United States Patent 10,406,199: A Detailed Analysis of Scope and Claims
Introduction
United States Patent 10,406,199, titled "Lisinopril formulations," is a significant patent that addresses the formulation and stability of lisinopril, a medication widely used for treating hypertension, heart failure, and acute myocardial infarction. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of Lisinopril
Lisinopril is an angiotensin-converting enzyme (ACE) inhibitor, crucial in managing cardiovascular diseases. Its efficacy and stability are paramount for patient treatment outcomes. The patent in question focuses on improving the formulation of lisinopril to enhance its stability and patient compliance.
Scope of the Patent
The patent covers various aspects of lisinopril formulations, including:
Formulation Composition
The patent describes a stable oral liquid formulation of lisinopril, which includes the active ingredient lisinopril or its pharmaceutically acceptable salt or solvate. The formulation also comprises a buffer system, sweeteners, flavoring agents, and preservatives to ensure stability and palatability[1].
Stability
A key aspect of the patent is the formulation's stability. The invention ensures that the lisinopril formulation remains stable at room temperature (about 25°C ± 5°C) for at least 18 months, and in some embodiments, up to 24 months. This stability is critical for maintaining the drug's potency and shelf life[1].
Buffer System
The buffer system in the formulation includes components like citric acid and sodium citrate, which help maintain a pH of about 4.9. This pH range is crucial for the stability of lisinopril[1].
Sweeteners and Flavoring Agents
The formulation may include sweeteners such as xylitol, sodium saccharin, or sucralose to improve the taste. Flavoring agents are also incorporated to enhance patient compliance, especially in pediatric or geriatric populations[1].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Claim 1: Formulation Composition
The first claim specifies the composition of the lisinopril formulation, including the amount of lisinopril (about 0.8 to about 1.2 mg/ml), xylitol (about 140 to about 160 mg/ml), citric acid (about 0.5 to about 1.2 mg/ml), and sodium citrate (about 1.2 to about 1.7 mg/ml)[1].
Claim 2: Buffer System
This claim details the buffer system, emphasizing the use of citric acid and sodium citrate to maintain the desired pH[1].
Claim 3: Stability
The claim regarding stability ensures that the formulation remains effective and stable over a specified period at room temperature[1].
Claim 4: Additional Components
This claim includes the use of preservatives like sodium benzoate and flavoring agents to enhance the formulation's stability and palatability[1].
Patent Landscape
Classification
The patent is classified under various categories, including A61K (Preparations for medical, dental, or toilet purposes) and A61P (Specific therapeutic activity of chemical compounds or medicinal preparations), particularly for cardiovascular system disorders[1].
Prior Art
The patent builds upon existing knowledge in the field of pharmaceutical formulations, particularly those related to ACE inhibitors. It addresses specific challenges such as stability and palatability, which were not fully resolved in prior art[1].
Competitive Landscape
The patent landscape for lisinopril formulations is competitive, with multiple patents and formulations existing. However, this patent stands out due to its focus on stability and patient compliance, which are critical factors in the pharmaceutical industry.
Economic and Commercial Impact
Market Demand
The demand for stable and palatable lisinopril formulations is high, given the widespread use of lisinopril in treating cardiovascular diseases. This patent could significantly impact the market by providing a more stable and patient-friendly formulation.
Cost Considerations
The cost of developing and maintaining a patent, as outlined by the KU Office of Research, can be substantial, ranging from $8,000 to $20,000 for a U.S. non-provisional patent application, and even higher for international patents. However, the commercial value of a stable lisinopril formulation could justify these costs[5].
Legal and Regulatory Aspects
Patentability Criteria
The invention must meet the criteria of novelty, usefulness, and non-obviousness to be patentable. The detailed description and claims of the patent ensure that these criteria are met[5].
Patent Prosecution
The patent prosecution process, which can take two to five years, involves arguments and amendments to the claims. The success of this process is crucial for the patent to be granted and maintained[5].
Conclusion
United States Patent 10,406,199 represents a significant advancement in the formulation of lisinopril, addressing critical issues of stability and patient compliance. The detailed claims and scope of the patent highlight its innovative approach to pharmaceutical formulation.
Key Takeaways
- Stable Formulation: The patent ensures the stability of lisinopril at room temperature for up to 24 months.
- Buffer System: The use of citric acid and sodium citrate maintains a pH of about 4.9.
- Palatability: Sweeteners and flavoring agents enhance patient compliance.
- Commercial Impact: The patent has significant market potential due to the high demand for stable lisinopril formulations.
- Legal and Regulatory: The patent meets the criteria of novelty, usefulness, and non-obviousness.
FAQs
Q1: What is the primary focus of United States Patent 10,406,199?
The primary focus is on the formulation and stability of lisinopril, an ACE inhibitor used in treating cardiovascular diseases.
Q2: How does the patent ensure the stability of lisinopril?
The patent ensures stability through a specific buffer system and by maintaining a pH of about 4.9, using components like citric acid and sodium citrate.
Q3: What are the key components of the lisinopril formulation?
The formulation includes lisinopril, xylitol, citric acid, sodium citrate, and preservatives like sodium benzoate.
Q4: Why is the stability of lisinopril important?
Stability is crucial for maintaining the drug's potency and shelf life, ensuring that the medication remains effective over its intended use period.
Q5: What is the commercial potential of this patent?
The patent has significant commercial potential due to the high demand for stable and palatable lisinopril formulations, which can enhance patient compliance and treatment outcomes.
Sources
- US10406199B2 - Lisinopril formulations - Google Patents
- U.S. Patent and Trademark Office (USPTO) - USAGov
- Patent Claims Research Dataset - USPTO
- Research and Course Guides: Patent Searching, Advanced - Clemson University
- Intellectual Property Protection - KU Office of Research
