Details for Patent: 10,478,560

Which drugs does patent 10,478,560 protect, and when does it expire?

Patent 10,478,560 protects XYOSTED (AUTOINJECTOR) and is included in one NDA.

This patent has sixteen patent family members in thirteen countries.

Summary for Patent: 10,478,560

Title:	Prefilled syringe 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
Assignee:	Antares Pharma Inc
Application Number:	US15/493,494
Patent Claim Types: see list of patent claims	Use; Dosage form;

US Patent 10,478,560: Claim Scope, Patent Strength, Exclusivity and Competitive Landscape

US Patent 10,478,560 claims a spring-driven injector built around a prefilled syringe that remains fixed in the housing during firing. The core protection combines five elements: a prefilled syringe, a housing and syringe support, a biasing energy source, controlled injection pressure, and shallow needle penetration sufficient to reduce or prevent medicament backflow.

The broadest practical infringement risk centers on claim 1. Claims 2-19 narrow that combination through pressure limits, penetration depths, syringe volume, guard-trigger interlocks, spring-and-ram geometry, proximal syringe support, and elastomeric cushioning.

What does US Patent 10,478,560 claim?

Claim 1 protects a combination injector architecture

Claim 1 is an apparatus claim. A potentially infringing device must contain every material limitation, either literally or under the doctrine of equivalents. The claim requires:

Claim element	Scope
Prefilled syringe	A syringe with a chamber containing medicament, a distal needle and a movable plunger
Housing	A structure that houses the prefilled syringe
Syringe support	A support that mounts the prefilled syringe to the housing
Energy source	A mechanism that biases the plunger with force sufficient to generate injection pressure
Fixed syringe position	The syringe is fixed relative to the housing before and during activation
Pressure and penetration relationship	The pressure and penetration depth must be sufficient to substantially prevent backflow
Injection path	Medicament moves from the chamber through the needle to the injection site

The fixed-position limitation is important. A device in which the syringe advances toward the skin during firing may present a non-infringement position, depending on how the syringe is supported and how “associated with the housing in a fixed position” is construed.

The claim does not expressly require a particular drug, syringe barrel material, needle gauge, actuation button, automated needle insertion mechanism, or electronic control system. It is therefore directed primarily to the mechanical injector platform rather than to a specific pharmaceutical product.

What technical combination is the patent targeting?

The claim set targets a low-volume, shallow-penetration injection system designed to deliver medicament into or near subcutaneous tissue while controlling leakage or backflow.

The principal technical variables are:

• syringe stability during firing;
• axial support of the syringe;
• spring-generated plunger force;
• injection pressure;
• needle penetration depth;
• guard and trigger sequencing; and
• shock absorption around the prefilled syringe.

The claims cover a conventional prefilled syringe only when it is integrated into the claimed injector architecture. A standalone prefilled syringe, needle, spring, or autoinjector without the claimed combination does not fall within claim 1.

How do claims 2 through 19 narrow the patent scope?

Pressure limitations in claims 2, 3 and 14

Claim 2 requires pressure of up to approximately 350 psi during injection. Claim 3 adds a lower pressure boundary of approximately 90 psi. Claim 14 requires pressure to remain substantially below 500 psi.

The relationship among these claims is significant:

Claim	Pressure limitation
Claim 1	Pressure sufficient, together with penetration depth, to substantially prevent backflow
Claim 2	Up to about 350 psi
Claim 3	At least about 90 psi and up to about 350 psi
Claim 14	Substantially below 500 psi

Claims 2 and 3 create a narrower pressure window. Claim 14 is broader than claim 2 in numerical terms but still requires the pressure to remain substantially below 500 psi. A device operating above 500 psi may avoid claim 14 but could still implicate claim 1 if the pressure and penetration limitations are otherwise met.

The pressure terms raise claim-construction questions:

1. Whether pressure is measured at the plunger, inside the syringe chamber, at the needle outlet, or at another point in the fluid path.
2. Whether “during the injection” means average pressure, peak pressure, or pressure over substantially the entire injection stroke.
3. How “up to about,” “at least at about,” and “substantially below” will be interpreted.
4. Whether pressure must be intentionally selected for backflow prevention or merely achieve that result.

A competitor with pressure data showing a short peak above 350 psi may still face risk under claim 1 or claim 14, depending on the measured pressure profile and the construction of the result-based limitation.

Penetration-depth limitations in claims 4, 5, 13, 15 and 16

The dependent claims define a shallow insertion profile:

Claim	Penetration depth or tissue target
Claim 4	About 0.5 mm to 5 mm
Claim 5	Subcutaneous depth
Claim 13	Subcutaneous injection site
Claim 15	About 1 mm to 4 mm
Claim 16	Up to about 3 mm

Claims 15 and 16 are narrower numerical subsets of claim 4. A device that penetrates 2 mm falls within each of those numerical ranges, assuming the other limitations are met. A device designed for conventional intramuscular injection would have a stronger non-infringement position against these dependent claims, although claim 1 is not expressly limited to intradermal or subcutaneous administration.

The penetration limitation is potentially difficult to apply in practice because actual penetration may vary with:

• skin thickness;
• injection angle;
• user-applied force;
• guard compression;
• needle length;
• tissue compliance; and
• device tolerances.

The patent’s strongest commercial relevance is likely for compact injectors intended for shallow subcutaneous or intradermal delivery.

Spring, ram and surrounding-syringe architecture in claims 6 and 7

Claim 6 specifies a spring as the energy source. Claim 7 requires:

• a ram biased by the spring;
• the ram acting against the plunger;
• a bell portion supporting the spring; and
• a hollow interior that receives the syringe when fired, with the spring surrounding the syringe.

This is a comparatively concrete mechanical limitation. Devices using a gas drive, motorized actuator, torsion mechanism, or alternative spring placement may avoid claims 6 and 7 while remaining exposed to claim 1.

Claim 7 is valuable as a design-specific fallback claim because it identifies the spatial relationship between the spring, ram and syringe. A competing device would need to examine whether its drive spring surrounds any portion of the syringe during firing and whether the actuator has an equivalent bell-shaped structure.

Syringe volume in claim 8

Claim 8 covers a chamber containing approximately 0.02 mL to 4 mL of medicament. This range encompasses many biologic and specialty-drug presentations, including small-volume intradermal products and larger subcutaneous doses.

The claim does not require the entire syringe to be filled to that volume. It refers to the amount of medicament contained in the chamber. Measurement disputes could arise where the syringe contains overfill, reconstitution liquid, air space, or a dual-chamber configuration.

Guard and trigger interlock claims 9 through 11

Claims 9-11 protect a retractable guard and sequencing between guard movement and activation:

• claim 9 requires a guard that moves between a protecting position and an injecting position;
• claim 10 requires a trigger mechanism that activates after guard retraction; and
• claim 11 requires the guard to be operably associated with the trigger so that guard retraction causes activation.

Claim 11 is the most specific. It may not cover devices in which the user must separately press a button after the guard reaches the injecting position, unless the trigger relationship is found equivalent.

These claims address accidental activation and needle protection. They may be relevant to reusable housings, single-use autoinjectors, and passive safety systems.

Proximal support and unsupported distal syringe in claims 12 and 13

Claim 12 requires axial support at the proximal portion of the syringe while leaving the distal portion substantially unsupported in the axial direction.

This limitation may distinguish designs that support the syringe along its full length or provide a distal cradle. It also creates a possible design-around path: a competitor could use a distal support, full-length sleeve, or alternative load path. The strength of that strategy depends on whether the accused support materially changes the syringe’s axial behavior.

Claim 13 adds a subcutaneous injection site requirement.

Syringe cushion claims 17 through 19

Claims 17-19 require a resilient sleeve or elastomeric cushion associated with the syringe support and syringe. The cushion must provide shock absorption during firing. Claim 18 adds support for the syringe flange. Claim 19 requires elastomeric material that compensates for syringe shape irregularities.

These claims address mechanical tolerance and breakage risks associated with prefilled glass syringes. They may be particularly relevant where the device uses a glass barrel, a flange-supported syringe, and a high-force spring drive.

How strong is the independent claim?

Claim 1 has broad commercial coverage but several limitations that can narrow enforcement.

Strengths

The claim combines structural and functional limitations. It does not depend solely on a specific spring, guard, or syringe geometry. A competitor could use a different internal mechanism and still infringe if its device has:

• a fixed prefilled syringe;
• a support mounted to the housing;
• a force-generating energy source;
• pressure and penetration sufficient to reduce backflow; and
• the claimed injection arrangement.

The fixed-syringe limitation may also distinguish conventional needle-insertion autoinjectors in which the syringe travels axially during activation.

Vulnerabilities

The claim has several potentially contestable limitations:

1. “Fixed position” may require a particular degree of positional immobility.
2. “Sufficient to substantially prevent backflow” is a functional result limitation that may require experimental proof.
3. “Injecting pressure” lacks an express measurement location in the claim.
4. “Penetration depth” may vary during use and may not be uniform across patients.
5. The claim does not identify a specific structure that establishes the pressure-depth relationship.

Prior-art combinations may be relevant if earlier patents disclose a fixed prefilled syringe, spring-driven plunger, shallow needle insertion and backflow control in separate references. The strongest validity challenge would likely focus on obviousness under 35 U.S.C. § 103 rather than anticipation under 35 U.S.C. § 102, unless a single reference discloses the complete combination.

What patent landscape surrounds US 10,478,560?

The relevant landscape is divided into six technical families rather than a single competing patent category.

Fixed-syringe autoinjectors

These patents generally cover:

• a syringe retained in a housing;
• a spring-driven plunger rod;
• a fixed needle or needle shield;
• manual or automatic trigger mechanisms; and
• single-use autoinjector assemblies.

They are the closest structural prior-art category because claim 1 requires a fixed prefilled syringe and housing support.

Needle-insertion and retractable-guard systems

A separate group covers:

• automatic needle insertion;
• passive needle guards;
• end-of-dose needle shielding;
• guard-trigger interlocks; and
• anti-accidental-activation mechanisms.

Claims 9-11 may overlap with this category, but they require the specific relationship between guard position and energy-source activation.

Intradermal and shallow subcutaneous injectors

These patents focus on:

• penetration depths below approximately 5 mm;
• pressure-controlled delivery;
• reduced leakage;
• bleb formation;
• short needles; and
• delivery of biologics or vaccines.

This is the most relevant functional landscape for claims 1, 4, 5, 13, 15 and 16.

Prefilled-syringe support and cushioning

These patents address:

• glass syringe breakage;
• flange loading;
• elastomeric sleeves;
• dimensional tolerances;
• radial and axial restraint; and
• shock absorption during firing.

Claims 12 and 17-19 are more likely to be compared against this mechanical-support art than against pharmaceutical composition patents.

Spring-and-ram drive systems

The relevant prior art includes:

• compression springs;
• telescoping plungers;
• hollow rams;
• springs surrounding syringes;
• bell-shaped drive members; and
• controlled-force injection systems.

Claims 6 and 7 are directed to this architecture.

Drug-device combination products

Even where a drug manufacturer does not own the injector patent, a commercial combination product may rely on the patent through:

• a device-license agreement;
• a contract-manufacturing arrangement;
• a component supply agreement; or
• a combination-product development partnership.

The patent itself does not claim a pharmaceutical composition, therapeutic indication, dosage regimen, or manufacturing process for a medicament.

What is the Orange Book status of US 10,478,560?

US 10,478,560 is a device patent based on the supplied claims. It is not, by claim subject matter alone, an Orange Book drug-substance, drug-product, formulation, or method-of-use patent.

The FDA Orange Book primarily identifies patents submitted for approved drugs under the Hatch-Waxman framework. A standalone injector patent generally does not create a Paragraph IV certification obligation unless it is properly submitted and accepted for listing against an approved drug product. FDA Orange Book listing is determined through the applicable drug-submission and listing process, not merely by the existence of a US patent. [1][2]

The patent therefore should not be treated as an automatic barrier to an ANDA for a competing drug. Its commercial relevance is stronger where the applicant intends to market the same or substantially similar injector as part of a drug-device combination.

When does US 10,478,560 lose exclusivity?

A precise expiration date cannot be established from the claims alone. US patent term ordinarily runs 20 years from the earliest effective nonprovisional filing date, subject to patent-term adjustment, patent-term extension, terminal disclaimers and other statutory adjustments under 35 U.S.C. §§ 154 and 156. [3][4]

The relevant exclusivity analysis is:

Exclusivity issue	Relevance
Patent term	Depends on the effective filing date and any adjustments
Patent-term adjustment	May extend the term for USPTO examination delay
Patent-term extension	Generally concerns regulatory review of eligible products and may not apply automatically to a device patent
Terminal disclaimer	Could tie expiration to an earlier patent
Continuation patents	May create later-expiring claims in the same family
Foreign counterparts	Have separate terms and prosecution outcomes
Trade secrets	Manufacturing know-how may survive patent expiration

Patent expiration must be determined from the USPTO patent record, the continuity data and any terminal-disclaimer or term-adjustment information. Patent expiration also does not eliminate regulatory exclusivity, contractual restrictions or separate patents covering a drug, formulation, cartridge, needle system or manufacturing process.

What generic entry risks exist?

Small-molecule products

For an ANDA applicant, the primary pathway risk usually comes from drug patents listed for the reference product, not from this device patent. Risk increases if:

• the proposed product uses the patented injector;
• the injector is part of the labeled dosage form;
• the device patent is listed against the reference drug;
• the applicant seeks approval for the same combination product; or
• a device supplier has licensed the patent and controls supply.

A generic manufacturer could potentially avoid the patent by using a different injector, a manually actuated syringe, a moving-syringe autoinjector, or a drive system outside the claimed pressure and support architecture.

Biologic products and biosimilars

The patent is not a biologic composition patent based on the supplied claims. It does not claim an antibody, protein sequence, formulation, cell line, purification process or therapeutic use.

A biosimilar sponsor would assess this patent only if its proposed product uses the claimed delivery device. The principal biologic patent risks would normally arise from separate patents covering:

• the active biologic;
• formulation and stability;
• prefilled syringe or cartridge presentation;
• injection-device integration;
• manufacturing and purification; and
• method of treatment.

Biosimilar patent dispute procedures under the Biologics Price Competition and Innovation Act concern relevant biologic patents, not every device patent associated with a presentation. [5]

Which companies may face competitive overlap?

Competitive overlap is likely among companies developing:

• spring-powered autoinjectors;
• fixed-syringe prefilled injectors;
• intradermal delivery systems;
• wearable or patch injectors;
• needle-shielded combination products; and
• glass-syringe support systems.

The relevant competitive set can include device manufacturers, contract development and manufacturing organizations, pharmaceutical companies with proprietary combination products, and suppliers of prefilled syringes.

A company’s use of a similar commercial product does not establish infringement. The decisive questions are whether the syringe remains fixed, whether the pressure and penetration limitations are met, whether the device contains the claimed support arrangement, and whether any relevant dependent-claim structure is present.

What manufacturing and IP barriers does the patent create?

The patent may increase development barriers in four areas:

1. Mechanical integration. The device must retain the prefilled syringe while transmitting plunger force without damaging the barrel or flange.
2. Force calibration. The drive must generate adequate pressure without exceeding the claimed pressure windows in claims 2, 3 or 14.
3. Depth control. The needle and guard geometry must control penetration within the claimed ranges.
4. Tolerance management. The cushion and support system must accommodate syringe dimensional variation and firing shock.

Design-around options include:

• moving the syringe during needle insertion;
• using a separate cartridge rather than a prefilled syringe;
• locating the energy source outside the syringe axis;
• using a motor or gas actuator;
• supporting the distal syringe portion;
• changing the guard-trigger sequence; or
• using a penetration depth outside the dependent-claim ranges.

Each option must still be tested against claim 1, which contains the broadest combination.

What patent litigation or Paragraph IV activity affects this patent?

No litigation, settlement agreement, Paragraph IV challenge, or license can be established from the claim text alone. The claim set also does not identify whether the patent has been asserted against a particular injector, pharmaceutical company or ANDA applicant.

Paragraph IV activity is relevant only if the patent is listed for an approved drug and an ANDA applicant certifies that the patent is invalid, unenforceable or will not be infringed. A device patent that is not listed in the Orange Book would generally be pursued through ordinary patent litigation rather than a Hatch-Waxman Paragraph IV proceeding. [1][2]

How does this patent compare with conventional autoinjector patents?

Issue	US 10,478,560	Conventional broad autoinjector patent
Prefilled syringe	Required	Often required, but not always
Syringe position	Fixed before and during firing	May be fixed or movable
Energy source	Required	Usually spring, gas or motor
Pressure	Functional requirement; dependent numerical ranges	Often not expressly claimed
Penetration depth	Central limitation	May be absent or limited to needle insertion
Backflow prevention	Express functional objective	Often not expressly claimed
Guard	Required only in claims 9-11	Commonly claimed
Syringe cushion	Required only in claims 17-19	Sometimes claimed
Drug identity	Not required	Usually not required
Formulation	Not claimed	Usually not claimed
Manufacturing process	Not claimed	Usually not claimed

The patent is strongest against products that combine a fixed prefilled syringe with shallow, pressure-controlled delivery. It is less directly relevant to conventional autoinjectors that use deeper injection, a moving syringe, a different drive arrangement or no prefilled syringe.

Key Takeaways

• Claim 1 is the central claim and covers a fixed prefilled syringe housed in an injector with an energy source that generates pressure and penetration conditions intended to prevent backflow.
• Claims 2, 3 and 14 define pressure-based fallback positions, with the most specific range being approximately 90-350 psi.
• Claims 4, 15 and 16 focus on shallow penetration, while claims 5 and 13 specify subcutaneous delivery.
• Claims 6 and 7 protect a spring-and-ram architecture in which the spring surrounds the syringe.
• Claims 9-11 cover retractable-guard and trigger sequencing.
• Claims 12 and 17-19 protect syringe support, shock absorption and elastomeric compensation.
• The patent does not claim a drug, biologic, formulation, treatment method or manufacturing process.
• Orange Book and Paragraph IV relevance depends on whether the patent was properly listed against an approved drug product.
• Biosimilar risk is indirect and arises only where the proposed combination product uses the claimed injector technology.
• The main design-around strategies involve syringe movement, alternative energy sources, different support geometry, separate trigger logic and altered penetration architecture.
• Patent-term timing requires the patent’s continuity, terminal-disclaimer and patent-term-adjustment records.

FAQs

Does US 10,478,560 cover every prefilled-syringe autoinjector?

No. The injector must satisfy all limitations of at least one claim. Claim 1 requires a fixed prefilled syringe, housing support, an energy source and pressure-depth conditions sufficient to substantially prevent backflow.

Can a device infringe if it uses a motor instead of a spring?

Potentially. Claim 1 broadly recites an energy source, not a spring. Claims 6 and 7 are narrower and require a spring and specified ram geometry.

Does the patent cover needleless jet injectors?

Not on the supplied claims. The claims require a needle having an injection tip configured to pierce an insertion location.

Is a 1 mL biologic automatically covered?

No. Volume and drug type alone do not establish infringement. Claim 8 includes approximately 0.02-4 mL, but the injector must also meet the other limitations of claim 1.

Can a manufacturer avoid the patent by using a distal syringe support?

Possibly for claims requiring the distal portion to be substantially unsupported, particularly claim 12. That change would not automatically avoid claim 1, which broadly requires a syringe support but does not expressly require distal support or lack of distal support.

References

1. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations.
2. U.S. Food and Drug Administration. (n.d.). Patent listing in the Orange Book.
3. United States Code, 35 U.S.C. § 154.
4. United States Code, 35 U.S.C. § 156.
5. United States Code, 42 U.S.C. § 262.
6. United States Patent No. 10,478,560, claims 1-19, as provided.

Drugs Protected by US Patent 10,478,560

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-001	Sep 28, 2018		RX	Yes	Yes			Y
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-002	Sep 28, 2018		RX	Yes	Yes			Y
Antares Pharma Inc	XYOSTED (AUTOINJECTOR)	testosterone enanthate	SOLUTION;SUBCUTANEOUS	209863-003	Sep 28, 2018		RX	Yes	Yes			Y

International Family Members for US Patent 10,478,560

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