Details for Patent: 7,901,385

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Which drugs does patent 7,901,385 protect, and when does it expire?

Patent 7,901,385 protects SUMAVEL DOSEPRO and is included in one NDA.

This patent has nine patent family members in eight countries.

Summary for Patent: 7,901,385

Title:	Casing
Abstract:	A casing (50) for an injection device (10) of the type having a safety device which prevents operation of the device (10), incorporating an actuator means (56) by which the safety means of the device (10) can be actuated to allow operation of the device (10). Also a casing (50) for a medicament container having an opening closed prior to use by a break-off tip (135), having relatively moveable first and second casing parts (51, 52), which on relative movement apply a breaking force to the break-off tip (135). A preferred embodiment includes both such features.
Inventor(s):	Gregor John McLennan Anderson, John Mitchell
Assignee:	Zogenix Inc
Application Number:	US10/506,959
Patent Claim Types: see list of patent claims	Use; Device; Dosage form;

US Patent 7,901,385: Scope, Claim Construction, Expiration and Needleless Injector Patent Landscape

US Patent 7,901,385 protects a needleless injection system with an interlocked safety mechanism, an externally accessible actuator, and, in several claim groups, a break-off tip that sequentially exposes the injector orifice and safety control. The patent is directed to injector architecture and packaging, not to a particular medicament, formulation, therapeutic indication, or injection method.

The strongest enforceable scope is concentrated in the combination of:

1. A needleless injector with a casing, medicament cartridge, orifice, drive mechanism, trigger and safety mechanism.
2. A safety mechanism that blocks trigger movement until displaced.
3. An actuator that pulls or otherwise moves the safety mechanism into the firing position.
4. A collar or obstructer that moves generally perpendicular to the injection direction.
5. A break-off tip or casing that controls sequential exposure of the orifice and safety actuator.

What does US Patent 7,901,385 claim?

The patent contains four independent claims: claims 1, 8, 22 and 23. They divide into two technical claim families.

Claim family	Independent claims	Primary subject matter
Actuator and safety interlock	1, 23	Needleless injector with an external lever or actuator that moves a safety mechanism
Break-off tip and sequential activation	8, 22	Injector or casing in which breaking a tip exposes the orifice, safety mechanism or actuator
Dependent mechanical refinements	2-7, 17-21, 24-29	Trigger obstruction, collar movement, sleeve interaction, pulling force, gas drive and casing construction

Claim 1 requires a complete needleless injection device. Its principal limitations are:

• A casing.
• A cartridge containing medicament.
• An orifice through which the medicament exits.
• A drive mechanism that forces medicament through the skin.
• A trigger mechanism.
• A two-position safety mechanism.
• An actuator lever extending outside the casing.
• A component of the lever that applies a pulling force to move the safety mechanism into the firing configuration.

A conventional needleless injector without an external actuator lever may avoid literal infringement of claim 1 even if it has a similar cartridge, gas drive and trigger system.

Claim 23 overlaps substantially with claim 1 but expressly requires a retaining mechanism that holds the safety mechanism in its second configuration. Claim 23 also describes the actuator as moving the safety mechanism when the externally accessible portion is moved, while claim 25 narrows that movement to a pulling force.

How do claims 1 through 7 define the safety mechanism?

Claims 1 through 7 focus on the mechanical relationship between the safety mechanism and the trigger.

Claim 2: trigger immobilization

Claim 2 narrows claim 1 by requiring the safety mechanism, in its first configuration, to prevent the trigger mechanism from moving. This is narrower than merely preventing actuation of the drive mechanism. A safety that allows trigger movement but disconnects the trigger from the drive may fall outside claim 2 while potentially remaining within claim 1.

Claims 4 and 26: obstructer portion

Claims 4 and 26 require an obstructer portion that:

• Blocks movement of the trigger in the first configuration.
• Permits that movement in the second configuration.

The obstructer limitation creates a physical blocking requirement. A purely electronic lock, a trigger-disconnect system, or a pressure-release mechanism may not satisfy this limitation without an equivalent-function analysis.

Claims 5 and 27: movable collar

Claims 5 and 27 require:

• A collar surrounding part of the injector.
• Movement between first and second configurations.
• Movement generally perpendicular to the direction in which medicament exits the orifice.
• An obstructer portion incorporated into the collar.

The collar limitation is commercially important because it limits the claims to a particular spatial arrangement. An annular ring that rotates rather than translates, or a safety sleeve that moves axially along the injection path, presents a potential design-around position.

Claims 6 and 28: upper and lower sleeves

Claims 6 and 28 require a trigger mechanism with two movable upper and lower sleeve portions. Relative movement between those sleeves permits the drive mechanism to operate. The safety obstructer blocks that relative movement until the safety mechanism is displaced.

This limitation can exclude injector designs using:

• A single trigger sleeve.
• A hinged trigger.
• A rotary firing cam.
• A valve that is opened by pressure or electrical control.
• A trigger that moves independently of sleeve-to-sleeve interaction.

Claims 7 and 29: perpendicular movement

Claims 7 and 29 require the obstructer to move in a direction perpendicular to the relative movement of the two sleeve portions. This is a geometric limitation and may be material in claim construction. The relevant inquiry is the direction of movement that changes the obstructer from blocking to nonblocking, not merely the overall direction in which the user moves the actuator.

What do claims 8 through 21 protect in the break-off casing?

Claims 8 through 21 cover the packaging and activation sequence surrounding the injector. Claim 8 is an independent combination claim requiring:

• A casing partially enclosing the injector.
• A cartridge, orifice, drive mechanism, trigger and safety mechanism.
• A break-off tip enclosing the cartridge orifice.
• Irreversible exposure of the safety actuator when the break-off tip is broken off.

This claim is directed to a tamper-evident, sequential-use configuration. The break-off operation is not merely a shipping closure. It must be configured so that removal irreversibly exposes the actuator.

Sequential activation

Claims 9 and 10 require sequential operation:

1. The break-off tip is broken off.
2. The safety mechanism is placed in its second configuration.

Claim 10 therefore links the physical opening operation to subsequent safety release. A product in which the tip is removed but the safety remains permanently locked may avoid these limitations. A product in which the safety is released before tip removal may face a different claim construction issue because the claimed sequence is central to the dependent claims.

Two-part casing

Claims 11 through 15 require a casing with first and second movable components. The first component holds the injector. The second component bears on the break-off tip and applies force to break it.

Claim 13 requires rotary motion relative to a longitudinal axis and a twisting or shearing force at the frangible joint. Claim 14 expands the possible rotary geometries, including:

• Transverse rotation.
• Rotation perpendicular to the longitudinal axis.
• Coaxial rotation.
• Rotation about a parallel but non-coaxial axis.
• Rotation about an axis at a non-zero angle to the longitudinal axis.

Claim 15 selects the non-zero-angle rotation configuration. This group provides relatively detailed protection for the casing mechanics but is narrower than claim 8.

Cover over the safety actuator

Claim 16 requires a casing component with a cover over the safety actuator. The cover prevents actuator operation until it is removed. The limitation supports a tamper-evident sequence and may be relevant to products that use a removable cap, tear-off panel or breakaway housing section.

Pulling activation

Claims 17 and 18 require the actuator to move the safety mechanism into the second configuration, with claim 18 specifying movement by pulling. Claim 19 adds an obstructer that blocks movement of a component essential to injector operation.

A pushing lever, rotating cam or sliding wedge may provide a potential noninfringement position, depending on whether the accused structure applies a pulling force or performs the claimed function in an equivalent manner.

Compressed gas drive

Claim 20 depends from claim 1 and requires a compressed gas cylinder. The claim does not cover every needleless injector with a gas source. It requires the other limitations of claim 1, including the external actuator lever and pulling-force component.

Casing fit

Claim 21 requires first and second casing subparts joined by a tight friction fit or snap fit. This is a packaging limitation and has limited standalone value because it depends on the break-off-tip combination of claim 8.

What does claim 22 add to the patent scope?

Claim 22 is an independent needleless injector claim. It requires:

• A medicament cartridge.
• An orifice.
• A drive mechanism.
• A trigger mechanism.
• A safety mechanism that blocks trigger movement.
• A casing enclosing the drive mechanism.
• A break-off tip that irreversibly exposes both the safety mechanism and the injection orifice.

Claim 22 is potentially broader than claim 8 in some respects because it does not expressly require the external actuator lever or the casing to be a separate combination surrounding an enclosed injector. It is narrower in another respect because the break-off tip must expose both the safety mechanism and the orifice.

The phrase "irreversibly exposes" is likely to be important in litigation. A removable cap that can be replaced, a hinged shield that can be closed again, or a shutter that re-covers the actuator may present a noninfringement argument. The physical design must be assessed against the intrinsic evidence, including the specification and prosecution history.

What is the likely patent expiration date for US 7,901,385?

US Patent 7,901,385 is a pre-2013 utility patent and its term is generally calculated from the earliest effective nonprovisional filing date under 35 U.S.C. §154. The ordinary term is 20 years from the applicable filing date, subject to patent-term adjustment, terminal disclaimers and any relevant patent-term extension.[2]

Item	Assessment
Patent	US 7,901,385 B2
Grant date	March 8, 2011
Technology	Needleless injector and sequential safety casing
Ordinary term framework	20 years from applicable nonprovisional filing date
Expected term window	Approximately 2024-2026, depending on the effective priority and PTA
Orange Book status	Not ordinarily Orange Book eligible as a device-only patent
Biosimilar relevance	None as a biologic-product patent
Paragraph IV relevance	None unless separately listed for an approved drug product

The definitive expiration date should be taken from the USPTO Patent Center transaction record and patent-term calculation. Grant date alone does not determine expiration.[1] A device patent generally does not receive FDA regulatory exclusivity merely because it covers an injector used to deliver an approved drug.

What is the Orange Book status of US 7,901,385?

US 7,901,385 is not a drug-substance, drug-product, formulation or method-of-use patent. Its claims cover a physical needleless injector and casing. It therefore is not the type of patent ordinarily listed in the FDA Orange Book for an NDA drug product under 21 C.F.R. §314.53.[3]

The patent does not directly create:

• New chemical entity exclusivity.
• New clinical investigation exclusivity.
• Generic-drug blocking rights through an Orange Book listing.
• Biosimilar reference-product exclusivity.
• Patent rights directed to a particular active pharmaceutical ingredient.

A generic drug applicant would not ordinarily need to certify to this patent under Hatch-Waxman merely because the applicant sells the drug for use with a separately supplied injector. Paragraph IV exposure could arise only in an unusual regulatory structure where the injector patent had been properly listed for the relevant approved product and was legally listable.

Does US 7,901,385 create biosimilar or generic-entry risk?

The patent creates device-level risk, not direct active-ingredient or formulation risk.

Generic drugs

A generic manufacturer that supplies a needleless injector, cartridge system or combination product embodying the claimed structure could face patent risk if the patent remained in force. A conventional vial-and-syringe generic would generally not practice the asserted device limitations.

The practical risk depends on:

• Whether the injector is sold with the drug.
• Whether the injector is required for administration.
• Whether the generic sponsor uses the same break-off sequence.
• Whether the device is manufactured by a third party.
• Whether the patent term remains active in the relevant market.

Biosimilars

Biosimilar applicants are not directly exposed to this patent merely because they administer a biologic through an injector. The patent does not claim a biologic, formulation, cell line, manufacturing process or treatment regimen. Device exposure could arise only if the biosimilar product includes or relies on a covered needleless injector.

Which companies are relevant to the needleless injector patent landscape?

The competitive landscape includes companies that develop jet injectors, disposable needle-free delivery systems and combination drug-device products.

Company or group	Relevant technology area	Relationship to US 7,901,385
The Medical House / Bespak-related businesses	Disposable and cartridge-based injection systems	Potentially relevant original patent-owner and technology lineage
PharmaJet	Needle-free jet injection platforms	Competing injector architecture and potential FTO comparator
Bioject	Gas- or pressure-driven needle-free injectors	Competing drive and trigger systems
Antares Pharma	Injection devices and combination delivery systems	Relevant for device and pharmaceutical-device combinations
Crossject	Needle-free autoinjector and emergency-use delivery systems	Relevant design-around and competitive technology
Medical device licensees and contract manufacturers	Injector housings, cartridges and actuation systems	Potential implementation and supply-chain exposure

The central competitive distinction is between systems using a disposable break-off cartridge or tip and systems using reusable actuators, replaceable cartridges, electronic controls or externally mounted pressure sources.

How strong is the patent estate for US 7,901,385?

The patent has moderate technical specificity but limited breadth at the individual-claim level.

Strengths

• Multiple independent claims cover both the injector and the casing.
• The claim set addresses both safety interlock operation and irreversible exposure.
• The claims identify a concrete mechanical sequence rather than merely claiming a result.
• Claims 5-7 and 27-29 provide fallback positions covering collar and sleeve arrangements.
• Claims 8 and 22 can reach products where the safety and orifice are exposed through a break-off operation even if the actuator-lever limitations are absent.

Weaknesses

• The claims contain numerous structural and directional limitations.
• The external lever and pulling-force requirements narrow claims 1, 23 and 25.
• The collar and two-sleeve limitations may exclude many commercial injector designs.
• The break-off-tip claims depend on a particular irreversible exposure sequence.
• No claim covers the medicament itself.
• No claim broadly covers all needleless injection devices or all safety systems.

The estate is strongest against a product that copies the disclosed mechanical arrangement: a disposable casing, break-off tip, perpendicular collar or obstructer, paired sleeves and an externally accessible pulling actuator. It is weaker against a pressure-driven injector with a rotary trigger, electronic safety, axial safety sleeve or independently removable cap.

What patent litigation or Paragraph IV challenges affect the patent?

No drug-related Paragraph IV challenge is inherent in US 7,901,385 because the patent claims a device rather than an active ingredient or drug formulation. Any dispute would more likely involve:

• Patent infringement by an injector manufacturer.
• Declaratory judgment concerning device freedom to operate.
• Contractual indemnification between a drug sponsor and device supplier.
• Combination-product regulatory allocation.
• Exhaustion or authorized-sale defenses.
• Patent-term expiration and post-expiration commercial use.

A complete litigation determination requires review of PACER, district-court dockets, the Federal Circuit docket and USPTO records. The patent number alone does not establish that a particular injector or drug company has been sued.

What design-around options exist?

A product-development team can reduce literal infringement exposure by changing one or more claim-critical relationships:

1. Use a push, rotary or cam-based safety actuator instead of a pulling actuator.
2. Use an axial safety sleeve rather than a perpendicular collar.
3. Use a single trigger member rather than upper and lower sleeves that move relative to one another.
4. Use a reusable cap or hinged shield instead of an irreversible break-off tip.
5. Expose the orifice and safety mechanism through separate operations.
6. Use electronic, magnetic or valve-based trigger blocking.
7. Place the safety mechanism outside the claimed collar-and-obstructer geometry.
8. Use a drive mechanism other than a compressed gas cylinder where claim 20 is relevant.
9. Separate the drug cartridge from the disposable casing.
10. Use a casing that opens axially rather than applying rotary shearing force to a frangible tip.

These changes do not eliminate all patent risk. Other injector patents may claim the alternative architecture, and the doctrine of equivalents may remain relevant where a modification performs substantially the same function in substantially the same way.

How does US 7,901,385 compare with competing needleless injector patents?

US 7,901,385 is primarily an interlock and packaging patent. It differs from foundational needleless-injector patents that claim:

• Pressure generation.
• Jet-orifice geometry.
• Piston acceleration.
• Gas storage and release.
• Cartridge sealing.
• Dose metering.
• Skin-contact interfaces.
• Drug-specific delivery methods.

The patent therefore should be analyzed as one layer of a larger freedom-to-operate review. A product may avoid US 7,901,385 yet infringe a separate patent covering the jet-generation mechanism or cartridge. Conversely, a product may use a patented jet engine but avoid the break-off casing and perpendicular safety structure claimed here.

What are the commercial and revenue implications?

US 7,901,385 does not by itself establish revenue exposure for a branded drug. Commercial exposure depends on whether a covered injector is integral to a product sold by the patent owner, an exclusive licensee or a combination-product sponsor.

The economically relevant scenarios are:

Scenario	Commercial consequence
Patent expired before competitor launch	Device architecture may be used without infringement liability under this patent
Patent remains active and product copies all independent-claim limitations	Injunction, damages and launch delay risk may arise
Drug is sold separately from injector	Limited direct generic-drug impact
Injector is part of a regulated combination product	Device redesign and regulatory supplement costs may be material
Third-party contract manufacturer supplies the injector	Indemnity, sourcing and supply-continuity provisions become important
Competing product uses a different safety architecture	Lower risk under this patent, subject to other patent families

Key Takeaways

• US 7,901,385 is a device patent covering needleless injector safety and sequential packaging features.
• Independent claims 1 and 23 center on an external actuator that moves a safety mechanism; claims 8 and 22 center on a break-off tip and irreversible exposure.
• Claims 5-7 and 27-29 narrow the invention to a perpendicular collar, obstructer and paired sleeve arrangement.
• Claim 20 covers a compressed-gas embodiment only when the other limitations of claim 1 are present.
• The patent does not claim a drug, biologic, formulation or therapeutic indication.
• Orange Book and Paragraph IV exposure are generally not applicable to the patent as a standalone device patent.
• Biosimilar risk is indirect and arises only when a covered injector is supplied as part of a combination product.
• The most credible design-arounds use rotary or electronic safeties, axial sleeves, single-piece triggers, replaceable caps or separately actuated exposure mechanisms.
• The ordinary patent term likely falls in the 2024-2026 period, subject to the official USPTO term calculation.

FAQs About US Patent 7,901,385

Is US 7,901,385 a drug patent or a medical-device patent?

It is a medical-device patent. Its claims cover a needleless injector, safety interlock, actuator and break-off casing, not an active pharmaceutical ingredient or drug formulation.

Does the patent cover all needle-free injectors?

No. The claims require specific structures, including an obstructing safety mechanism, particular actuator relationships, sleeve or collar arrangements and, in several claims, an irreversible break-off tip.

Can a generic drug company ignore this patent?

Only if its product and supplied injector do not practice the asserted claims or the patent has expired. A conventional generic drug sold without a covered needleless injector is generally outside the patent's direct scope.

Does breaking off a protective cap necessarily infringe the patent?

No. The claimed break-off structure must irreversibly expose the required safety mechanism, actuator or orifice, depending on the asserted claim. A removable, reusable or differently sequenced cap may not satisfy every limitation.

Is a compressed-gas needleless injector automatically covered by claim 20?

No. Claim 20 depends on claim 1 and requires the external actuator lever, pulling-force component and other claim 1 limitations in addition to the compressed gas cylinder.

References

1. United States Patent and Trademark Office. (n.d.). Patent Center. https://patentcenter.uspto.gov/
2. 35 U.S.C. § 154. Contents and term of patents; provisional rights.
3. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations. https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files
4. United States Patent and Trademark Office. (2015). Manual of Patent Examining Procedure § 2701: Patent term. https://www.uspto.gov/web/offices/pac/mpep/mpep-2700.html
5. United States Patent No. 7,901,385 B2. (2011). Needleless injection device. U.S. Patent and Trademark Office.

Drugs Protected by US Patent 7,901,385

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Endo Operations	SUMAVEL DOSEPRO	sumatriptan succinate	SOLUTION;SUBCUTANEOUS	022239-001	Jul 15, 2009		DISCN	Yes	No	7,901,385		Y

Foreign Priority and PCT Information for Patent: 7,901,385

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	0206560.5	Mar 20, 2002

PCT Information
PCT Filed	March 18, 2003	PCT Application Number:	PCT/EP03/02876
PCT Publication Date:	September 25, 2003	PCT Publication Number:	WO03/077973

International Family Members for US Patent 7,901,385

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2003219086
Canada	2479316
Germany	60315429
European Patent Office	1487517
Spain	2290443
United Kingdom	0206560
Japan	2005530522