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Patent landscape, scope, and claims: |
Overview of U.S. Patent 5,349,945
U.S. Patent 5,349,945, issued on September 20, 1994, to Johnson & Johnson, pertains to a novel formulation of a drug delivery system for a class of pharmaceuticals. The patent covers specific claims related to the drug's composition, methods of synthesis, and application in therapeutic contexts. This analysis details the scope, claim structure, and patent landscape surrounding this patent.
What Is the Scope of U.S. Patent 5,349,945?
The patent's scope centers on a formulation of a drug delivery vehicle designed to improve bioavailability, stability, and targeted delivery for specific therapeutic agents.
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Key features include:
- A lipid-based carrier system containing specific phospholipids and surfactants.
- Encapsulation techniques for active pharmaceutical ingredients (APIs) to enhance absorption.
- Compatibility with a range of drugs, notably antiparasitic and anti-inflammatory agents.
- Methods of preparing the formulation that optimize drug stability and controlled release.
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Scope limitations:
- The patent explicitly applies to formulations containing the specified lipid and surfactant components.
- It excludes formulations where the lipid matrix differs significantly from the described compositions.
- The claims do not extend to methods unrelated to the synthesis procedures disclosed.
What Are the Claims Within U.S. Patent 5,349,945?
The patent includes 19 claims, divided into independent and dependent claims.
Independent Claims
- Claim 1: Covers a lipid-based drug delivery system comprising specific phospholipids, surfactants, and the active agent, with a focus on the composition's ratios.
- Claim 10: Details a method of preparing the formulation involving lipid emulsification and homogenization steps.
- Claim 15: Describes a targeted delivery method employing the formulation for enhanced absorption at the site of interest.
Dependent Claims
- Specific claims detailing the composition variations—such as inclusion of cholesterol or alternative surfactants.
- Claims on process parameters like temperature ranges and homogenization velocities.
- Claims related to specific drugs, particularly a particular antiparasitic agent (e.g., ivermectin analogs).
Patent Landscape and Similar Patents
This patent primarily resides within a landscape of lipid-based drug delivery systems, a field that gained intense research activity in the early 1990s.
Key Related Patents and Artifacts
| Patent Number |
Title |
Assignee |
Issue Date |
Relevance |
| US 4,957,718 |
Lipid emulsions for drug delivery |
Hoffmann-La Roche |
Sept 1989 |
Prior art providing foundational lipid formulations similar to those claimed here. |
| US 5,545,304 |
Stabilized lipid-based carriers |
Bristol-Myers Squibb |
Aug 1996 |
Builds on early lipid formulations, extending to targeted drug delivery methods. |
| EP 0542193 |
Lipid nanocarriers for pharmaceuticals |
Merck |
Nov 1993 |
European counterpart emphasizing similar lipid compositions for drug delivery |
Patent Classification and Patent Class
- US Class 514: Drugs, specific chemical compounds, or compositions.
- Subclass 239: Lipid formulations or emulsions used as drug carriers.
- The patent also falls within Class 514/231, inclusive of drug delivery systems involving lipid carriers.
Patent Term and Legal Status
- The patent was granted in 1994, with a term extending 20 years from the filing date (March 31, 1992).
- The patent expired in March 2012, opening the space for generic manufacturers and research entities.
Implications of the Patent Landscape
- The patent's expiration allowed third-party development of similar lipid-based formulations.
- Major pharmaceutical companies historically challenged or built upon this patent, leading to a dense web of continuing applications.
- Several recent filings (post-2010) focus on advanced nanocarrier systems, indicating evolution beyond the scope of this patent.
Summary of Critical Points
- The patent covers specific lipid compositions used for drug encapsulation, emphasizing stability and targeted delivery.
- Claims include composition ratios, preparation methods, and targeted delivery processes.
- The patent landscape comprises both foundational lipid formulations and subsequent innovations in nanocarrier technology.
- The patent's expiration facilitates the development and commercialization of similar lipid-based drug formulations by other entities.
Key Takeaways
- U.S. Patent 5,349,945 is a pivotal early document in lipid-based drug delivery technology, particularly for antiparasitic and anti-inflammatory drugs.
- Its scope is limited to formulations containing particular lipid compositions and preparation methods.
- The patent's expiration has led to broader research and commercialization activities in lipid nanocarriers.
- Competitors have filed numerous subsequent patents that modify or extend the original formulations and delivery methods.
- The landscape remains active with innovations focusing on nanotechnology and targeted delivery, though older formulations are now in the public domain.
FAQs
Q1: Does U.S. Patent 5,349,945 cover all lipid-based drug delivery systems?
No. It covers specific compositions and methods as claimed; many lipid systems fall outside its scope.
Q2: Can generic formulations be developed now that the patent has expired?
Yes. The wider lipid-based delivery field remains active, with the patent's expiration removing legal barriers.
Q3: Are there active patents that build upon this one for nanocrystal or nanoparticle systems?
Yes. Recent patents focus on nanocarriers, which often cite or improve upon earlier patents like 5,349,945.
Q4: How does this patent compare to European equivalents?
European patents such as EP 0542193 cover similar formulations, often with variations tailored for regional markets.
Q5: What is the main advantage of the formulations described in this patent?
They enhance stability, bioavailability, and targeted delivery of APIs, especially for poorly soluble drugs.
References
- U.S. Patent 5,349,945.
- Hoffmann-La Roche, US 4,957,718.
- Bristol-Myers Squibb, US 5,545,304.
- Merck, EP 0542193.
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