United States Patent 10,045,959: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,045,959, titled "Methods of Therapeutic Monitoring of Nitrogen Scavenging Drugs," is a significant patent in the field of pharmaceuticals, particularly for the treatment of urea cycle disorders. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background
The patent was issued on August 14, 2018, to Horizon Therapeutics U.S. Holding LLC, with Horizon Therapeutics USA, Inc. as the exclusive licensee. This patent is part of a series of patents related to methods of therapeutic monitoring and treatment using nitrogen scavenging drugs[2].
Scope of the Patent
Purpose and Application
The patent describes methods for therapeutic monitoring of nitrogen scavenging drugs, which are used to treat urea cycle disorders. These disorders result from deficiencies in enzymes that are crucial for the removal of ammonia from the body. The methods outlined in the patent involve monitoring and adjusting the dosage of these drugs to ensure effective treatment and minimize side effects[2].
Key Aspects
- Monitoring Methods: The patent details specific methods for evaluating the efficacy and safety of nitrogen scavenging drugs. This includes measuring ammonia levels in the blood and adjusting the drug dosage accordingly.
- Patient Treatment: The methods are designed to treat patients with urea cycle disorders, ensuring that the drug therapy is optimized for each patient's needs.
- Clinical Significance: The patent highlights the importance of precise monitoring and adjustment of drug dosages to prevent complications associated with urea cycle disorders.
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims typically describe the core methods and processes involved in the therapeutic monitoring of nitrogen scavenging drugs. For example:
- Claim 1 might describe a method for monitoring ammonia levels in a patient's blood and adjusting the dosage of a nitrogen scavenging drug based on these levels.
- Claim 2 could outline a specific protocol for measuring ammonia levels and the criteria for adjusting the drug dosage[2].
Dependent Claims
Dependent claims build upon the independent claims, providing additional details or specific embodiments of the invention. These claims may include:
- Specific measurement techniques for ammonia levels.
- Particular dosage adjustment protocols.
- Additional monitoring parameters to ensure the efficacy and safety of the treatment[2].
Patent Landscape
Related Patents
The patent 10,045,959 is part of a larger family of patents held by Horizon Therapeutics related to nitrogen scavenging drugs. Other patents in this family include:
- U.S. Patent Nos. 8,642,012, 9,254,278, 9,326,966, 9,561,197, 9,962,359, 9,999,608, 10,045,958, 10,183,002, 10,183,003, 10,183,004, 10,183,005, 10,183,006, and 10,668,040[2].
Global Patent Landscape
To understand the global implications, it is essential to search international patent databases. Resources such as the European Patent Office (EPO), Japan Patent Office (JPO), World Intellectual Property Organization (WIPO), and other national patent offices provide access to global patent collections. This helps in identifying similar or related patents filed in other jurisdictions[1].
Competitors and Litigation
The patent landscape also involves potential competitors and litigation. For instance, Horizon Therapeutics has been involved in patent infringement lawsuits against companies like Teva Pharmaceuticals, which sought to manufacture generic versions of Horizon's patented drugs[2].
Search and Analysis Tools
USPTO Resources
The United States Patent and Trademark Office (USPTO) provides several tools for searching and analyzing patents, including the Patent Public Search tool, Global Dossier, and the Common Citation Document (CCD) application. These tools help in identifying prior art, related applications, and citation data[1].
Derwent Innovations Index
Resources like the Derwent Innovations Index, accessible through Web of Science, offer comprehensive global patent search and analysis capabilities. This can be useful for identifying similar inventions and understanding the broader patent landscape[4].
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. This dataset can be used to analyze the scope and trends of patent claims, including those related to the therapeutic monitoring of nitrogen scavenging drugs[3].
Economic Impact
Patents like 10,045,959 have significant economic implications, particularly in the pharmaceutical industry. They protect intellectual property, allowing companies to invest in research and development while ensuring a return on their investments.
Key Takeaways
- Scope and Claims: The patent 10,045,959 focuses on methods for therapeutic monitoring of nitrogen scavenging drugs, with detailed claims outlining the core processes and protocols.
- Patent Landscape: The patent is part of a larger family of related patents and is subject to global patent searches and potential litigation.
- Search and Analysis Tools: Various tools, including USPTO resources and the Derwent Innovations Index, are available for searching and analyzing patents.
- Economic Implications: The patent has significant economic implications, protecting intellectual property and facilitating investment in pharmaceutical research.
FAQs
Q: What is the primary focus of United States Patent 10,045,959?
A: The primary focus is on methods for therapeutic monitoring of nitrogen scavenging drugs used to treat urea cycle disorders.
Q: Who is the assignee of the patent 10,045,959?
A: The assignee is Horizon Therapeutics U.S. Holding LLC, with Horizon Therapeutics USA, Inc. as the exclusive licensee.
Q: What tools can be used to search and analyze patents related to this invention?
A: Tools include the USPTO's Patent Public Search, Global Dossier, Common Citation Document (CCD), and resources like the Derwent Innovations Index.
Q: Why is it important to conduct global patent searches for this invention?
A: Conducting global patent searches helps in identifying similar or related patents filed in other jurisdictions, which is crucial for understanding the global patent landscape and potential competitors.
Q: What economic implications does this patent have?
A: The patent protects intellectual property, allowing companies to invest in research and development while ensuring a return on their investments, which has significant economic implications in the pharmaceutical industry.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE: https://insight.rpxcorp.com/litigation_documents/15640879
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Duke University Libraries - Finding Patents Online: https://guides.library.duke.edu/c.php?g=289276&p=1929213
