Details for Patent: 10,183,002

Which drugs does patent 10,183,002 protect, and when does it expire?

Patent 10,183,002 protects RAVICTI and is included in one NDA.

This patent has thirty-three patent family members in twenty-three countries.

Summary for Patent: 10,183,002

Title:	Methods of therapeutic monitoring of nitrogen scavenging drugs
Abstract:	The present disclosure provides methods for evaluating daily ammonia exposure based on a single fasting ammonia blood level measurement, as well as methods that utilize this technique to adjust the dosage of a nitrogen scavenging drug, determine whether to administer a nitrogen scavenging drug, and treat nitrogen retention disorders.
Inventor(s):	Scharschmidt; Bruce (San Francisco, CA), Mokhtarani; Masoud (Walnut Creek, CA)
Assignee:	Horizon Therapeutics, LLC (Lake Forest, IL)
Application Number:	15/944,411
Patent Claim Types: see list of patent claims	Use;

Detailed Analysis of the Scope and Claims of United States Patent 10,183,002

Introduction

United States Patent 10,183,002, titled "Methods of Therapeutic Monitoring of Nitrogen Scavenging Drugs," is a patent issued to Horizon Therapeutics U.S. Holding LLC and exclusively licensed to Horizon Therapeutics USA, Inc. This patent is part of a broader portfolio related to the treatment of urea cycle disorders. Here, we will delve into the scope, claims, and the patent landscape surrounding this patent.

Patent Overview

The patent 10,183,002 was issued on January 22, 2019, by the U.S. Patent and Trademark Office (USPTO)[5].

Title and Abstract

The patent is focused on "Methods of Therapeutic Monitoring of Nitrogen Scavenging Drugs." The abstract outlines methods for monitoring and adjusting the dosage of nitrogen scavenging drugs, which are used to treat urea cycle disorders. These methods involve measuring specific biomarkers to ensure the efficacy and safety of the treatment.

Scope of the Patent

The scope of the patent is defined by its claims, which are the legally binding descriptions of the invention.

Independent Claims

The independent claims of the patent define the core aspects of the invention. For example, Claim 1 might describe a method for therapeutic monitoring that includes:

• Administering a nitrogen scavenging drug to a patient.
• Measuring the levels of specific biomarkers in the patient's blood.
• Adjusting the dosage of the drug based on the biomarker levels.

Dependent Claims

Dependent claims build upon the independent claims and provide additional details or limitations. These claims might include specific biomarkers, dosage ranges, or patient populations.

Claim Analysis

To understand the patent's scope, it is crucial to analyze each claim.

Claim Coverage Matrix

A Claim Coverage Matrix, as described in patent analytics, helps in categorizing patents and claims by scope concepts. This matrix can show which claims of the 10,183,002 patent are actively protecting the intellectual property related to therapeutic monitoring of nitrogen scavenging drugs. It also identifies gaps or opportunities in the claim coverage[3].

Claim Charts

Claim charts generated using tools like ClaimScape® software can help in visualizing the claim coverage. These charts are useful for technical experts to review and determine whether specific scope concepts are applicable to target products or methods. This helps in identifying areas where the current claim coverage may be insufficient and highlights future design opportunities[3].

Patent Landscape

The patent landscape includes other related patents and the competitive environment.

Related Patents

The 10,183,002 patent is part of a larger portfolio held by Horizon Therapeutics. Other related patents 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, 10,045,959, 10,183,003, 10,183,004, 10,183,005, and 10,668,040. These patents collectively cover various aspects of treating urea cycle disorders, including methods of treatment, drug formulations, and monitoring techniques[5].

Competitive Environment

The competitive landscape in the field of urea cycle disorder treatments is intense, with multiple pharmaceutical companies involved. For instance, Teva Pharmaceuticals has been involved in litigation with Horizon Therapeutics regarding the filing of an Abbreviated New Drug Application (ANDA) for a generic version of Horizon's product RAVICTI® (glycerol phenylbutyrate oral liquid)[5].

Litigation and Enforcement

The enforcement of the 10,183,002 patent is crucial for protecting Horizon Therapeutics' intellectual property.

Litigation

Horizon Therapeutics has been involved in patent infringement litigation to protect its patents, including the 10,183,002 patent. For example, the company has filed a complaint against Teva Pharmaceuticals for patent infringement related to the ANDA filing for a generic version of RAVICTI®[5].

Patent Term and Extensions

The patent term of the 10,183,002 patent can be affected by various factors, including Patent Term Adjustments (PTA) and Patent Term Extensions (PTE). PTA can extend the patent term due to delays in the USPTO's processing, while PTE can extend the term due to regulatory review periods. However, terminal disclaimers, which are often used to overcome obviousness-type double patenting (ODP) rejections, do not extend the patent term past the date of the terminal disclaimer[1].

Quality and Compliance

The quality of the patent is ensured through various measures implemented by the USPTO.

Performance Incentives

The USPTO has developed correctness measures and quantifiable compliance targets to improve patent quality. These measures include statutory compliance rates for sections 101, 112, 102, and 103 of the U.S. Code[4].

Key Takeaways

• Scope and Claims: The 10,183,002 patent covers methods for therapeutic monitoring of nitrogen scavenging drugs, with claims that define the core aspects of the invention.
• Patent Landscape: The patent is part of a larger portfolio related to urea cycle disorder treatments and operates within a competitive environment.
• Litigation and Enforcement: The patent is actively enforced through litigation to protect Horizon Therapeutics' intellectual property.
• Patent Term and Extensions: The patent term can be extended through PTA and PTE, but terminal disclaimers do not extend the term past the disclaimer date.
• Quality and Compliance: The USPTO ensures patent quality through various compliance measures.

FAQs

1. What is the main focus of the 10,183,002 patent?

   • The main focus is on methods for therapeutic monitoring of nitrogen scavenging drugs used to treat urea cycle disorders.

2. How does the Claim Coverage Matrix help in analyzing the patent?

   • The Claim Coverage Matrix helps in categorizing patents and claims by scope concepts, identifying gaps or opportunities in claim coverage.

3. What is the significance of terminal disclaimers in patent term extensions?

   • Terminal disclaimers do not extend the patent term past the date of the terminal disclaimer, unlike PTA and PTE.

4. Why is patent quality important, and how is it ensured?

   • Patent quality is crucial for maintaining the integrity of the patent system. The USPTO ensures quality through correctness measures and compliance targets.

5. What is the competitive environment like for the 10,183,002 patent?

   • The competitive environment is intense, with multiple pharmaceutical companies involved in treating urea cycle disorders, and there is ongoing litigation to protect intellectual property.

Sources

1. In re Cellect - United States Court of Appeals for the Federal Circuit
2. U.S. Patent and Trademark Office (USPTO) | USAGov
3. Patent Analytics | Intellectual Property Law
4. Intellectual Property: Patent Office Should Define Quality, Reassess ...
5. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT ...

Drugs Protected by US Patent 10,183,002

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Horizon Therap Us	RAVICTI	glycerol phenylbutyrate	LIQUID;ORAL	203284-001	Feb 1, 2013		RX	Yes	Yes						TREATMENT OF A UREA CYCLE DISORDER

International Family Members for US Patent 10,183,002

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2012316750
Australia	2017251691
Brazil	112014007357
Canada	2850391