United States Patent 6,503,911: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,503,911, titled "Sustained Release Formulations of Ranolazine," is a significant patent in the pharmaceutical field, particularly in the treatment of cardiovascular diseases. This patent, issued to various inventors, outlines innovative formulations for the sustained release of ranolazine, a drug used to treat angina pectoris and other cardiovascular conditions.
Background of the Patent
Invention Overview
The patent describes sustained-release formulations of ranolazine, which are designed to maintain effective plasma levels of the drug over an extended period, typically 24 hours. This is crucial for treating conditions such as angina pectoris, where consistent drug levels are necessary for effective symptom management[4].
Prior Art and State of the Art
The patent builds upon earlier work in the field, including other patents and patent applications that addressed similar challenges in sustained-release formulations. For instance, earlier formulations required complex mixtures of ingredients to achieve the desired release profile, which this patent aims to simplify[4].
Scope of the Patent
Claims
The patent includes several key claims that define the scope of the invention:
- Claim 1: This claim describes a sustained-release pharmaceutical formulation containing ranolazine and a partially neutralized pH-dependent binder. The binder controls the dissolution rate of ranolazine across the pH range of the stomach and intestines[4].
- Claim 2: This claim specifies the composition of the formulation, including the percentage of ranolazine and the types of binders used. For example, the ranolazine content can vary from about 50 wt.% to about 95 wt.%, with preferred ranges between 70 wt.% and 90 wt.%[4].
- Claim 3: This claim details the method of preparing the sustained-release formulation, including the steps involved in mixing the ingredients and forming the final product[4].
Dependencies and Relationships
The claims are interdependent, with later claims often depending on the earlier ones. For instance, Claim 2 depends on Claim 1, specifying additional details about the composition of the formulation. This dependency structure helps to narrow down the scope of the invention and ensure that all aspects of the formulation are covered[4].
Patent Landscape
Related Patents and Applications
The patent landscape surrounding US 6,503,911 includes several related patents and applications that address similar issues in sustained-release formulations:
- US Patent Applications 2003-0220944 and 2004-0063717: These applications also relate to sustained-release formulations of ranolazine and provide additional insights into the treatment of cardiovascular diseases[4].
- US Patent 6,503,911 and Other Related Patents: Other patents, such as those mentioned in the background section of the patent, contribute to the broader landscape by offering alternative solutions and improvements in sustained-release technology[4].
International Patent Family
The invention described in US 6,503,911 may also be part of an international patent family, with corresponding patents or applications filed in other countries. This can be verified through databases such as the World Intellectual Property Organization (WIPO) PATENTSCOPE or the European Patent Office (EPO) esp@cenet[1].
Technical Details and Innovations
pH-Dependent and pH-Independent Binders
A key innovation of this patent is the use of both pH-dependent and pH-independent binders to control the dissolution rate of ranolazine. This ensures that the drug is released consistently across different pH environments in the body, from the acidic stomach to the more basic intestines[4].
Simplification of Formulations
The patent aims to simplify earlier formulations by reducing the number of components required. This makes the manufacturing process easier and potentially more cost-effective, while maintaining the efficacy of the drug[4].
Commercial and Clinical Impact
Treatment of Cardiovascular Diseases
The sustained-release formulations described in this patent are specifically designed to treat cardiovascular diseases such as angina pectoris, heart failure, and arrhythmia. By providing consistent plasma levels of ranolazine over an extended period, these formulations can improve patient outcomes and quality of life[4].
Market and Competitive Landscape
The commercial impact of this patent is significant, as it provides a competitive edge in the market for cardiovascular medications. Companies holding this patent can differentiate their products from others by offering simpler, more effective sustained-release formulations[4].
Legal and Regulatory Aspects
Patent Validity and Enforcement
The validity and enforcement of US 6,503,911 depend on various legal and regulatory factors. This includes the patent's compliance with the requirements of novelty, non-obviousness, and utility, as well as any potential challenges or litigation related to patent infringement[1].
International Protection
To ensure global protection, the inventors or assignees of this patent would need to file corresponding patents in other countries. This can be facilitated through international patent cooperation treaties and agreements, such as the Patent Cooperation Treaty (PCT)[1].
Conclusion
United States Patent 6,503,911 represents a significant advancement in the field of pharmaceuticals, particularly in the treatment of cardiovascular diseases. The patent's scope, claims, and technical details highlight the innovation and practical application of sustained-release formulations of ranolazine. Understanding the patent landscape and the broader implications of this invention is crucial for both researchers and industry professionals.
Key Takeaways
- Sustained-Release Formulations: The patent describes formulations that maintain effective plasma levels of ranolazine over 24 hours.
- pH-Dependent and pH-Independent Binders: The use of both types of binders ensures consistent drug release across different pH environments.
- Simplification of Formulations: The patent simplifies earlier formulations by reducing the number of components required.
- Clinical Impact: The formulations are designed to treat cardiovascular diseases such as angina pectoris and heart failure.
- Commercial Impact: The patent provides a competitive edge in the market for cardiovascular medications.
FAQs
What is the main innovation of US Patent 6,503,911?
The main innovation is the use of both pH-dependent and pH-independent binders to control the dissolution rate of ranolazine, ensuring consistent drug release across different pH environments.
What conditions does the patent aim to treat?
The patent aims to treat cardiovascular diseases such as angina pectoris, heart failure, arrhythmia, and other related conditions.
How does the patent simplify earlier formulations?
The patent simplifies earlier formulations by reducing the number of components required, making the manufacturing process easier and potentially more cost-effective.
What is the significance of the patent in the pharmaceutical market?
The patent provides a competitive edge in the market for cardiovascular medications by offering simpler, more effective sustained-release formulations.
How can one verify if this patent is part of an international patent family?
One can verify this through databases such as the World Intellectual Property Organization (WIPO) PATENTSCOPE or the European Patent Office (EPO) esp@cenet.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- Canadian Patents Database - Patent 2678272 Summary: https://brevets-patents.ic.gc.ca/opic-cipo/cpd/eng/patent/2678272/summary.html
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents - RU2384332C2: https://patents.google.com/patent/RU2384332C2/en
- PubChem - Sustained release ranolazine formulations: https://pubchem.ncbi.nlm.nih.gov/patent/US-2005153982-A1
