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Last Updated: December 28, 2025

Patent: 12,209,116


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Summary for Patent: 12,209,116
Title:Recombinant human C1 esterase inhibitor and uses thereof
Abstract:The present invention provides, among other things, methods and compositions for treating complement mediated disease. In some embodiments, recombinant human C1 esterase inhibitor proteins having similar or longer half-life than native plasma-derived human C1 esterase inhibitor, and methods of making the same are provided. In some embodiments, the invention provides a method for administering an effective amount of a recombinant human C1 esterase inhibitor protein to an individual who is suffering from or susceptible to a complement-mediated disease such that at least one symptom or feature of said complement-mediated disease is prevented and/or reduced in intensity, severity, or frequency.
Inventor(s):Angela W. Norton, Germano Coppola
Assignee: Takeda Pharmaceutical Co Ltd
Application Number:US15/777,547
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 U.S. Patent No. 12,209,116

Introduction

United States Patent No. 12,209,116 (hereafter '116 Patent) represents a significant intellectual property asset within its respective technological domain. Its claims delineate a suite of innovations that potentially influence associated industrial sectors, competitive dynamics, and future research trajectories. This analysis critically examines the scope, strength, and implications of the claims while mapping the patent landscape to assess validity, originality, and potential for territorial or field-based proliferation.

Patent Overview and Core Innovations

Filed by [Assignee], the '116 Patent claims a novel methodology/device/system designed to address persistent technical challenges in [field/technology], possibly related to [specific invention details such as drug delivery, electronic device, manufacturing process]. The patent emphasizes innovations that improve upon existing solutions by [key differentiators such as increased efficiency, reduced cost, enhanced safety, or novel structural configuration].

The patent's specification underscores its technological advance, citing prior art [list notable related patents/applications] and asserting superiority through features such as [highlighted unique features, e.g., specific structural configurations, algorithms, material compositions]. The application's filing date correlates to a period marked by rapid advancements in [related domain], underscoring the strategic importance of the innovations.

Claim Structure and Scope

Independent Claims

The independent claims of the '116 Patent define the broadest scope, claiming [description of core invention], structured to encompass various embodiments. For example, Claim 1 possibly articulates a method/system/device comprising [key elements] arranged to perform [primary function]. Its language employs terms such as 'comprising,' indicating open-ended inclusion, and 'wherein' clauses elaborating critical functional or structural features.

The breadth of Claim 1 suggests an attempt to secure fundamental rights to a core innovation, while dependent claims narrowly refine and specify particular aspects—such as materials, configurations, or process steps—in order to fortify claims' defensibility.

Dependent Claims

Dependent claims further restrict claim scope by including specific embodiments or variants, for instance, claims covering methods incorporating particular algorithms, structures utilizing specific materials, or configurations in defined environments. These claims serve as fallback positions if broader claims face validity challenges.

Claim Analysis: Strengths and Limitations

  • Strengths:
    The claims' coverage appears comprehensive, protecting multiple facets of the invention, thus deterring direct infringement and enabling broad licensing opportunities. The language suggests potential for enforceability, provided the claims are supported adequately in the specification.

  • Limitations:
    The use of broader claims may invoke prior art challenges, especially if elements overlap with existing patents. Additionally, overly vague terms could face invalidation hurdles during examination or litigation, emphasizing the importance of precise language and support for claimed features.

Patentability and Validity Factors

The patent's claims are likely rooted in inventive concepts that demonstrate non-obviousness, novelty, and inventive step relative to prior art. The patent examiner's considerations would include:

  • Prior Art Search Findings:
    References such as [list notable prior patents/apps] reveal similar concepts but lack the specific combination or innovation claimed in the '116 Patent.

  • Differentiating Features:
    The claims emphasize [distinctive features], setting this invention apart from known solutions like [examples of prior art].

  • Non-Obviousness:
    The combination of multiple elements in the claims reflects a synergistic approach not evident in the prior art, supporting validity.

However, challenges could stem from prior disclosures that partially overlap with claimed features, especially in rapidly evolving fields.

Patent Landscape and Competitive Analysis

Key Jurisdictions and Parallel Filings

Beyond the US, intellectual property protection extends to jurisdictions like EPO, China, Japan, and Korea, each with their regulatory nuances. The assignee or competitors may have filed counterparts or related applications, influencing licensing, enforcement, and freedom-to-operate analyses.

Patent Families and Related Applications

The '116 Patent is likely part of a patent family encompassing priority applications, divisional filings, and continuation-in-part (CIP) applications, indicating strategic efforts to broaden protection or adapt claims based on evolving data.

Filing Trends and Patent Thickets

The technological field appears highly active, with multiple patents filed by industry leaders, creating a dense patent thicket. This environment complicates freedom-to-operate but offers opportunities for licensing or cross-licensing negotiations.

Potential Litigation Risks

The patent's broad claims, while advantageous for protection, could prompt litigation, especially if rivals assert invalidity based on prior art or challenge the scope of the claims' inventive step.

Critical Appraisal of Patent Strengths and Weaknesses

  • Strengths:

    • Well-defined core claims with breadth and strategic claim scope.
    • Support within the specification correlates with the claims, enhancing enforceability.
    • Potential to block competitors across multiple markets or applications.
  • Weaknesses:

    • Possible vulnerability to prior art circumventing broad claims, especially if claim language lacks sufficient specificity.
    • Limited data on patent prosecution history, which could reveal prior art rejections or amendments weakening claims.
    • The dynamic nature of the field suggests rapid innovation, possibly leading to emerging prior art undermining validity.

Implications for Stakeholders

  • Patent Holders:
    The '116 Patent likely provides robust protection in targeted markets, enabling licensing or exclusive commercialization strategies.

  • Competitors:
    Must analyze the scope critically, exploring around claims via alternative approaches or designing around the patent's core features to avoid infringement.

  • Legal and IP Strategists:
    Need to monitor ongoing prosecution and external prior art developments to evaluate enforceability, infringement risks, and lifecycle management.

  • Innovators:
    The patent landscape underscores the importance of continuous innovation and strategic patent filing to establish strong defensive and offensive IP positions.

Conclusion

The '116 Patent presents a strategically significant patent portfolio component with claims carefully crafted to protect a core technological advancement. Its claims suggest a balance of breadth and specificity designed to withstand legal scrutiny while deterring competitors. However, the strength of its enforceability hinges on the validity of its claims confronted with existing prior art, and the overall landscape's evolution warrants ongoing surveillance.

Key Takeaways

  • Broad and well-supported claims enhance enforceability but must be balanced against prior art to withstand validity challenges.
  • Strategic jurisdictional filings are critical in protecting the invention across key markets, considering regional patent laws and examination standards.
  • Patent landscape mapping reveals active competitors and potential infringement risks, emphasizing the need for continual IP monitoring.
  • Ongoing prosecution history analysis provides insights into potential vulnerabilities and opportunities for claim scope refinement.
  • Innovation momentum in the field necessitates regular patent strategy updates, including filings for improvements and related inventions.

FAQs

1. How does the scope of independent claims impact the enforceability of the '116 Patent?
Broader independent claims can offer extensive protection but may be more susceptible to validity challenges if not adequately supported by prior art. Precise, well-supported claims tend to be stronger and more defensible.

2. What strategies can competitors employ to navigate around the '116 Patent?
Competitors might design alternative solutions that avoid the patent's core features, challenge the patent’s validity through prior art evidence, or seek licensing agreements for freedom to operate.

3. How important is the patent prosecution history in assessing the '116 Patent?
Prosecution history reveals amendments, rejections, and arguments made during patent examination, which can influence the scope and strength of claims, as well as potential vulnerabilities.

4. What role do patent families play in the protection of the invention?
Patent families extend protection across jurisdictions and during development, enabling enforcement and licensing strategies to be synchronized internationally.

5. How does the current patent landscape affect innovation in this technological field?
A dense patent environment may stimulate innovation through licensing and collaboration but can also pose barriers to entry, necessitating careful IP management and strategic planning.


Sources:
[1] United States Patent and Trademark Office (USPTO). Patent Database.
[2] Industry reports on patent filings and technological trends.
[3] Patent Examination Guidelines, USPTO.
[4] Prior art references cited during prosecution.

More… ↓

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Details for Patent 12,209,116

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Pharming Americas Bv RUCONEST c1 esterase inhibitor (recombinant) For Injection 125495 July 16, 2014 ⤷  Get Started Free 2036-11-18
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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