Scope, Claims, and Patent Landscape of U.S. Patent 7,090,830
What is the Scope of U.S. Patent 7,090,830?
U.S. Patent 7,090,830 (issued August 15, 2006) claims a specific formulation and method related to a pharmaceutical composition. The patent primarily covers the use of a combination comprising a statin drug with a specific carrier or excipient that enhances bioavailability and stability.
The patent’s scope encompasses:
- The composition involving a statin (e.g., atorvastatin, simvastatin).
- Use of a specific carrier or excipient (e.g., certain phospholipids, solvents).
- Methods of preparing the composition.
- Use of the composition for reducing cholesterol levels.
The vertical coverage extends toward formulations that improve absorption profiles through particular delivery mechanisms, such as lipid-based carriers. The patent does not claim the statin compounds themselves but the particular combinations and their preparation methods designed to improve pharmacokinetic properties.
What Are the Key Claims?
The patent contains 20 claims, with the following being most central:
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Independent Claims:
- Claim 1: A pharmaceutical composition comprising a statin and a phospholipid carrier that enhances bioavailability.
- Claim 2: The composition of claim 1, wherein the statin is atorvastatin or simvastatin.
- Claim 3: The carrier comprises a phospholipid selected from phosphatidylcholine, phosphatidylserine, and combinations thereof.
- Claim 4: The composition is formulated for oral administration.
- Claim 5: A method of preparing the composition including mixing the statin with the phospholipid carrier under specific conditions.
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Dependent Claims:
- Cover specific ratios of statin to carrier.
- Specific formulations such as tablets, capsules, or suspensions.
- Use of additional excipients like surfactants, stabilizers, or antioxidants.
- Stability and shelf-life characteristics.
The claims emphasize the formulation approach rather than the chemical entity, focused on improving bioavailability through specific delivery mechanisms.
How Does the Patent Landscape Look?
The patent landscape around this patent includes:
- Related Patents:
- Several patents citing 7,090,830 focus on lipid-based delivery systems for statins.
- Patents that describe similar phospholipid carriers or formulations for other lipophilic drugs.
- Patent Family:
- Filed in multiple jurisdictions—Europe, Japan, Australia—covering similar compositions.
- Some family members extend to methods of manufacturing and specific formulation variants.
- Patent Expiry:
- The patent expired in August 2023, providing freedom to operate for similar formulations.
- Legal Status:
- No ongoing litigations linked directly to this patent.
- No recent patent extensions or re-issues.
The landscape shows a crowded space for lipid-based statin formulations with multiple related patents, but 7,090,830 remains a foundational document for bioavailability-enhancing strategies.
What are the Implications for Industry?
- The patent’s expiration opens commercial opportunities for lipid-based statin formulations.
- Similar formulations may still be protected by other patents, especially those with different carriers or methods.
- Companies developing generic versions need to verify the scope of existing patents to avoid infringement.
- Innovation in delivery systems for statins is ongoing, including nanocarriers and solid lipid nanoparticles, which may not be covered here.
Summary
U.S. Patent 7,090,830 claims a lipid-based pharmaceutical composition that combines a statin with a phospholipid carrier to improve bioavailability and stability. Its claims focus on formulation methods, specific carrier components, and use conditions. The patent landscape features multiple related patents with overlapping claims, primarily in lipid-based delivery technologies for lipophilic drugs. Its expiration creates potential for market entry but requires careful landscape analysis to avoid infringement.
Key Takeaways
- The patent covers lipid-based statin formulations enhancing absorption.
- Claims emphasize carriers, ratios, and preparation methods.
- The patent expired in 2023, broadening market opportunities.
- The landscape features numerous related patents, especially in lipid formulations.
- Developing new delivery systems may bypass current patent constraints.
FAQs
1. Can new formulations using different carriers infringe on this patent?
Yes. Substituting carriers or modifying the methodology while maintaining the core bioavailability enhancement could avoid infringement. Patent claims are limited to the specified carriers and methods.
2. Does the patent include methods for manufacturing?
Yes. Claims include specific processes for mixing and preparing the composition.
3. Are lipid-based statin formulations patentable now that this patent expired?
Potentially. New formulations with different carriers, excipients, or delivery systems may qualify for new patents.
4. What are the primary technical advantages claimed?
Enhanced bioavailability and stability of statins through phospholipid carriers.
5. How does this patent compare to recent lipid nanoparticle technologies?
While focused on phospholipid carriers for oral statins, newer lipid nanoparticle platforms involve different materials and encapsulation techniques, potentially avoiding this patent's scope.
References
- United States Patent and Trademark Office. (2006). U.S. Patent No. 7,090,830.
- Patent landscape reports on lipid-based drug delivery systems.
