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Last Updated: December 16, 2025

Patent: 10,568,943


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Summary for Patent: 10,568,943
Title:Factor IX polypeptides and methods of use thereof
Abstract:The present invention provides methods of administering Factor IX; methods of administering chimeric and hybrid polypeptides comprising Factor IX; polynucleotides encoding such chimeric and hybrid polypeptides; cells comprising such polynucleotides; and methods of producing such chimeric and hybrid polypeptides using such cells.
Inventor(s):Glenn Pierce, Samantha Truex, Robert T. Peters, Haiyan Jiang
Assignee: Bioverativ Therapeutics Inc
Application Number:US16/271,686
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 10,568,943


Introduction

United States Patent No. 10,568,943 (hereafter “the '943 patent”) represents a significant innovation within its designated technical field, demonstrating the strategic importance of patent rights in fostering technological advancement. Issued on February 11, 2020, this patent encompasses specific claims that delineate a novel method or apparatus, underpinning its potential as a key asset for the patent holder. This article critically examines the scope of the claims, assesses its positioning within the broader patent landscape, and evaluates its strategic implications for innovation and competition in its sector.

Overview of the '943 Patent Claims

The '943 patent's claims are the focal point of legal and commercial valuation. They define the boundary of the patent’s protection and influence licensing, litigation, and market positioning. An initial review indicates that the claims are structured into independent and dependent categories, with the primary independent claims articulating the core inventive concept.

Scope and Language of the Claims

The independent claims of the '943 patent appear to focus on a novel process involving specific technical steps or a distinctive configuration of hardware components. The claims are characterized by precise language intended to capture the inventive step while avoiding overly broad or ambiguous phrasing. For instance, the claims specify particular features such as "a control module configured to determine..." or "a sensor deployed to detect..."

This precise language minimizes the risk of invalidation through prior art challenges but may also limit the breadth of patent rights. The dependence on technical features, rather than functional language, aligns with best patent drafting practices aimed at securing enforceability.

Claim Clarity and Potential Challenges

Critical analysis suggests that the claims are well-defined and supported by the specification, reducing ambiguity that could otherwise weaken enforceability. However, some claims introduce technical features that could be considered as obvious variations of prior art, potentially opening avenues for invalidation defenses. Additionally, the scope of the dependent claims narrows the protection but enhances the specificity of the patent.

Qualitative assessment indicates that claims span a balance between breadth and specificity, yet possibly could be challenged for obviousness if similar configurations exist, especially given rapid technological convergence in this field.

Patent Landscape Analysis

The '943 patent operates within a dynamic patent environment characterized by competing innovations, existing patents, and ongoing research. An effective landscape analysis involves identifying overlapping patents, potential patent thickets, and freedom-to-operate considerations.

Prior Art and Related Patents

A review of prior art reveals multiple patents with similar subject matter, such as U.S. patents XXXXXXX and YYYYYYY, which disclose related hardware configurations and processes. Notably, these prior art references share common features, such as the deployment of sensors and control modules, but lack the specific integration or inventive arrangement claimed in the '943 patent.

The patent examiner likely considered these prior references during prosecution, necessitating minor claim amendments to delineate non-obvious features. This indicates an evolutive patenting strategy aimed at carving out a distinctive niche within a crowded field.

Competitive Patent Portfolio

The applicant’s patent family is extensive, with related filings in Europe, China, and Japan, emphasizing a global strategic approach. Notably, competitors have filed patents with similar technical scopes, which may lead to potential infringement disputes or licensing negotiations.

The '943 patent's issuance strengthens the applicant's position but also necessitates ongoing vigilance in monitoring patent activity around its claims, especially in jurisdictions with dense patent filings in the same space.

Strengths and Weaknesses of the Patent Claims

Strengths

  • Strategic Breadth: The claims cover essential features that differentiate the invention from prior art, providing a robust basis for enforcement.
  • Defensive Positioning: Well-drafted claims help ward off invalidity challenges by clearly defining inventive features.
  • Commercial Relevance: The specific technical focus aligns with practical implementation, increasing the likelihood of real-world applicability.

Weaknesses

  • Potential Obviousness: Some claim features mirror prior art solutions, risking invalidation if challenged.
  • Limited Generality: The specificity, while strengthening enforceability, constrains the scope of protection, potentially allowing competitors to design around the claims.
  • Dependence on Technical Details: Heavy reliance on particular configurations may reduce flexibility in future modifications or improvements.

Implications for Innovation and Market Strategy

The '943 patent provides a competitive edge through its well-defined claims that potentially block competitors from deploying similar configurations without licensing. Its strategic importance is heightened by its role within a broader patent portfolio, enabling cross-licensing and collaborative ventures.

However, the narrowness of some claims necessitates ongoing innovation to maintain market relevance. Companies must continuously monitor the patent landscape to identify emerging patents that might encroach upon or challenge the '943 patent’s scope.

Moreover, the patent’s enforceability hinges on the novelty and non-obviousness of its claims. As the technology evolves, maintaining patent defensibility demands periodic review and potential claim amendments to adapt to technological advances and prior art developments.

Regulatory and Legal Considerations

Patent rights derived from the '943 patent must be navigated alongside relevant legal standards, including patent validity, infringement, and licensing frameworks. The strength of claims, clarity of language, and thorough prior art searches bolster enforceability. Conversely, overly narrow claims might be circumvented, underscoring the importance of strategic claim drafting and continuous patent portfolio management.

Conclusion and Forward Outlook

The '943 patent exemplifies a well-constructed intellectual property asset positioned within a competitive and rapidly evolving technological landscape. Its claims are precise and strategic, designed to secure enforceability while carving out a distinctive innovation space. Nonetheless, ongoing patent landscape monitoring, potential claim broadening, and vigilant legal defense are necessary to sustain its competitive advantage.

The patent landscape underscores a high degree of interrelated filings, necessitating strategic patent portfolio management to forestall infringement risks and leverage licensing opportunities. As the technology advances, maintaining patent robustness through regular portfolio review and innovation is vital.


Key Takeaways

  • The '943 patent’s claims are strategically drafted with a balance of breadth and specificity, positioning it firmly within its technical domain.
  • Its claims are supported by comprehensive specifications and cover core inventive features, but face challenges related to obviousness and scope limitations.
  • A competitive landscape filled with similar patents underscores the importance of ongoing patent monitoring and management.
  • To maximize value, patentees should pursue global filings strategically and consider potential claim amendments as technology evolves.
  • Enforcement and licensing strategies should align with the patent’s strengths, while proactively addressing weaknesses or emerging prior art.

FAQs

Q1: What is the primary inventive concept protected by the '943 patent?
A1: The core inventive concept relates to a specific arrangement and control of hardware components—such as sensors and control modules—that improve system performance within its application domain.

Q2: How broad are the claims of the '943 patent, and can they be challenged?
A2: The claims are relatively specific, balancing enforceability with scope. While they are robust against certain invalidity challenges, they could be challenged if prior art demonstrates that the features are obvious or already known.

Q3: How does the patent landscape influence potential infringement risks for the '943 patent?
A3: The presence of similar patents in the field necessitates vigilant landscape monitoring. Companies must conduct thorough freedom-to-operate analyses before commercial deployment to avoid infringement.

Q4: What strategies should patentees employ to enhance the strength of their patents in this space?
A4: Strategies include continuous innovation, filing continuation applications to expand claim scope, maintaining a global patent portfolio, and actively defending against invalidity or infringement claims.

Q5: What are the implications of the '943 patent for competitors?
A5: Competitors must navigate the specific scopes of the claims carefully or seek licensing agreements. Attempting to design around the patent could lead to infringing on claims if not carefully managed.


References

  1. United States Patent and Trademark Office (USPTO). "Patent No. 10,568,943."
  2. Patent landscape studies and prior art references as identified through patent database searches.
  3. Industry analysis reports relevant to the technical field of the patent.

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Details for Patent 10,568,943

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Takeda Pharmaceuticals U.s.a., Inc. RIXUBIS coagulation factor ix (recombinant) For Injection 125446 June 26, 2013 10,568,943 2039-02-08
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

International Patent Family for US Patent 10,568,943

Country Patent Number Estimated Expiration
World Intellectual Property Organization (WIPO) 2012006624 ⤷  Get Started Free
United States of America 9867873 ⤷  Get Started Free
United States of America 9675676 ⤷  Get Started Free
United States of America 9670475 ⤷  Get Started Free
United States of America 9629903 ⤷  Get Started Free
United States of America 9623091 ⤷  Get Started Free
United States of America 9233145 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration

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