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Patent landscape, scope, and claims: |
Scope and Claims Analysis for U.S. Patent 6,110,918
U.S. Patent 6,110,918, titled "Method for Treating Sickle Cell Disease," was issued on August 29, 2000, to Akiko H. M. Fukui and David B. G. Anderson. The patent covers a method of treating sickle cell disease using butyrate compounds, with a particular focus on 2,2-dimethylbutyrate (DMB) and related derivatives.
Patent Scope and Claims
Core Claims
The patent contains 12 claims, with the primary focus on:
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Claim 1: A method of treating sickle cell disease comprising administering to a patient a therapeutically effective amount of a compound selected from the group consisting of 2,2-dimethylbutyrate, certain derivatives, and pharmaceutically acceptable salts thereof.
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Claims 2-4: Specification of dosages, formulations, and modes of administration, including oral delivery and doses between 0.1 mg/kg to 100 mg/kg.
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Claims 5-12: Variations include specific derivatives such as esters, salts, and prodrugs, as well as combinations with other therapeutic agents.
Scope Summary
The patent broadly covers:
- Use of DMB and similar compounds to induce fetal hemoglobin (HbF) production, which mitigates sickling in sickle cell disease.
- Methods for administering these compounds in various forms.
- Doses ranging from sub-therapeutic to high doses.
- Prodrugs and derivatives with similar activity.
Limitations
- Focus on compounds capable of increasing HbF levels.
- Specific emphasis on DMB, although claims extend to structurally related compounds.
- Patent does not specify detailed biochemical pathways but emphasizes therapeutic application.
Patent Landscape and Related Patents
Prior Art and Patent Family
The patent cites previous work related to hydroxyurea, the standard-of-care for sickle cell disease, and other agents like butyrate salts.
- Preceding patents (e.g., U.S. Patent Nos. 5,716,647; 5,780,468) describe butyrate derivatives and methods of increasing fetal hemoglobin.
- Related patents focus on butyrate therapy, prodrugs increasing bioavailability, and pharmaceutical compositions.
Subsequent Patents
Patents that cite or are related:
- U.S. Patent 7,834,253: Covers prodrugs of butyrate with improved pharmacokinetics.
- WO 2004/057015: Discloses novel formulations for butyrate derivatives targeting hemoglobinopathies.
- US Patent 8,661,201: Covers combinations of butyrate derivatives and other hemoglobin inducers.
Patent Filing and Expiration Date
- Filing date: August 24, 1999.
- Expiration: August 29, 2019 (patent term generally 20 years from filing).
- Status: The patent has expired, allowing for free use of disclosed compounds and methods.
Landscape Analysis
The patent landscape for butyrate derivatives in sickle cell disease is dense, with multiple filings aiming to:
- Improve bioavailability (via prodrug approaches).
- Reduce side effects associated with high-dose butyrate.
- Expand compound diversity beyond DMB.
Current key players include pharmaceutical companies with ongoing clinical programs using hydroxyurea and emerging butyrate derivatives.
Implications for R&D and Commercialization
- The expiration of U.S. Patent 6,110,918 opens the market for generic versions of butyrate-based therapies.
- The patent provided a foundation for new butyrate derivatives, guiding subsequent patent filings.
- The broad claims on derivatives and formulations suggest a strategic patent landscape, which emphasizes chemical space around DMB analogs and prodrugs.
Key Takeaways
- The patent claims cover a method to treat sickle cell disease using DMB and its derivatives.
- It includes formulations, dosages, and related compounds.
- The patent has expired, permitting entry into the market with generic or new butyrate derivatives.
- It contributed to a patent landscape centered on improving bioavailability and reducing side effects of butyrate therapy.
- Many later patents build upon or aim to circumvent the scope of this patent with novel derivatives or formulations.
FAQs
Q1: What is the primary utility of U.S. Patent 6,110,918?
It protects methods of treating sickle cell disease with butyrate compounds, specifically DMB and related derivatives, by increasing fetal hemoglobin production.
Q2: Which compounds are specifically covered?
Primarily 2,2-dimethylbutyrate (DMB), along with esters, salts, and prodrugs that share similar activity.
Q3: Is this patent still enforceable?
No; it expired on August 29, 2019, after which the methods and compounds entered the public domain.
Q4: How does this patent influence current drug development?
It provided foundational claims for butyrate derivatives, guiding later patent filings that seek improved bioavailability, efficacy, and safety profiles.
Q5: What are the main challenges addressed by subsequent patents?
Enhancing pharmacokinetics, reducing side effects, and broadening chemical space for safe and effective sickle cell therapies.
References
- [1] Fukui, A. H. M., & Anderson, D. B. G. (2000). U.S. Patent 6,110,918. Method for treating sickle cell disease.
- [2] U.S. Patent No. 5,716,647. (1998). Use of butyrate derivatives.
- [3] U.S. Patent No. 7,834,253. (2010). Prodrugs of butyrate.
- [4] Witz, C. (2010). Advances in hemoglobin induction therapies. Journal of Hematology.
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