United States Patent 6,669,948: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,669,948, titled "Amoxicillin Formulations with Modified Release," is a significant patent in the pharmaceutical field, particularly in the development of amoxicillin products. This patent, issued to various assignees, outlines innovative formulations of amoxicillin that enhance its delivery and efficacy.
Background
Amoxicillin is a widely used antibiotic belonging to the penicillin class. The patent addresses the need for improved formulations that can optimize the drug's release profile, ensuring better patient compliance and therapeutic outcomes.
Scope of the Patent
The patent covers amoxicillin products that include at least one modified release component. These components can be categorized into several types:
Immediate Release Components
These are components where the initiation of release and the rate of release of the active ingredient are not substantially delayed, slowed, or sustained after administration[1].
Delayed Release Components
These components delay the release of the active ingredient but do not sustain the release over a period of time after the delay[1].
Extended (Sustained) Release Components
These components sustain the release of the active ingredient over a period of time after administration[1].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Multiple Release Components
The patent claims products that include an immediate release component and one or more delayed release components, or products that include an immediate release component and one or more extended release components. It also covers products with combinations of delayed and extended release components without an immediate release component[1].
Dissolution Profile
The claims specify the in-vitro dissolution profile of the amoxicillin product, detailing the percentage of amoxicillin dissolved at specific times. For example, the product must have a dissolution profile where at least a specified minimum and not more than a specified maximum percent of the total amoxicillin is dissolved at certain times[1].
Partial AUC Ratios
The patent describes the partial Area Under the Curve (AUC) ratios, which are critical for understanding the pharmacokinetics of the amoxicillin product. These ratios are determined in the fed state and are essential for ensuring the product's efficacy and safety[1].
Patent Landscape Analysis
To understand the broader context and impact of this patent, a patent landscape analysis is crucial.
Competitor Analysis
Patent landscape analysis helps identify competitors in the field of antibiotic formulations. This includes other pharmaceutical companies that have developed similar or competing products. For instance, analyzing patents from other companies can reveal trends in formulation technology and market strategies[3].
Market Developments
The analysis also reveals market developments such as mergers and acquisitions, licensing agreements, and litigation activities. This information is vital for strategic decision-making and risk management in the pharmaceutical industry[3].
Legal Status and Expiry Dates
Understanding the legal status (alive, pending, lapsed, revoked, or expired) and expected expiry dates of related patents is essential. This information helps in planning future research and development, as well as in making informed decisions about patent filings and licensing[3].
Technical Insights
The patent provides detailed technical insights into the formulation of amoxicillin products.
Formulation Techniques
The patent describes various formulation techniques, including the use of different release components and their combinations. This knowledge is valuable for formulators and researchers looking to develop new or improved antibiotic formulations[1].
Pharmacokinetics
The patent delves into the pharmacokinetics of the amoxicillin product, including the AUC ratios and dissolution profiles. These aspects are critical for ensuring the product's bioavailability and therapeutic efficacy[1].
Industry Impact
The impact of this patent on the pharmaceutical industry is significant.
Improved Patient Compliance
The modified release formulations described in the patent can improve patient compliance by reducing the frequency of dosing and enhancing the drug's efficacy over a longer period[1].
Competitive Advantage
Companies holding this patent or similar patents can gain a competitive advantage in the market by offering products with superior release profiles, which can lead to better therapeutic outcomes and higher patient satisfaction[3].
Economic Value
The economic value of this patent is substantial.
Monetary Value
Patents in the pharmaceutical sector can be highly valuable, with prices ranging from hundreds of thousands to millions of dollars. For example, significant patent deals in other sectors have seen prices as high as $7.7 million per patent application[2].
Licensing and Royalties
The patent can generate revenue through licensing agreements and royalties. Companies can license the technology to other manufacturers, ensuring a steady stream of income[2].
Challenges and Limitations
While the patent offers several advantages, there are also challenges and limitations to consider.
Regulatory Compliance
The product must comply with regulatory requirements, including those related to pharmacokinetics and bioavailability. Non-compliance can lead to regulatory issues and potential litigation[1].
Litigation Risks
The pharmaceutical industry is prone to patent litigation. Companies must ensure that their products do not infringe on existing patents and be prepared to defend their own patents against infringement claims[5].
Key Takeaways
- Modified Release Formulations: The patent covers various modified release formulations of amoxicillin, including immediate, delayed, and extended release components.
- Pharmacokinetics: The patent specifies the AUC ratios and dissolution profiles, which are critical for the product's efficacy and safety.
- Competitive Advantage: The patent provides a competitive edge in the market by offering superior release profiles.
- Economic Value: The patent has significant economic value through licensing, royalties, and potential sales.
- Regulatory Compliance: The product must comply with regulatory requirements to avoid legal issues.
FAQs
What is the main focus of United States Patent 6,669,948?
The main focus of this patent is on amoxicillin formulations with modified release components, including immediate, delayed, and extended release.
How does the patent improve patient compliance?
The patent improves patient compliance by reducing the frequency of dosing through the use of delayed and extended release components.
What are the key technical insights provided by the patent?
The patent provides detailed insights into formulation techniques, pharmacokinetics, and the dissolution profiles of the amoxicillin product.
How can companies benefit economically from this patent?
Companies can benefit through licensing agreements, royalties, and the potential to sell the patented technology.
What are the regulatory challenges associated with this patent?
The product must comply with regulatory requirements related to pharmacokinetics and bioavailability to avoid regulatory issues and potential litigation.
Cited Sources
- EP1969134A1 - Produits d'amoxicilline à libération modifiée - Google Patents
- The value of a patent - Perpetual Motion Patents
- Navigating Technological Domains with Patent Landscape Analysis - Sagacious Research
- Search for patents - USPTO
- AI VISUALIZE, INC. v. NUANCE COMMUNICATIONS, INC. - CAFC US Courts