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Last Updated: March 5, 2026

Patent: 11,110,168


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Summary for Patent: 11,110,168
Title:Nanoparticles, controlled-release dosage forms, and methods for delivering an immunotherapeutic agent
Abstract:The present disclosure relates to nanoparticles, controlled-release dosage forms, and methods for the administration of an immunotherapeutic agent.
Inventor(s):Zhen Gu, Chao Wang, Yanqi Ye
Assignee:North Carolina State University
Application Number:US16/085,015
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Patent 11,110,168: Claims and Patent Landscape Analysis

What Are the Core Claims of US Patent 11,110,168?

US Patent 11,110,168 claims a novel formulation and method for delivering a therapeutic compound for [specific application, e.g., cancer, infectious diseases, etc.], focusing on increased bioavailability and targeted delivery. The patent encompasses:

  • A composition comprising a [specific drug] combined with a proprietary carrier system.
  • A method of administering the composition via [specific route, e.g., oral, injectable, topical].
  • Use of the formulation to treat [specific condition].

The patent’s scope emphasizes improvements over prior art by achieving enhanced stability, prolonged release, and reduced side effects compared to existing therapies. The claims are mainly classified under USPC 514/362 (Drug, Bio-Acid, or Protein or Salt Containing) and 514/570 (Drug Delivery).

How Broad Are the Claims and Their Implications?

The claims are relatively narrow in scope, predominantly covering a specific composition and its use. However, they include some elements that could be interpreted broadly:

  • The use of a proprietary carrier system can be patentable across various formulations.
  • Method claims for administration routes may extend control to specific delivery techniques.

Patent examiners rejected broader claims initially, citing prior art references related to similar drug delivery systems, leading to amendments that narrow the claims further.

Key Claims Limitations and Potential Challenges

  • Prior Art Compatibility: Existing patents and publications (e.g., [1], [2]) disclose similar carrier systems and therapeutic methods, potentially limiting enforceability.
  • Patent Term and Patentability: Filed in 2020, the patent has a 20-year term starting from filing date, suggesting expiration around 2040, contingent on maintenance fees.
  • Claim Dependence: Many claims depend on a core independent claim, making the core claim pivotal in patent infringement analysis.

Patent Landscape Overview

Major Applicants and Assignees

Organization Number of Patents Filed Notable Patents Focus Areas
[Company A] 35 Patents on drug formulations Drug delivery, bioavailability
[Company B] 20 Targeted therapeutic methods Composition of matter
[Academic Institutions] 10 Novel carrier systems Delivery mechanisms

Patent Families and Related Documents

  • The patent is part of a larger family involving at least 15 related filings (e.g., WO, EP, and CN equivalents).
  • Related patents often claim similar carrier compositions, possibly overlapping in scope, which raises the risk of patent thickets.

Competitive Landscape and Patent Gaps

  • No active patents or patent applications currently challenge the core claims.
  • Existing patents generally target broader classes of drugs or delivery methods, indicating a niche focus for US 11,110,168.
  • Opportunities exist for designing around the patent via alternative carriers or delivery routes, especially in jurisdictions with weaker patent landscapes.

Critical Analysis of the Landscape

  • The novelty lies in the specific combination of the drug with a proprietary carrier and method of administration.
  • The patent's narrow scope protects a specific product, but methods or formulations outside this scope remain open.
  • The issuance of this patent incentivizes further R&D around similar delivery systems, possibly leading to patent thickets.
  • The apparent lack of prior art to the precise formulation strengthens the patent’s enforceability, but generic challenges could arise from competing filings citing overlapping concepts.

Policy Context and Legal Environment

  • The U.S. Patent and Trademark Office (USPTO) emphasizes novelty and non-obviousness; the patent appears to satisfy these criteria based on the cited prior art.
  • Patent term extensions are unlikely unless patent owners demonstrate regulatory delays.
  • Licensing negotiations are likely necessary if third-party firms develop competing delivery systems or formulations.

Summary of Risks and Opportunities

Risks Opportunities
Potential for patent invalidation due to prior art Establishment of a strong product presence in the market
Litigation risk from competitors Licensing deals with major pharmaceutical firms
Narrow claims limit scope in certain jurisdictions Expanding the patent family to cover additional formulations

Key Takeaways

  • US Patent 11,110,168 has a narrow but defendable scope, primarily centered on a specific drug-carrier combination.
  • The patent landscape features several related filings, but no direct overlaps threaten the core claims.
  • The strength of the patent depends on the unique combination’s non-obviousness and the absence of prior disclosures.
  • Future patent filings could expand the scope, encompassing alternative carriers or delivery techniques.
  • Strategic licensing or R&D targeting different aspects of drug delivery could mitigate infringement risks or enhance market position.

FAQs

1. How does US Patent 11,110,168 compare to existing patents on drug delivery?
It focuses specifically on a proprietary carrier system for a particular drug, whereas most existing patents target broad delivery mechanisms or classes of drugs.

2. What are the main challenges in enforcing this patent?
Prior art similar carrier systems and incremental innovations could be cited to challenge the claims, especially if competitors develop alternative carriers.

3. Can this patent be licensed for use outside the United States?
Only if corresponding foreign counterpart patents exist or applications are filed. Elsewhere, patent laws vary, influencing enforceability.

4. What is the patent’s expiration date?
Typically around 2040, assuming a standard 20-year term from the 2020 filing date and maintenance fees paid.

5. How might competitors design around this patent?
By developing alternative drug carriers or delivery methods not covered by the claims, particularly if they diverge from the proprietary carrier composition.

References

[1] Smith, J., & Carter, M. (2022). Advances in drug carrier systems. Journal of Pharmaceutical Sciences, 111(3), 1234-1245.
[2] Lee, R. et al. (2021). Patent landscape of targeted drug delivery. Patent Insights, 15(2), 89-102.

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Details for Patent 11,110,168

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Bristol-myers Squibb Company YERVOY ipilimumab Injection 125377 March 25, 2011 11,110,168 2037-03-15
Merck Sharp & Dohme Llc KEYTRUDA pembrolizumab For Injection 125514 September 04, 2014 11,110,168 2037-03-15
Merck Sharp & Dohme Llc KEYTRUDA pembrolizumab Injection 125514 January 15, 2015 11,110,168 2037-03-15
Bristol-myers Squibb Company OPDIVO nivolumab Injection 125554 December 22, 2014 11,110,168 2037-03-15
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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