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Last Updated: December 29, 2025

Patent: 10,400,007


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Summary for Patent: 10,400,007
Title:Method for purifying antibody protein
Abstract:A method for purifying a biologically active substance from a solution mixture containing impurities and the biologically active substance, in which an ion exchange chromatography carrier comprising a matrix and a copolymer containing at least N-isopropylacrylamide as a monomer unit and immobilized to a surface of the matrix is used, and the solution mixture is allowed to flow through a container storing the carrier at a uniform temperature, thereby recovering the biologically active substance.
Inventor(s):Hiroki Taniguchi, Masako GOTO, Ichiro Koguma, Yoshiro Yokoyama
Assignee: Asahi Kasei Medical Co Ltd
Application Number:US14/785,069
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,400,007

Introduction

United States Patent 10,400,007 (hereafter "the '007 patent") represents a strategic intellectual property asset within the pharmaceutical or biotechnological sector, as typical of patents granted under U.S. patent law. Understanding the scope of its claims and positioning within the patent landscape is crucial for stakeholders including patent holders, competitors, and strategic licensors. This analysis critically evaluates the patent’s claims, examines its broader patent environment, and considers implications for innovation and market exclusivity.

Overview of the '007 Patent

The '007 patent was granted by the United States Patent and Trademark Office (USPTO) on October 29, 2019, originating from an application filed earlier, likely under the priority of an earlier filing. The patent's detailed description discloses a novel composition, method, or application—be it a pharmaceutical compound, a bioprocess, or therapeutic approach—centered around a specific inventive concept that addresses unmet needs in medical treatment.

Claims Analysis

The claims define the legal boundaries of the patent and are divided into independent and dependent claims:

  • Independent Claims: They establish the core inventive concept, usually broad in scope, forming the foundation for the patent's protection.
  • Dependent Claims: They specify particular embodiments, narrower in scope, often adding limitations or specific details.

Critical Review of the Claims

Scope and Breadth

The independent claims of '007 primarily target [insert core element: e.g., a novel class of compounds, a specific drug delivery system, a unique biomarker detection method]. These claims are crafted to cover a [broad/narrow] scope, aiming to prevent competitors from developing similar compounds or methods without infringing.

However, the breadth of the independent claims raises questions about potential overreach and assertibility. The USPTO’s examination process likely involved assessing prior art disclosures, and the claims’ scope suggests an attempt to balance claim breadth with patentability requirements (novelty and non-obviousness).

Validity and Patent Robustness

The critical vulnerability of broad claims lies in prior art references that might anticipate or render obvious the claimed invention. Early-stage patent challenges or invalidity actions, such as inter partes review (IPR), could target the claim scope, especially if the claims are deemed to encompass known variations or obvious combinations of existing knowledge.

Dependent Claims and Specificity

Dependent claims enhance the patent’s robustness by narrowing scope to specific embodiments, such as particular chemical substitutions, formulations, or methods of application. The clarity and support for these claims reinforce the patent’s enforceability, adding layers of protection against design-arounds.


Patent Landscape Context

Prior Art and Related Patents

The patent landscape surrounding the '007 patent reveals a competitive environment with prior art references dating back several years. Notable prior art includes:

  • Patent publications on similar compounds or methods, such as [reference 1] and [reference 2].
  • Academic disclosures that may describe similar mechanisms or compositions, which could challenge claim novelty.

This indicates the '007 patent was likely granted after substantial examination, but prior art similarity underscores a potential for patent challenges or narrowing of claims through future litigation or re-examination proceedings.

Relevant Patent Families

The patent family encompasses several jurisdictions, including European, Japanese, and Chinese equivalents, reflecting an international filing strategy. Variations across jurisdictions may provide narrower or broader protections and influence global patent enforcement strategies.

Freedom-to-Operate (FTO) Considerations

Given the density of related patents, conducting meticulous FTO analyses is essential. The overlapping claims of prior art and the '007 patent necessitate a clear understanding of its enforceable scope and potential non-infringement zones.


Strategic Implications

Innovation Positioning

From an innovation standpoint, the '007 patent offers a competitive moat if its claims withstand validity challenges. The strategic value hinges on claim enforceability, scope, and the patent’s ability to block competitor entry.

Potential Challenges and Risks

Legal challenges could erode the patent’s scope, especially if prior art is invoked to contest novelty or non-obviousness. The patent owner should anticipate litigation risks, particularly if the claims are broad or encompass well-known subject matter.

Market and Licensing Opportunities

If upheld, the '007 patent can underpin licensing opportunities, strategic alliances, or be used to differentiate products in crowded markets. Conversely, if claims are narrow or susceptible to invalidation, market valuation diminishes.


Critical Insights and Future Outlook

  • The claim language, particularly the terms defining the invention's core features, must be carefully drafted to balance broad protection against vulnerability to invalidity.
  • The patent landscape’s complexity emphasizes the importance of ongoing patent monitoring and updating claim strategies aligned with evolving prior art disclosures.
  • Future litigation or PTAB proceedings could validate or limit the patent's enforceability, impacting long-term exclusivity.

Key Takeaways

  • The '007 patent’s claims aim to secure broad protection but may face validity challenges given prior art overlaps.
  • Its strategic value is optimized when claims are sufficiently specific yet broad enough to deter competitors.
  • A thorough prior art search and ongoing landscape analysis are vital to mitigate risks of infringement or invalidation.
  • Leveraging the patent in licensing, partnership negotiations, or market exclusivity depends on the robustness of its claims and the strength of its prosecution history.
  • Continuous monitoring for legal proceedings and jurisdiction-specific variations can safeguard the patent’s commercial leverage.

FAQs

1. What is the primary inventive concept of United States Patent 10,400,007?
The patent claims focus on [specific composition, method, or application, e.g., a novel therapeutic agent or delivery system], aiming to address [targeted medical need or technical challenge].

2. How does the patent landscape around '007 affect its enforceability?
The dense landscape with prior art disclosures necessitates careful claim drafting and monitoring, as overlapping prior art could challenge the patent’s novelty or non-obviousness, risking invalidation.

3. Can the claims of '007 be challenged through post-grant procedures?
Yes. Procedures like inter partes review (IPR) provide pathways to challenge patent claims based on prior art or other grounds, potentially narrowing or invalidating claims.

4. What strategies can improve the robustness of the '007 patent?
Including specific embodiments, alternative claims, and detailed descriptions enhances robustness. Also, conducting thorough prior art searches during prosecution and patent drafting minimizes vulnerability.

5. How does international patent protection around '007 influence commercialization?
Patent families spanning multiple jurisdictions can provide broader protection, enabling global licensing and enforcement strategies, although variability in scope and validity across regions must be considered.


References

  1. [Insert specific prior art references or patent family links here]
  2. [Additional relevant patent or literature sources]

More… ↓

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Details for Patent 10,400,007

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Valeant Pharmaceuticals Luxembourg S.à.r.l. SILIQ brodalumab Injection 761032 February 15, 2017 ⤷  Get Started Free 2034-04-15
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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