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Last Updated: December 28, 2025

Patent: 9,452,203


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Summary for Patent: 9,452,203
Title:Use of C1-inhibitor for the treatment of secondary edema of the central nervous system
Abstract:The subject of the present invention is, in the most general aspect, the prevention and/or treatment of a secondary edema. In particular, the present invention relates to a C1-Inhibitor for use in a method of preventing the formation and/or reducing the size of a secondary edema of the central nervous system (CNS) in a subject wherein the subject has or has had at least one disorder selected from the group consisting of stroke, ischemic stroke, hemorrhagic stroke, perinatal stroke, traumatic brain injury and spinal cord injury. Preferably the secondary edema of the CNS is a secondary brain edema. Another subject of the present invention is the treatment of disorders associated with an increased permeability of the blood brain barrier or the blood spinal cord barrier. And a third subject is a plasma-derived C1-inhibitor for use in a method of preventing, reducing or treating brain ischemia-reperfusion injury.
Inventor(s):Kleinschnitz Christoph, Nolte Marc, Stoll Guido, Dickneite Gerhard, Schulte Stefan, Nieswandt Bernhard, Pragst Ingo
Assignee:CSL BEHRING GMBH
Application Number:US14364097
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 9,452,203


Introduction

United States Patent 9,452,203 (hereafter referred to as the '203 patent) consolidates intellectual property rights in the domain of [specific technology area, e.g., drug delivery systems, biotechnology, etc.]. As a pivotal patent granted in [year], it delineates a set of claims designed to establish proprietary rights over specific innovations. This analysis critically examines the scope and robustness of the claims, evaluates the patent’s strategic positioning within the existing patent landscape, and considers implications for innovation and commercialization prospects.


Overview of the '203 Patent

The '203 patent was issued on September 27, 2016, to assignees [Assignee Name], with inventors [Inventor Names]. It claims priority from earlier applications dating to [application dates], and encompasses innovations in [technology or process area]. The patent’s core claims revolve around [brief description of core invention, e.g., a novel delivery mechanism for biologics, a specific chemical compound, or a manufacturing method].

The patent’s central contribution appears to be [summarize key invention, e.g., enhancing stability of a drug formulation, improving targeting specificity, reducing manufacturing costs], with particular emphasis on [any novel features such as a specific structural configuration, material composition, or process step].


Claim Structure and Scope

The patent comprises [total number] claims, segmented into independent and dependent claims, with the independent claims outlining the broadest scope of protection.

Independent Claims

The independent claims primarily cover [core invention components – e.g., a composition comprising X and Y with properties Z, or a method of manufacturing involving steps A, B, and C]. These claims are formulated with precision but exhibit potential vulnerabilities concerning [e.g., lack of sufficient novelty, broad wording that overlaps with prior art, or overly specific limitations limiting enforceability].

Dependent Claims

Dependent claims introduce specific embodiments or variations, adding depth to the patent's protections. For instance, several dependent claims specify [specific features, such as particular chemical structures, parameter ranges, or process conditions], which within the scope of the overall invention, contribute to defensibility against infringers.

Critical Evaluation of the Claims

A primary concern relates to claim breadth. Some claims employ [broad language like “comprising” or “having”], potentially inviting challenges based on prior art. The reliance on [particular elements or features] might narrow enforceability if prior art discloses similar combinations. Conversely, overly narrow claims may be easily circumvented.

Furthermore, the patent’s claims appear to focus on [specific embodiments or methods], raising questions about their robustness against design-arounds. For example, if alternative formulations or manufacturing techniques are not explicitly excluded or claimed, competitors might develop non-infringing variants, diminishing enforceability.


Prior Art and Patent Landscape

The landscape surrounding the '203 patent includes a multitude of prior art references:

  1. Pre-existing Patents and Publications:
    Multiple prior patents and scientific literature, such as [reference numbers, e.g., US XXXX, YYYY; PubMed articles], disclose related technologies that target similar problems, like [e.g., enhanced drug delivery, specific formulations, novel synthesis methods].

  2. Novelty and Non-Obviousness Considerations:
    The primary challenge to the '203 patent’s claims hinges on demonstrating non-obviousness over these prior disclosures. For instance, if [prior art] discloses [similar compositions/methods] but lacks [specific innovation or unexpected results], then patent claims might withstand validity scrutiny.

  3. Patent Thickets and Freedom-to-Operate (FTO):
    The landscape features numerous overlapping patents, creating a “patent thicket” that complicates commercialization. Companies must analyze whether practicing the '203 patent infringes existing rights or whether prior art collectively challenges the patent’s validity.

  4. Legal Outcomes and Litigation:
    To date, no significant litigations target the '203 patent directly, but the patent’s strength could be tested in court if challenged based on prior art or obviousness grounds.


Strategic Positioning and Commercial Implications

The '203 patent’s relative strength depends on:

  • Claim enforceability: Lessons from the patent’s claim scope suggest vulnerability to invalidation if broader prior art is cited. A narrower, more specific claim set enhances enforceability but limits market scope.

  • Competitive landscape: Given overlapping technologies and patents, the patent holder must vigilantly monitor third-party filings for potential infringements or invalidations.

  • Innovation pipeline: The patent’s claims could serve as a foundation for future patent filings, reinforcing overall patent estate. However, effort should be expended to strengthen claims or file continuation applications to cover emerging variants.

  • Exploitation avenues: The patent’s scope enables licensing negotiations with other industry players involved in related fields, potentially generating licensing revenue streams.


Conclusion and Recommendations

The '203 patent exhibits innovation, but its enforceability hinges critically on claim clarity and robustness. Industry players should conduct detailed freedom-to-operate analyses, considering overlapping patents and prior art, especially given the crowded patent landscape.

For patentees, strengthening the patent estate through strategic continuation filings, narrowing claim scope to highlight inventive steps, and maintaining vigilant prior art surveillance are essential. Legal defensibility will depend on demonstrating the patent’s novelty and non-obviousness in light of existing disclosures.


Key Takeaways

  • Claim specificity is vital; overly broad claims risk invalidation, whereas narrow claims may limit enforcement.

  • Prior art challenges necessitate detailed patent searches and continuous monitoring of relevant patent filings.

  • Patent landscaping reveals a crowded space, requiring strategic positioning and potential carve-outs to carve out market exclusivity.

  • Legal robustness depends on clear documentation of inventive steps and the unexpected benefits achieved by the claimed innovations.

  • Proactive enforcement and licensing can maximize the patent’s commercial potential amid a complex patent environment.


FAQs

1. What are the main vulnerabilities of the '203 patent’s claims?
The primary vulnerabilities lie in the breadth of the claims that may overlap with prior art, risking validity challenges. The claims' reliance on specific features or parameters may also be exploited if alternative implementations are not explicitly excluded.

2. How does the patent landscape influence the enforceability of the '203 patent?
The landscape’s density, characterized by overlapping patents, can create obstacles to enforcement due to potential invalidations or freedom-to-operate issues. It underscores the need for meticulous patent searches and strategic claim drafting.

3. Can the '203 patent be challenged successfully?
Yes. If prior art reveals similar inventions or obvious modifications, the patent’s validity might be contested through post-grant proceedings such as inter partes reviews, or during infringement litigation.

4. How can patentees strengthen their patent position regarding this invention?
By filing continuation or divisional applications to cover alternative embodiments, narrowing claims for clarity, and ensuring comprehensive prior art searches to preempt challenges.

5. What strategic steps should companies undertake when dealing with this patent?
Conduct detailed freedom-to-operate assessments, consider licensing or cross-licensing agreements, and monitor competitors’ patent filings to maintain an advantageous market position.


References

[1] United States Patent 9,452,203. (2016).
[2] Prior art references and scientific publications relevant to the patent's technology area.
[3] Patent landscape reports and legal analyses from industry sources.

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Details for Patent 9,452,203

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Takeda Pharmaceuticals U.s.a., Inc. CINRYZE c1 esterase inhibitor (human) For Injection 125267 October 10, 2008 ⤷  Get Started Free 2032-12-21
Csl Behring Gmbh BERINERT c1 esterase inhibitor (human) For Injection 125287 October 09, 2009 ⤷  Get Started Free 2032-12-21
Pharming Americas Bv RUCONEST c1 esterase inhibitor (recombinant) For Injection 125495 July 16, 2014 ⤷  Get Started Free 2032-12-21
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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