United States Patent 9,427,421: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,427,421, titled "Effervescent Compositions Containing N-Acetylcysteine," is a significant patent in the pharmaceutical field, particularly for the treatment of acetaminophen poisoning. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Invention
The patent, assigned to ALPEX PHARMA S.A., pertains to effervescent pharmaceutical compositions containing N-acetylcysteine. N-acetylcysteine is an N-acetyl-L-amino acid derivative of the natural amino acid L-cysteine, known for its antiinfective and mucolytic properties[4].
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 focuses on effervescent compositions that contain a high amount of N-acetylcysteine, designed for the oral treatment of acetaminophen poisoning.
Claim Types
The patent includes various claim types, which are crucial for understanding its scope:
- Composition Claims: These claims define the specific formulation of the effervescent compositions, including the amount of N-acetylcysteine and other components.
- Method of Use Claims: These claims specify the methods for using the effervescent compositions, particularly for the treatment of acetaminophen poisoning[2].
Claims Analysis
Independent Claims
The patent includes independent claims that stand alone and define the invention. For example, Claim 1 might describe the effervescent composition containing N-acetylcysteine, while subsequent claims might detail specific aspects such as the concentration of N-acetylcysteine, other ingredients, and the method of preparation.
Dependent Claims
Dependent claims build upon the independent claims, providing additional details or limitations. These claims help to narrow down the scope and ensure that the invention is clearly defined.
Claim Length and Count
Research suggests that the length and count of independent claims can be metrics for measuring patent scope. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process[3].
Patent Landscape
Related Applications
The patent 9,427,421 is part of a series of related applications, including continuations and continuations-in-part. For instance, it is a continuation of U.S. application Ser. No. 14/800,228, which in turn is a continuation of earlier applications. This chain of applications indicates a thorough and iterative development process[2].
Classification
The patent is classified under various CPC (Cooperative Patent Classification) categories, including A61K 31/198, A61K 9/0007, and A61K 47/02. These classifications help in identifying the patent's place within the broader pharmaceutical and medical fields[2].
Examination Process
The examination process for this patent would have involved a detailed review of the claims to ensure they meet the requirements of patentability, including novelty, non-obviousness, and sufficient disclosure. The process tends to narrow the scope of patent claims, making them more specific and less broad[3].
Prior Art and Disclosure
The patent's validity depends on its disclosure and how it differentiates from prior art. For instance, the court's interpretation of Article 112 of the US Patent Law emphasizes that a provisional patent application must disclose sufficient detail so that one skilled in the field can implement the invention without undue experimentation[1].
Industry Impact
The patent's impact on the pharmaceutical industry is significant, particularly in the treatment of acetaminophen poisoning. Effervescent compositions offer a convenient and effective delivery method for N-acetylcysteine, enhancing patient compliance and treatment outcomes.
Exclusivity and Expiration
The patent's exclusivity period is crucial for the assignee, ALPEX PHARMA S.A., as it provides a monopoly on the invention for a specified period. The patent's term, subject to any disclaimers or adjustments, typically lasts for 20 years from the earliest filing date of the application from which the patent was granted[2].
Key Takeaways
- Specific Claims: The patent includes detailed claims defining the effervescent compositions and their use.
- Related Applications: It is part of a series of continuations, indicating a thorough development process.
- Classification: Classified under specific CPC categories, helping in identifying its place in the pharmaceutical field.
- Examination Process: The claims were likely narrowed during the examination process to ensure specificity and validity.
- Industry Impact: Significant impact on the treatment of acetaminophen poisoning with convenient effervescent compositions.
FAQs
What is the main subject of United States Patent 9,427,421?
The main subject of this patent is effervescent pharmaceutical compositions containing N-acetylcysteine, specifically designed for the oral treatment of acetaminophen poisoning.
Who is the assignee of this patent?
The assignee of this patent is ALPEX PHARMA S.A.
What are the key claim types in this patent?
The key claim types include composition claims and method of use claims.
How does the patent landscape influence this invention?
The patent landscape, including related applications and classifications, helps in understanding the invention's place within the broader pharmaceutical field and ensures its uniqueness and validity.
What is the significance of N-acetylcysteine in this patent?
N-acetylcysteine is significant due to its antiinfective and mucolytic properties, making it an effective treatment for acetaminophen poisoning.
How long does the exclusivity period for this patent typically last?
The exclusivity period typically lasts for 20 years from the earliest filing date of the application from which the patent was granted.
Sources
- The Analysis of the Temporary Patent Application System in the US - Clausius Press.
- United States Patent - Stroppolo et al. - Google Patents.
- Patent Claims and Patent Scope - SSRN.
- N-acetyl-L-cysteine - PubChem.
- Orange Book Companion - Orange Book Companion.
