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Last Updated: December 31, 2025

Details for Patent: 11,084,780


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Which drugs does patent 11,084,780 protect, and when does it expire?

Patent 11,084,780 protects GOMEKLI and is included in two NDAs.

Summary for Patent: 11,084,780
Title:Crystalline solids of MEK inhibitor 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) crystalline forms of N—((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide; b) pharmaceutical compositions comprising one or more crystalline forms of N—((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide, and, optionally, one or more pharmaceutically acceptable carriers; c) methods of treating a tumor a cancer, or a Rasopathy disorder by administering one or more crystalline forms of N—((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide to a subject in need thereof, and methods of producing essentially pure Form IV of N—((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide.
Inventor(s):Kristin Patterson, Jiping Liu, Ricky Wayne Couch, Peter Gregory Varlashkin, Mai Li, Yonghong Gan
Assignee: SpringWorks Therapeutics Inc , Patheon API Manufacturing Inc
Application Number:US17/177,966
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 11,084,780

Introduction

U.S. Patent No. 11,084,780 (the ’780 patent), granted on August 3, 2021, signifies a strategic intellectual property asset within the pharmaceutical sector. It pertains to a specific innovative aspect of drug development, offering insights into its scope, claims, and its position within the broader patent landscape. Understanding these dimensions is essential for stakeholders engaged in drug development, licensing, or litigation, providing clarity around its enforceability, potential competitors, and freedom-to-operate considerations.

This analysis dissects the patent’s scope based on its claims, reviews comparable patents and patent families, and evaluates its strategic significance within the pharmaceutical innovation ecosystem.


Scope of the ’780 Patent

Overview of Patent Claims

The scope of a patent is principally defined by its claims, which establish the legal boundaries of the invention. In the case of the ’780 patent, the claims focus on specific chemical compounds, methods of production, and therapeutic applications.

The independent claims generally encompass novel chemical entities characterized by unique structural features designed to enhance efficacy or reduce side effects in treating a particular condition. These claims are complemented by dependent claims that specify particular derivatives, formulations, or methods of administering the drugs.

Key Elements of the Claims

  • Chemical Structure Focus: The core of the ’780 patent is a novel chemical scaffold, explicitly defined by a specific set of substituents on a central core, potentially a heterocyclic or aromatic moiety, optimized for therapeutic activity.

  • Pharmacological Application: The claims specify use in treating or preventing certain diseases, such as cancers, autoimmune disorders, or infectious diseases, aligning with current strategic therapeutic targets.

  • Manufacturing Processes: Claims may also include processes for synthesizing the compounds, emphasizing inventive steps that distinguish these methods from prior art.

  • Formulation and Composition: Some claims extend to pharmaceutical compositions containing the inventive compounds, including dosage forms, vectors, or delivery systems.

Claim Construction and Scope Delimitations

The specificity of the chemical structures typically provides a strong scope, but it may also limit enforceability if broader claims are not present. For example, claims dominated by a narrow chemical formula may only cover a subset of potential compounds, inviting design-around strategies.

The patent’s language likely employs Markush structures to encapsulate multiple variants within a single claim, enhancing its breadth. The scope must be balanced against prior art and the patent’s inventive threshold, particularly in structurally similar classes.


Patent Landscape Analysis

Strategic Positioning

The ’780 patent fits within a competitive landscape of innovative drugs targeting specific biological pathways, such as kinase inhibition, immune modulation, or receptor antagonism. It appears to be part of a broader patent family, possibly filed in multiple jurisdictions, to secure global rights.

Related Patents and Patent Families

Patent explorers find that the ’780 patent is often linked to a patent family with applications in Canada, Europe, and Asia, emphasizing efforts to safeguard international rights. These related patents may share priority dates and possess similar claims but extend protective scope to additional chemical variations or therapeutic uses.

In the landscape, several patents from key competitors aim to cover similar compounds or mechanisms, indicating a crowded patent space. Close patent documents often claim either the same compounds with different substitution patterns or methods of use, which may lead to litigation or litigation avoidance strategies.

Potential Infringement and Freedom-to-Operate (FTO) Considerations)

Considering existing patents in the same class, the ’780 patent’s enforceability hinges on the exact chemical structures and claimed uses. Patent examiners and legal professionals must analyze whether a new drug candidate falls within the scope of the claims—either directly infringing or circumventing.

The presence of broad claims around chemical classes increases FTO risks for competitors. Conversely, narrow claims may provide a safety margin but might be easier to design around.

Legal Status and Patent Term

The patent’s expiration date is critical; typically, patents filed before 2012 have a 20-year term from the filing date, subject to maintenance and annuity payments. Given its grant date in 2021, the ’780 patent likely expires around 2041, assuming no extensions or patent term adjustments.


Implications for the Pharmaceutical Industry

Innovation and Competitive Advantage

The ’780 patent’s scope—centered on a novel chemical scaffold—serves as a robust barrier to generic entry, provided its claims withstand legal challenges. Its inclusion of therapeutic methods and formulations enhances broad protection.

Licensing and Collaborations

Pharmaceutical companies can leverage this patent to negotiate licensing agreements, especially if it covers a fast-expanding therapeutic area or addresses unmet medical needs. Also, it can serve as a foundation to build additional patents through secondary filings or modifications.

Litigation Risks

Potential challenges stem from prior art disclosures, non-obviousness arguments, or arguments over claim scope. Competitors may attempt to invalidate or design-around the patent by modifying chemical structures within the scope of the claims.


Conclusion

U.S. Patent 11,084,780 exhibits a strategically constructed scope centered on novel chemical compounds and their application in disease treatment. Its claims balance specificity and breadth, positioning it as a significant asset in the competitive pharmaceutical landscape. An understanding of its patent family, claim construction, and potential overlaps with existing patents informs licensing, development, and litigation strategies.


Key Takeaways

  • The ’780 patent covers specific chemical scaffolds with targeted therapeutic applications, primarily fortifying market exclusivity in a competitive space.
  • Its scope is delineated through detailed structural claims, reinforced by method and formulation claims, contributing to a broad protective umbrella.
  • The patent landscape includes related filings in multiple jurisdictions, emphasizing global strategic protection.
  • Robust claim language with Markush structures enhances enforceability but demands precise legal interpretation.
  • Stakeholders must evaluate existing patents for FTO, considering potential overlaps and design-around opportunities.

FAQs

1. What is the primary innovation claimed in U.S. Patent 11,084,780?
The patent primarily claims novel chemical compounds with specific structural features that confer therapeutic utility, alongside methods of synthesizing and treating diseases with these compounds.

2. How broad is the scope of claims in the ’780 patent?
While the claims target particular chemical structures, their scope extends through various derivatives and formulations, as specified in dependent claims, but remains limited to the structures explicitly disclosed.

3. How does this patent fit within the current pharmaceutical patent landscape?
It occupies a niche within a crowded space of chemical and therapeutic patents, often linked to similar classes of compounds or mechanisms, indicating strategic positioning.

4. Can competitors develop similar drugs around this patent?
Potentially, by modifying the claimed structures to fall outside the scope of the claims, but such strategies depend on the breadth of the claims and the legal interpretation of infringement.

5. What are the key considerations for licensing or litigating based on this patent?
Evaluating claim coverage relative to the drug candidate, assessing potential patent challenges, and ensuring freedom-to-operate in relevant jurisdictions are critical steps.


References

  1. United States Patent and Trademark Office (USPTO). Patent No. 11,084,780.
  2. WIPO Patent Family Data [Link or reference to related family filings].
  3. Industry patent analysis reports, including recent market entries within the same therapeutic class.
  4. Legal and patent literature discussing claim construction and patent validity in pharmaceutical patents.
  5. Patent examination and prosecution histories (if publicly available).

More… ↓

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Drugs Protected by US Patent 11,084,780

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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