Detailed Analysis of the Scope and Claims of United States Patent 8,486,972
Introduction
United States Patent 8,486,972, titled "Sublingual fentanyl spray," is a patent that addresses a specific formulation and delivery method for fentanyl, a potent opioid used for pain management. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent, issued on July 2, 2013, is assigned to a company that has developed a unique formulation and delivery system for sublingual administration of fentanyl. This invention aims to provide an effective and convenient method for managing pain using fentanyl[4].
Scope of the Patent
Objectives of the Invention
The primary objective of the invention is to provide a fentanyl formulation suitable for sublingual administration. This involves creating a device that delivers a therapeutically effective dose of fentanyl in the form of liquid droplets with specific size distributions. The invention focuses on ensuring effective pain management through this sublingual delivery method[4].
Key Components
- Device Description: The patent describes a device that includes a reservoir containing a unit dose of a liquid formulation of fentanyl or its derivatives. The device has an actuator that, when activated, delivers the unit dose in the form of liquid droplets.
- Droplet Size Distribution: The droplets have a mean diameter ranging from about 10 microns to about 200 microns, with preferred ranges specified to ensure optimal delivery and absorption[4].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention:
- Claim 1: This claim describes the device and its components, including the reservoir and actuator, and specifies the delivery of fentanyl in liquid droplets with a particular size distribution.
- Claim 10: This claim focuses on the method of administering fentanyl using the described device, emphasizing the sublingual delivery and the therapeutic effectiveness of the formulation[4].
Dependent Claims
Dependent claims further detail specific aspects of the invention, such as:
- Claim 2: This claim specifies the size distribution of the liquid droplets, providing more detailed ranges (e.g., from about 20 microns to about 100 microns).
- Claim 3: This claim describes the pharmaceutically acceptable liquid carrier used in the formulation[4].
Patent Landscape
Related Patents and Applications
The patent landscape for sublingual fentanyl formulations is complex, with multiple patents and applications addressing similar or related technologies. For instance:
- International Patent Offices: Similar patents may exist in other countries, accessible through databases like the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO)[1].
- Prior Art: The Common Citation Document (CCD) application can help consolidate prior art cited by various offices, providing a comprehensive view of the existing patent landscape[1].
Competing Technologies
Other companies and inventors may have developed competing technologies for sublingual fentanyl delivery. Analyzing these through patent analytics tools, such as those provided by Schwegman, can help identify gaps and opportunities in the current patent coverage[3].
Patent Analytics and Claim Coverage
Claim Coverage Matrix
To understand the full scope of protection provided by this patent, a Claim Coverage Matrix can be used. This matrix categorizes patents and claims by scope concepts, helping to identify which claims are actively protecting the intellectual property and where gaps or opportunities exist[3].
Interactive Claim Charts
Tools like ClaimScape® software generate interactive claim charts that can be reviewed by technical experts to determine the applicability of scope concepts to target products or methods. This helps in identifying areas where claim coverage is lacking and highlights future design opportunities[3].
Legal and Regulatory Considerations
Patent Litigation
Patents like US 8,486,972 can be involved in litigation, where the validity and infringement of claims are contested. For example, inter partes review (IPR) proceedings can challenge the patentability of certain claims[5].
Expiration and Maintenance
The patent's legal status, including its expiration date and any maintenance fees, is crucial for understanding its current and future impact on the market. As of the last update, the patent was active but subject to expiration based on its filing and grant dates[4].
International Implications
Global Dossier
The Global Dossier service provides access to the file histories of related applications from participating IP Offices, including the IP5 Offices. This can help in understanding the global patent family and any international implications or challenges to the patent[1].
Machine Translations
Access to machine translations of patents from other countries, such as those provided by the EPO, JPO, and WIPO, can facilitate a more comprehensive analysis of the global patent landscape[1].
Key Takeaways
- Specific Formulation and Delivery: The patent focuses on a specific formulation and delivery method for sublingual fentanyl administration.
- Detailed Claims: The claims are detailed and specify the device, formulation, and delivery characteristics.
- Patent Landscape: The patent landscape is complex, with multiple related patents and applications globally.
- Analytics Tools: Using patent analytics tools can help in understanding the full scope of protection and identifying gaps or opportunities.
- Legal Considerations: The patent's legal status and potential litigation are important factors to consider.
FAQs
Q: What is the primary objective of United States Patent 8,486,972?
A: The primary objective is to provide a fentanyl formulation suitable for sublingual administration for effective pain management.
Q: What are the key components of the device described in the patent?
A: The device includes a reservoir containing a unit dose of fentanyl formulation and an actuator that delivers the dose in liquid droplets with specific size distributions.
Q: How can one analyze the patent landscape for similar technologies?
A: Using tools like the Global Dossier, Common Citation Document (CCD), and patent analytics software can help in analyzing the patent landscape.
Q: What is the significance of the Claim Coverage Matrix in patent analytics?
A: The Claim Coverage Matrix helps in categorizing patents and claims by scope concepts, identifying gaps or opportunities in the current patent coverage.
Q: How can machine translations of patents from other countries be useful?
A: Machine translations provided by international patent offices can facilitate a more comprehensive analysis of the global patent landscape.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT: https://insight.rpxcorp.com/litigation_documents/12756397
- Patent Analytics | Intellectual Property Law: https://www.slwip.com/services/patent-analytics/
- US8486972B2 - Sublingual fentanyl spray - Google Patents: https://patents.google.com/patent/US8486972B2/en
- UNITED STATES PATENT AND TRADEMARK OFFICE ... - ExParte Inc: https://ai-lab.exparte.com/documents/ptab/ptacts-uspto/1464069/uWYAairWct6B3UmE0CNmc86OUOgJr9FLzKKOWFKba1ECTsyNsmPHn74/-13/IPR2015-01800_doc_10_exparte.pdf
