United States Patent 6,955,821: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,955,821, titled "Sustained release formulations of guaifenesin and additional drug ingredients," is a significant patent in the pharmaceutical industry, particularly in the field of drug delivery systems. This patent, issued to Reckitt Benckiser LLC, outlines innovative formulations for sustained release of guaifenesin, a common expectorant, along with other drug ingredients.
Background and Context
Guaifenesin is widely used to treat respiratory conditions such as coughs and congestion. The patent addresses the need for formulations that provide both immediate and sustained release of this drug, enhancing patient compliance and therapeutic efficacy.
Patent Scope and Claims
Overview of Claims
The patent includes several claims that define the scope of the invention. Here are the key aspects:
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Sustained Release Formulations: The patent describes formulations that combine guaifenesin with at least one additional drug ingredient. These formulations are designed to provide a sustained release of the active ingredients over a prolonged period[4].
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Polymer Combinations: The sustained release portion of the formulation typically includes a combination of hydrophilic and water-insoluble polymers in specific ratio ranges (e.g., 1:1 to 9:1, with preferred ranges of 3:2 to 6:1 and most preferably 2:1 to 4:1)[4].
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Formulation Types: The patent covers various forms of the sustained release formulations, including bi-layered tablets, capsules with beads or granules, and tablets with a core coated by an immediate release layer[4].
Claim Specifics
The claims are detailed and specific, ensuring that the invention is well-defined and distinguishable from prior art. For example:
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Claim 1: This claim describes a sustained release formulation comprising guaifenesin and at least one additional drug ingredient, with the sustained release portion including a combination of hydrophilic and water-insoluble polymers[4].
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Dependent Claims: Subsequent claims elaborate on the specific ratios of polymers, the types of formulations (e.g., bi-layered tablets, capsules), and the characteristics of the release profiles (e.g., maximum serum concentration and time of availability in the bloodstream)[4].
Patent Landscape
Prior Art and Related Patents
The patent landscape for sustained release formulations is complex, with numerous patents addressing various aspects of drug delivery. The '821 patent distinguishes itself through its specific combination of polymers and the design of the bi-layered tablets or capsules.
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Global Dossier: Using tools like the Global Dossier, one can see the patent family for this specific application, including related applications filed at participating IP Offices. This helps in understanding the global scope and any potential challenges or opportunities in different jurisdictions[1].
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International Patent Offices: Searching databases from other international intellectual property offices, such as the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO), can reveal similar or competing patents in other regions[1].
Litigation and Enforcement
The '821 patent has been involved in litigation, highlighting its importance and the competitive nature of the pharmaceutical industry.
- Reckitt Benckiser LLC v. Amneal Pharmaceuticals LLC: In this case, Amneal stipulated that its ANDA (Abbreviated New Drug Application) products satisfied every limitation of the asserted claims of the '821 patent except for one, indicating the patent's enforceability and the need for careful consideration in generic drug development[2].
Technical Details and Innovations
Formulation Design
The patent provides detailed descriptions of the formulation design, including the types of polymers used and their ratios. This is crucial for achieving the desired release profile.
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Bi-Layered Tablets: The bi-layered tablet design, with one portion comprising a sustained release formulation and the other an immediate release formulation, ensures both rapid onset and prolonged duration of action[4].
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Capsules and Granules: The use of capsules with beads or granules of both immediate and sustained release formulations offers flexibility in dosage forms and can enhance patient compliance[4].
Pharmaceutical Benefits
The sustained release formulations described in the patent offer several pharmaceutical benefits:
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Improved Efficacy: By providing a sustained release of guaifenesin, these formulations can maintain therapeutic levels of the drug over a longer period, improving the treatment efficacy for respiratory conditions[4].
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Enhanced Patient Compliance: The combination of immediate and sustained release components can reduce the frequency of dosing, making it easier for patients to adhere to their treatment regimen[4].
Economic and Market Impact
Market Dominance
The '821 patent has contributed to Reckitt Benckiser's market dominance in the respiratory drug market. The innovative formulations protected by this patent have allowed the company to differentiate its products and maintain a competitive edge.
- Revenue Generation: Patents like the '821 patent are crucial for generating revenue through licensing agreements, royalties, and the sale of proprietary products[3].
Competitive Landscape
The pharmaceutical industry is highly competitive, and patents play a critical role in this landscape.
- Generic Competition: The involvement of the '821 patent in litigation against generic drug manufacturers highlights the importance of patent protection in preventing generic competition and maintaining market share[2].
Search and Analysis Tools
USPTO Resources
For conducting a thorough analysis of the '821 patent and its landscape, several USPTO resources are invaluable:
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Patent Public Search: This tool provides enhanced access to prior art and allows for a comprehensive search of patent documents[1].
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Global Dossier: This service offers access to the file histories of related applications from participating IP Offices, facilitating a global view of the patent family[1].
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Patent and Trademark Resource Centers (PTRCs): These centers provide local search resources and training in patent search techniques, which can be beneficial for detailed analysis[1].
Conclusion
The United States Patent 6,955,821 is a pivotal patent in the field of pharmaceuticals, particularly in sustained release formulations. Its detailed claims and innovative design have significant implications for both the technical and economic aspects of drug development and market competition.
Key Takeaways
- Innovative Formulations: The patent describes novel sustained release formulations combining guaifenesin with other drug ingredients.
- Specific Polymer Combinations: The use of hydrophilic and water-insoluble polymers in specific ratios is a key aspect of the invention.
- Bi-Layered Tablets and Capsules: The patent covers various dosage forms, including bi-layered tablets and capsules with beads or granules.
- Pharmaceutical Benefits: The formulations offer improved efficacy and enhanced patient compliance.
- Economic Impact: The patent contributes to market dominance and revenue generation through licensing and royalties.
- Competitive Landscape: The patent is crucial in preventing generic competition and maintaining market share.
FAQs
What is the main innovation of the '821 patent?
The main innovation is the development of sustained release formulations of guaifenesin combined with other drug ingredients, using specific ratios of hydrophilic and water-insoluble polymers.
How does the bi-layered tablet design work?
The bi-layered tablet design includes one portion with a sustained release formulation and another portion with an immediate release formulation, ensuring both rapid onset and prolonged duration of action.
What are the benefits of the sustained release formulations described in the patent?
The benefits include improved efficacy by maintaining therapeutic levels of the drug over a longer period and enhanced patient compliance by reducing the frequency of dosing.
Has the '821 patent been involved in any litigation?
Yes, the '821 patent has been involved in litigation, such as the case against Amneal Pharmaceuticals LLC, highlighting its importance and enforceability.
How can one conduct a thorough analysis of the '821 patent and its landscape?
One can use USPTO resources like Patent Public Search, Global Dossier, and Patent and Trademark Resource Centers (PTRCs) to conduct a comprehensive analysis.
Sources
- USPTO - Search for patents. Retrieved from https://www.uspto.gov/patents/search
- Robins Kaplan - Reckitt Benckiser LLC v. Amneal Pharms. LLC. Retrieved from https://www.robinskaplan.com/newsroom/insights/reckitt-benckiser-llc-v-amneal-pharms-llc
- USPTO - Patent Claims Research Dataset. Retrieved from https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents - US6955821B2. Retrieved from https://patents.google.com/patent/US6955821B2/en
