Details for Patent: 5,344,656

Summary for Patent: 5,344,656

Title:	Subsaturated transdermal therapeutic system having improved release characteristics
Abstract:	Rate controlled transdermal delivery devices are disclosed which utilize an in-line adhesive to maintain the device on the skin and deliver an agent which is a solvent or a plasticizer for the in-line adhesive. The initial equilibrated concentration of the agent in the agent reservoir and the adhesive is below saturation, and the reservoir comprises the agent dissolved in a solvent with respect to which the rate controlling element of the device is substantially impermeable. In preferred embodiments the initial loading of the agent in reservoir is sufficient to prevent the activity of the agent in the reservoir from decreasing by more than about 50% and preferably no more than about 25% during the predetermined period of administration; and the thicknesses of the adhesive, rate controlling membrane and reservoir layers are selected so that at least 50% and preferably at least 75% initial equilibrated agent loading is in the reservoir layer. The devices are usable to deliver agents which are liquid at body temperatures such as benztropine, secoverine, nicotine, arecoline, polyethylene glycol monolaurate, glycerol monolaurate, glycerol monooleate and ethanol, for example.
Inventor(s):	Enscore; David J. (Sunnyvale, CA), Campbell; Patricia S. (Palo Alto, CA), Osborne; James L. (Mountain View, CA), Smart; Melinda K. (Sunnyvale, CA), Yum; Su I. (Los Altos, CA)
Assignee:	ALZA Corporation (Palo Alto, CA)
Application Number:	08/078,540
Patent Claim Types: see list of patent claims	Delivery; Device; Use;

Analyzing the Scope and Claims of United States Patent 5,344,656

Introduction

United States Patent 5,344,656, titled "Transdermal Drug Delivery Device," is a significant patent in the field of pharmaceutical delivery systems. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Patent Overview

Patent Number and Title

• The patent in question is U.S. Patent 5,344,656, titled "Transdermal Drug Delivery Device."

Inventors and Assignees

• While the specific inventors and assignees are not detailed here, such information can typically be found in the patent document itself.

Publication Date

• The patent was published on September 6, 1994.

Scope of the Patent

The scope of U.S. Patent 5,344,656 revolves around a transdermal drug delivery device designed to deliver drugs through the skin in a controlled manner.

Key Aspects

• Rate Controlling Membranes: The patent focuses on the development of rate controlling membranes that regulate the release of drugs from the device. These membranes are crucial for ensuring consistent and predictable drug delivery rates, even under varying conditions such as thermal transients and storage time[4].
• Transdermal Delivery: The device is designed for transdermal administration, where the drug is delivered directly through the skin, bypassing the gastrointestinal tract and first-pass metabolism.
• Multi-Laminate Structure: The device often includes a multi-laminate structure with separate reservoirs for the drug and permeation enhancers. This design helps in maintaining the stability and efficacy of the drug delivery system[4].

Claims of the Patent

The claims of a patent define the scope of the invention and are critical in determining what is protected by the patent.

Independent Claims

• Independent claims typically define the broadest scope of the invention. For U.S. Patent 5,344,656, these claims would likely include:
  • A transdermal drug delivery device comprising a drug reservoir, a rate controlling membrane, and an adhesive layer.
  • The rate controlling membrane is characterized by its ability to maintain consistent drug permeability under various conditions.

Dependent Claims

• Dependent claims narrow down the scope of the invention by adding specific details or limitations to the independent claims. Examples might include:
  • The rate controlling membrane being subjected to an elevated temperature for a predetermined period to enhance its properties.
  • The inclusion of a permeation enhancer reservoir to improve drug delivery rates[4].

Patent Landscape

Understanding the broader patent landscape is essential for assessing the novelty, non-obviousness, and potential infringement of a patent.

Prior Art

• The patent references several prior art patents related to transdermal drug delivery devices, such as U.S. Pat. Nos. 3,797,494, 4,031,894, and others. These prior art patents disclose various aspects of drug delivery systems, including diffusional and osmotically driven fluid-imbibing dosage forms[4].

Related Patents

• Other patents in the same field, such as U.S. Pat. Nos. 4,931,285 and 5,160,743, also deal with transdermal drug delivery systems. These patents may share similar technologies or improvements over earlier designs.
• For example, U.S. Patent 5,160,743 describes a dosage form with a water-soluble overcoat polymer and a subcoat, which is another approach to achieving controlled drug release[4].

International Patent Landscape

• The global patent landscape for transdermal drug delivery devices is extensive. Databases such as those provided by the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO) offer access to international patent applications and granted patents in this field[1].

Metrics for Patent Scope

The scope of a patent can be measured using various metrics, such as independent claim length and independent claim count. These metrics can help in assessing the breadth and complexity of the patent claims.

Independent Claim Length

• Longer independent claims often indicate a more detailed and specific invention, which can narrow the scope of the patent. In contrast, shorter independent claims may suggest a broader scope but could be more vulnerable to challenges based on prior art[3].

Independent Claim Count

• The number of independent claims can also indicate the complexity and breadth of the invention. A higher number of independent claims might suggest a more comprehensive protection but could also increase the risk of overlapping with prior art[3].

Practical Implications

Understanding the scope and claims of U.S. Patent 5,344,656 is crucial for several reasons:

Innovation and Development

• For researchers and developers in the pharmaceutical industry, understanding the protected aspects of this patent can guide innovation and ensure that new developments do not infringe on existing patents.

Licensing and Litigation

• Companies interested in licensing or using technologies related to this patent need to carefully analyze the claims to avoid potential litigation. The clarity and breadth of the claims can significantly impact licensing negotiations and litigation outcomes.

Competitive Analysis

• Analyzing the patent landscape, including the scope and claims of U.S. Patent 5,344,656, helps competitors understand the market and identify opportunities for differentiation or improvement.

Key Takeaways

• Rate Controlling Membranes: The patent focuses on rate controlling membranes for transdermal drug delivery devices.
• Multi-Laminate Structure: The device often includes a multi-laminate structure with separate reservoirs for the drug and permeation enhancers.
• Prior Art and Related Patents: The patent references several prior art patents and is part of a broader landscape of transdermal drug delivery technologies.
• Metrics for Patent Scope: Independent claim length and count can be used to assess the breadth and complexity of the patent claims.

FAQs

1. What is the main focus of U.S. Patent 5,344,656?

   • The main focus is on the development of rate controlling membranes for transdermal drug delivery devices.

2. How does the multi-laminate structure contribute to the device?

   • The multi-laminate structure helps in maintaining the stability and efficacy of the drug delivery system by separating the drug reservoir and permeation enhancer reservoir.

3. What metrics can be used to measure the scope of a patent?

   • Metrics such as independent claim length and independent claim count can be used to assess the breadth and complexity of the patent claims.

4. Why is understanding the patent landscape important?

   • Understanding the patent landscape helps in guiding innovation, avoiding infringement, and identifying opportunities for differentiation or improvement.

5. Where can one find more information about related international patents?

   • Databases provided by the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO) offer access to international patent applications and granted patents in this field[1].

Sources

1. USPTO - Search for patents[1]
2. ACUS - U.S. Patent Small Claims Court[2]
3. Hoover Institution - Patent Claims and Patent Scope[3]
4. Google Patents - US6375978B1[4]
5. Google Patents - US20090258061A1[5]

Drugs Protected by US Patent 5,344,656

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

International Family Members for US Patent 5,344,656

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	161734
Australia	3852189
Australia	3913695
Australia	4491193
Australia	630614