Analyzing the Scope and Claims of United States Patent 5,601,839: A Comprehensive Guide
Introduction
United States Patent 5,601,839, titled "Triacetin as a penetration enhancer for transdermal delivery of a basic drug," is a significant patent in the field of pharmaceuticals, particularly in the area of transdermal drug delivery. This article will delve into the details of the patent's scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent, filed on October 24, 1994, and granted on February 11, 1997, describes a composition and method for enhancing the transdermal penetration of basic drugs using triacetin as a penetration enhancer. This innovation is crucial for improving the efficacy of transdermal drug delivery systems.
Scope of the Patent
Overview
The scope of the patent revolves around the use of triacetin, a chemical compound, to enhance the transdermal penetration of basic drugs. This involves the creation of a matrix patch that includes triacetin, an adhesive, and the basic drug, facilitating the drug's passage through the skin.
Key Components
- Triacetin: The primary component that acts as a penetration enhancer.
- Matrix Patch: A formulation that includes triacetin, an adhesive, and the basic drug.
- Basic Drug: The pharmaceutical substance intended for transdermal delivery, such as oxybutynin or scopolamine[4].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims are critical as they outline what is considered novel and non-obvious about the invention.
- Claim 1: Describes the composition of the matrix patch, including triacetin, an adhesive, and a basic drug.
- Claim 2: Outlines the method of enhancing transdermal penetration using the composition described in Claim 1[4].
Dependent Claims
Dependent claims further specify the details of the independent claims, such as the types of adhesives and polymers that can be used, and the specific drugs that can be delivered.
- Adhesives and Polymers: Includes specifications on the use of polysiloxanes, polyurethane, and poly(ethylene-vinyl acetate)[4].
- Specific Drugs: Mentions drugs like oxybutynin, scopolamine, and atropine[4].
Patent Landscape
Related Patents and Technologies
The patent landscape in the field of transdermal drug delivery is extensive and includes various technologies and patents related to penetration enhancers and drug delivery systems.
- Other Penetration Enhancers: Patents like US-5891461-A, which describes the transdermal administration of olanzapine, highlight the broader use of different penetration enhancers in the field[5].
- Global Patent System: The Global Dossier service provided by the USPTO allows for the tracking of related applications and patent families across different intellectual property offices, indicating a global interest in such technologies[1].
Industry Impact
The invention described in US 5,601,839 has significant implications for the pharmaceutical industry, particularly in the development of more effective transdermal drug delivery systems.
- Enhanced Efficacy: The use of triacetin as a penetration enhancer can improve the efficacy of transdermal patches, making them more viable treatment options.
- Cost and Convenience: Transdermal delivery systems can offer advantages in terms of cost and patient compliance compared to other delivery methods.
Patent Scope Metrics
Research on patent scope often involves metrics such as independent claim length and independent claim count. These metrics can provide insights into the breadth and clarity of the patent claims.
- Independent Claim Length: Shorter independent claims are often associated with narrower and more focused inventions, which can be beneficial for patent maintenance and litigation[3].
- Independent Claim Count: A lower number of independent claims can indicate a more streamlined and specific invention, potentially reducing the complexity of the patent examination process[3].
Legal and Regulatory Aspects
Patent Validity and Litigation
The validity and scope of the patent claims are crucial for determining the patent's enforceability and its potential for litigation.
- Patent Examination Process: The examination process tends to narrow the scope of patent claims, ensuring that the granted patents are more specific and less likely to be overly broad[3].
- Office Actions: Tools like the Patent Examination Data System (PEDS) and the Common Citation Document (CCD) help in identifying and managing office actions, which are critical for the patent's validity[1].
International Patent Search
To ensure the novelty and non-obviousness of the invention, it is essential to conduct a thorough international patent search.
- European Patent Office (EPO): Databases like esp@cenet provide access to European patent databases and machine translations, aiding in the search for prior art[1].
- World Intellectual Property Organization (WIPO): The PATENTSCOPE search service offers full-text searches of international patent applications, further facilitating the identification of related patents[1].
Conclusion
United States Patent 5,601,839 represents a significant advancement in the field of transdermal drug delivery. Understanding the scope and claims of this patent, along with the broader patent landscape, is crucial for innovators and industry professionals.
Key Takeaways
- Triacetin as a Penetration Enhancer: The patent highlights the use of triacetin to enhance the transdermal penetration of basic drugs.
- Matrix Patch Composition: The invention involves a specific composition including triacetin, an adhesive, and the basic drug.
- Industry Impact: The patent has significant implications for the development of more effective transdermal drug delivery systems.
- Patent Scope Metrics: Metrics such as independent claim length and count can provide insights into the patent's breadth and clarity.
- International Patent Search: Conducting a thorough international patent search is essential for ensuring the novelty and non-obviousness of the invention.
FAQs
What is the primary component used as a penetration enhancer in US 5,601,839?
The primary component used as a penetration enhancer is triacetin.
What is the purpose of the matrix patch described in the patent?
The matrix patch is designed to facilitate the transdermal delivery of basic drugs using triacetin as a penetration enhancer.
How does the patent examination process affect the scope of patent claims?
The examination process tends to narrow the scope of patent claims, ensuring that the granted patents are more specific and less likely to be overly broad[3].
What tools are available for conducting an international patent search?
Tools such as the European Patent Office's esp@cenet, the World Intellectual Property Organization's PATENTSCOPE, and the USPTO's Global Dossier service are available for conducting an international patent search[1].
What are some metrics used to measure the scope of patent claims?
Metrics such as independent claim length and independent claim count are used to measure the scope of patent claims[3].
