United States Patent 5,843,014: Claim Scope, Expiration, and Electrotransport Patent Landscape

Executive summary: U.S. Patent No. 5,843,014 protects a user-interface and event-counting function for a patient-worn electrotransport drug-delivery device. Its core concept is simple: the device counts delivery events or other events, stores the count, and communicates that count through a predetermined number of display on/off cycles. The claims reach methods and devices using lights, LEDs, audible alarms, beepers, patient-condition sensors, and manually initiated events.

The patent issued on December 1, 1998. Its statutory 20-year term from the relevant nonprovisional filing date placed expiration in the 2016 period, subject to any recorded patent-term adjustment. The patent is therefore expired and does not create a current U.S. blocking right. It is a device-control patent, not an active-ingredient patent, formulation patent, or Orange Book-listed drug patent.

What does U.S. Patent 5,843,014 protect?

The patent protects event counting and low-information display encoding in a patient-worn electrotransport delivery system.

The independent claims are:

Claim	Category	Protected subject matter
1	Method	Counting events over a use period, storing the count, and displaying it through a predetermined number of on/off cycles
17	Apparatus	A patient-worn electrotransport device with a counter, stored count, and cycling display

The central limitation is the correlation between event count and display cycles. The display does not need to show a numerical value. A device may communicate the count by flashing an LED, sounding a beeper, or using both.

A device that merely indicates whether delivery is occurring would not necessarily satisfy the claims. The claimed system must count events and use a predetermined regimen that correlates the number of display cycles with the stored count.

What are the key claim limitations?

Counting and storing events

Claims 1 and 17 require:

An event to occur during a defined period of use.
The device to count the events.
The count to be stored.
The device to communicate the count through display cycling.

The claims do not require a particular memory technology, processor architecture, counter design, or software implementation. A microcontroller, discrete counter, nonvolatile memory, or equivalent electronic arrangement could satisfy the functional language if the remaining limitations are present.

Predetermined display regimen

Claims 1 and 17 require a predetermined relationship between the event count and the number of display on/off cycles. The regimen must be established in advance rather than generated randomly or solely as an uncorrelated status signal.

Dependent claims 2 and 18 cover a regimen in which each on/off cycle corresponds to between x and y events, with x and y being integers from 0 to 100. Claims 3 and 19 specify that zero cycles may represent zero events.

The claim language permits compression of the count. One flash could represent one event, ten events, or another defined number within the claimed range. The patent therefore covers both direct and grouped visual encoding.

Broad display formats

Claims 4 and 20 cover:

A light with lit and unlit states
An audible alarm with sounding and non-sounding states
A combination of visual and audible displays

Claims 5 and 21 specifically identify a light-emitting diode. Claims 6 and 22 specifically identify a beeper.

The claims do not appear limited to a liquid-crystal display, numerical screen, or particular LED color. The functional distinction is between an on state and an off state, or equivalent sounding and non-sounding states.

How do the method and apparatus claims differ?

The method claims cover operation of the system. The apparatus claims cover the device containing the counter and display.

Issue	Claims 1-16	Claims 17-29
Claim type	Method of displaying event count	Patient-worn electrotransport delivery device
Core requirement	Counting, storing, and displaying	Counter, stored count, and cycling display
Infringement focus	Device operation and software behavior	Hardware and programmed functionality
Event scope	Delivery, sensed condition, manual initiation	Same categories
Display scope	Light, sound, or combination	Light, sound, or combination

A product could implicate both groups. For example, a patient-worn patch with a microcontroller that counts drug-delivery intervals and flashes an LED could potentially practice both the apparatus claim and the corresponding method claim.

What events fall within the patent claims?

Electrotransport drug delivery

Claims 7, 23, and 24 specify drug delivery by electrotransport during a delivery interval. Claim 25 limits the period of use to up to approximately 24 hours.

The delivery interval must be shorter than the overall period of use under claims 8 and 24. This creates a distinction between:

The individual delivery event or interval; and
The broader period during which the device is worn or operated.

The claims are compatible with a device that delivers drug in repeated pulses, scheduled intervals, or other discrete treatment periods.

Patient-condition sensing

Claims 10, 11, 27, and 28 extend the event concept beyond drug delivery. They cover a sensor that detects a patient condition and counts instances in which that condition falls outside a predetermined range.

Potential examples include:

Physiological measurements outside a threshold
Temperature or pressure excursions
A monitored parameter exceeding a programmed limit
Patient-state events detected by an integrated sensor

The claims do not identify a specific sensor type or physiological parameter.

Manual initiation

Claims 12, 13, and 29 cover manually initiated events, including events triggered by patient activation of a switch.

This language could reach a device in which the patient presses a button to initiate delivery, acknowledge a condition, start a treatment interval, or create another countable event. The switch must be tied to the event-counting functionality; a button unrelated to the count would not by itself satisfy the limitation.

What is excluded from the patent’s claim scope?

The patent does not, based on the supplied claims, claim:

A specific drug or active pharmaceutical ingredient
A drug formulation or excipient system
An electrode composition
A transdermal reservoir
A particular iontophoretic current waveform
A specific battery or power architecture
A therapeutic indication
A manufacturing process for the patch
A numeric display as such
A general patient-monitoring system without the electrotransport-device context of the independent claims

The claims are directed to event accounting and user notification within a patient-worn electrotransport platform. A formulation or electrode patent would need to be analyzed separately.

How strong is the patent estate for electrotransport display counting?

The patent had meaningful historical scope but limited present-day commercial value because it has expired.

Historical strengths

The claims had several features favorable to enforcement:

Independent method and apparatus claims
Broad event definition
Coverage of visual and audible displays
Coverage of drug-delivery events, sensed conditions, and manual events
No limitation to a specific microprocessor, memory, or circuit design
Coverage of grouped event counts rather than only one-flash-per-event systems

Scope limitations

The claims also required several elements that narrowed infringement:

The device must be patient-worn.
The device must be an electrotransport delivery device.
The counter must count events over a period of use.
The count must be stored.
The display must cycle according to a predetermined correlation.
For the drug-delivery claims, the event must relate to an electrotransport delivery interval.

A conventional insulin pump, wearable monitor, or smartphone application would not automatically fall within the claims. The electrotransport and patient-worn limitations are important claim boundaries.

Patent-strength assessment

Factor	Assessment
Claim breadth	Moderate to broad within electrotransport user interfaces
Technical specificity	Functional rather than circuit-specific
Design-around difficulty	Moderate
Drug-chemistry coverage	None apparent
Formulation coverage	None apparent
Current enforceability	None after expiration
Historical relevance	Highest for early wearable electrotransport systems
Orange Book relevance	None apparent

When did U.S. Patent 5,843,014 lose exclusivity?

The patent issued December 1, 1998. Under the post-1995 patent-term regime, utility patents generally expire 20 years from the earliest effective nonprovisional filing date, subject to patent-term adjustment or extension under 35 U.S.C. §§ 154 and 156.

The statutory term placed this patent’s expiration in approximately 2016. A patent-term adjustment could change the exact date, but any such adjustment would not extend the patent into the current period absent an unusual recorded extension. Patent term extension under Section 156 is generally associated with qualifying regulatory review of a drug or medical device and would not ordinarily apply to a user-interface patent of this type. [2]

Milestone	Date or period
U.S. patent issued	December 1, 1998
Statutory term basis	20 years from applicable nonprovisional filing date
Estimated expiration period	2016
Current status	Expired
Current blocking effect	None for new U.S. activity

An expired patent can remain relevant to historical infringement claims arising before expiration, subject to applicable limitation periods and procedural defenses. It cannot support a new injunction against conduct occurring after expiration.

What is the Orange Book status of U.S. Patent 5,843,014?

U.S. Patent 5,843,014 is not an Orange Book drug patent based on the claim subject matter supplied.

The FDA Orange Book identifies patents submitted for approved drug products, including qualifying drug substance, drug product, and method-of-use patents. This patent claims a patient-worn electrotransport device and its event-display operation. It does not claim an active ingredient, drug formulation, or therapeutic method tied to a specific approved drug product. [3]

Orange Book issue	Assessment
Drug substance patent	No
Drug product or formulation patent	No
Method-of-use patent for a named drug	No
Device-control patent	Yes
Paragraph IV relevance	None apparent
ANDA blocking role	None apparent

A generic-drug applicant would not normally need to address this patent through a Paragraph IV certification unless the patent had been properly listed for a relevant approved drug product, which is inconsistent with the supplied claim scope.

Do Paragraph IV challenges or biosimilar risks apply?

Paragraph IV challenges

Paragraph IV litigation is directed to patents listed for an approved drug product in the FDA Orange Book. The patent’s claims are device-oriented and do not identify a drug product or active ingredient. It therefore does not present a conventional Paragraph IV barrier to an ANDA applicant.

A manufacturer could still face separate patent issues involving:

The electrotransport device itself
A drug formulation
Electrode materials
Drug-device combination packaging
Manufacturing methods
A branded patch or delivery platform

Those issues would arise from other patents, not from the claims supplied for U.S. Patent 5,843,014.

Biosimilar risk

Biosimilar litigation under the Biologics Price Competition and Innovation Act does not apply to this patent. The patent does not claim a biologic, biologic formulation, manufacturing process, or method of using a named biologic. It has no direct biosimilar exclusivity function.

What generic launch risks exist?

The patent creates no current generic-launch risk because it is expired. A current competitor can use the claimed event-counting concept without infringing this patent, although later patents may cover specific implementations.

The relevant commercial risk has shifted from patent blocking to freedom-to-operate review of newer patents covering:

Wearable patch construction
Closed-loop control
Dose scheduling
Wireless communications
Mobile-app integration
Sensor algorithms
Battery management
Electrode geometry
Drug reservoirs and adhesives
Combination products

An expired foundational patent can still affect prosecution and validity analysis as prior art. Its disclosure may support obviousness arguments against later patents that claim similar event-counting or status-display systems.

What design-arounds avoid the asserted claim architecture?

Before expiration, potential design-around strategies could have included:

Using a continuous numerical display rather than on/off cycle encoding.
Displaying only current delivery status without displaying a stored event count.
Transmitting the count to an external reader rather than displaying it on the patient-worn device.
Using an uncorrelated warning signal rather than a predetermined event-to-cycle regimen.
Omitting storage of the event count on the patient-worn device.
Counting cumulative dose instead of discrete events, if the implementation did not meet the event-count limitations.
Using a non-electrotransport device.
Removing the patient-worn configuration.
Displaying a code or message without cycling between on and off states.
Using a display function unrelated to drug delivery, patient-condition sensing, or manual event initiation.

The strength of any design-around would depend on the full system architecture and claim construction. Since the patent is expired, these approaches are no longer needed to avoid current infringement of this patent, but they remain useful in analyzing its historical scope.

What licensing deals or litigation affect the patent?

The claims supplied do not identify a license, settlement, consent judgment, reexamination, or litigation outcome. The patent itself is not a settlement agreement and does not create a commercial license.

No current litigation posture can be inferred from the claims alone. Any historical enforcement analysis would require the prosecution history, assignment records, maintenance-fee record, terminal disclaimer record, and federal court docket history. The patent’s expiration removes current injunctive leverage but does not erase historical ownership or pre-expiration damages issues.

How does this patent compare with formulation and electrotransport hardware patents?

Patent category	Typical protected subject matter	Relationship to U.S. 5,843,014
Drug substance patent	Active ingredient or chemical entity	Separate
Formulation patent	Drug composition, excipients, release profile	Separate
Electrode patent	Electrode materials and structure	Separate
Power-control patent	Current generation and regulation	Separate
Reservoir patent	Drug storage and delivery layer	Separate
Sensor patent	Physiological sensing hardware or algorithms	Potentially adjacent
Display-control patent	Event counting and display encoding	Core subject of 5,843,014
Manufacturing patent	Assembly or fabrication process	Separate

The patent is best classified as a control, monitoring, and user-interface patent within the broader electrotransport platform. It does not protect the commercial viability of a drug independently of the delivery device.

Key takeaways

U.S. Patent 5,843,014 covers counting and storing events in a patient-worn electrotransport device.
Its principal innovation is displaying the count through a predetermined number of light or sound on/off cycles.
Claims cover drug-delivery intervals, sensed patient conditions, and manually initiated events.
Claims 1 and 17 are the principal independent method and apparatus claims.
LEDs, beepers, lights, audible alarms, sensors, and manual switches are expressly covered by dependent claims.
The patent does not claim a drug, formulation, electrode, reservoir, or delivery chemistry.
The patent issued December 1, 1998 and expired in approximately 2016 under the 20-year patent-term framework.
It is not an Orange Book drug patent and does not create a conventional Paragraph IV or biosimilar barrier.
Current commercial freedom-to-operate risk must be assessed against later electrotransport, wearable-device, sensor, software, formulation, and manufacturing patents.
The patent remains relevant as prior art and for historical infringement analysis, but it has no current blocking effect after expiration.

FAQs

Is U.S. Patent 5,843,014 a drug patent or a medical-device patent?

It is primarily a medical-device control and display patent. Its claims concern event counting and display behavior in a patient-worn electrotransport delivery device, not the drug itself.

Does flashing an LED once per dose infringe the patent?

Historically, it could have raised infringement risk if the device counted and stored delivery events and used a predetermined correlation between the number of flashes and the count. The patent is now expired.

Does the patent cover a smartphone app that displays electrotransport delivery history?

Not based on the supplied claims alone. The independent claims require the patient-worn electrotransport delivery device and its display or device architecture. A separate external application would require a different infringement analysis.

Can a company launch an electrotransport product using this display concept today?

This patent does not prevent launch because it has expired. The company must still review later-expiring patents covering the specific patch, electronics, software, sensors, formulation, electrodes, and manufacturing process.

Does the patent create exclusivity for analgesic delivery?

No. Claim 26 identifies an analgesic as one possible drug, but the patent does not create exclusivity over analgesics generally. Its subject matter is the event-counting and display functionality of the electrotransport device.

References

U.S. Patent No. 5,843,014, claims 1-29 (issued Dec. 1, 1998).
35 U.S.C. §§ 154, 156, 271, 282 (2024).
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.
U.S. Patent and Trademark Office. (2024). Manual of Patent Examining Procedure, Chapter 2700: Patent term. USPTO.

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	231016	⤷ Start Trial
Australia	5311196	⤷ Start Trial
Australia	693683	⤷ Start Trial
Brazil	9607960	⤷ Start Trial
Canada	2214564	⤷ Start Trial
China	1144603	⤷ Start Trial
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Details for Patent: 5,843,014

Summary for Patent: 5,843,014