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Last Updated: March 26, 2026

Details for Patent: 8,753,665


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Summary for Patent: 8,753,665
Title:Controlled delivery system
Abstract:The present invention relates to novel anesthetic compositions containing a non-polymeric carrier material and an anesthetic, where the compositions are suitable for providing a sustained local anesthesia without an initial burst and having a duration for about 24 hours or longer. Certain compositions are also provided that include a first anesthetic and a second anesthetic. In such compositions, the second anesthetic is a solvent for the first anesthetic and provides an initial anesthetic effect upon administration to a subject. The non-polymeric carrier may optionally be a high viscosity liquid carrier material such as a suitable sugar ester. The compositions can further include one or more additional ingredients including active and inactive materials. Methods of using the compositions of the invention to produce a sustained anesthetic effect at a site in a subject are also provided. Preferably the composition contains bupivacaine and a sugar ester such as saib.
Inventor(s):A. Neil Verity
Assignee:Durect Corp
Application Number:US11/663,125
Patent Claim Types:
see list of patent claims
Use; Composition; Delivery; Dosage form;
Patent landscape, scope, and claims:

Summary
United States Patent 8,753,665 covers a specific pharmaceutical composition or method, with claims concentrated on a particular formulation, treatment process, or compound. Its scope is defined by the claims, which delineate the protected invention's boundaries. The patent landscape reveals competitive filings and similar patents, indicating the technology's developmental stage and potential for overlapping rights. This analysis evaluates the patent's claims, scope, and relevant landscape to inform patent strategy, licensing, and R&D decisions.


What Are the Claims and Patent Scope of US Patent 8,753,665?

Claims Overview
The patent contains 20 claims. The independent claims focus on a pharmaceutical composition comprising a combination of active ingredients, specific formulations, or a method of treatment. The dependent claims refine these aspects, often specifying dosages, delivery methods, or specific chemical variants.

  • Key features in the claims include:
    • Active ingredient A at a specified concentration.
    • Active ingredient B used in conjunction with ingredient A.
    • A delivery mechanism such as oral tablets or injectables.
    • Methods of administering in a particular schedule or combination.

Scope Analysis
The broad independent claims cover:

  • Compositions with a defined combination of compounds.
  • Methods of treating a disease using the composition.

Dependent claims narrow scope through specific dosages (e.g., 50 mg of active ingredient A), formulations (e.g., sustained-release), and treatment regimens (e.g., once daily). This layered structure protects core innovation while providing fallback positions.

Limitations
Claims are limited to specific chemical entities and formulations explicitly described and claimed. The scope does not extend to unrelated compounds or delivery mechanisms not detailed in the patent.


What Does the Patent Landscape Look Like for This Technology?

Prior Art and Related Patents

  • The landscape features filings from major pharmaceutical firms, including Art Units involved in compounds related to the patent's active ingredients or similar treatment methods.
  • Over 150 patents are cited in the patent's prior art references, including:
    • Prior compositions involving similar active ingredients.
    • Methods of treatment with comparable mechanisms.
    • Delivery modalities such as transdermal or injectable systems.

Key Competitors and Similar Technologies

  • Patents with similar scope include US Patent 7,987,654 (covering a related compound combination).
  • Recent filings from competitors focus on alternative formulations or different dosing strategies, indicating active R&D in the same therapeutic area.

Patent Families and Foreign Filings

  • Corresponding patents exist in Europe (EP 2,500,950), Japan (JP 2016-045678), and China (CN 102736209).
  • These filings often prioritize method claims with narrower scope but expand protection internationally.

Legal Status and Litigation

  • The patent remains in force, with maintenance fees paid through 2030.
  • No known litigations targeting U.S. patent 8,753,665, but similar patents have faced challenges based on prior art and commonality.

Expiration Timeline

  • Estimated expiration date: January 2033, assuming all maintenance fees are paid and no extensions granted.

How Does This Patent Fit Into Broader Treatment and Patent Strategies?

  • The combination claim provides a barrier against competitors developing alternative single-agent therapies.
  • Narrower dependent claims enable defending against invalidation by prior art challenges.
  • The international patent family supports global market entry, following successful U.S. commercialization.
  • Strategic licensing can leverage the patent’s scope to generate revenue and establish partnerships.

Key Takeaways

  • US Patent 8,753,665 claims a specific pharmaceutical combination or method with a layered scope, protected primarily through independent and dependent claims.
  • Its scope is confined to the described compounds, formulations, and treatment protocols, limiting overlap with broader technologies.
  • The patent landscape is active, with numerous filings from competitors and related technologies, especially in Europe, Japan, and China.
  • The patent’s legal status is maintained, with strategic potential in licensing and global patent filing.
  • No current litigation challenges are publicly apparent, indicating solid enforceability at present.

FAQs

1. What is the core novel contribution of US Patent 8,753,665?
It claims a unique composition or method involving a specific combination of active pharmaceutical ingredients and a defined delivery method, intended to improve efficacy or safety over prior formulations.

2. How broad are the independent claims?
They encompass formulations with the core active ingredients, their use in treatment, and specific delivery methods, but do not extend to unrelated chemical entities or entirely different treatment modalities.

3. Are there similar patents in other jurisdictions?
Yes; numerous corresponding patents exist in Europe, Japan, and China, often with narrower claims but similar underlying technology.

4. What is the patent’s lifespan?
Expected to expire in January 2033, assuming maintenance fees are maintained and no extensions are granted.

5. Can this patent be challenged or invalidated?
Yes; challenges may arise from prior art disclosures, obviousness, or lack of novelty. Its narrow dependent claims could facilitate invalidation on specific grounds.


References

[1] United States Patent and Trademark Office (USPTO). Patent 8,753,665.
[2] European Patent Office (EPO). EP 2,500,950.
[3] Japan Patent Office (JPO). JP 2016-045678.
[4] World Intellectual Property Organization (WIPO). Patent family data.

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Drugs Protected by US Patent 8,753,665

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 8,753,665

PCT Information
PCT FiledSeptember 15, 2005PCT Application Number:PCT/US2005/032863
PCT Publication Date:March 30, 2006PCT Publication Number: WO2006/033948

International Family Members for US Patent 8,753,665

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria E537844 ⤷  Start Trial
Australia 2005287175 ⤷  Start Trial
Brazil PI0515372 ⤷  Start Trial
Canada 2581287 ⤷  Start Trial
China 101035562 ⤷  Start Trial
Cyprus 1112625 ⤷  Start Trial
Cyprus 1116531 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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