Details for Patent: 10,398,588

Which drugs does patent 10,398,588 protect, and when does it expire?

Patent 10,398,588 protects MIUDELLA and is included in one NDA.

This patent has nine patent family members in seven countries.

Summary for Patent: 10,398,588

Title:	Intrauterine device with retrieval thread
Abstract:	An intrauterine contraceptive system may include a contraceptive intrauterine device, a retrieval thread permanently attached to the intrauterine device and an insertion device for inserting the intrauterine device into a uterus. The system may also include a release thread releasably coupled with the intrauterine device. The intrauterine device may be deployable out of a distal end of the insertion device and may be configured to change from a delivery configuration when housed in the insertion device to a deployed configuration when deployed in a uterus. The retrieval thread and the optional release thread may be at least partially housed within the insertion device during insertion of the intrauterine device into the uterus. The release thread may extend from the intrauterine device through the insertion device to an attachment point at or near a proximal end of the insertion device.
Inventor(s):	Michael Tal, Bob H. Katz, Mark James DeBisschop
Assignee:	Sebela Vlc Ltd
Application Number:	US15/477,189
Patent Claim Types: see list of patent claims	Use; Delivery; Device;

US Patent 10,398,588: Scope, Claim Construction, Expiration, and Intrauterine Contraceptive Patent Landscape

US Patent 10,398,588 protects an intrauterine contraceptive device and insertion method using a removable release thread, a permanently attached retrieval thread, and visual thread markers that help confirm placement depth. The claims target the interface between the IUD and inserter rather than the contraceptive active ingredient, polymer reservoir, or hormonal release rate.

The strongest protection is concentrated in claims 1, 7, 10, 11, and 16-17. A competing product would generally need to avoid at least one required feature of the applicable independent claim, such as a release thread that is pulled off after placement or a retrieval thread with the claimed visual-positioning function.

What does US Patent 10,398,588 protect?

The patent has two independent claim groups:

1. Device claims covering the physical IUD and thread arrangement.
2. Method claims covering delivery, release-thread removal, and confirmation of placement.

Claim	Subject matter	Principal limitation
1	IUD device	Frame with distal opening and releasable release thread
2	IUD device	Permanent retrieval thread, 5-9 cm long
3	IUD device	Retrieval thread at least partly housed in inserter
4	IUD device	Contrasting thread portions visible during examination
5	IUD device	First color extends 2-3 cm from attachment point
6	IUD device	Contrasting band between same-color thread portions
7	Delivery method	Advance IUD, pull release thread off, remove inserter
8	Delivery method	Use release thread to control advancement
9	Delivery method	Manipulate IUD using release thread
10	Delivery method	Release thread passes through frame opening
11	Delivery method	Leave retrieval thread uncut and extending through cervix
12	Delivery method	Remove release thread before removing inserter
13	Delivery method	Remove release thread and inserter together
14	Delivery method	View retrieval thread after insertion
15	Delivery method	Confirm contraceptive placement using thread visibility
16	Delivery method	View a marker at a known distance
17	Delivery method	View a color change at a known distance

The patent does not require a particular contraceptive hormone, dose, elastomer, frame shape beyond the claimed distal opening, or insertion tube diameter. The claims therefore reach both hormonal and nonhormonal IUD configurations if the thread architecture and insertion steps satisfy the limitations.

How should claim 1 be construed?

Claim 1 requires four material elements:

• An intrauterine contraceptive device.
• A frame.
• A distal end of the frame with an opening.
• A release thread releasably attached adjacent to that opening.

The release thread must perform a coupling function between the IUD and the insertion device. It must also be removable by pulling it off the IUD after the thread is no longer needed to secure the device to the inserter.

The claim is narrower than a conventional IUD claim directed only to a frame, drug reservoir, or retrieval string. A standard inserter string that remains attached to the IUD and is later cut would not automatically meet the release-thread limitation. The claim requires the release thread to be removed from the device, while the retrieval thread may remain permanently attached.

The phrase “adjacent the opening” gives the claim some spatial flexibility. It does not require the thread to be tied directly through the exact center of the opening. Claim 10, however, narrows the method implementation by requiring the release thread to extend through the opening and permitting release by pulling one end.

What additional protection do claims 2 through 6 provide?

Claims 2 through 6 add a distinct retrieval-thread subsystem.

Retrieval-thread length

Claim 2 requires a retrieval thread permanently attached to the frame and having a length between 5 and 9 centimeters. This numerical range creates a measurable infringement limitation. A thread shorter than 5 cm or longer than 9 cm may avoid claim 2, although it could still fall within claim 1 if the release-thread elements are present.

The claim does not state whether the 5-9 cm measurement is taken before or after clinical trimming. That issue could matter for products whose retrieval threads are cut during manufacture, packaged at variable lengths, or trimmed by the clinician during placement.

Housing within the inserter

Claim 3 requires the retrieval thread to be at least partly housed in the insertion device during insertion. This distinguishes systems in which the retrieval thread is fully exposed before deployment.

The limitation is operational rather than purely structural. A product may have a retrieval thread capable of being housed in the inserter but avoid the claim if the commercial insertion procedure does not place any portion of the thread inside the insertion device.

Contrasting colors

Claim 4 requires first and second thread portions with sufficiently contrasting colors to be visible during a physical examination. Claim 6 narrows the configuration to a contrasting band located between two portions having the first color.

Claim 5 specifies that the first color extends from the frame attachment point to a location 2-3 cm away. This feature creates a visual gauge. The claimed marker is not merely decorative coloring. It is tied to a known distance from the device and is used to assess position after insertion.

A product using a uniform thread color would likely avoid claims 4-6, but not necessarily claims 1-3 or 7-13.

What do claims 7 through 13 protect?

Claims 7-13 cover the delivery sequence.

The core sequence in claim 7 is:

1. Advance the IUD from the distal end of the inserter into the uterus.
2. Maintain removable coupling through the release thread.
3. Pull the release thread off the IUD.
4. Remove the release thread and insertion device.
5. Leave the IUD in the uterus.

This sequence is important because infringement analysis may depend on how the device is used, not merely on its physical configuration. A product that contains a removable thread but uses a different insertion sequence could avoid the method claims while remaining exposed under claim 1.

Release-thread control

Claim 8 covers use of the release thread to control advancement. Claim 9 covers manipulation of the device during or after deployment using that thread. These claims may reach procedures in which the operator uses tension on the thread to control release, reposition the IUD, or stabilize it during withdrawal of the inserter.

Removal order

Claims 12 and 13 cover two alternative removal techniques:

• Claim 12: pull the release thread through the insertion device first, then remove the insertion device.
• Claim 13: withdraw the release thread and insertion device together.

These alternatives reduce the ability to avoid the method claims based only on withdrawal order. A competing procedure would need to avoid the broader claim 7 sequence or another required limitation.

What do claims 14 through 17 add?

Claims 14-17 cover visual confirmation of placement.

The operator must view the retrieval thread in the vaginal cavity after removing the release thread and inserter. The placement determination is then based on the thread’s visible marker or color transition.

This creates a functional relationship among:

• The thread’s physical location.
• The known distance between the marker and frame.
• The clinical determination that the IUD is sufficiently deep in the uterus.

The claims do not require imaging, ultrasound, fluoroscopy, or a particular cervical measurement. They focus on visual inspection of the retrieval thread.

When does US Patent 10,398,588 lose exclusivity?

The patent issued on August 27, 2019. Its exclusivity is governed by the patent term calculated from the earliest effective nonprovisional filing date, subject to patent-term adjustment and any terminal disclaimer. The grant date does not establish the expiration date.[1]

Public patent-family records place the relevant family in the 2034 term period. The nominal endpoint should be treated as approximately 2034 unless the USPTO patent-term calculation shows an adjustment. The patent also remains subject to maintenance-fee requirements during its enforceable life.[1][2]

Event	Date or timing
Patent grant	August 27, 2019
Patent term basis	Earliest effective nonprovisional filing
Nominal term period	Approximately 2034, subject to USPTO adjustment
3.5-year maintenance-fee window	2022-2023 period
7.5-year maintenance-fee window	2026-2027 period
11.5-year maintenance-fee window	2030-2031 period

No Orange Book expiration date should be assumed from the patent number. The patent claims an IUD structure and insertion procedure, not a conventional drug substance or drug formulation.

What is the Orange Book status of US Patent 10,398,588?

US Patent 10,398,588 is a device-and-method patent. Its claims do not recite levonorgestrel, copper, a drug reservoir, a release-rate profile, or a specific FDA-approved drug product.

The FDA Orange Book principally records patents submitted for approved drug products and relevant patent certifications. A device patent may be listed in connection with a combination product if it meets FDA listing requirements, but the patent is not automatically an Orange Book patent merely because the device delivers contraception.[3]

For IUD products, the commercial regulatory record is distributed among product-specific approvals, labeling, manufacturing controls, and patent portfolios. Mirena, Kyleena, Skyla, Liletta, and Paragard have separate FDA approval histories and labeling requirements.[4-8]

Which products and companies are most relevant?

The principal commercial comparators are:

Product	Company or sponsor	Active contraceptive technology	Relevant patent-risk category
Mirena	Bayer	Levonorgestrel-releasing IUS	Hormone reservoir, frame, inserter, manufacturing
Kyleena	Bayer	Lower-dose levonorgestrel IUS	Reservoir, dose, frame, inserter
Skyla	Bayer	Lower-dose levonorgestrel IUS	Reservoir, device dimensions, inserter
Liletta	Medicines360 and manufacturer partners	Levonorgestrel-releasing IUS	Reservoir, manufacturing, inserter, method claims
Paragard	CooperSurgical	Copper IUD	Copper-bearing frame, manufacturing, insertion system

The patent’s claim language is most relevant to products using a removable release thread and a retrieval thread that doubles as a placement indicator. A product with a conventional fixed retrieval string and a separate inserter-release mechanism may present a different claim profile.

How strong is the patent estate for US Patent 10,398,588?

The patent has moderate claim breadth but narrow technical focus.

Strengths

• Claim 1 is directed to a concrete structural combination.
• Claim 7 captures the corresponding insertion procedure.
• Claims 12 and 13 cover both sequential and simultaneous withdrawal.
• Claims 14-17 connect thread visibility to placement confirmation.
• The patent can apply independently of the contraceptive active ingredient.

Limitations

• The release thread must be removable from the IUD.
• The frame must have the claimed distal opening relationship.
• Claims 2-6 require specific retrieval-thread characteristics.
• Color-marker claims may be avoided through uniform coloring, nonvisual indicators, or different marker locations.
• Method claims may depend on actual clinical use and instructions for use.
• The patent does not appear, from the supplied claims, to cover the hormonal formulation, drug-loading process, or therapeutic contraceptive mechanism.

The broadest practical design-around options are to use a fixed retrieval thread, remove the frame opening, use a release mechanism that does not pull a thread off the IUD, or use a deployment system in which the retrieval thread is never housed in the inserter.

What generic entry risks exist?

For levonorgestrel IUS products, generic or follow-on entry is likely to encounter several separate barriers:

1. FDA product-specific requirements for intrauterine delivery systems.
2. Equivalence of drug content and release characteristics.
3. Device geometry and inserter performance.
4. Sterility and packaging validation.
5. Patent claims covering the hormone reservoir or frame.
6. Patents covering insertion and thread handling.
7. Manufacturing know-how that may not be fully disclosed in the patent record.

US Patent 10,398,588 is unlikely to be the only barrier to a competing hormonal IUD. Its commercial impact is greatest where a challenger copies the claimed thread-release and visual-placement system. It is less significant against a product using a materially different inserter architecture.

A Paragraph IV certification would be relevant only if the patent is listed for the applicable approved product and the ANDA applicant relies on an abbreviated pathway that requires certification. A device patent not listed in the Orange Book would more commonly be asserted through ordinary patent litigation rather than as an Orange Book-based automatic stay mechanism.[3][9]

Which companies are challenging the patent?

No company-specific Paragraph IV challenge or reported litigation outcome can be attributed to US Patent 10,398,588 from the claim text alone. The patent is directed to an IUD device and insertion method, so any relevant challenge would likely appear in USPTO Patent Center, district-court litigation records, or a product-specific FDA patent listing rather than in the drug-label text.

The relevant potential challengers are manufacturers developing:

• Levonorgestrel intrauterine systems.
• Copper IUDs with modified insertion devices.
• Reusable or simplified inserters.
• Devices using nonthread-based deployment mechanisms.
• Follow-on IUDs relying on different retrieval-string designs.

What manufacturing and intellectual-property barriers does the patent create?

The patent may create manufacturing constraints in four areas:

Thread attachment

The release thread must be releasably attached near the frame opening, while the retrieval thread must be permanently attached. Those are different attachment requirements and may require separate assembly controls.

Thread routing

Claim 10 requires the release thread to extend through the frame opening. The routing path, pull direction, and release force may be subject to process tolerances.

Color placement

Claims 4-6 create potential quality-control requirements for thread color, band width, color contrast, and marker distance from the attachment point.

Inserter integration

Claims 3, 8, 9, 12, and 13 link the thread design to the inserter. A design-around that changes the thread architecture may require a new loading process, inserter geometry, clinician technique, and FDA validation package.

How does this patent compare with conventional IUD patent protection?

Protection category	US 10,398,588	Conventional IUD patent
Active ingredient	Not required	May claim levonorgestrel or copper
Drug reservoir	Not required	Often central to product protection
Frame	Required, with distal opening relationship	May claim specific geometry
Release thread	Central limitation	Often absent or fixed
Retrieval thread	Required only in dependent claims	Common but not necessarily color-coded
Inserter	Functionally important	May be claimed separately
Placement confirmation	Expressly claimed	Often absent
Manufacturing method	Not expressly claimed in supplied claims	May be separately protected
Regulatory pathway	Device/drug combination context	Product-specific FDA pathway

Key Takeaways

• US Patent 10,398,588 protects a removable release-thread system for deploying an IUD.
• Claim 1 is the principal device claim; claim 7 is the principal method claim.
• The patent separately protects permanent retrieval threads, 5-9 cm length, inserter housing, contrasting colors, and visual placement markers.
• The claims do not require a particular hormone, copper load, reservoir, or release rate.
• The patent issued August 27, 2019, with a nominal term extending into approximately 2034, subject to USPTO term calculations.
• It is not automatically an Orange Book patent because the claims are directed to a device and insertion method.
• The most practical design-arounds are fixed retrieval strings, nonthread release mechanisms, different frame-opening configurations, or nonvisual placement indicators.
• Generic-entry risk depends on the full product patent estate, not this patent alone.

FAQs About US Patent 10,398,588

Can an IUD infringe claim 1 without having a colored retrieval thread?

Yes. Claim 1 does not require a retrieval thread or color marker. A device may implicate claim 1 if it has the claimed frame opening and releasable release thread, even if it lacks the additional features in claims 2-6.

Does cutting a retrieval thread avoid the patent?

Not necessarily. Claims 2 and 11 require a permanently attached retrieval thread and, in claim 11, leaving it uncut during placement. Cutting the thread may avoid those limitations, but it does not necessarily avoid claim 1 or claim 7.

Does a fixed inserter string satisfy the release-thread limitation?

Usually not on the supplied claim language. The release thread must be releasably attached so that it can be pulled off the IUD. A string that remains attached and is merely cut may present a materially different structure.

Does the patent cover hormonal IUD formulations?

No express claim supplied here covers a hormone, reservoir, polymer matrix, dosage, or release rate. Formulation protection would need to arise from separate claims in another patent.

Can a competing IUD use a different visual placement marker?

Potentially. Claims 16 and 17 focus on a colored marker or color change at a known distance from the attachment point. A different marker location, nonvisual indicator, or different placement-confirmation method may avoid those dependent claims, subject to the remaining claim limitations.

References

1. United States Patent and Trademark Office. (2019). U.S. Patent No. 10,398,588, Intrauterine contraceptive device and method of insertion.
2. United States Patent and Trademark Office. (n.d.). Patent term adjustment and maintenance fee provisions.
3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, commonly known as the Orange Book.
4. U.S. Food and Drug Administration. (2022). Mirena prescribing information. Bayer HealthCare Pharmaceuticals Inc.
5. U.S. Food and Drug Administration. (2023). Kyleena prescribing information. Bayer HealthCare Pharmaceuticals Inc.
6. U.S. Food and Drug Administration. (2023). Skyla prescribing information. Bayer HealthCare Pharmaceuticals Inc.
7. U.S. Food and Drug Administration. (2023). Liletta prescribing information. Medicines360.
8. U.S. Food and Drug Administration. (2023). Paragard prescribing information. CooperSurgical, Inc.
9. 21 U.S.C. § 355(j). (2024). Abbreviated applications for new drugs and patent certifications.

Drugs Protected by US Patent 10,398,588

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Sebela Womens Hlth	MIUDELLA	copper	SYSTEM;INTRAUTERINE	218201-001	Feb 24, 2025		RX	Yes	Yes	10,398,588		Y			INTRAUTERINE DEVICE PROMOTING CONTRACEPTION UTILIZING COPPER WITHOUT BLOCKING OPENINGS OF TWO FALLOPIAN TUBES

International Family Members for US Patent 10,398,588

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2014334816
Australia	2019200369
Brazil	112016008594
Canada	2926933
European Patent Office	3057546
Spain	2685294