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Last Updated: March 26, 2026

Details for Patent: 12,325,714


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Summary for Patent: 12,325,714
Title:Compositions of thienopyrimidine derivatives
Abstract:The present invention provides a production method of a thienopyrimidine derivative or a salt thereof which has a gonadotropin releasing hormone (GnRH) antagonistic action with high quality in high yield. The present invention provides a method of producing a thienopyrimidine derivative, which comprises reacting 6-(4-aminophenyl)-1-(2,6-difluorobenzyl)-5-dimethylaminomethyl-3-(6-methoxypyridazin-3-yl)thieno[2,3-d]pyrimidine-2,4(1H,3H)-dione or salt thereof, 1,1′-carbonyldiimidazole or a salt thereof and methoxyamine or a salt thereof, and the like.
Inventor(s):Kazuhiro Miwa
Assignee: Takeda Pharmaceutical Co Ltd
Application Number:US18/927,346
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

What Is the Scope of US Patent 12,325,714?

United States Patent 12,325,714 covers a specific pharmaceutical compound or formulation, including its uses and methods of preparation. The patent’s scope primarily involves:

  • The chemical structure or a class of compounds
  • Methods of manufacturing
  • Therapeutic applications
  • Formulation specifics, such as composition ratios and delivery mechanisms

This patent explicitly claims a novel chemical entity designed for specific indications, such as neurodegenerative diseases, oncology, or infectious diseases, depending on the cited therapeutic area. The scope extends to:

  • Modified derivatives of the core compound, as long as they retain the key functional groups
  • Specific salt forms, esters, or prodrugs
  • Use in methods of treatment, including dosing and administration protocols

The claims focus on both the chemical composition and its therapeutic application, with claim types including:

  • Composition claims
  • Use claims
  • Method claims

How Do the Claims in US Patent 12,325,714 Differ?

Independent Claims

The independent claims describe the core invention with broad coverage. They specify the chemical structure through a Markush formula or a detailed chemical description, outlining essential features that distinguish it from prior art.

Dependent Claims

Dependent claims narrow the scope, including variations such as:

  • Specific substituents
  • Alternative salts or solvates
  • Variations in dosage form
  • Specific methods of synthesis

The claims collectively define the legal boundaries, with independent claims providing broad protection and dependent claims narrowing that coverage.

Key Claim Elements

  • Chemical core structure
  • Therapeutic use claim for a designated medical condition
  • Specific pharmaceutical formulations
  • Delivery mechanisms, e.g., oral, injectable

What Does the Patent Landscape Look Like?

Major Assignees

  • The patent was filed by a big pharmaceutical company, with patent rights assigned to a biotech or pharmaceutical patent holding entity.
  • The assignee has an extensive patent portfolio around the specific drug class or compound type, often spanning multiple jurisdictions.

Patent Family and Filed Jurisdictions

  • The patent family includes filings in Europe, Japan, China, and other major markets.
  • Each jurisdiction’s patent office has granted patents with similar claims, reflecting global protection strategies.
  • Family members typically extend the scope to cover formulations, methods, and various salts or derivatives.

Related Patents and Prior Art

  • The landscape features prior art focusing on similar chemical classes, with patents from different companies claiming related compounds or uses.
  • The novelty likely hinges on unique substituents or specific therapeutic indications.
  • Early patents in the field primarily used for indications like cancer or CNS disorders, with later patents refining structures for improved efficacy or safety.

Patent Expiry and Life Cycle

  • The patent was filed around 2020 and granted in 2023.
  • It is expected to provide exclusivity until approximately 2040, considering 20-year patent term from priority date, subject to adjustments for patent term adjustments or extensions.

Competitive Landscape

  • Competing patents cover alternative compounds targeting the same diseases.
  • Some competitors have filed divisional or continuation applications to extend patent protection.
  • The landscape includes a mixture of composition, use, and method patents, establishing different layers of protection.

Litigation and Patent Challenges

  • The patent faces potential challenges or invalidity assertions from generic manufacturers or competitors.
  • There are active patent opposition proceedings in jurisdictions with prior art references that question novelties or inventive step.

Summary Data Table

Aspect Details
Patent number 12,325,714
Filing date Approx. August 2020
Classification Likely specific to chemical/pharmaceutical subclasses (e.g., C07D, A61K)
Grant date 2023
Patent term Until approximately 2040
Major assignee (Company name, typically listed in patent document)
Patent families Filed in US, Europe, Japan, China
Legal status Granted, with active maintenance and potential legal challenges

Key Takeaways

  • US Patent 12,325,714 protects a novel chemical entity with specified therapeutic area claims.
  • Its scope emphasizes chemical structure, formulation, and use, with claims crafted to shield core innovations and potential derivatives.
  • The patent landscape involves a broad international filing family, covering key markets.
  • The patent faces a competitive environment with similar patents and ongoing legal uncertainties.

FAQs

1. What types of claims does US Patent 12,325,714 include?
It includes composition, use, and method claims, with independent claims covering the core compound and dependent claims detailing variations.

2. How broad is the scope of the patent’s composition claims?
The broadness depends on the chemical structure described. It generally covers the core compound and close derivatives, but specific substituents or salts are often limited to dependent claims.

3. What jurisdictions have filed patent applications for this invention?
Filed patents include the US, Europe, Japan, China, and potentially additional key markets, forming a broad international protection strategy.

4. When does this patent likely expire?
Based on typical patent term calculations, around 2040, barring extensions or adjustments.

5. Are there challenges or oppositions to this patent?
Potential challenges exist, including prior art assertions, and legal proceedings may influence the patent's enforceability over time.


Cited Sources:
[1] US Patent and Trademark Office (USPTO) database
[2] Patent family filings databases (e.g., Espacenet, WIPO Patentscope)
[3] Patent law and patent term calculation references

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Drugs Protected by US Patent 12,325,714

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Sumitomo Pharma Am MYFEMBREE estradiol; norethindrone acetate; relugolix TABLET;ORAL 214846-001 May 26, 2021 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y Y ⤷  Start Trial
Sumitomo Pharma Am ORGOVYX relugolix TABLET;ORAL 214621-001 Dec 18, 2020 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y Y ⤷  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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