United States Patent 6,103,260: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,103,260, titled "Simethicone/anhydrous calcium phosphate compositions," is a significant patent in the field of pharmaceutical formulations, particularly for oral solid dosage forms. This patent, granted on August 15, 2000, addresses the formulation of antifoam preparations using simethicone and anhydrous calcium phosphate.
Background
Simethicone is a common antifoaming agent used in various pharmaceutical and medical applications to alleviate symptoms of gas and bloating. The patent aims to improve the formulation of simethicone-containing products, making them more effective and easier to manufacture.
Scope of the Patent
The patent focuses on the development of free-flowing granular compositions that combine simethicone with anhydrous calcium phosphate. Here are the key aspects of the patent's scope:
Composition
The invention involves an admixture of simethicone and anhydrous calcium phosphate, which forms a free-flowing granular composition. This composition is designed for use in oral solid dosage forms such as tablets and capsules[4].
Components
- Simethicone: The primary active ingredient, known for its antifoaming properties.
- Anhydrous Calcium Phosphate: Acts as a filler and helps in maintaining the free-flowing nature of the granular composition.
- Optional Ingredients: Other components like titanium dioxide, maltodextrin, and calcium silicate can be included to enhance the formulation's properties[4].
Claims
The patent includes several claims that define the scope of the invention:
Main Claims
- Claim 1: A free-flowing granular composition comprising an admixture of simethicone and anhydrous calcium phosphate.
- Claim 2: The composition of claim 1, where the simethicone is present in a specific ratio to the anhydrous calcium phosphate.
- Claim 3: The composition of claim 1, further including other ingredients such as titanium dioxide or maltodextrin[4].
Dependent Claims
These claims elaborate on the specific ratios, particle sizes, and surface areas of the components, ensuring the composition meets the desired physical and functional properties.
Patent Landscape Analysis
To understand the strategic implications of this patent, it is crucial to analyze the broader patent landscape.
Saturation Level
The patent space related to simethicone and calcium phosphate formulations is moderately saturated. Several prior patents, such as U.S. Pat. No. 4,906,478 and U.S. Pat. No. 5,073,384, have addressed similar formulations, indicating a well-explored area. However, the specific combination and improvements presented in U.S. Patent 6,103,260 offer unique advantages[4].
Competitor Analysis
Companies like those mentioned in patent landscape analyses often have extensive portfolios in pharmaceutical formulations. For instance, a company focusing significantly on niche technologies related to antifoaming agents might have a smaller but highly concentrated patent portfolio in this area, as seen in Figure 3B of the patent landscape analysis[3].
Strategic Insights
- Entry Barriers: Entering this patent space can be challenging due to the existing saturation. However, identifying gaps and opportunities for innovation, as highlighted by a comprehensive patent landscape analysis, can guide strategic decisions.
- Alternative Technologies: The patent landscape analysis can also reveal alternative technologies or formulations that might offer better market opportunities or fewer legal hurdles[3].
Manufacturing Process
The patent details a specific manufacturing process to achieve the desired free-flowing granular composition:
Steps Involved
- Mixing simethicone with anhydrous calcium phosphate.
- Optionally adding other ingredients like titanium dioxide or maltodextrin.
- Ensuring the granular composition meets specific physical properties such as particle size and surface area[4].
Advantages and Improvements
The patent offers several improvements over existing formulations:
Ease of Manufacture
The composition can be easily and inexpensively formulated into potent swallowable or chewable tablets, making it more viable for mass production[4].
Stability and Efficacy
The combination of simethicone and anhydrous calcium phosphate enhances the stability and efficacy of the antifoaming agent, providing better therapeutic outcomes.
Market Impact
The patent has significant implications for the pharmaceutical market:
Therapeutic Applications
The improved formulation can be used to treat various gastrointestinal disorders, such as gas, bloating, and indigestion, more effectively.
Competitive Advantage
Companies holding this patent can gain a competitive edge by offering superior products that are easier to manufacture and more effective in treating digestive issues.
Legal Status
As of the current date, the patent has expired, which means that the technology is now in the public domain. This allows other companies to use and build upon the invention without needing to obtain a license or pay royalties.
Conclusion
United States Patent 6,103,260 represents a significant advancement in the formulation of simethicone-containing oral solid dosage forms. The patent's scope, claims, and the broader patent landscape provide valuable insights for pharmaceutical companies looking to innovate and dominate the market.
Key Takeaways
- The patent involves a free-flowing granular composition of simethicone and anhydrous calcium phosphate.
- The composition is designed for ease of manufacture and improved therapeutic efficacy.
- The patent space is moderately saturated, but there are opportunities for innovation and strategic entry.
- The expired patent status allows for public use and further development of the technology.
Frequently Asked Questions (FAQs)
Q: What is the primary focus of United States Patent 6,103,260?
A: The primary focus is on the development of a free-flowing granular composition combining simethicone and anhydrous calcium phosphate for oral solid dosage forms.
Q: What are the key components of the composition?
A: The key components are simethicone and anhydrous calcium phosphate, with optional ingredients like titanium dioxide and maltodextrin.
Q: How does the patent improve existing formulations?
A: The patent improves the ease of manufacture and enhances the stability and efficacy of the antifoaming agent.
Q: What is the current legal status of the patent?
A: The patent has expired, making the technology available for public use.
Q: How can companies benefit from this patent?
A: Companies can benefit by using the technology to develop superior products, gaining a competitive edge in the market, and further innovating based on the public domain technology.
Cited Sources:
- U.S. Patent 6,103,260 - Simethicone/anhydrous calcium phosphate compositions[4].
- Patent Landscape Analysis - Uncovering Strategic Insights[3].
- Simethicone Formulation - Justia Patents[2].
