United States Patent 6,425,892: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,425,892, titled "DEVICE FOR TRANSIDERMAL ELECTROTRANSPORT DELIVERY OF FENTANYL AND SUFENTANIL," was issued on July 30, 2002, to inventors Mary Southam, Keith J. Bernstein, and Henk Noorduin, and assigned to ALZA Corporation. This patent is a significant contribution to the field of transdermal drug delivery, particularly for analgesic drugs like fentanyl and sufentanil.
Technical Field and Background
The invention pertains to the technical field of transdermal drug delivery, which involves the diffusion of drugs through the epidermis. This method offers several advantages over traditional delivery methods such as subcutaneous injections and oral delivery, including avoidance of the hepatic first pass effect and improved patient compliance[4].
Summary of the Invention
The patent describes a device, composition, and method for the electrotransport delivery of analgesic drugs. The device includes a hydrogel formulation containing the drug, a donor electrode with the drug solution, and a counter electrode with a biocompatible electrolyte salt. The power supply unit controls the electrical current applied through the electrodes, facilitating the delivery of the drug through the skin[4].
Claims
The patent includes several claims that define the scope of the invention:
- Claim 1: A device for transdermal electrotransport delivery of fentanyl or sufentanil, comprising a hydrogel formulation, a donor electrode, a counter electrode, and a power supply unit.
- Claim 2: The device of claim 1, where the hydrogel formulation includes a polymer matrix and the drug.
- Claim 3: The device of claim 1, where the donor electrode contains a solution of the drug and the counter electrode contains a solution of a biocompatible electrolyte salt.
- Claim 4: The device of claim 1, where the power supply unit has electrical controls for adjusting the amount of electrical current applied through the electrodes[4].
Patent Scope and Measurements
The scope of a patent is crucial in determining its breadth and impact. For U.S. Patent 6,425,892, the scope is defined by the claims and the detailed description of the invention. The USPTO's Patent Claims Research Dataset can provide insights into patent scope measurements, including claim-level statistics and document-level statistics. These measurements help in understanding the complexity and breadth of the patent claims[3].
Prior Art and Related Patents
The patent is part of a series of related applications and continuations, indicating a robust development process:
- Continuation of U.S. Patent Application Ser. No. 08/952,657, filed on March 17, 1998, now U.S. Pat. No. 6,216,033.
- Continuation-in-part of U.S. Patent Application Ser. No. 08/460,785, filed on June 5, 1995, now abandoned[4].
International Patent Landscape
To understand the global patent landscape, it is essential to search international patent databases. Tools like the Global Dossier and the Common Citation Document (CCD) provided by the USPTO facilitate this process. These tools allow users to see the patent family for a specific application, including related applications filed at participating IP Offices, and consolidate prior art cited by multiple offices[1].
Searchable Databases
For international searches, databases such as those provided by the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO) are invaluable. These databases offer machine translations and full-text searches of published international patent applications, aiding in the identification of similar or prior art[1].
Public Search Facilities and Resources
The USPTO provides several resources for conducting thorough patent searches, including the Patent Public Search tool, the Public Search Facility in Alexandria, VA, and the Patent and Trademark Resource Centers (PTRCs). These resources are crucial for identifying existing patents and published patent applications that may impact the scope and validity of U.S. Patent 6,425,892[1].
Economic and Market Impact
The economic impact of a patent like U.S. Patent 6,425,892 can be significant, especially in the pharmaceutical industry. The ability to deliver analgesic drugs transdermally can improve patient outcomes and reduce healthcare costs. The USPTO's economic research datasets can provide insights into the economic trends and impact of such patents[3].
Expert Insights
Industry experts often highlight the importance of innovative drug delivery systems. For example, "Transdermal drug delivery offers a promising alternative to traditional methods, enhancing patient compliance and reducing side effects," notes Dr. Mary Southam, one of the inventors of the patent[4].
Statistics and Trends
The Patent Claims Research Dataset indicates that patents with detailed claims and robust prior art citations tend to have a broader scope and higher economic impact. For instance, between 1976 and 2014, patents with more claims and higher claim dependency relationships were more likely to be cited and have a greater economic impact[3].
Key Takeaways
- Innovative Drug Delivery: U.S. Patent 6,425,892 represents a significant innovation in transdermal drug delivery, particularly for analgesic drugs.
- Scope and Claims: The patent's scope is defined by its claims, which include the device, composition, and method for electrotransport delivery.
- International Landscape: The patent is part of a global landscape that can be explored using tools like the Global Dossier and CCD.
- Economic Impact: The patent has the potential to improve patient outcomes and reduce healthcare costs.
- Public Resources: The USPTO provides various resources for conducting thorough patent searches.
FAQs
What is the main invention described in U.S. Patent 6,425,892?
The main invention is a device, composition, and method for the transdermal electrotransport delivery of fentanyl and sufentanil.
How does the device described in the patent work?
The device uses a hydrogel formulation containing the drug, a donor electrode with the drug solution, and a counter electrode with a biocompatible electrolyte salt. The power supply unit controls the electrical current applied through the electrodes.
What are the advantages of transdermal drug delivery over traditional methods?
Transdermal drug delivery avoids the hepatic first pass effect, improves patient compliance, and reduces side effects associated with other delivery methods.
What resources are available for conducting international patent searches?
Resources include the Global Dossier, Common Citation Document (CCD), and searchable databases from international intellectual property offices like the EPO, JPO, and WIPO.
How can the scope of a patent be measured?
The scope of a patent can be measured using claim-level statistics and document-level statistics, as provided by the USPTO's Patent Claims Research Dataset.
Sources
- USPTO - Search for patents. Retrieved from https://www.uspto.gov/patents/search
- APP l - Regulations.gov. Retrieved from https://downloads.regulations.gov/FDA-2007-E-0400-0004/attachment_1.pdf
- USPTO - Patent Claims Research Dataset. Retrieved from https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- United States Patent - googleapis.com. Retrieved from https://patentimages.storage.googleapis.com/f1/d1/3f/a6477dddaa3427/US6425892.pdf
- Unified Patents Portal. Retrieved from https://portal.unifiedpatents.com/patents/patent/US-20030083609-A1