United States Patent 8,026,284: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 8,026,284, titled "Enterically coated cystamine, cysteamine and derivatives thereof," is a significant patent in the field of pharmaceuticals, particularly for the treatment of cystinosis and neurodegenerative diseases. This article will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent, assigned to the University of California, was granted on September 27, 2011. It involves the development of oral formulations of cysteamine and cystamine, which are crucial for treating cystinosis, a rare genetic disorder, and various neurodegenerative diseases[1].
Scope of the Patent
The scope of the patent is defined by its claims, which outline the specific aspects of the invention that are protected. Here, the patent covers enterically coated formulations of cysteamine, cystamine, and their derivatives. Enteric coating is a technology that protects the drug from the acidic environment of the stomach, ensuring it is released in the intestines where it can be more effectively absorbed.
Key Components of the Scope
- Active Ingredients: The patent focuses on cysteamine and cystamine, which are known for their therapeutic benefits in treating cystinosis and neurodegenerative diseases.
- Enteric Coating: The use of enteric coating is a critical aspect, as it enhances the bioavailability and stability of the active ingredients.
- Derivatives: The patent also includes derivatives of cysteamine and cystamine, expanding the scope to related compounds that may offer similar therapeutic benefits[1].
Claims of the Patent
The claims section is the heart of any patent, as it defines what is legally protected. For US Patent 8,026,284, the claims can be categorized into several types:
Independent Claims
These claims stand alone and define the broadest scope of the invention. For example, Claim 1 might describe the enterically coated formulation of cysteamine or cystamine in general terms[1].
Dependent Claims
These claims build upon the independent claims and provide more specific details. For instance, a dependent claim might specify the type of enteric coating material used or the particular dosage form (e.g., tablets, capsules)[1].
Patent Landscape
Understanding the patent landscape is crucial for assessing the impact and uniqueness of the invention.
Prior Art
The patent landscape includes prior art that was considered during the examination process. This involves other patents and publications related to cysteamine, cystamine, and enteric coating technologies. The USPTO's search tools, such as the Patent Public Search and Global Dossier, are essential for identifying relevant prior art[4].
Related Patents
Other patents in the same field can provide insights into the competitive landscape. For example, patents related to cystinosis treatments or neurodegenerative disease therapies might overlap or complement the scope of this patent.
International Patent Filings
The global patent landscape is also relevant. The Common Citation Document (CCD) and databases from other international intellectual property offices, such as the European Patent Office (EPO) and the World Intellectual Property Organization (WIPO), can reveal whether similar inventions have been patented or applied for in other jurisdictions[4].
Metrics for Measuring Patent Scope
To evaluate the quality and breadth of the patent, metrics such as independent claim length and independent claim count can be used. Research has shown that narrower claims at publication are associated with a higher probability of grant and a shorter examination process[3].
Examination Process
The examination process for this patent would have involved a thorough review of the claims and prior art. The USPTO's examination process tends to narrow the scope of patent claims, ensuring that the granted patent is well-defined and not overly broad[3].
Practical Implications
For pharmaceutical companies and researchers, this patent provides valuable insights into the formulation and delivery of cysteamine and cystamine. The enteric coating technology can enhance the efficacy and patient compliance of these treatments.
Market Impact
The patent's impact on the market involves the potential for improved treatments for cystinosis and neurodegenerative diseases. Companies holding this patent can leverage the protected technology to develop new products or improve existing ones, potentially gaining a competitive edge.
Legal Status and Expiration
As of the current date, the patent is active but has an expiration date. Understanding the legal status is crucial for determining the period during which the invention is protected and when it will enter the public domain[1].
Conclusion
The United States Patent 8,026,284 is a significant contribution to the field of pharmaceuticals, particularly in the treatment of cystinosis and neurodegenerative diseases. The scope and claims of the patent are well-defined, protecting the enterically coated formulations of cysteamine, cystamine, and their derivatives. The broader patent landscape highlights the importance of this invention within the global intellectual property framework.
Key Takeaways
- Enteric Coating Technology: The patent protects the use of enteric coating for cysteamine and cystamine formulations.
- Therapeutic Applications: The invention is crucial for treating cystinosis and neurodegenerative diseases.
- Patent Scope: The claims define the specific aspects of the invention, including the active ingredients and coating materials.
- Global Relevance: The patent's impact is assessed within the context of international intellectual property databases and prior art.
- Legal Status: The patent is active but has a defined expiration date.
FAQs
Q: What is the main focus of United States Patent 8,026,284?
A: The main focus is on enterically coated formulations of cysteamine, cystamine, and their derivatives for treating cystinosis and neurodegenerative diseases.
Q: What is the significance of enteric coating in this patent?
A: Enteric coating protects the drug from stomach acid, ensuring it is released in the intestines for better absorption.
Q: How does the patent landscape impact this invention?
A: The patent landscape includes prior art and related patents, which help define the uniqueness and competitive position of the invention.
Q: What metrics can be used to evaluate the scope of this patent?
A: Metrics such as independent claim length and independent claim count can be used to assess the breadth and quality of the patent.
Q: When does the patent expire?
A: The patent's expiration date is determined by its filing and grant dates, typically 20 years from the earliest filing date.
Sources
- US8026284B2 - Enterically coated cystamine, cysteamine and derivatives thereof - Google Patents
- U.S. Patent and Trademark Office (USPTO) | USAGov
- Patent Claims and Patent Scope - SSRN
- Search for patents - USPTO