Detailed Analysis of the Scope and Claims of United States Patent 9,884,044
Introduction
United States Patent 9,884,044, titled "Treatment using dantrolene," is a significant patent in the pharmaceutical sector, particularly related to the formulation and use of dantrolene sodium. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Patent Number and Status
The patent number is 9,884,044, and it was issued by the United States Patent and Trademark Office (USPTO). As of the latest information, this patent has expired, with its lifetime ending in June 2022[5].
Inventors and Assignees
The patent is assigned to Eagle Pharmaceuticals, Inc., a company that has developed several formulations related to dantrolene sodium, including the RYANODEX product[5].
Publication and Prior Art
The patent was published with a prior art date that reflects the earliest known public disclosure of the invention. The prior art keywords include "dantrolene," "formulation," "sodium," and "treatment," indicating the core aspects of the invention[4].
Claims Analysis
Independent and Dependent Claims
The patent includes both independent and dependent claims. Independent claims define the broadest scope of the invention, while dependent claims narrow down the scope by adding additional limitations.
- Independent Claims: These claims typically describe the essential features of the invention. For example, Claim 1 might describe a formulation of dantrolene sodium for injectable suspension, specifying the composition and concentration of the active ingredient.
- Dependent Claims: These claims build upon the independent claims by adding specific details or limitations. For instance, a dependent claim might specify the method of preparation, the dosage form, or the particular indications for use[4].
Claim Scope and Breadth
The scope of the claims is crucial in determining the patent's validity and enforceability. Narrower claims are generally more likely to be granted and upheld, as they are less likely to be considered overly broad or invalid. The study on patent scope metrics suggests that narrower claims at publication are associated with a higher probability of grant and a shorter examination process[3].
Patent Scope Metrics
Independent Claim Length and Count
Research on patent scope metrics indicates that independent claim length and count can be useful indicators of patent breadth. Shorter independent claims and fewer independent claims often suggest a narrower and more focused invention, which can be beneficial in the patent examination process[3].
Patent Landscape
Related Patents and Family
The patent 9,884,044 is part of the RYANODEX family of patents, which includes a total of seven patents expiring between 2022 and 2025. These patents collectively cover various aspects of dantrolene sodium formulations, including different compositions, methods of preparation, and therapeutic uses[5].
Global Dossier and Patent Family
Using tools like the Global Dossier, one can view the patent family for this specific application, including all related applications filed at participating IP Offices. This provides a comprehensive view of the global patent landscape for dantrolene sodium formulations[1].
Search and Examination Process
Patent Public Search and Other Resources
The USPTO's Patent Public Search tool and other resources like the Patent and Trademark Resource Centers (PTRCs) can be utilized to conduct thorough searches for prior art and related patents. This is essential in understanding the novelty and non-obviousness of the invention claimed in patent 9,884,044[1].
Common Citation Document (CCD)
The Common Citation Document (CCD) application consolidates prior art citations from multiple IP offices, helping to visualize the search results for the same invention on a single page. This tool can be particularly useful in assessing the prior art landscape relevant to patent 9,884,044[1].
Legal and Regulatory Aspects
Orange Book Listing
The patent 9,884,044 was listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book), which is a critical regulatory milestone for pharmaceutical patents. This listing indicates that the patented formulation has been approved by the FDA and is recognized as a therapeutic equivalent to other approved drugs[5].
Expiration and Post-Expiration Implications
Patent Expiration
With the patent having expired in June 2022, the exclusive rights to the invention are no longer in effect. This means that other companies can now manufacture and market similar formulations of dantrolene sodium without infringing on Eagle Pharmaceuticals' patent rights[5].
Generic Competition
The expiration of the patent opens the door for generic competition. Other pharmaceutical companies can now develop and market generic versions of the dantrolene sodium formulation, potentially reducing costs and increasing accessibility for patients.
Key Takeaways
- Patent Scope and Claims: The patent's scope is defined by its claims, with narrower claims generally being more favorable in the examination process.
- Patent Landscape: The patent is part of a larger family of patents related to dantrolene sodium formulations.
- Regulatory Aspects: The patent was listed in the FDA’s Orange Book, indicating FDA approval.
- Expiration: The patent has expired, allowing for generic competition.
FAQs
What is the main subject of United States Patent 9,884,044?
The main subject of United States Patent 9,884,044 is a formulation of dantrolene sodium for injectable suspension, particularly related to the treatment of certain medical conditions.
Who is the assignee of the patent?
The patent is assigned to Eagle Pharmaceuticals, Inc.
What is the significance of the Orange Book listing for this patent?
The Orange Book listing indicates that the patented formulation has been approved by the FDA and is recognized as a therapeutic equivalent to other approved drugs.
What are the implications of the patent's expiration?
The expiration of the patent means that other companies can now manufacture and market similar formulations of dantrolene sodium without infringing on Eagle Pharmaceuticals' patent rights, leading to potential generic competition.
How can one search for related patents and prior art?
Tools like the USPTO's Patent Public Search, Global Dossier, and Common Citation Document (CCD) can be used to conduct thorough searches for related patents and prior art.
Sources
- USPTO: Search for patents - USPTO. Retrieved from https://www.uspto.gov/patents/search
- ACUS: U.S. Patent Small Claims Court. Retrieved from https://www.acus.gov/research-projects/us-patent-small-claims-court
- SSRN: Patent Claims and Patent Scope. Retrieved from https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2844964
- Google Patents: US9884044B2 - Treatment using dantrolene. Retrieved from https://patents.google.com/patent/US9884044B2/en
- Eagle Pharmaceuticals: Eagle Pharmaceuticals Announces Fifth Orange Book Listed Patent. Retrieved from https://investor.eagleus.com/news-releases/news-release-details/eagle-pharmaceuticals-announces-fifth-orange-book-listed-patent
