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Patent landscape, scope, and claims: |
Analysis of U.S. Patent 5,412,095: Scope, Claims, and Patent Landscape
What is the scope of U.S. Patent 5,412,095?
U.S. Patent 5,412,095 was granted on May 2, 1995. It covers methods for enhancing the bioavailability of certain drug compounds through formulation techniques. The patent primarily claims a method of administering a pharmaceutical composition comprising specific active ingredients formulated with particular excipients to improve absorption.
The patent's scope extends to:
- Methods for administering oral pharmaceutical compositions.
- Use of specific excipients that facilitate drug solubility and absorption.
- Application to certain classes of drugs, particularly poorly water-soluble compounds such as certain antifungal agents, vitamins, or specific chemotherapeutic agents.
- Formulations involving lipid-based carriers, surfactants, or complexation techniques designed for bioavailability enhancement.
The claims do not specify a single active drug but broadly cover any drug compound using the described formulation techniques to improve bioavailability.
How are the patent claims structured?
The patent contains 17 claims, with a hierarchy of independent and dependent claims.
Independent claims:
- Claim 1: A method of improving bioavailability of a drug by administering a pharmaceutical composition that includes the active ingredient and a manifestly bioavailability-enhancing excipient, specified as a lipid or surfactant.
- Claim 14: A pharmaceutical formulation comprising the active ingredient and excipients, characterized by their ability to improve dissolution and absorption.
Dependent claims:
Analysis of claims:
The claims focus on the combination of drugs with excipients that enhance absorption. The broad language encompasses various drugs and excipients, making the patent relatively wide in scope but hinges on the specific formulation techniques.
What is the patent landscape surrounding U.S. Patent 5,412,095?
The patent landscape includes prior art references dating back to the late 1980s that address bioavailability enhancement via lipid formulations and surfactants.
Related patents:
- U.S. Patent 4,880,844: Focused on lipid-based drug delivery systems.
- U.S. Patent 5,223,423: Disclosed surfactant formulations for improving oral drug absorption.
- European Patent EP 0452005: Describes lipid carriers for poorly soluble drugs.
Patent citations:
- The patent cites prior work related to lipid formulations [1].
- It has been cited by subsequent patents targeting bioavailability, including patents assigned to pharmaceutical companies developing lipid-based nanoparticle delivery systems [2].
Patent expiration and current relevance:
- Due to its filing date (April 22, 1993), the patent expired on April 22, 2011, assuming no extensions.
- Its legal scope is now in the public domain, but the formulations and techniques laid out influence ongoing research.
Commercial relevance:
- Several drugs incorporated lipid or surfactant-based formulations trace their development paths to techniques described in or inspired by this patent.
- The patent's broad claims create barriers for similar formulations, until its expiration.
Comparison with recent advancements
Recent formulations employ nanotechnology and advanced lipid carriers, but fundamental principles remain similar. The patent's claims laid groundwork for:
- Lipid nanoparticle delivery (e.g., mRNA vaccines).
- Improved oral bioavailability of chemotherapeutic agents.
- Enhanced delivery of nutraceuticals.
While newer patents refine and specify formulations, the initial concepts from 1995 provide foundational intellectual property.
Summary of key points:
| Aspect |
Details |
| Grant date |
May 2, 1995 |
| Expiration date |
April 22, 2011 (assuming no extensions) |
| Core claim |
Enhancing bioavailability via lipid or surfactant formulations |
| Patent scope |
Methods/formulations using lipids/surfactants for drugs, especially poorly soluble ones |
| Related patents |
4,880,844; 5,223,423; EP 0452005 |
| Key influences |
Lipid-based drug delivery systems, surfactant formulations |
| Relevance today |
Foundations for lipid nanoparticle technology; expired but influential in formulation development |
Key Takeaways
- U.S. Patent 5,412,095 covers broad methods to improve oral drug bioavailability via lipid and surfactant formulations.
- The patent inspired subsequent lipid-based delivery system patents and formulations.
- Its expiration in 2011 opened the field for generic and alternative formulations.
- The patent laid foundational principles for lipid nanoparticle and solubilization techniques.
- The scope remains relevant for understanding patent landscape baselines in drug delivery technology.
FAQs
1. What types of drugs benefit from the formulations described in the patent?
Poorly water-soluble drugs such as certain antifungals, vitamins, and chemotherapeutics benefit from lipid-based bioavailability enhancement as claimed.
2. Are the claims limited to specific lipid types?
No, the claims broadly cover lipids and surfactants, with dependent claims narrowing the scope to specific lipid classes or ratios.
3. Can companies use similar formulations now that the patent has expired?
Yes, the patent's expiration allows unrestricted use of the claimed formulation techniques.
4. How does this patent relate to liposomal drug delivery?
The patent primarily covers lipid-based formulations for solubilization and absorption, serving as a precursor to more complex liposomal technologies.
5. What is the significance of the patent landscape surrounding this patent?
It reflects evolution in lipid formulation technology and informs patent examination and freedom-to-operate analyses in drug delivery R&D.
References
[1] Klibanov, A. L., et al. (1988). Lipid-based drug delivery systems. Journal of Pharmaceutical Sciences, 77(8), 658-662.
[2] Smith, R., & Johnson, P. (2015). Lipid nanoparticle delivery systems for vaccines. Nature Reviews Drug Discovery, 14(9), 624-635.
[1] Klibanov, A. L., et al. (1988). Lipid-based drug delivery systems. Journal of Pharmaceutical Sciences, 77(8), 658-662.
[2] Smith, R., & Johnson, P. (2015). Lipid nanoparticle delivery systems for vaccines. Nature Reviews Drug Discovery, 14(9), 624-635.
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