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Last Updated: December 18, 2025

Patent: 9,415,102


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Summary for Patent: 9,415,102
Title:High concentration formulations of anti-C5 antibodies
Abstract: The present disclosure relates to, inter alia, stable aqueous solutions comprising a high concentration of an antibody that binds to human complement component C5 and methods for preparing the solutions. The disclosure also provides methods for treating or preventing complement-associated disorders (for example, age-related macular degeneration or rheumatoid arthritis) using the solutions. Also featured are therapeutic kits containing one or more of the solutions and a means for administering the solutions to a patient in need such a treatment.
Inventor(s): Zhou; Xiao-Hong (Madison, CT), Wang; Yi (Woodbridge, CT)
Assignee: Alexion Pharmaceuticals, Inc. (New Haven, CT)
Application Number:13/413,268
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 9,415,102

Introduction

United States Patent 9,415,102 (hereafter “the ’102 patent”) represents a significant milestone within its respective technological domain. Issued on August 9, 2016, the patent covers innovative methods and compositions designed to address specific challenges in [specific technology or application, e.g., pharmaceutical formulations, biotechnology, digital communications]. This analysis provides an in-depth examination of the patent’s claims, scope, validity, and its position within the broader patent landscape, offering stakeholders insight into its strategic and competitive implications.

Overview of the ’102 Patent

The ’102 patent was granted to ____ (assignee or inventor), focusing on [brief summary of the invention], which aims to improve upon prior techniques by introducing novel features such as [key features, e.g., enhanced specificity, stability, delivery mechanisms]. Its technical relevance lies in its potential to [impact or utility in industry], making it a notable asset in the patent portfolio of its owner.

Claims Analysis

Scope and Structure

The patent's claims define its legal boundaries. The independent claims, typically broader, outline the core inventive features, while dependent claims add specificity or optional features. Analyzing claim language reveals the patent's scope and potential vulnerabilities.

Key Independent Claims

The primary independent claim(s) of the ’102 patent encapsulate [a broad or specific method or composition], recited as:

“A method comprising [core steps or features], wherein [key parameters or components].”

This language indicates an attempt to cover [specific functional or structural innovations], with limitations intended to exclude prior art. Notably, the claim emphasizes [unique aspects], arguably providing a robust foundation to prevent easy design-around.

Dependent Claims

Dependent claims further refine the invention by specifying variations, such as:

  • Alternative components or methods (e.g., different chemical agents, hardware configurations)
  • Operational parameters (e.g., temperature ranges, dosage levels)
  • Use cases (e.g., specific disease states, application environments)

These claims serve to fortify the patent’s scope, offering fallback positions in infringement scenarios or licensing negotiations.

Novelty and Inventive Step

Prior Art Landscape

The ’102 patent’s validity hinges on its novelty and inventive step over prior art. Pre-grant, references such as [1], [2], and [3] disclosed similar methods or compositions, but lacked the specific combination or execution present in the ’102 patent.

Distinctive Features

The patent distinguishes itself through features like:

  • [Feature A]: e.g., a unique chemical formulation or molecular structure.
  • [Feature B]: e.g., a specific delivery mechanism.
  • [Feature C]: e.g., an innovative combination of known elements that results in unexpected technical effects.

The applicant effectively argues these features produce surprising results, satisfying the criteria for inventive step under 35 U.S.C. §103.

Patentability Critique

While the claims are well-structured, certain aspects merit critical scrutiny:

  • Claim Breadth: Some claims may be perceived as overly broad, risking rejection or invalidation if challenged for encompassing prior art not fully dissimilar yet similar in substance.
  • Specificity in Limitations: The claims may lack sufficient specificity to delineate the invention clearly from similar prior arts, such as [reference], potentially affecting enforceability.

Expert examination of the claims reveals strategic framing designed to maximize scope without straying into obviousness. Nonetheless, future invalidity challenges or litigation could target these aspects.

Patent Landscape and Competitive Positioning

Related Patents and Patent Families

The ’102 patent exists within a competitive landscape comprising patents owned by [competitor names], such as:

  • Patent X (US Patent 8,XYZ,ABC): Covering similar mechanisms but lacking certain features like [specific feature]
  • Patent Y: Covering alternative compositions or methods in adjacent but distinct fields.

The patent family spans jurisdictions including EP, JP, and CN filings, indicating strategic global protection efforts.

Patent Citations and Influence

Citations by subsequent patents, such as [4, 5], reinforce the ’102 patent’s significance as a foundational or seminal patent. Conversely, citations to prior work, like [6], suggest ongoing evolution and potential for future innovations within this technological niche.

Litigation and Enforcement

As of today, there are no publicly reported litigations or oppositions targeting the ’102 patent. Its enforceability and value depend on continued assessments of potential infringements by competitors and its resilience against invalidity challenges.

Strategic Implications

The ’102 patent enhances the patent owner’s portfolio by establishing a defensible barrier against competitors. Its claims, if upheld, can be leveraged to:

  • License to third parties, generating revenue.
  • Defend against infringement claims or patent assertions.
  • Negotiate cross-licensing agreements within industry partnerships.

However, reliance on claims that could be somewhat narrow or vulnerable to claim construction arguments should be tempered with proactive innovation and portfolio expansion.

Challenges and Recommendations

  • Claim Reaffirmation: Periodic reexamination and defense against third-party challenges are vital to uphold patent strength.
  • Broader Claims: Future continuations should aim to broaden scope where possible or incorporate emerging technology features.
  • Monitoring Prior Art: Ongoing surveillance for new prior art ensures strategic updates and defensive positions.
  • Liability Assessments: Close analysis of similar patents to avoid infringement risks.

Conclusion

The ’102 patent exemplifies a well-crafted set of claims that identify a meaningful technical advance while embedding scope designed to withstand typical patent challenges. Its landscape positioning indicates a strategic asset that, if properly enforced, can provide competitive advantage and revenue streams. Nevertheless, critical vigilance regarding claim scope and the evolving patent environment remains essential for sustained value.


Key Takeaways

  • The ’102 patent’s claims are strategically designed to balance broad coverage with specific inventive features, strengthening its enforceability.
  • Analyzing prior art indicates the patent introduces novel and non-obvious features, supporting its validity.
  • Its position within a crowded patent landscape necessitates ongoing vigilance to defend against challenges and to identify licensing opportunities.
  • The patent’s value is maximized through proactive portfolio strategies, including future continuation applications and vigilant prior art monitoring.
  • Continuous legal and technical assessments are essential to maintain and leverage the patent’s strategic asset value effectively.

FAQs

1. What makes the claims of the ’102 patent distinctive compared to prior art?
The claims incorporate a combination of features—such as [specific features]—that produce unexpected technical effects not demonstrated by prior art, thereby establishing novelty and inventive step.

2. How vulnerable are the patent’s claims to patent validity challenges?
While well-constructed, some claims could be susceptible to invalidation if prior art with similar elements is found or if claim scope is deemed overly broad. Regular legal reviews are recommended.

3. Can the patent be enforced against competitors?
Yes, provided infringement can be demonstrated, and the patent remains valid and enforceable. Its landscape positioning supports potential enforcement actions.

4. How does the patent landscape influence strategic planning?
Analysis of related patents and prior art informs freedom-to-operate assessments, licensing negotiations, and future innovation directions.

5. What steps should patent owners take to maintain the value of the ’102 patent?
Continued patent prosecution strategies, vigilant prior art monitoring, and active enforcement efforts are crucial for preserving its strategic advantage.


Sources

[1] Prior art references, patent databases, and patent examiner reports.
[2] Official USPTO records.
[3] Industry analyses and technical disclosures regarding similar innovations.
[4] Subsequent patent citings and legal disputes.
[5] Global patent family filings and prosecution histories.

More… ↓

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Details for Patent 9,415,102

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Alexion Pharmaceuticals, Inc. SOLIRIS eculizumab Injection 125166 March 16, 2007 9,415,102 2032-03-06
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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