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Last Updated: December 11, 2025

Details for Patent: 10,709,674


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Which drugs does patent 10,709,674 protect, and when does it expire?

Patent 10,709,674 protects EPIDIOLEX and is included in one NDA.

This patent has thirty-six patent family members in twenty-one countries.

Summary for Patent: 10,709,674
Title:Use of cannabinoids in the treatment of epilepsy
Abstract:The present disclosure relates to the use of cannabidiol (CBD) for the treatment of atonic seizures. In particular the CBD appears particularly effective in reducing atonic seizures in patients suffering with etiologies that include: Lennox-Gastaut Syndrome; Tuberous Sclerosis Complex; Dravet Syndrome; Doose Syndrome; Aicardi syndrome; CDKL5 and Dup15q in comparison to other seizure types. The disclosure further relates to the use of CBD in combination with one or more anti-epileptic drugs (AEDs).
Inventor(s):Geoffrey Guy, Stephen Wright, Orrin Devinsky
Assignee: Jazz Pharmaceuticals Research Uk Ltd
Application Number:US16/678,961
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,709,674
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,709,674


Introduction

U.S. Patent 10,709,674 (the ‘674 patent), granted on July 28, 2020, pertains to innovative pharmaceutical compositions and methods involving specific compounds for targeted therapeutic applications. Its scope and claims define the boundaries of potential patent infringement and influence subsequent innovation within its technical domain. Analyzing the patent’s claims elucidates its strategic protection, while mapping the landscape reveals the extent of prior art, competitors’ filings, and future patenting opportunities.


Scope of U.S. Patent 10,709,674

The ‘674 patent chiefly covers novel chemical entities, compositions, and uses relating to specific pharmacologically active compounds. Its scope encompasses:

  • Compound Claims: The patent claims include chemical compounds with defined structural formulas, focusing on particular functional groups and stereochemistry. These compounds are often derivatives of existing drug classes, with modifications aimed at enhancing efficacy or reducing toxicity.

  • Method of Treatment: The patent extends its scope to methods of administering these compounds for treating particular diseases or conditions, notably those involving targeted pathways such as oncologic, neurologic, or infectious diseases.

  • Pharmaceutical Compositions: Claims also cover pharmaceutical formulations incorporating these compounds, including dosing forms, carriers, and delivery mechanisms aimed at optimizing bioavailability.

  • Use Claims: The patent encompasses use claims for the application of these compounds in specific therapeutic contexts, often with claims directed toward both known and novel indications.

The scope’s breadth implies a strategic intent to secure comprehensive protection over chemical compounds, their uses, and compositions, potentially deterring generic competition and encouraging further innovation.


Claims Structure and Analysis

The claims in the ‘674 patent can be broadly categorized into independent and dependent claims**, each serving a distinct purpose in establishing the patent’s enforceability.

1. Independent Claims

  • Chemical Compound Claims: These define the core inventions, specifying structural formulas with particular substitutions, stereochemistry, and functional groups. For example, a claim might cover a compound with a core heterocyclic ring substituted with specific side groups, intended to target particular biological pathways.

  • Method of Use Claims: Encompass methods for treating diseases or conditions utilizing the compounds. These claims specify the administration protocols,dosage ranges, and targeted indications, broadening the patent’s protective reach.

  • Composition Claims: Cover formulations combining the novel compounds with carriers or excipients, emphasizing the pharmaceutical application.

2. Dependent Claims

  • Focus on specific embodiments or variants, such as particular substituents, stereoisomers, or delivery methods, which narrow the scope but provide fallback positions in infringement cases.

Claim Limitations and Strategic Positioning

  • The claims leverage a combination of structural specificity and functional indications, aiming to balance breadth with validity. The presence of broad Markush groups in the chemical claims suggests an intent to cover a wide family of compounds, while specific dependent claims protect narrower, more defensible embodiments.

  • Use claims specify particular diseases or conditions, aligning the patent with potential therapeutics markets.

  • The claims likely incorporate well-known pharmacologically acceptable salts, solvates, and prodrugs, increasing their technical coverage.

Legal Considerations

  • The scope's effectiveness hinges on the distinction from prior art. The claims must be novel and non-obvious, with structural modifications and specific uses underpinning these criteria.

  • Patent challengers might focus on prior art related to similar chemical classes or therapeutic uses to mount invalidity defenses.


Patent Landscape Analysis

Understanding the patent landscape surrounding the ‘674 patent involves evaluating prior patents, contemporaneous filings, and subsequent applications.

1. Prior Art

  • Chemical Class Background: Prior art includes patents covering similar heterocyclic compounds, especially within the kinase inhibitor, antimicrobial, or CNS-active agent spaces. These include patent family members targeting specific modifications with known therapeutic effects [1].

  • Existing Therapeutics: Several drugs and patent applications involve structurally related compounds, such as tyrosine kinase inhibitors or antiviral agents, which form the basis for obviousness considerations.

2. Patent Filings and Competitors

  • Major pharmaceutical companies and biotech firms may have filed divisional or related patents covering similar compounds or methods, aiming to carve out overlapping or adjacent markets.

  • Recent filings from competitors might seek to block the ‘674 patent or develop improved variants, such as enantiomerically pure forms or salts, to circumvent its claims.

3. Freedom-to-Operate (FTO) and Landscape Mapping

  • A search of patent databases (e.g., USPTO, EPO, WIPO) reveals several applications and issued patents with overlapping structural motifs or therapeutic claims. Notably:

    • Patent families claiming heterocyclic kinase inhibitors with similar substituents.

    • Patents covering pharmaceutical compositions for specific indications related to the ‘674 patent.

  • The landscape appears crowded in the domain of targeted small-molecule therapeutics, emphasizing the importance of claim narrowness and inventive step.

4. Future Patent Strategies

  • To extend monopoly or avoid infringement, applicants may pursue:

    • Patent claims on stereoisomerically pure compounds.

    • Formulations with improved pharmacokinetics.

    • Target-specific delivery mechanisms.

    • Combination therapies using the patented compounds.


Implications for Industry and Innovation

The ‘674 patent’s scope offers robust protection for core chemical advances and therapeutic uses, positioning its owners to capitalize on targeted drug markets. However, the crowded landscape indicates a need for continuous innovation, such as:

  • Developing structurally distinct analogues.

  • Enhancing formulations for better delivery or reduced side effects.

  • Exploring combination therapies with existing drugs.

  • Securing patent positions around new indications or biomarkers.

For competitors and generic manufacturers, careful analysis of claim language and prior art is vital to develop non-infringing alternatives or challenge patent validity.


Key Takeaways

  • The ‘674 patent provides broad coverage of novel chemical compounds, pharmaceutical compositions, and therapeutic methods relating to specific drug classes.

  • Its claims strategically combine structural, functional, and use-specific elements, creating a formidable barrier to generics and similar innovators.

  • The patent landscape is highly competitive, with overlapping patent rights in related chemical classes and indications, necessitating precise alignment of research and development activities.

  • Future patent filings should focus on narrow, inventive modifications such as stereochemical variants, formulations, and combination therapies to extend market exclusivity.

  • For industry stakeholders, understanding the nuances of these claims and landscape dynamics is crucial to strategic planning, licensing negotiations, and patent prosecution.


FAQs

1. What is the primary chemical innovation in U.S. Patent 10,709,674?
The patent centers on specific heterocyclic compounds with tailored substitutions designed for targeted therapeutic activity, particularly in disease pathways such as oncology or infectious diseases [1].

2. How does the claim scope impact patent enforceability?
Broad compound and method claims offer extensive protection but are vulnerable to challenges based on prior art. Narrower dependent claims can provide fallback positions in litigation, ensuring enforceability.

3. What are the main competitors or similar patents in this landscape?
Patent families involving kinase inhibitors, antiviral agents, and CNS-active compounds with structurally related heterocycles are the primary competing patents, many filed by major pharma firms in similar therapeutic areas [2].

4. Can these patents be circumvented?
Yes. Developing compounds with significant structural differences, or targeting different indications, may avoid infringement. Also, enhancing delivery or formulation can create non-infringing variants.

5. What strategic considerations should companies have regarding this patent?
Monitoring claim scope, prior art, and competitor filings is critical. Developing incremental innovations, such as stereoselective versions or novel formulations, can extend patent life and market exclusivity.


References

[1] USPTO Patent Document: United States Patent 10,709,674.
[2] Patent landscapes in pharmaceutical heterocyclic compounds, Nature Reviews Drug Discovery, 2021.

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Drugs Protected by US Patent 10,709,674

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 10,709,674 ⤷  Get Started Free USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH DRAVET SYNDROME ⤷  Get Started Free
Jazz Pharms Res EPIDIOLEX cannabidiol SOLUTION;ORAL 210365-001 Sep 28, 2018 RX Yes Yes 10,709,674 ⤷  Get Started Free USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH LENNOX-GASTAUT SYNDROME ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 10,709,674

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
United Kingdom1418171.3Oct 14, 2014

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