Detailed Analysis of the Scope and Claims of United States Patent 5,356,896
Introduction
United States Patent 5,356,896, titled "Stabilized pharmaceutical compositions comprising an HMG-CoA reductase inhibitor compound," is a significant patent in the pharmaceutical industry, particularly in the field of cardiovascular health. This patent, issued on October 18, 1994, covers compositions and methods related to the stabilization of HMG-CoA reductase inhibitors, which are crucial for treating conditions like high cholesterol.
Background
HMG-CoA reductase inhibitors, such as fluvastatin, are widely used to lower cholesterol levels. However, these compounds can be unstable, which affects their efficacy and shelf life. The invention described in this patent addresses this issue by providing stabilized pharmaceutical compositions.
Scope of the Patent
Pharmaceutical Compositions
The patent covers pharmaceutical compositions that include an HMG-CoA reductase inhibitor compound, such as fluvastatin, and a stabilizing agent. These compositions are designed to maintain the stability of the active ingredient over extended periods, even under various environmental conditions[4].
Stabilizing Agents
The stabilizing agents used in these compositions are typically alkaline mediums, such as sodium bicarbonate or sodium carbonate. These agents help maintain a pH level that ensures the stability of the HMG-CoA reductase inhibitor. The compositions can be formulated in various dosage forms, including tablets and capsules[4].
Stability and Efficacy
The patent highlights that the stabilized compositions can retain at least 95% of the initial amount of the drug after 2 years at temperatures of +25°C and +30°C. This extended storage stability is a critical aspect of the invention, ensuring that the pharmaceuticals remain effective over their shelf life[4].
Claims of the Patent
Composition Claims
The patent includes claims related to the specific compositions of the stabilized pharmaceuticals. These claims detail the percentages of the drug substance (e.g., fluvastatin) and the stabilizing agents (e.g., sodium bicarbonate or sodium carbonate) that are combined to achieve optimal stability[4].
Method Claims
In addition to composition claims, the patent also covers methods for preparing these stabilized compositions. These methods include aqueous or solvent-based techniques, such as wet granulation, to ensure the stability of the final product[4].
Dosage Form Claims
The patent claims various dosage forms, including tablets and capsules, which can be formulated to include higher levels of poorly compressible excipients while maintaining sufficient free-flowing and processible characteristics[4].
Patent Landscape
Related Patents and Applications
The patent landscape for HMG-CoA reductase inhibitors is extensive, with numerous patents and applications covering various aspects of these compounds. For example, other patents may focus on different stabilizing agents, formulation methods, or specific applications of these inhibitors[1][4].
International Patent Considerations
The global patent landscape for pharmaceutical compositions involving HMG-CoA reductase inhibitors includes patents and applications filed in various countries. Resources like the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO) provide access to international patent databases, which can be crucial for understanding the global scope of similar inventions[1].
Patent Analytics and Claim Coverage
To fully understand the patent landscape and the coverage of this patent, tools like patent analytics can be invaluable. These tools help in categorizing patents by claims and scope concepts, making it easier to identify gaps in coverage and potential future design opportunities. For instance, a Claim Coverage Matrix can show which patents and claims are actively protecting the intellectual property related to HMG-CoA reductase inhibitors[3].
Practical Implications
Manufacturing and Storage
The stabilized compositions described in this patent have significant practical implications for manufacturing and storage. The extended stability ensures that the pharmaceuticals can be stored and transported without significant degradation, which is crucial for maintaining their efficacy[4].
Clinical Use
For clinicians, the stability of these compositions means that patients can rely on the consistent efficacy of the medication over its shelf life. This is particularly important for chronic conditions where long-term treatment is necessary.
Legal Status
The patent has expired, which means that the specific compositions and methods described are no longer under patent protection. However, understanding the claims and scope of this patent can still provide valuable insights into the development of similar pharmaceutical compositions.
Key Takeaways
- Stability: The patent focuses on stabilizing HMG-CoA reductase inhibitors to ensure their efficacy over extended periods.
- Composition: The compositions include an HMG-CoA reductase inhibitor and an alkaline stabilizing agent.
- Method: The patent covers methods for preparing these stabilized compositions.
- Dosage Forms: Various dosage forms, including tablets and capsules, are covered.
- Patent Landscape: The global patent landscape for similar inventions is extensive and includes international patent databases.
- Practical Implications: The stabilized compositions have significant implications for manufacturing, storage, and clinical use.
FAQs
What is the main focus of United States Patent 5,356,896?
The main focus of this patent is on stabilizing pharmaceutical compositions that include HMG-CoA reductase inhibitors to ensure their efficacy over extended periods.
What are the key components of the stabilized compositions?
The key components include an HMG-CoA reductase inhibitor compound (e.g., fluvastatin) and an alkaline stabilizing agent (e.g., sodium bicarbonate or sodium carbonate).
How do the stabilizing agents work?
The stabilizing agents maintain a pH level that ensures the stability of the HMG-CoA reductase inhibitor, thereby extending the shelf life of the pharmaceutical composition.
What are the practical implications of this patent?
The practical implications include improved manufacturing and storage conditions, as well as consistent efficacy of the medication for clinical use.
Is the patent still under protection?
No, the patent has expired, which means the specific compositions and methods described are no longer under patent protection.
How can one analyze the patent landscape for similar inventions?
Tools like patent analytics, Claim Coverage Matrix, and international patent databases can be used to analyze the patent landscape and identify gaps in coverage and potential future design opportunities.
Sources
- USPTO: "Search for patents - USPTO" - https://www.uspto.gov/patents/search
- Canadian Patents Database: "Patent 2509265 Summary" - https://brevets-patents.ic.gc.ca/opic-cipo/cpd/eng/patent/2509265/summary.html?wbdisable=true
- SLWIP: "Patent Analytics | Intellectual Property Law" - https://www.slwip.com/services/patent-analytics/
- Google Patents: "Stabilized pharmaceutical compositions comprising an HMG-CoA reductase inhibitor compound" - https://patents.google.com/patent/US5356896A/en
- United States Patent: "Stabilized pharmaceutical compositions comprising an HMG-CoA reductase inhibitor compound" - https://patentimages.storage.googleapis.com/ca/ee/bc/40acdd9590048b/US5356896.pdf
