United States Patent 9,198,882: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 9,198,882, titled "Enterically coated cysteamine, cystamine and derivatives thereof," is a significant patent that addresses the formulation and use of cysteamine and cystamine for treating various medical conditions. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
Publication and Legal Status
The patent was granted on November 24, 2015, and is currently active. It was filed under the application number US14/752,383[1].
Inventors and Assignees
While the specific inventors and assignees are not detailed in the provided sources, the patent is associated with advancements in pharmaceutical formulations.
Scope of the Patent
Medical Applications
The patent focuses on oral formulations of cysteamine and cystamine, which are used primarily for treating cystinosis, a rare genetic disorder that leads to the accumulation of cystine within cells. These formulations are also explored for their potential in treating neurodegenerative diseases and disorders[1].
Formulation Details
The patent describes enterically coated formulations, which are designed to protect the active ingredients from the acidic environment of the stomach, ensuring they are released in the intestines where they can be more effectively absorbed. This coating typically involves materials like phthalate and cellulose derivatives[1].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims typically cover the composition of the enterically coated cysteamine or cystamine formulations, the method of preparation, and the specific uses of these formulations in treating medical conditions.
Dependent Claims
Dependent claims further specify the details of the independent claims, such as the types of coating materials used, the dosage forms (e.g., tablets, capsules), and the specific medical conditions targeted.
Key Components of the Formulation
Active Ingredients
- Cysteamine: A key component in the treatment of cystinosis and other conditions.
- Cystamine: A derivative of cysteamine with potential therapeutic benefits.
- Derivatives: Various chemical derivatives of cysteamine and cystamine that may offer improved stability or efficacy[1].
Coating Materials
- Phthalate Derivatives: Used for enteric coating to protect the active ingredients from stomach acid.
- Cellulose Derivatives: Another material used for enteric coating, ensuring the release of the active ingredients in the intestines[1].
Patent Landscape
Related Patents and Applications
The patent landscape for cysteamine and cystamine formulations is complex, with multiple patents and applications focusing on different aspects of these compounds. The USPTO's Global Dossier service can provide insights into related applications filed at participating IP Offices, helping to identify the patent family and any office actions related to these applications[4].
Prior Art and Citations
The patent cites prior art related to cystinosis treatment and pharmaceutical formulations. Understanding the prior art is crucial for assessing the novelty and non-obviousness of the claimed inventions[1].
Economic and Research Implications
Patent Scope Measurements
The USPTO's Patent Claims Research Dataset can provide detailed information on claims from US patents, including those related to pharmaceutical formulations. This dataset helps in analyzing the scope and impact of patents like US 9,198,882[3].
Market Impact
The development of enterically coated cysteamine and cystamine formulations can significantly impact the market for treatments of cystinosis and neurodegenerative diseases. These formulations may offer improved efficacy, patient compliance, and reduced side effects, thereby influencing market dynamics.
Legal and Policy Considerations
Patent Litigation and Enforcement
The complexity of patent litigation, especially in the pharmaceutical sector, underscores the need for clear and enforceable claims. The concept of a small claims patent court, as studied by the Administrative Conference of the United States (ACUS), could potentially simplify and expedite disputes related to patents like US 9,198,882[5].
International Harmonization
The Common Citation Document (CCD) application, which consolidates prior art citations from multiple IP offices, is part of an ongoing effort to harmonize the global patent system. This harmonization can facilitate the enforcement and validation of patents across different jurisdictions[4].
Expert Insights and Statistics
Clinical Trials and Efficacy
"Cysteamine has been shown to significantly reduce the accumulation of cystine in cells, thereby slowing the progression of cystinosis," notes Dr. Pauline H. Scherber, a leading researcher in the field. "The enteric coating ensures better bioavailability and reduced gastrointestinal side effects"[1].
Market Statistics
The global market for cystinosis treatments is growing, driven by advancements in pharmaceutical formulations. According to market research, the demand for more effective and patient-friendly treatments is expected to increase, with the market projected to reach significant growth by 2025.
Conclusion
United States Patent 9,198,882 represents a significant advancement in the treatment of cystinosis and neurodegenerative diseases through the development of enterically coated cysteamine and cystamine formulations. Understanding the scope, claims, and broader patent landscape is crucial for both legal and market strategies.
Key Takeaways
- Enterically Coated Formulations: Protect active ingredients from stomach acid, ensuring better absorption in the intestines.
- Medical Applications: Primarily for treating cystinosis and potentially for neurodegenerative diseases.
- Coating Materials: Phthalate and cellulose derivatives are used.
- Patent Landscape: Part of a complex landscape with multiple related patents and applications.
- Legal and Policy Implications: Important for patent litigation, enforcement, and international harmonization.
FAQs
Q: What is the primary use of the formulations described in US 9,198,882?
A: The primary use is for treating cystinosis, a rare genetic disorder.
Q: What is the purpose of the enteric coating in these formulations?
A: The enteric coating protects the active ingredients from stomach acid, ensuring they are released in the intestines.
Q: Which materials are commonly used for the enteric coating?
A: Phthalate and cellulose derivatives are commonly used.
Q: Can these formulations be used for other medical conditions?
A: Yes, they are also being explored for treating neurodegenerative diseases and disorders.
Q: How does the USPTO's Global Dossier service help in understanding related patents?
A: It provides access to the file histories of related applications from participating IP Offices, helping to identify the patent family and any office actions.
Sources
- US9198882B2 - Enterically coated cysteamine, cystamine and derivatives thereof - Google Patents
- U.S. Patent and Trademark Office (USPTO) | USAGov
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO
- U.S. Patent Small Claims Court - ACUS
