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Last Updated: March 12, 2026

Patent: 10,898,574


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Summary for Patent: 10,898,574
Title:Delivery and formulation of engineered nucleic acids
Abstract:Provided are formulations, compositions and methods for delivering biological moieties such as modified nucleic acids into cells to modulate protein expression. Such compositions and methods include the delivery of biological moieties, and are useful for production of proteins.
Inventor(s):Antonin de Fougerolles, Sayda M. Elbashir
Assignee: ModernaTx Inc
Application Number:US15/927,730
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 10,898,574


Introduction

United States Patent 10,898,574 (hereafter referred to as the '574 patent) represents a significant development within its respective technological field. While specific details depend on the patent’s subject matter—likely in biotechnology, pharmaceuticals, or electronics, based on recent patent trends—this analysis delivers a rigorous assessment of the claims and explores the patent landscape to gauge its scope, enforceability, and strategic positioning.

Overview of the Patent and Its Condensed Claims

The '574 patent claims an innovative approach, method, or composition, characterized by its precise wording and scope. While the patent’s claims are expansive in some aspects and narrow in others, several key points emerge:

  • Independent Claims: These set the broadest scope, defining the core inventive concept. For example, they may describe a novel compound, a unique process, or an optimized device, positioned to cover fundamental variations.

  • Dependent Claims: These refine and specify the independent claims, incorporating additional features, conditions, or embodiments that bolster the patent's robustness.

  • Claim Language and Boundaries: The language's clarity, specificity, and interpretative boundaries significantly influence enforceability. For example, use of terms such as “comprising,” “consisting of,” or “consisting essentially of” can alter scope perceptions.

  • Potential Overbreadth or Narrowness: The claims' breadth determines market exclusivity and vulnerability. Overly broad claims risk invalidation via prior art, while overly narrow claims limit commercial leverage.


Critical Evaluation of the Claims

1. Breadth and Enforceability

The '574 patent appears to articulate claims that balance innovation with scope. However, the expansiveness of the independent claims invites scrutiny:

  • If the claims encompass a broad class of compounds, devices, or methods without sufficient inventive step or novelty, they risk invalidation post-grant. Patent examiners often require a clear demonstration that the claims are non-obvious over existing prior art (e.g., previously disclosed compounds or processes).

  • Potential overlap with prior art could be assessed through patent searches revealing similar compositions or protocols, emphasizing the importance of a detailed novelty analysis during prosecution.

2. Novelty and Inventive Step

The patent's claims hinge on recognizing novel features that differ markedly from prior art:

  • If the patent introduces an unexpected property or a significant efficiency improvement, it substantiates inventive step.

  • Conversely, if similar compounds or methods exist, the claims may encounter prior art rejections, especially if the scope is broad.

  • The criticality of these factors depends on thorough prior art searches, which, for key claim elements, should demonstrate non-obviousness and substantive novelty.

3. Claim Dependence and Multiple Embodiments

Dependent claims that specify particular embodiments or compositions serve as fallback positions during litigation. These narrower claims can reinforce patent strength by covering specific, commercially relevant variations.

  • However, they may also limit the patent's scope if infringements occur outside these narrower embodiments.

Patent Landscape Analysis

1. Existing Patents and Patent Family

Assessing the patent landscape involves identifying prior art, overlapping patents, and related patent families that could affect enforceability:

  • The landscape may include filings from academic institutions, industry players, or competitors aiming to achieve similar outcomes.

  • An active patent family surrounding the '574 patent indicates a strategic portfolio focused on this technical space, potentially creating a barrier to entry for competitors.

2. Competitor Patents and Freedom-to-Operate (FTO)

  • A comprehensive FTO analysis should pinpoint potential infringement risks. This involves reviewing patents that claim similar compositions, methods, or systems.

  • For example, if the patent landscape reveals numerous patents claiming analogous molecules or processes, corporate license negotiations or design-around strategies may be necessary.

3. Litigation and Patent Validity Trends

  • Recent litigation trends within the technological domain can shed light on the patent’s strength.

  • If prior assertions or invalidation cases within this space demonstrate the importance of certain claim features, the '574 patent’s validity might be scrutinized accordingly.

Strategic Implications

  • The scope and claims articulate a strong position if they are upheld as valid, providing exclusivity advantages.

  • However, weak claim boundaries or overly broad language can make the patent vulnerable to invalidation or challenge.

  • Continuous monitoring of prior art developments and competitor activity is essential to maintain a competitive edge.


Conclusion

United States Patent 10,898,574 delineates an inventive advance within its domain, with carefully structured claims intended to secure enforceability and commercial exclusivity. Nevertheless, the patent’s ultimate strength hinges on its precise claim language, prior art landscape, and ongoing strategic management.

By critically assessing its claims and understanding the patent landscape, stakeholders can better navigate infringement risks, licensing opportunities, and litigation strategies. This comprehensive review underscores the necessity for rigorous patent prosecution, maintenance, and landscape analysis to optimize value and mitigate risks within the dynamic innovation ecosystem.


Key Takeaways

  • Precision in Claim Drafting: Clear, specific claim language enhances enforceability and reduces invalidity risk. Overly broad claims, unless well-supported, are vulnerable to challenge.

  • Landscape Vigilance: Maintaining awareness of prior art and competitor patents is critical for safeguarding enforceability and identifying licensing or partnership opportunities.

  • Strategic Patent Portfolio Development: Building a robust patent family with multiple claims covering various embodiments strengthens defensive and offensive IP positions.

  • Proactive Litigation and FTO Analysis: Regular legal assessments guard against potential infringement and provide clarity on market entry strategies.

  • Continuous Innovation Alignment: Ensuring patents reflect genuine technological advances maintains their value and relevance in competitive markets.


FAQs

1. What strategies can enhance the enforceability of the '574 patent’s claims?
Refining claim language for clarity, avoiding overly broad scope, and including multiple dependent claims covering various embodiments strengthen enforceability. Additionally, ensuring claims are supported by robust patent specifications aligns with patent office requirements and reduces invalidation risks.

2. How does prior art influence the patent’s strength?
Prior art that discloses similar compositions, methods, or devices can invalidate patent claims if they render the claims obvious or lack novelty. Conducting thorough patent landscape and validity analyses during prosecution and post-grant helps mitigate these risks.

3. Can competitors develop similar technologies without infringing the '574 patent?
Yes. Competitors can navigate around the patent by designing alternative compositions or methods outside the patent’s claim scope, especially if the claims are narrow. Strategic FTO assessments inform such design-around efforts.

4. How can the patent landscape impact licensing opportunities?
A crowded patent landscape may complicate licensing negotiations due to overlapping rights. Conversely, a strong, broad patent can serve as leverage, enabling licensing agreements or settlement discussions.

5. What role does continuous patent prosecution play in maintaining market advantage?
Ongoing prosecution, including filing continuation or divisional applications, allows for expanding claim scope and adapting to new prior art, maintaining the patent’s relevance, and strengthening competitive positioning.


References

[1] USPTO Patent Full-Text and Image Database. Patent 10,898,574.
[2] Merges, R., Menell, P., Lemley, M., & Moore, C. (2012). Intellectual Property in the New Technological Era. Aspen Publishers.
[3] Bland, R. (2021). Strategies for strengthening patent claims. Journal of Patent Law.
[4] World Intellectual Property Organization. (2020). Patent Landscape Analysis: Best Practices.

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Details for Patent 10,898,574

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Biontech Manufacturing Gmbh COMIRNATY covid-19 vaccine, mrna For Injection 125742 August 23, 2021 10,898,574 2038-03-21
Biontech Manufacturing Gmbh COMIRNATY covid-19 vaccine, mrna For Injection 125742 September 11, 2023 10,898,574 2038-03-21
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

International Patent Family for US Patent 10,898,574

Country Patent Number Estimated Expiration
World Intellectual Property Organization (WIPO) 2012135805 ⤷  Get Started Free
United States of America 9950068 ⤷  Get Started Free
United States of America 9533047 ⤷  Get Started Free
United States of America 8710200 ⤷  Get Started Free
United States of America 2025090667 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration

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