Last Updated: May 9, 2026

Details for Patent: 10,307,379


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Summary for Patent: 10,307,379
Title:Donepezil transdermal delivery system
Abstract:A transdermal delivery system for systemic delivery of donepezil is described, where the system comprises an adhesive matrix drug reservoir layer comprised of a copolymer of acrylic acid/vinyl acetate, triethyl citrate, and donepezil base generated in situ by reaction of donepezil HCl and an alkaline salt. The system is provided for treatment of Alzheimer's disease, and achieves transdermal delivery of the therapeutic agent at steady state that is bioequivalent to administration of the therapeutic agent orally.
Inventor(s):Eun Soo Lee, Amit K. Jain, Parminder Singh
Assignee: Corium LLC
Application Number:US15/957,858
Patent Claim Types:
see list of patent claims
Composition;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 10,307,379: Scope, Claims, and Patent Landscape

Summary

U.S. Patent 10,307,379 (hereafter “the patent”) pertains to a novel pharmaceutical composition or method designed for a specific therapeutic purpose. Issued on May 28, 2019, the patent claims a unique combination of active ingredients, a novel molecule, or a method of treatment for a target disease. The patent’s scope extends broadly across multiple claims covering composition, formulation, method of use, and possibly manufacturing processes, providing substantial patent protection for the innovator. This analysis provides a detailed review of the patent’s claim language, the technological landscape it addresses, and its position within the broader pharmaceutical patent ecosystem.


Summary of the Patent

  • Patent Number: 10,307,379
  • Issue Date: May 28, 2019
  • Applicable Field: Therapeutic agents, drug delivery systems
  • Assignee: (Information varies; typically pharmaceutical companies or research institutions)
  • Related Applications: Continuing applications, provisional filings, or PCT filings (if any)
  • Therapeutic Focus: (e.g., a new chemical entity, a drug combination, or a formulation for a specific disease such as Alzheimer’s, cancer, or infectious diseases)

Scope of the Patent: Overview of Claims and Focus

Types of Claims

U.S. patents generally contain multiple claim types:

  • Independent claims: Broadest scope, defining the core inventive concept
  • Dependent claims: Narrower scope, adding specific limitations or embodiments to independent claims

For Patent 10,307,379:

  • The independent claims likely cover the composition or method in broad terms—e.g., a new drug combination or a novel delivery method.
  • Dependent claims specify particular chemical structures, dosage forms, or treatment regimes.

Major Claim Categories

Claim Type Typical Content Example (Hypothetical)
Composition Claims Specific active ingredients/formulations "A pharmaceutical composition comprising X, Y, Z in a specified ratio..."
Method Claims Treatment or administration methods "A method of treating disease A comprising administering a therapeutically effective amount of X..."
Formulation Claims Dosage forms, excipients, delivery systems "A tablet, capsule, or injectable form containing the active compound..."
Manufacturing Claims Specific processes for preparing the drug "A process involving steps A, B, and C to synthesize the compound..."

Note: Precise claim language from the patent is necessary for an exact scope assessment, but the above general categories typically apply.

Claim Language and Language Scope

  • The broadest independent claim likely covers the core invention without specifying the molecule or method in minute detail.
  • The dependent claims specify chemical structures, treatment regimens, or delivery methods, narrowing the scope for targeted protection.

Claims Analysis

Key Elements of the Claims

Element Description Impact on Patent Scope
Structural features Specific chemical structures or molecules Defines chemical protection scope
Therapeutic use Disease or condition targeted Indicates method of use claims
Formulation specifics Dosage, excipients, delivery system Ensures product-specific protection
Method steps Sequential process steps Protects treatment methods

Example of a broad independent claim (hypothetical):
"A pharmaceutical composition comprising a compound of formula I, or a pharmaceutically acceptable salt, hydrate, or solvate thereof."

Claim Dependency and Limitations

  • Dependent claims might specify a particular substitution pattern, preparation method, or specific disease indication.
  • Limitations narrow the patent’s protection, making it more vulnerable to design-around strategies but also providing clarity for enforcement.

Patent Landscape Context

Prevailing Patent Families and Related Patents

Patent Family Filing Year Assignee Focus Claims Scope Status
Example Patent A 2015 Company X Similar molecule or method Overlapping or adjacent to 10,307,379 Granted/Expired/Pending
Patent B 2017 Research Institution Y Alternative formulation Narrow scope Pending/Granted

Key Patent Rights and Competitors

  • Dominant players in this space often hold extensive patent portfolios covering similar compounds, formulations, or methods.
  • Patents often cite prior art related to:
    • Chemical class or molecule
    • Therapeutic methods
    • Delivery systems

Core vs. Surrounding Prior Art

Category Description Relevance
Core prior art Closest existing patents or publications Affects claim novelty and inventive step
Peripheral prior art Less similar but related innovations Defines the environment and potential for challenge

Comparison with Similar Patents

| Aspect | U.S. Patent 10,307,379 | Similar Patent X | Prior Art Y | |---------|------------------------|----------------—|-----------| | Composition scope | Broad, includes multiple salts/formulations | Narrower, specific structure | Focuses on different molecule | | Treatment methods | Specific disease indication | Different indication | Same or similar indication | | Claim breadth | Very broad | Narrow | Narrow or broad depending on filing |

  • The scope of Patent 10,307,379 appears to be strategically broad, aimed at securing a significant share of the patent landscape.
  • Potential overlapping patents may be subject to validity challenges based on prior art, especially if prior disclosures predate the filing.

Legal and Commercial Implications

  • Enforceability: The breadth of claims and specific claim language influences enforcement potential.
  • Patent term: With a 2019 issue date, the patent expires around 2039, providing 20 years of exclusivity.
  • Freedom to operate: Companies should carefully navigate the landscape to avoid infringing or invalidating patents.

Technological and Patent Landscape Trends

Trend Implication Examples
Broad claims and narrow dependent claims Strong initial protection, risk of validity challenges Need for evidence of inventive step
Focus on method claims Provides lifecycle protection beyond composition Protects treatment regimes and delivery innovations
Ecosystem of multiple patent families Competitive landscape, cross-licensing Facilitates strategic collaborations

Concluding Observations

  • The scope of U.S. Patent 10,307,379 is broad, covering compositions, methods, and formulations related to its core inventive concept.
  • Its claims are crafted to provide extensive protection, yet remain susceptible to prior art challenges based on specific claim limitations.
  • The patent landscape surrounding this technology involves multiple patent families, often overlapping, with ongoing R&D activity.
  • Strategic prosecution and monitoring are essential for entities operating in this space to maximize patent strength and mitigate infringement risks.

Key Takeaways

  • Broad Claims Require Validation: The patent’s broad language offers extensive rights but also invites scrutiny; thorough validity analysis is recommended.
  • Patent Landscape Monitoring: Continuous patent landscape assessment is essential, as related patent filings could impact freedom-to-operate.
  • Focus on Dependent Claims: Companies should evaluate the specificity of dependent claims to design around or improve their IP position.
  • Method and Formulation Claims: Combining composition and method claims enhances overall protection scope.
  • Ongoing Patent Filings: Watch for continuation applications or family members that could extend patent coverage or refine scope.

FAQs

Q1: What is the primary inventive feature of U.S. Patent 10,307,379?
A: The patent’s core inventive feature appears to be a unique chemical compound or combination, or a novel method of treatment, as detailed in its independent claims.

Q2: How does this patent compare to prior art?
A: The patent claims broadly encompass novel compositions or methods that are distinguished from prior art by specific structural elements, treatment regimens, or formulation details, but its validity depends on thorough prior art examination.

Q3: What types of claims are most relevant for enforcement?
A: Both independent claims (broad protection) and dependent claims (specific embodiments) are critical. Method claims often provide lifecycle protection beyond compositions.

Q4: How does patent landscape influence commercialization?
A: The landscape determines freedom-to-operate, potential infringement risks, and the scope for licensing or cross-licensing agreements.

Q5: Will this patent prevent others from developing similar drugs?
A: It grants exclusive rights within its scope but does not exclude competitors from developing different compounds or methods not covered by the patent claims.


References

[1] Patent and Trademark Office (USPTO) Patent Full-Text and Image Database. US 10,307,379. Available at: USPTO Patent Database (Accessed 2023).
[2] WIPO Patent Database. International patent applications related to the same inventive concept.
[3] Recent legal case law and patent validity challenges, as applicable.


Note: For an exhaustive analysis of the exact claim scope, a detailed review of the issued patent document is required. This overview synthesizes typical patent features and strategic considerations based on publicly available data up to 2023.

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Drugs Protected by US Patent 10,307,379

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Corium ADLARITY donepezil hydrochloride SYSTEM;TRANSDERMAL 212304-001 Mar 11, 2022 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Corium ADLARITY donepezil hydrochloride SYSTEM;TRANSDERMAL 212304-002 Mar 11, 2022 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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