Detailed Analysis of the Scope and Claims of United States Patent 6,099,863
Introduction
United States Patent 6,099,863, titled "Fast-Dissolving Galantamine Hydrobromide Tablet," is a significant patent in the pharmaceutical field, particularly in the area of drug delivery systems. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent, granted on August 8, 2000, pertains to a fast-dissolving tablet formulation of galantamine hydrobromide, a drug used in the treatment of Alzheimer's disease. The inventors aimed to create a formulation that would improve the bioavailability and patient compliance of galantamine hydrobromide.
Scope of the Patent
Invention Overview
The patent describes a fast-dissolving tablet that contains galantamine hydrobromide as the active ingredient. This formulation is designed to dissolve quickly in the mouth, making it easier for patients to administer, especially those with difficulty swallowing tablets or capsules[5].
Key Components
- Active Ingredient: Galantamine hydrobromide, a cholinesterase inhibitor used to treat Alzheimer's disease.
- Excipients: The patent lists various excipients such as sweeteners, flavoring agents, and disintegrants that facilitate the fast-dissolving property of the tablet.
- Manufacturing Process: The method of preparing the tablets involves mixing the active ingredient with excipients and then compressing the mixture into a tablet form.
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention:
- Claim 1: A fast-dissolving tablet comprising galantamine hydrobromide, a sweetener, a flavoring agent, and a disintegrant.
- Claim 5: A method of preparing a fast-dissolving tablet comprising mixing galantamine hydrobromide with excipients and compressing the mixture into a tablet form[5].
Dependent Claims
Dependent claims further specify the details of the independent claims, such as the types of sweeteners, flavoring agents, and disintegrants that can be used, as well as the proportions of these components.
Patent Landscape
Classification and Categorization
The patent is classified under various categories in the U.S. Patent Classification system, including those related to pharmaceutical compositions and drug delivery systems. For instance, it falls under the category of "Drug, Bio-Affecting and Body Treating Compositions" and more specifically under subclasses related to "Cholinergic Agents" and "Tablets, Lozenges, or Pills"[5].
Related Patents and Prior Art
The patent landscape for fast-dissolving tablets and galantamine hydrobromide formulations is extensive. Other patents and prior art in this area include various formulations and delivery systems for similar drugs. For example, patents related to sustained-release systems and other drug delivery mechanisms are relevant in understanding the broader context of this invention[1].
International Patent Landscape
Similar patents and classifications exist in other jurisdictions. For instance, the European Patent Office (EPO) and the Japan Patent Office (JPO) have their own classification systems for pharmaceutical patents. The EPO's classification system, such as the Y01N class for nanotechnology, although not directly relevant here, illustrates the complexity and specificity of patent classification systems globally[4].
Impact and Significance
Patient Compliance
The fast-dissolving tablet formulation of galantamine hydrobromide significantly improves patient compliance, especially for elderly patients who may have difficulty swallowing traditional tablets or capsules.
Bioavailability
The quick dissolution of the tablet in the mouth can enhance the bioavailability of the drug, leading to more effective treatment outcomes.
Market and Competition
The patent has implications for the pharmaceutical market, particularly in the area of Alzheimer's disease treatment. It competes with other formulations and delivery systems, and its unique features can provide a competitive edge in terms of patient compliance and efficacy.
Legal and Regulatory Considerations
Patent Protection
The patent provides exclusive rights to the inventors and assignees for a specified period, protecting their invention from unauthorized use or reproduction.
Regulatory Approvals
The formulation would need to comply with regulatory requirements such as those set by the FDA, including clinical trials and safety evaluations, before it can be marketed and sold.
Future Developments and Trends
Advances in Drug Delivery Systems
The field of drug delivery systems is continuously evolving, with new technologies and formulations being developed. Future trends may include more sophisticated delivery systems, such as nanotechnology-based formulations, which could further enhance the efficacy and compliance of drugs like galantamine hydrobromide[4].
Patent Litigation and Enforcement
As with any patent, there is a potential for litigation and enforcement issues. The complexity of patent claims and the need for a small claims patent court, as discussed in recent studies, highlight the challenges in resolving patent disputes efficiently[2].
Key Takeaways
- Innovation in Drug Delivery: The patent represents an innovative approach to improving drug delivery systems, particularly for patients with swallowing difficulties.
- Scope and Claims: The patent's scope is defined by its independent and dependent claims, which specify the components and method of preparation of the fast-dissolving tablet.
- Patent Landscape: The patent is part of a broader landscape of pharmaceutical patents, with classifications and categorizations that reflect its unique features.
- Impact and Significance: The patent has significant implications for patient compliance, bioavailability, and market competition.
- Legal and Regulatory Considerations: The patent is subject to regulatory approvals and legal protections that ensure its exclusive use for a specified period.
FAQs
Q: What is the main innovation of United States Patent 6,099,863?
A: The main innovation is the development of a fast-dissolving tablet formulation of galantamine hydrobromide, designed to improve patient compliance and bioavailability.
Q: What are the key components of the fast-dissolving tablet?
A: The key components include galantamine hydrobromide as the active ingredient, sweeteners, flavoring agents, and disintegrants.
Q: How does the patent protect the invention?
A: The patent provides exclusive rights to the inventors and assignees for a specified period, protecting the invention from unauthorized use or reproduction.
Q: What are the regulatory requirements for this formulation?
A: The formulation must comply with regulatory requirements such as those set by the FDA, including clinical trials and safety evaluations.
Q: How does this patent fit into the broader patent landscape?
A: The patent is part of a broader landscape of pharmaceutical patents, classified under categories related to drug delivery systems and pharmaceutical compositions.
Sources
- United States Patent and Trademark Office: US 9,040,086 B2 - Timed, Sustained Release Systems for Propranolol[1].
- Administrative Conference of the United States: U.S. Patent Small Claims Court[2].
- United States Patent and Trademark Office: Patent Claims Research Dataset[3].
- OECD: Capturing Nanotechnology's Current State of Development via Patents[4].
- United States Patent and Trademark Office: US 6,099,863 - Fast-Dissolving Galantamine Hydrobromide Tablet[5].
