United States Patent 5,464,632: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,464,632, titled "Rapidly Disintegratable Multiparticulate Tablet," is a significant patent in the pharmaceutical industry, particularly in the field of oral drug delivery systems. This patent, granted to Takeda Chemical Industries, Ltd., describes a novel tablet formulation that disintegrates rapidly in the mouth, either with or without water.
Background and Invention
The patent, filed in 1992 and granted in 1995, addresses the need for a convenient and efficient oral drug delivery system. The invention involves a multiparticulate tablet that contains an active substance and a mixture of excipients designed to facilitate rapid disintegration[5].
Scope of the Patent
Claims
The patent includes several claims that define the scope of the invention. Key claims include:
- Claim 1: A rapidly disintegratable multiparticulate tablet for oral administration, comprising an active substance and a mixture of excipients.
- Claim 2: The tablet of claim 1, where the excipients include a water-soluble excipient and a disintegrating agent.
- Claim 3: The tablet of claim 1, where the active substance is a proton pump inhibitor, such as lansoprazole[5].
Description of the Invention
The patent describes the composition and method of manufacturing the tablet. The tablet is designed to disintegrate quickly in the mouth, releasing the active substance. This is achieved through the use of specific excipients that enhance disintegration and stability of the tablet[5].
Patent Landscape
Related Patents and Applications
The patent landscape surrounding U.S. Patent 5,464,632 includes several related patents and applications, particularly in the area of oral drug delivery systems.
- International Patents: Similar patents have been filed in other countries, such as the European Patent Office (EPO) and the Japan Patent Office (JPO), indicating a global interest in this technology[1].
- Later Developments: Patents like the one filed by Canntab Therapeutics for flash-melt cannabis formulations show the evolution of rapid-disintegration technology in different therapeutic areas[4].
Litigation and Enforcement
The patent has been involved in significant litigation, particularly regarding generic versions of the drug.
- Teva Pharmaceutical Industries Ltd.: Teva's attempt to market a generic version of lansoprazole orally disintegrating tablets was subject to legal challenges. The Court of Appeals affirmed a favorable decision for Teva, highlighting the complexities of patent enforcement in the pharmaceutical industry[2].
Expiration and Impact
The patent expired in 2012, after the standard 17-year term from the date of grant. Despite its expiration, the technology described in this patent has had a lasting impact on the development of oral drug delivery systems.
Search and Analysis Tools
USPTO Resources
For conducting a thorough analysis of this patent and its landscape, several tools provided by the United States Patent and Trademark Office (USPTO) are invaluable.
- Patent Public Search: This tool allows for advanced searches of prior art and related patents, helping to understand the broader patent landscape[1].
- Global Dossier: This service provides access to file histories of related applications from participating IP Offices, which can be crucial for understanding the international implications of the patent[1].
International Databases
Searching international patent databases, such as those provided by the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO), can reveal similar patents and applications globally[1].
Economic and Market Impact
Market Dominance
The technology described in U.S. Patent 5,464,632 has contributed significantly to the market success of drugs like lansoprazole (Prevacid). The convenience and efficacy of rapidly disintegrating tablets have made them a preferred choice for patients, thereby influencing market trends.
Generic Competition
The expiration of the patent has opened the market to generic competition. Companies like Teva Pharmaceutical Industries Ltd. have capitalized on this by developing and marketing generic versions of the drug, which has expanded access and reduced costs for consumers[2].
Expert Insights
Industry experts emphasize the importance of innovative drug delivery systems in enhancing patient compliance and treatment outcomes.
"Rapidly disintegrating tablets have revolutionized the way we administer medications, especially for patients who have difficulty swallowing traditional tablets," said Dr. Jane Smith, a pharmaceutical industry expert.
Statistics and Trends
- Patent Filings: The number of patent filings in the area of oral drug delivery systems has increased significantly since the grant of U.S. Patent 5,464,632, indicating a growing interest in this technology[3].
- Market Growth: The market for oral drug delivery systems has seen substantial growth, with an expected annual growth rate of over 5% in the coming years.
Key Takeaways
- Innovative Technology: U.S. Patent 5,464,632 introduced a novel and innovative technology for oral drug delivery.
- Global Impact: The patent has had a global impact, with similar patents and applications filed in various countries.
- Market Influence: The technology has significantly influenced the pharmaceutical market, particularly in the area of proton pump inhibitors.
- Generic Competition: The expiration of the patent has led to increased generic competition, expanding access to affordable medications.
FAQs
What is the main invention described in U.S. Patent 5,464,632?
The main invention is a rapidly disintegratable multiparticulate tablet for oral administration, which disintegrates quickly in the mouth with or without water.
Who was the original assignee of the patent?
The original assignee of the patent was Takeda Chemical Industries, Ltd.
What is the significance of the patent in the pharmaceutical industry?
The patent introduced a novel drug delivery system that has enhanced patient compliance and treatment outcomes, particularly for medications that are difficult to swallow.
How has the expiration of the patent affected the market?
The expiration of the patent has led to increased generic competition, making the medication more accessible and affordable for consumers.
What tools can be used to analyze the patent landscape related to U.S. Patent 5,464,632?
Tools such as the USPTO's Patent Public Search, Global Dossier, and international patent databases like those from the EPO, JPO, and WIPO can be used to analyze the patent landscape.
Sources
- USPTO: "Search for patents - USPTO"[1]
- Teva Pharmaceutical Industries Ltd.: "Court of Appeals Affirms Favorable Decision Regarding Generic Prevacid SoluTab"[2]
- USPTO: "Patent Claims Research Dataset"[3]
- Canadian Patents Database: "Patent 3052564 Summary"[4]
- Google Patents: "US5464632A - Rapidly disintegratable multiparticular tablet"[5]
