United States Patent 9,480,644: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,480,644, titled "Nasal drug products and methods of their use," was granted to Opiant Pharmaceuticals, Inc. and pertains to nasal spray formulations, devices, and methods of treatment, particularly for the opioid receptor antagonist naloxone. This patent is significant in the pharmaceutical industry, especially in the context of opioid overdose treatment.
Patent Overview
Patent Title and Number
- Title: Nasal drug products and methods of their use
- Number: US 9,480,644 B2
Grant Date
The patent was granted on January 24, 2017[2].
Assignee
The patent is assigned to Opiant Pharmaceuticals, Inc.[2].
Scope of the Patent
Claim Coverage
The patent covers specific nasal spray formulations, devices, and methods of treatment. Here are some key aspects of the scope:
- Formulations: The patent includes claims related to pharmaceutical compositions comprising an opioid receptor antagonist, such as naloxone, adapted for nasal delivery[4].
- Devices: The patent describes pre-primed devices filled with the pharmaceutical composition, which are designed for easy and effective administration[4].
- Methods of Treatment: The claims also encompass methods of treating opioid overdose using the nasal spray formulations[4].
Independent Claims
Independent claims are crucial as they define the broadest scope of the invention. For US 9,480,644, these claims typically include the composition, device, and method aspects.
- Independent Claim Length and Count: Research suggests that the length and count of independent claims can be metrics for measuring patent scope. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process[3].
Claims Analysis
Claim Structure
The claims in US 9,480,644 are structured to cover the core aspects of the invention:
- Composition Claims: These claims detail the specific formulation of the nasal spray, including the active ingredient and any excipients.
- Device Claims: These claims describe the pre-primed device and its components.
- Method Claims: These claims outline the methods of treating opioid overdose using the nasal spray.
Claim Validity and Scope
The validity and scope of the claims are critical for the patent's enforceability and the protection it offers. The claims must be novel, non-obvious, and sufficiently described.
- Novelty and Non-Obviousness: The claims must be new and not obvious to one skilled in the art. The patent office ensures this through the examination process, which may narrow the scope of claims to ensure they meet these criteria[3].
Patent Landscape
Related Patents and Applications
The patent landscape for US 9,480,644 includes other patents and applications related to nasal drug delivery systems and opioid overdose treatment.
- Patent Family: The Global Dossier service provided by the USPTO allows users to see the patent family for this specific application, including all related applications filed at participating IP Offices[1].
International Protection
The protection of this patent extends beyond the United States through international patent applications and grants.
- International Patent Offices: Databases such as the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO) provide access to international patent applications and grants related to this invention[1].
Regulatory Environment
FDA Approval
The two-milligram dose of NARCAN, covered by this patent, was approved by the FDA in January 2017. This approval is crucial for the commercialization and use of the product[2].
USPTO Rules and Practices
Recent developments in USPTO rules, such as the withdrawal of the proposed rule change on Terminal Disclaimer Practice, are significant for patent portfolios. This withdrawal ensures that patents like US 9,480,644 are not at risk of invalidation due to changes in non-statutory double patenting practices[5].
Economic and Social Impact
Market Significance
The patent for NARCAN nasal spray has significant market implications, particularly in the context of the opioid crisis. It provides a critical treatment option for opioid overdose.
- Market Demand: The demand for effective opioid overdose treatments is high, and this patent helps Opiant Pharmaceuticals, Inc. to meet this demand with a patented product[2].
Competitive Landscape
The pharmaceutical industry is highly competitive, and patents like US 9,480,644 play a crucial role in protecting intellectual property and maintaining a competitive edge.
- Patent Thickets: The proposed USPTO rule change aimed to reduce patent thickets, which can deter competition. However, the withdrawal of this rule ensures that companies can maintain their strategic patent portfolios without fear of unwarranted invalidation[5].
Search and Analysis Tools
USPTO Resources
Several tools provided by the USPTO are useful for searching and analyzing patents like US 9,480,644:
- Patent Public Search: This tool offers enhanced access to prior art and is useful for conducting comprehensive patent searches[1].
- Global Dossier: This service provides access to the file histories of related applications from participating IP Offices, which is beneficial for understanding the global patent landscape[1].
International Databases
International databases such as those provided by the EPO, JPO, and WIPO are essential for a global analysis of related patents and applications[1].
Conclusion
United States Patent 9,480,644 is a pivotal patent in the pharmaceutical industry, particularly in the treatment of opioid overdose. Understanding its scope, claims, and the broader patent landscape is crucial for both legal and business strategies.
Key Takeaways
- Scope and Claims: The patent covers specific nasal spray formulations, devices, and methods of treatment for opioid overdose.
- Regulatory Approval: The FDA approval of the two-milligram dose of NARCAN is a critical factor in its commercialization.
- Patent Landscape: The patent is part of a larger global patent family and is protected through various international patent applications.
- Economic Impact: The patent has significant market implications and helps maintain a competitive edge in the pharmaceutical industry.
- Search and Analysis Tools: Various USPTO and international tools are available for searching and analyzing this patent.
FAQs
What is the main subject of United States Patent 9,480,644?
The main subject of US 9,480,644 is nasal drug products and methods of their use, specifically for the opioid receptor antagonist naloxone.
Who is the assignee of this patent?
The patent is assigned to Opiant Pharmaceuticals, Inc.
What is the significance of FDA approval for this patent?
The FDA approval of the two-milligram dose of NARCAN is crucial for the commercialization and use of the product.
How does the patent landscape impact this patent?
The patent is part of a larger global patent family, and its protection extends through various international patent applications and grants.
What tools are available for searching and analyzing this patent?
Tools such as the USPTO's Patent Public Search, Global Dossier, and international databases like those from the EPO, JPO, and WIPO are available for searching and analyzing this patent.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- GlobeNewswire - Opiant Pharmaceuticals, Inc. Announces FDA Orange Book Listings: https://www.globenewswire.com/news-release/2017/03/09/933819/37234/en/Opiant-Pharmaceuticals-Inc-Announces-FDA-Orange-Book-Listings-for-Two-New-NARCAN-Nasal-Spray-Patents.html
- SSRN - Patent Claims and Patent Scope: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2844964
- Google Patents - US9480644B2: https://patents.google.com/patent/US9480644B2/en
- Procopio - Threat to Many Patent Portfolios Fades as USPTO Withdraws Controversial Proposed Rule: https://www.procopio.com/double-patenting-withdrawn/
