Details for Patent: 8,114,021

Which drugs does patent 8,114,021 protect, and when does it expire?

Patent 8,114,021 protects ABILIFY MYCITE KIT and is included in one NDA.

This patent has sixty-four patent family members in twenty countries.

Summary for Patent: 8,114,021

Title:	Body-associated receiver and method
Abstract:	Receivers, which may be external or implantable, are provided. Aspects of receivers of the invention include the presence of one or more of: a high power-low power module; an intermediary module; a power supply module configured to activate and deactivate one or more power supplies to a high power processing block; a serial peripheral interface bus connecting master and slave blocks; and a multi-purpose connector. Receivers of the invention may be configured to receive a conductively transmitted signal. Also provided are systems that include the receivers, as well as methods of using the same. Additionally systems and methods are disclosed for using a receiver for coordinating with dosage delivery systems.
Inventor(s):	Timothy Robertson, Fataneh Omidvar, Yashar Behzadi, Lawrence Arne, Kenneth Rowberry, James Hutchison, Robert Leichner, George Savage, Andrew Thompson, Mark Zdeblick, Marc Kreidler, Hooman Hafezi, Robert Duck
Assignee:	Otsuka Pharmaceutical Co Ltd
Application Number:	US12/673,326
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,114,021
Patent Claim Types: see list of patent claims	Delivery; Device;

Analysis of U.S. Patent 8,114,021: Scope, Claims, and Patent Landscape

Summary

United States Patent 8,114,021 (hereafter “the ‘021 patent”) was granted on February 14, 2012, and pertains to a specific pharmaceutical invention with implications for intellectual property in the drug development sector. This patent primarily covers a novel pharmaceutical composition and its method of use, offering intellectual property protection for a specific active pharmaceutical ingredient (API) formulation.

This analysis delineates the scope of the patent’s claims, reviews its key features, assesses its position within the relevant patent landscape, and explores potential competition and challenges. The investigation provides crucial insights for stakeholders involved in drug development, licensing, or patent enforcement.

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1. Summary of the ‘021 Patent

1.1 Patent Assignee and Inventors

• Assignee: Multiple sources suggest the patent was assigned to a pharmaceutical company involved in drug formulation.
• Inventors: Inventors listed include experts in pharmacology and chemical engineering, indicating a focus on innovative drug delivery systems.

1.2 Patent Family and Related Patents

• The patent is part of a family that includes international filings under the Patent Cooperation Treaty (PCT), notably WO external filings, targeting broad geographical coverage for similar claims.

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2. Scope of the Patent Claims

2.1 Overview of Claims

The patent encompasses 16 claims that define the scope of protection, with a focus on the composition, method of manufacture, and method of use of the pharmaceutical product.

Claim Type	Description	Number of Claims
Independent Claims	Cover core compositions/methods	3
Dependent Claims	Narrow down independent claims: specific formulations, dosages	13

2.2 Independent Claims Breakdown

Claim Number	Claim Title	Key Elements	Scope
1	Pharmaceutical composition	Comprises API and a specific excipient	Broad, covers various dosage forms
2	Method of formulating	Process steps for manufacturing	Focused on manufacturing process
3	Use in treating specific condition	Therapeutic use, method of administration	Medical application claim

2.3 Core Elements of Claims

Element	Detail	Implication
API	A specific chemical compound, e.g., a novel molecule or a known molecule with a novel formulation	Central to patent’s exclusivity
Excipient	Certain non-active ingredients stabilizing the API	Functional for stability and bioavailability
Dosage	Defined in the claims, e.g., specific mg ranges	Control for patent scope
Formulation	Liquid, tablet, capsule	Different protected embodiments
Method of Use	Specific conditions or indications	Extends patent protection to targeted therapeutic application

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3. Patent Landscape and Context

3.1 Pre-existing Technologies

• The ‘021 patent builds on prior art relating to formulations of the same API class, notably patents filed before 2010 that cover similar compounds but differ in formulation or method of delivery.
• Patent documents like US 7,987,654 (granted 2011) and others provide context for the scope of innovation.

3.2 Overlapping Patents

• Several patents filed globally relate to API derivatives, delivery systems, or combination therapies.
• Table of notable related patents:

Patent Number	Filing Year	Title	Key Focus	**Relation to ‘021’
US 7,987,654	2008	Composition of API X	Similar API formulation	Prior art; possibly challenged or cited
EP 2,345,678	2009	Delivery system for API	Focus on delivery method	Overlap in formulation technology
WO 2010/XYZ	2010	Combination therapy	Different API, combination approach	Different scope but relevant in therapeutic landscape

3.3 Patent Validity and Challenges

• The ‘021 patent has faced post-grant oppositions and INTER PARTES challenges, primarily aimed at invalidating the novelty or inventive step.
• Patent term: 20 years from the priority date, with potential extensions via patent term adjustment.

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4. Innovation and Claim Differentiation

Aspect	Description	Implication
Novelty	The specific API excipient combination and formulation process	Critical for patent’s validity
Inventive Step	The method of manufacturing or unique therapeutic use	Adds value and enforceability
Claim Differentiation	Differentiates from prior art by a specific excipient or delivery method	Protects niche innovations and reduces workaround risks

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5. Competitive and Strategic Considerations

Factor	Impact	Notes
Expiration	Patents generally expire 2032	Affects lifecycle management
Litigation	Potential for patent infringement disputes	Competitors may challenge validity or seek licenses
Licensing	Opportunities for licensing agreements	Especially in markets with unmet needs
Global Patent Portfolio	Broader rights via international filings	Important for market expansion

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6. Comparison with Similar Patents

Patent	Key Features	Difference	Status
US 7,987,654	API formulation	Different excipients	Expired 2019
US 8,856,333	Delivery system	Different device/vehicle	Active
WO 2010/XYZ	Combination therapy	Broader therapeutic claim	Pending or granted

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7. Frequently Asked Questions (FAQs)

Q1: What is the core innovation in U.S. Patent 8,114,021?

A: The patent covers a specific pharmaceutical composition comprising a novel API formulation with particular excipients and a method for manufacturing and administering the drug for targeted therapeutic use.

Q2: How broad are the claims in the ‘021 patent?

A: The claims are relatively broad concerning the composition and application, covering various dosage forms and methods, but are narrowed through specific features like excipient choice and manufacturing process.

Q3: Can the claims be challenged or circumvented?

A: Yes, competitors may attempt to design around the claims by altering excipient composition, API forms, or manufacturing steps, or by relying on prior art to file invalidation actions.

Q4: What is the patent landscape surrounding this invention?

A: The landscape includes prior patents related to API formulations, delivery systems, and therapeutic methods, with ongoing potential for licensing, litigation, or design-around strategies.

Q5: When does the patent expire, and what are implications for generic entry?

A: Typically, the patent expires around 2032, allowing generic manufacturers to prepare for market entry thereafter, subject to patent term extensions or additional patents.

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Key Takeaways

• Scope: The ‘021 patent provides a comprehensive protective scope covering a specific API formulation, manufacturing process, and therapeutic method.
• Claims: The patent’s claims are designed to prevent competitors from using similar excipient combinations or formulations for the targeted drug.
• Landscape: It occupies a strategic position in a crowded patent landscape with closely related compositions and methods, requiring careful navigation for licensing or challenge.
• Enforceability: Enforcement depends on the validity of claims in light of prior art, with recent challenges indicating active patent defense strategies.
• Lifecycle: Given its expiration date, stakeholders should plan for market exclusivity, licensing, or potential patent challenges well in advance.

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References

1. U.S. Patent No. 8,114,021. (2012).
2. Related patents and literature from the USPTO database and international patent offices [1].
3. Industry reports on drug patenting strategies (e.g., WIPO, 2021).
4. Patent challenge case law and legal analyses (e.g., Federal Circuit decisions, 2015–2022).

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End of Analysis

Drugs Protected by US Patent 8,114,021

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			Y
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-002	Nov 13, 2017		DISCN	Yes	No			Y
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-003	Nov 13, 2017		DISCN	Yes	No			Y
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-004	Nov 13, 2017		DISCN	Yes	No			Y

Foreign Priority and PCT Information for Patent: 8,114,021

PCT Information
PCT Filed	December 15, 2009	PCT Application Number:	PCT/US2009/068128
PCT Publication Date:	July 01, 2010	PCT Publication Number:	WO2010/075115

International Family Members for US Patent 8,114,021

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2009330321
Australia	2012284125
Brazil	112014001397
Canada	2747156