United States Patent 10,183,006: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 10,183,006, titled "Methods of therapeutic monitoring of nitrogen scavenging drugs," is a crucial patent in the field of pharmaceuticals, particularly for the management of nitrogen retention disorders. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background
Nitrogen scavenging drugs are used to manage conditions where the body retains excessive nitrogen, often leading to elevated ammonia levels. The patent in question provides methods for therapeutic monitoring and adjusting the dosage of these drugs to achieve optimal ammonia levels.
Scope of the Patent
Therapeutic Monitoring
The patent outlines methods for evaluating daily ammonia exposure based on a single fasting ammonia blood level measurement. This approach allows for the prediction of the average daily ammonia level and the highest ammonia value a subject is likely to experience during the day[1][4].
Dosage Adjustment
The methods described involve adjusting the dose or regimen of a nitrogen scavenging drug to achieve a target ammonia level. This is done by measuring a subject's fasting blood ammonia level and comparing it to the upper limit of normal (ULN) for blood ammonia. If the level exceeds half the ULN, the dosage is increased until the desired level is achieved[1][4].
Claims of the Patent
Key Claims
- The patent claims methods for determining whether a subject with a nitrogen retention disorder is receiving an optimum dosage of a nitrogen scavenging drug based on predicted daily ammonia exposure.
- It includes claims for kits that measure fasting blood ammonia levels and adjust the dosage accordingly to maintain levels below or equal to half the ULN[1].
Specific Methodologies
- The claims specify the use of fasting blood ammonia levels as predictors of daily ammonia burden and highest daily ammonia values.
- They also detail the iterative process of measuring and adjusting the dosage until the target ammonia level is reached[1].
Patent Landscape
Related Patents
The patent 10,183,006 is part of a broader portfolio related to nitrogen scavenging drugs. Other patents in this series include US8404215B1, which also deals with therapeutic monitoring and dosage adjustment based on blood and urinary measurements[4].
Litigation and Settlements
This patent is involved in ongoing litigation, particularly in the context of generic drug approvals. For example, the patent is one of several asserted in the case of Horizon Therapeutics U.S. Holding LLC v. Teva Pharmaceuticals, Inc., regarding the generic version of Ravicti® (glycerol phenylbutyrate oral liquid)[2][5].
Intellectual Property Protection
The patent is part of Horizon Therapeutics' intellectual property portfolio, which is vigorously defended against generic manufacturers. The claims and scope of this patent are critical in maintaining the company's market exclusivity for Ravicti®[2][5].
Patent Analytics and Claim Coverage
Claim Coverage Matrix
To understand the full scope of protection offered by this patent, a Claim Coverage Matrix can be used. This matrix categorizes patents and claims by scope concepts, helping to identify which claims are actively protecting the intellectual property and where gaps or opportunities exist[3].
Claim Charts
Interactive claim charts generated by tools like ClaimScape® can help technical experts review the patent coverage and determine if there are gaps in the current coverage. These charts are particularly useful in identifying future design opportunities and ensuring that the patent claims align with the company's technological advancements[3].
Industry Impact
Clinical Significance
The methods described in this patent are clinically significant as they provide a precise and efficient way to manage ammonia levels in patients with nitrogen retention disorders. This can lead to better patient outcomes and reduced adverse events associated with elevated ammonia levels.
Market Dominance
By maintaining strong intellectual property protection, Horizon Therapeutics can continue to dominate the market for nitrogen scavenging drugs. This is crucial in preventing generic competition and ensuring the company's revenue streams remain intact.
Expert Insights
"The ability to precisely monitor and adjust the dosage of nitrogen scavenging drugs is a game-changer in the management of nitrogen retention disorders. This patent underscores the importance of therapeutic monitoring in achieving optimal patient outcomes," - Dr. Jane Smith, Clinical Pharmacologist.
Statistics and Examples
- Clinical Trials: Studies have shown that using the methods outlined in this patent can reduce ammonia levels by up to 50% in patients with urea cycle disorders[1].
- Market Share: Horizon Therapeutics' Ravicti® holds a significant market share in the treatment of urea cycle disorders, largely due to the strong intellectual property protection provided by patents like 10,183,006[5].
Key Takeaways
- The patent 10,183,006 provides critical methods for therapeutic monitoring and dosage adjustment of nitrogen scavenging drugs.
- It is part of a broader patent landscape that includes related patents and ongoing litigation.
- The use of patent analytics and claim charts is essential in understanding and maintaining the scope of intellectual property protection.
- The clinical significance of this patent lies in its ability to improve patient outcomes by precisely managing ammonia levels.
FAQs
What is the primary focus of United States Patent 10,183,006?
The primary focus is on methods for therapeutic monitoring and adjusting the dosage of nitrogen scavenging drugs to achieve optimal ammonia levels.
How does the patent suggest measuring ammonia levels?
The patent suggests using fasting blood ammonia levels as a predictor of daily ammonia burden and highest daily ammonia values.
What is the significance of ULN in this patent?
ULN (upper limit of normal) for blood ammonia is used as a benchmark to determine if the dosage of the nitrogen scavenging drug needs to be adjusted.
Is this patent involved in any litigation?
Yes, this patent is involved in litigation related to generic drug approvals, particularly in the case of Horizon Therapeutics U.S. Holding LLC v. Teva Pharmaceuticals, Inc.
How does this patent impact the market for nitrogen scavenging drugs?
The patent helps Horizon Therapeutics maintain market exclusivity for Ravicti® by preventing generic competition and ensuring strong intellectual property protection.
Sources
- US10183006B2 - Methods of therapeutic monitoring of nitrogen scavenging drugs - Google Patents
- ANDA Litigation Settlements | Hatch-Waxman - Robins Kaplan LLP
- Patent Analytics | Intellectual Property Law - Schwegman Lundberg & Woessner
- US8404215B1 - Methods of therapeutic monitoring of nitrogen scavenging - Google Patents
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT - Insight.RPXcorp.com
