Details for Patent: 10,376,652

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Which drugs does patent 10,376,652 protect, and when does it expire?

Patent 10,376,652 protects OZEMPIC and is included in one NDA.

This patent has fourteen patent family members in eleven countries.

Summary for Patent: 10,376,652

Title:	Automatic injection device with a top release mechanism
Abstract:	The present invention relates to a handheld mechanical injection device by which set doses of a liquid medicament can be injected from a medical reservoir. The medicament is expelled through an injection needle by release of a power reservoir in the device, the power reservoir being fully or partially released by actuation of a user operable release member being positioned at or near an upper end of the injection device, the upper end being that end of the injection device which is opposite the injection needle.
Inventor(s):	Tom Hede Markussen
Assignee:	Novo Nordisk AS
Application Number:	US15/441,638
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,376,652
Patent Claim Types: see list of patent claims	Use; Device;

United States Patent 10,376,652: Injection-Pen Claims, Patent Scope, Expiration and Competitive Landscape

United States Patent No. 10,376,652 protects a mechanical handheld injection device that combines a rotatable dose-setting mechanism, a torsion-spring power reservoir, an axially actuated release member, a multi-part drive system, a threaded piston rod, and a dose display. The independent claim is directed to the overall architecture rather than to a particular drug, formulation, needle, or therapeutic indication.

The patent is therefore primarily a medical-device patent. It is not a conventional drug patent and would not ordinarily create an Orange Book patent listing for the active pharmaceutical ingredient in a medicine delivered through the device. Its commercial value depends on whether a competing pen uses the claimed combination of mechanical elements.

What does United States Patent 10,376,652 protect?

The claims protect a disposable or reusable pen-style injection device having five core limitations:

1. A rotatable dose-setting member.
2. A torsion spring that stores energy for dose delivery.
3. A proximal push-button-like release member.
4. A multi-component driver that disengages from the housing to release the stored energy.
5. A dose display that corresponds to the selected dose.

Claim 1 is the controlling independent claim. Claims 2 through 15 narrow the protection by specifying the spring-loading relationship, release mechanism, drive-member movement, ratchet structure, piston-rod configuration, and display arrangement.

Claim 1 limitation map

Claim 1 element	Technical function	Infringement significance
Handheld injection device	Defines the device category	A syringe, pump, or automated injector may fall outside this limitation
Rotatable dose-setting member	Allows the user to select a dose	A purely linear dose selector may avoid this element
Torsion-spring power reservoir	Stores rotational energy for delivery	A motor-driven, gas-driven, or compression-spring device may avoid the limitation
Axially arranged release member	Release operates along the device axis	A radial trigger or side-mounted actuator may avoid this limitation
Push-button-like release member	User actuates delivery by pressing the proximal control	A touch interface or separate trigger may require a different analysis
Multi-component driver	Driver has at least a piston-rod-driving part and another axially movable part	A unitary driver may avoid literal infringement
Axial movement into a disconnected position	Driver part disconnects from the housing to release energy	This is a central mechanical limitation
User-applied force to the release member	Axial driver movement is caused by user actuation	Automatic or electronically controlled release may fall outside the claim
Proximal release position	Button is at the end opposite the needle	Side-actuated designs may avoid this limitation
Dose display	Display indicates the selected dose	A device without a dose display may avoid the claim

The claim does not require a particular insulin, GLP-1 product, cartridge volume, needle gauge, injection speed, or therapeutic use. It also does not expressly require that the device be disposable.

How broad is the independent claim?

Claim 1 is broad at the product-category level but structurally specific at the drive-mechanism level. The principal enforcement question is whether the accused device has the claimed axial disconnection of a multi-component driver.

A competitor could potentially avoid literal infringement by using:

• A compression spring instead of a torsion spring.
• A motor or electromechanical actuator instead of a spring-powered drive.
• A clutch that disengages radially rather than axially.
• A drive component that remains mechanically connected to the housing during release.
• A side-mounted trigger rather than a proximal push button.
• A dose selector that is not rotatable.
• A display that does not correspond to the selected dose.
• A single-piece driver rather than the claimed multi-component driver.

The claim uses functional language such as "adapted to drive," "adapted to release," and "adapted to display." Under United States patent law, those limitations generally require the accused apparatus to possess the recited capability, not merely that the function could theoretically be performed after modification. Claim construction would determine how the terms "multi-component driver," "disconnected from the housing," "push button like," and "display member" are interpreted. See 35 U.S.C. §§ 102, 103, 112 and Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005).

What do claims 2 through 6 add?

Claims 2 through 6 define the relationship between dose setting, spring loading, and release.

Torsion-spring loading

Claim 2 requires the amount of power supplied to the spring to depend on the angle of rotation of the dose-setting member. This links dose selection directly to spring energy. A design in which the spring is always fully energized and dose volume is controlled by a separate clutch may present a noninfringement position under claim 2, although it could remain relevant to claim 1.

Operative connection and key/keyway engagement

Claims 3 through 5 require a release member operatively connected to the dose-setting member and engaging it through a key/keyway connection while the device is in the dose-setting position. The connection is released when the device enters the dose-injecting position.

This creates a mechanical interlock with two functions:

• Preventing unintended drive release during dose selection.
• Permitting energy release only after the dose-setting member reaches the injection position.

A competing device using splines, a pawl, a bayonet interface, or a separate clutch could raise claim-construction issues. The doctrine of equivalents could still be relevant if the alternative connection performs substantially the same function in substantially the same way with substantially the same result, subject to prosecution-history estoppel.

Dose delivery through a needle

Claim 6 ties the torsion-spring release to expulsion of medicine from a reservoir through an injection needle. This limitation reinforces the pen-injector context but does not narrow the claim to a specific drug or cartridge supplier.

What do claims 7 through 11 protect?

Claims 7 through 11 focus on the drive member and its axial operating positions.

Claim	Added limitation
7	Rotatable drive member, first axial position for dose setting, second axial position for injection, and spring-energy release in the second position
8	Drive member rotates the piston rod when energy is released
9	Drive member is prevented from rotating in the first position
10	Resilient member biases the drive member toward the dose-setting member
11	Axial force on the dose-setting member moves the drive member from the first to the second position

These claims create a nested protection strategy. Even if a device avoided claim 1 through a dispute over the multi-component driver, claims 7 through 11 could apply if the device uses a rotating drive member with distinct axial dose-setting and dose-injection positions.

The most commercially important limitation is claim 9. It requires rotational blocking during dose setting. This prevents the piston rod from advancing while the user is selecting a dose. Claim 10 adds a biasing spring, while claim 11 places the axial transition under the user's control.

A competing pen using a continuously rotatable drive member, an electronic lockout, or a radial clutch may present a design-around position. A device with axial movement but no spring bias may avoid claim 10 while remaining potentially relevant to claims 7, 8, 9, or 11.

What formulations and dose displays are protected?

Claims 12 and 13 add a specific dose-display and piston-rod architecture.

Dose indicator barrel

Claim 12 requires:

• A rotatable dose-setting member.
• A rotatable display member.
• Display rotation over an angle corresponding to at least one revolution.
• A dose-indicator barrel.
• Numerals arranged along a substantially helical path.

This limitation is directed to a mechanical dose window and rotating barrel arrangement. It may cover multi-revolution dose displays in which numerals move helically relative to a fixed housing window.

A digital display, linear scale, non-helical marking system, or electronically generated dose readout could avoid literal infringement of claim 12. A mechanical display with equivalent helical indicia remains a potential concern.

Piston rod and longitudinal drive track

Claim 13 requires a piston rod with:

• A threaded outer surface.
• A drive track arranged in a longitudinal direction on the outer surface.

This is narrower than a conventional piston rod with only circumferential threads. A device using a smooth rod, a separate lead screw, or a differently configured drive track could avoid this claim.

What do claims 14 and 15 add?

Claim 14 requires operative connection of the drive member to the dose-setting member through a ratchet. The ratchet can permit dose escalation and controlled dose reduction while producing tactile or audible feedback.

Claim 15 requires the multi-component driver to be rotatably arranged. This narrows claim 1 by requiring rotation of the driver assembly, not merely axial movement.

Claims 14 and 15 are important dependent claims because they target commercially common pen architectures: a ratcheting dose selector combined with a rotating, spring-driven piston-rod mechanism.

When does United States Patent 10,376,652 lose exclusivity?

The statutory patent term is generally measured as 20 years from the earliest effective nonprovisional filing date, subject to patent-term adjustment, terminal disclaimers, and any applicable patent-term extension. The grant date, August 13, 2019, does not ordinarily determine the expiration date. See 35 U.S.C. § 154.

The baseline term should be determined from the patent's continuity data and earliest effective filing date in the USPTO Patent Center record. A patent-term calculation based only on the grant date would be incorrect. Patent-term adjustment can extend the baseline date, while a terminal disclaimer can shorten it.

Because this patent claims a device rather than an active drug, pediatric exclusivity under the Hatch-Waxman framework would not ordinarily extend the patent as an Orange Book drug patent. A separate device-related regulatory exclusivity period is not created merely by obtaining this patent.

What is the Orange Book status of Patent 10,376,652?

United States Patent 10,376,652 is not, based on the claim subject matter provided, an active-ingredient, formulation, or method-of-use patent for a drug product. It covers an injection-device structure.

The FDA Orange Book generally records patents submitted for approved drug products, including patents covering active ingredients, drug compositions, formulations, and approved methods of use. A standalone mechanical injector patent is not automatically listed merely because the injector delivers an FDA-approved medicine. See FDA, Approved Drug Products with Therapeutic Equivalence Evaluations.

Consequently:

• The patent does not by itself create a 30-month stay against an ANDA.
• It does not independently block approval of a generic drug.
• It does not establish exclusivity for insulin, semaglutide, liraglutide, or another active ingredient.
• It may still create a device-supply or combination-product risk if a generic or follow-on sponsor uses the patented injector.

For combination products, the commercial impact depends on whether the drug sponsor supplies the device, licenses it from the patent owner, purchases it from a contract manufacturer, or permits the ANDA or NDA applicant to select an alternative injector.

Are there Paragraph IV challenges to Patent 10,376,652?

A Paragraph IV certification applies to a patent listed in the Orange Book for an approved drug product. A standalone injector patent generally is not subject to a Paragraph IV challenge unless it has been properly submitted and listed against a relevant drug product.

The more likely challenge routes for this patent are:

• Inter partes review at the Patent Trial and Appeal Board.
• Post-grant review, if statutory timing requirements are met.
• Ex parte reexamination.
• Declaratory-judgment litigation.
• Infringement litigation against an injector manufacturer or drug sponsor.

A Paragraph IV notice against a drug patent would not, by itself, resolve infringement of an unlisted device patent. The parties would need to address the device patent through separate litigation or licensing arrangements.

Which companies compete with this patent architecture?

The relevant competitive field includes manufacturers of mechanical pen injectors and drug sponsors that commercialize prefilled or cartridge-based pens.

Company or platform	Relevant design category	Potential overlap area
Novo Nordisk	Spring-driven and disposable pen systems	Dose selector, dose display, piston-rod drive
Sanofi	SoloStar and related pen platforms	Rotating selector, dose display, spring or clutch architecture
Eli Lilly	KwikPen and related systems	Dose setting, dose display, piston-rod delivery
Ypsomed	UnoPen and other pen platforms	Multi-part drive, dose selector, cartridge delivery
SHL Medical	Disposable and reusable injector platforms	Drive mechanisms, user actuation, dose display
Owen Mumford	Auto-injector and pen systems	Mechanical actuation and cartridge delivery
Nemera	Pen and drug-delivery platforms	Device architecture and contract manufacturing
DCA Design and other engineering suppliers	Pen-injector development	Mechanical arrangements that may be separately patented

The presence of a torsion spring and rotating dose selector is not sufficient to establish infringement. The critical comparison is the detailed release and clutch architecture, including whether a driver moves axially into a housing-disconnected position.

How strong is the patent estate?

The patent has moderate potential strength at the combination level and narrower strength for its dependent mechanical claims.

Strength factors

• Claim 1 combines multiple structural and functional limitations.
• The axial release arrangement can distinguish the patent from radial-trigger designs.
• Claims 7 through 11 create additional positions around the drive-member architecture.
• Claims 12 and 13 address a specific mechanical display and piston-rod configuration.
• Claims 14 and 15 cover ratcheting and rotating-driver implementations.

Vulnerability factors

• The claims combine known pen-injector components, creating possible obviousness arguments under 35 U.S.C. § 103.
• Terms such as "push button like," "multi-component driver," and "disconnected from the housing" may require claim construction.
• A product may avoid infringement by changing only one required architectural relationship.
• The device claims do not protect the drug, cartridge formulation, needle, or manufacturing process.
• Patent value depends heavily on prosecution history and the scope of amendments made before allowance.

The strongest practical protection is likely the combination of the torsion spring, proximal push button, axial driver movement, housing disengagement, and dose display. Individual features such as a ratchet, threaded piston rod, or rotating dose barrel are more likely to appear in competing portfolios.

What manufacturing and licensing risks exist?

Manufacturing risk is concentrated in the mechanical drive module. A contract manufacturer producing a pen with the following characteristics should conduct a claim-by-claim freedom-to-operate review:

• Rotating dose selector.
• Torsion spring.
• Proximal push button.
• Axially movable clutch or driver.
• Rotating piston rod.
• Helical dose-indicator barrel.
• Ratchet connection between selector and driver.

A license may be commercially preferable where the patented architecture is embedded in an established pen platform. Redesign risk is higher when the device is already validated under combination-product requirements, because changing the drive mechanism can trigger new design verification, human-factors work, stability studies, container-closure assessments, and regulatory submissions.

The patent does not itself establish ownership of a complete pen platform. Related continuation, divisional, foreign, and earlier family patents may carry broader or different claims. A complete freedom-to-operate opinion therefore requires review of the entire patent family, prosecution history, terminal disclaimers, and live claims in relevant jurisdictions.

What patent litigation affects this patent?

The supplied claim text does not identify an infringement action, settlement, inter partes review, or Paragraph IV case involving United States Patent 10,376,652. Patent litigation status must be determined from the USPTO Patent Center record, PTAB proceedings, PACER, and relevant district-court dockets.

The principal litigation issues would likely be:

1. Whether the accused device has a multi-component driver.
2. Whether one driver part moves into a position disconnected from the housing.
3. Whether the release member is axially arranged and located at the proximal end.
4. Whether the drive member occupies distinct dose-setting and dose-injection positions.
5. Whether the product's display uses a substantially helical numeral arrangement.
6. Whether prosecution amendments limit the scope of equivalents.

What generic-entry scenarios exist?

Because the patent protects an injector rather than a drug substance, generic-entry exposure is indirect.

Scenario	Patent impact
Generic uses its own syringe or pen	Lower direct exposure if the alternative device avoids the claims
Generic licenses the reference pen	Licensing cost and supply dependence
Generic uses a contract-manufactured equivalent pen	Direct infringement and indemnity risk
Generic launches a vial-and-syringe presentation	Device patent may have little or no relevance
Generic uses an autoinjector with electronic drive	Potential design-around, subject to claim construction
Biosimilar uses a prefilled pen	Combination-product device review and possible patent clearance
Drug sponsor changes pen supplier	New device architecture may avoid this patent but create other patent risks

A biosimilar or generic sponsor must separate drug patents from device patents. A non-infringing active ingredient route does not eliminate risk if the sponsor adopts a patented delivery system.

Key Takeaways

• United States Patent 10,376,652 is a mechanical injection-device patent, not a conventional active-ingredient patent.
• Claim 1 requires a rotatable dose selector, torsion spring, proximal push button, dose display, and multi-component driver with axial housing disengagement.
• Claims 7 through 11 add a two-position rotating drive member, rotational blocking during dose setting, spring bias, and axial actuation.
• Claims 12 through 14 cover a helical dose-indicator barrel, longitudinal piston-rod drive track, and ratchet connection.
• The patent does not independently create drug exclusivity or a Paragraph IV barrier unless properly listed against a specific approved drug product.
• The main design-around paths involve changing the spring type, trigger position, clutch direction, driver construction, dose display, or piston-rod mechanism.
• Commercial risk is highest for pen manufacturers and drug sponsors using a torsion-spring, rotating-selector platform with an axially disengaging clutch.
• The patent's enforceability and ultimate term depend on its prosecution history, continuity data, patent-term adjustment, and any terminal disclaimer.

FAQs

Does Patent 10,376,652 cover insulin?

No. The claims cover the injection-device mechanism. They do not claim insulin, an insulin formulation, or a particular insulin indication.

Does using a different drug avoid infringement?

Not necessarily. Infringement depends primarily on the device structure. A different drug may still be delivered through a device that practices the claimed mechanical combination.

Can an electronic injector infringe this patent?

Possibly, but the analysis depends on whether the electronic injector has the claimed torsion spring, axial release member, multi-component driver, and related mechanical features. A fully motor-driven device may avoid several limitations.

Does the patent cover a needle?

Claim 6 refers to delivery through an injection needle, but the patent does not claim a particular needle design, gauge, cannula material, or needle-safety system.

Is a license required to sell a generic drug using a patented pen?

Not automatically. The sponsor must determine whether its specific device practices the live claims. If it does, the sponsor may need a license, a redesign, or a litigation strategy.

References

1. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. U.S. Department of Health and Human Services.

2. Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005).

3. United States Patent No. 10,376,652. (2019). Injection device. United States Patent and Trademark Office.

4. United States Code, Title 35, §§ 102, 103, 112, and 154.

5. United States Patent and Trademark Office. (2024). Patent Center. U.S. Department of Commerce.

Drugs Protected by US Patent 10,376,652

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	10,376,652		Y		Y
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-004	Oct 6, 2022		RX	Yes	Yes	10,376,652		Y		Y
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-002	Apr 9, 2019		RX	Yes	Yes	10,376,652		Y		Y
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-003	Mar 28, 2022		RX	Yes	Yes	10,376,652		Y		Y

Foreign Priority and PCT Information for Patent: 10,376,652

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Denmark	2005 00113	Jan 21, 2005

International Family Members for US Patent 10,376,652

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2006207744
Brazil	PI0606607
Canada	2594764
China	100571805
China	101107031