Details for Patent: 7,978,064

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Which drugs does patent 7,978,064 protect, and when does it expire?

Patent 7,978,064 protects ABILIFY MYCITE KIT and is included in one NDA.

This patent has one hundred and twenty-eight patent family members in twenty-three countries.

Summary for Patent: 7,978,064

Title:	Communication system with partial power source
Abstract:	The system of the present invention includes a conductive element, an electronic component, and a partial power source in the form of dissimilar materials. Upon contact with a conducting fluid, a voltage potential is created and the power source is completed, which activates the system. The electronic component controls the conductance between the dissimilar materials to produce a unique current signature. The system can be used in a variety of different applications, including as components of ingestible identifiers, such as may be found in ingestible event markers, e.g., pharma-informatics enabled pharmaceutical compositions.
Inventor(s):	Mark Zdeblick, Timothy Robertson, Aleksandr Pikelny, Hooman Hafezi
Assignee:	Otsuka Pharmaceutical Co Ltd
Application Number:	US12/564,017
Patent Claim Types: see list of patent claims	Use; Process; Device;

US Patent 7,978,064: Claim Scope, Expiration, Litigation Risk and Ingestible Sensor Patent Landscape

US Patent 7,978,064, titled “Communication System with Partial Power Source,” covers an ingestible or fluid-activated communication device that generates its own electrical potential through contact between dissimilar materials and a conductive liquid. A control circuit varies conductance between the materials, causing the liquid to radiate a detectable current signature that encodes information.[1]

The patent’s commercial importance is concentrated in four elements: a galvanic power source, a control device that modulates current, ionic or mass transfer through a conductive fluid, and remote detection of the resulting signal. Claims 7 through 12 are directed most specifically to pharmaceutical event markers. Claims 13 through 17 broaden the technology to communication through conducting fluids, including physiological fluids.

The patent is not an active-ingredient patent. It does not claim a chemical drug, therapeutic indication, formulation excipient, or conventional pharmaceutical manufacturing process. It is a device and method patent relevant to ingestible sensors, digital medicines, medication-adherence systems, and physiological-fluid communication.

What does US Patent 7,978,064 cover?

The patent covers a passive or “partial-power” signaling architecture in which the conductive liquid supplies the electrochemical energy. The device does not require a conventional battery as the claimed power source.

The core technical sequence is:

1. Two electrically isolated materials contact a conductive liquid.
2. The materials develop a voltage potential difference.
3. A control device changes conductance between the materials.
4. The conductance change alters current flow, ionic emission, or mass transfer.
5. The surrounding liquid radiates a current signature.
6. A receiver remotely detects and decodes the signature.

The claims therefore combine electrochemistry, low-power switching, conductive-fluid signaling, and remote event detection.

Patent identification and legal status

Item	Detail
Patent	US 7,978,064 B2
Title	Communication System with Partial Power Source
Issue date	July 12, 2011
Technology	Conductive-fluid communication and ingestible event marking
Principal commercial field	Ingestible sensors and digital medicines
Claim categories	System, event-marking apparatus, manufacturing method, ionic-emission communication
Active-ingredient claim	None
Orange Book drug patent	Not a conventional Orange Book-listed drug patent
Expected statutory term	Extends into the late 2020s, subject to the USPTO term record and any applicable adjustment
Key assignee context	Proteus-related ingestible-sensor technology

The patent’s claims are structurally broad in claims 1 and 13, but infringement generally requires proof of the claimed electrochemical and conductance-control architecture. A product that merely contains a sensor, transmits radio signals, or detects ingestion does not necessarily practice these claims.

How are the independent claims structured?

Claim 1: Conductive-liquid communication system

Claim 1 requires:

• a control device for altering conductance;
• a first material electrically connected to the control device;
• a second material electrically connected to the control device;
• electrical isolation between the two materials;
• a voltage potential difference generated when the materials contact a conducting liquid;
• variable current flow caused by the control device;
• information encoded in a signal radiated by the conducting liquid; and
• remote detection by a receiver.

This is the principal system claim. It is not limited to a pharmaceutical product, ingestion, physiological fluid, or a particular pair of electrode materials.

The claim’s breadth comes from its functional language. It does not specify a particular semiconductor, electrode composition, switching frequency, receiver architecture, or modulation protocol. Its limiting features are the combination of electrochemical power generation and conductance-based signaling through the conducting liquid.

Claim 7: Ingestible event-marking apparatus

Claim 7 narrows the technology to an event marking apparatus associated with ingestion of a pharmaceutical product. It requires:

• an ingestible pharmaceutical product;
• a support structure;
• a control device secured to the structure;
• first and second electrically isolated materials;
• a non-conductive membrane;
• an extended current path around the membrane through conductive fluid;
• a voltage potential difference generated by contact with conductive fluid;
• switching logic controlling conductance; and
• a remotely detectable current signature.

Claim 7 is the most commercially relevant claim for ingestible digital medicines. It is also more vulnerable to design-around than claim 1 because it requires a pharmaceutical product, a support structure, and a non-conductive membrane positioned to extend the current path.

Claim 10: Manufacturing method

Claim 10 covers manufacturing an operational device by:

• securing a control module to a support structure;
• depositing an anode material;
• depositing a cathode material at an electrically isolated location;
• electrically coupling both materials to the control module;
• selecting materials that produce voltage in conductive fluid; and
• using the control module to vary conductance and produce a remotely detectable current signature.

This claim can reach manufacturing activity even when the finished device is incorporated into a larger dosage form by another entity. Its practical enforcement value depends on whether the accused manufacturer performs each deposition, coupling, and control step.

Claim 13: Ionic-emission communication system

Claim 13 is the second broad independent system claim. It focuses on:

• two solid materials;
• voltage generation through contact with conductive fluid;
• ionic emission as the power mechanism;
• conductance variation by a control module;
• control of mass transfer between the material and the fluid; and
• communication through variation in ionic-emission rate.

Claim 13 uses electrochemical terminology more explicitly than claim 1. Claims 14 and 15 further define mass transfer, oxidation, and reduction. Claim 17 identifies physiological fluid as the conducting fluid.

What do dependent claims 2 through 6 and 8 through 17 add?

Claims	Added limitation	Commercial or legal effect
2	Switching module changes conductance	Narrows the control device to a switching implementation
3	Support structure carries the materials	Targets integrated sensor construction
4	Current-path extender	Supports signal amplification through geometry
5	Current-path extender is a membrane	Narrows the extender architecture
6	Materials on opposite sides of support with non-conductor between them	Targets layered or sandwich constructions
8	First material is anode; second is cathode	Adds electrochemical polarity
9	Materials deposited on different sides of support	Covers multilayer fabrication
11	Non-conductive material increases current-path length	Targets signal boosting by path extension
12	Non-planar electrode surfaces increase area	Covers textured, folded, rough, or three-dimensional electrodes
14	Conductance changes mass transfer from the second material	Narrows the ionic mechanism
15	Oxidation at one material and reduction at the other	Expressly defines galvanic electrochemistry
16	Coating delays communication enablement	Covers delayed activation or timed exposure
17	Conducting fluid is physiological fluid	Targets bodily fluids, including gastrointestinal fluid

Claims 11 and 12 are important for physical design. They attempt to prevent simple signal-strength workarounds based on longer electrochemical paths or increased electrode surface area.

What technical elements are most important for infringement?

A potentially infringing product would normally need to satisfy five technical questions.

1. Does the product use two dissimilar or otherwise electrochemically active materials?

The claims require materials that produce a voltage potential difference when contacting a conductive liquid. A conventional battery enclosed inside a capsule may not satisfy this limitation if the battery, rather than the liquid-contacting materials, supplies the claimed potential.

2. Are the materials electrically isolated before activation?

Claims 1, 7, and 13 require separate electrical paths or electrically isolated materials. A single conductive coating or integrated electrode may avoid literal infringement if it does not provide the claimed two-material architecture.

3. Does a control device vary conductance between the materials?

The control operation is central. A device that merely produces a fixed electrochemical signal without actively varying conductance may avoid the independent claims, depending on its circuit design and claim construction.

4. Is the information carried by the conducting liquid or ionic emission?

The claims require a signal radiated by the conducting liquid, or communication through ionic-emission rate. A sensor using only conventional RF transmission from an onboard antenna may present a materially different architecture.

5. Can a receiver remotely detect the signature?

The claims require remote detectability. Local electrochemical sensing without a remote receiver may fall outside the literal scope.

What patent landscape surrounds US 7,978,064?

The relevant landscape has four overlapping patent groups:

Patent group	Covered subject matter	Relationship to US 7,978,064
Conductive-fluid communication	Ionic emission, electrochemical signaling, fluid-mediated transmission	Closest technical overlap
Ingestible event markers	Sensors activated by gastrointestinal fluid and associated with a dosage form	Commercially overlapping
Digital medicine systems	Ingestible sensor, wearable receiver, software platform, adherence record	Often complementary rather than duplicative
Drug-specific patents	Active ingredient, formulation, indication, dosage regimen	Separate from the ’064 patent

The Proteus patent estate included related filings directed to ingestible event markers, sensor construction, receiver systems, signal processing, and integration with pharmaceutical products. A freedom-to-operate review cannot stop at the ’064 patent. A commercial digital medicine product may practice separate patents covering:

• the ingestible sensor;
• the external receiver or wearable patch;
• the data-processing platform;
• synchronization with a mobile device;
• authentication of the ingestion event;
• drug-device integration;
• specific formulations or dosage forms; and
• methods of monitoring adherence or treatment response.

The ’064 claims are therefore best viewed as an electrochemical signaling layer within a broader patent estate.

What formulations are protected by US 7,978,064?

The patent does not claim a specific active pharmaceutical ingredient or therapeutic formulation. Claim 7 requires “a pharmaceutical product in an ingestible form,” but the claim does not identify a particular drug.

The patent can therefore be relevant to multiple dosage forms, including:

• tablets;
• capsules;
• multiparticulates;
• orally disintegrating dosage forms;
• solid oral dosage forms containing an embedded sensor; and
• pharmaceutical products secured to or carrying the event-marking system.

The claim does not automatically cover every formulation containing an ingestible sensor. A competing formulation may avoid claim 7 if the sensor is not secured to the product, lacks the required support structure or membrane, or uses a different activation and signaling mechanism.

Drug-specific patents remain separately relevant. For example, a product combining an ingestible sensor with aripiprazole could face protection from the digital-medicine patent estate and from aripiprazole formulation or method-of-use patents. The ’064 patent itself does not claim aripiprazole, Abilify, MyCite, or any other named drug.

What is the Orange Book status of US 7,978,064?

US 7,978,064 is not the type of patent ordinarily listed in the FDA Orange Book as a drug-substance, drug-product, or approved-use patent.[2] It claims a communication system and event-marking apparatus rather than the active ingredient or approved pharmaceutical formulation.

The consequences are significant:

• An ANDA applicant generally would not address this patent through an Orange Book Paragraph IV certification unless the patent were separately listed against a relevant approved drug.
• A patent infringement action based on the ’064 patent would more likely arise from manufacture, use, sale, or importation of an ingestible sensor or digital medicine product under 35 U.S.C. § 271.
• The patent does not itself create FDA drug exclusivity.
• The patent does not block approval of a conventional generic drug that does not use the claimed sensor architecture.

A digital medicine product may still have separate Orange Book-listed patents covering the drug, formulation, or approved method of use. Those listings must be analyzed independently from the ’064 patent.

When does US 7,978,064 lose exclusivity?

The patent’s statutory term runs from the relevant nonprovisional filing date and normally lasts 20 years, subject to patent-term adjustment, terminal disclaimer, and any applicable regulatory extension.[3]

The patent issued in 2011 and is expected to remain relevant into the late 2020s. The precise expiration date must be taken from the USPTO Patent Center term calculation for US 7,978,064, including any patent-term adjustment. Because the patent is a device patent rather than a drug patent, Hatch-Waxman patent-term extension under 35 U.S.C. § 156 is generally not the principal term framework.

The business impact of expiration is narrower than the expiration of an active-ingredient patent. Expiration would remove the ’064 patent as a barrier to the claimed electrochemical signaling architecture, but would not eliminate separate patents covering:

• ingestible event-marker designs;
• receiver patches;
• software;
• data transmission;
• drug-device combinations;
• specific formulations; or
• methods of using digital medicines.

Are there Paragraph IV challenges to US 7,978,064?

No direct Paragraph IV pathway is inherent in this patent because the claims are not conventional drug claims and the patent is not, by its claim language, an active-ingredient or drug-product patent.

A generic drug manufacturer could face infringement risk only if its product incorporates an ingestible event marker or related system practicing the claims. In that case, the dispute would likely involve ordinary patent infringement litigation, declaratory judgment, licensing, or design-around analysis rather than a conventional Paragraph IV challenge.

A drug company seeking to launch an ordinary generic tablet without an ingestible sensor would generally have no reason to address the ’064 claims.

What patent litigation and settlement risks affect the technology?

The highest litigation risk applies to products that combine:

• a pharmaceutical dosage form;
• an embedded or attached electrochemical sensor;
• activation in gastrointestinal fluid;
• conductance modulation;
• ionic or current-signature communication; and
• a wearable or external receiver.

Potential defendants could include the sensor manufacturer, pharmaceutical sponsor, contract manufacturer, or entity responsible for the combined drug-device product. Liability may differ by actor because claim 10 is a manufacturing method claim, while claims 1 and 13 are system claims and claim 7 is an apparatus claim.

Settlement agreements may also be structured around:

• field-of-use licenses;
• specific drug products;
• geographic territory;
• sensor supply arrangements;
• rights to sublicense pharmaceutical companies; and
• covenants not to sue for particular product configurations.

Public patent records do not establish that every commercial digital-medicine product is licensed under this specific patent. Commercial agreements should be reviewed separately from assignment records and patent ownership records.

How strong is the patent estate for an ingestible sensor competitor?

The ’064 patent has meaningful blocking potential where a competitor uses the same electrochemical principle. Its strongest features are:

• broad coverage of conductive-liquid power generation;
• conductance-based modulation;
• remote detection;
• ionic-emission communication;
• application to pharmaceutical ingestion; and
• claims covering both systems and manufacturing methods.

Its principal weaknesses or design-around opportunities are:

• reliance on two electrically isolated materials;
• dependence on conductive-fluid activation;
• required conductance variation;
• required fluid-radiated or ionic-emission signaling;
• membrane and support-structure limitations in the ingestible claims; and
• lack of coverage for conventional battery-powered RF systems.

A competitor using a sealed battery, optical signaling, ultrasound, magnetic coupling, or a fully different electrochemical architecture may reduce exposure. The analysis turns on the actual circuit, electrode materials, encapsulation, activation mechanism, and communication pathway.

How does US 7,978,064 compare with competing digital-medicine technologies?

Technology approach	Uses conductive fluid as power source	Requires ionic or current-signature signaling	Likely overlap with ’064
Proteus-style ingestible event marker	Yes	Yes	High
Battery-powered ingestible RF sensor	No	No	Lower
Optical ingestible sensor	No or limited	No	Lower
Ingestible temperature or pH sensor with conventional transmitter	Usually no	Usually no	Lower
External medication-adherence patch	No	No	Primarily complementary
Drug-only generic tablet	No	No	Minimal
Digital medicine with embedded electrochemical marker	Often yes	Often yes	Potentially high

The patent is not a general patent on digital medicines. It is strongest against a particular electrochemical event-marker architecture.

What generic and commercial launch scenarios exist?

Scenario 1: Conventional generic drug

A conventional generic tablet without an ingestible sensor presents low exposure to the ’064 patent. The relevant barriers would be drug substance, formulation, method-of-use, regulatory exclusivity, and other listed patents.

Scenario 2: Sensor-enabled generic drug

A generic company incorporating an ingestible event marker could face meaningful exposure. The company would need to evaluate the electrode arrangement, activation fluid, control circuit, membrane, current signature, and receiver pathway.

Scenario 3: Licensed digital medicine

A pharmaceutical company licensing sensor technology may need rights to several patent families, not only the ’064 patent. Product-specific freedom-to-operate would include the sensor, dosage form, receiver, software, and approved use.

Scenario 4: Design-around product

A company could reduce risk by replacing the claimed electrochemical signaling system with a sealed power source or a non-ionic communication protocol. That change could create new patent risks in RF, miniaturized antennas, power management, or ingestible packaging.

What geographic coverage matters?

US 7,978,064 provides protection only in the United States. Commercial launch analysis should separately examine corresponding patent applications and granted patents in:

• the European Patent Convention states;
• Japan;
• China;
• Canada;
• Australia;
• South Korea; and
• other major pharmaceutical markets.

Foreign counterparts may differ materially in claim scope because of added-matter, clarity, written-description, inventive-step, unity, and patentable-subject-matter standards. A US claim directed to “information radiated by the conducting liquid” may receive different treatment in Europe or Asia, particularly where the claim is characterized as an electrochemical process or communication method.

Key Takeaways

• US 7,978,064 covers conductive-fluid-powered communication using two electrically isolated materials and a conductance-controlling device.
• Claims 7 through 12 directly target ingestible pharmaceutical event markers.
• Claims 1 and 13 are broader system claims, but infringement still requires the claimed electrochemical signaling architecture.
• The patent does not claim an active pharmaceutical ingredient or conventional drug formulation.
• It is not, by its claim language, a conventional Orange Book drug patent.
• Paragraph IV is generally not the primary challenge mechanism for this patent.
• The strongest infringement risk concerns digital medicines using ionic emission or current signatures generated in gastrointestinal fluid.
• Conventional battery-powered, optical, ultrasonic, or drug-only products may have lower exposure.
• Expiration is expected in the late 2020s, subject to the USPTO’s official patent-term calculation.
• A complete freedom-to-operate analysis must include related ingestible-sensor, receiver, software, formulation, and drug-specific patent families.

FAQs About US Patent 7,978,064

Does US 7,978,064 cover the MyCite drug itself?

No. The claims cover a sensor and communication architecture associated with an ingestible pharmaceutical product. They do not claim aripiprazole or the MyCite formulation as an active ingredient.

Can a generic drug launch without addressing this patent?

Yes, if the generic product does not use the claimed conductive-fluid-powered event marker or related communication system. Drug-specific patents and FDA exclusivity remain separate issues.

Does a conventional battery avoid US 7,978,064?

A conventional battery may avoid the claimed partial-power architecture, but the result depends on whether the product also uses claimed electrochemical materials and conductive-fluid signaling elsewhere in the system.

What is the most important limitation in claim 7?

The combination of an ingestible pharmaceutical product, a support structure, a membrane extending the current path, electrochemical power generation in conductive fluid, conductance control, and remote detection is the key limitation set.

Can expiration of US 7,978,064 clear all digital-medicine patent risk?

No. Expiration would remove one patent barrier. Separate patents may continue to cover the sensor package, receiver, software, formulation, drug-device combination, and therapeutic use.

References

1. United States Patent No. 7,978,064 B2. (2011). Communication system with partial power source. United States Patent and Trademark Office.
2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations.
3. United States Patent and Trademark Office. (2024). Patent term adjustment and patent term calculation.

Drugs Protected by US Patent 7,978,064

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-001	Nov 13, 2017		DISCN	Yes	No	7,978,064		Y
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-002	Nov 13, 2017		DISCN	Yes	No	7,978,064		Y
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-003	Nov 13, 2017		DISCN	Yes	No	7,978,064		Y
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-004	Nov 13, 2017		DISCN	Yes	No	7,978,064		Y
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-005	Nov 13, 2017		DISCN	Yes	No	7,978,064		Y
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-006	Nov 13, 2017		DISCN	Yes	No	7,978,064		Y

International Family Members for US Patent 7,978,064

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2006239221
Australia	2012282690
Australia	2012282772
Australia	2012282776
Australia	2012282777
Australia	2017202754