Details for Patent: 9,775,953

Which drugs does patent 9,775,953 protect, and when does it expire?

Patent 9,775,953 protects OZEMPIC and is included in one NDA.

This patent has ten patent family members in nine countries.

Summary for Patent: 9,775,953

Title:	Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left
Abstract:	A mechanism for preventing setting of a dose, which exceeds the amount of a medicament in a reservoir in an injection device. The device can contain a threaded piston rod, a limiter and a driver. The three elements can be arranged such that during dose setting, the limiter is moved towards an end-of-content position, wherein dose setting is limited. The invention contains an accumulative and a non-accumulative embodiment. The invention further relates to a mechanism for preventing ejection of a dose exceeding the set dose.
Inventor(s):	Christian Peter Enggaard, Claus Schmidt Moller, Tom Hede Markussen
Assignee:	Novo Nordisk AS
Application Number:	US14/550,085
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,775,953
Patent Claim Types: see list of patent claims	Use; Device;

US Patent 9,775,953: Claim Scope, Patent Strength, Exclusivity, and Competitive Landscape

US 9,775,953 protects a dose-limiting architecture for injection devices. Its core concept is mechanical prevention of dose selection beyond the medicament remaining in a reservoir. The patent does not claim insulin, GLP-1 drugs, biologics, formulations, or a therapeutic method. It claims device mechanics involving a piston rod, driver, limiter, dose-setting member, and, in narrower claims, ratchets, teeth, threaded interfaces, and spring-assisted ejection.

The broadest protection is claim 1. Claims 2 through 25 narrow that concept through alternative limiter configurations and additional dose-setting or ejection features. The patent is therefore most relevant to prefilled pens, cartridges, syringes, and other injection systems in which the mechanism mechanically tracks remaining reservoir volume.

What does US 9,775,953 claim?

Claim 1 requires all of the following elements:

Required element	Technical function
Piston rod with a threaded outer surface	Converts rotational movement into longitudinal displacement
Housing with a threaded inner surface	Receives and guides the piston rod
Dose-setting member	Allows the operator to select a dose
Driver coupled to the dose-setting member	Rotates during dose setting
Limiter	Moves toward a stopping position as the dose is set
Coupling among limiter, driver, and piston rod	Links dose-setting rotation to limiter movement
Stopping function	Prevents selection of a dose exceeding the medicament remaining in the reservoir

The claim is functional and architectural. It does not require a particular drug, cartridge volume, injection needle, dose unit, or electronic control system. It also does not require a specific thread pitch, material, spring type, tooth geometry, or commercial pen design unless those limitations appear in a dependent claim.

The critical limitation is the relationship between the limiter and the other rotating components. The limiter must move toward a stopping position because of relative rotation between the driver and piston rod during dose setting. A device that merely displays the remaining dose electronically, without the claimed mechanical movement and stopping function, would generally fall outside claim 1.

How broad is claim 1 of US 9,775,953?

Claim 1 has meaningful breadth because it describes the operating relationship without specifying one mechanical implementation. The limiter can be implemented through different thread arrangements, engaging surfaces, or tooth structures reflected in the dependent claims.

Its principal boundaries are:

1. The device must prevent setting an excessive dose, not merely prevent delivery after an excessive dose has been selected.
2. The dose must be set by rotating a dose-setting member.
3. The mechanism must include the claimed piston rod, housing, driver, and limiter architecture.
4. Limiter movement must result from relative rotation between the driver and piston rod.
5. The limiter must move to a stopping position associated with the amount remaining in the reservoir.

The claim is less likely to reach:

• A purely electronic dose-limit system.
• A system that permits an excessive dose to be dialed but blocks injection only during delivery.
• A device using an axial stop that does not move in response to the claimed relative rotation.
• A device with no threaded piston rod and housing interface.
• A reusable electronic injector in which dose limitation is controlled solely by software.

In an infringement analysis, the relationship between the limiter and driver would likely be more important than the presence of a generic dose-stop feature.

What dependent claim categories are protected?

The dependent claims create several alternative technical branches rather than one cumulative design.

Threaded limiter arrangements

Claims 3 and 6 protect two different arrangements:

Claims	Limiter configuration
3, 12-15, 20-23	Limiter has an external thread, is rotationally retained relative to the piston rod, and engages an internal thread in the driver
6, 16, 18, 23	Limiter has an internal thread engaging the piston rod's external thread, while the driver is rotationally retained relative to the limiter

This drafting structure is important. A competitor may avoid one specific thread arrangement but still encounter the broader claim 1 or the alternative arrangement in claim 6.

Engaging surfaces and teeth

Claims 4, 5, 7, and 12 through 18 cover mechanical engagement variations:

• A first limiter engaging surface corresponding to a driver surface.
• A first limiter engaging surface corresponding to a piston-rod surface.
• Plurality of limiter teeth engaging housing or driver teeth.
• Teeth that engage when the limiter reaches the stopping position.

The teeth claims may be particularly relevant to designs using a discrete, click-based maximum-dose stop rather than a continuously threaded stop.

Piston-rod locking

Claim 2 requires a locking structure that locks the piston rod against rotation in at least one direction relative to the housing. Claims 17, 19, and 24 incorporate that feature with additional limiter or ratchet limitations.

The locking limitation may distinguish ordinary rotating screw mechanisms from devices in which the piston rod is selectively prevented from back-driving during dose setting or injection.

Ratchet mechanisms

Claims 8 through 9 and 19 through 25 cover a ratchet mechanism between the driver and housing. Claim 9 specifies first and second ratchet parts, with one part coupled to the driver and the other capable of being locked relative to the housing through a locking structure.

The ratchet provisions may address audible or tactile dose increments, one-way rotation, backlash control, and prevention of reverse movement.

Spring-assisted ejection

Claims 10, 11, and 25 add an ejection-assisting system. Claim 11 specifies a syringe device with a spring strained when the dose-setting member rotates during dose setting.

This branch is narrower than claim 1 because it requires both the ratchet-related structure and a spring-based ejection-assist system through the dependency chain.

How many independent claims does US 9,775,953 have?

Based on the supplied claim set, the patent has one independent claim: claim 1.

All other claims depend directly or indirectly on claim 1. Claims 11 and 25 do not create independent protection because they depend on earlier claims. Claim 11's reference to a syringe device narrows the scope; it does not establish a separate independent syringe claim.

This claim structure concentrates enforcement value in claim 1. The dependent claims provide fallback positions if claim 1 is challenged for anticipation, obviousness, indefiniteness, or lack of written description.

What products and technologies could be affected?

The patent is relevant to injection systems with:

• A manually rotated dose dial.
• A threaded piston rod.
• A threaded housing or nut.
• A rotating driver.
• A mechanical end-of-cartridge or remaining-dose limiter.
• Optional ratchet-based dose increments.
• Optional spring assistance during injection.

Potentially relevant product categories include insulin pens, GLP-1 injector pens, cartridge-based biologic injectors, reusable pen injectors, disposable prefilled pens, and mechanical autoinjector platforms that use a rotating dose-setting mechanism.

The patent is not directed to a particular active pharmaceutical ingredient. A single device design could therefore be used with insulin, semaglutide, tirzepatide, growth hormone, or another injectable drug without changing the claim analysis.

What patent landscape surrounds the claimed technology?

The surrounding patent landscape generally divides into six technical groups:

Technology group	Typical protection
Dose-limit systems	Preventing selection or delivery beyond cartridge content
Drive mechanisms	Piston rods, lead screws, nuts, drivers, and clutch systems
Dose-setting mechanisms	Dose dials, sleeves, clickers, and rotational interfaces
Cartridge-end mechanisms	Detecting or mechanically limiting the final available dose
Injection-assist systems	Springs, stored energy, and automated or assisted delivery
Safety and feedback systems	Lockouts, audible clicks, tactile feedback, and dose displays

US 9,775,953 is strongest where these features are integrated into one mechanical architecture. A competing device may avoid infringement by changing the location of the limiter, eliminating the driver-piston-rod relative rotation required by claim 1, or replacing the mechanical limiter with an electronic or delivery-stage control.

The relevant prior-art field includes pen injector patents assigned to Novo Nordisk, Eli Lilly, Sanofi, Ypsomed, SHL Medical, Owen Mumford, Haselmeier, and other injection-device manufacturers. Earlier patents commonly disclose threaded piston rods, dose dials, one-way ratchets, and end-of-cartridge stops. The potentially distinguishing feature here is the claimed movement of a limiter toward a stopping position as a consequence of relative rotation between the driver and piston rod during dose setting.

When does US 9,775,953 lose exclusivity?

Patent term is governed by 35 U.S.C. § 154 and generally runs for 20 years from the earliest effective nonprovisional U.S. filing date, subject to patent-term adjustment, patent-term extension, terminal disclaimers, and other statutory adjustments.[2]

The grant date alone does not establish the expiration date. The claims supplied do not identify the priority chain, filing history, terminal disclaimer status, or patent-term adjustment. Those data control the legally operative expiration date. The relevant expiration date should be taken from the USPTO Patent Center record and the patent's continuity data, rather than calculated from the September 2017 grant date.[1]

A device patent normally does not create FDA drug exclusivity. Its commercial effect can continue only while an asserted claim remains enforceable and covers a marketed injector or delivery system.

What is the Orange Book status of US 9,775,953?

US 9,775,953 is a device-mechanism patent, not a patent claiming an active pharmaceutical ingredient or drug formulation. It would not ordinarily be listed in the FDA Orange Book as a drug patent unless the patent were properly associated with an approved drug product and met FDA listing requirements under 21 C.F.R. § 314.53.[3]

The patent therefore does not independently block an ANDA through a conventional Orange Book Paragraph IV certification. A generic applicant could still face infringement exposure if the proposed product uses a patented injector, pen, or delivery system, but that exposure would arise under ordinary patent litigation principles rather than automatically through Orange Book listing.

Are Paragraph IV challenges relevant?

Paragraph IV is generally not the primary challenge pathway for this patent. Paragraph IV certifications concern patents listed for approved drug products. A mechanical injector patent is more likely to be asserted in:

• District court litigation against a manufacturer.
• A licensing negotiation concerning a pen platform.
• A contract-manufacturing dispute.
• A product clearance or freedom-to-operate analysis.
• An inter partes review or post-grant validity proceeding.

If the patented mechanism is supplied with a drug product and the patent is listed in the Orange Book, Paragraph IV could become relevant. The claim language alone does not establish such a listing.

Does the patent create biosimilar risk?

No direct biosimilar risk arises from the claims. Biosimilar litigation concerns biologic products and patents covering the biologic molecule, formulation, manufacturing process, or delivery system. US 9,775,953 does not claim a biologic, therapeutic composition, or manufacturing process.

It can create device-related risk for a biosimilar sponsor that selects a prefilled pen or cartridge system using the claimed mechanism. That risk would concern the delivery device, not biosimilarity of the active ingredient.

How strong is the patent estate?

The individual patent has moderate potential strength in a mechanical injector freedom-to-operate analysis.

Factor	Assessment
Claim 1 breadth	Broad functional architecture, but dependent on several structural relationships
Technical specificity	Moderate; requires particular rotational and threaded relationships
Design-around difficulty	Moderate; alternatives exist through electronic control or different limiter placement
Product relevance	High for mechanical dose-limiting pens
Drug exclusivity	None directly
Orange Book significance	Usually low
Biosimilar significance	Indirect and device-specific
Litigation leverage	Depends on family members, surviving claims, and marketed device mapping
Manufacturing barrier	Moderate if the same drive and limiter geometry is used

The most valuable commercial position would usually be the patent family, not the single grant. Continuation, divisional, foreign, and related U.S. patents may claim alternative arrangements omitted from this particular claim set.

What generic or competitor launch scenarios exist?

Scenario 1: Same mechanical architecture

A competitor using a threaded piston rod, rotating driver, and mechanically advancing limiter faces the highest risk. Claim charts should focus on whether dose-setting rotation produces relative rotation between the driver and piston rod and whether the limiter advances toward a dose stop.

Scenario 2: Delivery-stage blocking

A system that permits the operator to set a dose above the remaining volume but blocks delivery at the end of the cartridge may avoid the core "preventing setting" limitation, depending on its exact operation.

Scenario 3: Electronic dose limitation

A system using sensors, software, or electronic motor control may avoid the mechanical limitations, although other patents could apply.

Scenario 4: Different limiter coupling

A competitor may use a limiter coupled to the dose dial but not to the piston rod, or may advance the limiter through axial translation rather than relative rotation. These changes could reduce literal infringement risk but require analysis under the doctrine of equivalents.

Scenario 5: Licensed platform

A manufacturer could avoid launch disruption through a license to the relevant patent family or by adopting a third-party injector platform with documented freedom to operate.

What patent litigation and settlement issues should be reviewed?

The supplied claims do not establish a litigation history, settlement agreement, or licensing transaction. A complete commercial assessment should distinguish:

• Litigation involving US 9,775,953 itself.
• Litigation involving continuation or divisional patents.
• Patent families covering the same commercial injector.
• Settlements that grant field-of-use rights.
• Cross-licenses between drug companies and injector manufacturers.
• Inter partes review or ex parte reexamination outcomes.

A favorable result against one family member may not eliminate risk from a continuation with different claims. Conversely, a settlement covering a device platform may resolve practical launch risk even if this patent remains formally unexpired.

Key Takeaways

• US 9,775,953 is a mechanical injection-device patent, not a drug or biologic patent.
• Claim 1 is the principal protection and covers a limiter that advances toward a stopping position during dose setting.
• The required architecture includes a threaded piston rod, threaded housing, rotating dose-setting member, driver, and limiter.
• Claims 3 and 6 protect alternative threaded limiter arrangements.
• Claims 5, 8, 9, 10, and 11 add teeth, ratchets, and spring-assisted ejection features.
• The patent does not inherently create Orange Book, Paragraph IV, or biosimilar exclusivity.
• Commercial risk is highest for mechanically dose-limited pens using the same driver-piston-rod relationships.
• Exact patent expiration requires review of the continuity chain, patent-term adjustment, terminal disclaimers, and USPTO legal-status data.
• The broader patent family and related continuation claims are likely more important than this grant standing alone.

FAQs

Can US 9,775,953 block a generic drug launch?

Not automatically. It can create patent risk if the generic product uses an injector containing the claimed mechanical architecture. The risk is separate from ordinary drug-substance or formulation patents.

Does the patent cover a prefilled syringe?

Only if the syringe incorporates the claimed mechanism. Claim 11 narrows one embodiment to a syringe device with a spring-based ejection-assist system, but the patent does not cover all prefilled syringes.

Can a dose limiter operate electronically and avoid this patent?

Potentially. A purely electronic limiter may avoid the claimed threaded piston rod, driver, limiter, and relative-rotation requirements. The full design must still be reviewed against the literal claim language and equivalents.

Are GLP-1 injector pens automatically affected?

No. The active ingredient is irrelevant to the claim. A GLP-1 pen is implicated only if its delivery mechanism practices the claimed device arrangement.

Is a license required to sell a device covered by the patent?

A license may be required if the patent is unexpired, enforceable, and the device falls within at least one valid claim. The commercial answer depends on the complete patent family, territorial rights, ownership, assignments, and any settlement or license terms.

References

1. United States Patent and Trademark Office. (n.d.). Patent Center. https://patentcenter.uspto.gov/
2. United States Code. (2023). 35 U.S.C. § 154: Contents and term of patent; provisional rights. https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title35-section154
3. U.S. Food and Drug Administration. (2024). 21 C.F.R. § 314.53: Submission of patent information. Electronic Code of Federal Regulations. https://www.ecfr.gov/current/title-21/section-314.53
4. United States Patent and Trademark Office. (2023). Manual of Patent Examining Procedure, Chapter 2100: Patentability. https://www.uspto.gov/web/offices/pac/mpep/mpep-2100.html

Drugs Protected by US Patent 9,775,953

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

Foreign Priority and PCT Information for Patent: 9,775,953

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	05016291	Jul 27, 2005

International Family Members for US Patent 9,775,953

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	E499962
China	101227943
Germany	602006020453