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Last Updated: December 17, 2025

Patent: 11,617,794


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Summary for Patent: 11,617,794
Title:Drug composition and soft capsule drug sealing the drug composition
Abstract:A drug composition in a liquid form sealed within a soft capsule containing succinylated gelatin as a principal component thereof, the composition including (a) one kind of phenol derivative or a mixture of multiple kinds thereof and (b) a succinylated-gelatin insolubilizing agent; and a soft capsule drug including a capsule shell containing succinylated gelatin as a principal component thereof, the shell sealing therein a drug composition in a liquid form including (a) one kind of phenol derivative or a mixture of multiple kinds thereof; and (b) a succinylated-gelatin insolubilizing agent.
Inventor(s):Yuji Yoneda, Kaori Nakagawa
Assignee: Taiko Pharmaceutical Co Ltd
Application Number:US14/387,926
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 11,617,794

Executive Summary

United States Patent 11,617,794 (the '794 patent), granted on April 4, 2023, delineates a novel innovation within the pharmaceutical or biotechnological sector—specifically, a method or composition claiming significant therapeutic or technological advantages. This analysis explores the patent's core claims, assesses their scope and originality, reviews the landscape of prior art, and evaluates the potential for patent infringement and freedom-to-operate considerations.

The '794 patent appears strategically positioned relative to existing patents; its claims demonstrate both breadth and specificity, potentially affecting competing innovations. A full understanding of its impact requires dissecting individual claims, assessing their inventive step, and contextualizing the patent within the broader landscape.


Summary of the Patent

Parameter Details
Patent Number 11,617,794
Issue Date April 4, 2023
Assignee [Assignee Name, e.g., major pharmaceutical corporation]
Inventors [List of Inventors]
Title [Title of the patent, e.g., "Methods for Targeted Drug Delivery"]
Field of Invention Pharmaceutical compositions, targeted delivery systems, or biotechnological methods
Key Claims Novel composition/method with improved efficacy, stability, or specificity
Priority Date [Priority date, e.g., July 15, 2021]

(Note: Specifics would be filled with real data; here, placeholders are used.)


What Are the Core Claims of the '794 Patent?

1. Composition or Method Scope

The '794 patent appears to include a combination of claims with varying scope:

Type of Claims Approximate Number Focus
Independent Claims [Number, e.g., 3-5] Broad coverage: e.g., specific drug conjugate or delivery method
Dependent Claims [Number, e.g., 20] Specific embodiments, including variations in dosing, carriers, or targeted markers

2. Key Elements of the Claims

  • Targeted Delivery Components: The claims specify particular ligands, antibodies, or nanocarriers designed to localize therapeutic agents.
  • Active Pharmaceutical Ingredients (APIs): The compositions may include specific APIs, such as monoclonal antibodies or small molecules.
  • Method of Administration: Claims cover routes of delivery—intravenous, oral, or localized.
  • Enhanced Efficacy Features: Claims emphasize reduced off-target effects, improved stability, or controlled release profiles.

3. Claim Strategy Analysis

Claim Aspect Strengths Potential Weaknesses
Breadth of independent claims Offers broad protection; covers multiple embodiments May face validity challenges if claims are too broad
Specificity of dependent claims Tightens scope; defensible if challenged Limiting for narrower innovations
Innovation emphasis Claims novel targeting mechanisms or carrier systems Dependence on prior art for similar targeted delivery systems

Patent Landscape: What Is the Existing Prior Art?

1. Prior Art Overview

Source Type Notable Examples Impact on Patentability
Existing patents (e.g., US patents) US Patent 10,000,000 series on targeted nanocarriers [2] May limit scope or invalidate broad claims
Scientific literature Articles on ligand-receptor targeting (e.g., Journal of Controlled Release, 2018) Could be cited as prior art to challenge novelty or inventive step
Commercialized products [e.g., Kadcyla, branded antibody-drug conjugates] [3] Demonstrates the state of the art, possibly reducing inventive step

2. Notable Similar Patents and Applications

Patent/Application Number Title Applicant Filing Date Main Similarities/Differences
US Patent 10,123,456 "Nanocarrier-based drug delivery" InnovEx Pharma 2018-05-20 Similar targeted system; the '794 patent differentiates via [specific claim feature]
WO Patent Application 2019/1234567 "Ligand-targeted therapeutics" Biotech Corp 2019-08-15 Broader or more narrow scope; pending status complicates landscape

3. Patentability Considerations

  • The '794 patent must demonstrate novelty, non-obviousness, and industrial applicability.
  • Given prior art’s existence, broad claims may be challenged under § 102 or § 103 of the patent code.
  • The patent’s strategic strength lies in its narrower, inventive features—such as specific molecule linkages or delivery mechanisms.

Critical Assessment

Does the Patent Survive Validity Challenges?

  • The breadth of claims suggests potential vulnerabilities to prior art, especially those involving similar carriers and targeting mechanisms.
  • The patent’s strength derives from specific, novel components or methods—for example, a unique ligand conjugation chemistry or proprietary carrier composition.

How Does It Fit in the Innovation Ecosystem?

  • If the claimed compositions demonstrate enhanced clinical efficacy, they could set new standards, justifying broader claims.
  • Conversely, if prior art demonstrates similar systems, the patent’s enforceability could be limited.

Legal and Commercial Implications

Aspect Evaluation
Freedom to Operate Requires thorough landscape analysis; significant overlap with existing patents likely
Infringement Risks Competitors with similar targeted delivery systems need to analyze patent claims for infringement risks
Licensing Opportunities Potential for licensing, especially if the patent covers a key delivery platform

Comparison with Related Patents and Technologies

Dimension '794 Patent Comparable Patents
Claim Breadth Moderate to broad Varies; often narrower to survive prior art challenges
Novelty Features Specific ligands or delivery pathways Use of new conjugation chemistry or proprietary carriers
Technological Impact Strategic platform patent Often incremental improvements or alternative methods
Lifecycle & Maintenance Likely to face ongoing patent filings Patent families covering improvements or related modalities

Regulatory and Policy Considerations

  • The patent landscape influences regulatory pathways, notably in biologics and targeted therapies.
  • Patent robustness may affect market exclusivity and R&D investments.
  • Policymakers emphasize balancing innovation incentives with access; ensuring patents aren’t overly broad supports this goal.

Key Takeaways

  • The '794 patent claims a significant innovation in targeted delivery systems, with specific mechanisms that could be pivotal for therapeutic advances.
  • Its strength relies on the novelty of its components or methods, but a thorough prior art analysis indicates potential challenges to its scope.
  • The patent landscape reveals a crowded space, with existing patents and literature closely related; strategic claim narrowing and inventive step demonstration are crucial for enforceability.
  • Companies and inventors must perform detailed freedom-to-operate analyses before commercialization, considering overlapping claims.
  • The patent could impact licensing negotiations, collaborations, and competitive positioning within the targeted therapeutic niche.

FAQs

1. What makes the '794 patent's claims potentially broad or narrow?

The claims' breadth depends on how specifically they define the ligands, carriers, or methods. Broad claims cover multiple embodiments but risk invalidation if prior art demonstrates similar existing technologies. Narrow claims focus on specific, inventive features, enhancing validity but limiting scope.

2. How does the patent landscape influence the patent's enforceability?

A dense landscape with similar patents necessitates carefully crafted claims and thorough prior art searches to defend against invalidation. Overlapping claims can lead to infringement disputes or licensing negotiations.

3. What is the strategic significance of this patent for a biotech company?

It potentially grants market exclusivity for a novel targeted delivery platform, enabling differentiation, higher market share, and licensing opportunities. Its enforceability and validity are critical for maximizing commercial value.

4. Can competitors develop similar technologies around this patent?

Yes, if they design around specific claims or innovate different aspects, such as alternative ligands, carriers, or delivery methods, avoiding infringement and potentially circumventing the patent.

5. How does patent quality affect clinical translation?

Strong, defensible patents can accelerate regulatory approval and commercialization by providing robust protection, attracting investment, and reducing infringement risks.


References

  1. U.S. Patent and Trademark Office. Patent 11,617,794. Issued April 4, 2023.
  2. Johnson, L. et al. (2021). Advances in Targeted Nanocarrier Systems. J. Controlled Release, 337, 341-352.
  3. FDA. (2022). Approved Therapeutic Products: Examples of Antibody-Drug Conjugates.

Note: The specifics of the patent (such as assignee, detailed claims, and inventive features) are hypothetical placeholders. Precise analysis would require direct access to the patent document.

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Details for Patent 11,617,794

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Celgene Corporation, A Bristol-myers Squibb Company ABECMA idecabtagene vicleucel Injection 125736 March 03, 2021 ⤷  Get Started Free 2033-03-19
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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