United States Patent 10,493,051: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,493,051, titled "Cysteine composition and injection," is a significant patent in the pharmaceutical sector, particularly for the treatment of neonate patients requiring total parental nutrition (TPN). This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Publication Number and Authority
The patent, numbered US10,493,051B1, was granted by the United States Patent and Trademark Office (USPTO). It is classified under various categories, including chemical and pharmaceutical compositions[4].
Inventors and Assignees
While the specific inventors and assignees are not detailed here, it is crucial to note that patents like this are often assigned to pharmaceutical companies or research institutions that have developed the invention.
Prior Art and Legal Status
The patent's prior art includes various solutions and compositions related to cysteine, cystine, and other chemical compounds. The legal status is listed as active, although this is an assumption and not a legal conclusion[4].
Scope of the Patent
Invention Description
The patent describes a cysteine composition, specifically a solution comprising 50 mg of cysteine hydrochloride monohydrate dissolved in one mL of water. This composition is designed for use in TPN, addressing the nutritional needs of neonate patients[4].
Technical Details
The composition includes cysteine hydrochloride monohydrate, water, and may include other components to ensure stability and efficacy. The solution is formulated to minimize the presence of aluminum and other contaminants, which is critical for neonatal care[4].
Claims of the Patent
Independent and Dependent Claims
The patent includes both independent and dependent claims. Independent claims define the broad scope of the invention, while dependent claims narrow down the scope by adding specific limitations.
- Independent Claims: These typically describe the core elements of the invention, such as the composition of cysteine hydrochloride monohydrate in water.
- Dependent Claims: These claims build upon the independent claims by adding additional features, such as the concentration of cysteine, the presence of stabilizers, or the method of preparation[4].
Claim Analysis
Each claim is carefully crafted to ensure the patent covers a unique and novel aspect of the invention. For example, claims might specify the exact concentration of cysteine, the pH range of the solution, or the method of sterilization.
"The claims of a patent define the scope of the protection granted by the patent, and thus they are critical to determining the boundaries of the patentee’s exclusive rights"[3].
Patent Landscape
Related Patents and Applications
The patent landscape for cysteine compositions and TPN solutions is complex, with numerous patents and applications filed by various pharmaceutical companies and research institutions. Tools like the USPTO's Patent Public Search and Global Dossier can help identify related patents and applications, including those from international offices[1].
Competitor Patents
Other companies may have similar patents or applications for cysteine compositions. For instance, Avadel Pharmaceuticals has been involved in the development of similar products, highlighting the competitive nature of this field[2].
International Patent Offices
To fully understand the global patent landscape, it is essential to search databases from other international intellectual property offices, such as the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO)[1].
Search and Analysis Tools
USPTO Resources
The USPTO provides several tools for searching and analyzing patents, including the Patent Public Search tool, Global Dossier, and the Patent Examination Data System (PEDS). These resources help in identifying prior art, related applications, and the status of patent families[1].
Common Citation Document (CCD)
The CCD application consolidates citation data from participating IP offices, enabling a comprehensive view of prior art cited for the same invention across different offices[1].
Economic and Research Implications
Patent Claims Research Dataset
The USPTO's Patent Claims Research Dataset provides detailed information on claims from U.S. patents and applications, which can be used to analyze trends and scope measurements in patent claims. This dataset can help in understanding the broader economic implications of patents like US10,493,051[3].
Practical Applications
Clinical Use
The cysteine composition patented in US10,493,051 is specifically designed for use in neonatal care, addressing a critical need for TPN solutions that are safe and effective for newborn patients.
Commercial Considerations
Companies like Avadel Pharmaceuticals are evaluating the commercial launch of similar products, indicating the potential market demand and competition in this sector[2].
Challenges and Future Directions
Regulatory Approval
Obtaining regulatory approval, such as from the FDA, is a significant challenge for any new pharmaceutical product. The approval process involves rigorous testing and evaluation to ensure safety and efficacy[2].
Patent Litigation
Given the competitive nature of the pharmaceutical industry, patent litigation is a common challenge. Companies must ensure their patents are robust and defensible against potential infringement claims.
Key Takeaways
- Patent Scope: The patent covers a specific cysteine composition for TPN solutions, with detailed claims defining the scope of protection.
- Claims Analysis: Independent and dependent claims are crucial for understanding the patent's boundaries.
- Patent Landscape: The landscape includes related patents and applications from various international offices.
- Search Tools: USPTO resources like Patent Public Search and Global Dossier are essential for comprehensive analysis.
- Economic Implications: The Patent Claims Research Dataset helps in understanding broader economic trends.
- Practical Applications: The patent has significant clinical and commercial implications.
FAQs
What is the main composition described in US Patent 10,493,051?
The main composition is a solution comprising 50 mg of cysteine hydrochloride monohydrate dissolved in one mL of water.
What is the primary use of the patented composition?
The composition is designed for use in total parental nutrition (TPN) solutions for neonate patients.
How can one search for related patents and applications?
Tools like the USPTO's Patent Public Search, Global Dossier, and international patent office databases can be used to search for related patents and applications.
What is the significance of the Common Citation Document (CCD)?
The CCD consolidates citation data from participating IP offices, providing a comprehensive view of prior art cited for the same invention.
How does the Patent Claims Research Dataset help in analyzing patents?
The dataset provides detailed information on claims from U.S. patents and applications, helping in analyzing trends and scope measurements in patent claims.
Sources
- USPTO: Search for patents - USPTO. (2018, October 18).
- Biospace: Avadel Pharmaceuticals Receives U.S. FDA Approval for Nouress.
- USPTO: Patent Claims Research Dataset - USPTO. (2017, August 28).
- Google Patents: US10493051B1 - Cysteine composition and injection.
