Details for Patent: 9,616,180

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Which drugs does patent 9,616,180 protect, and when does it expire?

Patent 9,616,180 protects OZEMPIC and is included in one NDA.

This patent has fourteen patent family members in eleven countries.

Summary for Patent: 9,616,180

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:	US14/797,350
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,616,180
Patent Claim Types: see list of patent claims	Use; Device;

US Patent 9,616,180: Injection Device Claims, Patent Scope, Exclusivity and Competitive Landscape

US Patent 9,616,180 protects a mechanically powered handheld injection device rather than a drug substance. Its core combination is a rotatable dose-setting member, a torsion-spring power reservoir, a proximal push-button release, and a multi-component driver that changes axial position to switch between dose-setting and dose-injection modes. The broadest enforceable scope is concentrated in claim 1. Claims 7 through 14 add a more specific drive architecture, dose display, piston-rod configuration and ratchet connection.[1]

The patent does not claim insulin, GLP-1 agonists, biologics, a drug formulation or a therapeutic method. It therefore does not create standalone Orange Book exclusivity for a pharmaceutical active ingredient. Commercial risk depends on whether a competing pen uses the claimed mechanical architecture or a substantially equivalent arrangement.

What does US Patent 9,616,180 protect?

The patent protects a handheld injection-device architecture with five central elements:

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, including a piston-rod-driving part and a second part that disconnects from the housing.
5. Axial movement of the driver component to release the stored spring energy.

Claim 1 is an apparatus claim. It requires the elements to be present in the same handheld injection device. A product that has only a torsion spring, or only a push-button release, does not necessarily fall within the claim.

Claim 1: the principal combination

Claim 1 requires a rotatable dose-setting member positioned around the longitudinal axis of the device housing. The user rotates that member to establish the dose. The power reservoir is a torsion spring, distinguishing the claimed device from systems powered by a compression spring, gas cartridge, motor or manually advanced piston rod.

The claim also requires a release member positioned at the most proximal end of the device. This limitation matters because the release control is not merely any actuator. It must be a push-button-like member at the end opposite the needle-mounting end.

The multi-component driver is the principal mechanical limitation. At least one driver part drives the piston rod, while another driver part moves axially into a position disconnected from the housing. That disconnection releases the energy stored in the torsion spring.

The claim therefore combines dose selection, energy storage, release control and drive disengagement into one structural system.

“Comprising” and combination scope

Claim 1 uses the open-ended term “comprising.” A competing pen can contain additional components and still infringe if it includes every claimed element. Extra electronics, dose sensors, a secondary clutch or a different housing configuration would not by themselves avoid the claim.

The claim is narrower than a general claim to a spring-powered injection pen because it requires the specified multi-component driver and axial release mechanism. A competing device may avoid literal infringement by using a single-piece driver, radial disengagement, a motor-controlled clutch or a non-torsional energy source.

How do claims 2 through 6 narrow the patent scope?

Claim	Added limitation	Practical significance
2	Spring power depends on dose-setting-member rotation angle	Links dose selection directly to torsion-spring charging
3	Release member is operatively connected to dose-setting member	Requires functional interaction between the controls
4	Key/keyway connection during dose setting	Adds a positive mechanical coupling
5	Key/keyway connection releases in dose-injecting position	Defines a mode-dependent decoupling function
6	Spring energy expels medicine through a needle	Connects the drive system to actual injection

Claim 2 narrows the device by requiring the amount of stored power to vary with rotation of the dose-setting member. A device in which the torsion spring is preloaded to a constant level and a separate mechanism meters delivery may fall outside this limitation, although it could still implicate claim 1.

Claims 3 through 5 focus on the relationship between dose setting and release. The key/keyway connection is particularly important. During dose setting, the release member and dose-setting member must engage through that connection. During dose injection, they must disengage.

Claim 6 links the mechanical system to delivery of a set dose through an injection needle. It does not require a particular drug, concentration or container size.

What additional drive-system features are protected by claims 7 through 14?

Claims 7 through 14 define a more detailed implementation of the claim 1 architecture.

Claims 7 through 11: axial drive-member switching

Claim 7 requires a rotatable drive member that engages a drive track associated with the piston rod. The drive member occupies:

• A first axial position when the device is in dose-setting mode.
• A second axial position when the device is in dose-injection mode.

The drive member releases the accumulated spring energy in the second position.

Claim 8 requires the drive member to rotate the piston rod during energy release. Claim 9 requires the drive member to be prevented from rotating in the first axial position. These limitations create a mechanical clutch or lock between setting and injection modes.

Claim 10 adds a resilient member, such as a linear spring, that biases the drive member toward the dose-setting member. Claim 11 requires axial movement of the dose-setting member to move the drive member between the two positions.

Together, claims 7 through 11 cover a mode-switching mechanism in which axial displacement, rather than simple rotational engagement, determines whether the piston rod can advance.

Claims 12 through 14: display, piston rod and ratchet

Claim 12 covers a rotating dose display with a dose-indicator barrel. The numerals follow a substantially helical path on the barrel’s outer surface, and the barrel rotates through at least one revolution.

Claim 13 requires a piston rod with a threaded outer surface and a drive track arranged longitudinally along that surface. This claim addresses a piston rod that combines screw advancement with longitudinal drive engagement.

Claim 14 adds a ratchet between the drive member and dose-setting member. The ratchet can control dose increments, prevent reverse motion, generate audible feedback or limit rotation during dose selection.

These claims are commercially narrower than claim 1 but may be more useful against a product with a visibly similar dose dial, clutch and ratcheted drive mechanism.

How strong is the patent estate for US 9,616,180?

The strength of the asserted claim set depends on whether the patent’s earliest priority date, prosecution history and family claims support the combination now recited. On the supplied claims alone, the estate has a mixed profile.

Strengths

The principal strengths are:

• The claims cover a complete operating architecture rather than an isolated component.
• The proximal push-button limitation is concrete and readily testable.
• Claims 7 through 11 define a specific axial clutch or drive-switching arrangement.
• The claims cover both the energy-storage system and the transition from dose setting to dose injection.
• The open-ended “comprising” language permits additional device components.

Vulnerabilities

The main vulnerabilities are:

• Torsion-spring injection pens were known before the likely filing period for this technology.
• Dose-setting members, ratchets, threaded piston rods and dose barrels were established pen components.
• The novelty and obviousness inquiry will focus on the particular combination of axial driver movement, housing disengagement and proximal release.
• Terms such as “push button like,” “operatively connected,” “adapted to” and “multi-component driver” may require construction in litigation.
• Claim 1 may face an obviousness challenge if prior art combines a torsion-spring pen with an axial clutch or end-button release.

A validity assessment should separate anticipation from obviousness. A single reference must disclose every limitation for anticipation. For obviousness, a challenger may combine references or rely on common technical knowledge, subject to motivation, predictability and objective indicia under 35 U.S.C. §103.[2]

What is the Orange Book status of US Patent 9,616,180?

US Patent 9,616,180 is a device patent based on the claims supplied. It does not claim an active pharmaceutical ingredient or a drug formulation. On that basis:

Regulatory issue	Relevance
Orange Book drug-substance listing	Not supported by the device claims
Orange Book formulation listing	Not supported by the device claims
Paragraph IV certification	Generally directed to listed drug patents, not a standalone device patent
505(b)(2) exclusivity	Not created by the device patent alone
Biosimilar litigation under the BPCIA	Not directly implicated
Medical-device clearance or approval	May be relevant to the marketed injector, separate from patent rights

FDA device regulation and pharmaceutical patent listing are separate systems. A pen used to deliver an approved drug may be reviewed as part of a combination product, but that regulatory status does not convert the injector patent into an Orange Book drug patent.[3]

When does US Patent 9,616,180 lose exclusivity?

The patent’s enforceable term depends on its earliest effective nonprovisional filing or priority date, terminal disclaimers, patent-term adjustment and any applicable patent-term extension. The issue date alone does not determine expiration.[4]

For a typical utility patent governed by the modern 20-year term, the base term is measured from the relevant earliest filing date, subject to statutory adjustments. Patent-term adjustment may extend the term for certain USPTO delays. A terminal disclaimer can shorten the enforceable term where the patent is tied to another patent.

The following events can alter practical exclusivity:

• Patent expiration.
• Disclaimer or expiration of a related patent.
• Post-grant cancellation or reexamination.
• Invalidity ruling in district court.
• A settlement restricting assertion or permitting a defined launch.
• Noninfringement based on a redesigned drive system.

Patent expiration also does not eliminate regulatory requirements for a competing injector or combination product.

What generic entry risks exist?

For a drug product delivered through a pen, generic or follow-on entry creates two separate risks.

Drug-product risk

The active ingredient, formulation and method-of-use patents may be listed or asserted separately. Those patents control the pharmaceutical exclusivity analysis.

Device risk

A competing manufacturer may need to use a pen with a torsion-spring drive, dose dial, threaded piston rod and end button. If so, the competitor must assess infringement of claim 1 and the narrower drive claims.

Potential design-around strategies include:

• Replacing the torsion spring with a compression spring or motor.
• Using a single-piece drive member.
• Releasing the drive through radial movement instead of axial movement.
• Placing the release actuator on the side rather than at the proximal end.
• Separating dose setting from spring charging.
• Eliminating the key/keyway connection.
• Preventing rotation through a different clutch or electromagnetic brake.
• Using a non-helical electronic display.
• Replacing the longitudinal piston-rod drive track with a different transmission interface.

A design that avoids claims 7 through 14 may still require analysis under claim 1. Conversely, a design that resembles the commercial product may avoid infringement if it lacks the claimed driver-disconnection sequence.

Which companies are potential competitors in this technology?

The relevant competitive field includes manufacturers of disposable, reusable and cartridge-based injection pens, including companies developing delivery systems for insulin, GLP-1 drugs, growth hormone and other injectable therapies.

The principal competitive categories are:

Category	Typical technical approach	Relevance to the patent
Mechanical disposable pens	Dial, torsion or compression spring, threaded piston rod	Highest potential overlap
Reusable cartridge pens	Replaceable cartridge and reusable drive mechanism	Depends on driver and release structure
Autoinjectors	Automatic needle insertion and dose delivery	May overlap only if the claimed pen architecture is used
Electronic pens	Motor, sensor and electronic dose control	Often stronger design-around position
Wearable injectors	Pump or motor-driven delivery	Usually structurally distinct
Syringe-based systems	Manual plunger actuation	Generally outside the claimed architecture

The patent’s commercial relevance is greatest where a product uses a mechanical dial-driven pen with an end-mounted actuation button and a torsion-powered piston drive. It is less relevant to motorized pumps, wearable injectors and conventional manual syringes.

What patent litigation or Paragraph IV challenges affect this patent?

The supplied information does not establish a district-court case, PTAB proceeding, Paragraph IV certification, license, settlement or FDA listing associated with US Patent 9,616,180. The claims themselves do not identify a drug product, NDA, ANDA, biosimilar application or commercial license.

A conventional Paragraph IV dispute would ordinarily concern a listed drug patent and an ANDA applicant’s certification under the Hatch-Waxman framework.[5] A standalone injection-device patent is more likely to be enforced through a conventional patent-infringement action involving the device manufacturer, combination-product sponsor or component supplier.

Potential litigation issues would include:

• Construction of “multi-component driver.”
• Meaning of “disconnected from the housing.”
• Whether axial movement is required for the same driver component that releases the spring.
• Whether a push button must be located at the absolute proximal end.
• Whether “operatively connected” requires direct mechanical engagement.
• Whether a substitute clutch is equivalent to the claimed axial disengagement mechanism.
• Whether the asserted product has every element of claim 1 in a single device.

What manufacturing and IP barriers does the patent create?

The patent can create manufacturing friction even where a competitor believes its device is outside the literal claims. The most sensitive components are the drive member, housing interface, clutch surfaces, ratchet, torsion spring and threaded piston rod.

Tooling and validation increase switching costs. A redesigned device may require new injection molds, spring calibration, dose-accuracy testing, human-factors validation, container-closure testing and combination-product submissions. Those costs do not expand the legal scope of the patent, but they can delay commercial entry.

A freedom-to-operate review should map each component against claims 1, 7, 8, 9, 10, 11, 12, 13 and 14. Claims 2 through 6 are more dependent on the exact control relationship and delivery sequence.

How does this patent compare with conventional injection-pen patents?

US 9,616,180 is narrower than a broad patent covering any dose-setting injection pen, but it is more technically integrated. Its value lies in the interaction between the dose dial, torsion spring, axial driver movement and proximal release.

Patent type	Typical scope	Relative relevance
Broad pen-device patent	Any manually set and delivered dose	Potentially broader, less architecture-specific
Spring-drive patent	Energy storage and piston actuation	Overlaps the power reservoir
Clutch patent	Selective engagement of drive components	Overlaps claims 7 through 11
Display patent	Dose barrel and numeral arrangement	Overlaps claim 12
Piston-rod patent	Thread and drive-track geometry	Overlaps claim 13
Ratchet patent	Incremental dose setting	Overlaps claim 14
US 9,616,180	Integrated pen architecture	Combination-focused scope

Key Takeaways

• US 9,616,180 is a mechanical injection-device patent, not a drug-substance patent.
• Claim 1 is the principal claim and requires a torsion spring, proximal push-button release and multi-component axial driver.
• Claims 7 through 11 define the most important clutch and drive-switching architecture.
• Claims 12 through 14 cover the dose display, piston-rod drive track and ratchet connection.
• The patent does not independently create Orange Book or Paragraph IV exclusivity for a drug.
• The strongest design-around options involve changing the energy source, driver architecture, release direction or dose-setting relationship.
• Litigation risk depends more on the structural architecture of the marketed pen than on the therapeutic product delivered through it.
• Exact expiration, licensing, litigation and family status require review of the official patent record, prosecution history and related family members.[1]

FAQs About US Patent 9,616,180

Does US 9,616,180 cover insulin?

No. The claims cover an injection-device mechanism. They do not claim insulin, an insulin formulation or a specific therapeutic use.

Can an electronic injection pen infringe US 9,616,180?

It can, but only if it contains all required claim elements. An electronic controller does not automatically avoid infringement if the device still uses the claimed torsion-spring and axial-driver architecture.

Does a competing pen need to avoid every dependent claim?

No. A product must avoid at least one limitation of each asserted claim. Avoiding claims 7 through 14 does not eliminate risk under claim 1.

Is a proximal release button required?

Yes, for claim 1. The release member must be a push-button-like member located at the most proximal portion of the device, opposite the needle end.

Can a compression-spring pen fall within the patent?

A compression-spring device would not satisfy the torsion-spring limitation in claim 1 as written. It could still require review against other patents in the same family or competitive patent estate.

References

1. United States Patent No. 9,616,180, claims 1-14. U.S. Patent and Trademark Office.
2. 35 U.S.C. §§102-103 (2018).
3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations.
4. 35 U.S.C. §§154, 156 (2018).
5. 21 U.S.C. §355(j) (2018).

Drugs Protected by US Patent 9,616,180

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	9,616,180		Y		Y
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-004	Oct 6, 2022		RX	Yes	Yes	9,616,180		Y		Y
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-002	Apr 9, 2019		RX	Yes	Yes	9,616,180		Y		Y
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-003	Mar 28, 2022		RX	Yes	Yes	9,616,180		Y		Y

Foreign Priority and PCT Information for Patent: 9,616,180

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

International Family Members for US Patent 9,616,180

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