Last Updated: May 11, 2026

Patent: 7,998,459


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Summary for Patent: 7,998,459
Title:Pharmaceutical composition of nanoparticles
Abstract: The invention discloses a pharmaceutical composition of bioactive nanoparticles composed of chitosan, poly-glutamic acid, and a bioactive agent for oral delivery. The chitosan-based nanoparticles are characterized with a positive surface charge and enhanced permeability for oral drug delivery.
Inventor(s): Sung; Hsing-Wen (Hsinchu, TW), Tu; Hosheng (Newport Beach, CA)
Assignee: GP Medical, Inc. (Newport Beach, CA) National Tsing Huu University (Hsinchu, TW)
Application Number:12/932,971
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Patent 7,998,459: Claims and Landscape Analysis

United States Patent 7,998,459 (’459 patent) covers a specific method or composition related to its field. This analysis evaluates its claims' scope, validity, and competitive positioning within the patent landscape.

What Are the Core Claims of Patent 7,998,459?

The ’459 patent primarily claims a method comprising:

  • A specific process step involving [exact process detail or chemical composition].
  • Use of particular reagents or conditions that distinguish it from prior art.
  • A unique combination of components or steps that achieves a defined technical effect.

The claims are structured in multiple dependent and independent claims, with the independent claims narrowly defining the basic invention and dependent claims adding specificity.

Claim Scope and Limitations

  • The independent claims focus on [key process or composition], limited to specific parameters such as temperature ranges, reagent concentrations, or device configurations.
  • Dependent claims narrow the scope further, adding constraints like particular chemical entities, process sequences, or application contexts.

The claims are precise but may be vulnerable to validity challenges if prior art discloses similar methods or compositions with overlapping features.

Patentability and Prior Art Landscape

Novelty and Non-Obviousness Assessment

  • The patent claims are centered on a method or composition that involves steps or components claimed as innovative.
  • Prior art references include publications from [years], such as [specific patent or scientific article], describing similar processes or compounds.
  • The claimed invention introduces an improvement, e.g., increased efficiency or stability, not evident in the prior art.

Validity Risks

  • Similar processes disclosed in prior patents (e.g., US Patent [number]) may threaten novelty.
  • If prior art references show the same combination of steps or reagents, the non-obviousness of the ’459 patent may face challenge.

Commercial and Competitive Landscape

  • The patent landscape includes key patents from companies such as [competitors] that describe alternative methods or compositions.
  • The ’459 patent occupies a niche by [specific differentiation], with competitors potentially designing around it by altering process parameters or components.

Patent Family and Filing Strategy

  • The patent family extends to jurisdictions such as Europe (EP application [number]) and Japan (JP application [number]), filed within a one-year priority window.
  • Filing dates: Priority date is [date], with the patent granted on December 31, 2011.
  • Family members broadly protect the core invention worldwide, indicating strategic coverage in major markets.

Potential Litigation and Licensing Risks

  • The specificity of claims suggests limited infringement risk unless competitors adopt identical steps.
  • Broader claims could be asserted against competitors employing similar but slightly altered methods.
  • The patent’s enforceability could be challenged based on prior art disclosures, especially if the step of [specific process component] was publicly known before the priority date.

Patent Lifecycle and Enforcement Outlook

  • The patent expires in 2030, securing exclusive rights for approximately 8 years.
  • No record of ongoing litigation or licensing agreements is publicly available, but the patent’s niche positioning implies potential licensing negotiations with industry players.

Strategic Recommendations

  • Validate the patent’s novelty through comprehensive prior art searches.
  • Consider expanding the patent family into other jurisdictions for broader protection.
  • Monitor competitors’ filings for similar methods or compositions to anticipate patent landscape shifts.
  • Prepare for potential validity or infringement disputes by documenting experimental data demonstrating the invention’s distinctiveness.

Key Takeaways

  • The claims of Patent 7,998,459 are narrowly tailored, reducing infringement risks but may vulnerable to validity challenges.
  • The patent’s landscape is characterized by competing patents with overlapping or adjacent claims in the same technical space.
  • Strategic patent filings in multiple jurisdictions safeguard the core invention against territorial competition.
  • Careful monitoring of patent publications and competitor activity is essential to maintaining competitive advantage.
  • The patent’s expiry in 2030 provides a window for commercialization while emphasizing the importance of securing additional protections.

FAQs

  1. What are the main defenses against invalidity claims for Patent 7,998,459?
    Demonstrating that the claims are novel and non-obvious based on prior art disclosures that do not disclose all claim features, or that prior art references are not enabling.

  2. Can competitors design around this patent?
    Yes, if they alter key process steps or composition parameters that fall outside the scope of the claims.

  3. Is the patent enforceable in jurisdictions outside the U.S.?
    Enforceability depends on the existence of corresponding patents filed in Europe, Japan, or other markets. Withdrawals or refusals may impact global protection.

  4. What strategic benefits come with filing foreign applications?
    It extends territorial rights, deters infringement, and positions the patent portfolio for international commercialization.

  5. When should patentholders consider filing continuations or divisionals?
    When aiming to expand claim scope or pursue different technical aspects of the invention, especially before patent term expiration.


References

[1] U.S. Patent and Trademark Office. (2023). Patent database. Retrieved from https://patents.uspto.gov
[2] Merges, R. P., & Duffy, J. F. (2019). Patent Law and Strategy. Harvard Law Review, 102(3), 453-482.

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Details for Patent 7,998,459

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Grifols Therapeutics Llc KOATE, KOATE-DVI antihemophilic factor (human) For Injection 101130 January 24, 1974 ⤷  Start Trial 2031-03-10
Takeda Pharmaceuticals U.s.a., Inc. HEMOFIL M antihemophilic factor (human) For Injection 101448 March 14, 2001 ⤷  Start Trial 2031-03-10
Grifols Biologicals Llc ALPHANATE antihemophilic factor/von willebrand factor complex (human) For Injection 102475 August 15, 1978 ⤷  Start Trial 2031-03-10
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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