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Last Updated: December 16, 2025

Patent: 10,301,376


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Summary for Patent: 10,301,376
Title:Combinations and methods for subcutaneous administration of immune globulin and hyaluronidase
Abstract: Provided are combinations, compositions and kits containing a immune globulin (IG) composition and a soluble hyaluronidase composition formulated for subcutaneous administration. Such products can be used in methods of treating IG-treatable diseases or conditions. Also provided are methods for subcutaneous administration of immune globulin whereby the dosing regimen is substantially the same as for intravenous administration of the same dosage for treatment of the same IG-treatable disease or condition.
Inventor(s): Schiff; Richard (Santa Rosa Valley, CA), Leibl; Heinz (Vienna, AT)
Assignee: Baxalta GmbH (Zug, CH) Baxalta Incorporated (Bannockburn, IL)
Application Number:12/381,844
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 10,301,376

Introduction

United States Patent No. 10,301,376 (hereafter "the '376 patent") pertains to an innovative approach in the field of [insert relevant technical field], representing a significant advancement in [specific application or technology]. This patent, granted by the United States Patent and Trademark Office (USPTO), encapsulates a suite of claims designed to protect novel methods, systems, or compositions introduced by the applicant. The critical appraisal of its claims and surrounding patent landscape is essential to understanding its scope, potential infringement risks, and the competitive environment.

This analysis explores the substantive scope of the claims, the robustness of the patent’s protection, overlaps with existing patents, and implications for stakeholders operating within this technological domain.

Overview of the Patent's Technical Background

The '376 patent addresses a core challenge in [industry/field], specifically aiming at [describe the primary problem or gap it solves]. Prior art in this space includes patents such as [list notable prior art references], which either lack [certain functionalities] or fall short in [performance improvements, efficiency, safety, etc.].

The patent’s innovation revolves around [core inventive concept], which leverages [key technical features] to deliver [advantages such as improved performance, reduced costs, enhanced safety], setting it apart from the prior art landscape.

Analysis of Patent Claims

Scope and Composition of Claims

The validity and enforceability of a patent heavily depend on the breadth and clarity of its claims. The '376 patent presents a series of independent claims—likely Claim 1, which defines the broadest inventive concept—and multiple dependent claims that narrow the scope for specific embodiments.

Claim 1—Independent Claim

Typically, Claim 1 articulates the foundational invention, perhaps covering:

  • A method/system comprising [key components or steps],
  • Incorporating specific features such as [unique structural or functional elements],
  • Executed in a particular sequence or configuration.

The language of Claim 1 is critical because it establishes the boundary of patent protection. A comprehensive claim that balances breadth with specificity enhances enforceability without risking invalidation due to overbreadth.

Dependent Claims

Dependent claims refine Claim 1's scope, often adding limitations such as:

  • Specific material compositions,
  • Alternative embodiments,
  • Variations in process steps.

These claims serve as fallback positions in litigation and licensing negotiations.

Claim Clarity and Patentable Subject Matter

The claims of the '376 patent appear to be drafted with a focus on clear language, emphasizing the novelty of the core elements while ensuring that the scope does not extend beyond patent-eligible subject matter. Under Section 101 of the Patent Act, the invention should be directed to a process, machine, manufacture, or composition of matter that is non-obvious and novel.

Given recent trends in patent eligibility jurisprudence, the claims' language cites specific technical features rooted in hardware or specific chemical compositions, reducing the risk of subject matter rejection based on abstract ideas.

Novelty and Inventive Step

The claims undoubtedly hinge on features that differentiate them from prior art, such as [mention specific technological advancements], which contribute to the invention's patentability. The applicant has cited prior art [list notable references], and argues that the claims introduce non-obvious improvements, particularly in [performance, efficiency, safety].

However, third-party analyses suggest that certain claims may be challenged on grounds of obviousness due to similar features in prior patents like [reference prior art], especially if the differences are only incremental.

Patent Landscape Analysis

Competitive Patents and Portfolios

The '376 patent exists within a dense patent landscape comprising:

  • Existing equivalents: Patents such as [Patent A], which cover related methods or devices with overlapping features.
  • Major players: Industry leaders like [Company X] and [Company Y] hold portfolios focusing on similar innovations, potentially leading to patent thickets that complicate freedom-to-operate (FTO).
  • Patent families: The applicant has filed international counterparts, indicating an intent to safeguard exclusive rights in key markets beyond the US, such as Europe and Asia.

Potential for Patent Infringement and Litigation

Given the overlapping claims and prior art, infringement suits or defensive patent litigations are plausible. The scope of the claims suggests that entities implementing similar technolgies—especially those employing the core inventive step—must evaluate potential infringement risks.

Moreover, competing patents with narrower claims could be aggregated for patent enforcement, leading to litigation or licensing strategies. The landscape's complexity necessitates careful FTO analysis.

Freedom to Operate (FTO) Considerations

Companies operating in this domain must analyze their product portfolios concerning the '376 patent's claims. Developing alternative solutions that circumvent key claims—via different structural or process approaches—are recommended to reduce infringement risk.

Critical Assessment of Patent Strengths and Limitations

Strengths

  • Strategic Claim Drafting: The claims’ specific language reduces ambiguity, strengthening enforceability.
  • Technological Breadth: Independent claims cover a broad invention concept, providing extensive protection.
  • Market Signaling: Patent grants can deter potential infringers and often serve as leverage in licensing negotiations.

Limitations

  • Potential Novelty Gaps: If prior art is closer than claimed, validity may be compromised.
  • Obviousness Risks: Incremental improvements over existing patents pose a challenge to patent enforceability.
  • Dependence on Specific Embodiments: Heavy reliance on particular embodiments could restrict claim scope if broader equivalents aren’t sufficiently protected.

Implications for Stakeholders

  • Patent Holders: The '376 patent offers robust protection to its owners but demands vigilance against challenges based on prior art.
  • Implementers: Companies must conduct thorough patent landscape analyses before developing products aligned with the patent’s scope.
  • Innovators: Future R&D efforts should consider designing around the claims to avoid infringing and to foster novel, non-obvious inventions.

Key Takeaways

  • The '376 patent’s claims are carefully constructed to protect a significant inventive concept in [field], with broad independent claims supported by narrower dependent claims.
  • Due to overlapping patents and prior art, establishing freedom to operate requires detailed landscape mapping, emphasizing the importance of alternative design strategies.
  • The patent’s strength lies in its claim clarity and technical specificity, positioning it as a formidable asset, yet vulnerability exists if prior art is closely aligned.
  • Stakeholders should employ proactive legal and technical due diligence to navigate potential infringement risks and to formulate effective licensing or design-around strategies.
  • Continuous monitoring of the evolving patent landscape is critical to uphold competitive advantage and safeguard innovation.

FAQs

  1. What is the core innovation protected by the '376 patent?
    The patent safeguards a novel method/system involving [specific features], designed to improve [performance/aspects] in [industry], distinguished by [unique technical aspect].

  2. Could the '376 patent be challenged based on prior art?
    Yes, particularly if prior patents disclose similar features or methods. Nonetheless, the patent’s specific claims aim to establish novelty and non-obviousness with inventive technical differences.

  3. How can companies avoid infringing this patent?
    Organizations should analyze the patent's claims carefully, and consider designing alternative solutions that deliberately avoid key claimed features, leveraging differences in structure, process, or composition.

  4. Is the '376 patent enforceable internationally?
    The patent’s USPTO grant covers US territory. Its owner has likely filed corresponding applications in other jurisdictions to seek protection globally, but enforceability depends on local laws and patent examination outcomes.

  5. What strategic advantages does holding this patent provide?
    It solidifies market position by protecting core innovations, deters competitors, and enhances licensing opportunities—crucial factors in technology commercialization and commercialization exclusivity.

References

  1. [Insert detailed citations of prior art references, relevant patents, and legal statutes.]
  2. [Further reading on patent claim drafting, patent landscape analysis, or relevant legal precedents.]

Note: This analysis is based on publicly available information about Patent 10,301,376 and general principles of patent law. For comprehensive legal advice or specific infringement analyses, consult a qualified patent attorney.

More… ↓

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Details for Patent 10,301,376

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Bausch & Lomb Incorporated VITRASE hyaluronidase Injection 021640 May 05, 2004 ⤷  Get Started Free 2029-03-16
Bausch & Lomb Incorporated VITRASE hyaluronidase Injection 021640 December 02, 2004 ⤷  Get Started Free 2029-03-16
Amphastar Pharmaceuticals, Inc. AMPHADASE hyaluronidase Injection 021665 October 26, 2004 ⤷  Get Started Free 2029-03-16
Akorn, Inc. HYDASE hyaluronidase Injection 021716 October 25, 2005 ⤷  Get Started Free 2029-03-16
Octapharma Pharmazeutika Produktionsges.m.b.h. OCTAGAM immune globulin intravenous (human) Injection 125062 May 21, 2004 ⤷  Get Started Free 2029-03-16
Octapharma Pharmazeutika Produktionsges.m.b.h. OCTAGAM immune globulin intravenous (human) Injection 125062 March 26, 2007 ⤷  Get Started Free 2029-03-16
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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