United States Patent 5,770,219: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,770,219, titled "Solid matrix system for transdermal drug delivery," is a significant invention in the field of pharmaceuticals, particularly in the area of transdermal drug delivery systems. This patent, granted on June 23, 1998, outlines a novel configuration for delivering drugs through the skin, a method that has become increasingly important in modern medicine.
Invention Overview
The patent describes a solid matrix system designed for the transdermal administration of drugs. This system involves a solid matrix that contains the active drug, along with other components such as permeation enhancers, stabilizers, and adhesives. The matrix is applied to the skin, allowing the drug to be released and absorbed over a prolonged period[5].
Claims Analysis
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims are crucial as they delineate what is considered novel and non-obvious about the invention.
- Claim 1: This claim describes the solid matrix system comprising a drug, a permeation enhancer, and an adhesive, all integrated into a single layer or multiple layers.
- Claim 5: This claim specifies the method of preparing the solid matrix system, including the steps of mixing the drug with the permeation enhancer and adhesive, and then forming the mixture into a desired shape.
Dependent Claims
Dependent claims further elaborate on the independent claims by adding additional limitations or features. For example:
- Claim 2: This claim depends on Claim 1 and adds the specification that the solid matrix system includes a stabilizer to enhance the shelf life of the drug.
- Claim 6: This claim depends on Claim 5 and details the use of a specific type of adhesive that improves the system's adhesion to the skin[5].
Scope of the Patent
The scope of the patent is defined by the claims and the detailed description provided in the specification. Here are some key aspects:
Components of the System
The patent specifies that the solid matrix system must include:
- A drug or active pharmaceutical ingredient.
- A permeation enhancer to facilitate the drug's passage through the skin.
- An adhesive to ensure the system adheres to the skin.
- Optional components such as stabilizers and other additives to enhance the system's performance and shelf life[5].
Method of Use
The method of using the system involves applying the solid matrix to the skin, where the drug is released over a specified period. This method is designed to provide a controlled and sustained release of the drug, which can improve patient compliance and therapeutic efficacy.
Patent Landscape
Prior Art and Related Patents
The patent landscape for transdermal drug delivery systems was already quite developed by the late 1990s. Several patents and publications had addressed various aspects of transdermal delivery, including the use of permeation enhancers and adhesives. However, the specific configuration and method described in Patent 5,770,219 were considered novel and non-obvious at the time of its issuance.
Citations and References
The patent cites several prior patents and publications that relate to transdermal drug delivery systems. For example, it references earlier work on permeation enhancers and adhesive systems, highlighting the advancements made by the current invention[5].
Impact on the Pharmaceutical Industry
The invention described in Patent 5,770,219 has had a significant impact on the pharmaceutical industry. It has contributed to the development of more effective and user-friendly transdermal drug delivery systems, which have become a staple in modern pharmacotherapy.
Clinical Applications
Transdermal drug delivery systems, as described in the patent, have been used for a variety of clinical applications, including pain management, hormone replacement therapy, and the treatment of cardiovascular diseases. These systems offer advantages such as reduced side effects, improved patient compliance, and sustained drug release[5].
Economic and Legal Considerations
Patent Scope and Quality
The scope and quality of patents, including those related to pharmaceuticals, have been subjects of ongoing debate. Metrics such as independent claim length and count are used to measure patent scope and clarity, which are critical for determining patent quality and validity[3].
Litigation and Licensing
Patents like 5,770,219 can be involved in litigation and licensing agreements. The clarity and breadth of the claims can affect the likelihood of disputes and the costs associated with licensing and litigation[3].
Current Status and Expiration
As of the current date, the patent has expired, as it was granted in 1998 and the typical term for a U.S. patent is 20 years from the filing date. This means that the technology described in the patent is now in the public domain and can be freely used without infringing on any patent rights.
Key Takeaways
- Novel Configuration: The patent describes a novel solid matrix system for transdermal drug delivery.
- Components and Method: The system includes a drug, permeation enhancer, adhesive, and optional stabilizers, applied to the skin for sustained drug release.
- Impact on Industry: The invention has significantly contributed to the development of effective transdermal drug delivery systems.
- Patent Landscape: The patent was part of a broader landscape of transdermal drug delivery innovations.
- Economic and Legal Considerations: The patent's scope and quality are important for determining its validity and potential for litigation.
FAQs
What is the main innovation of United States Patent 5,770,219?
The main innovation is the solid matrix system designed for transdermal drug delivery, which includes a drug, permeation enhancer, adhesive, and optional stabilizers.
How does the solid matrix system work?
The system works by applying the solid matrix to the skin, where the drug is released over a prolonged period, facilitated by the permeation enhancer and held in place by the adhesive.
What are the clinical applications of this invention?
The invention has been used in various clinical applications, including pain management, hormone replacement therapy, and the treatment of cardiovascular diseases.
Is the patent still in effect?
No, the patent has expired as it was granted in 1998 and the typical term for a U.S. patent is 20 years from the filing date.
How does this patent fit into the broader patent landscape for transdermal drug delivery?
The patent is part of a broader landscape of innovations in transdermal drug delivery, building on earlier work on permeation enhancers and adhesive systems.
Cited Sources
- United States Patent and Trademark Office. Patent Claims Research Dataset. Retrieved from https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Hoover Institution. Patent Claims and Patent Scope. Retrieved from https://www.hoover.org/sites/default/files/ip2-wp16001-paper.pdf
- Justia Patents. US Patent for Solid matrix system for transdermal drug delivery. Retrieved from https://patents.justia.com/patent/5770219
- United States Patent and Trademark Office. Search for patents. Retrieved from https://www.uspto.gov/patents/search
- United States Patent 5,770,219. Solid matrix system for transdermal drug delivery. Retrieved from https://patents.justia.com/patent/5770219