Details for Patent: 9,533,102

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Which drugs does patent 9,533,102 protect, and when does it expire?

Patent 9,533,102 protects OTREXUP and XYOSTED (AUTOINJECTOR) and is included in two NDAs.

This patent has sixteen patent family members in thirteen countries.

Summary for Patent: 9,533,102

Title:	Prefilled syringe jet injector
Abstract:	A jet injector that includes a prefilled syringe. The syringe includes a fluid chamber that contains a medicament. The syringe also has an injection-assisting needle, and a plunger is movable within the fluid chamber. A housing is configured for allowing insertion of the needle to a penetration depth. An energy source is configured for biasing the plunger to produce an injecting pressure in the medicament in the fluid chamber of between about 80 and 1000 p.s.i. to jet inject the medicament from the fluid chamber through the needle to an injection site.
Inventor(s):	Paul R. Lesch, Jr.
Assignee:	Antares Pharma Inc
Application Number:	US14/930,689
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,533,102
Patent Claim Types: see list of patent claims	Use; Device; Dosage form;

US Patent 9,533,102: Jet Injector Scope, Claims, Expiration and Patent Landscape

US Patent 9,533,102 protects a spring-powered, needle-assisted jet injector that uses a prefilled syringe, controlled injection pressure, specified needle penetration depth, and structural features that reduce medicament backflow. The independent claim is directed to a combination of device architecture and operating parameters. The strongest coverage is concentrated in claims 1, 8, 9, 13-15, and 16.

The patent does not claim a drug, active ingredient, therapeutic indication, or formulation. It is a medical-device patent. Its commercial relevance depends on whether a competing injector uses the claimed pressure ranges, penetration depths, prefilled syringe architecture, and safety-trigger configuration.

What does US Patent 9,533,102 protect?

The patent protects a jet injector with five required elements:

1. A prefilled syringe containing medicament.
2. A needle-assisted injection system.
3. An energy source that biases the syringe plunger.
4. Injection pressure maintained within a defined range during injection.
5. Needle penetration depth and pressure selected to reduce backflow.

Claim 1 is the governing independent claim. A competing product must satisfy every limitation of claim 1 to infringe that claim. Dependent claims add narrower pressure, depth, spring, syringe, guard, trigger, and cushioning limitations.

Claim element	Scope
Prefilled syringe	Container, fluid chamber, medicament, needle and plunger
Needle	Needle at the distal chamber end with a fluid pathway
Housing	Houses the syringe and controls insertion depth
Syringe support	Mounts and supports the prefilled syringe
Energy source	Biases the plunger
Pressure	Approximately 80 to 1,000 psi during injection
Backflow limitation	Pressure and penetration depth substantially prevent backflow
Needle depth	Approximately 0.5-5 mm or 11-13 mm in dependent claims
Spring embodiment	Spring-powered injector
Ram embodiment	Bell-shaped ram surrounding the syringe
Syringe support embodiment	Proximal axial support with distal portion substantially unsupported
Syringe material	Blown glass
Needle attachment	Needle adhered to glass
Fill volume	Approximately 0.02-4 mL
Guard and trigger	Retractable guard linked to activation
Cushion	Cushion compensating for syringe shape

The claim is a combination claim. A product using only a prefilled syringe, or only a spring-powered injector, would not necessarily fall within the claim. Infringement analysis must address the full combination.

How broad is independent claim 1?

Claim 1 is broad in hardware terms but narrower in operational terms.

The claim does not require:

• A particular active pharmaceutical ingredient.
• A particular therapeutic indication.
• A particular syringe manufacturer.
• A particular needle gauge.
• A particular spring geometry.
• A particular electronic control system.
• A particular injection volume within the claimed range.
• A specific marketed drug.

The claim does require an injection pressure that “substantially remains” between about 80 psi and 1,000 psi during injection. That limitation creates both commercial value and litigation risk. Pressure must be evaluated over the injection event, not merely at the initial firing point.

The claim also requires a relationship between pressure, penetration depth, and backflow prevention. A device that reaches the claimed pressure but does not use a penetration depth and pressure sufficient to substantially prevent backflow may contest infringement. Conversely, a device that uses the same pressure and depth relationship may present risk even if its spring, housing, or trigger design differs.

What do claims 2 through 6 add?

Claims 2 through 6 create narrower pressure and penetration-depth positions.

Claim	Added limitation	Commercial effect
2	Pressure below about 500 psi and above about 90 psi	Targets lower-pressure commercial embodiments
3	Pressure remains at least about 100 psi	Establishes a 100 psi lower boundary
4	Pressure from at least about 100 psi up to about 350 psi	Narrows the range to a practical operating window
5	Needle penetration depth of about 0.5-5 mm	Covers shallow intradermal or subcutaneous-style penetration
6	Needle penetration depth of about 11-13 mm	Covers substantially deeper penetration

Claims 5 and 6 are alternative depth embodiments. A product designed for a penetration depth between 5 mm and 11 mm may avoid those dependent claims while remaining exposed to claim 1 if all other limitations are met.

The use of “about” gives the claims some tolerance but does not eliminate the need for quantitative testing. Courts generally assess the ordinary meaning of approximate numerical terms in view of the specification, prosecution history, technical context, and expert evidence.

What structural features are protected by claims 7 through 12?

Spring-powered injector and surrounding ram

Claim 7 requires an energy source comprising a spring. Claim 8 narrows that embodiment to a ram biased by the spring, with a bell portion on which the spring is seated. The bell portion has a hollow interior that receives the prefilled syringe when the device fires, so the spring surrounds the syringe.

This limitation can distinguish the patented architecture from:

• Gas-powered injectors.
• Electromechanical injectors.
• Linear actuators.
• Spring mechanisms positioned beside the syringe.
• Devices in which the spring does not surround the syringe.

Claim 8 is likely more useful against devices that copy the mechanical layout than against products that merely operate within the same pressure range.

Proximal syringe support

Claim 9 requires axial support at the proximal portion of the syringe while leaving the distal portion substantially unsupported in the axial direction. This limitation addresses load transfer during injection and may permit a degree of syringe movement or expansion at the distal end.

Claim 10 requires blown glass. Claim 11 requires the needle to be adhered to the glass. Together, claims 9-11 target a particular prefilled syringe construction rather than a generic cartridge.

Potential design-arounds include:

• Moulded plastic syringe barrels.
• Glass syringes with a mechanically retained needle.
• Distal as well as proximal axial support.
• A cartridge that is not a prefilled syringe.
• A needle mounted to a separate hub rather than adhered directly to the glass.

Medicament volume

Claim 12 covers a chamber containing approximately 0.02 mL to 4 mL of medicament. Because the range is broad, many injectable products could fall within it. The claim does not require a specific fill volume within that range to be commercially optimized.

What do claims 13 through 16 protect?

Claims 13-15 cover safety and activation architecture.

Claim 13 requires a retractable guard with:

• A protecting position in which the needle is inside the guard.
• An injecting position in which the needle tip is exposed.

Claim 14 requires a trigger mechanism operably associated with the energy source and configured to activate after guard retraction.

Claim 15 goes further by requiring the guard to activate the trigger when it reaches the injecting position.

This creates a two-part safety mechanism: the needle is initially shielded, and firing is linked to guard movement. A device with a manually operated trigger that remains independent of guard position may avoid claim 15, although it could still face claims 1 and 13-14.

Claim 16 covers a syringe cushion associated with the syringe support and prefilled syringe to compensate for syringe shape. This limitation may reach elastomeric or compliant components that accommodate manufacturing tolerances, barrel geometry, or dimensional variation.

What is the likely patent term and expiration timing?

The patent number indicates a US utility patent granted on January 3, 2017. The statutory expiration generally depends on the earliest effective nonprovisional filing date, applicable patent-term adjustment, terminal disclaimers, and any patent-term extension. For a patent claiming priority to an earlier family filing, the relevant expiration may fall in the late 2020s rather than 2037.

The grant date alone does not establish the expiration date. The controlling record is the USPTO patent-term data, including:

• Earliest effective filing date.
• Patent-term adjustment.
• Terminal disclaimer status.
• Any reexamination certificate.
• Any patent-term extension.

For business planning, a late-2020s expiration assumption is more appropriate than treating January 3, 2037, as the end date.

Event	Significance
Earliest effective filing date	Determines the 20-year patent-term baseline
Issue date	January 3, 2017, based on the patent number record
PTA	May extend the baseline term
Terminal disclaimer	May shorten the term if tied to another patent
PTE	Typically relevant to regulated products, but unlikely to apply to a standalone injector
Maintenance fees	Required at 3.5, 7.5 and 11.5 years after grant

What is the Orange Book status of US Patent 9,533,102?

US Patent 9,533,102 is not, by its claim subject matter, a conventional Orange Book drug patent. Its claims cover an injector device, not an active ingredient, drug formulation, method of use, or drug-device combination identified in an approved NDA.

The Orange Book primarily lists patents submitted by NDA holders for approved drug products under 21 U.S.C. § 355(b)(1). A standalone injector patent generally does not create an Orange Book-listed patent challenge for an ANDA applicant.

The practical result is:

• No ordinary Paragraph IV challenge is directed solely to this device patent.
• Generic-drug approval does not automatically clear the patent.
• A drug manufacturer may still face separate device patent exposure when selling a drug in a patented injector.
• A combination-product sponsor must separately assess device rights, drug patents, and FDA product-specific requirements.

Are biosimilar risks relevant?

Biosimilar risk is limited because the patent does not claim a biologic molecule or biologic formulation. The patent could matter to a biologic sponsor that uses a prefilled, needle-assisted jet injector for administration.

A biosimilar applicant would ordinarily analyze:

• The reference product’s injector configuration.
• Device compatibility and human-factors requirements.
• Whether the injector is supplied by the reference sponsor or a third-party manufacturer.
• Freedom to operate for the delivery device.
• Whether the biosimilar can use a conventional autoinjector, vial, or prefilled syringe instead.

The patent is therefore a delivery-device risk, not a biosimilar molecule risk.

Which companies and technologies are relevant to the competitive landscape?

The relevant competitive set includes companies developing needle-assisted jet injectors, spring-driven autoinjectors, prefilled syringe systems, and wearable or cartridge-based delivery systems.

Company or technology category	Potential overlap
Antares Pharma injector platforms	Prefilled syringe, spring-driven delivery and needle-assisted injection
PharmaJet systems	Needle-free jet injection; potentially outside the needle limitations
Bioject systems	Jet injection and pressure-driven delivery
Bespak and device-component suppliers	Autoinjector and prefilled syringe integration
West Pharmaceutical Services	Cartridge, syringe and delivery-system components
Ypsomed and SHL Medical	Autoinjector and prefilled syringe platforms
On Drug Delivery and similar platform suppliers	Injectable-device architecture and combination products
Conventional autoinjectors	May avoid jet-injection pressure and needle-depth limitations

The closest technical competitors are not necessarily the closest legal competitors. A needle-free jet injector may avoid the “injection-assisting needle” limitation. A conventional autoinjector may use a needle and prefilled syringe but not maintain the claimed pressure or use jet injection through the needle.

How strong is the patent estate?

The patent is strongest when a competitor uses the following combination:

• A prefilled glass syringe.
• A needle adhered to the glass.
• A spring-powered ram.
• A spring that surrounds the syringe.
• Approximately 100-350 psi during injection.
• A penetration depth of approximately 0.5-5 mm or 11-13 mm.
• A retractable guard that activates firing.
• A proximal-only syringe support and compensating cushion.

The estate is weaker against products that alter one or more core operating parameters or architecture:

• Pressure below approximately 80-90 psi.
• Pressure above approximately 1,000 psi.
• Non-jet injection.
• Needle-free delivery.
• Penetration depths outside the dependent ranges.
• Gas, motor or electromechanical power.
• Plastic cartridges.
• Separate needle hubs.
• Manually triggered guards.
• Distal syringe support.
• No prefilled syringe.

The most important validity pressure points are the numerical pressure limitations, the functional backflow limitation, the meaning of “substantially remains,” and the relationship between penetration depth and backflow prevention. Prior-art combinations involving spring-powered injectors, prefilled syringes, injection-depth guards, and pressure-controlled delivery may be relevant to obviousness.

What generic launch risks exist?

A generic drug manufacturer faces no automatic Paragraph IV pathway against this patent because it is not principally a drug patent. Commercial risk arises if the manufacturer or its device partner markets a drug in an injector that practices the claims.

Potential launch paths include:

1. Use a conventional prefilled syringe and needle.
2. Use an autoinjector that does not perform needle-assisted jet injection.
3. Use a pressure profile outside the claimed ranges.
4. Use a different spring and ram architecture.
5. Use a cartridge or disposable cassette rather than the claimed syringe.
6. Separate guard movement from trigger activation.
7. Use a needle depth outside the dependent claim ranges.

A noninfringement position should be supported by pressure-versus-time data, penetration-depth measurements, syringe-support drawings, guard-trigger testing, and component-level teardown evidence.

What manufacturing and IP barriers are most important?

The principal manufacturing barriers are integration and tolerancing rather than a single component.

Critical parameters include:

• Syringe barrel strength under jet-injection pressure.
• Needle-to-glass adhesion.
• Plunger friction and seal performance.
• Spring force curve.
• Ram alignment.
• Guard travel and trigger timing.
• Syringe dimensional variation.
• Cushion compression.
• Needle penetration depth.
• Pressure decay during the injection event.

A competing manufacturer can often design around an individual claim element, but changing one element may affect injection performance, safety, container closure integrity, and FDA human-factors validation.

What litigation and settlement issues should be reviewed?

Because the patent is a device patent, relevant disputes may appear in district-court patent litigation, International Trade Commission investigations, licensing transactions, or commercial supply agreements rather than in Paragraph IV litigation.

The principal litigation questions are:

• Whether the accused device uses a prefilled syringe.
• Whether the pressure remains within the claimed range for the entire injection.
• Whether the pressure is measured at the chamber, plunger, or needle.
• Whether the needle depth is controlled by the housing.
• Whether the guard mechanically activates the trigger.
• Whether the syringe is structurally supported as required.
• Whether prior art discloses the pressure-depth relationship.
• Whether “substantially prevent backflow” is definite and enabled.

Settlement agreements involving this patent would need to be reviewed for field-of-use restrictions, geographic scope, authorized-device provisions, supply obligations, and carve-outs for conventional syringes or autoinjectors. Patent-license terms cannot be inferred from the claims alone.

How does US Patent 9,533,102 compare with conventional autoinjector patents?

Issue	US 9,533,102	Conventional autoinjector
Delivery mode	Jet injection through a needle	Plunger-driven injection through a needle
Pressure limitation	Express pressure ranges	Often no comparable pressure range
Needle penetration	Express depth relationship	Usually needle insertion followed by drug delivery
Backflow	Express functional objective	May not be a claim limitation
Syringe	Prefilled syringe	Often prefilled syringe or cartridge
Power source	Spring embodiment claimed	Spring commonly used
Guard	Retractable guard	Common
Trigger	Guard-linked firing embodiment	Common but not universal
Key design-around	Alter jet-pressure and depth relationship	Avoid jet-injection conditions

The patent’s distinctive feature is the combination of needle insertion and high-pressure jet delivery. Ordinary autoinjector operation does not necessarily satisfy that combination.

Key Takeaways

• US Patent 9,533,102 is a device patent covering a prefilled-syringe jet injector.
• Claim 1 combines pressure, penetration depth, backflow prevention, syringe support, housing, needle and energy-source limitations.
• Claims 2-6 narrow the pressure and needle-depth ranges.
• Claims 8-11 target a spring-surrounding ram and a supported blown-glass syringe with an adhered needle.
• Claims 13-15 cover a retractable guard linked to injector activation.
• Claim 16 covers a syringe cushion that compensates for syringe shape.
• The patent is not ordinarily an Orange Book-listed drug patent and does not create a conventional Paragraph IV pathway.
• Biosimilar exposure is limited to delivery-device implementation.
• The strongest design-around options involve changing pressure, delivery mode, syringe architecture, guard-trigger operation or spring/ram geometry.
• The likely commercial term is tied to the family’s earliest effective filing date, with expiration expected in the late 2020s rather than 20 years from the 2017 grant date.
• Freedom-to-operate analysis should rely on pressure traces, insertion-depth measurements, syringe-support analysis and guard-trigger testing.

FAQs

Can a conventional prefilled syringe infringe US Patent 9,533,102?

Not necessarily. The syringe must be used within the claimed jet-injector combination, including the pressure, housing, needle, support and backflow-related limitations.

Does the patent cover needle-free jet injectors?

The claims require an injection-assisting needle. A purely needle-free injector is outside that express limitation, subject to any separate patent rights.

Does a pressure spike at firing satisfy the pressure limitation?

A transient spike alone may not satisfy a requirement that pressure substantially remain within the claimed range during injection. The full pressure profile and measurement location are material.

Can a device avoid the patent by using a plastic syringe?

A plastic syringe may avoid claims 10 and 11, which are directed to blown glass and an adhered needle. It may still face claim 1 or other claims if the remaining limitations are met.

Is a guard-triggered autoinjector automatically covered?

No. Guard-trigger operation is addressed by claims 13-15, but the product must also satisfy the independent claim and all applicable dependent limitations.

References

1. United States Patent and Trademark Office. (2017). United States Patent No. 9,533,102, Jet injector. U.S. Department of Commerce.

2. United States Patent and Trademark Office. (n.d.). Manual of Patent Examining Procedure, Chapter 2700: Patent term. U.S. Department of Commerce.

3. U.S. Food and Drug Administration. (2023). Approved drug products with therapeutic equivalence evaluations. U.S. Department of Health and Human Services.

4. U.S. Food and Drug Administration. (2024). Applications for FDA approval to market a new drug: Patent submission and certification requirements. 21 C.F.R. § 314.53.

5. U.S. Code. (2024). Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355.

Drugs Protected by US Patent 9,533,102

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Cosette	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-005	Nov 7, 2014		DISCN	Yes	No	9,533,102		Y
Cosette	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-001	Oct 11, 2013		DISCN	Yes	No	9,533,102		Y
Cosette	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-006	Mar 24, 2016		DISCN	Yes	No	9,533,102		Y
Cosette	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-002	Oct 11, 2013		DISCN	Yes	No	9,533,102		Y
Cosette	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-007	Mar 24, 2016		DISCN	Yes	No	9,533,102		Y

International Family Members for US Patent 9,533,102

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Brazil	PI0614025
Canada	2595730
China	101132820
Denmark	1850892
European Patent Office	1850892