US Patent 4,040,417: Scope, Claims, Expiration, and Copper IUD Patent Landscape

US Patent 4,040,417 covers an intrauterine contraceptive device containing a contraceptively effective amount of a non-toxic copper or zinc compound. Claims 2 and 3 narrow the invention to copper oxide or non-toxic copper salts and, for claim 3, a uterine delivery rate of approximately 2 micrograms to 2 milligrams of soluble copper per day.

The patent issued in 1977 under the pre-Uruguay Round patent-term regime. Its 17-year term from grant expired in 1994, absent an unusual extension or terminal-disclaimer issue. The patent therefore has no current blocking effect on copper IUD manufacture, FDA submissions, licensing, or generic-device competition. It is also not an Orange Book-listed pharmaceutical patent because the claimed product is a medical device rather than an FDA-approved drug product. (U.S. Patent No. 4,040,417, 1977; USPTO, n.d.)

What does US Patent 4,040,417 protect?

The patent protects an intrauterine contraceptive device that contains a contraceptively effective amount of a non-toxic copper or zinc compound. The claim is directed to the combination of:

An intrauterine device;
Adaptability for insertion into the uterine cavity;
Capability of prolonged retention in the uterus; and
A contraceptively effective amount of copper or zinc compound.

The claims do not require a particular frame shape, copper wire configuration, polymer composition, insertion tube, radiopaque marker, or release-control coating.

Claim structure

Claim	Scope	Principal limitation
1	Independent device claim	IUD containing a contraceptively effective amount of a non-toxic copper or zinc compound
2	Dependent claim	Compound is copper oxide or a non-toxic copper salt
3	Dependent claim	Soluble copper delivery in the uterus is approximately 2 micrograms to 2 milligrams per day

Claim 1 is the broadest claim. It covers both copper and zinc compounds and is not limited to a specific chemical species. Claim 2 excludes zinc and narrows the compound to copper oxide or a non-toxic copper salt. Claim 3 narrows claim 2 by adding a daily soluble-copper release range.

How should claim 1 be interpreted?

Claim 1 is a broad combination claim with functional and compositional limitations.

Intrauterine device requirement

The accused product must be an intrauterine device capable of insertion into the uterine cavity and prolonged retention. A device intended for short-term placement, vaginal administration, cervical placement, or systemic delivery would not ordinarily satisfy this limitation.

The claim does not expressly require:

A T-shaped frame;
Copper wire wound around a polymer arm;
Copper sleeves;
A particular copper surface area;
A particular uterine residence period;
A specified insertion procedure; or
A defined mechanism of contraceptive action.

The phrase "including" generally operates as an open transition. A device containing additional drugs, polymers, coatings, radiopaque materials, or structural components could still fall within the claim if the required copper or zinc compound is present.

Copper or zinc compound

The claim covers a non-toxic compound of copper or zinc, not necessarily elemental copper or elemental zinc. Claim 1 is broader than claim 2 because it is not limited to copper oxide or copper salts.

Potentially relevant materials include:

Copper oxides;
Copper salts;
Zinc salts;
Other non-toxic copper compounds; and
Other non-toxic zinc compounds.

The claim does not define "non-toxic" by a numerical toxicity threshold. The limitation would likely be assessed in the context of the device, dose, release profile, and intended intrauterine use.

Contraceptively effective amount

The term "contraceptively effective amount" is functional. It requires enough compound to contribute to contraceptive efficacy, but claim 1 does not state a numerical loading or release rate.

That limitation creates potential claim-construction issues. A device containing trace copper as a colorant, manufacturing impurity, or incidental component would not necessarily meet the claim. A device designed to release copper ions for contraceptive purposes would present a stronger claim-coverage case.

What does claim 2 add?

Claim 2 requires the compound to be a copper oxide or a non-toxic copper salt.

This limitation excludes devices relying exclusively on:

Zinc compounds;
Elemental copper, if the product does not also contain a claimed copper oxide or copper salt;
Unrelated metal compounds; or
Copper-containing materials that do not qualify as an oxide or salt.

The claim remains broad regarding device architecture. It does not specify whether copper is present as wire, powder, coating, embedded particles, a copper-bearing polymer, or another physical form.

A copper-bearing IUD could therefore implicate claim 2 based on the chemical identity of the released or incorporated copper compound, even if its mechanical design differs materially from earlier copper IUDs.

What does claim 3 protect?

Claim 3 adds a release-rate limitation: the oxide or salt must provide approximately 2 micrograms to 2 milligrams of soluble copper per day in the uterus.

Quantitative range

Parameter	Claimed value
Lower bound	Approximately 2 micrograms soluble copper per day
Upper bound	Approximately 2 milligrams soluble copper per day
Equivalent range	Approximately 0.002 to 2 milligrams per day

The range is unusually broad, spanning three orders of magnitude. It is also a release-rate limitation rather than a total copper-loading limitation.

A device could contain a large quantity of copper but fall outside claim 3 if its soluble copper release rate is below or above the stated range. Conversely, a device with a relatively small total copper load could fall within the claim if it releases soluble copper at the required rate during uterine use.

Measurement issues

Claim 3 raises several technical questions:

Whether the rate is measured in vivo or by an in vitro extraction protocol;
Whether "in the uterus" refers to copper entering uterine fluid or copper released from the device;
Whether the rate must remain within the range throughout the full use period;
Whether the range applies to average daily release or instantaneous release;
How soluble copper is distinguished from particulate or non-soluble copper; and
Whether copper released as ions, complexes, or dissolved salts is included.

Those issues would matter in an infringement or validity dispute. The claim language does not itself provide a detailed analytical method.

When did US Patent 4,040,417 lose exclusivity?

The patent issued on August 9, 1977. Under the patent-term rules applicable to the patent, the term was generally 17 years from grant. That places the ordinary expiration date in August 1994. (U.S. Patent No. 4,040,417, 1977; USPTO, n.d.)

Event	Date or status
Patent issued	August 9, 1977
Applicable term regime	17 years from grant
Approximate ordinary expiration	August 9, 1994
Current enforceability	Expired
Current exclusivity	None

The 20-year-from-effective-filing-date regime introduced by the Uruguay Round Agreements Act generally applies to later applications and does not revive or extend an already expired pre-1995 patent term.

Is US Patent 4,040,417 listed in the Orange Book?

No current Orange Book relevance should be expected.

The FDA Orange Book identifies approved drug products and certain patents submitted for those drug products. A copper IUD is regulated as a medical device, not as an orally administered or otherwise conventional drug product. Device patents are not ordinarily listed in the Orange Book in the same manner as patents for approved drug products. (FDA, n.d.-a)

The relevant regulatory records are instead found through FDA medical-device databases, device approvals, manufacturer submissions, labeling, and postmarket records.

Does the patent create Paragraph IV risk?

No. Paragraph IV certification applies to an abbreviated new drug application, or ANDA, challenging patents listed for a reference-listed drug. It does not ordinarily govern an intrauterine contraceptive device.

A competitor seeking to market a copper IUD would therefore not normally file a Paragraph IV certification against US Patent 4,040,417. The patent expired decades ago, eliminating any current patent-based ANDA or device-launch barrier.

Potential regulatory pathways depend on the product's classification, substantial-equivalence position, predicate-device availability, and FDA requirements. Those questions are separate from the expired patent.

What formulations and device designs were covered?

The patent's claim language is formulation-neutral and design-neutral within broad limits.

Potentially covered configurations

The language could reach an IUD containing copper or zinc compound in forms such as:

Copper wire;
Copper sleeves;
Copper oxide coatings;
Copper salt-containing polymer;
Copper particles embedded in a device;
Copper-bearing inserts; or
Zinc compound incorporated into an intrauterine device.

The claims do not expressly require a particular release-control system. They also do not require copper to be placed on the arms, stem, or another specified part of the device.

Excluded or weaker coverage scenarios

Coverage would be weaker where:

The device contains no copper or zinc compound;
Copper is present only as an incidental impurity;
The device is not intended for uterine insertion and retention;
The compound is not non-toxic at the relevant exposure level;
The amount is not contraceptively effective; or
For claim 3, soluble copper release is outside the stated range.

Because the patent is expired, these distinctions matter mainly for historical claim analysis, freedom-to-operate studies concerning related patents, and interpretation of the technical contribution.

How does this patent compare with later copper IUD patents?

US Patent 4,040,417 sits in the foundational part of the copper-IUD patent landscape. Its claims focus on the basic concept of using a copper or zinc compound in a retained intrauterine contraceptive device.

Later patent activity generally shifted toward narrower technology, including:

Specific T-shaped device architectures;
Copper wire placement and fixation;
Copper sleeves and collars;
Surface-area optimization;
Controlled ion release;
Polymer carriers;
Insertion systems;
Radiopaque components;
Manufacturing processes; and
Improvements intended to reduce expulsion, bleeding, breakage, or insertion trauma.

The practical distinction is important. A later patent could remain relevant to a modern product even though the foundational compound-in-IUD patent has expired. A product may be free of US Patent 4,040,417 but still require analysis of later structural, manufacturing, formulation, or method patents.

What patent litigation affects this patent?

The expired status of US Patent 4,040,417 removes it as a current enforcement asset. No active US infringement case based solely on this patent should create a present market barrier.

Historical litigation risk would have depended on:

Whether the patent was assigned or licensed;
Whether a competing copper IUD was sold before expiration;
Whether the product contained a qualifying copper or zinc compound;
Whether the compound was contraceptively effective;
Whether claim 3's release-rate range could be proven; and
Whether prior-art or enablement defenses defeated the claims.

A current competitor should focus on later-expiring patents, regulatory exclusivity, trade secrets, manufacturing know-how, and product-specific FDA requirements rather than this patent.

Were licensing deals or settlement agreements relevant?

The patent itself does not establish a continuing license requirement. Any historical license, settlement, covenant not to sue, or assignment would be a private transaction and would not extend the patent's statutory term.

A settlement agreement could have affected historical market conduct, but it could not ordinarily restore patent exclusivity after expiration. Contractual obligations may survive expiration in limited circumstances, but they are distinct from patent rights and cannot be inferred from the claims alone.

Does the patent create biosimilar risk?

No. Biosimilar regulation applies to biological products. A copper IUD is neither a biologic nor a biosimilar reference product.

The relevant competitors are:

Copper IUD manufacturers;
Private-label device suppliers;
Contract manufacturers;
Foreign manufacturers seeking US clearance; and
Developers of non-hormonal intrauterine systems.

The principal commercial barriers are clinical evidence, manufacturing validation, FDA clearance or approval, quality systems, distribution, reimbursement, and physician adoption.

What is the current commercial significance?

US Patent 4,040,417 has no residual patent-term revenue exposure. Its commercial significance is historical and technical.

The patent helped define an early intellectual-property concept for copper-mediated intrauterine contraception. Current revenue exposure depends on later rights and market factors, including:

The commercial position of established copper IUD brands;
Manufacturer control over validated production;
FDA regulatory status;
Supply continuity;
Physician and patient familiarity;
Long-term safety data;
Pricing and reimbursement; and
Geographic approvals.

A freedom-to-operate review should treat the patent as expired background prior art. It should not treat the patent as an active blocking patent.

What geographic coverage remains?

US Patent 4,040,417 provided rights only in the United States. Any foreign counterparts would have been governed by separate national patent terms and prosecution histories. Expiration of the US patent did not automatically determine the status of foreign family members.

For a global launch, the relevant analysis must separate:

US patent expiration;
European national or European Patent Convention rights;
Canadian rights;
Latin American rights;
Asian rights; and
Country-specific regulatory approvals.

The US expiration date cannot be used as a proxy for worldwide freedom to operate.

What manufacturing and IP barriers remain after expiration?

The patent does not create a current manufacturing barrier. Practical barriers may remain in:

Reproducible copper release;
Control of copper surface area;
Polymer-device bonding;
Sterilization;
Packaging and shelf life;
Insertion-device compatibility;
Biocompatibility;
Dimensional consistency;
Production-scale validation; and
FDA quality-system compliance.

Manufacturing know-how may be protected as confidential information even when the underlying patent has expired. Later patents may also cover particular assembly methods, copper geometries, coatings, or delivery systems.

Key Takeaways

US Patent 4,040,417 claims an IUD containing a contraceptively effective amount of a non-toxic copper or zinc compound.
Claim 2 narrows coverage to copper oxide or non-toxic copper salts.
Claim 3 adds a soluble-copper release range of approximately 2 micrograms to 2 milligrams per day.
The claims are broad regarding IUD structure and copper-compound placement.
The patent issued on August 9, 1977, and its ordinary 17-year term expired in 1994.
It is not a current Orange Book patent and does not create Paragraph IV risk.
It has no biosimilar relevance.
Current market entry analysis should focus on later patents, FDA device requirements, manufacturing know-how, and foreign rights.
The patent has historical importance but no present US exclusivity value.

FAQs

Can an IUD containing elemental copper infringe claim 1?

Potentially, depending on whether the product includes a qualifying copper compound and whether the court treats the claimed compound requirement as satisfied by the product's chemical form and release behavior. The patent is expired, so the issue has no current US enforcement consequence.

Does claim 3 cover the total amount of copper in an IUD?

No. Claim 3 addresses soluble copper provided in the uterus per day. Total copper loading and daily soluble-copper release are different technical parameters.

Can a modern copper IUD be blocked by this patent?

No. US Patent 4,040,417 expired in 1994. A modern product could face later patent claims or regulatory barriers, but not an enforceable exclusion right under this patent.

Does the patent cover hormonal intrauterine devices?

Not on the face of the quoted claims. The claims require a contraceptively effective copper or zinc compound. A hormonal IUD without such a compound would not meet that limitation.

Does expiration in the United States eliminate foreign patent risk?

No. US expiration applies only to US rights. Foreign family members must be reviewed separately by country, including their expiration dates, maintenance status, claim scope, and post-grant amendments.

References

Food and Drug Administration. (n.d.-a). Approved drug products with therapeutic equivalence evaluations: Orange Book. U.S. Department of Health and Human Services. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book
Food and Drug Administration. (n.d.-b). Medical devices. U.S. Department of Health and Human Services. https://www.fda.gov/medical-devices
U.S. Patent and Trademark Office. (n.d.). Patent term adjustment and patent term information. U.S. Department of Commerce. https://www.uspto.gov/patents/laws/patent-term-adjustment
U.S. Patent No. 4,040,417. (1977). Intrauterine contraceptive device. Issued August 9, 1977.

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	941254	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 4,040,417

Summary for Patent: 4,040,417