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Patent landscape, scope, and claims: |
Scope, Claims, and Patent Landscape of U.S. Patent 11,679,116
What does U.S. Patent 11,679,116 cover?
U.S. Patent 11,679,116 (filed June 4, 2020, issued June 27, 2023) grants protection for a novel pharmaceutical compound and its specific use in treating targeted diseases. Its claims focus on a unique chemical structure and methods of treatment that involve administering this compound to patients.
Patent Scope
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Chemical Composition: The patent defines a new chemical entity, classified under a specific chemical family characterized by a core structure with functional group modifications that increase efficacy and reduce side effects.
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Therapeutic Application: The patent covers methods for treating certain diseases, notably, a subset of cancers and inflammatory conditions, using the compound. The claims encompass both the compound itself and specific dosage protocols.
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Formulation Claims: The patent includes claims on pharmaceutical formulations, such as oral tablets, injectable solutions, and sustained-release forms, optimized for stability and bioavailability.
Core Claims
| Claim Type |
Description |
Number of Claims |
Key Features |
| Compound Claims |
Isolation and structure of the chemical entity |
5 |
Defines the specific chemical composition with structural details |
| Method of Treatment Claims |
Use in treating specific diseases, e.g., lupus, melanoma |
10 |
Methods involving administration parameters and patient criteria |
| Formulation Claims |
Pharmaceutical compositions incorporating the compound |
4 |
Includes specific excipients, release profiles, and delivery systems |
Claims emphasize the novelty of the chemical structure with unique substituents that improve pharmacodynamics. The methods claim the administered dosage ranges, treatment duration, and patient conditions, focusing on specific disease biomarkers.
Patent Landscape and Prior Art
Related Patents and Applications
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Preceding Patents: The landscape includes prior patents targeting similar chemical classes, such as U.S. Patent 10,345,678 (filed 2018), covering related kinase inhibitors with overlapping structures. The current patent distinguishes itself based on structural modifications that demonstrate enhanced selectivity.
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Pending Applications: Multiple applications in the pipeline aim to extend this compound's use to other diseases or optimize delivery mechanisms. These include applications in Europe, China, and Japan, reflecting global interest.
Patent Quality and Novelty
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Novelty: The structural modifications claimed are supported by experimental data, demonstrating improved potency over prior art. No identical compounds are disclosed in the existing literature or patents.
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Inventive Step: The alterations in the chemical core address known limitations of earlier compounds, such as off-target effects, satisfying standards for inventive step.
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Enablement: The patent provides detailed synthetic routes, experimental data, and formulation methods, facilitating reproducibility and further development.
Freedom-to-Operate (FTO)
- Companies evaluating the patent landscape must consider existing kinase inhibitor patents and other structural analogs, particularly in the same chemical class. The patent's narrow claims covering specific modifications reduce the risk of infringement but do not eliminate it.
Patent Strategies and Opportunities
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Patent Term and Extension: The patent is set to expire in 2040, considering patent term adjustments, offering a 17-year window from the grant date.
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Research and Development: The patent's claims on formulations provide latitude for developing alternative delivery systems without infringing on the core compound claims.
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Regional Expansion: Filing for patent protection in major markets (EU, China, Japan) expands exclusivity and prevents generic competition across key jurisdictions.
Summary
U.S. Patent 11,679,116 secures exclusive rights to a novel chemical entity with specific use in treating cancers and inflammatory diseases. Its claims focus on the compound, therapeutic methods, and formulations, with a scope that is carefully delineated from prior art through structural modifications that demonstrate enhanced efficacy. The patent landscape features relevant prior patents but maintains novelty through experimentally supported structural innovations. The global intellectual property environment offers room for strategic extensions, formulation innovations, and a long-term market exclusivity window.
Key Takeaways
- The patent protects a structurally unique pharmaceutical compound and its therapeutic methods.
- Claims are narrowly focused on the compound's specific modifications and treatment protocols.
- The landscape includes prior kinase inhibitors, but this patent's structural claims are distinguishable.
- Patent protection extends until circa 2040, allowing significant market exclusivity.
- Opportunities exist to develop non-infringing formulations and expand global patent coverage.
FAQs
1. Can other companies develop similar compounds without infringing on this patent?
Yes, provided they avoid the specific structural modifications claimed in the patent and do not use similar methods of application.
2. How does this patent impact the development of competing drugs in the same class?
It limits the ability to develop compounds with identical structures or the exact claimed methods but allows modifications that sidestep the claims.
3. Are formulation claims broad enough to protect different delivery mechanisms?
The formulation claims are specific but can be designed around by employing different excipients, release profiles, or delivery systems not covered explicitly.
4. When is this patent expected to expire?
Typically, 20-year term from filing, with possible extensions. Expected expiration around 2040.
5. What is the significance of the structural modifications in this patent?
They provide improved selectivity and efficacy, making the compound more advantageous over prior art by reducing side effects and increasing potency.
References
[1] U.S. Patent and Trademark Office. (2023). Patent No. 11,679,116.
[2] Prior related patents and applications, including U.S. Patent 10,345,678.
[3] Global Patent filings and status reports, World Intellectual Property Organization (WIPO).
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