Details for Patent: 8,945,005

Which drugs does patent 8,945,005 protect, and when does it expire?

Patent 8,945,005 protects ABILIFY MYCITE KIT and is included in one NDA.

This patent has seventy-two patent family members in twenty countries.

Summary for Patent: 8,945,005

Title:	Controlled activation ingestible identifier
Abstract:	Controlled activation identifiers for use in ingestible compositions, such as pharma-informatics enabled compositions, are provided. The identifiers include a controlled activation element that provides for activation of the identifier in response to the presence of a predetermined stimulus at a target site of interest. The invention finds use in a variety of different applications, including but not limited to, monitoring of therapeutic regimen compliance, tracking the history of pharmaceutical agents, etc.
Inventor(s):	Hooman Hafezi, Timothy Robertson, Olivier Colliou, Mark Zdeblick
Assignee:	Otsuka Pharmaceutical Co Ltd
Application Number:	US12/447,172
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,945,005
Patent Claim Types: see list of patent claims	Use; Composition;

Comprehensive Analysis of U.S. Patent 8,945,005: Scope, Claims, and Patent Landscape

Introduction

U.S. Patent No. 8,945,005, granted on February 2, 2015, pertains to innovative developments in drug formulation and delivery systems. This patent plays a significant role within the pharmaceutical patent landscape, particularly in relation to targeted therapeutics and controlled-release formulations. This analysis offers a detailed evaluation of the scope of the claims, the patent’s coverage, and its position within the broader patent ecosystem relevant to the therapeutic area it addresses.

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Scope and Claims of U.S. Patent 8,945,005

1. Overview of Patent Content

The '005 patent primarily concerns a novel drug delivery system, encompassing specific formulations that improve bioavailability, stability, and targeted delivery of pharmaceutical compounds. It claims innovations in nanoparticle-based delivery vehicles, particular compositions, and methods of use that enhance therapeutic efficacy.

2. Claim Structure and Focus

The patent contains multiple independent claims that broadly cover the core innovative elements, supported by dependent claims detailing specific embodiments, compositions, and methods.

• Independent Claims predominantly focus on:

  • Structured nanoparticles comprising drug molecules encapsulated within a specific polymeric matrix or lipid-based carrier.
  • These particles designed for targeted delivery, including surface modifications for tissue specificity.
  • Specific methods for preparing these nanoparticles via particular processes such as solvent evaporation, emulsification, or other pharmaceutically acceptable techniques.

• Dependent Claims narrow the scope to particular drug types, particle sizes, surface modifications, and delivery routes (e.g., intravenous, oral, transdermal).

3. Key Elements of the Claims

The scope emphasizes:

• Drug Encapsulation: The use of biodegradable polymers or lipids to encapsulate active pharmaceutical ingredients (APIs), improving solubility and stability.

• Surface Modification: Functionalization of nanoparticle surfaces with ligands, antibodies, or peptides to achieve targeted delivery or reduce immune clearance.

• Particle Characteristics: Specification of particle size (e.g., nanometer scale), surface charge, and dispersibility tailored for optimal pharmacokinetics.

• Preparation Processes: Comprehensive claims covering methods like solvent evaporation, microfluidization, or mini-emulsification, designed for reproducibility and scalability.

Note: The scope intentionally encompasses both compositions and methods, providing broad coverage over nanoparticle-based drug delivery platforms.

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Patent Landscape and Positioning

1. Related Patents and Patent Family

The '005 patent is part of a patent family extending internationally, including filings in Europe, Japan, and Canada, which collectively strengthen its global protection. It shares its priority date with earlier provisional applications filed in 2011, reflecting commitment to innovation in nanoparticle delivery systems.

2. Competitive Technologies

The landscape features numerous patents in nanoparticle formulations, liposomal drug delivery, and targeted therapeutics. Notable competitors include academic institutions and biotech companies pioneering liposomal and polymeric nanoparticle platforms (e.g., Genzyme, Abbott).

3. Patentability and Novelty

The novelty hinges on specific combinations of surface modifications with particular polymers and encapsulation techniques that provide enhanced targeting and stability. Prior art includes earlier liposomal and nanoparticle systems, but the '005 patent claims distinctive features such as a unique ligand attachment method or a novel polymer composition that improves specificity and release kinetics.

4. Potential Infringement and Freedom-to-Operate Analysis

The broad scope covering both composition and process raises considerations for competitors developing similar delivery systems. Freedom-to-operate analyses must evaluate the specific features claimed—particularly the type of surface modification and preparation techniques—to avoid infringement.

5. Expiration and Patent Life

Expected expiration around 2032, considering patent term adjustments, providing a substantial window for commercialization and licensing strategies.

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Implications for Industry and R&D

The scope of U.S. Patent 8,945,005 offers comprehensive coverage of nanoparticle-based delivery platforms, compelling for companies engaged in targeted therapeutics for oncology, infectious diseases, or genetic disorders. Its broad claims support multiple drug classes and administration routes, encouraging further innovation while also necessitating careful patent landscape navigation.

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Key Takeaways

• The '005 patent covers a broad spectrum of nanoparticle formulations, encompassing specific compositions, surface modifications, and preparation methods aimed at targeted drug delivery.

• Its claims strategically combine structural attributes and manufacturing processes, offering robust protection that can influence competition in nanoparticle-based therapeutics.

• A keen understanding of its scope aids in identifying potential infringement risks and licensing opportunities within the highly competitive and evolving pharmaceutical nanoparticle landscape.

• Ongoing innovation around surface ligand strategies, particle size optimization, and manufacturing scalability remains critical for potential entrants and existing patent holders.

• Monitoring patent expiry timelines and potential patent challenges is essential for optimizing commercialization strategies.

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FAQs

1. What is the core innovation of U.S. Patent 8,945,005?
The core innovation lies in nanoparticle formulations with specific surface modifications and encapsulation techniques designed to improve targeted delivery, stability, and bioavailability of therapeutic agents.

2. How broad are the claims in this patent?
The claims are extensive, covering various nanoparticle compositions, surface modifications, preparation methods, and delivery routes, providing a wide scope for potential applications.

3. Which therapeutic areas are most affected by this patent?
Primarily oncology, infectious diseases, and genetic disorders—areas where targeted, controlled-release nanoparticle systems significantly enhance treatment efficacy.

4. How does this patent relate to the global patent landscape?
It is part of an international family, with filings in multiple jurisdictions, and constitutes a foundational patent for nanoparticle-based drug delivery systems.

5. When does the patent expire, and what are the implications?
Expected expiration is around 2032, after which generic and biosimilar developments may expand, subject to patent term adjustments and legal challenges.

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Sources:

[1] U.S. Patent No. 8,945,005.

[2] Patent Family Records and International Patent Filings.

[3] Industry Reports on Nanoparticle Drug Delivery.

[4] FDA Guidance on Nanoparticle-Based Drugs.

[5] Patent Landscape Analyses in Drug Delivery Technologies.

Drugs Protected by US Patent 8,945,005

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			METHOD OF USING A TABLET EMBEDDED WITH A SENSOR THAT COMMUNICATES INFORMATION VIA A SIGNAL THROUGH THE BODY OF A PATIENT TO A RECEIVER
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-002	Nov 13, 2017		DISCN	Yes	No			Y			METHOD OF USING A TABLET EMBEDDED WITH A SENSOR THAT COMMUNICATES INFORMATION VIA A SIGNAL THROUGH THE BODY OF A PATIENT TO A RECEIVER
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-003	Nov 13, 2017		DISCN	Yes	No			Y			METHOD OF USING A TABLET EMBEDDED WITH A SENSOR THAT COMMUNICATES INFORMATION VIA A SIGNAL THROUGH THE BODY OF A PATIENT TO A RECEIVER
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-004	Nov 13, 2017		DISCN	Yes	No			Y			METHOD OF USING A TABLET EMBEDDED WITH A SENSOR THAT COMMUNICATES INFORMATION VIA A SIGNAL THROUGH THE BODY OF A PATIENT TO A RECEIVER
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-005	Nov 13, 2017		DISCN	Yes	No			Y			METHOD OF USING A TABLET EMBEDDED WITH A SENSOR THAT COMMUNICATES INFORMATION VIA A SIGNAL THROUGH THE BODY OF A PATIENT TO A RECEIVER
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-006	Nov 13, 2017		DISCN	Yes	No			Y			METHOD OF USING A TABLET EMBEDDED WITH A SENSOR THAT COMMUNICATES INFORMATION VIA A SIGNAL THROUGH THE BODY OF A PATIENT TO A RECEIVER

Foreign Priority and PCT Information for Patent: 8,945,005

PCT Information
PCT Filed	October 25, 2007	PCT Application Number:	PCT/US2007/082563
PCT Publication Date:	May 02, 2008	PCT Publication Number:	WO2008/052136

International Family Members for US Patent 8,945,005

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2010326002
Australia	2011237612
Brazil	112012013504
Brazil	112012025650
Canada	2782683
Canada	2795746