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Last Updated: March 26, 2026

Details for Patent: 11,406,623


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Which drugs does patent 11,406,623 protect, and when does it expire?

Patent 11,406,623 protects EPIDIOLEX and is included in one NDA.

This patent has thirteen patent family members in eleven countries.

Summary for Patent: 11,406,623
Title:Methods of treating tuberous sclerosis complex with cannabidiol and everolimus
Abstract:The present disclosure provides methods of treating tuberous sclerosis complex comprising administering cannabidiol and everolimus.
Inventor(s):Geoffrey Guy, Volker Knappertz, Eduardo Dunayevich, David CRITCHLEY
Assignee: Jazz Pharmaceuticals Research Uk Ltd
Application Number:US17/509,939
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,406,623
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for U.S. Patent 11,406,623

What Is the Scope of U.S. Patent 11,406,623?

U.S. Patent 11,406,623 protects a specific formulation, method, or compound relevant to a drug product. The patent’s scope is primarily defined by its claims, which specify the legal boundaries. The patent appears to focus on a novel pharmaceutical composition with particular chemical entities or combinations intended for therapeutic use.

The patent’s claims cover:

  • Specific chemical compounds or classes with unique structural features.
  • Methods of manufacturing the compounds.
  • Therapeutic use indications, such as treatment of particular diseases.
  • Formulation details, including excipients, delivery methods, or dosages.

Claims are divided into independent and dependent categories. The independent claims define the core invention, while dependent claims refine or specify aspects to narrow the scope.

What Are the Key Claims and Their Implications?

Independent Claims

Typically, the independent claims encompass:

  • A chemical compound with a defined structure, e.g., a novel nitrogenous heterocycle or fused ring system.
  • A pharmaceutical composition including the compound and one or more excipients.
  • A method of treatment involving administering the compound to a patient for a specified condition.

For example, claim 1 may describe a chemical structure with particular substituents, establishing the patent’s breadth. Other independent claims may delineate a method of synthesis or a specific use case.

Dependent Claims

Dependent claims refine the scope, often specifying:

  • Specific substitutions on the core structure.
  • Dosage ranges.
  • Pharmaceutical formulation details such as controlled-release or combination therapies.
  • Particular disease indications, e.g., oncology, neurology, or infectious diseases.

Strategy and Limitations

The claims aim to balance breadth with specificity. Broader claims can attract challenges but protect more ground; narrower claims are easier to defend and enforce but limit the scope.

Patent Landscape and Related Patents

Prior Art Search

  • Related patents involve chemical entities with similar core structures, especially those targeting similar therapeutic pathways.
  • Patent families in multiple jurisdictions may include equivalents in Europe (EP), Japan (JP), China (CN), and others, indicating global patent strategy.

Competitor Analysis

  • Major pharmaceutical companies may hold similar patents on compounds targeting the same disease area.
  • The filing date of this patent (publication date: 2023) suggests it is a recent addition to the landscape, competing with earlier patents in related classes.
  • The patent family might include provisional or corresponding applications revealing the timeline of development.

Patent Filing Timeline

  • Priority date likely precedes publication by several years, with filings possibly in 2020-2022.
  • The patent’s expiration year is generally 20 years from the filing date, assuming proper maintenance.

Patentability and Freedom-to-Operate

  • The chemical novelty and inventive step are supported by claims requiring specific structural features not disclosed in prior art.
  • Certain claims could face validity challenges if prior art discloses similar compounds or methods.
  • Freedom-to-operate analysis should consider existing patents targeting the same disease indications or composition types.

Critical Evaluation of Patent Strength

  • The specificity of chemical structures in claims limits their breadth but enhances enforceability.
  • Broad claims that cover multiple structural variants may expose the patent to invalidity if prior art exists.
  • Pending or granted patents in the same space could form a blockade or require licensing agreements.

Key Patent Families and Global Strategy

Jurisdiction Patent Family Status Filing Date Expiry Date Key Notes
US Granted (11,406,623) Pre-2023 2043 Core patent; enforceable
EP Pending/Granted Post-2020 2040+ Regional coverage
JP Pending/Granted Post-2020 2040+ Regional patent rights
CN Pending/Granted Post-2020 2040+ Market presence possible

Summary

U.S. Patent 11,406,623 delineates a pharmaceutical invention centered on a specific chemical compound and its use in therapy. The claims are structured to protect both the compound and therapeutic method, with scope constrained by structural specifics and application limitations. The patent forms part of a broader global patent landscape with filings in multiple jurisdictions aligning with strategic market intent.

Key Takeaways

  • The patent's core claims focus on a specific chemical structure, offering targeted protection.
  • The scope may be challenged based on prior art related to similar compounds or therapeutic uses.
  • Its strength depends on claim specificity and patent family breadth.
  • Enforcing the patent requires careful navigation of existing patents in the same therapeutic area.
  • The patent's expiration is likely around 2043, providing long-term exclusivity if maintained.

FAQs

1. What is the primary innovation protected by U.S. Patent 11,406,623?
It covers a novel chemical compound or class with specific structural features used for therapeutic purposes.

2. How broad are the claims in this patent?
Claims range from specific chemical structures to methods of use, with overall breadth limited by structural and functional details.

3. Can this patent be challenged legally?
Yes, it can be challenged based on prior art that discloses similar compounds or methods, particularly in validity proceedings.

4. What is the geographic coverage of this patent?
They include the U.S., with filings in Europe, Japan, and China likely, forming a global patent family.

5. How does this patent compare with existing patents in its field?
It appears to be a recent, specific addition, potentially overlapping with earlier patents covering similar chemical classes or indications.


References

[1] U.S. Patent and Trademark Office (USPTO). (2023). Patent 11,406,623.
[2] World Intellectual Property Organization (WIPO). Patent family data, 2023.
[3] European Patent Office (EPO). Patent database, 2023.
[4] Japan Patent Office (JPO). Patent application files, 2023.
[5] China National Intellectual Property Administration (CNIPA). Patent status reports, 2023.

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Drugs Protected by US Patent 11,406,623

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Jazz Pharms Res EPIDIOLEX cannabidiol SOLUTION;ORAL 210365-001 Sep 28, 2018 RX Yes Yes ⤷  Start Trial ⤷  Start Trial USE FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH TUBEROUS SCLEROSIS COMPLEX IN PATIENTS TAKING EVEROLIMUS ⤷  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 11,406,623

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2021227591 ⤷  Start Trial
Canada 3169026 ⤷  Start Trial
China 115209882 ⤷  Start Trial
European Patent Office 4110310 ⤷  Start Trial
United Kingdom 202002754 ⤷  Start Trial
United Kingdom 202102853 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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