United States Patent 10,653,719: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,653,719, titled "Stable, Highly Pure L-Cysteine Compositions for Injection and Methods of Use," is a significant patent in the pharmaceutical industry, particularly in the field of parenteral administration of L-cysteine. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Inventors and Assignees
The patent was issued to inventors John Maloney, Aruna Koganti, and Phanesh Koneru, and it is assigned to Exela Pharma Sciences, LLC[5].
Patent Scope
The patent covers stable, highly pure L-cysteine compositions designed for injection. These compositions are crucial for parenteral administration, ensuring the stability and purity of L-cysteine, which is a vital amino acid in various medical treatments.
Key Components of the Invention
- L-Cysteine or Pharmaceutically Acceptable Salts/Hydrates: The patent specifies the use of L-cysteine or its pharmaceutically acceptable salts and hydrates.
- Pharmaceutically Acceptable Carrier: The composition includes a carrier that is safe for injection.
- Purity and Concentration: The patent emphasizes the importance of maintaining a high purity level, with specific concentrations of L-cysteine hydrochloride monohydrate, and strict limits on impurities such as aluminum[5].
Claims
The patent includes multiple claims that define the scope of the invention. Here are some of the key claims:
Claim 12
This claim describes a solution of L-cysteine comprising a pharmaceutically acceptable carrier, about 50 mg/mL of L-cysteine hydrochloride monohydrate, or an equivalent amount of a pharmaceutically acceptable L-cysteine or a salt or hydrate thereof, with less than about 150 ppb of aluminum[5].
Claim 1 of Related Patents
Other related patents, such as U.S. Patent 10,905,713 and U.S. Patent 10,933,089, also issued to the same inventors and assignee, have similar claims focusing on the stability and purity of L-cysteine compositions for injection[5].
Patent Landscape
Historical Context
The development of stable L-cysteine compositions is part of a broader trend in pharmaceutical research aimed at improving the stability and purity of injectable solutions. Historical patents, such as those listed in the "Digest of Patents: 1790 to 1839" and "List of Patents: 1790 to 1847," show the evolution of patent law and the types of inventions that have been protected over time[1].
Current Patent Environment
The USPTO's database and resources, such as the Patent Claims Research Dataset, provide detailed information on claims from U.S. patents and applications, which can be used to analyze the patent landscape in this field. This dataset includes claim-level statistics and document-level statistics, helping to understand the scope and trends in patent filings[3].
Global Dossier and International Patent System
The Global Dossier service offered by the USPTO allows users to access file histories of related applications from participating IP Offices, including the IP5 Offices. This service helps in understanding the global patent family for a specific application and can be useful in analyzing the international patent landscape for L-cysteine compositions[4].
Litigation and Enforcement
The patent has been involved in litigation, as seen in the case of Exela Pharma Sciences, LLC vs. Eton Pharmaceuticals, Inc., where Exela alleged infringement of several patents, including U.S. Patent 10,653,719. This highlights the importance of patent protection and enforcement in the pharmaceutical industry[5].
Public Access and Search Facilities
The USPTO provides various resources for searching and accessing patent information, including the Public Search Facility in Alexandria, VA, and the Patent and Trademark Resource Centers (PTRCs) across the country. These resources are essential for conducting thorough patent searches and understanding the patent landscape[4].
Common Citation Document (CCD)
The CCD application consolidates prior art cited by participating offices for the family members of a patent application, facilitating a more comprehensive analysis of the patent landscape by visualizing search results from multiple offices on a single page[4].
Economic and Statistical Insights
The Patent Claims Research Dataset and other economic research datasets from the USPTO provide statistical insights into patent scope and trends. For instance, the dataset derived from the Patent Application Publication Full-Text and Patent Grant Full Text files offers detailed information on claims and their dependency relationships, which can be used to analyze the economic impact and strategic positioning of patents like U.S. Patent 10,653,719[3].
Conclusion
United States Patent 10,653,719 is a critical patent in the field of pharmaceuticals, particularly for the development of stable and highly pure L-cysteine compositions for injection. Understanding its scope, claims, and the broader patent landscape is essential for both inventors and businesses operating in this sector.
Key Takeaways
- Invention Scope: The patent covers stable, highly pure L-cysteine compositions for parenteral administration.
- Claims: Specific claims define the composition, including the concentration of L-cysteine and limits on impurities.
- Patent Landscape: The patent is part of a larger trend in pharmaceutical research and is supported by various USPTO resources and international patent services.
- Litigation and Enforcement: The patent has been involved in litigation, highlighting its importance in the pharmaceutical industry.
- Public Access: Various resources are available for searching and accessing patent information.
FAQs
Q: Who are the inventors of U.S. Patent 10,653,719?
A: The inventors are John Maloney, Aruna Koganti, and Phanesh Koneru.
Q: What is the main subject of U.S. Patent 10,653,719?
A: The patent covers stable, highly pure L-cysteine compositions for injection.
Q: Where can I find detailed information on the claims of this patent?
A: Detailed information on the claims can be found in the patent document available on the USPTO website or through legal documents related to the patent.
Q: How does the Global Dossier service help in understanding the patent landscape?
A: The Global Dossier service provides access to file histories of related applications from participating IP Offices, allowing users to see the patent family and related data for a specific application.
Q: What resources are available for searching and accessing patent information?
A: Resources include the USPTO's Public Search Facility, Patent and Trademark Resource Centers (PTRCs), and online databases like the Patent Claims Research Dataset.
Sources
- How to Search for an Historical U.S. Patent - NYPL Libguides
- U.S. Patent and Trademark Office (USPTO) | USAGov
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT ...
