Details for Patent: 10,220,155

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Which drugs does patent 10,220,155 protect, and when does it expire?

Patent 10,220,155 protects OZEMPIC and is included in one NDA.

This patent has fifteen patent family members in thirteen countries.

Summary for Patent: 10,220,155

Title:	Syringe device with a dose limiting mechanism and an additional safety mechanism
Abstract:	A syringe device for ejecting a dose of a medicament, the syringe device comprising: a dose limiting mechanism arranged to interact with a dose ejecting mechanism to prevent ejection of a dose exceeding a set dose, and a safety mechanism, which is arranged such with respect to the dose ejecting mechanism that, if the dose limiting mechanism fails, the safety mechanism prevents ejection of a dose exceeding the set dose.
Inventor(s):	Jacob Eiland, Christian Peter Enggaard, Claus Schmidt Moller, Tom Hede Markussen
Assignee:	Novo Nordisk AS
Application Number:	US11/996,397
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,220,155
Patent Claim Types: see list of patent claims	Use; Device;

United States Patent 10,220,155: Claim Scope, Patent Landscape, Exclusivity and Competitive Risk

U.S. Patent No. 10,220,155 protects a spring-assisted syringe or injection-pen architecture with three required control layers: dose setting, dose limiting, and an independent safety mechanism that prevents overdose if the primary limiter fails. The strongest protection is concentrated in claim 1 and claim 7. The patent is directed to a drug-delivery device, not to a particular active pharmaceutical ingredient, formulation, biologic, or therapeutic indication.

The principal design-around risk is a device that uses a different automatic-drive architecture, lacks a mechanically redundant safety mechanism, or limits dose through electronic or non-threaded structures. The principal infringement risk is a disposable or reusable pen that uses a threaded piston rod, a rotatable dose selector, a preloaded torsion spring, and a second mechanical limiter that independently caps piston-rod travel.

What does U.S. Patent 10,220,155 protect?

U.S. Patent 10,220,155 is identified by the supplied claims as a syringe-device patent covering an automatic or assisted dose-ejection mechanism. The patent does not require a specific drug cartridge, needle, therapeutic compound, delivery volume, or indication.

Claim 1 requires the accused device to include all of the following:

Required element	Technical scope
Housing	A structural body supporting the dose-setting and ejection components
Dose-setting member	Rotatable relative to the housing and longitudinally fixed
Piston rod	Moves distally to eject the selected dose
Rotational-to-translational conversion	Rotation is converted into axial piston-rod movement
Ejection-assisting system	A pre-strained torsional spring rotates a driver
User initiation	The user starts ejection, after which spring force supplies the ejection force
Dose limiter	Prevents delivery above the selected dose
Redundant safety structure	Independently prevents overdose if the dose limiter fails

The claim is a combination claim. A device that has only a torsion spring, only a dose limiter, or only an automatic piston drive does not meet claim 1 unless it also has the other required elements.

How broad is independent claim 1?

Claim 1 is structurally broad but functionally constrained. It does not limit the claim to insulin, a particular pen format, a particular cartridge, or a particular injection volume. It can potentially cover reusable pens, disposable pens, cartridge-based injectors, and other syringe-like delivery devices if they contain the claimed mechanical arrangement.

The most material limitations are:

1. The dose-setting member must rotate while remaining longitudinally fixed.
2. The torsional spring must be pre-strained.
3. The spring must rotate a driver.
4. The spring must provide the ejection force after the user initiates delivery.
5. The device must have both a dose-limiting mechanism and a separate safety mechanism.
6. The safety mechanism must protect against failure of the dose limiter.

The phrase "without the aid of a user" narrows the claim toward a spring-assisted ejection system. A device requiring the user to manually depress a button throughout piston travel may fall outside the claim, depending on the mechanism and claim construction.

The redundancy requirement is commercially important. Many injection devices use a single dose stop or a single travel limitation. Claim 1 requires a second structure that remains capable of preventing an overdose if the primary limiter does not operate.

What additional limitations appear in claims 2 through 8?

How does claim 2 narrow the piston-rod structure?

Claim 2 requires:

• A housing passage for the piston rod;
• A threaded inner surface in the housing passage;
• A threaded outer surface on the piston rod; and
• Translational piston-rod displacement caused by relative rotation between the piston rod and the housing.

This claim targets a threaded piston-rod arrangement. A device using a non-threaded rack, pawl, cam, hydraulic actuator, or linear actuator may avoid claim 2 while still potentially implicating claim 1.

What does claim 3 add?

Claim 3 requires the dose limiter or safety structure to limit relative rotational movement between the piston rod and housing to rotation corresponding to the selected dose.

This limitation ties the dose quantity to angular travel. It is particularly relevant to pen mechanisms in which piston displacement is generated by screw rotation.

What is protected by claims 4 through 6?

Claims 4 through 6 cover an end-stop arrangement associated with dose setting.

Claim 4 requires:

• A first stopping surface;
• A corresponding second stopping surface on the housing;
• Dose setting to move the first stopping surface away from the second; and
• Ejection to stop when the surfaces abut.

Claim 5 places the first stopping surface on the dose-setting member.

Claim 6 places the first stopping surface on a cylinder coupled to the dose-setting member, with the cylinder adapted to indicate the selected dose.

These claims connect dose display and mechanical dose limitation. A dose-indicator cylinder that also carries the maximum or selected-dose stop presents a higher risk under claims 4 through 6 than a device using a visually separate electronic display.

What is the scope of claim 7?

Claim 7 is the most technically specific dependent claim and may provide the clearest infringement pathway for a conventional screw-driven spring-assisted pen.

It requires:

• A limiter with a threaded passage;
• The limiter threaded to the piston rod;
• A driver with a passage for the limiter;
• The driver rotationally retained relative to the limiter;
• The driver coupled to the dose-setting member;
• Driver rotation during dose setting;
• Relative rotation between driver and piston rod causing the limiter to move away from a stopping position; and
• The limiter preventing delivery above the selected dose.

The claim describes a safety limiter that is repositioned during dose setting and then functions as a mechanical stop during ejection. A competitor using the same sequence with different component names would face a meaningful literal-infringement risk.

What does claim 8 protect?

Claim 8 requires the torsional spring to be pre-strained while the dose-limiting mechanism is in a stopping position.

This limitation links the stored spring energy to the initial stop condition. A spring that is tensioned only after the limiter leaves the stopping position may present a non-infringement position, subject to the specification and prosecution history.

What is the likely claim construction risk?

Several terms require specification and prosecution-history review before a definitive infringement opinion.

"Syringe device"

The title and claim language use "syringe device," but the structural limitations appear compatible with injection pens and other drug-delivery devices. The term should not automatically be limited to a conventional barrel-and-plunger syringe.

"Structure for transforming"

The phrase "structure for transforming rotational movement ... into translational movement" may be analyzed under 35 U.S.C. §112(f) if it is treated as a means-plus-function limitation. If so, the claim may be limited to the corresponding structures disclosed in the specification and their statutory equivalents rather than every mechanism that converts rotation into linear motion [2].

"Safety mechanism structure"

This phrase is also functionally expressed. The scope may depend on whether the patent discloses a specific limiter, threaded passage, driver relationship, or stopping arrangement as the corresponding structure.

"If the dose limiting mechanism fails"

This language requires more than two stops that happen to coexist. The second mechanism must be capable of preventing a dose exceeding the selected dose when the primary dose limiter fails. Functional redundancy is central to the claim.

How many patents cover this type of injection device?

The relevant patent landscape is crowded because spring-assisted drug-delivery devices combine several mature technology areas:

Technology area	Typical patent subject matter	Relevance to Patent 10,220,155
Dose selectors	Rotatable knobs, dose rings and click mechanisms	Directly relevant
Screw-driven piston rods	Threaded rods, nuts, drivers and clutches	Directly relevant
Spring-assisted delivery	Torsion, compression and helical springs	Directly relevant
Dose limiting	Stops, splines, threaded limiters and end-of-dose structures	Directly relevant
Redundant safety	Secondary stops, backup clutches and fail-safe limiters	Core inventive concept
Dose indicators	Number sleeves, cylinders and windows	Relevant to claims 4-6
Cartridge interfaces	Ampoule, cartridge, needle hub and septum structures	Usually outside the express claim scope
Electronic controls	Sensors, motors and software dose control	Potential design-around area
Manufacturing methods	Assembly, spring loading and calibration processes	Separate patent families

Major drug-delivery companies, device manufacturers and platform suppliers have historically sought protection in these areas, including Novo Nordisk, Sanofi, Eli Lilly, Ypsomed, SHL Medical and other injector-platform companies. The existence of patents in these portfolios does not establish that any particular family reads on Patent 10,220,155 or that any company is challenging it.

What is the patent term and expiration date?

The patent issued on February 26, 2019, based on the patent number and issue sequence. The issue date alone does not establish the expiration date.

U.S. utility patents generally expire 20 years from the earliest effective nonprovisional filing date, subject to patent-term adjustment, terminal disclaimers, patent-term extension, and the priority chain recorded in the patent file [3]. A continuation may therefore expire on the same date as an earlier parent application even if it issued years later.

Patent 10,220,155 is a device patent. It does not receive Hatch-Waxman drug exclusivity merely because the device delivers a medicinal product. Patent-term extension under 35 U.S.C. §156 is generally associated with regulatory review of a covered product and must be evaluated against the particular product and regulatory approval record [4].

Exclusivity category	Relevance to Patent 10,220,155
Utility-patent term	Applies
Patent-term adjustment	Must be checked in the patent record
Patent-term extension	Not established from the claims
New chemical entity exclusivity	Not applicable to the device claims
New clinical investigation exclusivity	Not applicable to the device claims
Orphan-drug exclusivity	Not applicable to the device claims
Pediatric exclusivity	Not applicable unless linked to a qualifying drug product
Biologic exclusivity	Not applicable to the device claims

What is the Orange Book status of Patent 10,220,155?

Patent 10,220,155 is not, based on the supplied claims, a drug-substance, formulation, composition, or method-of-use patent. Its claims are directed to a syringe device.

The FDA Orange Book lists patents submitted for approved drug products, including qualifying patents covering drug substances, formulations, compositions, and methods of use. A standalone injector-device patent is not automatically an Orange Book-listed patent for every drug administered through that device [5].

A device patent could become commercially relevant to an abbreviated new drug application if a drug product's approved presentation or delivery system depends on the patented device. That would require a product-specific listing and regulatory analysis. The patent claims alone do not establish an Orange Book listing.

Does Patent 10,220,155 create Paragraph IV risk?

Paragraph IV risk is product-specific. An ANDA applicant makes a Paragraph IV certification when it asserts that a listed patent is invalid, unenforceable, or will not be infringed by the proposed generic product [6].

For this patent:

• A conventional tablet or injectable generic that does not use the claimed syringe architecture would ordinarily have no direct claim risk.
• A generic or follow-on injectable sold with a substantially similar spring-assisted pen could face infringement risk if the patent is listed against the relevant drug product or asserted independently.
• A device supplier, rather than the generic drug applicant, may be the practical target in a device-related infringement dispute.
• The patent is not itself evidence of a Paragraph IV notice or ANDA challenge.

A Paragraph IV certification and an actual lawsuit cannot be inferred from the existence of the patent.

What biosimilar risk exists?

The patent does not claim a biologic, biosimilar molecule, cell line, manufacturing process, or formulation. It therefore creates no direct biosimilar-molecule barrier.

A biologic sponsor could still assert the patent against a biosimilar presentation using the claimed injector. That risk would depend on:

1. Whether the biosimilar uses the same or an equivalent delivery device;
2. Whether the device is sold with the biologic or supplied separately;
3. Whether the patent remains unexpired;
4. Whether the patent is asserted under the relevant commercial arrangement; and
5. Whether the biosimilar sponsor uses a device design around.

The strongest biosimilar risk is presentation-specific, not molecule-wide.

What generic launch scenarios exist?

Launch scenario	Likely exposure
Vial-and-syringe generic	Low direct exposure to these claims
Prefilled syringe without torsion spring	Generally outside the claimed architecture
Disposable spring-assisted pen	Potentially high exposure
Reusable screw-driven pen	Potentially high exposure
Electronic motor-driven injector	Lower literal risk, subject to equivalents
Pen using a single dose stop	May avoid the redundant-safety limitation
Pen using a non-threaded piston drive	May avoid claims 2 and 7
Same mechanism with a different dose display	Claims 1-3 may remain relevant

The highest-risk launch is a pen that duplicates the claimed mechanical sequence: dose selection, limiter withdrawal, spring loading, user initiation, automatic piston movement, and secondary overdose prevention.

What manufacturing and intellectual-property barriers matter?

The claims do not cover only the final commercial appearance. They reach internal mechanical relationships that may be difficult to change without affecting dose accuracy and user experience.

Potential barriers include:

• Thread geometry between the piston rod and housing;
• Torsion-spring preload and calibration;
• Driver-to-limiter rotational retention;
• Stop-surface placement;
• Dose-indicator cylinder integration;
• Assembly order and spring loading;
• Tolerance control for the redundant safety stop;
• Validation of failure-mode performance.

A design-around that changes the external housing but preserves the internal limiter and driver relationships may not avoid the claims. Conversely, changing the actuation principle from torsion-spring rotation to a motor, compression spring, pneumatic drive, or direct manual actuation may materially reduce risk.

What litigation, licensing and settlement information is material?

The claims alone do not establish any infringement action, Paragraph IV notice, settlement, covenant not to sue, or license involving Patent 10,220,155. Those issues require review of USPTO Patent Center, federal court dockets, International Trade Commission records, FDA listing data, and assignment records.

The most important legal documents would be:

1. The full patent prosecution history;
2. Any terminal disclaimer;
3. Patent-term-adjustment calculation;
4. Continuation and divisional applications;
5. Cited and citing patent families;
6. Federal court complaints and claim-construction orders;
7. Any inter partes review petition or final written decision;
8. License or settlement filings;
9. Assignment and security-interest records; and
10. Product-specific Orange Book entries.

No licensing economics, royalty rate, settlement payment, or product revenue exposure can be attributed to this patent from the claim language.

How strong is the patent estate?

The individual claim set is strongest where a competitor uses all of the following:

• A rotatable, axially fixed dose selector;
• A screw-driven piston rod;
• A preloaded torsion spring;
• A spring-driven driver;
• A primary dose limiter;
• A secondary mechanical safety limiter; and
• A dose-indicator cylinder or end-stop structure.

The estate is weaker against:

• Manual-only injection devices;
• Motor-driven systems;
• Devices using axial or compression springs rather than torsion springs;
• Electronic dose control with no corresponding mechanical limiter;
• Devices that use a single integrated stop rather than redundant safety;
• Devices in which the piston rod does not rotate relative to the housing; and
• Delivery systems that do not use a threaded piston rod.

The patent's commercial value depends less on the active drug and more on whether the protected architecture is embedded in a platform used across multiple products.

Key Takeaways

• Patent 10,220,155 is a mechanical drug-delivery-device patent, not a drug-composition patent.
• Claim 1 requires a spring-assisted ejection mechanism plus both a dose limiter and a redundant safety mechanism.
• Claim 7 provides the most specific protection for a threaded piston rod, threaded limiter and rotationally retained driver.
• Claims 4 through 6 extend protection to dose-setting stops and dose-indicator cylinders.
• The patent does not establish drug exclusivity, biologic exclusivity, or Orange Book protection by itself.
• Paragraph IV and biosimilar risk are presentation-specific and depend on the product using the claimed device.
• The most credible design-arounds change the actuation technology, eliminate the threaded piston relationship, or remove the claimed redundant mechanical-safety architecture.
• The exact expiration date requires the priority chain, patent-term-adjustment record and any terminal disclaimer.
• No litigation, settlement, license, or revenue exposure follows from the claim text alone.

FAQs About U.S. Patent 10,220,155

Can a prefilled syringe infringe Patent 10,220,155?

A conventional manually operated prefilled syringe is less likely to meet the claims because the claims require a rotatable dose-setting member and a pre-strained torsional spring that assists ejection. A prefilled syringe incorporating those mechanisms could present risk.

Does the patent cover insulin specifically?

No. The supplied claims do not identify insulin or any other active ingredient. They cover device structure and operation.

Does a motor-driven injector automatically avoid the patent?

No. A motor-driven device may avoid the torsion-spring limitation, but the full design must be compared against every claim limitation, including equivalents and any additional claims in the patent.

Can a company sell the same injector with a different drug?

Changing the drug does not avoid infringement if the device itself practices an unexpired claim. The patent is directed to the syringe-device architecture.

Is a patent expiration date of 2039 implied because the patent issued in 2019?

No. U.S. utility-patent term is generally measured from the earliest effective nonprovisional filing date, not the issue date. A 2019 issue date does not imply expiration in 2039 [3].

References

1. United States Patent No. 10,220,155, claims 1-8 (issued Feb. 26, 2019), U.S. Patent and Trademark Office.
2. U.S. Patent and Trademark Office. (2024). Manual of Patent Examining Procedure §2181: Identifying a 35 U.S.C. §112(f) or pre-AIA 35 U.S.C. §112, sixth paragraph limitation.
3. U.S. Patent and Trademark Office. (2024). Patent term adjustment and patent term calculation guidance.
4. 35 U.S.C. §156. Patent term extension.
5. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
6. 21 U.S.C. §355(j)(2)(A)(vii)(IV). Patent certification requirements for abbreviated new drug applications.

Drugs Protected by US Patent 10,220,155

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-001	Dec 5, 2017		DISCN	Yes	No	10,220,155		Y		Y
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-004	Oct 6, 2022		RX	Yes	Yes	10,220,155		Y		Y
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-002	Apr 9, 2019		RX	Yes	Yes	10,220,155		Y		Y

Foreign Priority and PCT Information for Patent: 10,220,155

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	05016286	Jul 27, 2005

PCT Information
PCT Filed	July 17, 2006	PCT Application Number:	PCT/EP2006/007006
PCT Publication Date:	February 15, 2007	PCT Publication Number:	WO2007/017053

International Family Members for US Patent 10,220,155

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	E447992
Australia	2006278928
Brazil	PI0613926