Detailed Analysis of the Scope and Claims of United States Patent 5,968,979
Introduction
United States Patent 5,968,979, titled "Triglycerides and ethyl esters of phenylalkanoic acid and phenylalkenoic acid useful in treatment of various disorders," is a significant patent in the field of pharmaceuticals, particularly in the treatment of metabolic and genetic disorders. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Invention
The patent, filed on February 7, 1995, and granted on October 19, 1999, is assigned to Brusilow Enterprises LLC. The invention revolves around the use of triglycerides and ethyl esters of phenylalkanoic acid and phenylalkenoic acid for therapeutic purposes. These compounds are particularly useful in treating disorders such as urea cycle disorders, thalassemia, and other conditions where nitrogen scavenging is beneficial[1][4].
Scope of the Invention
The scope of the patent encompasses the preparation, composition, and therapeutic applications of triglycerides and ethyl esters of phenylalkanoic acid and phenylalkenoic acid. Here are some key aspects:
Chemical Compounds
The patent describes the synthesis and properties of triglycerides and ethyl esters of phenylalkanoic acid and phenylalkenoic acid. These compounds are designed to be metabolized into phenylacetate, which is then used to scavenge nitrogen and reduce ammonia levels in the body[1].
Therapeutic Applications
The primary therapeutic applications include the treatment of urea cycle disorders, such as ornithine transcarbamylase deficiency, and other conditions like thalassemia. Clinical studies have shown that these compounds can increase hemoglobin levels in patients with thalassemia when used in combination with other treatments[1].
Claims of the Patent
The patent includes several claims that define the scope of protection:
Composition Claims
These claims cover the specific chemical compositions of the triglycerides and ethyl esters of phenylalkanoic acid and phenylalkenoic acid. They detail the molecular structures and the methods of preparation[1].
Method Claims
The method claims describe the processes for synthesizing these compounds and their therapeutic use. This includes the administration routes and dosages for treating various disorders[1].
Use Claims
These claims specify the therapeutic uses of the compounds, including their application in treating urea cycle disorders and other metabolic conditions[1].
Patent Landscape
Understanding the patent landscape around US 5,968,979 is crucial for assessing its impact and the competitive environment.
Related Patents
Several related patents and applications have been filed over the years, building upon or related to the original invention. For example, patents like WO2015063659A1 describe processes for the preparation of glycerol phenylbutyrate, a compound covered under the original patent[2].
Citations and Family Applications
The patent has been cited in numerous other patent applications and grants, indicating its influence on subsequent research and development. Family applications include US6060510A and US6083984A, which further elaborate on the treatment of various disorders using these compounds[1][2].
Competitors and Assignees
Over time, the assignee of the patent has changed, with Horizon Therapeutics LLC being a notable entity involved in the development and commercialization of these compounds. This shift reflects the evolving landscape of pharmaceutical companies and their interests in nitrogen scavenging therapies[5].
Impact on Therapeutic Treatments
The invention has had a significant impact on the treatment of urea cycle disorders and other metabolic conditions.
Clinical Studies and Outcomes
Clinical studies have demonstrated the efficacy of these compounds in reducing ammonia levels and improving patient outcomes. For instance, the combination of hydroxyurea and sodium phenylbutyrate has shown increased hemoglobin levels in thalassemia patients[1].
Market and Commercialization
The commercialization of these compounds has led to the development of drugs like Ravicti (glycerol phenylbutyrate), which is used to treat urea cycle disorders. This highlights the practical application and market impact of the patent[2].
Patent Analytics and Claim Coverage
To fully understand the protection and coverage provided by this patent, patent analytics tools are essential.
Claim Coverage Matrix
A Claim Coverage Matrix can help identify which patents and claims are actively protecting the intellectual property related to these compounds. This tool categorizes patents by claims and scope concepts, facilitating a comprehensive analysis of the patent landscape[3].
Claim Charts and Scope Concepts
Interactive claim charts generated by tools like ClaimScape® software can help technical experts review patent coverage and identify gaps or future design opportunities. These charts are particularly useful for determining the applicability of scope concepts to target products or methods[3].
Key Takeaways
- Therapeutic Use: The patent covers the use of triglycerides and ethyl esters of phenylalkanoic acid and phenylalkenoic acid for treating urea cycle disorders and other metabolic conditions.
- Chemical Compounds: The invention includes specific chemical compositions and methods of preparation.
- Patent Landscape: The patent has been influential, with numerous citations and related applications.
- Impact: It has led to significant advancements in the treatment of metabolic disorders and the commercialization of related drugs.
- Patent Analytics: Tools like Claim Coverage Matrix and claim charts are crucial for understanding the patent's protection and identifying opportunities.
Frequently Asked Questions
What are the primary therapeutic applications of the compounds described in US 5,968,979?
The primary therapeutic applications include the treatment of urea cycle disorders and other conditions like thalassemia.
How are the compounds synthesized according to the patent?
The patent describes the synthesis of triglycerides and ethyl esters of phenylalkanoic acid and phenylalkenoic acid through specific chemical processes.
What is the significance of glycerol phenylbutyrate in this context?
Glycerol phenylbutyrate is a key compound covered under the patent, used in the treatment of urea cycle disorders and commercially available as Ravicti.
How has the patent landscape evolved around US 5,968,979?
The patent landscape has evolved with numerous related patents and applications, changes in assignees, and the commercialization of related drugs.
What tools are used to analyze the claim coverage of this patent?
Tools like Claim Coverage Matrix and interactive claim charts generated by ClaimScape® software are used to analyze the claim coverage and identify gaps or opportunities.
Cited Sources
- US5968979A - Triglycerides and ethyl esters of phenylalkanoic acid and phenylalkenoic acid useful in treatment of various disorders - Google Patents
- WO2015063659A1 - Process for the preparation of glycerol phenylbutyrate - Google Patents
- Patent Analytics | Intellectual Property Law - SLWIP
- Triglycerides and ethyl esters of phenylalkanoic acid and phenylalkenoic acid useful in treatment of various disorders - PubChem
- US-5968979-A - Unified Patents Portal - Unified Patents Portal
