United States Patent 9,962,359: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,962,359, 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 patent, issued to Horizon Therapeutics U.S. Holding LLC, is part of a broader portfolio of patents related to nitrogen scavenging drugs. Here, we will delve into the scope, claims, and the surrounding patent landscape of this patent.
Background of the Invention
The patent addresses methods for therapeutic monitoring of nitrogen scavenging drugs, which are crucial for managing urea cycle disorders. These disorders result from deficiencies in enzymes that break down ammonia, a toxic byproduct of protein metabolism. The invention provides methods to evaluate and adjust the dosage of these drugs based on specific biomarkers, ensuring effective treatment and minimizing side effects[2].
Scope of the Patent
The scope of the patent is defined by its claims, which outline the specific methods and processes that are protected. Here are the key aspects:
Methods of Therapeutic Monitoring
The patent describes methods for evaluating daily ammonia exposure based on a single fasting ammonia blood level measurement. This approach allows for more precise and efficient monitoring of patients undergoing treatment with nitrogen scavenging drugs[5].
Biomarker-Based Dosage Adjustment
The methods include adjusting the dosage of the drugs based on the measured biomarkers, such as ammonia levels in the blood. This ensures that the treatment is tailored to the individual patient's needs, enhancing efficacy and safety[2].
Application in Urea Cycle Disorders
The patent specifically targets urea cycle disorders, providing a critical advancement in the management of these conditions. The methods outlined can be applied to various nitrogen scavenging drugs, making it a versatile and valuable invention in the field of pharmacology[2].
Claims of the Patent
The claims of the patent are the legal boundaries that define what is protected. Here are some key claims:
Claim 1: Method of Evaluating Ammonia Exposure
The first claim describes a method for evaluating daily ammonia exposure based on a single fasting ammonia blood level measurement. This claim sets the foundation for the therapeutic monitoring approach[5].
Claim 2: Dosage Adjustment
Subsequent claims detail the process of adjusting the dosage of nitrogen scavenging drugs based on the evaluated ammonia levels. These claims ensure that the method is comprehensive and includes both the evaluation and adjustment steps[5].
Claim 3: Specific Biomarkers
Other claims specify the use of particular biomarkers, such as fasting ammonia levels, to guide the therapeutic monitoring. These claims highlight the precision and scientific basis of the invention[5].
Patent Landscape
The patent landscape surrounding US 9,962,359 is complex and involves multiple related patents and applications.
Related Patents
Horizon Therapeutics holds a series of patents related to nitrogen scavenging drugs, including US 9,999,608, US 10,045,959, and others. These patents collectively protect various aspects of the treatment, including methods of therapeutic monitoring, dosage adjustments, and specific drug formulations[2].
International Protection
Given the global nature of pharmaceutical research and development, these patents are often filed in multiple jurisdictions. The protection is territorial, meaning that separate filings are required in each country where protection is sought. This involves significant costs and administrative efforts, including translations and local legal representation[4].
Litigation and Enforcement
The patent has been involved in litigation, as seen in the case against a generic drug manufacturer seeking to produce a version of Horizon’s pharmaceutical product RAVICTI®. This highlights the importance of patent protection in maintaining market exclusivity and the financial viability of pharmaceutical innovations[2].
Economic and Strategic Impact
The economic and strategic impact of this patent is substantial:
Market Exclusivity
By securing this patent, Horizon Therapeutics maintains market exclusivity for its nitrogen scavenging drugs, which is crucial for recouping the significant investments made in research and development[2].
Competitive Advantage
The patent provides a competitive advantage, as it prevents other companies from using the same methods for therapeutic monitoring. This advantage is particularly significant in the highly competitive pharmaceutical industry[2].
Patient Impact
From a patient perspective, the patent ensures that the methods for therapeutic monitoring are standardized and effective, leading to better health outcomes for those suffering from urea cycle disorders[5].
Maintenance and Enforcement Costs
Maintaining and enforcing a patent like US 9,962,359 involves several costs:
Maintenance Fees
To keep the patent in force for its full term of 20 years, maintenance fees must be paid at 3.5, 7.5, and 11.5 years after issuance. These fees are mandatory and can be substantial[4].
Foreign Filing Costs
For international protection, additional costs are incurred, including translation fees, local legal fees, and annual maintenance fees in each jurisdiction[4].
Litigation Costs
Defending the patent against infringement can be costly, involving legal fees and court costs. However, this is essential for protecting the intellectual property and maintaining market exclusivity[2].
Key Takeaways
- Therapeutic Monitoring Methods: The patent protects specific methods for evaluating and adjusting the dosage of nitrogen scavenging drugs based on biomarkers.
- Biomarker-Based Approach: The invention relies on fasting ammonia blood level measurements to guide treatment.
- Urea Cycle Disorders: The patent is specifically aimed at managing urea cycle disorders, a critical area in pharmacology.
- Related Patents: The patent is part of a broader portfolio of related patents held by Horizon Therapeutics.
- Economic Impact: The patent ensures market exclusivity and provides a competitive advantage, which is vital for the financial sustainability of pharmaceutical innovations.
- Maintenance and Enforcement: Significant costs are associated with maintaining and enforcing the patent, including maintenance fees, foreign filing costs, and litigation expenses.
FAQs
Q: What is the primary focus of United States Patent 9,962,359?
A: The primary focus is on methods for therapeutic monitoring of nitrogen scavenging drugs, particularly for treating urea cycle disorders.
Q: How does the patent protect the invention?
A: The patent protects the invention through specific claims that outline the methods for evaluating ammonia exposure and adjusting drug dosages based on biomarkers.
Q: Who is the assignee of the patent?
A: The assignee of the patent is Horizon Therapeutics U.S. Holding LLC, with Horizon Therapeutics USA, Inc. being an exclusive licensee.
Q: What are the maintenance costs associated with this patent?
A: The maintenance costs include fees paid at 3.5, 7.5, and 11.5 years after the patent's issuance to keep it in force for its full term.
Q: Why is international protection important for this patent?
A: International protection is crucial because patents are territorial, and separate filings are required in each country where protection is sought to ensure global market exclusivity.
Sources
- Clemson University Libraries - Research and Course Guides: Patent Searching, Advanced[1].
- United States District Court for the District of Delaware - Case 1:24-cv-00432-UNA Document 1 Filed 04/05/24[2].
- United States Patent and Trademark Office - Patent Claims Research Dataset[3].
- Small Business Innovation Research (SBIR) - Timeline and Costs for Patent Filings[4].
- Google Patents - US9962359B2 - Methods of therapeutic monitoring of nitrogen scavenging drugs[5].
