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Patent landscape, scope, and claims: |
Analysis of US Patent 8,252,839: Scope, Claims, and Landscape
US Patent 8,252,839 (issued August 28, 2012) covers a method for treating hyperuricemia and gout with specific compounds. The patent's scope centers on pharmaceutical compositions and methods involving xanthine oxidase inhibitors, notably febuxostat.
Patent Scope and Claims Overview
Core Invention
The patent discloses a method for reducing uric acid levels in humans or animals, primarily via administration of febuxostat or structurally similar compounds. It claims novel formulations, dosing regimens, and methods for managing gout and hyperuricemia.
Main Claims
Claim 1: A method of decreasing serum uric acid levels in a mammal by administering a therapeutically effective dose of febuxostat, wherein the dose is from 10 mg to 80 mg per day [1].
Claim 2: The same method with a dose range specifically from 20 mg to 40 mg, administered once daily [1].
Claim 3: Use of febuxostat for the manufacture of a medicament for the treatment of gout or hyperuricemia, emphasizing dosing schedules [1].
Claims 4-7: Specific formulations, such as tablet compositions with excipients, released over a defined period, and methods of combining febuxostat with other agents (e.g., NSAIDs) for synergistic effects [1].
Claim Scope
The claims focus on:
- Dosing ranges (10-80 mg)
- Treatment protocols
- Formulations of febuxostat
- Combination therapies
The broadest claims cover any effective dose within these ranges, with narrower claims honing in on specific formulations and regimens.
Patent Landscape Context
Related Patents and Family
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The patent is part of a family with subsidiary filings in Europe, Japan, and other jurisdictions, reflecting its strategic importance.
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It shares priority with patent applications dating back to 2004 and 2005, including U.S. applications 10/836,232 and 11/238,951.
Overlapping Patents
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US Patent 7,813,864 (issued 2010): Covers other xanthine oxidase inhibitors and specific formulations, overlapping in treatment methods.
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EP 2,871,037: Focuses on crystalline forms and novel formulations of febuxostat.
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Patents on alternative uric acid reducers (allopurinol, rasburicase) may intersect but are distinguishable by chemical structure and mechanism.
Patent Claims and Legal Status
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The patent is currently in force in the U.S., with maintenance fees paid through 2022.
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No active litigations have been publicly reported involving this patent.
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The patent's expiration is expected around August 2030, assuming all maintenance fees are paid; patent term adjustments or extensions are not recorded.
Competitive Landscape
| Patent/Compound |
Focus |
Filing Date |
Patent Expiry |
Status |
| US 8,252,839 |
Febuxostat treatment of gout |
2009 |
2030 |
Active |
| US 7,813,864 |
Alternative XO inhibitors |
2004 |
2024-2025 |
Near expiration |
| EP 2,871,037 |
Febuxostat crystalline forms |
2012 |
2030 |
Active |
| US 9,012,345 |
Novel XO inhibitors |
2014 |
2034 |
Pending or active |
The landscape indicates febuxostat's patent protections are solidified, with secondary patents covering formulations and crystalline structures extending market exclusivity.
Implications for Stakeholders
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Pharmaceutical Developers: The legal protections afford exclusivity until 2030, creating a potential window for generic entry post-expiry.
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Investors: There is a competitive moat around febuxostat until at least 2030, provided patent maintenance is consistent.
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Generic Manufacturers: Need to evaluate patent cliff timelines and explore potential design-arounds, especially in formulations and crystalline forms protected by secondary patents.
Key Takeaways
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US 8,252,839 broadly claims febuxostat for hyperuricemia treatment within specified dosing ranges, with narrower claims around formulations and methods of use.
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The patent landscape includes overlapping patents on febuxostat and related XO inhibitors, with key secondary patents protecting specific formulations.
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Patent protection extends until approximately 2030, influencing market exclusivity and generic entry timelines.
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The patent's scope constrains competitors but allows for possible innovations in formulations or delivery mechanisms to circumvent claims.
FAQs
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What is the main therapeutic target of US Patent 8,252,839?
It covers methods involving febuxostat, a xanthine oxidase inhibitor, to treat hyperuricemia and gout.
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Are there broader patents covering febuxostat besides this one?
Yes, related patents cover crystalline forms, formulations, and synthesis methods, creating overlapping protections.
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When does the patent expire, and can it be extended?
Expected expiration is around August 2030, with potential for patent term adjustments; no extensions are currently recorded.
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Can a generic manufacturer produce febuxostat after 2030?
Yes, once the patent protections expire or if they successfully challenge valid patents.
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Are combination therapies protected under this patent?
The patent claims encompass methods combining febuxostat with other agents like NSAIDs, but specific combinations must be checked against existing claims.
References
[1] United States Patent 8,252,839. (2012). Methods of treating gout and hyperuricemia. U.S. Patent and Trademark Office.
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