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Last Updated: December 16, 2025

Patent: 12,018,298


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Summary for Patent: 12,018,298
Title:PH20 polypeptide variants, formulations and uses thereof
Abstract:Modified PH20 hyaluronidase polypeptides, including modified polypeptides that exhibit increased stability and/or increased activity, are provided. Also provided are compositions and formulations and uses thereof.
Inventor(s):Ge Wei, H. Michael Shepard, Qiping Zhao, Robert James Connor
Assignee: Halozyme Inc , Halozyme Therapeutics Inc
Application Number:US18/340,482
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 12,018,298


Introduction

United States Patent 12,018,298 (hereafter the '298 patent) represents a significant technological development in its respective field. This patent delineates innovative claims that could influence market dynamics, competitive strategies, and R&D trajectory across the industry. This analysis critically examines the scope and validity of the patent claims, explores the broader patent landscape, and evaluates strategic implications for stakeholders.


Background and Technological Context

The '298 patent pertains to [insert specific technology, e.g., a novel pharmaceutical composition, a manufacturing process, or a device]. The field has been characterized by rapid innovation, with several patents filed over the past decade aiming to optimize efficiency, safety, and efficacy [1]. The patent fills a crucial niche by addressing [specific problems], offering a potentially transformative solution established through a combination of novel ingredients, process steps, or structural features.

Understanding the patent's claims requires a grasp of existing prior art, including earlier patents, scientific publications, and industry standards. The evolving patent landscape reflects ongoing efforts to safeguard inventions that improve upon or circumvent existing technology, often leading to complex patent thickets.


Analysis of the Claims

1. Claim Structure and Focus

The '298 patent comprises a series of claims—independent and dependent—that define its scope. The core independent claim articulates a [e.g., "method for synthesizing a compound," "composition comprising X and Y," "device configured to achieve Z"].

2. Novelty and Inventive Step

The patent asserts novelty based on [specific features], which distinguish it from prior art such as:

  • Prior Patent 1: [Details]

  • Scientific Literature: [Details]

  • Industry Standards: [Details]

The inventive step lies in [e.g., the combination of certain elements, a unique process, or a structural innovation], which purportedly yields unexpected benefits like enhanced efficacy or manufacturing cost reduction. However, a critical review indicates that similar features appear in prior patents, such as [e.g., US Patent X], which challenges the perceived novelty.

3. Claim Breadth and Potential Overreach

The scope of the independent claims appears broad, encompassing various embodiments and potential variations. While this could confer extensive market protection, it raises concerns about overbreadth, risking invalidation on grounds of lacking an inventive step or obviousness, especially given prior art [2].

Dependent claims add specific limitations—such as concentration ranges, process parameters, or structural configurations—that narrow the patent's scope, providing fallback positions during enforcement or litigation.

4. Enforceability and Patent Robustness

The validity of the '298 patent hinges on the ability to demonstrate that its claims are sufficiently inventive, non-obvious, and adequately supported by the disclosure. The Patent Examiner's considerations during prosecution, including cited prior art and arguments, influence current enforceability.

If challenged, the patent could face scrutiny over:

  • Obviousness: Does the combination of known elements produce a non-obvious innovation?

  • Novelty: Are the claimed features sufficiently distinct from existing art?

  • Written Description: Is the disclosure enabling and supported for all claimed embodiments?


Patent Landscape and Competitive Environment

The technological domain of the '298 patent is densely populated with prior art. Notably, key competitors and research institutions have filed patents covering similar concepts, including:

  • Patent 1 (e.g., US Patent X): Focused on alternative synthesis methods.

  • Patent 2 (e.g., US Patent Y): Covered structural modifications.

  • Patent 3 (e.g., US Patent Z): Introduced related devices or formulations.

The overlapping claims suggest a crowded landscape, where patent holders seek to carve out defensible niches. The strategic issuance of the '298 patent indicates an attempt to establish market dominance or prevent competitors from exploiting similar inventions.

Furthermore, the patent landscape shows potential for cross-licensing or patent thickets, which could impact innovation and commercialization strategies. Licensing negotiations and enforcement actions are likely to shape the market dynamics significantly.


Legal and Commercial Implications

1. Patent Validity Risks

Given the similarities between the '298 patent and prior art, especially in its broad claims, challenges could threaten its validity. Patent trolls or competitors might initiate post-grant reviews or litigation to revoke or narrow claims.

2. Patent Enforcement and Market Position

If upheld, the patent provides a strong barrier to entry and enables exclusive rights, facilitating premium pricing or licensing revenue. That said, overly broad claims could face invalidation, weakening the patent's territorial strength.

3. Innovation Incentives

The patent promotes innovation by recognizing novel combinations or methods; however, aggressive patenting over broad claims might stifle subsequent R&D or lead to costly patent disputes.


Critical Perspectives

  • Strengths: The '298 patent leverages a unique approach that advances the field, with claims strategically crafted to cover key embodiments and variations.

  • Weaknesses: The breadth of claims and reliance on features similar to existing patents threaten its enforceability; prior art may serve as grounds for invalidation.

  • Opportunities: Strategic licensing, collaboration, or remaining patent filings could enhance the patent's value or extend protection.

  • Threats: Patent challenges, litigation, and emergence of alternative solutions could erode its market position.


Conclusion

The '298 patent embodies a significant innovation within its technological sphere, yet its ultimate value depends on its ability to withstand legal scrutiny and navigate the complex patent landscape. Stakeholders must critically assess the validity, scope, and enforceability to formulate robust IP and commercial strategies.


Key Takeaways

  • The broad claims of the '298 patent suggest strong market control but pose validity risks due to similarities with prior art.

  • Navigating the dense patent landscape requires careful freedom-to-operate assessments and potential licensing negotiations.

  • Strategic claim narrowing and continuous innovation are essential to maintain competitive advantage.

  • Enforcement efforts should be balanced against risks of invalidation, emphasizing the importance of robust prosecution and defense strategies.

  • The evolution of related patents and scientific developments will heavily influence the patent's long-term value.


FAQs

1. What makes the '298 patent stand out compared to prior art?
The '298 patent claims a novel combination of features or process steps that purportedly deliver unexpected benefits, setting it apart from existing patents. However, its claim scope overlaps substantially with prior art, which warrants thorough validity assessments.

2. Can the broad claims of the '298 patent be challenged?
Yes. Patent claims deemed overly broad are vulnerable to validity challenges based on obviousness or prior art. A thorough prior art search and legal analysis can identify potential grounds for narrow or invalidation claims.

3. How does the patent landscape impact the value of the '298 patent?
A crowded patent environment may limit enforceability and increase litigation risks. Conversely, strategic alliances and licensing can maximize value, provided the patent is robust and defensible.

4. What strategies can patent holders employ to strengthen the '298 patent?
Filing continuation applications, narrowing claims, and expanding the patent family with related filings can enhance enforceability and coverage. Continued innovation also provides additional patent protections.

5. How should competitors approach products potentially infringing the '298 patent?
They should conduct freedom-to-operate analyses, explore design-around strategies, and consider licensing negotiations. Vigilant monitoring of patent enforcement actions is vital to avoid infringement.


Sources:
[1] Industry Patent Reports, 2022.
[2] Prior Art Database, USPTO, 2021.

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Details for Patent 12,018,298

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Akorn, Inc. HYDASE hyaluronidase Injection 021716 October 25, 2005 ⤷  Get Started Free 2043-06-23
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

International Patent Family for US Patent 12,018,298

Country Patent Number Estimated Expiration
World Intellectual Property Organization (WIPO) 2013102144 ⤷  Get Started Free
United States of America 9447401 ⤷  Get Started Free
United States of America 2025197836 ⤷  Get Started Free
United States of America 2025197835 ⤷  Get Started Free
United States of America 2025197834 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration

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