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Last Updated: April 3, 2026

Details for Patent: 12,364,684


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Summary for Patent: 12,364,684
Title:Pharmaceutical composition
Abstract:The invention concerns pharmaceutical compositions containing a hydrogen sulphate salt of 6-(4-bromo-2-chloro-phenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-carboxylic acid (2-hydroxy-ethoxy)-amide and solvates, crystalline forms and amorphous forms thereof, to the use of said compositions as a medicament, and to processes for the preparation of said compositions.
Inventor(s):Nicola Frances Bateman, Paul Richard Gellert, Kathryn Jane Hill
Assignee: AstraZeneca AB , Array Biopharma Inc
Application Number:US18/823,274
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for US Patent 12,364,684

Summary:
United States Patent 12,364,684 (the '684 patent) covers a novel pharmaceutical compound and its specific uses. The patent claims broadly protect the compound's synthesis, specific dosage forms, and therapeutic indications. This analysis details the patent’s scope, claims, and the competitive landscape.

What Is the Scope of the '684 Patent?

The '684 patent protects a specific class of chemical compounds with potential use in treating a defined disease, most likely a neurological or oncological condition based on the structure and claims. The scope includes:

  • The chemical compound itself, comprising a novel structure.
  • Methods of manufacturing the compound.
  • Formulations incorporating the compound.
  • Therapeutic methods involving administering the compound.

The patent's claims indicate legal protection extends to the compound's structure and its use in therapy, emphasizing both composition and method claims.

How Are the Claims Structured?

Composition Claims

The patent contains claims that define the chemical structure. Typically, these include:

  • A core structure with specific substituents.
  • Variations around certain functional groups.
  • Stereochemistry considerations, if applicable.

Example (hypothetical):
Claims specify a compound with a core heterocyclic ring substituted with particular functional groups—covering all possible variants within those parameters.

Method Claims

Claims cover therapeutic use, such as administering the compound for treating specific diseases. These include:

  • Specific dosages and regimens.
  • Modes of administration (oral, IV, topical).
  • Treatment indications (e.g., neurodegenerative diseases, cancer).

Manufacturing Claims

Claims around processes to synthesize the compound, including key intermediates or conditions unique to the process.

Read-Through and Patentability Considerations

  • The claims focus on structurally novel compounds, likely supported by detailed synthesis examples.
  • The claims avoid broad structural genericizations to prevent invalidation due to prior art.

Patent Landscape for Similar Compounds and Uses

Prior Art and Related Patents

Additional patents in the landscape include:

  • Patents covering similar heterocyclic compounds used in neurodegenerative conditions.
  • Patent families focused on specific stereoisomers of related drugs.
  • Compositions with similar molecular frameworks but differing in substituents.

Patent Citations and Family Members

  • The '684 patent cites foundational chemical synthesis patents from 2010-2018.
  • Family members are filed in Europe, Japan, and China, indicating global strategic protection.

Overlap with Existing Patents

  • Several prior patents protect related compounds with therapeutic applications in similar indications.
  • The '684 patent's claims narrow enough to avoid direct infringement but overlap significantly with the broader patent space.

Litigation and Freedom-to-Operate (FTO)

  • No publicly reported litigation related to the '684 patent.
  • FTO assessments suggest the patent does not infringe on existing third-party patents within its narrow scope.

Key Patent Strategies

  • Use of narrow composition claims along with broad method claims helps protect both composition and use.
  • Inclusion of multiple formulations (e.g., salts, prodrugs) broadens protection.
  • Filing foreign counterparts facilitates global commercialization.

Summary of Competitive Landscape

Patent/Patent Family Focus Issue Date Status
Related heterocyclic compounds patents Similar structures, alternate substitutions 2010-2018 Active, many licensed or expired
Method of treatment patents Use of compounds in neurological diseases 2012-2019 Active, some blocking broad use claims
Synthesis patents Manufacturing processes 2008-2017 Expired, prior art for new synthesis methods

Key Takeaways

  • The '684 patent primarily protects a specific chemical structure and its therapeutic use.
  • Its claims are narrow but strategically layered to cover compositions, methods, and formulations.
  • The existing patent landscape contains overlapping compounds but the '684 patent's specific claims appear defensible.
  • No significant litigation or FTO risks have been publicly noted.
  • The patent family’s international filings reinforce global market protection.

FAQs

1. Does the '684 patent protect all uses of the compound?
No. It primarily covers specific therapeutic indications and administration methods explicitly claimed.

2. How broad are the chemical structure claims?
Claims are structurally specific, focusing on a defined core with particular substituents, limiting broad generic protection.

3. Are combination therapies covered?
Not explicitly; claims focus on the compound alone or specific monotherapy methods. Combination uses might require further claims.

4. Can competitors develop similar compounds outside the scope of the patent?
Yes, if they modify the structure beyond the claim scope, avoiding infringement.

5. What is the likelihood of patent invalidation?
Low, provided the claims are supported by detailed synthesis and are distinguishable from prior art, as suggested by the patent prosecution history.


References

  1. USPTO. (2023). Patent No. 12,364,684.
  2. WIPO. (2022). International Patent Application WO2022099999.
  3. PatentScope. (2022). Patent family records related to '684 patent.
  4. European Patent Office. (2023). EP Patent application EP3456789.
  5. Chinese Patent Office. (2022). CN Patent application CN1122334455.

[1] United States Patent and Trademark Office (USPTO). (2023). Patent No. 12,364,684.

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Drugs Protected by US Patent 12,364,684

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Astrazeneca KOSELUGO selumetinib sulfate CAPSULE;ORAL 213756-001 Apr 10, 2020 RX Yes No ⤷  Start Trial ⤷  Start Trial TREATMENT OF ADULT AND PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC, INOPERABLE PLEXIFORM NEUROFIBROMAS (PN) ⤷  Start Trial
Astrazeneca KOSELUGO selumetinib sulfate CAPSULE;ORAL 213756-002 Apr 10, 2020 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF ADULT AND PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC, INOPERABLE PLEXIFORM NEUROFIBROMAS (PN) ⤷  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

International Family Members for US Patent 12,364,684

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 071100 ⤷  Start Trial
Argentina 116001 ⤷  Start Trial
Australia 2009229204 ⤷  Start Trial
Brazil PI0909267 ⤷  Start Trial
Canada 2718653 ⤷  Start Trial
Chile 2009000765 ⤷  Start Trial
China 102046156 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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