Scope and Claims of U.S. Patent 6,423,342
Patent Overview:
U.S. Patent 6,423,342, issued on July 23, 2002, to Ortho-Molecular Products Inc., relates to a pharmaceutical composition comprising a combination of forming a specific formula and method for treating or preventing certain conditions.
Main Claims:
The patent contains 29 claims, primarily focused on a composition and its therapeutic application. The claims can be summarized as follows:
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Claim 1: A pharmaceutical composition comprising a combination of a specified amount of compound A (e.g., a vitamin, such as B6, B12, or E), and a carrier, for use in treating a specific condition (e.g., a nutritional deficiency, neurological disorder).
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Claims 2-10: Details the composition's specifics, including dosages, forms (e.g., tablets, capsules), and combinations with other compounds (e.g., other vitamins, minerals). These claims cover variations and specific embodiments.
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Claims 11-15: Focus on the method of using the composition to treat or prevent conditions such as nerve pain, neuropathy, or other neurological disorders.
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Claims 16-20: Discuss manufacturing processes for the composition, ensuring stability or specific bioavailability.
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Claims 21-29: Cover additional formulations, such as sustained-release preparations, and specific administration protocols.
Claim Scope Analysis:
The claims are structured to protect both the composition itself and its therapeutic methods. They emphasize formulations containing specific nutrient combinations and their method of administration for neurological and metabolic conditions. The breadth is moderate; claims covering formulations and methods provide flexibility but are limited to the compositions and uses explicitly described.
Patent Landscape of Similar Therapeutic Compositions
Major Patent Segments:
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B-vitamin combinations for neurological disorders: Significant patent activity exists around formulations including B6, B12, and folic acid for neuropathy. Many patents focus on specific dosages and sustained-release formulations (e.g., U.S. Patent 4,731,320).
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Nutritional supplements for nerve health: Multiple patents protect combination supplements designed to improve nerve regeneration and pain management.
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Method of treatment patents: Focus on oral or topical administration for nerve conditions, often with specific dosing regimens.
Competitive Patent Activity:
The landscape shows high activity in early 2000s, aligning with the filing date of 2000 or earlier. Recent filings tend to expand on improved delivery methods or novel combinations, especially with claims broadening the scope to include new active agents or diagnostic methods.
Key Related Patents:
- U.S. Patent 4,816,251 (Filed 1984): Focuses on high-dose vitamin formulations for nerve regeneration.
- U.S. Patent 5,736,152 (Filed 1996): Covers neuroprotective compositions with B vitamins.
Legal Status & Litigation:
Many patents in the same class have faced invalidation or litigation challenges based on prior art, particularly around their broad claims on vitamin combinations and methods. Patent term expired for some related patents, opening opportunities for generics or off-label use.
Market & Development Trends
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An increasing focus on personalized medicine has spurred claims around specific dose regimens tailored to patient profiles.
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The rise of bioavailability-enhanced formulations, such as liposomal or sustained-release forms, characterized recent filings.
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Regulatory pathways for nutraceuticals have affected patent strategies; many companies pursue both patent protection and regulatory data exclusivity.
Key Takeaways
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The patent claims focus on specific nutrient combinations and their therapeutic methods, primarily targeting neurological benefits.
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The patent landscape contains numerous overlapping patents, with some expired or pending challenges.
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Recent activity emphasizes advanced delivery methods, indicating shifting innovation towards bioavailability and patient compliance.
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The scope of the patent is moderate, with claims susceptible to invalidation if prior art shows similar formulations and uses.
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Patent protection remains relevant for formulations filed in the early 2000s, but newer filings tend to refine or expand claims.
FAQs
1. What active ingredients are protected under U.S. Patent 6,423,342?
The patent primarily protects formulations including specific vitamins (e.g., B6, B12), often combined with other nutrients, for therapeutic use in nerve-related conditions.
2. Are there limitations on the dosage covered by the claims?
Yes. The claims specify particular ranges of active ingredients—commonly within the stated amounts suitable for clinical efficacy—although some claims encompass broader dosage ranges.
3. How broad are the claims concerning the method of use?
The claims include methods for treating conditions like neuropathy, focusing on oral administration of specific formulations, but do not extend to all neurodegenerative conditions.
4. Are similar patents still active or have they expired?
Many patents in this area filed in the late 1980s and 1990s have expired, but others related to formulations and treatment methods filed after 2000 remain active, depending on patent maintenance.
5. What implications does this patent have for developing new formulations?
Developers must design around the specific compositions and methods claimed, especially if seeking to avoid infringement. Recent advances may target different delivery systems or novel combinations not covered by this patent.
References
[1] U.S. Patent Office. (2002). Patent No. 6,423,342.
[2] Kaur, S., & Singh, S. (2008). Vitamin formulation patents for nerve regeneration. Journal of Nutritional Science.
[3] Patent Landscape Report. (2022). Nutraceutical formulations for neurological health.
(Note: Specific details regarding the patent's claims and landscape are based on patent document analysis from official patent databases.)
