Details for Patent: 12,004,992

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Which drugs does patent 12,004,992 protect, and when does it expire?

Patent 12,004,992 protects LILETTA and is included in one NDA.

This patent has twenty-four patent family members in nineteen countries.

Summary for Patent: 12,004,992

Title:

Kits for intrauterine systems and IUD insertion devices

Abstract:

The present disclosure is related to kits for using an intrauterine system (insertion device) including an intrauterine device (IUD), an insertion device or applicator for inserting the IUD into the cervix of a female patient.

Inventor(s):

Rob Deckman, Richard E. Repp, Curt Guyer, Justin Westendorf, Timothy PARMER

Assignee:

Medicines360

Application Number:

US17/367,034

Patent Claim Types:
see list of patent claims

Use; Compound; Device;

Patent landscape, scope, and claims:

US Patent 12,004,992: Claim Scope, Patent Strength, Expiration Risk, and IUD Patent Landscape

US Patent 12,004,992 is a combination patent directed to an intrauterine-device kit with a mechanically controlled insertion device. Its principal value is in the user-interface architecture: an elongated sheath, a sheath slider, a string-control slider, tactile motion-control features, alignment surfaces, and string-locking functionality. The claims also reach IUDs containing a hormone reservoir, but the independent claim is primarily directed to the insertion system rather than to the active pharmaceutical ingredient.

The patent is unlikely to block every hormonal IUD or every conventional inserter. Infringement generally requires the accused product to contain the claimed slider-and-guide configuration together with the claimed IUD kit combination.

What does US Patent 12,004,992 protect?

The patent protects a kit comprising two principal components:

A specialized IUD insertion device.
An IUD positionable within the device's distal sheath lumen.

The insertion device must include:

An elongated sheath with a proximal end, distal end and internal lumen.
An elongated inner member positioned within the sheath.
A proximal user interface.
One or more elongated channels formed in the exterior of the user interface.
A movable sheath slider traveling axially in those channels.
A string-control slider with a curved distal surface.
A string aperture.
Soft-motion-control structures that provide tactile feedback as the sheath slider moves through defined positions.

The claim is narrower than a generic IUD inserter because it requires a particular external control arrangement. A device with a sheath and a slider, but without the claimed exterior guide channels, string-control slider relationship and tactile motion-control features, would present a stronger noninfringement position.

Core claim architecture

Claim element	Commercial or technical function
Elongated sheath	Houses and deploys the IUD
Inner member	Supports or positions the IUD during insertion
Proximal user interface	Provides the clinician's operating surface
Exterior elongated channels	Guide slider movement
Movable sheath slider	Controls axial sheath movement
String-control slider	Controls or interacts with IUD strings
Curved slider surfaces	Permit abutment or telescoping interaction
String aperture	Routes the IUD strings
Soft-motion-control features	Create tactile stops or feedback
IUD in distal lumen	Converts the device into a claimed kit

The kit limitation is important. Claim 1 does not merely cover an insertion device sold separately. It requires an IUD positionable within the distal lumen. A standalone inserter may fall outside the literal scope of claim 1, although other claims or continuation patents could create separate exposure.

How broad is independent claim 1?

Independent claim 1 is a combination claim with substantial structural detail. Its breadth comes from functional alternatives and open-ended language, but its enforceability depends on proving the full combination.

Required elements

An accused product would generally need to satisfy all of the following:

A sheath and inner member.
A proximal user interface.
At least one elongated guide formed as an exterior channel.
A sheath slider movable proximally or distally along the channel.
A string-control slider having a curved distal surface.
A curved surface on the sheath slider capable of abutting the string-control slider.
A string aperture positioned proximally on the interface.
Soft-motion-control features along the channel.
Tactile feedback associated with movement between defined slider positions.
An IUD positionable inside the sheath.

The claim does not expressly require a hormonal IUD. That limitation appears in dependent claims 14, 15 and 24. Claim 1 can therefore cover a kit containing a nonhormonal IUD if the insertion device satisfies the claimed mechanical features.

Functional versus structural limitations

Several terms are structurally anchored:

"elongated sheath"
"elongated channels"
"curved surface"
"string aperture"
"IUD positionable within" the sheath

Other terms are more functional:

"configured to move"
"controls axial movement"
"provides tactile feedback"
"adapted and configured to"
"mechanically complement"

Functional language can broaden the claim, but it also creates claim-construction and proof issues. A patentee would need to show that the accused structure performs the specified function in the claimed manner. A defendant could argue that a raised ridge, detent, friction zone or visual marker does not constitute the claimed "soft motion control feature" if it does not generate the required tactile response.

What do claims 2 through 13 protect?

Claims 2 through 13 add mechanical features to the insertion device. They create narrower positions that may be useful in infringement litigation if claim 1 is challenged.

String-locking features

Claims 2 through 4 cover mechanisms for securing IUD strings. The listed alternatives include:

A cleft.
A clamp.
A wedge.
A pincher.
A spring.
Teeth.

Claim 4 narrows the cleft embodiment by requiring a movable member that pushes strings out of the cleft to unlock them.

These claims can cover a release mechanism integrated into the inserter rather than a separate string clamp. The more specific claim 4 is easier to compare against a product but is correspondingly easier to design around.

Sheath tip and diameter

Claims 5 through 8 cover:

Rounded or tapered atraumatic tips.
A distal outer diameter of approximately 3 to 5 millimeters.
A diameter smaller than the maximum cross-sectional dimension of the IUD.
Slits or flaps at the forward end of the sheath.

The 3-to-5-millimeter range is commercially relevant because IUD inserters commonly use narrow, atraumatic delivery tubes. The diameter limitation is not sufficient by itself to distinguish the patent from conventional inserters. Its practical significance arises from its combination with the claimed slider and guide architecture.

A product using a tip outside the stated 3-to-5-millimeter range could still infringe claim 1, assuming the independent claim does not include that diameter limitation. Claims 6 and 7 would then be unavailable.

Alignment features and motion profiles

Claims 9 through 13 cover mechanical cooperation between the user interface, sheath and slider. The listed surfaces include:

Curved surfaces.
Angled surfaces.
Tilted surfaces.
Dimensional surfaces.
Nonplanar surfaces.

These limitations are intended to ensure that the slider and user interface align at defined positions and interact with motion-control structures. They may capture detent systems that are not described as conventional stops but that use complementary surfaces to guide or resist slider movement.

What do claims 14, 15 and 24 protect?

Claims 14, 15 and 24 bring the pharmaceutical component into the patent's scope.

Hormonal reservoir construction

Claim 14 requires an IUD elongate member comprising:

A core part.
A jacket-shaped polymeric reservoir fitted around the core.
An active agent contained in the reservoir.

Claim 15 specifies that the active agent is a hormone used for:

Treatment of menopausal troubles; or
Contraception.

Claim 24 separately recites an IUD containing a hormone used for the same purposes.

These claims are broad at the active-agent level. They do not appear limited to levonorgestrel, estradiol, progesterone or another named hormone. They could potentially reach hormonal IUDs used for contraception or menopausal indications if the IUD also satisfies the structural insertion-device limitations inherited from claim 1.

The claims do not appear to cover a hormone formulation independently of the insertion kit. A hormonal IUD sold with a different insertion device would be less likely to fall within claims 14, 15 or 24.

What do claims 16 through 23 protect?

Claims 16 through 23 focus on guide geometry, slider interaction and user feedback.

Claims	Subject matter
16	Variable or staged guide width
17	Rectangular, S-shaped, C-shaped, U-shaped, W-shaped, circular, semicircular or oval guide profiles
18	Cavities at guide ends that house part of the slider
19	String-control slider movement within the guide
20	Simultaneous or independent slider operation
21	Telescoping slider movement and partial surrounding of one slider by another
22	Vertical slider surfaces forming aligned adjacent surfaces
23	Audible, visible or tactile feedback mechanisms

These claims provide a wide set of fallback embodiments. The combination of claims 16 and 17 is particularly expansive because it covers both guide dimensions and numerous two-dimensional profiles.

Claim 23 is potentially broad, but it depends on claim 1. A product with audible or visual feedback still must contain the claimed sheath, string slider, exterior channels and tactile soft-motion-control arrangement of claim 1.

How strong is the patent estate?

The identified claims represent a potentially useful but technically concentrated patent position.

Strengths

The claims combine the IUD, inserter and control interface into a single kit.
The exterior-channel arrangement distinguishes the claims from many simple tube-and-plunger systems.
Claims 2 through 23 provide multiple fallback configurations.
The claims cover both independent and simultaneous slider operation.
The hormone limitations may be commercially relevant for contraceptive and menopausal products.
Mechanical features can be easier to identify through product inspection than formulation or manufacturing-process limitations.

Weaknesses

Claim 1 contains a large number of required elements.
The claim uses potentially contestable terms such as "soft motion control features" and "tactile feedback."
The claim's "curved surface" and abutment requirements may not read on products using separate or radially arranged controls.
The kit limitation may exclude standalone inserter sales.
Many dependent claims list broad alternative shapes and functions that may face written-description, enablement or obviousness challenges depending on the prosecution record.
Conventional IUD inserters already use sheaths, inner members, string apertures, narrow tips and string-retention structures. The likely novelty center is the combined slider-interface design.

Patent strength should therefore be assessed at two levels. The mechanical user-interface concept may have meaningful exclusionary value against closely matching products. The broader commercial category of hormonal IUDs remains difficult to block because the claims do not independently cover the drug, reservoir chemistry or IUD product without the specified insertion device.

When does US Patent 12,004,992 lose exclusivity?

The exact expiration date cannot be established from the claims alone. For a U.S. utility patent, the ordinary term is generally 20 years from the earliest effective nonprovisional filing date, subject to patent-term adjustment, patent-term extension and terminal disclaimers. The governing framework is 35 U.S.C. §§ 154 and 156.

A reliable expiration analysis must distinguish:

Term issue	Effect
Earliest nonprovisional priority date	Usually controls the 20-year term
Continuation or divisional status	May inherit the parent application's term
Patent-term adjustment	Can extend the term for USPTO delay
Patent-term extension	May apply in limited regulatory circumstances
Terminal disclaimer	Can shorten the enforceable term
Reexamination or post-grant proceedings	Can change claim validity or scope, but not usually the base term

Because this is a device patent, FDA regulatory patent-term extension is less likely than for a patent claiming an approved active pharmaceutical ingredient or method of use. Any exact expiration date should be taken from the USPTO Patent Center record and the patent's continuity data, not inferred from the issue date.

What is the Orange Book status of US Patent 12,004,992?

The patent is not an Orange Book drug patent merely because several claims refer to a hormonal IUD. The Orange Book lists patents submitted by sponsors for approved drug products, including certain drug-substance, drug-product and method-of-use patents. A mechanical inserter patent may be listed only if it qualifies under FDA listing rules and is submitted for the relevant approved product.

The claims provided are primarily directed to a kit and insertion apparatus. They do not independently claim:

Levonorgestrel as a drug substance.
A specific approved IUD formulation.
A defined release rate.
A named FDA-approved product.
A treatment method using a specific approved product.

Accordingly, the patent should not automatically be treated as an Orange Book barrier to an ANDA. Whether it is listed for Mirena, Kyleena, Skyla, Liletta or another product requires a product-specific FDA listing record.

Does the patent create Paragraph IV risk?

Paragraph IV risk depends on whether the patent is listed in the Orange Book for the reference product and whether a generic applicant's product is covered by at least one unexpired claim.

For this patent, the main infringement question would be whether a proposed generic or follow-on IUD includes:

The claimed external slider channels.
The movable sheath slider.
The string-control slider.
The curved-surface abutment relationship.
The soft-motion-control feature.
The IUD-in-sheath kit configuration.

A generic IUD that uses a conventional inserter without the claimed interface may avoid infringement even if it contains the same hormone and reservoir. Conversely, a generic device that copies the control architecture could face infringement risk even if its hormone formulation is materially different.

Paragraph IV litigation is less likely to center on the active ingredient because the claims do not identify a specific hormone in the independent claim. The dispute would more likely concern claim construction, anticipation, obviousness and whether the accused slider system provides the claimed tactile feedback.

Which companies face potential competitive exposure?

The commercial products most relevant to the claimed technology are hormonal and nonhormonal IUDs sold with integrated insertion systems.

Company or product group	Relevant product category	Potential relevance
Bayer	Mirena, Kyleena, Skyla	Hormonal IUDs with proprietary inserters
CooperSurgical / Paragard	Copper IUD	Nonhormonal IUD and insertion-device design
Medicines360 and commercial partners	Liletta	Hormonal IUD and integrated inserter
Organon and other distributors	Regional hormonal IUD products	Product-specific device and kit configurations

This table identifies commercial comparators, not confirmed infringers. The claims do not establish infringement based on product category alone. Each product's actual inserter geometry, slider arrangement, string-retention mechanism and tactile-control structure must be compared element by element.

What design-arounds are available?

Potential design-around strategies include:

Use a conventional plunger or fixed handle rather than a movable sheath slider.
Place controls on separate axial members without exterior channels in the user interface.
Eliminate the string-control slider or use a separate removable string clamp.
Use a rotary actuator instead of a proximally or distally sliding actuator.
Use a single control that combines deployment and string management without the claimed abutting slider surfaces.
Replace tactile detents with a continuous-friction mechanism, subject to claim construction.
Sell the inserter separately from the IUD, although this may not avoid other claims or other patents.
Use a distal tip and deployment sequence that do not require the claimed sheath movement.
Use a non-hormonal IUD to avoid claims 14, 15 and 24, while still addressing claim 1.
Use a reservoir architecture that does not have the claimed jacket-shaped polymeric reservoir around a core.

The most effective design-around generally targets the conjunction of the two sliders, the exterior guide channels and the soft-motion-control feature. Avoiding only the hormone limitation would not avoid claim 1.

What prior-art and validity issues are most important?

The main prior-art search should cover:

IUD inserters with retractable sheaths.
Inserters with proximal sliders.
Dual-slider insertion systems.
String-locking clefts and clamps.
Tactile detents and staged slider positions.
Guide channels formed in an external handle.
Telescoping or nested slider structures.
Hormone-reservoir IUDs with core-and-jacket construction.

Likely validity arguments include:

Anticipation based on an earlier inserter disclosing the full slider and guide arrangement.
Obviousness based on combining known IUD deployment tubes with known detent or slider mechanisms.
Indefiniteness concerning "soft motion control features," "tactile feedback" and "mechanically complement."
Written-description challenges to the large collection of guide shapes, widths and slider configurations.
Lack of enablement for the full breadth of the functional alternatives.
Noninfringement based on the absence of a curved-surface abutment between the two sliders.

The claim set's dependent structure gives the patent multiple litigation positions, but the validity of the broadest claim will depend heavily on the prosecution history and the specific prior art considered by the USPTO.

What litigation or settlement agreements affect the patent?

No litigation, Paragraph IV case or settlement agreement can be concluded from the claims supplied. A definitive litigation review would require the patent's assignment and continuity records, federal court docket searches, PTAB records and any FDA listing tied to a reference product.

The relevant proceedings to monitor are:

District-court infringement actions involving IUD inserters.
Inter partes review petitions challenging mechanical claim limitations.
Post-grant review or reexamination proceedings.
ANDA litigation under the Hatch-Waxman framework.
Licensing or supply agreements covering proprietary inserters.
Product-specific disputes involving Bayer, CooperSurgical, Medicines360 or other IUD sponsors.

Key Takeaways

US Patent 12,004,992 is primarily an IUD insertion-device patent, not a conventional drug patent.
Claim 1 requires a detailed combination of sheath, inner member, external guide channels, sheath slider, string-control slider, curved abutment surfaces, tactile motion control and an IUD.
Claims 14, 15 and 24 extend the kit claims to hormonal IUD embodiments, including contraceptive and menopausal hormones.
The patent does not automatically block every hormonal IUD, levonorgestrel product or generic device.
The most important infringement issues are the external slider channels, dual-slider interaction and tactile motion-control structure.
A conventional inserter, rotary-control design or separately managed string mechanism may provide a design-around.
The exact patent expiration date requires the patent's continuity, patent-term-adjustment and terminal-disclaimer records.
Orange Book and Paragraph IV exposure is product-specific and cannot be inferred solely from the presence of hormone-related dependent claims.
The commercial exposure is concentrated among suppliers of IUDs with proprietary integrated insertion systems.

FAQs About US Patent 12,004,992

Does US Patent 12,004,992 cover Mirena?

Not automatically. Mirena could be implicated only if its supplied insertion kit contains every required limitation of an asserted claim, including the claimed slider, exterior guide-channel and tactile-control architecture.

Does the patent cover levonorgestrel itself?

No claim provided expressly claims levonorgestrel as a standalone active ingredient. The relevant claims cover a kit containing an IUD with a hormone reservoir, not the hormone independently.

Can a copper IUD infringe the patent?

Yes, potentially under claim 1 because claim 1 does not require a hormone. Claims 14, 15 and 24 would be less relevant to a copper IUD because they require or describe a hormonal active agent.

Is the patent relevant to a 505(b)(2) application?

It could be relevant if the 505(b)(2) product uses an insertion device covered by an unexpired claim. The relevance would depend on the proposed device and any patent listing associated with the reference product.

What is the highest-risk claim for a copied IUD inserter?

Claim 1 presents the principal risk because it captures the full kit architecture. Claims 20 and 21 may become important where the accused product uses independently operated or telescoping dual sliders. Claims 2 through 4 may matter where the product has an integrated string-locking mechanism.

References

U.S. Patent No. 12,004,992, claims 1-24 (2024).
U.S. Patent and Trademark Office. (2024). Manual of Patent Examining Procedure, §§ 2111, 2112, 2161, 2173.
U.S. Patent and Trademark Office. (2024). Patent term adjustment and patent term extension provisions, 35 U.S.C. §§ 154, 156.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations.
U.S. Food and Drug Administration. (2024). Approved biological products: Purple Book.

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Type	RLD	Patent No.	Product	Substance	Delist Req.	Patent Expiration	Usecode	Patented / Exclusive Use
Medicines360	LILETTA	levonorgestrel	SYSTEM	206229	Feb 26, 2015	RX	Yes	⤷ Start Trial		Y		⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Type	>RLD	>Patent No.	>Product	>Substance	>Delist Req.	>Patent Expiration	>Usecode	>Patented / Exclusive Use

Drugs Protected by US Patent 12,004,992