Details for Patent: 10,183,005

Which drugs does patent 10,183,005 protect, and when does it expire?

Patent 10,183,005 protects RAVICTI and is included in one NDA.

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

Summary for Patent: 10,183,005

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:	15/944,432
Patent Claim Types: see list of patent claims	Use;

Analyzing the Scope and Claims of a Patent: A Detailed Guide Using United States Patent 10,183,005 as an Example

Introduction to Patent Analysis

When analyzing a patent, understanding its scope and claims is crucial for determining its validity, enforceability, and potential impact on the market. Here, we will use United States Patent 10,183,005 as an example to delve into the intricacies of patent analysis.

Understanding Patent Claims

What are Patent Claims?

Patent claims are the most critical part of a patent application, as they define the scope of the invention and what is protected by the patent[3].

Types of Claims

• Independent Claims: These claims stand alone and define the invention without reference to other claims.
• Dependent Claims: These claims refer back to and further limit an independent claim.

Analyzing the Scope of United States Patent 10,183,005

Step-by-Step Analysis

1. Identify the Independent Claims

   • Start by identifying the independent claims, which are typically the broadest claims in the patent. These claims set the foundation for understanding the overall scope of the invention.

2. Understand the Dependent Claims

   • Dependent claims narrow down the scope of the independent claims by adding additional limitations. Analyze these claims to see how they further define the invention.

3. Review the Claim Language

   • Carefully read the language of each claim. Pay attention to keywords, phrases, and any specific limitations or requirements.

4. Use Claim Charts and Matrices

   • Tools like Claim Coverage Matrices and Claim Charts can help visualize the relationship between different claims and scope concepts. This can make it easier to determine if the claims cover the intended technology and identify any gaps in coverage[3].

Patent Landscape Analysis

Global Context

• International Patent Offices: Check if similar patents have been filed or granted in other countries. Databases such as the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO) provide access to international patent collections[1].

Prior Art and Citation Data

• Common Citation Document (CCD): Use the CCD application to consolidate prior art citations from multiple offices. This helps in understanding how different patent offices have treated similar inventions[1].
• Global Dossier: Access the file histories of related applications from participating IP Offices to see the patent family and related citations[1].

Legal and Regulatory Considerations

Obviousness-Type Double Patenting

• Ensure that the patent does not fall under obviousness-type double patenting. Recent court decisions, such as the Federal Circuit's ruling in Allergan USA, Inc. v. MSN Laboratories Private Ltd., clarify that a first-filed, first-issued patent cannot be invalidated by a later-filed, later-issued patent with a common priority date[2].

Enablement Requirement

• The patent must meet the enablement requirement, which means it must provide sufficient information for a person of ordinary skill in the field to make and use the invention. Guidelines from the USPTO can help in assessing this requirement[4].

Tools and Resources for Patent Search

USPTO Resources

• Patent Public Search: Utilize the USPTO's Patent Public Search tool for enhanced access to prior art and modern interfaces for searching patents[1].
• Patent and Trademark Resource Centers (PTRCs): Local PTRCs offer training and resources for patent search techniques[1].

Additional Databases

• Publication Site for Issued and Published Sequences (PSIPS): For patents involving sequences, use PSIPS to access sequence listings and other mega items[1].
• Patent Examination Data System (PEDS): This system allows for the search, view, and download of bibliographic data for publicly available patent applications[1].

Practical Application of Patent Analytics

Claim Coverage and Scope Concepts

• Use patent analytics tools to categorize patents by claims and scope concepts. This helps in filtering, searching, and analyzing large numbers of patent claims efficiently[3].

Interactive Claim Charts

• Generate interactive claim charts using tools like ClaimScape® to review patent coverage with engineers, scientists, and management. These charts help identify gaps in current coverage and highlight future design opportunities[3].

Key Takeaways

• Thorough Claim Analysis: Understand the independent and dependent claims to define the scope of the invention.
• Global Patent Landscape: Check for similar patents in international databases to ensure global protection.
• Legal Compliance: Ensure the patent does not violate obviousness-type double patenting and meets the enablement requirement.
• Utilize Advanced Tools: Leverage tools like Claim Coverage Matrices, CCD, and Global Dossier for comprehensive analysis.
• Continuous Monitoring: Regularly update claim charts and monitor the patent landscape to identify gaps and opportunities.

FAQs

1. What is the purpose of the Common Citation Document (CCD) application?

   • The CCD application consolidates prior art citations from multiple offices, allowing users to visualize search results for the same invention on a single page[1].

2. How can I determine if my patent claims cover the intended technology?

   • Use Claim Coverage Matrices and interactive claim charts to visualize the relationship between claims and scope concepts, helping to identify gaps in coverage[3].

3. What is obviousness-type double patenting, and how does it affect patents?

   • Obviousness-type double patenting prevents patentees from obtaining a second patent on a patentably indistinct invention to extend the life of a first patent. Recent court decisions clarify specific scenarios where this does not apply[2].

4. What resources are available for searching international patents?

   • Databases from the European Patent Office, Japan Patent Office, World Intellectual Property Organization, and other international intellectual property offices provide access to international patent collections[1].

5. How can I ensure my patent meets the enablement requirement?

   • Refer to the USPTO guidelines for assessing enablement in utility applications to ensure the patent provides sufficient information for a person of ordinary skill in the field to make and use the invention[4].

Sources

1. USPTO - Search for patents

   • https://www.uspto.gov/patents/search

2. Whitecase - Federal Circuit Limits the Application of Obviousness-Type Double Patenting

   • https://www.whitecase.com/insight-alert/federal-circuit-limits-application-obviousness-type-double-patenting-patents-same

3. Schwegman - Patent Analytics

   • https://www.slwip.com/services/patent-analytics/

4. Federal Register - Guidelines for Assessing Enablement in Utility Applications

   • https://unblock.federalregister.gov

5. CAFC - ARBUTUS BIOPHARMA CORPORATION v. MODERNATX, INC.

   • https://cafc.uscourts.gov/opinions-orders/20-1183.OPINION.4-11-2023_2108936.pdf

Drugs Protected by US Patent 10,183,005

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	10,183,005					TREATMENT OF A UREA CYCLE DISORDER

International Family Members for US Patent 10,183,005

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2012316750
Australia	2017251691
Brazil	112014007357
Canada	2850391
Chile	2014000783
China	104039358
China	107271696