United States Patent 6,024,981: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,024,981, titled "Rapidly dissolving robust dosage form," is a significant innovation in the field of pharmaceuticals, particularly in the development of oral dosage forms. This patent, granted to Cima Labs, addresses the need for dosage forms that are both robust for storage and processing yet rapidly dissolve in the mouth.
Background and Context
The development of rapidly dissolving dosage forms has been a focus area in pharmaceutical research due to their convenience and patient compliance. Prior to this patent, existing technologies such as those from Zydis and other manufacturers had limitations in terms of production, storage, and cost[1].
Scope of the Patent
Overview
The patent describes a hard tablet that can be stored, packaged, and processed in bulk but dissolves rapidly in the mouth. This innovation combines the benefits of robustness with the convenience of rapid dissolution.
Key Components
- Active Ingredient Protection: The active ingredient is protected by a protective material, which can be an adsorbate, microgranule, or coating. This protection ensures the stability of the active ingredient during storage and handling[1].
- Dosage Form Design: The dosage form may include multiple active agents, each protected by different means. This allows for a versatile formulation that can accommodate various pharmaceutical needs[1].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention:
- Rapid Dissolution: The dosage form is designed to dissolve rapidly in the mouth, providing immediate release of the active ingredient[1].
- Robustness: The tablet is robust enough to be stored, packaged, and processed in bulk without compromising its integrity[1].
- Protective Coating: The use of protective coatings or microcapsules to ensure the stability and controlled release of the active ingredient[1].
Dependent Claims
Dependent claims further specify the details of the invention, including:
- Amount of Protective Material: The protective material is generally provided in an amount of between about 5 and about 96% by weight of the protected particle[1].
- Sustained Release Formulations: The patent also covers sustained release formulations where the active ingredient is released over a period of 10 hours or more[1].
Patent Landscape
Prior Art
The patent builds upon prior art in the field, including technologies from Zydis and other manufacturers. However, it addresses significant limitations of these prior technologies, such as high production costs and storage issues[1].
Related Patents
Other patents in this field include:
- U.S. Pat. No. 5,178,878: This patent by Wehling et al. describes oral dosage forms including microparticles and effervescents that rapidly disintegrate in the mouth[1].
- U.S. Pat. No. 4,940,588: This patent by Sparks et al. discusses the use of microgranules for protecting active ingredients[1].
Impact on the Pharmaceutical Industry
Patient Compliance
The rapidly dissolving robust dosage form enhances patient compliance by providing a convenient and easy-to-use medication form. This is particularly beneficial for patients who have difficulty swallowing traditional tablets or capsules.
Production and Storage
The robust nature of the dosage form simplifies production, storage, and transportation, reducing costs and logistical challenges associated with more fragile formulations.
Economic and Legal Considerations
Patent Scope and Quality
The scope of this patent is well-defined, avoiding the issues of overly broad claims that can lead to licensing and litigation costs. The patent's clarity and specificity align with the metrics for measuring patent scope discussed in research papers, such as independent claim length and count[3].
Global Patent System
The patent is part of a broader global patent system, and its validity can be assessed through tools like the Global Dossier and Common Citation Document (CCD) provided by the USPTO and other international intellectual property offices[4].
Technical Harmonization
The development of this patent contributes to the technical harmonization of the global patent system. It aligns with efforts to standardize and streamline patent processes, making it easier for innovators to protect and commercialize their inventions globally[4].
Key Takeaways
- Innovative Dosage Form: The patent introduces a robust yet rapidly dissolving dosage form, enhancing patient compliance and simplifying production and storage.
- Protected Active Ingredients: The use of protective materials ensures the stability and controlled release of active ingredients.
- Economic Benefits: The robust nature of the dosage form reduces production, storage, and transportation costs.
- Legal Clarity: The patent's well-defined scope avoids issues related to overly broad claims, aligning with metrics for patent quality.
FAQs
What is the main innovation of United States Patent 6,024,981?
The main innovation is the development of a hard tablet that is robust for storage and processing but dissolves rapidly in the mouth.
How does the patent address the limitations of prior technologies?
It addresses the high production costs, storage issues, and difficulties in masking unpleasant tastes associated with prior technologies like those from Zydis.
What are the key components of the dosage form described in the patent?
The key components include the active ingredient protected by a protective material, such as an adsorbate, microgranule, or coating, and the robust tablet design.
How does the patent impact patient compliance?
The rapidly dissolving dosage form enhances patient compliance by providing a convenient and easy-to-use medication form, especially beneficial for patients who have difficulty swallowing traditional tablets or capsules.
What are the economic benefits of this patent?
The robust nature of the dosage form reduces production, storage, and transportation costs, making it more economically viable than prior technologies.
Sources
- US6024981A - Rapidly dissolving robust dosage form - Google Patents
- Patent Claims Research Dataset - USPTO
- Patent Claims and Patent Scope - SSRN
- Search for patents - USPTO
- US Patent for Rapidly dissolving robust dosage form - Justia Patents
