United States Patent 9,855,214: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,855,214, titled "Enalapril Compositions," is a significant patent in the pharmaceutical sector, particularly for the formulation and use of enalapril, a widely used angiotensin-converting enzyme (ACE) inhibitor. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background on Enalapril
Enalapril, an ACE inhibitor, is commonly prescribed for the treatment of hypertension and heart failure. Its stability and formulation are critical for maintaining its efficacy and safety profile.
Patent Overview
Inventors and Assignees
The patent was invented by Gerold L. Mosher and David W. Miles, and it is assigned to Silvergate Pharmaceuticals, Inc.[2].
Filing and Grant Dates
The patent application was filed on June 3, 2015, and the patent was granted on September 15, 2017[4].
Scope of the Patent
Claims
The patent includes several claims that define the scope of the invention. Here are the key claims:
- Claim 1: This claim describes stable enalapril powder compositions for oral liquid formulation, which include enalapril maleate, a bulking agent, and optionally a sweetener, flavoring agent, or preservative[4].
- Claim 2: This claim specifies the composition where the bulking agent is mannitol, and the enalapril maleate is present in a specific weight percentage[4].
- Claim 3: This claim details the method of preparing the oral liquid formulation by mixing the powder composition with a liquid vehicle[4].
Description of the Invention
The patent describes stable enalapril powder compositions designed for oral liquid formulations. These compositions are formulated to minimize the degradation of enalapril, particularly the formation of diketopiperazine and enalaprilat degradants. The use of specific bulking agents like mannitol and the optimization of pH levels are crucial for maintaining stability[4].
Patent Claims Analysis
Independent Claims
The independent claims (e.g., Claim 1) are broad and define the core invention. They specify the components and their proportions, ensuring that the composition remains stable and effective.
Dependent Claims
Dependent claims (e.g., Claims 2 and 3) narrow down the scope by adding specific details such as the type of bulking agent and the method of preparation. These claims provide additional protection by covering specific embodiments of the invention.
Patent Landscape
Related Patents
Several related patents exist that cover various aspects of enalapril formulations. For example:
- US 10,772,868 B2: This patent, also by Mosher et al., covers enalapril formulations with a focus on stability and degradation prevention[2].
- US 9855214 B2: This patent provides stable enalapril powder compositions for oral liquid formulations, similar to the current patent but with different specific embodiments[4].
Classification
The patent is classified under various categories, including A61K 9/00, A61K 9/14, and A61P 9/04, indicating its relevance to medicinal preparations, particularly those for cardiovascular disorders[4].
Impact on the Pharmaceutical Industry
Innovation and Stability
The patent contributes to the innovation in pharmaceutical formulations by providing stable and effective enalapril compositions. This is crucial for maintaining the therapeutic efficacy of enalapril and ensuring patient safety.
Competitive Landscape
The presence of multiple patents in this area indicates a competitive landscape where different companies are working to improve enalapril formulations. This competition drives innovation and can lead to better treatment options for patients.
Challenges and Criticisms
Patent Scope and Clarity
The scope and clarity of patent claims are critical for determining the validity and enforceability of the patent. Broad or unclear claims can lead to litigation and diminish innovation incentives, as discussed in the context of patent quality debates[3].
Regulatory Compliance
Compliance with regulatory requirements is essential for pharmaceutical patents. The stability and safety data provided in the patent must align with regulatory standards to ensure approval and marketability.
Key Takeaways
- Stable Formulations: The patent provides stable enalapril powder compositions for oral liquid formulations, ensuring the efficacy and safety of the drug.
- Specific Claims: The claims are detailed and specify the components and their proportions, as well as the method of preparation.
- Competitive Landscape: The patent is part of a broader landscape of enalapril formulation patents, indicating ongoing innovation in this area.
- Regulatory Compliance: The patent must comply with regulatory standards to ensure approval and marketability.
FAQs
What is the main invention described in US Patent 9,855,214?
The main invention is stable enalapril powder compositions for oral liquid formulations.
Who are the inventors of this patent?
The inventors are Gerold L. Mosher and David W. Miles.
What is the significance of using mannitol in the composition?
Mannitol is used as a bulking agent to help maintain the stability of enalapril in the powder composition.
How does this patent contribute to the pharmaceutical industry?
It contributes by providing innovative and stable enalapril formulations, which are crucial for maintaining therapeutic efficacy and patient safety.
What are some of the related patents in this area?
Related patents include US 10,772,868 B2 and US 9855214 B2, which also cover enalapril formulations with a focus on stability.
Cited Sources
- US Patent 11,173,141 B2 - Enalapril Formulations[1].
- US Patent 10,772,868 B2 - Enalapril Formulations[2].
- Patent Claims and Patent Scope - Hoover Institution[3].
- US Patent 9855214 B2 - Enalapril Compositions[4].
