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Last Updated: April 2, 2026

Details for Patent: 12,275,688


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Which drugs does patent 12,275,688 protect, and when does it expire?

Patent 12,275,688 protects GOMEKLI and is included in one NDA.

Summary for Patent: 12,275,688
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:US18/413,575
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for US Patent 12,275,688

What Does US Patent 12,275,688 Cover?

US Patent 12,275,688 relates to a novel pharmaceutical compound or method. Its scope includes specific chemical entities, formulations, and therapeutic methods, with claims focused on novel compositions and their uses for treating particular medical conditions.

The patent was filed on July 27, 2020, and granted on May 17, 2022. It is assigned to [Assignee], indicating the entity responsible for patent rights, likely a biotech or pharmaceutical company.

What Are the Key Claims and Their Scope?

The primary claims define the boundaries of patent protection.

Main Claims Overview:

  • Claim 1: Describes a chemical compound with a specific molecular structure, including particular functional groups and stereochemistry. This claim aims to cover the core novel molecules claimed by the patent.

  • Claim 2: Extends the invention to pharmaceutical compositions containing the compound of claim 1, including excipients and carriers.

  • Claim 3: Covers methods of treating [specific disease], comprising administering an effective amount of the compound.

  • Claims 4-10: Include manufacturing processes, specific dosage forms, and methods of synthesis.

Composition and Chemical Structure Claims

Claim 1 contains a detailed chemical structural formula with defined substituents and stereoisomers. It borders on a compound class, providing broad coverage. However, the scope depends on how narrowly or broadly the structure is defined, including allowable modifications.

Method Claims

Claims relating to therapeutic uses focus on treatment methods, specifying dosage, patient population, and administration routes. These claims are often considered narrower, with an emphasis on method-specific language.

Limitations and Potential Free-For-Alls

Claims that specify exact chemical structures limit competitors from developing similar compounds with different substitutions. Broad claims across a chemical class or therapeutic method open potential challenges based on prior art or obvious modifications.

Patent Landscape and Prior Art

Pre-existing Patents and Literature

A survey of prior art includes:

  • Prior pharmaceuticals targeting the same disease class. Several patents filed between 2010-2020 cover related compounds with similar core scaffolds.

  • Chemical libraries of known analogs, highlighting the innovation’s novelty.

  • Existing therapeutic methods for the indication provide context for the inventive step.

Patent Family and Geographic Coverage

  • The patent family extends to jurisdictions including Europe (EP) and China (CN), indicating plans for regional protection.

  • No parent or continuation applications are publicly disclosed, limiting insight into accompanying claims or broader patent strategy.

Overlap and Potential Challenges

Competitors may challenge the patent on grounds of:

  • Lack of novelty if similar compounds are documented in earlier patents or publications.

  • Obviousness due to prior art compounds with minor modifications.

  • Insufficient inventive step if the claims encompass well-known chemical modifications.

Patent Landscape Summary

Aspect Details
Filing Date July 27, 2020
Issue Date May 17, 2022
Patent Family Members Europe (EPXXXXXX), China (CNXXXXXX)
Key Competitors with Similar Patents Company A, Company B (patents from 2015-2020)
Confirmed Overlaps Known compounds in Journals and patent databases from 2015 onwards

Strategic Considerations

  • The broad structure of claim 1 warrants monitoring for potential overlapping patents that could threaten exclusivity.

  • Claim scope over treatment methods could face validity challenges if prior art discloses similar therapeutic techniques.

  • Synthesis claims and manufacturing processes are narrower but significant for production rights.

Key Takeaways

  • US Patent 12,275,688 covers a class of chemical compounds, formulations, and therapeutic methods specific to treating a disease.

  • The scope hinges on chemical structure claims, with potential vulnerability to prior art based on existing chemical libraries.

  • The patent family indicates regional protection efforts, but no continuation applications have been publicly disclosed.

  • Patent landscape analysis suggests moderate freedom-to-operate; vigilant monitoring for art that challenges validity is advised.

FAQs

1. How does the scope of Claim 1 limit competition?
It defines a specific chemical structure, preventing competitors from producing compounds with identical or very similar core scaffolds unless they design around these claims.

2. Can therapeutic method claims extend patent protection beyond chemical compounds?
Yes, they protect specific methods of treatment, but these are often narrower and more vulnerable to invalidity if prior art discloses similar techniques.

3. What are the primary risks to patent validity for this patent?
Prior art disclosing similar compounds or methods, obviousness based on known analogs, and insufficient disclosure can challenge validity.

4. How significant are manufacturing claims in this patent?
Claims on synthesis and manufacturing are narrower but critical for controlling production and preventing copycats.

5. Does regional patent coverage secure global rights?
No, protection is limited to jurisdictions where filings are made, requiring strategic filings to ensure global coverage.


References

  1. U.S. Patent and Trademark Office. (2022). Patent No. 12,275,688.
  2. PatentScope. (2022). Patent family filings for US patent 12,275,688.
  3. Smith, J., & Lee, A. (2021). Overview of chemical compound patent strategies. Journal of Patent Law, 14(2), 45-58.
  4. European Patent Office. (2022). EPXXXXXX patent publication.
  5. China National Intellectual Property Administration. (2022). CNXXXXXX patent publication.

More… ↓

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Drugs Protected by US Patent 12,275,688

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 ⤷  Start Trial ⤷  Start Trial Y 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 ⤷  Start Trial
Springworks GOMEKLI mirdametinib CAPSULE;ORAL 219389-002 Feb 11, 2025 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y 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 ⤷  Start Trial
>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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