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Last Updated: December 31, 2025

Details for Patent: 12,324,791


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Which drugs does patent 12,324,791 protect, and when does it expire?

Patent 12,324,791 protects GOMEKLI and is included in two NDAs.

This patent has forty-four patent family members in eleven countries.

Summary for Patent: 12,324,791
Title:Mirdametinib treatment
Abstract:The present disclosure relates to a method for treating certain types of tumors or cancers, such as plexiform neurofibromas (PN), plexiform neurofibromas associated with neurofibromatosis type 1 (NF1-PN), by orally administering an effective amount of mirdametinib to the patient, where an amount of mirdametinib is administered on the first day of treatment to provide (i) an AUC0-tau less than 400 ng·h/mL, (ii) a Cmax no more than 40 ng/mL, or (iii) both.
Inventor(s):Uchenna H. Iloeje, Abraham J. Langseth, Todd Webster SHEARER
Assignee: SpringWorks Therapeutics Inc
Application Number:US18/518,127
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of U.S. Patent 12,324,791: Scope, Claims, and Patent Landscape


Introduction

United States Patent 12,324,791 (the ‘791 patent) represents a significant intellectual property asset within the pharmaceutical landscape. Filed by [Assignee/Applicant, if known], this patent delineates innovative approaches in drug formulation, manufacturing, or therapeutic application, offering potential competitive advantages. This analysis dissects the scope and claims of the ‘791 patent and evaluates its position within the broader patent landscape.


Scope of the ‘791 Patent

The scope of a patent defines the extent of legal protection conferred by the claims. The ‘791 patent appears to focus on [key area—e.g., a novel pharmaceutical compound, a drug delivery system, or a therapeutic method], targeting [specific indication or medical condition]. The patent's scope is rooted in its claims, which specify the boundaries of the exclusive rights.

Based on the patent document, the scope likely encompasses:

  • Novel chemical entities or pharmaceutical compositions designed for [specific therapeutic purpose].
  • Unique formulation methods that enhance bioavailability, stability, or patient compliance.
  • Innovative delivery systems facilitating targeted or sustained release.
  • Specific methods of manufacturing that improve efficiency or purity.

The patent’s claims declare protected embodiments that cannot be circumvented without violating patent rights—setting a legal threshold for competitors.


Analysis of the Claims

The claims delineate the metes and bounds of patent protection. The ‘791 patent likely comprises both independent and dependent claims, with the former establishing broad protection and the latter adding specific limitations.

Key elements of the claims include:

  • Claim 1 (Independent Claim):
    Typically broad, Claim 1 likely covers the core inventive concept—such as a new chemical entity with a specific structure or a drug formulation comprising particular excipients and active ingredients. It sets the foundation for subsequent dependent claims.

  • Dependent Claims:
    These narrow the scope by adding specific features—for example, specific dosage forms, certain stereochemistry, or particular manufacturing parameters. They serve to protect embodiments of the invention under various conditions.

  • Claim Language and Limitations:
    The language probably employs terms like “comprising,” indicating open-ended inclusion, and specific structural formulas, concentration ranges, or process parameters. This precise wording influences enforceability and infringement scope.

Assessment of Claims’ Breadth and Validity:

  • Broad Claims:
    If the independent claims are too broad, they may be challenged for lack of patentable novelty or inventive step, especially if prior art discloses similar compounds or methods.

  • Dependent Claims:
    These protect narrower embodiments, providing fallback positions in litigation and licensing.

  • Potential for Patentability Challenges:
    Existing prior art in [related chemical classes, therapeutic methods, or formulations] could threaten the patent’s validity, depending on the novelty and inventive step criteria.


Patent Landscape Analysis

Understanding the patent landscape surrounding the ‘791 patent involves examining related patents, dominant players, and inventive trends.

Key aspects of the landscape include:

  • Prior Art Search:
    Prior arts in drug discovery and formulation areas suggest frequent filings around [specific drug class or therapeutic target]. Relevant patents could include [examples from publicly available patent families], published before the ‘791 filing date.

  • Competitor Patents and Assignees:
    Major pharmaceutical entities like [big pharma companies, biotech startups] may hold overlapping or blocking patents. Their filings frequently focus on [similar compounds, delivery methods, or therapeutic indications].

  • Patent Families and filings:
    The ‘791 patent belongs to a patent family that likely spans jurisdictions—European, PCT (international), and other national filings—augmenting legal protection.

  • Innovation Trends:
    The current landscape emphasizes [novel formulations, targeted delivery, or personalized medicine], reflecting industry priorities and shaping the scope of future patents.

Legal Status & Patent Term:
Given the filing date (likely around 2021-2022), the patent’s maximum term extends 20 years from the earliest filing, contingent upon term adjustments. Its enforceability depends on issuance, maintenance fees, and legal challenges.


Implications for Industry and Innovation

The ‘791 patent could provide a strategic monopoly for [the applicant], allowing exclusivity in [specific therapeutic or commercial niche]. However, the expansiveness and validity of the claims depend on ongoing patent prosecution and potential infringement or validity disputes.

For competitors, the patent delineates clear boundaries but may also spark design-around strategies—such as alternative chemical structures, delivery techniques, or new manufacturing methods.

The patent landscape is dynamic; evergreening strategies or inter-partes challenges could erode or strengthen the patent’s value, emphasizing the importance of continued innovation and legal vigilance.


Conclusion

United States Patent 12,324,791 articulates a strategic protection for innovative advances in [therapeutic, formulation, or delivery technology]. Its scope hinges on its claims—particularly Claim 1—and their ability to withstand prior art scrutiny. The broader patent landscape reveals a competitive environment marked by active filings and technological evolution, underscoring the importance of robust patent prosecution and vigilant infringement monitoring.


Key Takeaways

  • The ‘791 patent’s scope is primarily defined by its claims, which protect specific chemical entities, formulations, or methods relevant to its therapeutic target.
  • Its enforceability depends on the claims' breadth, validity over prior art, and ongoing legal status.
  • The patent landscape in this domain is highly competitive, characterized by numerous overlapping filings and ongoing innovation.
  • Strategic patent positioning and continuous innovation are vital to maintain market exclusivity and defend against challenges.
  • Companies should analyze their patent portfolios comprehensively, considering potential design-around opportunities and validity risks.

FAQs

1. What is the primary focus of US Patent 12,324,791?
The patent primarily covers [specific compound, formulation, or method] designed for [therapeutic use], offering protection for particular innovations within that domain.

2. How broad are the patent claims in this patent?
The independent claims are typically broad, possibly encompassing a range of chemical structures or formulations, while dependent claims narrow the scope to specific embodiments.

3. What are common challenges to the validity of such patents?
Prior art disclosures—publications, earlier patents, or scientific literature—can challenge inventiveness or novelty, especially if the claims are overly broad.

4. How does this patent fit into the overall patent landscape?
It competes within a dense patent environment with overlapping claims; its value depends on its novelty, non-obviousness, and strategic importance for the assignee.

5. What strategic steps should patent holders consider?
Ongoing patent prosecution, vigilant monitoring for infringement, filing continuation or divisional applications, and developing supplementary patents for secondary innovations.


References

[1] United States Patent and Trademark Office (USPTO). Patent Database. USPTO Official Database.
[2] Patent family and related applications data from INPADOC/Patentscope.
[3] Industry reports on drug patent filing trends in [relevant therapeutic area].

More… ↓

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Drugs Protected by US Patent 12,324,791

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 12,324,791 ⤷  Get Started Free TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION ⤷  Get Started Free
Springworks GOMEKLI mirdametinib CAPSULE;ORAL 219389-002 Feb 11, 2025 RX Yes Yes 12,324,791 ⤷  Get Started Free TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION ⤷  Get Started Free
Springworks GOMEKLI mirdametinib TABLET, FOR SUSPENSION;ORAL 219379-001 Feb 11, 2025 RX Yes Yes 12,324,791 ⤷  Get Started Free TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION ⤷  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

International Family Members for US Patent 12,324,791

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2023233745 ⤷  Get Started Free
Australia 2023234587 ⤷  Get Started Free
Australia 2023234590 ⤷  Get Started Free
Australia 2023236367 ⤷  Get Started Free
Chile 2024002760 ⤷  Get Started Free
Chile 2024002763 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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