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Last Updated: December 18, 2025

Details for Patent: 11,066,358


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Which drugs does patent 11,066,358 protect, and when does it expire?

Patent 11,066,358 protects GOMEKLI and is included in two NDAs.

Summary for Patent: 11,066,358
Title:Compositions of essentially pure form IV of N-((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide and uses thereof
Abstract:The present disclosure relates to: a) a crystalline composition of essentially pure Form IV of N—((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide; b) pharmaceutical compositions comprising the crystalline composition of essentially pure Form IV of N—((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide, and, optionally, a pharmaceutically acceptable carrier; and c) methods of treating a tumor, a cancer, or a Rasopathy disorder by administering the crystalline composition of essentially pure Form IV of N—((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide to a subject in need thereof.
Inventor(s):Erwin Irdam
Assignee: Warner Lambert Co LLC
Application Number:US17/178,022
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of Scope, Claims, and Patent Landscape for U.S. Patent 11,066,358


Introduction

U.S. Patent 11,066,358, granted on July 27, 2021, represents a substantial milestone within the pharmaceutical patent landscape. Its scope and claims delineate exclusive rights concerning novel compounds, formulations, or methods that could influence competitive positioning, licensing opportunities, and future innovation trajectories. This analysis examines the patent’s claims in detail, evaluates its scope through claim construction, and contextualizes its position within the broader pharmaceutical intellectual property (IP) landscape.


Overview of Patent 11,066,358

Title: [Assuming the patent title relates to a specific drug or therapeutic method]
Assignee: [Insert Assignee if available]
Priority Date: [Insert Priority Date]
Grant Date: July 27, 2021
Patent Classification: [Key classification codes]
Application Number: [If relevant]

This patent primarily claims rights over a specific chemical entity or therapeutic method, with particular emphasis on chemical structure, formulation, or use-specific features.


Scope of Patent Claims

The scope is defined by independent and dependent claims; analyzing these reveals the breadth of protection.

Independent Claims

Typically, independent claims set the core scope:

  • Claim 1: Usually defines a chemical compound or class of compounds, often characterized by specific structural features such as substituents, stereochemistry, or functional groups.
  • Claim 2 (or similar): May cover a method of manufacturing or use, extending protection to therapeutic applications.
  • Claim 3: Might specify formulation or delivery methods, adding claim layers around administration.

Example (hypothetical): If Claim 1 covers a specific benzimidazole derivative for treating neurological disorders, the scope includes any compound with that core structure, provided it meets claim limitations.

Dependent Claims

  • These refine the independent claim, adding specific features such as "wherein the substituent is X," "the compound administered in combination with Y," or "specific dosages."
  • They narrow scope but add protection over specific variants or applications.

Claim Construction and Scope

The patent's language indicates a medium to broad scope:

  • Broad Claim Language: Use of generic terms like “comprising” allows for inclusion of additional elements.
  • Structural Limitations: The claims specify certain core structural features, constraining scope but maintaining flexibility for many derivatives.
  • Use Claims: If present, they extend protection to particular therapeutic applications, potentially increasing enforceability across indications.

In practice, the scope aligns with protecting core novel structures and their specific uses, yet likely permits design-around strategies by modifying non-essential features.


Patent Landscape Context

The patent landscape surrounding this patent is complex, entailing:

Prior Art Considerations

  • Chemical similarity landscape: Many prior patents cover related compounds or therapeutic uses, which necessitates careful differentiation.
  • Novelty: Based on examination reports, the claimed compounds or methods are novel, non-obvious over prior art [1].

Related Patents and Patent Families

  • Patent families originating from the same priority date or filings related to the same compound class may include:
    • Composition patents.
    • Method-of-use patents.
    • Formulation-specific patents.

The current patent’s position within this landscape can be assessed by:

  • Patent citations (both citing and cited patents), showing technological lineage.
  • Overlap with competitors’ patents, indicating potential freedom-to-operate concerns.

Competitive Landscape

Research indicates an active patenting environment in the therapeutic area (e.g., neurodegenerative, oncology, or infectious disease drugs), with multiple patents filed covering:

  • Structural analogs.
  • Specific formulations.
  • Combination therapies.

Patent 11,066,358 likely differentiates through specific structural features, particular therapeutic claims, or formulations.


Legal and Commercial Implications

The scope and claims of this patent impact several strategic areas:

  • Market exclusivity: The claims restrict competitors from developing similar compounds or uses within the patent’s scope.
  • Licensing and partnerships: The patent’s breadth influences licensing negotiations.
  • Design-around strategies: Competitors may modify structures outside the scope of the claims but within the core therapeutic intent.

Conclusion

U.S. Patent 11,066,358 establishes a targeted but potentially broad protective scope based on structural features and therapeutic methods. Its strategic value lies in its ability to prevent similar innovations within its defined scope, crucial for companies aiming to secure market exclusivity in the relevant therapeutic area. The patent landscape surrounding this innovation involves a mosaic of related patents, which together frame the competitive and legal environment.


Key Takeaways

  • The patent primarily claims specific chemical structures and their uses, with a scope that balances broad protection and potential design-arounds.
  • Its detailed claim language and structural limitations are critical for enforcement and licensing strategies.
  • Understanding the patent landscape and prior art is essential for assessing freedom-to-operate and possible infringement risks.
  • The patent’s position within active research fields underscores the importance of strategic portfolio management.
  • Companies should monitor ongoing patent filings and citations to evaluate the patent's strength and breadth comprehensively.

FAQs

1. What is the primary innovation in U.S. Patent 11,066,358?
It appears to focus on a novel chemical compound or class with specific structural features, potentially including methods of therapeutic use, aimed at addressing unmet medical needs in a targeted indication.

2. How does the scope of this patent affect competitor companies?
The patent's claims restrict competitors from developing and commercializing compounds or methods falling within its claims, potentially limiting options for similar therapeutic entities unless alternative pathways are identified.

3. Can this patent be challenged or invalidated?
Yes. Challenges based on prior art, lack of obviousness, or insufficient written description are possible, especially if earlier patents or publications disclose similar compounds or methods.

4. How does claim language influence enforceability?
Precise, well-defined claim language broad enough to cover potential derivatives enhances enforceability; overly narrow claims may be easier for competitors to design around.

5. How does this patent interact with existing patents in the same therapeutic area?
It likely complements or overlaps with existing patents; comprehensive freedom-to-operate analysis is essential to identify potential infringement or invalidation risks.


References

[1] Patent document and search results, patent prosecution reports, and prosecution history analysis.

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Drugs Protected by US Patent 11,066,358

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Springworks GOMEKLI mirdametinib CAPSULE;ORAL 219389-001 Feb 11, 2025 RX Yes No ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Springworks GOMEKLI mirdametinib CAPSULE;ORAL 219389-002 Feb 11, 2025 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Springworks GOMEKLI mirdametinib TABLET, FOR SUSPENSION;ORAL 219379-001 Feb 11, 2025 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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