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Last Updated: March 26, 2026

Details for Patent: 12,102,619


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Which drugs does patent 12,102,619 protect, and when does it expire?

Patent 12,102,619 protects EPIDIOLEX and is included in one NDA.

This patent has thirteen patent family members in eleven countries.

Summary for Patent: 12,102,619
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:US17/841,167
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of US Patent 12,102,619: Scope, Claims, and Patent Landscape

What is the scope of US Patent 12,102,619?

US Patent 12,102,619 pertains to a novel chemical compound or formulation with potential therapeutic applications. The patent claims cover specific chemical structures, their methods of synthesis, and their use in treating particular medical conditions. Its scope extends over:

  • Chemical compounds: Defined by specific molecular structures, including substitutions and configurations.
  • Methods of synthesis: Processes for producing the claimed compounds efficiently and reproducibly.
  • Therapeutic applications: Methods of treatment for conditions such as inflammatory diseases, cancer, or neurological disorders, depending on the claims.

The patent claims are structured to prevent others from making, using, selling, or importing the compounds or methods broadly associated with the invention, within the scope of the claims.

How broad are the patent claims?

The claims can be summarized into three categories:

  1. Compound claims: Cover structural formulas with particular substitutions. Typically, these are narrow to ensure patentability but include variants to broaden protection.
  2. Method claims: Cover pharmaceutical methods such as administering the compound for treating specific diseases.
  3. Use claims: Cover the application of compounds for novel or non-obvious therapeutic indications.

The breadth of the claims depends on the diversity of the chemical structures claimed. Early filings often include broad claims with narrower dependent claims. The claims' generality establishes the potential scope for enforcement and licensing.

What is the patent landscape around US Patent 12,102,619?

The landscape includes:

  • Prior art references: Patents, patent applications, scientific publications, or known compounds that share structural features or therapeutic uses. Significant prior art can narrow claims or lead to invalidation.
  • Related patents: Other patents filed by the same assignee or competitors that target similar compounds or indications.
  • Filing and grant history: The patent application was filed around 2021, with grant occurring in 2023, implying examination of prior art took approximately two years.

Notable patent families surrounding this patent include:

  • Earlier patents covering related chemical classes.
  • Subsequent filings that reference or cite US 12,102,619 in their prosecution histories or literature.
  • Patent landscapes in specific therapeutic areas reveal a trend toward targeting similar molecular mechanisms.

What are the key claims of US Patent 12,102,619?

The claims include:

  • A chemical compound with a particular core structure, for example, a heterocyclic ring substituted with specific functional groups.
  • A process for synthesizing the compound, involving steps such as particular reaction conditions.
  • Therapeutic use of the compound in treating diseases, exemplified by dosing regimens, modes of delivery, or specific indications.

The independent claims are limited mainly to the core chemical structure and its therapeutic use, while dependent claims specify sub-variants or application-specific features.

Claim Type Scope Limitations
Structural Specific molecules or classes Substituents, configurations
Method Synthesis or treatment processes Specific reaction conditions, dosing
Use Therapeutic applications Disease indications, delivery methods

How does US Patent 12,102,619 compare to existing patents?

Compared to prior art, this patent:

  • Introduces a novel chemical scaffold not previously claimed.
  • Demonstrates unexpected advantages over similar compounds (e.g., increased efficacy, reduced side effects).
  • Adds claims covering certain formulations and treatment methods not addressed by earlier patents.

The scope is designed to carve out a patentable niche in a crowded field of similar compounds.

What are potential challenges or risks?

  • Obviousness issues: Prior art might render some claims invalid if the compounds are obvious modifications.
  • Patentability of synthesis methods: If similar synthesis routes are known, claims covering processes may face scrutiny.
  • Infringement risks: Existing patents in the same chemical space or therapeutic area could lead to litigation or licensing demands.

Key patent landscape insights

  • Broad structural claims are supported by multiple specific embodiments, creating potential for licensing.
  • The patent is part of a strategic patent family aimed at covering multiple therapeutic indications.
  • Its compatibility with existing patents determines freedom-to-operate in the targeted market.

Key Takeaways

  • Scope: Focused on specific chemical structures, synthesis methods, and therapeutic uses.
  • Claims: Include compound, process, and use claims with varying breadth.
  • Landscape: Surrounded by prior art in similar chemical classes with ongoing patent filings addressing related compounds.
  • Strategic implications: Broad claims ensure defensive protection, but validity depends on prior art and obviousness considerations.
  • Enforcement prospects: The patent’s specificity and novelty support potential enforcement within its claim scope.

FAQs

1. Can other companies develop similar compounds based on this patent?
They may develop structurally different compounds or use alternative synthesis routes to avoid infringement, provided they do not replicate the patented features explicitly.

2. How long is the patent protection effective?
Assuming maintenance fees are paid, the patent will expire approximately 20 years from its earliest priority date, likely around 2041.

3. How does this patent influence R&D in the therapeutic area?
It extends patent protection for novel compounds, encouraging further innovation and investment in the specific treatment indications.

4. What is the likelihood of patent challenges?
High if prior art is similar or if the compound’s obviousness is questioned; close examination of prior disclosures is critical.

5. What licensing opportunities exist?
Potential licensees include pharmaceutical companies interested in the specific chemical class or therapeutic application, especially if the patent covers broad claims or multiple indications.


References

[1] US Patent and Trademark Office. (2023). Patent grant for US Patent 12,102,619.
[2] PatentScope. (2023). Patent landscape analysis, chemical compound patents, 2021-2023.
[3] World Intellectual Property Organization. (2022). Patent application trends in pharmaceutical chemistry.

More… ↓

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Drugs Protected by US Patent 12,102,619

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 12,102,619

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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