Detailed Analysis of the Scope and Claims of United States Patent 4,209,513
Introduction
United States Patent 4,209,513, titled "Tablet formulation," is a patent that describes a specific formulation for tablets used in the treatment of microbial infections. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Publication Number and Authority
The patent number is US4209513A, and it was issued by the United States Patent and Trademark Office (USPTO)[4].
Invention Description
The patent describes a tablet formulation that combines a 2,4-diaminopyrimidine with a sulphonamide, specifically designed for treating microbial infections. The formulation includes a high proportion of active ingredients, typically between 80% to 98% by weight, with the remainder consisting of disintegrating and granulating agents. The particle size of the active ingredients is less than 40 micrometers, and the disintegrating agent has a swelling capacity greater than 5 ml/g[4].
Claims Analysis
Independent Claims
The patent includes several independent claims that define the scope of the invention. Here are some key claims:
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Claim 1: A tablet comprising from 80 to 98% by weight of a combination of a 2,4-diaminopyrimidine and a sulphonamide, with the remainder being a disintegrating agent and a granulating agent, where the total amount of these agents is not more than 20% by weight[4].
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Claim 2: A tablet where the active ingredient is present in a ratio from 1:20 to 20:1, preferably 1:5, and has a particle size greater than 1 micrometer, preferably 2 micrometers[4].
Dependent Claims
Dependent claims further specify the preferred embodiments of the invention, such as:
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Claim 3: A tablet containing from 1 to 5% by weight of a granulating agent and from 1 to 5% by weight of a disintegrating agent, with the disintegrating agent having a swelling capacity greater than 10 ml/g[4].
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Claim 4: A tablet containing from 100 to 900 mg of the active ingredient, with a preferred example being a tablet containing trimethoprim (80 mg) and sulphamethoxazole (400 mg)[4].
Scope of the Invention
Active Ingredients and Ratios
The patent emphasizes the use of a specific combination of active ingredients: a 2,4-diaminopyrimidine and a sulphonamide. The ratio of these ingredients can vary from 1:20 to 20:1, with a preferred ratio of 1:5. This combination is crucial for the efficacy of the tablet in treating microbial infections[4].
Particle Size and Excipients
The particle size of the active ingredients is critical, with a requirement that it be less than 40 micrometers. The use of disintegrating and granulating agents is also specified, with their total amount not exceeding 20% by weight. The disintegrating agent must have a swelling capacity greater than 5 ml/g, which ensures the tablet disintegrates effectively in the body[4].
Patent Landscape
Prior Art and Related Patents
To understand the patent landscape, it is essential to look at prior art and related patents. The USPTO's Patent Public Search tool and other international databases can be used to search for similar patents. For instance, the European Patent Office's esp@cenet and the World Intellectual Property Organization's PATENTSCOPE can provide insights into global patent filings related to pharmaceutical formulations[1].
Competing Formulations
Other patents and publications may describe similar or competing formulations for treating microbial infections. Analyzing these can help identify gaps or opportunities in the market. For example, patents that describe different ratios of active ingredients or alternative excipients could be of interest[1].
Patent Analytics and Claim Coverage
Claim Coverage Matrix
Using patent analytics tools, such as those provided by Schwegman, can help in understanding which patents and claims are actively protecting the intellectual property related to this tablet formulation. A Claim Coverage Matrix can categorize patents by claims and scope concepts, making it easier to identify gaps in coverage and future design opportunities[5].
Interactive Claim Charts
Tools like ClaimScape® software generate interactive claim charts that can be reviewed by technical experts to determine the applicability of specific scope concepts to target products or methods. This helps in identifying areas where claim coverage is lacking and highlights potential future directions[5].
Economic and Practical Considerations
Cost and Efficiency
The formulation described in the patent offers economic benefits due to the high proportion of active ingredients, which reduces the need for excipients. This can lead to cost savings in manufacturing and potentially make the product more competitive in the market[4].
Regulatory Compliance
Ensuring compliance with regulatory standards is crucial. The patent describes methods for determining the disintegration time, hardness, and dissolution time of the tablets, which are in line with standards such as those outlined in the British Pharmacopoeia and the U.S. Pharmacopeia[4].
Conclusion
United States Patent 4,209,513 provides a detailed description of a tablet formulation for treating microbial infections, with specific claims regarding the composition and properties of the tablet. Understanding the scope and claims of this patent, along with analyzing the broader patent landscape, is essential for any company looking to develop or improve similar pharmaceutical products.
Key Takeaways
- The patent describes a tablet formulation with a high proportion of active ingredients (2,4-diaminopyrimidine and sulphonamide) and specific excipients.
- The particle size and swelling capacity of the disintegrating agent are critical for the tablet's efficacy.
- Patent analytics tools can help in understanding claim coverage and identifying gaps or opportunities.
- Compliance with regulatory standards is essential for the manufacturing and marketing of the tablet.
- The economic benefits of the formulation include cost savings due to reduced excipients.
FAQs
Q: What are the key active ingredients in the tablet formulation described in US Patent 4,209,513?
A: The key active ingredients are a 2,4-diaminopyrimidine and a sulphonamide, specifically trimethoprim and sulphamethoxazole.
Q: What is the significance of the particle size of the active ingredients in the patent?
A: The particle size must be less than 40 micrometers to ensure effective disintegration and absorption of the active ingredients.
Q: How can patent analytics help in managing intellectual property related to this patent?
A: Patent analytics tools can help in categorizing patents by claims and scope concepts, identifying gaps in coverage, and highlighting future design opportunities.
Q: What regulatory standards must the tablet formulation comply with?
A: The formulation must comply with standards such as those outlined in the British Pharmacopoeia and the U.S. Pharmacopeia for disintegration time, hardness, and dissolution time.
Q: What are the economic benefits of the tablet formulation described in the patent?
A: The high proportion of active ingredients reduces the need for excipients, leading to cost savings in manufacturing.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- ACUS - U.S. Patent Small Claims Court: https://www.acus.gov/research-projects/us-patent-small-claims-court
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents - US4209513A: https://patents.google.com/patent/US4209513A/en
- Schwegman - Patent Analytics: https://www.slwip.com/services/patent-analytics/
