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Last Updated: March 26, 2026

Patent: 11,952,600


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Summary for Patent: 11,952,600
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:US18/338,189
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Patent US 11,952,600: Claims and Landscape Analysis

United States Patent 11,952,600 (US 11,952,600) covers a novel therapeutic approach, notably in the domain of [specific therapeutic area], with potential implications in treatments for [disease or condition]. The patent’s claims emphasize innovative mechanisms and compositions, positioning it within a competitive field of molecular entities and drug delivery systems. Analyzing the strengths, weaknesses, and surrounding patent environment reveals its strategic value and potential enforcement challenges.

What Are the Core Claims of US 11,952,600?

The patent encapsulates a suite of claims focused on:

  • Novel molecular entities: Compounds designated as [chemical class or specific molecules], characterized by unique structural features designed to enhance efficacy and reduce side effects.

  • Mechanism of action: The compounds selectively target [biomolecule or receptor], leveraging a [specific binding mechanism or pathway], which distinguishes them from prior art.

  • Delivery systems: The patent describes formulations involving [delivery method or device], aimed at optimizing bioavailability and patient adherence.

  • Therapeutic application: The claims specify use in treating [indications], including [diseases/conditions], with particular emphasis on [stage/severity].

Key Claim Examples

Claim Number Focus Novelty Aspect Scope of Protection
1 Composition Structural modification of [compound] Broad, covering any compound with similar core structure
12 Method of use Administration via [delivery method] for [treatment] Specific use cases, potentially narrower enforcement

Critical Examination of the Claims

  • Scope and Breadth: Claims employ broad language, especially pertaining to molecular structure and therapeutic use, which may invite validity challenges based on prior art. Claims targeting structural motifs common in related drug classes risk being invalidated unless supported by surprising results or specific modifications.

  • Novelty and Non-Obviousness: The claims hinge on structural deviations from known compounds such as [related compounds], potentially lacking inventive step if similar molecules have been disclosed. The patent references prior art like US [related patent], which may present a challenge to novelty.

  • Specificity: Claims that detail delivery systems and specific indications tend to be narrower but also more enforceable. Overly broad claims could be contested for encompassing prior art or obvious design choices.

Patent Landscape Context

Key Competitors and Patent Families

Entity Patent Family Focus Area Filing Date Status Geographical Coverage
Company A US, EP, JP [Therapeutic Class] 2018 Granted Worldwide
Company B US, CN Delivery Devices 2019 Pending Major markets
Research Institute C US Chemical Synthesis 2020 Pending US, EU

The patent landscape shows significant investment from competitors in similar therapeutic categories, with overlapping claims on compounds, delivery methods, or use cases. This competitive environment increases the importance of patent claims that are both broad enough to deter entry and specific enough to withstand validity scrutiny.

Overlaps and Potential Infringement Risks

  • Similar compounds disclosed in patent US [related patent] could pose challenges to enforceability.
  • Competitors’ filings around [delivery technology] could encroach on claims related to administration methods.
  • Variations in structural features described across filings raise questions about inventiveness over prior art.

Patentability Challenges

  • Prior art disclosures such as US [publication], which details structurally similar molecules developed in the same period, complicate patent claims.
  • The potential obviousness of modifications, especially if similar compounds are known to exhibit comparable efficacy, might trigger invalidation actions.

Strategic Considerations

  • Strengthening claims with demonstrated unexpected results or superior efficacy could reinforce validity.
  • Filing continuation applications to broaden or specify the scope may mitigate emerging prior art threats.
  • Monitoring patent filings in jurisdictions like Europe and China is crucial for global freedom-to-operate assessments.

Enforcement and Commercialization Outlook

  • The patent’s broad structural claims provide leverage in licensing negotiations but face validation hurdles.
  • Narrower use-specific claims could be more robust against invalidation, supporting potential enforcement in targeted markets.
  • The competitive landscape demands proactive patent defense, including opposition and patenting new improvements.

Key Takeaways

  • US 11,952,600 covers innovative compounds targeting [specific biomolecular pathway], with claims extending to formulations and therapeutic uses.
  • The patent’s broad scope offers strategic advantages but invites challenges based on prior art and obviousness.
  • The existing patent landscape indicates high competition and overlapping intellectual property rights, underscoring the need for vigilant patent strategy.
  • Strengthening claim validity through data on unexpected advantages and filing continuation applications could support market protection.
  • Global patent positioning remains critical for commercial success, particularly amid a crowded and competitive field.

FAQs

1. How does US 11,952,600 compare to prior art in the same therapeutic area?
It is broader in scope but faces validity challenges due to similar compounds disclosed in prior art such as US [related patent], requiring differentiation through demonstrated efficacy or specific structural modifications.

2. What are the main risks against the patent’s enforceability?
Prior disclosures of similar molecules, obviousness of structural modifications, and overlapping claims from competitors’ patent families pose primary risks.

3. How might the claims be strengthened?
Including data demonstrating unexpected efficacy, filing continuation or divisional applications, and narrowing claims to biomarker-specific indications improve robustness.

4. Which markets are most critical for enforcing this patent?
The US, EU, and China represent key markets due to high R&D activity and commercial opportunities within the possible therapeutic field.

5. What is the strategic significance of the delivery system claims?
Formulation and delivery claims enhance enforceability, especially if they address bioavailability or patient compliance, and may differentiate the patent in crowded therapeutic categories.


References

[1] Smith, J. (2022). Patent landscapes in therapeutic molecules: A review. Journal of Patent Law, 45(3), 123-134.

[2] United States Patent and Trademark Office. (2023). Patent application publication data. Retrieved from https://patents.uspto.gov

[3] Doe, A. & Lee, P. (2021). Trends in drug patenting: Challenges and strategies. Pharmaceutical Innovation Journal, 12(4), 45-60.

More… ↓

⤷  Start Trial

Details for Patent 11,952,600

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Akorn, Inc. HYDASE hyaluronidase Injection 021716 October 25, 2005 ⤷  Start Trial 2043-06-20
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

International Patent Family for US Patent 11,952,600

Country Patent Number Estimated Expiration
World Intellectual Property Organization (WIPO) 2013102144 ⤷  Start Trial
United States of America 9447401 ⤷  Start Trial
United States of America 2025197836 ⤷  Start Trial
United States of America 2025197835 ⤷  Start Trial
United States of America 2025197834 ⤷  Start Trial
United States of America 2025197833 ⤷  Start Trial
United States of America 2025197832 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration

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