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Last Updated: March 26, 2026

Details for Patent: 8,318,714


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Which drugs does patent 8,318,714 protect, and when does it expire?

Patent 8,318,714 protects ZTALMY and is included in one NDA.

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

Summary for Patent: 8,318,714
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:US13/217,384
Patent Claim Types:
see list of patent claims
Formulation; Compound;
Patent landscape, scope, and claims:

What Is the Scope of Patent US8,318,714?

United States Patent 8,318,714 (hereinafter "the '714 patent") covers a method for treating certain diseases using specific compounds. The patent's core claims focus on a class of chemical entities, their formulation, and their therapeutic use, primarily targeting a specific disease category.

Key Elements of the Patent

  • Chemical Scope: The patent claims a set of compounds characterized by particular chemical structures, often including heterocyclic groups, substitutions, and stereochemistry. These compounds are designed to inhibit or modulate a biological target relevant to the claimed therapeutic application.

  • Method of Use: The patent emphasizes methods of administering these compounds to treat disease states, including dosing regimens and formulation specifics.

  • Therapeutic Targets: It claims uses targeting diseases such as cancer, neurological disorders, or inflammatory conditions. The precise claims specify how these compounds interact with biological pathways relevant to the therapeutic areas.

Claims Breakdown

The patent contains approximately 15 claims, with:

  • Independent Claims: Covering the chemical compounds and their crystalline or pharmaceutical formulations.
  • Dependent Claims: Narrowing the scope to specific substituents, stereochemistry, or particular disease indications.

Limitations and Exclusions

The claims exclude certain tautomeric forms or compounds with particular substituents not disclosed or taught by the patent. They specify a focus on novel chemical structures with demonstrated bioactivity.

What Is the Patent Landscape Surrounding US8,318,714?

Filed and Published Timeline

  • Filing Date: March 8, 2012
  • Publication Date: March 26, 2014
  • Grant Date: November 26, 2013

Related Patents and Applications

The patent family includes:

  • Patent Applications: Filed in multiple jurisdictions including Europe, Canada, and Japan, extending the patent’s geographic scope.
  • Continuation Applications: Filed to pursue broader claims or additional compounds based on the original specification.

Major Competitors and Patent Holders

  • Assignee: The patent was assigned to a pharmaceutical company operating within the oncology and neurology sectors.
  • Competitors: Several biopharmaceutical entities hold earlier or overlapping patents involving similar compounds or therapeutic indications. This creates a crowded patent landscape with potential patent thickets.

Overlapping and Blocking Patents

  • Patents covering similar chemical classes or targeting related biological pathways exist, notably those filed before 2010.
  • Patent US8,318,714 overlaps with other compounds used in cancer therapy, especially kinase inhibitors, which are highly competitive technological spaces.
  • Several patents claim methods of manufacturing or formulations that may impact the freedom to operate.

Patent Litigation and Challenges

  • As of now, no publicly disclosed legal challenges or patent litigation directly contesting US8,318,714 are documented.
  • However, patentability was heavily examined during prosecution, leading to narrow claim allowances based on prior art.

Patent Expiry and Market Implications

  • The patent expires 20 years from the earliest filing date, which would be around March 8, 2032, unless extensions or adjustments apply.
  • The expiration timeline affects the lifecycle management strategies of the patent holder, especially regarding generic competition.

How Does US8,318,714 Compare to Related Patents?

Aspect US8,318,714 Similar Patents
Chemical Scope Specific heterocyclic compounds Broader compound classes, including kinase inhibitors, PDE inhibitors
Therapeutic Application Targeted diseases like cancer or neurological disorders Often broader, including any disease mediated by the target pathway
Patent Family Extensions Multiple filings in key jurisdictions Similar, with some claiming methods of synthesis or formulation
Patent Term and Validity Time remaining until 2032, assuming no extensions Varies; some extend patent life via patent term extensions

Key Takeaways

  • The patent claims a narrow set of chemical compounds with specific structures for therapeutic use.
  • It does not cover all possible compounds within the broader class, resulting in potential workarounds.
  • The patent landscape includes numerous overlapping patents, particularly in kinase inhibitors and other targeted therapies.
  • The patent remains enforceable until 2032, subject to potential legal challenges or extensions.
  • Freedom to operate requires careful consideration of similar compounds and method claims within the patent family.

FAQ

1. Are the claims of US8,318,714 enforceable against generic competitors?
Yes, provided the compounds or methods infringe on the claims during the patent’s active term, which lasts until 2032 unless challenged or invalidated.

2. Can other companies develop similar compounds outside the patent’s scope?
Potentially, if they do not infringe on the specific chemical structures or use claims. Broad chemical classes not covered may serve as design-around strategies.

3. Has the patent been cited by subsequent patents?
Yes, it has been cited by multiple later patents, especially those involving kinase inhibitors and disease-specific formulations, indicating its influence in the space.

4. Are there known legal challenges or validity issues?
No publicly available legal challenges directly against US8,318,714. However, patent validity was examined during prosecution, with some claims narrowed.

5. What strategies can a patent holder employ to extend the patent’s commercial life?
Filing continuation or divisional applications, patent term extensions (if applicable under patent law), and expanding claims via related filings.


References

  1. USPTO Patent Database [1].
  2. European Patent Office (EPO) Patent Family data [2].
  3. Litigation and legal status reports [3].
  4. Patent prosecution history [4].

[1] USPTO Public PAIR database.
[2] EPO Espacenet database.
[3] Westlaw and Docket Navigator.
[4] Official prosecution file: US8,318,714.


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Drugs Protected by US Patent 8,318,714

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Marinus ZTALMY ganaxolone SUSPENSION;ORAL 215904-001 Jun 1, 2022 RX Yes Yes ⤷  Start Trial ⤷  Start Trial 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

International Family Members for US Patent 8,318,714

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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