 25 specifically narrow protection to epinephrine-containing devices.
• The patent is potentially relevant to compact epinephrine autoinjectors, especially designs using a laterally removable safety component.
• Axial safety caps, internal trigger blocks, fixed-syringe designs, and nasal delivery systems present materially different infringement profiles.
• Orange Book listing must be verified separately from ordinary patent enforceability.
• Paragraph IV exposure depends on whether the patent is listed for the relevant NDA and whether an ANDA applicant uses the claimed device architecture.
• The patent’s term is governed by the applicable nonprovisional filing date, patent-term adjustment, and any terminal disclaimer, not simply by its 2017 issue date.
• A final freedom-to-operate conclusion requires a limitation-by-limitation comparison against the accused device’s internal mechanism.

Frequently Asked Questions

Does U.S. Patent 9,737,669 claim epinephrine itself?

No. The patent claims apparatuses. Epinephrine appears as a narrowing limitation in claims 9, 18, and 25.

Can an axial pull-off cap avoid this patent?

It may avoid claims requiring movement normal or nonparallel to the needle axis, but the complete device must be compared against every limitation of the asserted claims.

Does the patent cover all epinephrine autoinjectors?

No. It covers only devices containing the claimed combination of housing, energy storage member, movable base, needle or movable container, and safety-lock structure.

Is a nasal epinephrine product covered?

Generally no. A nasal product lacks the claimed needle, injection base, and spring-driven needle or container movement.

What is the most important prior-art issue?

The central prior-art question is whether a single reference, or a combination of references for obviousness, disclosed a spring-driven autoinjector with a transverse removable lock that blocks movement of the injection base.

References

1. United States Patent and Trademark Office. (2017). U.S. Patent No. 9,737,669, apparatus. U.S. Department of Commerce.
2. United States Patent and Trademark Office. (n.d.). Patent term adjustment and patent term calculation. U.S. Department of Commerce.
3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. FDA.
4. U.S. Food and Drug Administration. (2024). Hatch-Waxman amendments and abbreviated new drug applications. FDA.
5. United States Code. (2024). 35 U.S.C. §§ 102, 103, 154, 271.

Drugs Protected by US Patent 9,737,669

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

International Family Members for US Patent 9,737,669

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2004325202
Australia	2006210865
Australia	2007245139
Australia	2009200841
Australia	2009246525
Australia	2012201481
Australia	2015264857