United States Patent 3,948,262: A Detailed Analysis
Introduction
The United States Patent 3,948,262, titled "Novel drug delivery device," is a significant patent in the field of pharmaceuticals and medical devices. This patent, assigned to Alza Corporation, pertains to a drug delivery system designed to administer drugs at a controlled rate over a prolonged period. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
The patent was filed on June 17, 1975, and granted on March 30, 1976. It is part of a series of patents related to transdermal drug delivery systems developed by Alza Corporation, a pioneer in this field[5].
Scope of the Patent
The patent 3,948,262 describes a novel drug delivery device designed to deliver drugs through the skin at a controlled rate. Here are the key aspects of the scope:
Device Description
The device consists of a reservoir containing the drug, a rate-controlling membrane, and an adhesive layer to secure the device to the skin. This configuration allows for the steady release of the drug into the bloodstream over an extended period[5].
Mechanism of Action
The device operates by using the rate-controlling membrane to regulate the flow of the drug from the reservoir through the skin. This ensures a consistent and predictable delivery rate, which is crucial for maintaining therapeutic levels of the drug in the body[5].
Claims
The patent includes several claims that define the scope of the invention:
Main Claims
- Claim 1: A drug delivery device comprising a reservoir containing a beneficial drug, a rate-controlling membrane, and an adhesive layer.
- Claim 2: The device of claim 1, where the rate-controlling membrane is permeable to the drug.
- Claim 3: The device of claim 1, where the adhesive layer is compatible with the skin and does not interfere with the drug delivery[5].
Dependent Claims
The patent also includes several dependent claims that further specify the materials, dimensions, and configurations of the device components.
Patent Landscape Analysis
Defining Scope and Keywords
To analyze the patent landscape around US 3,948,262, one must define the relevant technology field and keywords. Key terms include "transdermal drug delivery," "controlled release," "rate-controlling membrane," and "adhesive layer"[3].
Search and Organize Patents
Using patent databases, one can search for patents related to these keywords. Organizing these patents by factors such as filing date, assignee, and technology subcategories helps in understanding the evolution and trends in this field.
Identify Trends and Key Players
Alza Corporation is a significant player in this domain, with multiple patents related to transdermal drug delivery systems. Other key players include Ciba-Geigy Corporation, which was involved in litigation related to similar patents[1].
Analyze Citations and Evolution
The patent 3,948,262 has been cited in numerous subsequent patents, indicating its influence on the development of drug delivery technology. Analyzing these citations reveals how the technology has evolved over time, with improvements in materials, design, and delivery mechanisms[3].
Competitive Landscape
The competitive landscape in the field of transdermal drug delivery is highly competitive, with several companies holding patents for similar devices.
Key Competitors
- Alza Corporation: As the assignee of the patent, Alza has a strong portfolio in this area.
- Ciba-Geigy Corporation: Involved in the development and marketing of similar products, such as the ESTRADERM patch[1].
Technological Trends
The trend in this field is towards more efficient and targeted drug delivery systems. Advances in materials science and biotechnology have led to the development of more sophisticated devices that can deliver a wide range of drugs through the skin.
Legal and Litigation Context
The patent 3,948,262 has been involved in several legal disputes, particularly in the context of patent infringement.
Ciba-Geigy v. Alza
In one notable case, Ciba-Geigy and Alza sued PACO for infringing Alza's patents, including the '262 patent. This litigation highlights the importance of this patent in protecting intellectual property rights in the pharmaceutical industry[1].
Impact on the Pharmaceutical Industry
The invention described in US 3,948,262 has had a significant impact on the pharmaceutical industry by providing a reliable and efficient method for delivering drugs through the skin.
Therapeutic Applications
Transdermal drug delivery systems have been used to treat a variety of conditions, including nicotine addiction, hormonal imbalances, and pain management. The controlled release mechanism ensures consistent therapeutic levels, improving patient compliance and outcomes.
Future Directions
The future of transdermal drug delivery is promising, with ongoing research into new materials and technologies that can enhance the efficacy and safety of these devices.
Advances in Materials
New materials and formulations are being developed to improve the permeability and stability of the rate-controlling membrane and the adhesive layer.
Personalized Medicine
There is a growing trend towards personalized medicine, where drug delivery systems can be tailored to individual patient needs. This could involve using advanced biotechnology to create customized drug delivery profiles.
Key Takeaways
- Innovative Design: The patent 3,948,262 introduced a novel design for transdermal drug delivery, featuring a reservoir, rate-controlling membrane, and adhesive layer.
- Competitive Landscape: The field is highly competitive, with key players like Alza Corporation and Ciba-Geigy Corporation.
- Legal Significance: The patent has been involved in significant litigation, highlighting its importance in protecting intellectual property.
- Therapeutic Impact: Transdermal drug delivery systems have revolutionized the treatment of various conditions by providing a reliable and efficient delivery method.
- Future Trends: Ongoing research is focused on advancing materials and technologies to enhance the efficacy and safety of these devices.
Frequently Asked Questions
Q: What is the main innovation described in US Patent 3,948,262?
A: The main innovation is a transdermal drug delivery device with a reservoir, a rate-controlling membrane, and an adhesive layer to deliver drugs at a controlled rate.
Q: Who are the key players in the field of transdermal drug delivery?
A: Key players include Alza Corporation and Ciba-Geigy Corporation.
Q: What are the therapeutic applications of transdermal drug delivery systems?
A: These systems are used to treat conditions such as nicotine addiction, hormonal imbalances, and pain management.
Q: How has the patent 3,948,262 impacted the pharmaceutical industry?
A: It has provided a reliable and efficient method for delivering drugs through the skin, improving patient compliance and outcomes.
Q: What are the future directions in the development of transdermal drug delivery systems?
A: Future directions include advances in materials, personalized medicine, and the use of advanced biotechnology to create customized drug delivery profiles.
Sources
- CIBA-GEIGY CORP. v. ALZA CORP., 795 F. Supp. 711 - Casetext.
- US4434153A - Drug delivery system comprising a reservoir containing a plurality of tiny pills - Google Patents.
- How to Do Patent Landscape Analysis - Goldstein Patent Law.
- US3964482A - Drug delivery device - Google Patents.
- Drugs covered by patent 3,948,262 - Drug Patent Watch.
