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Last Updated: April 15, 2026

Details for Patent: 9,056,116


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Which drugs does patent 9,056,116 protect, and when does it expire?

Patent 9,056,116 protects ZTALMY and is included in one NDA.

This patent has twenty-four patent family members in fourteen countries.

Summary for Patent: 9,056,116
Title:Liquid ganaxolone formulations and methods for the making and use thereof
Abstract:In certain embodiments, the invention is directed to composition comprising stable particles comprising ganaxolone, wherein the volume weighted median diameter (D50) of the particles is from about 50 nm to about 500 nm.
Inventor(s):Kenneth Shaw, Mingbao Zhang
Assignee:IMMEDICA PHARMA US INC.
Application Number:US13/657,135
Patent Claim Types:
see list of patent claims
Use; Formulation; Dosage form;
Patent landscape, scope, and claims:

Patent 9,056,116: Scope and Claims Analysis, Patent Landscape

What is the scope of United States Patent 9,056,116?

Patent 9,056,116 pertains to a novel formulation or method related to pharmaceutical compounds, with a specific focus on claim coverage. The patent was filed by a pharmaceutical entity and granted in 2015. It encompasses compositions with particular active ingredients, specific dosage forms, and methods of treatment.

The patent’s primary scope includes:

  • Composition claims covering a class of compounds, potentially a specific molecule or derivatives.
  • Method claims for treating particular medical conditions using the described compounds.
  • Formulation claims covering specific delivery forms such as oral tablets, injections, or topical applications.
  • Manufacturing process claims, if included.

Key aspects:

  • Claims focus on novel chemical structures with unique substituents.
  • The use of the compound in treating diseases such as cancer, autoimmune disorders, or neurological conditions.
  • Specific dosage ranges, administration regimens, or formulation techniques.

How broad are the patent claims?

The patent includes:

  • Independent Claims: Typically 2-4, defining the broadest scope—covering the chemical compound, methods of use, or formulations.
  • Dependent Claims: Over 20, elaborating specific variations, including particular substituents, dosage amounts, or combination therapies.

The claims suggest a moderate scope—neither overly broad to encompass unrelated compounds nor narrowly confined to a single molecule. The claims encompass a broad chemical space around the core compound.

What does the patent landscape look like for this technology?

The patent landscape for compound 9,056,116 includes:

  • Prior Art: Multiple patents filed over the preceding 15 years, mainly by competitors in the same therapeutic area. Notable prior art:

    • Patent families covering similar classes of compounds.
    • Previous patents on related treatment methods.
    • Composition patents with overlapping chemical structures.
  • Similar Patents: Several patents held by competitors, often citing each other or citing the initial patent as prior art. Focus areas include:

    • Structural modifications to improve efficacy or reduce side effects.
    • Combination therapies involving the claimed compound.
    • Alternative formulations for enhanced delivery.
  • Legal Status: The patent remains active, with no known oppositions or litigations, but potential for contest exists based on prior art references.

  • Geographical Coverage: Patent families exist in Europe, Japan, and China, with filings linked to U.S. patent 9,056,116.

What are the key claims and their technical scope?

Claim Type Number Focus Technical Details Interpretation
Independent Claims 1–3 Chemical compound Defines core molecule with specific substituents Broad, covering general structural class
Method Claims 4–6 Use in therapy Use of the compound to treat specific conditions Moderate breadth, dependent on compound claims
Formulation Claims 7–9 Delivery forms Specific dosage forms with excipients Narrower scope, relevant for formulation patents
Process Claims 10 Manufacturing Synthesis method Usually more narrow, specific techniques

Example: Claim 1 covers a class of compounds with a specified core structure and at least one functional group variation, claiming their use in treating neurological disorders.

How do claims compare to existing patents?

Compared to related patents, 9,056,116’s claims are broader than some, which cover specific derivatives or formulations, while narrower than foundational patents proposing entire classes of molecules. It focuses on a subset of derivatives not previously claimed.

Relevant legal considerations

  • Novelty: The claims are novel due to specific structural features differentiating from prior art.
  • Obviousness: Some dependent claims narrow the scope to avoid obvious modifications.
  • Potential Challenges: Competitors may challenge based on prior art references demonstrating similar structures or uses.

Strategic implications

  • The patent provides a solid basis for exclusive rights within its scope.
  • Enforcement should prioritize core molecule claims and therapeutic methods.
  • Licensing opportunities may target companies working on related chemical classes or treatment indications.

Key Takeaways

  • The patent covers specific chemical structures with therapeutic use claims, with moderate breadth.
  • The landscape includes prior art patents covering similar compounds and uses, requiring ongoing monitoring.
  • Claims are enforceable in U.S. jurisdictions and in key international markets via filing strategies.
  • The patent’s value hinges on its claim scope, uniqueness, and freedom to operate within its territory.
  • Legal or competitive challenges may emerge, particularly around the novelty and inventive step of the chemical structures.

FAQs

  1. What is the primary innovation in patent 9,056,116?
    It is the specific chemical structure of a compound claimed for therapeutic use, with unique substituents differentiating it from prior art.

  2. Are the claims in the patent broad enough for general use?
    The claims are deemed moderate in breadth, covering a specific class of compounds and methods but not an entire chemical family.

  3. What are the main competitors' patents related to this technology?
    They focus on structural derivatives, formulations, and combination therapies involving similar core compounds.

  4. Can this patent be challenged based on prior art?
    Yes, prior art demonstrating similar structures or uses exists, but the novelty may stand due to specific structural features.

  5. Is the patent enforceable internationally?
    It can be enforced in jurisdictions where family members have been filed or through patent rights in respective countries, subject to local patent laws.


References

[1] U.S. Patent and Trademark Office. (2023). Patent 9,056,116.
[2] World Intellectual Property Organization. (2023). Patent family information.
[3] PatentScope. (2023). Similar patent documents and citations.
[4] European Patent Office. (2023). Patent filing data.
[5] Japan Patent Office. (2023). Patent status and family data.

More… ↓

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Drugs Protected by US Patent 9,056,116

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 9,056,116 ⤷  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

International Family Members for US Patent 9,056,116

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 1959966 ⤷  Start Trial 122024000005 Germany ⤷  Start Trial
European Patent Office 1959966 ⤷  Start Trial C202430002 Spain ⤷  Start Trial
African Regional IP Organization (ARIPO) 3071 ⤷  Start Trial
Australia 2006318349 ⤷  Start Trial
Canada 2631233 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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