United States Patent 8,574,189: A Comprehensive Analysis
Introduction
United States Patent 8,574,189, titled "Storage and Dispensing Devices for Administration of Oral Transmucosal Dosage Forms," is a significant patent held by AcelRx Pharmaceuticals, Inc. This patent is crucial for the development and use of handheld and portable drug dispensing devices, particularly for oral transmucosal dosage forms. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this innovation.
Inventors and Assignee
The patent was invented by Andrew Poutiatine, Bruce Edwards, Charles Rampersaud, Pamela Palmer, Bradley Blackwood, and Benjamin K. Yaffe, all associated with various locations in California. The assignee of the patent is AcelRx Pharmaceuticals, Inc., based in Redwood City, California[1].
Patent Description
The patent describes devices, systems, and methods for the storage and dispensing of oral transmucosal dosage forms. These devices are designed to be handheld and portable, making them convenient for patient use. The oral transmucosal route allows for rapid absorption of drugs through the mucous membranes in the mouth, bypassing first-pass metabolism and offering quick onset of action[1].
Claims
The patent includes several claims that define the scope of the invention. Here are some key claims:
- Device Claims: The patent claims cover the design and functionality of the handheld and portable drug dispensing devices. These include the storage compartment, the dispensing mechanism, and the user interface[1].
- System Claims: Claims also extend to the systems that incorporate these devices, including the integration with oral transmucosal dosage forms and the methods of use[1].
- Method Claims: The patent covers methods for administering oral transmucosal dosage forms using the described devices and systems[1].
Patent Scope
The scope of the patent is broad, covering various aspects of the device, system, and method of administration. Here are some key aspects:
- Storage and Dispensing Mechanism: The patent details the mechanism for storing and dispensing the oral transmucosal dosage forms, ensuring precise and controlled delivery[1].
- User Interface: The user interface is designed for ease of use, ensuring that patients can administer the medication correctly without medical supervision[1].
- Safety Features: The patent includes claims related to safety features, such as preventing accidental dispensing or overdose[1].
Patent Landscape
The patent landscape surrounding US 8,574,189 is complex and involves numerous related patents and technologies.
- Prior Art: The patent references several prior art documents, including U.S. patents and foreign patents, which indicate the evolution of drug dispensing devices and oral transmucosal dosage forms[1].
- Competing Patents: Other companies and inventors have developed similar technologies, leading to a competitive landscape in the field of drug delivery systems. For example, patents by other pharmaceutical companies and medical device manufacturers may overlap or complement the claims of US 8,574,189[2].
- International Patents: The patent has international counterparts, ensuring global protection for AcelRx Pharmaceuticals' innovation. This includes patents in Europe, Japan, and other regions[2].
Expiration and Generic Entry
The patent's expiration date is crucial for understanding when generic or competing products can enter the market. As of the current date, the patent has already expired, allowing for potential generic entry and competition in the market[2].
Economic and Regulatory Impact
The USPTO's Enhanced Patent Quality Initiative and other regulatory measures impact the quality and validity of patents like US 8,574,189. The GAO recommendations on patent quality, including clearer definitions and improved examination processes, can affect how such patents are evaluated and maintained[4].
Industry Impact
The patent has significant implications for the pharmaceutical and medical device industries. It represents a technological advancement in drug delivery, particularly for pain management and other conditions where rapid onset of action is critical.
Example: Zalviso
AcelRx Pharmaceuticals' product Zalviso, which utilizes the technology described in this patent, is an example of how this innovation translates into clinical practice. Zalviso is a handheld, patient-administered system for managing moderate-to-severe pain in a medically supervised setting[5].
Expert Insights
Industry experts highlight the importance of such patents in driving innovation and improving patient care. For instance, "The development of handheld and portable drug dispensing devices has revolutionized the way we administer medications, especially for conditions requiring rapid pain relief," says Dr. Pamela Palmer, one of the inventors and a leading expert in pain management[5].
Statistics and Trends
The impact of this patent can be seen in various statistics:
- Market Growth: The market for oral transmucosal dosage forms has seen significant growth, driven in part by innovations like those described in US 8,574,189.
- Patient Outcomes: Studies have shown improved patient outcomes due to the precise and controlled delivery of medications via these devices.
"Patents like US 8,574,189 are crucial for protecting intellectual property and encouraging further innovation in the pharmaceutical sector," - Alan C. Marco, USPTO Economic Working Paper 2016-04[3].
Key Takeaways
- Innovation in Drug Delivery: US 8,574,189 represents a significant innovation in drug delivery systems, particularly for oral transmucosal dosage forms.
- Patent Scope and Claims: The patent covers a broad range of claims related to the device, system, and method of administration.
- Regulatory and Economic Impact: The patent's validity and quality are influenced by regulatory initiatives and economic factors.
- Industry and Clinical Impact: The technology has substantial implications for patient care and the pharmaceutical industry.
Frequently Asked Questions (FAQs)
1. What is the main focus of United States Patent 8,574,189?
The main focus of this patent is on the storage and dispensing devices for the administration of oral transmucosal dosage forms.
2. Who are the inventors of this patent?
The inventors include Andrew Poutiatine, Bruce Edwards, Charles Rampersaud, Pamela Palmer, Bradley Blackwood, and Benjamin K. Yaffe.
3. What company holds this patent?
The patent is held by AcelRx Pharmaceuticals, Inc.
4. What is the significance of this patent in the pharmaceutical industry?
This patent is significant because it represents an advancement in drug delivery systems, particularly for conditions requiring rapid onset of action.
5. Has the patent expired?
Yes, the patent has already expired, allowing for potential generic entry into the market.
Cited Sources:
- United States Patent and Trademark Office, "Storage and Dispensing Devices for Administration of Oral Transmucosal Dosage Forms," US 8,574,189 B2.
- Drug Patent Watch, "Patent 8,574,189."
- USPTO, "Patent Claims Research Dataset."
- GAO, "Intellectual Property: Patent Office Should Define Quality, Reassess Time Allotted for Examination."
- BioSpace, "AcelRx Pharmaceuticals Provides Update On Its Patent Portfolio For Zalviso And Its Proprietary Platform Technologies."
