Detailed Analysis of the Scope, Claims, and Patent Landscape for United States Patent 6,090,410
Introduction
United States Patent No. 6,090,410, granted on July 18, 2000, protecting a specific pharmaceutical invention, stands as a key asset within the landscape of drug patent portfolios. It delineates a scope of claims that influence the development, manufacture, and commercialization of targeted drug compounds. This analysis provides an exhaustive review of the patent’s claims, its scope, and the broader patent landscape related to its technological domain.
Overview of Patent 6,090,410
Title: Method for Increasing the bioavailability of therapeutic agents through co-administration with bile acids or their derivatives.
This patent predominantly addresses methods and compositions aimed at enhancing the bioavailability of orally administered drugs by utilizing bile acids or their derivatives as absorption enhancers. The primary inventive concept involves co-administering specific bile acid compounds with therapeutic agents to improve absorption, thereby potentially reducing required dosages and mitigating side effects.
Filing and Priority:
Filed on September 3, 1998, with priority based on earlier provisional applications, the patent consolidates a body of evidence on the role of bile acids in drug absorption.
Scope and Claims Analysis
1. Independent Claims
The patent’s core scope derives from its independent claims, which typically define the broadest legal protections. The key independent claims include:
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Claim 1: A method of increasing the bioavailability of a therapeutic agent by co-administering with a bile acid or derivative thereof, wherein the bile acid enhances absorption of the drug in the gastrointestinal tract.
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Claim 12: An oral pharmaceutical composition comprising a therapeutic agent and a bile acid or derivative that enhances bioavailability.
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Claim 16: A method employing a bile acid or derivative to facilitate absorption of a drug in a subject, specifically targeting poorly absorbed drugs.
Scope of Claims:
These claims broadly cover methods and compositions involving the co-administration of a therapeutic agent with bile acids or derivatives for bioavailability enhancement. They do not specify particular drugs, bile acids, or dosage forms, thus enabling extensive application across various therapeutic categories.
2. Dependent Claims
Dependent claims specify particular embodiments and add limitations such as:
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Specific bile acids like cholic acid, chenodeoxycholic acid, deoxycholic acid, and their derivatives.
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Particular drug types, including antibiotics, antifungals, peptides, and other biologics with known absorption issues.
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Dosage ranges, formulations (e.g., capsules, tablets), and administration routes (primarily oral).
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Specific molar ratios or concentrations of bile acids and drugs.
These narrower claims serve to protect specific formulations and methods, providing fallback positions and detailed protection areas within the broader claims.
3. Claim Scope Interpretation
The patent’s claims encompass:
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Use of various naturally occurring and synthetic bile acids and derivatives, including their salts and conjugates.
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A broad spectrum of therapeutic agents, especially those with poor oral absorption, such as peptides, proteins, and lipophilic drugs.
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Co-administration strategies that may involve formulations, combination dosages, or separate administration timed to optimize absorption.
This breadth sustains the patent's relevance across multiple drug development initiatives targeting bioavailability improvement.
Patent Landscape Context
1. Prior Art and Patent Citations
Prior art references include earlier studies on bile acids' role in drug absorption (e.g., U.S. Patent No. 5,670,416) and scientific literature delineating the mechanism of bile acids as absorption enhancers. The patent cites numerous scholarly articles demonstrating the efficacy of bile acids, aligning its claims with well-documented physiological phenomena.
2. Related Patents and Competitors
Subsequent patents have built upon or challenged the scope of 6,090,410. Notable related patents include:
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US Patent 6,375,988: Focuses on specific bile acid derivatives with improved stability and absorption properties.
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WO Patent applications: Covering novel delivery systems utilizing bile acids for oral peptides and biologics.
Competitors have sought to develop proprietary bile acid formulations with enhanced efficacy or reduced toxicity, indicating ongoing innovation around this patent’s foundational technology.
3. Expiration and Patent Term
Filed in 1998 and granted in 2000, the patent's 20-year term expired in 2018. The expiration opens opportunities for generic development and broader commercialization without infringing on this patent’s rights.
Implications for Industry and Innovation
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Scope Breadth: The broad claims covering multiple bile acids and therapeutic drugs provided substantial protection for the patent holder, facilitating licensing and partnerships.
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Research and Development: Companies developing bioavailability enhancement agents must navigate around these claims by identifying non-infringing bile acids or alternative absorption strategies.
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Post-Expiration Landscape: The end of patent protections spurs increased competition, generic manufacturing, and innovation in bioavailability enhancement technologies.
Conclusion
United States Patent 6,090,410 offers a comprehensive method and composition claim set for using bile acids as absorption enhancers. Its broad scope encompasses numerous therapeutic agents and bile acid derivatives, establishing a foundational patent in the field of drug bioavailability. The patent landscape reveals continued innovation, with subsequent patents extending or refining this approach. Given its expiration, the technology remains pivotal for ongoing drug development and formulation strategies.
Key Takeaways
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The patent's broad claims effectively cover a widespread approach of co-administering bile acids with various drugs to enhance absorption.
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Its detailed dependent claims specify preferred bile acids and formulations, enabling targeted commercialization and licensing.
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Post-expiration, the technology can be freely utilized, fostering innovation and competition.
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Ongoing patent activity indicates continued interest in optimizing bile acid-based absorption enhancers.
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Companies should consider designing around these claims by exploring novel bile acid derivatives or alternative bioavailability strategies.
FAQs
1. What is the primary innovation of Patent 6,090,410?
It introduces methods and compositions that co-administer bile acids or their derivatives with therapeutic agents to enhance drug absorption via increased bioavailability.
2. Which therapeutic agents are covered under this patent?
The patent broadly encompasses drugs with poor oral absorption, including peptides, proteins, antibiotics, antifungals, and lipophilic drugs.
3. How does the patent define a bile acid or derivative?
It includes naturally occurring bile acids like cholic acid, chenodeoxycholic acid, deoxycholic acid, their salts, conjugates, and synthetic derivatives designed to mimic or improve absorption effects.
4. Can this patent be still enforced?
No; the patent expired in 2018, ending its enforceable life but leaving a legacy in bioavailability enhancement methods.
5. How does this patent influence current drug formulation strategies?
It set a precedent for employing bile acids as safe, effective absorption enhancers, prompting ongoing research into derivative optimization and alternative absorption technologies.
References
- U.S. Patent No. 6,090,410. (2000). Method for increasing the bioavailability of therapeutic agents through co-administration with bile acids or their derivatives.
- Prior art references and scientific publications on bile acids as absorption enhancers.
- Related patents aimed at bile acid derivatives and drug delivery systems.
