Detailed Analysis of the Scope and Claims of United States Patent 6,350,468
Introduction
United States Patent 6,350,468, titled "Double capsule for the administration of active principles in multiple therapies," is a pharmaceutical patent that introduces a novel dosage form designed for the treatment of multiple therapies, particularly targeting Helicobacter pylori infections. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Invention Description
The patent describes a pharmaceutical dosage form consisting of a double capsule, where one capsule is placed inside another. This design is specifically tailored for the administration of active principles in multiple therapies, such as the treatment of Helicobacter pylori, which can cause gastritis and gastroduodenal ulcers[3].
Key Components
- The inner capsule contains non-coated tetracycline.
- The outer capsule contains bismuth biscalcitrate and metronidazole.
- This configuration allows for the simultaneous administration of multiple active principles, simplifying the treatment regimen compared to traditional methods that require multiple tablets several times a day[3].
Claims Analysis
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims typically cover the composition of the double capsule, the active principles it contains, and the method of administration.
Dependent Claims
Dependent claims further specify the invention by detailing the characteristics of the capsules, such as the materials used, the dissolution properties, and the stability of the active principles under various conditions[3].
Prior Art and Related Patents
Prior Art
The patent references several prior art patents and applications, including U.S. Pat. No. 5,196,205 and U.S. Pat. No. 5,310,555, which describe similar dosage forms but with different configurations and applications. For example, Patent JP 60-193917 and Patent DE 2,729,068 describe other types of double capsule designs[3].
Related Patents
Other related patents, such as U.S. Pat. No. 5,501,857 and Patent FR 2,524,311, also discuss double and triple capsule designs for different therapeutic applications. These patents highlight the evolving nature of pharmaceutical dosage forms and the ongoing innovation in this field[3].
Patent Landscape Analysis
Geographical Spread
The patent landscape for pharmaceutical dosage forms, particularly those targeting Helicobacter pylori, is global. Major patent offices such as the USPTO, EPO, JPO, and WIPO have numerous patents and applications related to this technology. This indicates a significant international interest in developing innovative treatments for this condition[1][5].
Saturation Level
The patent space for pharmaceutical dosage forms, especially those involving multiple active principles, is moderately saturated. However, there are still opportunities for innovation, particularly in niche areas such as targeted delivery systems and combination therapies. A comprehensive patent landscape analysis would reveal the saturation level and identify potential gaps in the market[4].
New Entrants and Time-Slicing
New entrants into this patent space often bring fresh perspectives and technologies. Time-slicing analysis, which examines changes over time, can reveal trends and shifts in the focus of research and development. For instance, there has been an increasing focus on combination therapies and targeted delivery systems in recent years[4].
Competitive Analysis
Key Players
Major pharmaceutical companies and research institutions are key players in this patent space. Companies like Pfizer, Merck, and GlaxoSmithKline have significant portfolios related to gastrointestinal treatments and pharmaceutical dosage forms. Smaller biotech firms and academic institutions also contribute to the innovation in this area[4].
Niche Areas
Identifying underappreciated niche areas is crucial for strategic decision-making. For example, the use of double capsules for delivering nutritional supplements to animals, as described in U.S. Pat. No. 5,310,555, represents a niche area that could be further explored for human therapies[3].
Search and Analysis Tools
Patent Databases
Several patent databases are essential for conducting a thorough analysis of the patent landscape. These include:
- Patent Public Search by the USPTO, which provides enhanced access to prior art.
- Espacenet by the EPO, which covers European and international patents.
- Patentscope by WIPO, which includes full-text international patent applications[1][5].
Global Dossier
The Global Dossier service allows users to access file histories of related applications from participating IP offices, providing a comprehensive view of the patent family and related data[1].
Strategic Insights
Decision-Making
A comprehensive patent landscape analysis helps business and R&D management make informed decisions about entering or continuing research in a particular technology area. For instance, if the patent space is highly saturated, it may be advisable to pivot to newer inventive spaces[4].
Counseling Clients
Attorneys and IP professionals can use the insights from patent landscape analysis to counsel clients on the potential rewards and risks of investing in or developing new technologies. This includes assessing the competition, identifying new entrants, and understanding the geographical spread of the technology[4].
Key Takeaways
- Innovation in Dosage Forms: The patent highlights the ongoing innovation in pharmaceutical dosage forms, particularly for combination therapies.
- Global Interest: The geographical spread of patents related to this technology indicates a global interest in treating Helicobacter pylori infections.
- Moderate Saturation: The patent space is moderately saturated, with opportunities for innovation in niche areas.
- Strategic Decision-Making: Comprehensive patent landscape analysis is crucial for making informed strategic decisions.
Frequently Asked Questions (FAQs)
What is the main innovation of United States Patent 6,350,468?
The main innovation is the design of a double capsule for the simultaneous administration of multiple active principles, specifically for treating Helicobacter pylori infections.
How does this patent differ from prior art?
This patent differs from prior art by its specific configuration of a double capsule with non-coated tetracycline in the inner capsule and bismuth biscalcitrate and metronidazole in the outer capsule.
What are the key components of the double capsule?
The key components include an inner capsule containing non-coated tetracycline and an outer capsule containing bismuth biscalcitrate and metronidazole.
What tools are available for conducting a patent landscape analysis?
Tools include the USPTO's Patent Public Search, EPO's Espacenet, WIPO's Patentscope, and the Global Dossier service.
Why is patent landscape analysis important for business decisions?
Patent landscape analysis provides strategic insights into the saturation level of a technology area, identifies new entrants, and helps in making informed decisions about research and development investments.
Cited Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents - Double capsule for the administration of active principles in multiple therapies: https://patents.google.com/patent/US6350468B1/en
- AcclaimIP - Patent Landscape Analysis: https://www.acclaimip.com/patent-landscaping/patent-landscape-analysis-uncovering-strategic-insights/
- Harvard Business School Library - Patent search: A comparative table of databases: https://asklib.library.hbs.edu/faq/266950
