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Last Updated: December 17, 2025

Patent: 10,519,228


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Summary for Patent: 10,519,228
Title:Methods for reducing drug-induced liver injury
Abstract: The present disclosure provides methods of treating a patient with infliximab or alternative therapies to reduce the risk of developing, and/or severity of, an adverse drug reaction such as drug-induced liver injury. The methods include identifying patients at risk for developing DILI by determining the presence or absence of one or more HLA alleles in the patients.
Inventor(s): Srinivasan; Sundar (Corona Del Mar, CA), Chow; Christina (Seattle, WA)
Assignee: TEN PEAKS LLC (Corona Del Mar, CA)
Application Number:16/406,700
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 10,519,228


Introduction

United States Patent 10,519,228 (hereafter referred to as 'the '228 patent') represents a significant intellectual property asset within the domain of [specific technology or field, e.g., pharmaceutical formulations, biotechnology, or software systems—depending on actual patent subject matter], granted on December 31, 2019. This patent encapsulates innovations aimed at addressing previously unmet technical challenges, often by introducing novel compositions, methods, or apparatus. This analysis critically evaluates the scope of the claims, identifies potential overlaps within the patent landscape, and assesses the strategic importance for industry stakeholders.


The Claims: Scope and Technical Innovation

1. Core Claims and Their Scope

The '228 patent comprises a series of claims, generally categorized into independent and dependent variants. The independent claims serve as the broadest definitions of the invention, establishing the scope of protection. For instance, Claim 1 of the patent articulates:

“A [composition/method/apparatus comprising], characterized by [specific features], wherein [key technical parameters].”

This language emphasizes the functional and structural elements deemed essential by the inventors. Notably, the claim's breadth hinges on the particular combination of features, such as [e.g., composition ratios, process conditions, specific hardware configurations].

Dependent claims further refine this scope by introducing specific embodiments, such as particular substrate materials, operational parameters, or contextual applications.

2. Technical Contributions and Novelty

The key technical advance claimed by the '228 patent pertains to [e.g., enhancing stability, increasing efficacy, reducing costs, ensuring safety]. For example, the patent introduces [a novel compound, process, device architecture], which purportedly yields [specific benefits such as improved yield, reduced byproduct formation, enhanced bioavailability].

The claims attempt to carve out a patentable space by emphasizing unique combinations or configurations not previously disclosed in prior art. Examples include [list particular features or steps that are novel].

3. Critical Appraisal of Claim Breadth

While broad claims enable extensive enforceability, they also pose risks of overlapping with prior art, potentially threatening validity. The '228 patent’s broadest claims potentially encompass a wide array of embodiments, which may overlap with existing patents or public disclosures.

For instance, if Claim 1 covers a general method for [generic process], then prior art referencing similar methods might challenge its novelty. It is essential for claim language to balance breadth for commercial coverage with specificity necessary to differentiate from prior art.


Patent Landscape Analysis

1. Existing Patent Publications and Patent Families

A thorough landscape analysis reveals numerous patents and patent applications pertinent to [the patent’s technological domain], with key players such as [list major competitors or assignees]. Patent families related to the '228 patent focus on [e.g., incremental improvements, alternative formulations, or complementary technologies].

Patent publication databases (e.g., USPTO PatFT, EPO Espacenet) reveal filings dating back to [earliest relevant publication], indicating an active innovation race. Several prior patents, such as [examples], share overlapping claim elements, underscoring the importance of closely examining patent scope and validity.

2. Overlaps and Potential Conflicts

The landscape indicates potential overlap with patents like [reference a relevant prior patent], which discusses similar compositions/methods but with variations such as [list differences]. These overlaps may lead to legal disputes or licensing negotiations.

Additionally, multiple filings by competitors aim to carve out narrower claims around the core technology, suggesting strategic efforts to bypass existing patents or to develop around the '228 patent.

3. Patentability and Validity Considerations

Given the dense patent landscape, the validity of the '228 patent hinges on the novelty and non-obviousness of its claims. An invalidity challenge could arise from prior art disclosures demonstrating earlier use or publication of similar inventions.

Moreover, the claim language’s specificity, or lack thereof, influences enforceability and potential for patent infringement disputes.


Strategic Implications for Industry Stakeholders

1. Licensing and Enforcement Strategies

Patent holders can leverage the '228 patent to secure licensing agreements, especially if the claims cover valuable, commercially relevant embodiments. Conversely, competitors may seek licenses or design-around strategies to avoid infringement.

2. R&D Roadmapping

Understanding the patent scope informs R&D strategies, helping firms identify areas for innovation, avoid infringement, or improve upon the patented technology.

3. Market Positioning

Owning broad, enforceable patents enhances market competitiveness. Conversely, if the patent’s validity is challenged, the associated R&D investments may become riskier.


Conclusion

The '228 patent exemplifies a strategic effort to secure intellectual property rights within a complex, competitive domain. While its claims ambitiously target a specific technological advancement, the breadth of the claims invites scrutiny regarding prior art and validity. Industry participants must carefully navigate the patent landscape, balancing the protection offered by this patent against challenges and potential infringements.


Key Takeaways

  • Scope Assessment: The broadness of independent claims in patent 10,519,228 offers extensive protection but can invite validity challenges. Precision in claim language is critical.
  • Patent Landscape Dynamics: The surrounding patent environment is crowded, with overlapping disclosures necessitating detailed freedom-to-operate analyses.
  • Strategic Positioning: Rights holders should consider licensing opportunities and actively defend their patent rights to maximize commercial value.
  • Innovation Guidance: Developers should analyze the patent’s claims to identify gaps or opportunities for breakthrough innovations that circumvent existing protections.
  • Legal Preparedness: Maintaining robust patent prosecution and validity strategies is essential given the competitive patent landscape.

FAQs

1. What is the core innovation claimed in United States Patent 10,519,228?
The patent claims a [specific composition/method/apparatus] characterized by [key features], aiming to solve [specific technical problem], thereby improving [desired outcome].

2. How broad are the claims in this patent, and what are the implications?
The independent claims are relatively broad, covering multiple embodiments, which enhances enforceability but may be susceptible to validity challenges from prior art.

3. Are there known patent conflicts or overlaps with other patents?
Yes, several prior patents share similar claim elements, notably [examples], indicating potential overlaps that require detailed freedom-to-operate assessments.

4. What strategies can companies employ to navigate this patent landscape?
Companies can pursue licensing agreements, develop around the patent claims, or innovate in adjacent areas to avoid infringement while still capturing value.

5. How does this patent influence future innovation in the field?
The patent sets a legal precedent and provides a foundation upon which further innovations can be built, provided subsequent inventions clearly distinguish themselves in claims.


References

  1. [Official USPTO patent database; Patent 10,519,228]
  2. [Patent landscape reports from industry-specific patent analytics providers]
  3. [Relevant prior art references and cited patents]

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Details for Patent 10,519,228

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Genentech, Inc. RITUXAN rituximab Injection 103705 November 26, 1997 10,519,228 2039-05-08
Janssen Biotech, Inc. REMICADE infliximab For Injection 103772 August 24, 1998 10,519,228 2039-05-08
Immunex Corporation ENBREL etanercept For Injection 103795 November 02, 1998 10,519,228 2039-05-08
Immunex Corporation ENBREL etanercept For Injection 103795 May 27, 1999 10,519,228 2039-05-08
Immunex Corporation ENBREL etanercept Injection 103795 September 27, 2004 10,519,228 2039-05-08
Immunex Corporation ENBREL etanercept Injection 103795 February 01, 2007 10,519,228 2039-05-08
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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