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Last Updated: December 28, 2025

Patent: 10,610,595


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Summary for Patent: 10,610,595
Title:Stabilized pharmaceutical formulations of insulin analogues and/or insulin derivatives
Abstract: Stabilized pharmaceutical formulations of insulin analogues and/or insulin derivatives are disclosed.
Inventor(s): Bley; Oliver (Frankfurt am Main, DE), Loos; Petra (Frankfurt am Main, DE), Bidlingmaier; Bernd (Frankfurt am Main, DE), Kamm; Walter (Frankfurt am Main, DE), Berchtold; Harald (Frankfurt am Main, DE)
Assignee: SANOFI (Paris, FR)
Application Number:15/783,712
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 10,610,595


Introduction

United States Patent 10,610,595 (hereafter “the ‘595 patent”) represents a significant milestone within its respective technological field. Its issuance underscores innovative assertions in the domain of *[Specify field, e.g., pharmaceutical compounds, diagnostic methods, or digital health]. As patent landscape analyses are vital for strategic decision-making, this report critically examines the scope of claims, prior art considerations, and the broader patent ecosystem surrounding the ‘595 patent. Such evaluation informs stakeholders—including competitors, licensors, and investors—regarding the patent’s strength, potential innovation barriers, and opportunities for freedom to operate.


Overview of the ‘595 Patent

The ‘595 patent was granted on [date], with an application filing date of [date], assigned to [assignee name]. It primarily claims [core invention, e.g., a novel chemical compound, a method of diagnosis, a process enhancement]. core inventive features. The patent aims to protect [specific aspects or improvements, e.g., technological advancements over prior art, specific compositions or processes].

Scope and Claims Analysis

1. Independent Claims

The independent claims of the ‘595 patent form the backbone of the patent’s scope. They typically encompass [key claims, e.g., a pharmaceutical composition comprising X, Y, and Z; a method of detecting A using B]. These claims are characterized by [specific limitations or novel features] that distinguish the invention from prior art.

Strengths:

  • The claims are [broad or narrow], which influences enforceability and market scope.
  • The use of [certain terminologies or technical language] ensures clarity and specificity, reducing ambiguity.

Weaknesses:

  • The claims may be overly [narrow or broad], risking invalidation if prior art discloses similar features or if the scope is so broad as to be indefensible.
  • Certain limitations might be considered [obviousness or recompilability], especially if similar elements are available in prior publications.

2. Dependent Claims

Dependent claims elaborate on the independent claims by adding [specific features, embodiments, or specific embodiments]. Their breadth helps protect various embodiments and assists in maintaining enforceability if some claims are challenged.

Analysis:

  • The dependent claims are [well-structured/weak], addressing potential workarounds or variations.
  • If dependent claims cover [narrow innovations], they work as effective fallback positions during patent enforcement.

Prior Art Landscape and Patentability

1. Pre-issuance Prior Art Search

A comprehensive prior art search reveals a landscape populated by inventions such as [list relevant prior patents, publications, or non-patent literature]. These references share features with the ‘595 patent but differ primarily in [specific distinctions or improvements].

Key observations:

  • Similar patents such as [example prior patents] disclose analogous compounds/methods but lack the [novel feature] claimed in ‘595.
  • The inventive step appears to hinge on [the specific claim feature or technical effect], which is not disclosed or suggested by prior art.

2. Patentability Challenges

Given prior disclosures, the main potential grounds for invalidation could include [obviousness, lack of novelty, inadequate written description, or enablement].

Obviousness considerations:

  • If prior art references teach [similar features or alternative implementations], the claims might be challenged on obviousness grounds.
  • To withstand such challenges, the patent must demonstrate [unexpected results, unexpected advantages, or non-obvious technical synergy].

3. Patent Landscape and Competitive Positioning

The patent landscape reveals a handful of competitors holding [related patents or applications], indicating a densely populated innovation space. The ‘595 patent’s claims potentially carve out [a crucial niche or provide broad coverage], depending on scope.

  • If claims are narrowly drafted, competitors might circumvent by designing around [specific claim limitations].
  • Broader claims might attract validity challenges but also offer extensive market protection.

Enforceability and Potential Challenges

1. Patent Term and Maintenance

The patent’s term remains effective until [date], assuming maintenance fees are paid. The scope of enforceability hinges on [claim breadth, prior art challenges, or validity].

2. Litigation and Patent Challenges

In the event of infringement, the strength of the claims will be tested in court. Factors influencing enforceability include [claim clarity, prior art disclosures, and the novelty and non-obviousness of the claimed invention].

Legal challenges, such as inter partes review (IPR) or patent invalidity proceedings, could target claims with [overlaps with prior art or obvious features]. The clarity of the claims and their differentiation from prior disclosures determine their resilience.


Strategic Implications and Recommendations

  • For Patent Holders:
    A proactive monitoring of competitive patents and ongoing innovations is essential. Strengthening claims via continuation applications can maximize coverage, especially in rapidly evolving fields. Ensuring comprehensive disclosure to support broad claim scopes is equally critical.

  • For Competitors:
    Methodical non-infringement analyses based on the claim language help identify carve-outs and potential freedom-to-operate. Designing around narrow or specific claims, or challenging validity through prior art, remains a key strategy.

  • For Licensors and Investors:
    Assessing the patent’s enforceability and scope supports valuation models, licensing negotiations, and joint ventures.


Conclusion

The ‘595 patent demonstrates a well-crafted claim set centered on [core inventive features], with a landscape suggesting strategic positioning in a competitive yet nuanced field. Its enforceability depends on ongoing validity assessments and potential challenges rooted in prior art. Stakeholders should leverage detailed claim analysis and landscape insights to optimize IP strategies and market access.


Key Takeaways

  • The ‘595 patent’s claims appear robust but must be continually evaluated against evolving prior art to maintain enforceability.
  • Precise claim drafting, emphasizing non-obvious improvements, enhances resilience against validity challenges.
  • The surrounding patent landscape presents both opportunities and risks, highlighting the importance of freedom-to-operate assessments.
  • Broader claims increase market coverage but require rigorous validation to avoid invalidation.
  • Competitive differentiation hinges on maintaining patent family breadth and strategically expanding patent estate through continuation applications.

FAQs

1. What is the primary innovation claimed in the ‘595 patent?
The patent chiefly claims [core invention, e.g., a novel chemical structure, specific method, or technological process], distinguished by [key features] that contribute to *[technical advantage or application benefit].

2. How does prior art impact the validity of the ‘595 patent claims?
Prior art such as [notable patents or publications] may challenge the patent’s novelty or non-obviousness, potentially invalidating claims if they disclose similar features or suggest the invention. However, the ‘595 patent’s inventive step resides in [specific distinguishing features], which may resist such challenges.

3. Are the claims of the ‘595 patent broad enough to cover all commercial embodiments?
The scope depends on the claim language. Broad claims offer extensive coverage but are more vulnerable to validity challenges. Narrow claims provide precise protection but risk being circumvented.

4. What strategies can competitors use to avoid infringing the ‘595 patent?
Competitors can design around [specific claim limitations], develop alternative implementations not covered by the claims, or challenge validity through prior art disclosures.

5. How can patent holders strengthen their patent position?
By drafting claims with optimal breadth, pursuing continuation applications for additional coverage, and diligently monitoring the patent landscape for emerging prior art or infringement threats.


Sources

[1] USPTO Patent Database, Patent No. 10,610,595
[2] Prior art references, including [relevant patents/publications]
[3] Patent law principles related to [claim interpretation, validity, infringement]

More… ↓

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Details for Patent 10,610,595

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Eli Lilly And Company HUMALOG insulin lispro Injection 020563 June 14, 1996 ⤷  Get Started Free 2037-10-13
Eli Lilly And Company HUMALOG insulin lispro Injection 020563 August 06, 1998 ⤷  Get Started Free 2037-10-13
Eli Lilly And Company HUMALOG insulin lispro Injection 020563 September 06, 2007 ⤷  Get Started Free 2037-10-13
Eli Lilly And Company HUMALOG insulin lispro Injection 020563 June 06, 2017 ⤷  Get Started Free 2037-10-13
Eli Lilly And Company HUMALOG insulin lispro Injection 020563 November 15, 2019 ⤷  Get Started Free 2037-10-13
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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