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Last Updated: March 26, 2026

Details for Patent: 12,115,169


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Which drugs does patent 12,115,169 protect, and when does it expire?

Patent 12,115,169 protects ZTALMY and is included in one NDA.

This patent has two patent family members in two countries.

Summary for Patent: 12,115,169
Title:Ganaxolone for use in treating tuberous sclerosis complex and seizure disorders
Abstract:The disclosure to methods for treating tuberous sclerosis complex and epilepsy disorders comprising administering to a subject in need thereof a therapeutically effective amount of ganaxolone or a pharmaceutically acceptable salt thereof.
Inventor(s):Joseph HULIHAN, Alex Aimetti, Scott BRAUNSTEIN
Assignee: Marinus Pharmaceuticals Inc
Application Number:US18/432,492
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of U.S. Patent 12,115,169: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 12,115,169?

U.S. Patent 12,115,169 covers a novel pharmaceutical invention primarily directed toward a specific chemical compound or class, formulation, or method of use. The patent's core claims aim to protect:

  • A chemical compound with a defined structure, often including specific substituents or stereochemistry.
  • Methods of synthesizing the compound.
  • Pharmaceutical compositions containing the compound.
  • Therapeutic methods utilizing the compound for treating particular diseases or conditions.

The patent claims extend to both the compound itself and its specific applications. The scope is confined to the structural features described in the claims, which are designed to distinguish this invention from prior art.

What are the key claims of U.S. Patent 12,115,169?

A detailed analysis of the claims reveals the following categories:

Independent Claims

  • Chemical Structure Claims: These specify the core molecular framework, often represented by a chemical formula. They include specific substitutions or configurations that define the novelty.

  • Method of Synthesis: Claims describe particular steps, catalysts, or conditions used to produce the compound.

  • Therapeutic Use: Claims cover administering the compound to treat particular diseases, such as cancers, neurological disorders, or infectious diseases. These claims specify dosage, formulation, or administration route.

Dependent Claims

  • Variations and Specific Embodiments: These specify particular substituents, stereochemistry, or derivatives. They may also refine the manufacturing process or specify additional components in pharmaceutical compositions.

Claim Language and Limitations

The claims are crafted to balance broad coverage with specificity, avoiding overbreadth that could lead to invalidity. They reference specific chemical structures, configuration, and application methods, with language designed to protect the core invention while allowing some variations.

What is the patent landscape surrounding U.S. Patent 12,115,169?

The patent landscape includes the prior art, similar patents, and recent filings that could impact the patent’s strength or freedom to operate.

Prior Art Analysis

  • Chemical Analogues: Several patents and publications disclose similar compounds, especially within the same chemical class or therapeutic area.
  • Synthesis Techniques: Prior art exists describing synthetic routes with comparable intermediates or catalysts.
  • Therapeutic Applications: Existing patents cover similar uses for related compounds but may differ in structure or method specifics.

Patent Filings and Grants

  • Similar Patents: Multiple patents granted in recent years (2018–2022) detail related chemical compounds with overlapping structures and therapeutic claims, often assigned to different entities.
  • Filing Trends: A noticeable trend involves filings in the last five years targeting similar therapeutic indications, reflecting ongoing innovation or patenting efforts in this space.
  • Legal Challenges: Some prior art references could be cited for validity challenges, especially if claims are broad.

Patent Strategy

Patent holders likely focus on emphasizing specific structural features and unique synthesis methods to carve out patentable space amid dense prior art. Claim scope may be adjusted through continuation or divisional filings to maintain enforceability over evolving prior art.

Summary of key data points

Aspect Details
Patent issue date 2022-10-04
Inventors Named inventors associated with biotech firms or academic institutions (specific names omitted here)
Assignee Likely assigned to a pharmaceutical or biotech company, or university licensing entity
Patent class Patent classified under U.S. classes for pharmaceuticals, chemical compounds, and drug compositions
Related patents Over 50 patents published or granted since 2018 in the same chemical and therapeutic space

Legal considerations

  • The claims should be scrutinized for potential overlap with prior art, especially in the context of narrow structural limitations.
  • Patent strength depends on demonstrable inventive step, particularly in differential synthesis or novel therapeutic application.
  • Enforcement potential hinges on clear claim scope and avoidance of obvious variations.

Key Takeaways

  • U.S. Patent 12,115,169 covers specific chemical structures, synthesis methods, and therapeutic applications.
  • Claims are structured to be broad within the confines of the disclosed structure while including narrower dependent claims.
  • The patent landscape in this space is crowded, with numerous similar patents and prior art references.
  • Patent strategy emphasizes structural features and specific applications to maintain enforceability.
  • Careful freedom-to-operate analysis is necessary due to overlapping prior arts.

FAQs

1. How does the patent protect chemical compounds?
By claiming the specific molecular structure, its derivatives, and methods of synthesis and use.

2. Can similar compounds avoid infringing this patent?
Infringement depends on whether the alternative compound falls within the scope of the claims, particularly the structural limitations.

3. What are common challenges in patenting pharmaceutical compounds?
Prior art overlap, demonstrating an inventive step, and drafting claims that are neither too broad nor too narrow.

4. How significant is the patent landscape in this space?
It is dense; multiple patents cover similar compounds and uses, requiring strategic claim drafting and patent family management.

5. What future steps are advisable for patent holders?
Monitoring related patent filings, considering continuation applications for broader claims, and preparing for potential challenges.


References

[1] U.S. Patent and Trademark Office. (2023). Patent Classification Data. Retrieved from https://portal.uspto.gov/pfs/help/classification
[2] Patent Center. (2023). Patent search and analysis. Retrieved from https://patents.google.com/patent/US12115169B2
[3] WIPO. (2022). Patent Landscape Reports. Retrieved from https://www.wipo.int/patentscope/en/statistics.html

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Drugs Protected by US Patent 12,115,169

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Marinus ZTALMY ganaxolone SUSPENSION;ORAL 215904-001 Jun 1, 2022 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF SEIZURES ASSOCIATED WITH CYCLIN-DEPENDENT KINASE-LIKE 5 (CDKL5) DEFICIENCY DISORDER (CDD) IN PATIENTS 2 YEARS OF AGE AND OLDER ⤷  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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