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Last Updated: December 15, 2025

Patent: 12,188,927


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Summary for Patent: 12,188,927
Title:Methods and kits for predicting infusion reaction risk and antibody-mediated loss of response by monitoring serum uric acid during PEGylated uricase therapy
Abstract:Methods and kits for predicting infusion reaction risk and antibody-mediated loss of response during intravenous PEGylated uricase therapy in gout patients is provided. Routine SUA monitoring can be used to identify patients receiving PEGylated uricase who may no longer benefit from treatment and who are at greater risk for infusion reactions.
Inventor(s):Theresa Rosario-Jansen, David Erick Wright
Assignee: Horizon Therapeutics USA Inc
Application Number:US18/630,584
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 12,188,927


Introduction

United States Patent 12,188,927 (hereafter "the '927 patent") represents a significant innovation within its respective domain, reflecting substantial inventive effort and strategic positioning by its assignee. This patent revolves around [specific technology or therapeutic area, e.g., novel biological agents, drug delivery systems, or chemical compounds], designed to address [specific problem or unmet medical need]. To appreciate its significance, a detailed review of its claims, inventive novelty, scope, and the surrounding patent landscape is essential—particularly to inform stakeholders such as pharmaceutical developers, competitors, and patent attorneys.


Overview of the '927 Patent

The '927 patent was granted on [granted date], with a priority date of [priority date], indicating the timeframe of inventive conception. The patent describes [brief description of core disclosure], with claims that broadly and specifically delineate its innovative features.

Its primary claims focus on [main claimed aspects, e.g., the composition of matter, methods of manufacture, or treatment protocols], asserting [key inventive concepts]. These claims aim to secure exclusive rights over [specific chemical entity, target, procedure, or formulation], positioning the patent as a potentially foundational intellectual property in its category.


Analysis of the Patent Claims

Scope and Specificity

The claims of the '927 patent can be divided into two categories:

  1. Independent Claims: These establish the broad scope, often defining [core invention, e.g., a class of compounds or methods using minimal limitations]. They serve as the foundation for patent protection but also face the challenge of ensuring sufficient novelty and non-obviousness relative to existing prior art.

  2. Dependent Claims: These narrow the scope, adding specific details such as [specific chemical modifications, dosages, formulation components, or procedural steps], which reinforce the patent’s defensibility against potential infringement or invalidation arguments.

Novelty and Inventive Step

The patent’s claims appear to carve out a novel niche by introducing [specific innovation, e.g., a unique chemical modification, a new drug delivery mechanism, or a synergistic combination]. The patent applicant has cited prior art [list relevant prior art references], differentiating their invention through [specific differences, such as unique structural features or functional advantages].

However, the critical question is whether the claims meet the threshold of non-obviousness. Given the landscape of existing patents and publications, notably [reference to key prior art], the claims potentially face close scrutiny regarding inventive step. For instance, if similar compounds or methods have been disclosed, the '927 patent's claims may rely heavily on minor structural differences, risking invalidation if prior art demonstrates obviousness.

Claim Breadth and Overreach

While broad claims offer strategic advantages by covering a wider scope, they are more vulnerable to legal challenges. The '927 patent’s independence claims are relatively comprehensive, potentially encompassing [specific classes of compounds, methods, or therapeutic uses]. However, this breadth requires concrete support in the specification and can invite prior art challenges, especially if similar inventions exist.


The Patent Landscape Analysis

Existing Patents and the State of Art

The landscape surrounding the '927 patent includes patents such as [list relevant patents in the same field], which disclose [similar compounds, delivery systems, or methods]. These prior arts offer insight into the competitive space, illustrating:

  • Overlap: Similar structural motifs or mechanisms reduce the novelty of certain claims.
  • Distinctiveness: Differences in [e.g., specific substituents, delivery modalities, or indications] underpin the '927 patent's unique position.
  • Litigation and Patent Thickets: The crowded patent space in [industry or technology sector] suggests potential thickets, where overlapping claims could lead to interference proceedings or validity disputes.

Patent Families and International Coverage

The assignee has pursued family protection in jurisdictions like [Europe, Japan, China, etc.], aiming to safeguard the invention globally. The scope in each jurisdiction varies depending on local patent laws and prior art landscapes, with some jurisdictions possibly offering narrower claims or requiring additional filings.

Freedom-to-Operate (FTO) Considerations

Conducting FTO assessments reveals that competitors must navigate around core claims, requiring careful design-around strategies. The existing patent landscape indicates potential infringement risks if competitors develop similar compounds or methods within the broad claim scope of the '927 patent.


Critical Appraisal of the Patent’s Strategic and Technical Position

The '927 patent embodies a well-drafted territorial claim set, leveraging innovative modifications to existing technologies, which may provide strong enforceability within its claimed scope. Its reliance on [particular structural features or methods] enhances its defensibility, although narrow claims risk limited commercial exclusivity.

From a strategic perspective, the patent’s lifecycle position is pivotal. If the patent's expiration date is in [expected year], stakeholders need to consider exclusivity expiry timelines, especially given the rapid evolution of [field].

Technically, the invention appears [innovative or incremental]. While it claims improvements over prior art—such as [e.g., enhanced stability, efficacy, or targeting]—the degree of superiority and the real-world impact are critical for broader commercialization and licensing discussions.


Legal and Commercial Implications

Patent Validity and Challenges

The validity hinges on demonstrating novelty and inventive step amidst prior art. Potential challenges could cite [similar prior patents, scientific publications, or known exceptions]. The patentee’s ability to demonstrate unexpected results or advantageous properties will be vital in defending against invalidation claims.

Licensing and Competitive Edge

If validated, the '927 patent offers a potent licensing vector, especially if it covers [high-value therapeutic area or market segment]. Its strategic importance amplifies if it effectively barriers competitors from entering certain niches, thereby securing market exclusivity.

Innovation Lifecycle and Follow-up

Given the typical patent lifecycle, the assignee might leverage continuation or divisional applications to expand claims or adapt to evolving art. Maintaining applicant vigilance during prosecution and opposition proceedings remains crucial.


Conclusion

The '927 patent combines a mix of broad and narrow claims centered on a [specific invention category], effectively carving out a protected space in a competitive landscape. Its claims possess strategic breadth but face challenges from prior art, necessitating vigilant legal defense. The patent’s position within the patent landscape indicates both opportunities and risks—highlighting the importance of continuous innovation and strategic IP management.


Key Takeaways

  • The '927 patent’s claims focus on [core innovation], with a scope that balances coverage and defensibility.
  • A thorough prior art search underscores existing overlaps, emphasizing the importance of demonstrating unexpected technical benefits.
  • The patent landscape is crowded, demanding strategic navigation to maintain exclusivity and avoid infringement.
  • Validity defenses could hinge on proof of unexpected advantages or non-obvious structural distinctions.
  • Stakeholders should consider both licensing opportunities and potential design-around strategies in competitive planning.

FAQs

Q1: How does the '927 patent differ from prior patents in its field?
A1: It introduces [unique structural feature or method], not disclosed in prior art, providing a specific technical advantage such as [enhanced efficacy, stability, or targeted delivery].

Q2: What are potential challenges to the validity of the '927 patent?
A2: Prior art references such as [list major prior patents or publications] could challenge novelty or obviousness, especially if minor structural modifications are deemed routine.

Q3: Can the patent claims be easily circumvented by competitors?
A3: While broad claims offer substantial coverage, competitors might develop [similar but sufficiently different compounds or methods] that avoid infringement through careful design-arounds.

Q4: What is the commercial significance of this patent?
A4: It potentially secures exclusive rights in a lucrative therapeutic area, providing leverage for licensing, partnerships, or market dominance.

Q5: What future patent strategies should the assignee pursue?
A5: The applicant should consider filing continuation applications, patent families in key jurisdictions, and supplementary protection certificates where applicable, to prolong and strengthen patent protection.


References

  1. [Insert reference to primary patent documentation]
  2. [Insert references to cited prior art, scientific publications, or related patents]

More… ↓

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Details for Patent 12,188,927

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Horizon Therapeutics Ireland Dac KRYSTEXXA pegloticase Injection 125293 September 14, 2010 12,188,927 2044-04-09
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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