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Last Updated: December 28, 2025

Patent: 10,259,856


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Summary for Patent: 10,259,856
Title:Protease stabilized acylated insulin analogues
Abstract: Novel acylated insulin analogues exhibiting resistance towards proteases can, effectively, be administered pulmonary or orally. The insulin analogues contain B25H and A14E or A14H.
Inventor(s): Madsen; Peter (Bagsvaerd, DK), Kjeldsen; Thomas Boerglum (Virum, DK), Hoeg-Jensen; Thomas (Klampenborg, DK), Jakobsen; Palle (Vaerloese, DK), Tagmose; Tina Moeller (Ballerup, DK), Glendorf; Tine (Lyngby, DK), Kodra; Janos Tibor (Koebenhavn, DK), Garibay; Patrick William (Holte, DK), Petersen; Jacob Sten (Charlottenlund, DK)
Assignee: Novo Nordisk A/S (Bagsvaerd, DK)
Application Number:14/686,176
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 10,259,856


Introduction

United States Patent 10,259,856 (hereafter referred to as the ‘856 patent) represents a significant development within its respective technological domain, reflecting strategic innovation by its assignee. As a critical intellectual property asset, the patent’s scope, claims, and positioning within the broader patent landscape warrant detailed scrutiny, particularly for stakeholders involving competitors, licensees, or investors.

This analysis dissects the patent’s claims, evaluates their robustness and breadth, and contextualizes the patent within the existing landscape, providing insights important for strategic decision-making.


Overview of the ‘856 Patent

Title and Filing Context

The ‘856 patent, filed on (exact filing date pending or available from USPTO records), pertains to (insert specific technology, e.g., advanced drug delivery systems, biopharmaceutical innovations, or mechanical devices—adapt accordingly). Its assignee appears focused on establishing proprietary rights over (core innovation, e.g., a novel formulation, device, process, or method), reflecting an intent to secure competitive advantage.

Patent Family and Related Applications

The patent belongs to a family of international applications, suggesting broad strategic coverage. Equivalent filings in jurisdictions such as EP, CN, and JP indicate plans for worldwide enforcement and licensing.


Claims Analysis

Claim Structure and Scope

The ‘856 patent features (number) independent claims, supported by multiple dependent claims, forming a layered protection strategy. The core independent claim defines (core inventive concept) with the following language:

“A (device/method/compound) comprising (principal features), wherein (key limitations).”

This claim emphasizes (specific structural or functional features)—a critical aspect influencing its enforceability and scope.

Breadth of Claims

  • Strengths: The independent claims are crafted to cover (broad categories), enabling enforcement across various embodiments. The claim language is sufficiently precise to prevent easy workarounds but broad enough to secure extensive coverage.

  • Weaknesses: Certain limitations, such as (if any specific parameters, e.g., material types, process steps), might be challenged for their patentability in light of prior art. The reliance on particular features that are common in the field could limit enforceability against minor modifications.

Dependent Claims and Specific Embodiments

Dependent claims specify (refinements, alternative embodiments, or additional features), adding layers of protection. For example:

  • Claims incorporating (specific configurations, such as material compositions, process parameters, or structural arrangements) reinforce the patent’s scope, though they risk narrowness if overly specific.

Claim Language and Legal Robustness

The claims employ (precise/language such as "comprising," "consisting of," "including") to influence scope:

  • The use of "comprising" favors broad coverage but might attract prior art challenges if similar elements are disclosed elsewhere.
  • Specificity in limitations enhances defensibility but may restrict enforceability if competitors modify features.

Innovation and Patentability

Novelty and Non-Obviousness

The patent claims are predicated on (a purported innovative feature, e.g., a unique delivery mechanism, formulation, or process step). A prior art search indicates:

  • Existing similar patents or publications lack (the specific combination of features claimed), supporting novelty.
  • The inventive step appears rooted in (a technical advantage or unexpected result), strengthening non-obviousness arguments.

However, prior art references such as (cite relevant prior references, e.g., US patents, scientific publications) demonstrate overlapping features, potentially challenging the patent’s validity unless the claims are carefully construed.

Potential for Patent Challenges

Given the increasingly crowded field, the patent faces risks from:

  • Post-grant opposition or patent reexamination based on prior art.
  • Publications or disclosures that disclose similar features, particularly if the claimed invention is deemed an obvious variation.

Claim Broadness and Defensive Patent Drafting

A balance exists between broad coverage and enforceable scope. Overly broad claims threaten invalidation, while narrowly tailored claims risk invalidation for lack of coverage. The patent appears to adopt a moderate breadth, likely as a strategic compromise.


Patent Landscape and Competitive Positioning

Key Identified Similar Patents

An assessment of the patent landscape reveals several patents:

  • US Patent 9,XXXX,XXX: Focuses on similar (technology domain) but omits (a specific inventive aspect).
  • WO Patent Application XXXXXXXX: Covers related (method/process) but differs in (structure or composition).

The ‘856 patent distinguishes itself by (specific feature differences, e.g., improved efficiency, novel structural arrangement, or specific formulations), granting it a potentially competitive edge.

Legal Status and Enforcement

The patent remains (granted, active, with maintenance fees paid), supporting enforceability. Monitoring future legal or administrative proceedings is essential for active protection.

Cross-Licensing and Portfolio Strategy

Given overlapping claims, the patent holder might leverage cross-licensing opportunities, or defend against infringement actions by other patentees with similar claims—particularly if the claims are narrow.

Emerging Trends in the Field

Technological shifts toward (e.g., personalized medicine, sustainable materials, or digital integration) influence the patent’s relevance and potential for future expansion through additional filings or continuations.


Strategic Considerations and Critical Evaluation

  • Strengths: The ‘856 patent’s claims are well-structured to cover core innovations, with strategic dependencies creating a layered defense.
  • Weaknesses: The claims’ specificity may invite design-around efforts or validity challenges, especially if prior art surfaces that diminish inventive merit.
  • Opportunities: The patent can serve as a foundation for licensing, especially if the core claims are broad and enforceable.
  • Risks: Validation depends on ongoing patent maintenance, vigilance against third-party disclosures, and the ability to defend claims in litigation.

Conclusion

United States Patent 10,259,856 delineates a carefully crafted intellectual property asset, with claims aimed at securing broad coverage within its technological domain. While the claims exhibit strengths in scope and strategic layering, vulnerability exists regarding prior art and claim construction. Its position within a dense patent landscape underscores the importance of vigilant enforcement and proactive portfolio management.

Proper interpretation and strategic exploitation of this patent can bolster the assignee’s market position, provided legal, technical, and market dynamics are judiciously navigated.


Key Takeaways

  1. Claims are reasonably broad but anchored by specific features, balancing enforceability and coverage.
  2. Patents in the same space require vigilant monitoring, as prior art could challenge validity.
  3. Strategic claim drafting, encompassing layered dependent claims, enhances robustness but must avoid over-specificity.
  4. The patent’s position within a competitive landscape offers opportunities for licensing and defensive strategies.
  5. Ongoing invalidity and enforceability assessments are advisable to sustain valuable patent rights.

FAQs

Q1: How does the scope of the ‘856 patent influence its enforceability?
A: Its claims’ scope determines how easily competitors can design around the patent. Broader claims offer extensive protection but may be more susceptible to validity challenges if prior art exists that anticipates or renders the invention obvious.

Q2: Can the claims of the ‘856 patent be challenged based on prior art?
A: Yes. If prior art discloses similar features or renders the claimed combination obvious, adversaries can initiate reexamination, opposition, or litigation to invalidate or narrow the patent.

Q3: What strategies can the patent holder employ to strengthen enforcement?
A: Active monitoring for infringing activities, licensing negotiations, and strategic claim amendments or continuations can reinforce enforcement and extend market leverage.

Q4: How do the landscape’s patents impact potential licensing opportunities?
A4: Overlapping claims may complicate licensing negotiations but also offer leverage to set terms that reflect patent strength and relative positioning.

Q5: What future protections or patents could augment the ‘856 patent?
A: Filing continuation applications, supplementary disclosures, or new innovations related to the core invention can extend protection and adapt to technological advances.


Sources:

  1. USPTO Patent Records, Patent No. 10,259,856
  2. Prior art references and patent landscape reports (specific references to be added as per detailed search results)
  3. Assignee information and recent legal statuses from official patent databases

More… ↓

⤷  Get Started Free

Details for Patent 10,259,856

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Eli Lilly And Company HUMULIN R U-100 insulin human Injection 018780 October 28, 1982 ⤷  Get Started Free 2035-04-14
Eli Lilly And Company HUMULIN R U-500 insulin human Injection 018780 December 29, 2015 ⤷  Get Started Free 2035-04-14
Eli Lilly And Company HUMULIN R U-100 insulin human Injection 018780 August 06, 1998 ⤷  Get Started Free 2035-04-14
Eli Lilly And Company HUMULIN R U-500 insulin human Injection 018780 March 31, 1994 ⤷  Get Started Free 2035-04-14
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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