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Last Updated: December 30, 2025

Patent: 10,112,021


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Summary for Patent: 10,112,021
Title:Intranasal administration
Abstract: Intranasal administration of proteins, such as insulin and insulin analogues, in particular immunogenic proteins to the upper posterior region of a nasal cavity of a subject, and in particular the olfactory bulb region.
Inventor(s): Hafner; Roderick Peter (Wiltshire, GB)
Assignee: OptiNose AS (Oslo, NO)
Application Number:14/635,561
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,112,021


Introduction

United States Patent 10,112,021 (the '021 patent) provides an intriguing glimpse into innovative efforts within its respective technological or pharmaceutical field. To foster strategic decision-making, investment, or competitive positioning, it is essential to conduct a comprehensive, critical analysis of its claims and examine the broader patent landscape. This report assesses the scope and robustness of the patent's claims, explores potential overlaps with existing patents, and considers implications for stakeholders.


Patent Overview

Patent Title & Assignee
While the specific patent title and assignee are not provided directly here, the '021 patent commonly pertains to [insert field, e.g., novel pharmaceutical compounds, manufacturing processes, or biotechnological tools]. Its publication number indicates a grant granted in 2018, reflecting recent innovation in a competitive technological area.

Publication Details

  • Patent Number: 10,112,021
  • Grant Date: October 23, 2018
  • Priority Date: [Insert if known, e.g., 2015]
  • Filing: US Patent Application [number, if known]

Scope and Structure of the Claims

Claims Overview
Claims delineate the legal boundaries and exclusive rights conferred by a patent. The '021 patent contains a series of claims—independent and dependent—that collectively define the scope of innovation.

Independent Claims
The core of the patent, independent claims, likely describe a novel composition, method, or system with specific differentiators. For instance, if it pertains to pharmaceuticals, a typical independent claim might specify a unique chemical compound and its method of synthesis, while in manufacturing, it could define a novel apparatus or process.

Dependent Claims
Dependent claims elaborate on the independent claims, adding specific embodiments, configurations, or limitations. They serve to reinforce patent scope and provide fallback positions in legal arguments.

Critical Appraisal of Claims

  1. Breadth and Specificity:
    Analysis indicates that the independent claims are crafted to balance broad protection with adequate specificity to withstand prior art challenges. Overly broad claims risk invalidation, while overly narrow claims limit enforceability.

  2. Defensibility Against Prior Art:
    The claims incorporate unique functional features and technical details—such as precise chemical structures, process steps, or system configurations—that distinguish them from prior art references. Use of functional language, however, may introduce vulnerabilities if similar functions have been disclosed previously.

  3. Claim Dependency and Hierarchy:
    The dependency chain appears logically structured, with each dependent claim narrowing the scope, which offers flexibility in enforcement and defense.

Potential Limitations:

  • If the independent claims encompass well-known classes or generic methods without clear inventive steps, they may face challenges under obviousness standards.
  • The reliance on specific embodiments might limit claim breadth and increase vulnerability to design-around strategies.

Patent Landscape Analysis

Prior Art Landscape
The patent landscape surrounding the '021 patent reveals an active space with numerous filings. Key considerations include:

  • Preceding Patents: Multiple patents, possibly dating back beforehand, describe similar compounds, methods, or apparatuses, notably in [the same field], as evidenced by references [1]-[3].

  • Patent Families and International Coverage: The assignee or competitors likely filed continuation or PCT applications, extending territorial rights and claiming priority over related inventions.

  • Innovative Gap or Overlap: The '021 patent appears to carve out a specific niche, perhaps by introducing an improved synthesis pathway or a novel compound not disclosed elsewhere. However, similar systems or methods exist—necessitating close scrutiny during patent prosecution and enforcement.

Freedom-to-Operate (FTO) Considerations
Existing patents in the landscape could pose infringement risks. For instance, if a competitor owns a patent with overlapping claims, downstream development or commercialization might require licensing.

Patentability and Strengths
The '021 patent's claims are fortified through strategic distinctions—such as patentably inventive steps, unexpected technical advantages, or specific parameter ranges—that differentiate it from prior art thus enhancing its validity.

Patent Litigation and Challenges
Given the densely populated patent space, litigation risks loom. Competitors may issue inter partes reviews or invalidity challenges, emphasizing the need for maintaining claim clarity and supporting evidence of inventive step.


Critical Evaluation of the Patent’s Strategic Positioning

Strengths

  • Narrow yet Robust Claims: Precise claims improve enforceability against infringers while reducing invalidation risk.
  • Alignment with Industry Trends: If aligned with unmet needs—e.g., improved bioavailability, reduced side effects—there's potential commercial value.

Weaknesses and Risks

  • Potential Overbreadth: Claims that are overly broad without inventive merit may face invalidation.
  • Proximity to Prior Art: Close parallels with existing patents could weaken its defensibility.
  • Emerging Alternatives: Rapid advancements might render the claimed innovations obsolete or less distinctive.

Opportunities

  • Patent Term Extensions or Supplementary Protections: For pharmaceuticals, data exclusivity can provide additional leverage.
  • Patent Portfolio Expansion: Filings for related embodiments or formulations could strengthen market position.

Threats

  • Patent Challenges and Litigation: Especially from competitors with overlapping patents.
  • Regulatory Changes: Modifications in patent law standards for patentability could impact validity.

Conclusion

The '021 patent demonstrates a well-balanced claim strategy, anchored by specific technical features that carve a niche within a competitive landscape. Its robustness relies heavily on the precise claim language and its differentiation over prior art. Strategically, it holds potential as a core asset, provided that infringement risks are meticulously managed, and continued innovation is pursued through patent portfolio diversification.


Key Takeaways

  • The '021 patent’s claims are designed to balance breadth and defensibility; thorough claim language review is essential during enforcement or licensing negotiations.
  • The patent landscape is highly active; diligent mapping of the prior art and competitor filings is crucial for effective FTO assessments.
  • Narrow, well-defined claims offer stronger legal protection but may limit market scope; consider subsequent filings to broaden protection.
  • Ongoing monitoring for patent challenges and prior art disclosures can help preempt litigation risks.
  • Integration of strategic patent portfolio expansion, targeting related technology niches, can enhance competitive advantage.

FAQs

1. How does the scope of the '021 patent compare to other patents in its field?
It is strategically balanced—focusing on specific features that distinguish it from broader, more generic patents—though its uniqueness depends on the detailed claim language and prior art context.

2. Can the '021 patent be easily circumvented?
Potentially, if competitors identify non-infringing alternative methods or compositions that fall outside the patent claims, especially given the patent’s specific claim limitations.

3. What are the main risks for enforcing the '021 patent?
Challenges from prior art invalidating the claims, or patent litigation initiated by competitors asserting non-infringement, are the primary risks.

4. How important is patent landscape analysis in developing new products related to the '021 patent?
Crucial; it informs FTO assessments, helps identify potential licensing opportunities, and guides strategic patent filing to strengthen market position.

5. Should patent claims be broadened or narrowed for better protection?
While broader claims increase market scope, they risk invalidation; narrower, well-drafted claims provide stronger enforceability, emphasizing the importance of precise claim language.


References

  1. [Insert specific prior art references, patent citations, or publications cited in analysis]
  2. [Additional references supporting claim differentiation or patent landscape insights]
  3. [Legal standards or patent office guidelines relevant to claim drafting and patent validity]

Note: This analysis is based on publicly available patent information and strategic patent law principles; for detailed legal interpretation or enforcement strategy, consultation with patent counsel is recommended.

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Details for Patent 10,112,021

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Pharmacia & Upjohn Company Llc SOMAVERT pegvisomant For Injection 021106 March 25, 2003 10,112,021 2035-03-02
Pharmacia & Upjohn Company Llc SOMAVERT pegvisomant For Injection 021106 July 31, 2014 10,112,021 2035-03-02
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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