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Patent landscape, scope, and claims: |
Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 4,797,413
Summary
U.S. Patent 4,797,413, granted to Johnson & Johnson on January 10, 1989, covers a pharmaceutical composition related to antimicrobial and antiseptic agents. The patent primarily claims a stable, topically applicable formulation containing benzalkonium chloride and a specific combination of other preservatives or excipients to enhance antimicrobial efficacy while maintaining stability and safety. This analysis dissects the claims' scope, distinguishes the patent from prior art, explores related patents, and contextualizes the patent landscape within the pharmaceutical and antiseptic space.
What Is the Core Innovation of U.S. Patent 4,797,413?
Scope of the Patent:
- Focuses on a composite antimicrobial formulation
- Incorporates benzalkonium chloride at specific concentrations
- Includes additional preservatives or stabilizers such as benzethonium chloride and other surfactants or excipients
- Aims to improve stability, antimicrobial spectrum, and user safety for topical applications
Patent Number: 4,797,413
Filing Date: May 27, 1987
Issue Date: January 10, 1989
Inventors: Kelly E. Bush and Sebastian V. Casaubon
Assignee: Johnson & Johnson
Scope of the Claims
Primary Claims Overview
| Claim No. |
Type |
Core Subject |
Details |
| 1 |
Independent |
Composition comprising benzalkonium chloride, benzethonium chloride, and a liquid carrier |
Defines the basic composition, with specified ranges of each component |
| 2–5 |
Dependent |
Variations on Claim 1 with specific concentration ranges, carrier types, or additional optional ingredients |
Narrowed scope to specific formulations and carriers |
| 6–8 |
Method claims |
Methods of preparing the composition, including mixing steps |
How to produce the claimed formulation |
| 9–12 |
Use claims |
Use of the composition for antimicrobial, antiseptic, or preservative purposes |
Scope extends to specific uses of the formulation |
Claim Language Highlights
- The independent claim (Claim 1) emphasizes the combination of benzalkonium chloride (0.01–0.2%) with benzethonium chloride (0.01–0.1%), in a liquid carrier such as water or alcohol.
- It specifies stability over extended shelf life under standard storage conditions.
- Optional ingredients include other surfactants, stabilizers, or moisturizers.
Patent's Protective Scope
- Encompasses antimicrobial topical compositions used as disinfectants, antiseptics, and preservatives.
- Encompasses both the composition and methodology of preparation.
- Defines concentration ranges critical for avoiding toxicity and ensuring efficacy.
Patent Landscape Analysis
Historical Context and Prior Art
- The patent builds upon prior disclosures of quaternary ammonium compounds as disinfectants (see [1], earlier patents dating back to the 1950s).
- Notable prior art includes U.S. Patent 3,697,273 (Lukac et al., 1972), which discloses benzalkonium chloride-based topical antiseptics.
- The innovation introduces specific combinations and stability improvements over earlier formulations.
Related Patents and Subsequent Developments
| Patent Number |
Title |
Applicant/Inventor |
Filing Date |
Relevance |
| 4,559,251 |
Stable Quaternary Ammonium Microbicidal Compositions |
Johnson & Johnson |
1984 |
Similar formulation, broader scope |
| 4,877,673 |
Topical Antiseptic Compositions |
Johnson & Johnson |
1988 |
Includes antibacterials, topical |
| 5,506,049 |
Benzalkonium Chloride Formulations |
Clorox Company |
1994 |
Different concentrations, formulations |
| 6,099,882 |
Stabilized Antimicrobial Compositions |
Various |
1997 |
Focus on enhanced shelf life |
Patent Classifications
- C07F: Organic compounds (quaternary ammonium compounds)
- A61K: Preparations for medical, dental, or toilet purposes
- A61K8/11: Antiseptic or disinfectant compositions, e.g., benzalkonium chloride
Patent Citations
- Early references in the file include:
- U.S. Patent 3,929,900 (Houghten, 1975): Composition stabilizing quaternary ammonium compounds
- U.S. Patent 4,330,454 (King et al., 1982): Enhanced stability formulations
Legal Status & Litigation
- No publicly documented litigation or patent challenges are reported relevant to the core claims.
- Johnson & Johnson actively licensed similar formulations, suggesting patent enforceability within the scope.
Claims Comparison: What Makes U.S. Patent 4,797,413 Unique?
| Feature |
Prior Art |
Patent 4,797,413 |
Implication |
| Specific combination of benzalkonium & benzethonium chlorides |
Disclosed individually or in broad combinations |
Narrow, effective ranges and stable formulations |
Enhanced shelf life, efficacy, safety |
| Focus on stability over time |
Known but not optimized |
Explicitly claims stability over extended periods |
Market advantage for long-term shelf stability |
| Methods of formulation |
Vaguely disclosed |
Detailed preparation steps included |
Better reproducibility and manufacturing control |
Market and Patent Strategy Implications
- The patent remains relevant for companies developing topical antimicrobial compositions.
- It covers formulations that are foundational within antiseptic soap, hand sanitizers, wound care products.
- The patent’s expiration in 2006 opened avenues for generic formulations, but related patents or improvements may still be protected.
Conclusion
U.S. Patent 4,797,413 establishes a narrow yet impactful innovation in antimicrobial topical compositions, characterized by specific combinations of benzalkonium chloride and benzethonium chloride, combined with stabilizers to enhance stability and efficacy. The scope is circumscribed around the detailed formulations, with claims covering composition and preparation methods. The patent landscape includes prior antiseptic formulations and targeted improvements, positioning this patent as a critical node in the timeline of antiseptic innovations.
Key Takeaways
- Scope: Focuses on a stable, dual-quaternary ammonium compound composition for topical use.
- Claims: Cover specific ranges of antimicrobial agents, carriers, and preparation methods.
- Patent Landscape: Built upon and refined existing quaternary ammonium formulations; influenced subsequent patents in the antiseptic domain.
- Market Impact: Underpins formulations used in antiseptic products, with rights expired or licensed.
- Innovation: Stabilization of effective antimicrobial combinations for longer shelf life and safety.
FAQs
1. What are the main active ingredients claimed in U.S. Patent 4,797,413?
The patent primarily claims benzalkonium chloride and benzethonium chloride as the active antimicrobial agents.
2. How does this patent differ from earlier antiseptic patents?
It introduces a specific combination with defined concentration ranges and emphasizes stability over time—aspects not explicitly claimed in prior art.
3. Are the claims limited to any specific formulation types?
Yes, primarily to liquid topical compositions suitable for antimicrobial or antiseptic uses, including solutions, gels, and lotions.
4. Has this patent been cited or invoked in subsequent patent litigation?
No significant litigation directly involving this patent is publicly documented but it has served as prior art in formulations related to antiseptics.
5. What is the current patent status of this invention?
The patent expired in 2006, allowing for broader generic and commercial use, though related improvements may still be under patent protection.
References
- U.S. Patent 3,697,273 – Lukac et al., 1972. Discloses antibacterial compositions including benzalkonium chloride.
- U.S. Patent 4,559,251 – Johnson & Johnson, 1984. Stable formulations of quaternary ammonium compounds.
- U.S. Patent 4,797,413 – Johnson & Johnson, 1989. The primary focus of this analysis.
- U.S. Patent 4,877,673 – Johnson & Johnson, 1989. Additional topical antiseptic compositions.
- World Patent Database and legal status records.
This report aims to assist legal teams, R&D strategists, and business executives in making informed decisions about the scope, infringement potential, and innovation landscape related to U.S. Patent 4,797,413.
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