Understanding the Scope and Claims of United States Patent 9,561,204
Introduction
United States Patent 9,561,204, titled "Effervescent compositions containing N-acetylcysteine," is a significant patent in the field of pharmaceuticals, particularly for the treatment of acetaminophen poisoning and other conditions. Here, we will delve into the details of the patent, including its scope, claims, and the broader patent landscape.
Background of N-Acetylcysteine
N-Acetylcysteine (NAC) is a well-known mucolytic agent and antioxidant used in various medical treatments. It is particularly effective in treating acetaminophen (paracetamol) overdose, which can cause severe liver damage. The patent in question focuses on an effervescent composition that enhances the delivery and efficacy of NAC.
Patent Overview
The patent, US9561204B2, was granted for an effervescent composition containing a high amount of NAC. This composition is designed for oral administration, making it more convenient and potentially more effective than traditional forms of NAC.
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 are some key points:
Effervescent Composition
The patent covers an effervescent composition that includes NAC as the active ingredient. This composition is characterized by its ability to release carbon dioxide gas when it comes into contact with water, which helps in the rapid dissolution and absorption of NAC[1].
High NAC Content
The composition is notable for containing a high amount of NAC, which is crucial for its therapeutic efficacy. This high concentration is a key aspect of the patent, distinguishing it from other formulations that may contain lower doses of NAC.
Pharmaceutical Excipients
The patent also details various pharmaceutical excipients that can be used in the composition, such as carbonates, organic acids, and polyols. These excipients play a critical role in the effervescent reaction and the stability of the formulation[1].
Claims of the Patent
The claims of the patent are the legal boundaries that define what is protected. Here are some of the main claims:
Independent Claims
The patent includes independent claims that describe the composition and its method of preparation. For example, Claim 1 describes the effervescent composition comprising NAC, a carbonate, and an organic acid[1].
Dependent Claims
Dependent claims further specify the composition by detailing the types and amounts of excipients, the method of manufacture, and the physical form of the composition (e.g., tablets, powders)[1].
Patent Landscape
The patent landscape surrounding US9561204B2 involves several key aspects:
Prior Art
The patent examiner would have considered prior art related to NAC formulations and effervescent compositions. The novelty and non-obviousness of the invention would have been evaluated against existing patents and publications[2].
Classification
The patent is classified under various categories, including A61K47/08 and A61K9/00, which pertain to medicinal preparations and their physical forms. This classification helps in identifying similar patents and ensuring that the invention does not infringe on existing patents[1].
International Protection
While the patent is granted in the United States, the inventors could have sought international protection through a Patent Cooperation Treaty (PCT) application. This would allow them to file for patents in multiple countries within a specified timeframe[2].
Commercial and Practical Implications
The commercial and practical implications of this patent are significant:
Treatment of Acetaminophen Poisoning
The effervescent composition of NAC offers a more effective and convenient treatment for acetaminophen poisoning. This can lead to better patient outcomes and reduced healthcare costs.
Market Competition
The patent provides a competitive advantage to the holder, allowing them to market and sell the effervescent NAC composition exclusively. This can impact market dynamics and pricing strategies in the pharmaceutical industry.
Cost and Licensing
The cost of developing and maintaining the patent, including prosecution and potential international filings, can be substantial. However, if the invention has high commercial value, these costs can be recovered through licensing agreements or sales[2].
Challenges and Controversies
Patents, especially those in the pharmaceutical sector, often face challenges and controversies:
Patent Scope and Quality
There is ongoing debate about patent scope and quality, with some arguing that broader patents can stifle innovation. The metrics used to measure patent scope, such as independent claim length and count, can influence the perceived quality of the patent[3].
Litigation and Licensing
Patent litigation and licensing costs can be high, especially if the patent is challenged or if there are disputes over infringement. The study on a potential small claims patent court highlights the need for more efficient and cost-effective dispute resolution mechanisms[5].
Key Takeaways
- Effervescent Composition: The patent covers an effervescent composition containing a high amount of NAC, designed for oral administration.
- Pharmaceutical Excipients: The composition includes various excipients that facilitate the effervescent reaction and stability.
- Claims and Scope: The patent's claims define the protected aspects, including the composition, method of preparation, and physical form.
- Commercial Implications: The patent offers a competitive advantage and potential for improved patient outcomes in treating acetaminophen poisoning.
- Challenges: The patent faces challenges related to scope, quality, and potential litigation costs.
FAQs
Q: What is the primary use of the effervescent composition described in US9561204B2?
A: The primary use is for the oral treatment of acetaminophen poisoning and other conditions where NAC is beneficial.
Q: What are the key components of the effervescent composition?
A: The composition includes NAC, carbonates, and organic acids, along with other pharmaceutical excipients.
Q: How does the effervescent composition enhance the delivery of NAC?
A: The effervescent reaction helps in the rapid dissolution and absorption of NAC, making it more effective and convenient.
Q: What are the potential commercial implications of this patent?
A: The patent provides a competitive advantage, potentially leading to better patient outcomes and reduced healthcare costs.
Q: What are some of the challenges faced by pharmaceutical patents like US9561204B2?
A: These patents often face challenges related to scope, quality, and litigation costs, as well as debates over patent breadth and validity.
Sources
- US9561204B2 - Effervescent compositions containing N-acetylcysteine - Google Patents
- Intellectual Property Protection - KU Office of Research
- Patent Claims and Patent Scope - SSRN
- Search for patents - USPTO
- U.S. Patent Small Claims Court - ACUS
