Understanding the Scope and Claims of United States Patent 5,958,446
Introduction
United States Patent 5,958,446, titled "Transdermal Analgesic Systems Having a Reservoir Compartments," is a significant patent in the field of pharmaceuticals and drug delivery systems. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Title and Abstract
The patent, granted on September 28, 1999, pertains to transdermal analgesic systems designed to deliver pain-relieving medications through the skin. The abstract describes a system with reservoir compartments that contain the active pharmaceutical ingredient, ensuring a controlled and sustained release of the drug[4].
Claims Analysis
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims typically describe the essential features of the transdermal system, such as:
- The presence of reservoir compartments containing the analgesic.
- The use of a rate-controlling membrane to regulate the release of the drug.
- The composition of the adhesive layer that secures the system to the skin[4].
Dependent Claims
Dependent claims further specify the details of the invention, often building upon the independent claims. For example:
- Specific materials used for the reservoir compartments and the rate-controlling membrane.
- The dimensions and configuration of the system.
- The types of analgesics that can be used in the system[4].
Patent Scope
Technical Scope
The technical scope of the patent is focused on the design and functionality of transdermal analgesic systems. It covers the structural elements, such as reservoir compartments, rate-controlling membranes, and adhesive layers, as well as the materials and methods used to construct these systems.
Legal Scope
Legally, the patent grants the inventor exclusive rights to make, use, and sell the described transdermal analgesic systems. This includes the right to enforce the patent against any infringers and to license the technology to other parties.
Patent Landscape
Prior Art
The patent landscape for transdermal drug delivery systems was already well-established by the time this patent was granted. Prior art includes numerous patents related to transdermal systems, such as those by Keith Alec D, Gale Robert M, and Cleary Gary W, which describe various aspects of transdermal drug delivery[4].
Related Patents
Several related patents and applications were filed around the same time, indicating a vibrant and competitive field. For example, patents like US 4470962 A and US 4588580 A also deal with transdermal drug delivery systems, highlighting the ongoing innovation in this area[4].
Global Patent Family
The patent is part of a global patent family, with corresponding applications and grants in various countries such as Australia, Canada, China, Europe, Japan, and others. This global reach underscores the international interest and importance of this technology[4].
Economic and Practical Implications
Market Impact
The invention described in this patent has significant market implications. Transdermal analgesic systems offer a convenient and effective way to manage pain, which is a major healthcare concern. The controlled release mechanism ensures consistent drug delivery, enhancing patient compliance and treatment efficacy.
Cost and Accessibility
The design and materials used in these systems can affect their cost and accessibility. The patent's focus on specific materials and configurations may influence the manufacturing costs and, subsequently, the market price of these systems.
Legal and Regulatory Considerations
Patent Litigation
Patent litigation, as seen in cases like Hyatt v. United States Patent and Trademark Office, highlights the complexities and challenges associated with patent enforcement and interpretation. The scope and claims of a patent must be carefully defined to avoid disputes and ensure that the inventor's rights are protected[2].
Regulatory Compliance
Regulatory bodies, such as the USPTO, play a crucial role in ensuring that patents comply with legal standards. Tools like the Patent Public Search and Global Dossier help in assessing the novelty and non-obviousness of inventions, which are critical for patent grant and enforcement[1].
Future Directions and Innovations
Advancements in Drug Delivery
The field of transdermal drug delivery continues to evolve with advancements in materials science, nanotechnology, and biotechnology. Future innovations may include more sophisticated rate-controlling mechanisms, new types of analgesics, and improved adhesive technologies.
Small Claims Patent Court
The concept of a small claims patent court, as studied by the Administrative Conference of the United States (ACUS), could impact the landscape for patent disputes related to inventions like this. Such a court could provide a more streamlined and cost-effective way to resolve patent infringement cases, particularly for smaller entities[5].
Key Takeaways
- Patent Scope: The patent covers the design and functionality of transdermal analgesic systems with reservoir compartments and rate-controlling membranes.
- Claims: Independent and dependent claims define the essential features and specific details of the invention.
- Patent Landscape: The patent is part of a broader landscape of transdermal drug delivery systems, with significant prior art and related patents.
- Economic and Practical Implications: The invention has substantial market impact, affecting patient care and healthcare costs.
- Legal and Regulatory Considerations: Careful definition of scope and claims is crucial for patent enforcement and compliance with regulatory standards.
FAQs
What is the main invention described in US Patent 5,958,446?
The main invention is a transdermal analgesic system with reservoir compartments and a rate-controlling membrane to deliver pain-relieving medications through the skin.
How does the patent protect the inventor's rights?
The patent grants the inventor exclusive rights to make, use, and sell the described transdermal analgesic systems, and to enforce these rights against any infringers.
What is the significance of the global patent family for this invention?
The global patent family ensures that the inventor has protection and rights in multiple countries, facilitating international trade and collaboration.
How might future innovations in drug delivery impact this patent?
Future innovations could lead to more advanced rate-controlling mechanisms, new types of analgesics, and improved adhesive technologies, potentially expanding or modifying the scope of this patent.
What role could a small claims patent court play in disputes related to this patent?
A small claims patent court could provide a more efficient and cost-effective way to resolve patent infringement disputes, particularly beneficial for smaller entities involved in such cases.
Sources
- USPTO: "Search for patents - USPTO" - https://www.uspto.gov/patents/search
- CAFC: "Hyatt v. United States Patent and Trademark Office" - https://cafc.uscourts.gov/opinions-orders/21-2324.OPINION.9-8-2022_2001161.pdf
- USPTO: "Patent Claims Research Dataset" - https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- EPO: "EP 2269606 A2 20110105 - Transdermal analgesic systems having ..." - https://data.epo.org/gpi/EP2269606A2
- ACUS: "U.S. Patent Small Claims Court" - https://www.acus.gov/research-projects/us-patent-small-claims-court
