Details for Patent: 7,978,064

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):	Zdeblick; Mark (Portola Valley, CA), Robertson; Timothy (Belmont, CA), Pikelny; Aleksandr (Los Angeles, CA), Hafezi; Hooman (Redwood City, CA)
Assignee:	Proteus Biomedical, Inc. (Redwood City, CA)
Application Number:	12/564,017
Patent Claim Types: see list of patent claims	Use; Process; Device;

United States Patent 7,978,064: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 7,978,064, titled "Communication system with partial power source," is a significant innovation in the field of ingestible electronics and pharmaceuticals. This patent, held by Proteus Biomedical, Inc., introduces a novel system that leverages body fluids to generate power for ingestible devices. Here, we delve into the scope, claims, and the broader patent landscape surrounding this invention.

Overview of the Patent

The patent describes a communication system that includes a conductive element, an electronic component, and a partial power source. This system is designed to be ingestible and/or digestible, making it suitable for use within the human body[1].

Key Components

• Dissimilar Materials: The system uses dissimilar materials positioned on a framework. When these materials come into contact with a conducting fluid (such as stomach fluid), a voltage potential difference is created.
• Control Logic: This voltage potential difference powers up control logic within the framework, which modulates the conductance between the dissimilar materials.
• Conducting Fluid: The system relies on a conducting fluid to complete the circuit, allowing ions or current to flow between the dissimilar materials[1].

Scope of the Patent

The scope of this patent is broad and versatile, extending beyond pharmaceutical applications.

Pharmaceutical Applications

• The system can be integrated into orally ingestible pharmaceutical formulations, such as pills or capsules. Upon ingestion, the system comes into contact with stomach fluid, activating the voltage potential difference and powering the control logic[1].
• It can be used to determine when a patient takes a pharmaceutical product, providing a unique and identifiable current signature that can be monitored[1].

Beyond Pharmaceuticals

• The system is not limited to pharmaceutical environments. It can be used in any setting where a conducting fluid is present, such as in various industrial or consumer products (e.g., jet fuel, salt water, tomato sauce, motor oil)[1].

Claims of the Patent

The patent claims are crucial in defining the boundaries of the inventor’s rights.

Types of Claims

• Device Claims: The patent includes claims related to the device itself, such as the configuration of dissimilar materials and the control logic.
• Process Claims: It also includes claims related to the process of activating the system and modulating conductance.
• Use Claims: Claims are made for the various uses of the system, including its application in pharmaceutical products and other environments[5].

Claim Specificity

The claims are designed to capture a broad range of embodiments while ensuring they are commensurate with what is taught in the patent application. This balance is critical to avoid claims being too narrow (allowing easy design-around) or too broad (risking invalidation due to lack of support in the specification)[3].

Patent Landscape

The patent landscape surrounding ingestible electronics and pharmaceuticals is complex and evolving.

Regulatory Environment

• The U.S. Patent and Trademark Office (USPTO) and courts closely scrutinize patent claims, especially in the pharmaceutical and biotechnology industries, to ensure they meet the written description and enablement requirements of 35 U.S.C. § 112(a)[3].

Industry Impact

• Innovations like the one described in this patent are crucial for the pharmaceutical industry, enabling better patient compliance monitoring and personalized medicine.
• However, the rigid stance on genus claims by the Federal Circuit has made it challenging for innovators to secure broad yet valid patent protection in these fields[3].

Related Patents

• Other patents, such as those related to specific pharmaceutical formulations (e.g., US Patent 7053092 for 5HT1a Receptor subtype agonist), highlight the ongoing innovation in this space[4].

Technical and Practical Applications

The technical and practical applications of this patent are significant.

Ingestible Sensors

• The system can be integrated with ingestible sensors to monitor the course of pharmacotherapy, providing real-time data on drug adherence and efficacy[4].

Safety and Efficacy

• The ingestible circuitry is designed to be safe and efficacious, with minimal unwanted side effects even in chronic use scenarios[1].

Economic and Market Implications

The economic and market implications of this patent are substantial.

Market Potential

• The ability to monitor patient compliance and provide real-time data can significantly enhance the value of pharmaceutical products, improving patient outcomes and reducing healthcare costs.
• The versatility of the system opens up new market opportunities beyond traditional pharmaceutical applications[1].

Competitive Landscape

• Companies like Proteus Biomedical, Inc., and Otsuka Pharmaceutical Co., Ltd., are at the forefront of this technology, with products like ABILIFY MYCITE KIT already approved and in use[5].

Challenges and Future Directions

Despite the advancements, there are challenges and future directions to consider.

Regulatory Challenges

• The ongoing scrutiny by regulatory bodies and courts means that patent holders must continually ensure their claims are well-supported and not overly broad[3].

Technological Advancements

• Future innovations may focus on improving the efficiency of the power generation, enhancing the durability of the ingestible components, and expanding the range of applications[1].

Key Takeaways

• Innovative Power Source: The patent introduces a novel power source that leverages body fluids to activate ingestible devices.
• Broad Applications: The system is versatile and can be used in various environments beyond pharmaceuticals.
• Regulatory Scrutiny: The patent claims must be carefully crafted to meet regulatory requirements.
• Market Potential: The technology has significant market potential, especially in improving patient compliance and outcomes.
• Ongoing Innovation: The field is dynamic, with ongoing technological advancements and regulatory challenges.

FAQs

What is the main innovation of United States Patent 7,978,064?

The main innovation is a communication system that uses dissimilar materials and body fluids to generate power for ingestible devices.

How does the system activate?

The system activates when the dissimilar materials come into contact with a conducting fluid, such as stomach fluid, creating a voltage potential difference.

What are the potential applications of this patent?

The applications include monitoring patient compliance with pharmaceuticals, and use in various other environments where a conducting fluid is present.

Who holds this patent?

The patent is held by Proteus Biomedical, Inc.

What are the regulatory challenges associated with this patent?

The patent claims must meet the written description and enablement requirements of 35 U.S.C. § 112(a), which can be challenging in the pharmaceutical and biotechnology industries.

Sources

1. US7978064B2 - Communication system with partial power source - Google Patents
2. Patent Claims Research Dataset - USPTO
3. Eviscerating Patent Scope - DigitalCommons@NYLS
4. Digital Pills with Ingestible Sensors - Encyclopedia MDPI
5. Details for Patent: 7978064 - DrugPatentWatch

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