Details for Patent: RE28399

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Summary for Patent: RE28399

Title:	Intrauterine contraceptive method
Abstract:	1. A METHOD OF CONTRACEPTION WHICH COMPRISES PLACING A CONTRACEPTIVELY EFFECTIVE AMOUNT OF AN ELEMENTAL METAL SELECTED FROM THE GROUP CONSISTING OF COPPER AND ZINC IN THE UTERINE CAVITY, SAID ELEMENTAL METAL HAVING AN EXPOSED SURFACE AREA OF AT LEAST ABOUT 20 SQUARE MILLIMETERS.
Inventor(s):
Assignee:
Application Number:
Patent Claim Types: see list of patent claims

United States Patent RE28399: Claim Scope, Enforceability, and Copper IUD Patent Landscape

United States Patent RE28399 covers a contraceptive method that places copper or zinc in the uterine cavity with at least approximately 20 square millimeters of exposed elemental-metal surface area. The claim is broad in device design but narrow in material composition and minimum exposed area. The patent is historical and no longer creates an effective U.S. exclusivity barrier for copper intrauterine devices. Current commercial competition is controlled primarily by FDA approval, manufacturing capability, product liability, and newer device-specific patent rights rather than RE28399.

What does U.S. Patent RE28399 claim?

The operative claim requires four principal elements:

Claim element	Scope
Therapeutic objective	A method of contraception
Anatomical site	Placement in the uterine cavity
Active material	Elemental copper or elemental zinc
Minimum exposure	At least about 20 mm² of exposed surface area

The claim is a method claim, not a composition-of-matter claim and not a claim limited to a particular intrauterine-device architecture.

Its text does not require:

• A T-shaped device
• A plastic frame
• A wire coil
• A specified copper mass
• A particular insertion technique
• A specified residence time
• A release rate
• A particular patient population
• A prescription or physician-administered procedure
• A named commercial product

A product could therefore fall within the literal conceptual scope of the claim even if its physical design differs substantially from the commercial ParaGard configuration, provided the product places the required elemental metal in the uterine cavity and exposes at least approximately 20 mm².

How should the RE28399 claim be construed?

What does “elemental metal” mean?

“Elemental metal” ordinarily refers to copper or zinc in metallic form, rather than a copper or zinc salt, oxide, complex, or other compound. A copper-containing polymer, copper salt coating, or soluble copper compound would not automatically satisfy the limitation.

A device containing metallic copper on its surface is a stronger literal infringement case than a device that releases copper ions from a nonmetallic matrix. The claim focuses on the presence of the elemental metal and its exposed surface area, not solely on ionic release.

Copper alloys present a more difficult construction issue. If the exposed surface is an alloy rather than elemental copper, literal infringement may depend on whether the claimed “elemental metal” is present as a distinct metallic phase or coating. An alloy-based product could also raise a doctrine-of-equivalents issue, but equivalence would depend on the patent prosecution history and the factual role of copper in the accused device.

What does “exposed surface area” mean?

The claim requires surface area exposed to the uterine environment. The relevant area is not necessarily the total geometric area of the copper component. A copper wire embedded in plastic contributes only the copper surface that remains exposed.

The claim does not specify whether surface area must be measured:

• Before insertion or after insertion
• Including microscopic roughness
• On one side or both sides of the device
• By nominal geometry or physical measurement
• At the time of manufacture or during clinical use

A court would likely focus on the ordinary technical meaning of exposed surface area and the specification’s measurement methodology, if the specification defines one.

The phrase “at least about 20 square millimeters” contains both a floor and a tolerance modifier. “At least” establishes a minimum. “About” introduces flexibility around the 20 mm² figure. The permitted deviation would depend on the patent disclosure, prosecution history, measurement precision, and technical context.

Is the contraceptive effect a limiting requirement?

The phrase “contraceptively effective amount” is likely a functional limitation. The metal must be present in an amount sufficient to produce contraception, rather than merely being present in a nominal or incidental quantity.

This limitation may create proof issues. The patent owner would need to establish that the accused device provides a contraceptive effect attributable to the claimed copper or zinc placement. The limitation does not necessarily require a particular pregnancy-prevention rate, because the claim does not recite a numerical efficacy threshold.

How broad is RE28399 compared with a commercial copper IUD patent?

RE28399 is broad at the method level but incomplete as a modern product specification. It captures the basic therapeutic concept of placing exposed elemental copper or zinc in the uterine cavity. It does not claim the detailed engineering used to control insertion, retention, radiopacity, flexibility, positioning, or manufacturing.

Issue	RE28399	Typical later copper-IUD patent
Claim type	Method of contraception	Device, component, formulation, or manufacturing method
Active material	Copper or zinc	Often copper geometry, coating, alloy, or release structure
Minimum area	About 20 mm²	May specify total copper area, wire dimensions, or placement
Device structure	Not specified	Often frame, arms, stem, retrieval string, or carrier
Release profile	Not specified	May address corrosion or ion release
Manufacturing	Not specified	May claim winding, bonding, molding, or assembly
Clinical use	Broad uterine placement	May specify insertion or positioning features

A later patent cannot extend the life of RE28399. It can, however, create a separate infringement risk for a new product even after RE28399 has expired.

When did RE28399 lose exclusivity?

RE28399 is an old reissue patent. Its enforceable term was tied to the term of the original patent and could not be extended indefinitely by the reissue process. The patent is expired and has no current U.S. blocking right against copper or zinc intrauterine contraception.

The important legal distinction is between:

1. Patent expiration, which removes the right to exclude; and
2. Regulatory approval, which determines whether a competitor may lawfully market a product.

The expiration of RE28399 does not create automatic FDA approval for a competing copper IUD. A manufacturer still needs an approved NDA, a suitable abbreviated or hybrid regulatory pathway if available, manufacturing controls, clinical support, and compliance with device and drug requirements.

Because the claim is expired, a current manufacturer generally faces no damages exposure for practicing the claim itself. The patent remains relevant as prior art and as historical evidence concerning the claimed copper-IUD concept.

What is the Orange Book status of RE28399?

RE28399 is not a current Orange Book exclusivity asset. The Orange Book primarily identifies patents and regulatory exclusivities associated with approved drug products. A copper IUD is a combination product with drug and device characteristics, and its regulatory treatment does not place every historical method patent into the Orange Book.

For a currently marketed copper IUD, the relevant patent picture must be reviewed through:

• The FDA approval record
• The Orange Book, if the product has an applicable listing
• FDA patent and exclusivity submissions
• Patent Center and assignment records
• Product-specific patent litigation
• State and federal regulatory requirements

The presence or absence of RE28399 from a current product’s Orange Book listing would not change the fact that the patent is expired.

Does RE28399 create Paragraph IV risk?

No current Paragraph IV risk arises from an expired patent. A Paragraph IV certification is relevant when an ANDA applicant challenges a listed patent as invalid, unenforceable, or not infringed. An expired claim cannot ordinarily support a meaningful 30-month stay or a forward-looking exclusionary remedy.

Historically, a generic or follow-on applicant could have addressed the patent through a Paragraph IV certification if the patent was listed and unexpired at the relevant time. That historical issue has no present commercial consequence for RE28399.

Current competition may involve a different regulatory pathway. A new copper IUD may require a full NDA or another FDA route because the product combines a physical delivery system with a pharmacologically active metallic component. The availability of a conventional ANDA pathway depends on FDA determinations concerning active ingredient, dosage form, delivery system, labeling, and therapeutic equivalence.

What FDA products compete with ParaGard?

ParaGard

ParaGard is the principal long-standing U.S. copper intrauterine contraceptive. It contains copper on a plastic intrauterine frame and is approved for contraception. CooperSurgical has been the principal commercial company associated with the product in the U.S. market.

The historical commercial position of ParaGard does not result from continuing exclusivity under RE28399. Its position has rested on FDA approval, manufacturing infrastructure, physician familiarity, clinical data, distribution, and the difficulty of bringing a new intrauterine product to market.

Miudella

Miudella is a newer copper intrauterine contraceptive associated with Sebela Pharmaceuticals and Sebela Women’s Health. FDA approval of Miudella created a second modern U.S. copper-IUD commercial platform after decades of limited competition in the category. Its approval is commercially important because it demonstrates that market entry can occur without relying on the expired RE28399 patent.

Miudella and ParaGard may compete on:

• Device dimensions
• Duration of approved use
• Copper configuration
• Insertion system
• Provider training
• Patient access
• Insurance coverage
• Manufacturing capacity
• Clinical and tolerability data

Neither product’s commercial position should be analyzed solely through the lens of RE28399.

Which patents protect modern copper IUD products?

Modern patent estates may include several categories:

Device-architecture patents

These may cover:

• Frame geometry
• Flexible arms
• Stem construction
• Retrieval strings
• Positioning elements
• Insertion tubes
• Radiopaque markers
• Retention structures

Copper-placement patents

These may cover:

• Copper wire winding
• Copper sleeves
• Copper collars
• Copper beads
• Copper segments
• Copper surface distribution
• Copper attachment to a polymer frame

Manufacturing patents

These may cover:

• Forming and winding the copper component
• Securing copper to the frame
• Molding or overmolding
• Sterilization
• Packaging
• Automated assembly
• Dimensional inspection

Clinical-use patents

These may address:

• Duration of contraceptive use
• Replacement intervals
• Use in specific populations
• Postpartum placement
• Emergency-contraception use
• Placement protocols

A freedom-to-operate analysis for a new copper IUD therefore requires a claim-by-claim review of active patents, pending applications, continuations, terminal disclaimers, and foreign counterparts. RE28399 alone is insufficient to assess current infringement exposure.

What patent litigation affects copper IUD competition?

RE28399 does not present a current litigation barrier because it is expired. The more relevant litigation risks involve:

• Alleged defects in device design
• Perforation or migration claims
• Breakage or fragmentation
• Insertion-system failures
• Product labeling
• Manufacturing contamination
• Trade secrets
• Regulatory exclusivity
• Later patents directed to device architecture or production

Copper IUD litigation may also be driven by product-liability claims rather than patent infringement. Those proceedings can affect reserve requirements, insurance costs, labeling, and commercial launch timing even when the underlying patent estate is weak.

How strong is the patent estate surrounding the claimed invention?

The estate represented by RE28399 is legally weak as a current commercial asset because the patent has expired. Its original claim was technically broad, which would have created substantial historical leverage if valid and unexpired.

Its principal strengths were:

• Broad coverage of copper and zinc
• No limitation to a specific frame design
• No limitation to a particular insertion mechanism
• Low stated surface-area threshold
• Coverage of the underlying contraceptive method

Its principal vulnerabilities were:

• Broad functional language
• Potential prior art involving metal-bearing intrauterine devices
• Possible obviousness combinations involving known IUD structures and known spermicidal or contraceptive metals
• Uncertainty around “about 20 square millimeters”
• Proof issues concerning contraceptive effectiveness
• Lack of detailed structural limitations

The patent’s commercial importance was likely greatest as a foundational method patent. It is not a current barrier to entry.

What generic or follow-on launch scenarios exist?

A follow-on manufacturer has several possible launch strategies:

Launch strategy	Principal issue
Generic-equivalent copper IUD	FDA pathway and therapeutic equivalence
New NDA product	Clinical, manufacturing, and regulatory cost
505(b)(2)-type approach	Applicability to the product’s drug-device characteristics
Device redesign	Avoidance of later structural patents
Licensed launch	Access to manufacturing, clinical, or regulatory rights
Foreign-first launch	Separate national regulatory and patent analysis

A manufacturer can avoid RE28399 by expiration alone. It still must evaluate active patents covering the specific device design and production process.

How does the U.S. landscape compare with foreign markets?

Patent risk varies by country because:

• Reissue rights are largely U.S.-specific
• Patent terms differ by filing and grant history
• Supplementary protection certificates generally do not apply in the same way to an old copper-IUD method patent
• Regulatory classifications differ
• Device and medicinal-product requirements are not harmonized completely
• Foreign family members may have expired on different dates

A global launch review should separate U.S. patent status from European, Canadian, Australian, Latin American, and Asian rights. The expiration of U.S. RE28399 does not establish freedom to operate elsewhere.

Key Takeaways

• RE28399 claims contraception by placing elemental copper or zinc in the uterine cavity.
• The claim requires at least about 20 mm² of exposed metal surface area.
• It is not limited to a T-shaped IUD, copper wire, plastic frame, or any particular device structure.
• “Elemental metal,” “exposed surface area,” and “contraceptively effective amount” are the principal construction issues.
• RE28399 is expired and does not create current U.S. exclusivity.
• It does not create a current Paragraph IV or Orange Book litigation risk.
• ParaGard and Miudella compete through FDA approval, manufacturing, clinical evidence, and newer product-specific rights.
• Current freedom-to-operate risk depends on later device, manufacturing, insertion-system, and method-of-use patents.
• Regulatory approval remains the principal barrier to a new copper-IUD launch after expiration of the foundational patent.

FAQs

Can a new copper IUD practice RE28399 without a license?

Yes. Because RE28399 is expired, the claim does not impose a current U.S. patent-license requirement.

Does a copper coating automatically satisfy the RE28399 claim?

Not necessarily. The coating must be elemental copper, exposed to the uterine environment, and present in a contraceptively effective amount with approximately the required surface area.

Does a zinc IUD fall within the claim?

Potentially. Zinc is expressly included in the claim, but the product would still need to satisfy the exposed-area and contraceptive-effect limitations.

Can an alloy-based IUD avoid the claim?

Possibly, depending on the composition and whether elemental copper or zinc is present in the claimed form. Alloy construction would require a technical and prosecution-history analysis.

Is FDA approval required after the patent expires?

Yes. Patent expiration removes the exclusionary right but does not authorize commercial marketing. The manufacturer must satisfy the applicable FDA approval, manufacturing, labeling, and quality requirements.

References

1. U.S. Patent and Trademark Office. (n.d.). U.S. Patent RE28399. Patent Center and Patent Assignment Search.

2. U.S. Food and Drug Administration. (n.d.). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/

3. U.S. Food and Drug Administration. (n.d.). ParaGard T 380A intrauterine copper contraceptive: Prescribing information.

4. U.S. Food and Drug Administration. (2024). FDA approves new copper intrauterine device for contraception. FDA medical product announcements.

5. U.S. Patent and Trademark Office. (2015). Manual of Patent Examining Procedure, Chapter 2700: Patent terms and extensions. https://www.uspto.gov/web/offices/pac/mpep/mpep-2700.html

6. U.S. Food and Drug Administration. (n.d.). Approved drug products and therapeutic equivalence evaluations. FDA Center for Drug Evaluation and Research.

Drugs Protected by US Patent RE28399

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

International Family Members for US Patent RE28399

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	941254