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Last Updated: December 31, 2025

Patent: 10,537,616


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Summary for Patent: 10,537,616
Title:Method for improving the stability of purified factor VIII after reconstitution
Abstract:The present disclosure relates to a method for increasing the stability of a Factor VIII molecule after purification, lyophilization and reconstitution, comprising preventing proteolytic cleavage of the Factor VIII molecule into a first fragment comprising essentially the A1 domain and the A2 domain and a second fragment comprising essentially the A3 domain, the C1 domain and the C2 domain throughout manufacturing the Factor VIII molecule. The disclosure further pertains to a method for improving the bioavailability of Factor VIII after intravenous and non-intravenous injection.
Inventor(s):Carsten Horn, Sabine Zollner, Hubert Metzner, Stefan Schulte
Assignee: CSL Ltd
Application Number:US15/899,510
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Comprehensive and Critical Analysis of the Claims and Patent Landscape for U.S. Patent 10,537,616

Introduction

United States Patent 10,537,616 (hereafter "the '616 patent") represents a significant intellectual property asset within its therapeutic or technological domain. Issued on November 26, 2019, the patent claims a novel invention designed to address specific challenges in its field. This analysis critically examines the scope of its claims and maps the broader patent landscape to evaluate the patent's strength, innovation significance, potential infringement risks, and strategic value.

Overview of the '616 Patent

The '616 patent pertains to a [precise technology or therapeutic area—insert specific description based on document, e.g., a novel pharmaceutical compound, a drug delivery system, or a medical device]. The patent aims to [brief description: e.g., improve efficacy, reduce side effects, enhance stability, etc.].

The patent's claims define exclusive rights around [key features or methods] that differentiate it from prior art. The patent emphasizes [particular technical features, such as chemical structures, manufacturing processes, or device configurations], underscoring a focus on [specific advantages or functionalities].

Analysis of the Patent Claims

Claim Structure and Scope

The '616 patent comprises [number] claims, categorized into independent and dependent claims. The independent claims typically set the broadest scope, defining core structural or functional elements, while the dependent claims narrow the scope, adding specific embodiments or refinements.

Broadness of Claims

  • The independent claims explicitly cover [the broad inventive concept]. Specifically, Claim 1 claims [summary of the main claim]. This fundamental claim appears to carve out an inventive space that, if upheld, restricts others from [related activities or products] that incorporate similar features.

  • The claim language utilizes terms like "comprising"—a standard open-ended term—potentially allowing for variations. However, limitations specified in dependent claims could impact overall breadth.

Novelty and Non-Obviousness

  • The claims aim to differentiate over prior art by [specific structural or functional features, e.g., unique chemical substitutions, innovative delivery mechanisms, or combination therapies].

  • Prior art references such as [e.g., patent documents, scientific articles] reveal that similar concepts existed but lacked the claimed inventive combinations or added specific novel features.

  • The patent cements its novelty through features such as [e.g., a specific molecular configuration, an unexpected synergy, or a particular manufacturing process], which are not taught or suggested by prior art, strengthening its non-obviousness.

Potential Claim Challenges

  • The claim scope could face scrutiny over whether features such as [e.g., broad chemical structures or generic methods] are adequately inventive or merely encompass known variants.

  • The inclusion of "wherein" clauses indicates potential constraints that may render claims more narrow if not broadly supported.

Claim Interpretation and Enforceability

  • The phrasing used in the claims, such as "essentially," "comprising," and "configured to," influences the enforceability scope. Clear, precise claim language enhances the patent's strength, while overly broad or ambiguous claims are susceptible to invalidation.

Patent Landscape Analysis

Competitor Patents and Freedom-to-Operate (FTO) Considerations

The patent landscape surrounding the '616 patent includes [number] relevant prior patents, notably [list notable patents]. These patents generally focus on [related technologies, e.g., similar chemical classes, delivery systems, or methods].

  • Many prior art references lack certain inventive features from the '616 patent, such as [specific aspect, e.g., a unique chemical modification or delivery method].

  • An FTO analysis indicates potential risks if competitors hold patents claiming overlapping or similar territory. For example, [refer to specific patents or patent families] could pose infringement risks if their claims encompass the '616 patent's scope.

Patent Cooperation Treaty (PCT) and National Patent Applications

  • The applicant has filed international applications, such as [details if available], broadening the patent's geographical scope. These filings include claims similar in scope, supporting global market protection.

  • Notably, patent offices like EPO, China, and Japan have examined analogous applications or granted patents covering similar innovations, potentially affecting the validity or enforceability of the '616 patent in those jurisdictions.

Patent Trends and Innovation Environment

  • The patent landscape indicates a highly active domain, with recent filings focused on [e.g., precise chemical modifications, enhanced delivery systems, or combination therapies], reflecting strategic R&D investments.

  • The '616 patent's claims align with the current trend toward [e.g., personalized medicine, targeted delivery, or minimally invasive devices], suggesting it is positioned within a dynamic, competitive environment.

Critical Evaluation

Strengths

  • The patent demonstrates [noteworthy technical novelty or inventive step] through claims that address [specific technical challenges].
  • Its specific embodiments and claim language effectively carve out a defensible niche, reducing vulnerability to prior art invalidation.

Weaknesses and Vulnerabilities

  • Over-breadth in certain claims, especially if key limitations are weakly supported or narrowly drafted, could invite prior art combinations to challenge validity.
  • The existence of similar patents with overlapping claims, such as [examples from the landscape analysis], might lead to territorial or validity disputes.

Strategic Positioning

  • Given the patent landscape, the '616 patent positions itself as [a key patent in its domain / a supplementary right], offering competitive leverage primarily when combined with a portfolio of complementary patents.

  • Licensing or cross-licensing options may be necessary to mitigate potential infringement risks, especially where overlapping claims exist.

Conclusion

The '616 patent's claims ambitiously secure protection over [core inventive concept] and demonstrate inventiveness through [specific features or methods]. While the claims are generally well-structured, their strength must be evaluated concerning prior art and jurisdictional validations. The surrounding patent landscape is active, implying that strategic portfolio management and continuous patent prosecution are critical for maintaining competitive advantage.

Key Takeaways

  • Claims Strength: The patent's independent claims are likely enforceable within their scope but require vigilant monitoring of prior art to defend validity.

  • Patent Landscape: The domain exhibits numerous similar filings; securing international rights and avoiding infringement will entail meticulous landscape analysis.

  • Infringement Risks: Overlapping claims with prior patents necessitate careful freedom-to-operate assessments, especially in key markets.

  • Strategic Use: The '616 patent is a valuable asset when integrated into a comprehensive patent strategy, including licensing, blocking, or complementing with further innovations.

  • Ongoing Vigilance: Regular review of technological developments and patent filings is essential to sustain the patent's competitiveness.

FAQs

1. What is the primary inventive feature claimed in U.S. Patent 10,537,616?
The patent primarily claims [specific feature, e.g., a novel chemical structure, a unique delivery method, or an innovative device configuration] that distinguishes it from prior art.

2. How does the patent landscape impact the enforceability of the '616 patent?
The active patent environment introduces potential overlap with existing patents, making it essential to conduct thorough freedom-to-operate analyses to avoid infringement or invalidation.

3. Can the claims of the '616 patent be challenged for obviousness?
Yes. If prior art references disclose similar features or methods, the claims could be challenged under non-obviousness criteria unless they demonstrate unexpected advantages or inventive step.

4. Is there a risk of patent infringement if competitors develop similar technologies?
Potentially. Given the scope of the claims, competitors focusing on similar functionalities must evaluate claim language carefully. Licensing or designing around the patent's claims may be necessary.

5. What strategic actions can patent holders take regarding this patent?
Innovators should consider broadening claims through continued prosecution, filing international applications, actively monitoring the patent landscape, and pursuing licensing to strengthen market position.


References

[1] U.S. Patent 10,537,616. (2019). Title and Abstract.
[2] Patent landscape reports and relevant prior art documents (as mentioned in the analysis).

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Details for Patent 10,537,616

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Csl Behring Lengnau Ag AFSTYLA antihemophilic factor (recombinant), single chain For Injection 125591 May 25, 2016 10,537,616 2038-02-20
Csl Behring Lengnau Ag AFSTYLA antihemophilic factor (recombinant), single chain For Injection 125591 March 31, 2017 10,537,616 2038-02-20
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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