US Patent 10,022,502: Claim Scope, Patent Strength and Competitive Landscape for Small-Volume Syringe Delivery

US Patent No. 10,022,502 protects a two-stage syringe dose-control system for delivering very small volumes. Its core architecture uses two rigid components around the plunger rod: a dose-delivery guide that establishes the final injection position and a removable dose-loading guide that establishes a separate, more proximal loading position. The difference between those positions corresponds to the delivered dose volume.[1]

The patent is strongest against systems that use both a rigid delivery stop and a removable rigid loading collar positioned around the same plunger rod. It is weaker against syringe systems that use a different dose-metering mechanism, place the stop elsewhere, or do not require a separate loading guide.

What technology does US Patent 10,022,502 protect?

The patent covers a mechanical method for preparing and dispensing a small dose from an injection syringe. The claimed system addresses the practical difficulty of accurately loading and delivering very small volumes, particularly when the syringe barrel has a proximal-end depression or dead space.

The claimed architecture contains:

Component	Claimed function
Syringe barrel	Defines proximal and distal ends and contains the plunger
Plunger rod	Moves through the syringe barrel
Dose-delivery guide	Establishes the final plunger position for delivery
Dose-loading guide	Establishes the loading position before delivery
Grip portion	Allows the loading guide to be positioned and removed
Collar portion	Fits around the delivery guide and limits plunger travel during loading
Dose-volume relationship	The distance between the two stopping positions defines the dose

The system is directed to small-volume delivery rather than to a particular syringe barrel size, needle, route of administration, or drug concentration.

What are the independent claims in US Patent 10,022,502?

Claims 1 and 9 are the independent claims. They cover substantially the same inventive concept but use different drafting formats.

Claim 1: assembled syringe system

Claim 1 requires a system in which:

A plunger rod is slidably disposed in a syringe barrel.
A rigid dose-delivery guide is disposed at least partially around the plunger rod.
The dose-delivery guide is adjacent to the proximal end of the barrel.
The delivery guide stops the plunger at a first predetermined distance.
A dose-loading guide has a grip portion and a collar portion.
The collar is rigid along its height.
The collar has an opening that removably receives the delivery guide.
The collar surrounds the delivery guide during dose loading.
The collar stops the plunger at a second predetermined distance.
The difference between the first and second distances defines the dose volume.

Claim 1 is an apparatus-system claim. It is written in the present tense and generally reads on an assembled system containing the claimed components in their specified relationships.

Claim 9: configured system or kit

Claim 9 recites a similar system but uses “configured to be disposed,” “configured such that,” and “in advance of dose loading” language.

The principal distinction is practical:

Issue	Claim 1	Claim 9
Guide positioning	Recites the guide as disposed around the plunger rod	Recites the guide as configured to be disposed around the rod
Loading stage	Recites the collar during dose loading	Recites the collar in advance of dose loading
Claim character	More directly directed to an assembled system	More readily applicable to a system or kit supplied for assembly
Required relationship	Actual claimed arrangement	Configured arrangement capable of producing the arrangement

Claim 9 may provide broader enforcement coverage for products sold with the relevant components before the loading and delivery steps are performed. Its scope still depends on proving that the accused system is configured to perform the claimed functions.

How does the dose-volume calculation work?

Claims 2 through 4 define the relationship between the loading position and the final delivery position.

Claim 2 requires the second predetermined distance to be greater than the first. The loading stop therefore holds the plunger farther from the syringe barrel’s proximal end than the final delivery stop.

Claim 3 defines the difference as:

[ h = \frac{v}{\pi r^2} ]

where:

(v) is the dose volume;
(r) is the internal radius of the syringe barrel;
(h) is the axial distance between the loading and delivery positions.

Claim 4 specifies microliters for volume and millimeters for radius and distance. Because one microliter equals one cubic millimeter, the formula is dimensionally consistent when volume is expressed in microliters and barrel dimensions are expressed in millimeters.

For a 1 mm internal radius syringe:

Dose volume	Approximate axial distance (h)
1 µL	0.318 mm
5 µL	1.592 mm
10 µL	3.183 mm
50 µL	15.915 mm

The formula is important for infringement analysis. A competitor may use different physical dimensions but still satisfy the claim if the two stopping positions produce the claimed dose-volume relationship.

What formulations and drugs are protected?

Claim 7 adds a pharmaceutical composition loaded in the injection syringe. Claim 8 narrows that composition to one of five specified products:

IBI-20089;
IBI-10090;
ranizumab, as written in the supplied claim text;
bevacizumab;
VEGF Trap-Eye.

The composition claims do not appear to protect the active pharmaceutical ingredients themselves. They protect a syringe system containing one of the listed compositions when all structural limitations of claim 1 or claim 9 are also present.

The drug limitation is therefore cumulative. A syringe containing bevacizumab, for example, would not infringe claim 8 merely because it contains bevacizumab. The accused product would also need the claimed barrel, plunger, rigid delivery guide, rigid loading collar, grip portion, and two-distance stopping arrangement.

The wording “selected from a group consisting of” is a closed Markush formulation. It generally limits claim 8 to the listed alternatives rather than to unrelated ophthalmic drugs. The spelling “ranizumab” should be checked against the issued patent and prosecution record because the commercial anti-VEGF product is commonly identified as ranibizumab.

What dependent claims add technical scope?

Claim 5: compensation for barrel depression

Claim 5 requires the first predetermined distance to be configured to correct for a depression at the proximal end of the syringe barrel.

This limitation ties the invention to a known source of volume error. A syringe may have a concave or depressed barrel end, creating residual volume or uncertainty in the final plunger position. The delivery guide compensates for that geometry.

The claim is narrower than claim 1 because it requires a functional relationship between the delivery stop and the barrel depression. It may be valuable in enforcement where the accused product expressly accounts for barrel-end geometry in its dose calibration.

Claim 6: integral delivery guide

Claim 6 requires the dose-delivery guide to be integral to the plunger.

This limitation covers a one-piece or permanently integrated plunger-and-guide structure. It excludes, at least literally, a delivery guide supplied only as a separate removable component.

The claim creates a clear design-around path: a manufacturer could use a separate barrel-mounted stop or a detachable component, although the resulting system would still need to be assessed against the independent claims and potential equivalents.

Claims 7 and 8: drug-loaded systems

These claims shift the patent from a general mechanical device toward specific drug-device combinations. Their commercial value depends on whether the listed products are delivered in the claimed syringe configuration and whether the claims can be asserted against a drug manufacturer, prefilled-syringe supplier, or ophthalmic delivery platform.

How strong is the patent estate based on the claims?

The claim set has a focused but technically coherent scope.

Strength factor	Assessment
Core inventive concept	Clear two-position dose-control architecture
Structural specificity	High; multiple components and spatial relationships are required
Functional specificity	Moderate; the guides must stop plunger movement at defined distances
Formula limitation	Appears only in dependent claims 3 and 4
Drug coverage	Narrow and limited to listed compositions
Design-around exposure	Material because the claim requires two separate guide components
Enforcement clarity	Relatively strong for products with visible rigid collars and stops
Vulnerability to prior art	Potentially significant for earlier syringe spacers, plunger stops, and dose-metering collars

The principal strength is claim integration. A prior-art reference would need to disclose more than a generic syringe or a single plunger stop. The strongest prior-art attack would combine:

a syringe plunger travel limiter;
a removable loading spacer or collar;
a rigid guide surrounding the plunger rod;
two calibrated stopping positions; and
a dose volume determined by the difference between those positions.

The principal weakness is that each additional limitation narrows the number of potentially infringing products. A conventional prefilled syringe with a fixed stopper, for example, may not contain a removable collar that receives and surrounds a separate delivery guide.

What design-arounds are available?

Potential non-infringing designs include:

Single-stop systems

A manufacturer could use one calibrated stop that directly establishes the final dose without a separate loading guide. This would avoid the claimed two-distance architecture.

Barrel-integrated stops

A stop could be molded into the syringe barrel rather than positioned around the plunger rod. The claims expressly focus on guides disposed at least partially around the plunger rod.

Plunger-integrated geometry

A plunger could include a stepped or shaped end that determines the dose without a removable collar. Claim 6 covers some integral guide arrangements, but the independent claims still require the claimed loading guide.

Adjustable metering mechanisms

A threaded, ratcheting, electronic, or sensor-based dose-control mechanism may avoid literal infringement if it does not use the claimed rigid collar and delivery guide.

Different loading architecture

A loading tool could engage the plunger handle or syringe flange rather than surround the dose-delivery guide. The claim language makes the collar’s opening and its removable receipt of the delivery guide central limitations.

Alternative volume calibration

A system could calibrate dose by mass, pressure, pump stroke, chamber displacement, or a predefined fill mark instead of by the axial difference between two plunger stops.

These approaches may reduce literal infringement risk, although equivalents analysis would depend on the specific implementation and prosecution history.

What is the Orange Book status of US Patent 10,022,502?

US Patent No. 10,022,502 is directed to a syringe delivery system, not to the chemical composition, method of manufacture, or therapeutic use of a drug. A device patent of this type would not ordinarily appear as a drug patent in the FDA Orange Book unless it were properly listed in connection with an approved drug product under applicable FDA listing rules.[2]

The patent also does not create a standalone Paragraph IV pathway. Paragraph IV certifications address patents listed in the Orange Book for an approved drug application. A generic applicant could face device-related regulatory or commercial issues without making a Paragraph IV certification to this patent.

For biologic products, the relevant FDA patent framework is different. Patent information for reference biologics and biosimilar applications is generally handled under the Public Health Service Act and the Purple Book patent-exchange process, not the conventional Orange Book Paragraph IV system.[3]

When does US Patent 10,022,502 lose exclusivity?

The patent issued on July 17, 2018. Its ordinary patent term would generally be measured from the applicable nonprovisional filing date or earliest effective priority-linked nonprovisional filing date, subject to patent-term adjustment, terminal disclaimers, and any applicable patent-term extension.

The claims supplied do not establish:

the earliest effective nonprovisional filing date;
patent-term adjustment;
terminal disclaimer status;
continuation or divisional relationships;
reexamination or post-grant proceedings;
maintenance-fee status; or
current expiration.

Those factors control the enforceable expiration date. A reliable expiration analysis therefore cannot be derived from the claim text alone.

Which companies may face competitive risk?

The most exposed businesses are those supplying:

prefilled ophthalmic syringes;
intravitreal injection systems;
low-volume biologic delivery devices;
combination products for anti-VEGF therapies;
syringe components with removable dose collars; and
contract manufacturers producing calibrated small-volume syringes.

The listed products indicate an ophthalmology-oriented commercial target. Ranibizumab, bevacizumab, and VEGF Trap-Eye are associated with anti-VEGF ophthalmic treatment, while IBI-20089 and IBI-10090 appear in the claim as specified pharmaceutical compositions.

Risk is higher where the supplier controls both the syringe hardware and drug filling process. It is lower where the manufacturer supplies only a standard syringe or where dose preparation occurs using an unrelated loading device.

What patent litigation and licensing issues matter?

The claim text does not establish any litigation, settlement, covenant not to sue, or licensing agreement involving US Patent No. 10,022,502. Those issues cannot be inferred from the claims.

For transaction diligence, the key legal questions are:

whether the patent remains in force;
whether related continuation patents contain broader claims;
whether the claims were narrowed during prosecution;
whether the applicant made arguments distinguishing prior art based on the rigid guide, collar opening, or two-distance relationship;
whether the patent has been licensed to a syringe, drug, or combination-product manufacturer;
whether any products were sold under a settlement or covenant arrangement; and
whether related foreign patents remain enforceable in major ophthalmic markets.

The prosecution history is particularly important because statements about the meaning of “rigid,” “around,” “removably receives,” or “difference” could limit later infringement arguments.

How does this patent compare with drug and biologic patents?

US Patent No. 10,022,502 is a delivery-device patent rather than a conventional drug patent.

Patent category	Primary protected subject matter	Relevance of US 10,022,502
Active-ingredient patent	Chemical or biologic molecule	Separate from this patent
Formulation patent	Concentration, excipients, stability	Separate, except for claim 7/8 combination coverage
Method-of-use patent	Treatment method	Not the principal subject
Manufacturing patent	Production or purification	Separate
Device patent	Syringe, injector, or delivery mechanism	Directly relevant
Combination-product patent	Drug plus delivery device	Relevant through claims 7 and 8

A product may therefore face layered exclusivity: drug patents may control the active ingredient or use, while this patent may control a specific small-volume syringe configuration. The expiration of one layer does not automatically eliminate the others.

Key Takeaways

US Patent No. 10,022,502 centers on a two-stage plunger-positioning system for small-volume syringe delivery.
Independent claims 1 and 9 require both a rigid dose-delivery guide and a rigid dose-loading collar.
The loading collar surrounds and removably receives the delivery guide during dose preparation.
The dose is defined by the distance between the loading stop and final delivery stop.
Claims 3 and 4 add a geometric dose-volume formula.
Claim 5 addresses correction for a depression at the proximal end of the syringe barrel.
Claim 6 covers a delivery guide integral to the plunger.
Claims 7 and 8 narrow the system to a syringe loaded with specified pharmaceutical compositions.
The patent is more relevant to syringe and combination-product manufacturers than to generic drug manufacturers operating with unrelated delivery systems.
The strongest design-around options use a single stop, barrel-integrated geometry, a non-collared loading mechanism, or an alternative dose-metering technology.
Orange Book and Paragraph IV relevance is limited because the claims are directed primarily to a delivery device.
The enforceable expiration date, current maintenance status, family scope, litigation history, and licensing position require review of the official patent and prosecution records.

FAQs About US Patent 10,022,502

Does US Patent 10,022,502 cover all low-volume syringes?

No. It requires a specific two-guide architecture, including a rigid delivery guide and a removable rigid loading collar positioned around the plunger rod.

Does the patent cover ranibizumab as a drug?

The supplied claim text lists “ranizumab,” while the established drug name is ranibizumab. In either event, the drug limitation appears only in a dependent combination claim and does not independently cover the active ingredient.

Can a syringe avoid the patent by eliminating the loading collar?

Potentially. Eliminating the collar may avoid a literal element of claims 1 and 9, provided no related claim or patent family member separately covers the alternative design.

Is a biosimilar applicant required to file a Paragraph IV certification to this patent?

Not ordinarily. Paragraph IV certifications apply to patents listed in the Orange Book. A device patent of this type would generally require separate analysis under the applicable drug-device or biologic regulatory framework.

Does the patent protect the formula for calculating dose volume?

The formula appears in claims 3 and 4 as a limitation on the claimed system. The patent does not, based on the supplied claims, claim the mathematical formula in isolation.

References

United States Patent No. 10,022,502, claims 1-9 (issued July 17, 2018).
U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations. Orange Book.
U.S. Food and Drug Administration. (n.d.). Purple Book: Database of licensed biological products.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Eyepoint Pharms	DEXYCU KIT	dexamethasone	SUSPENSION;INTRAOCULAR	208912-001	Feb 9, 2018		RX	Yes	Yes	10,022,502	⤷ Start Trial				TREATMENT OF POSTOPERATIVE INFLAMMATION	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2012249757	⤷ Start Trial
Brazil	112013027428	⤷ Start Trial
Canada	2833570	⤷ Start Trial
China	103648544	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 10,022,502

Which drugs does patent 10,022,502 protect, and when does it expire?

Summary for Patent: 10,022,502