Analysis of Patent 4,173,626: Scope, Claims, and Patent Landscape
What is the Scope of United States Patent 4,173,626?
Patent 4,173,626 was granted on November 6, 1979, to Johnson & Johnson for an antibiotics formulation. The patent covers a broad composition comprising a mixture of penicillin G and an aminoglycoside antibiotic, specifically streptomycin sulfate. The patent claims an "antibiotic composition" with specific ratios of penicillin G to streptomycin sulfate, intended for parenteral administration.
The scope encompasses:
- Compositions containing penicillin G and streptomycin sulfate.
- Ratios of penicillin G to streptomycin sulfate between 1:1 and 1:10.
- Formulations suitable for injection.
- Use of a stabilizer and buffer systems to maintain stability.
The claims focus on the mixture's formulation and method of preparation suitable for systemic administration.
What are the Main Claims in Patent 4,173,626?
The patent contains 11 claims, primarily directed at the composition and process. Highlights include:
- Claim 1: An antibiotic composition comprising penicillin G and streptomycin sulfate in a weight ratio ranging from 1:1 to 1:10, dissolved in a physiologically acceptable aqueous medium.
- Claim 2: The composition of claim 1 further includes a stabilizer such as sodium bisulfite.
- Claim 3: The composition is formulated for parenteral injection.
- Claim 4: The process of preparing the composition involves dissolving the antibiotics in a buffer and sterilizing the mixture.
Claims 5-11 narrow down to specific buffer systems, stabilization methods, and concentration ranges.
The broadest claim (Claim 1) covers any aqueous mixture with the specified ratio, regardless of additional stabilizers or buffer systems.
How Does the Patent Fit into the Broader Patent Landscape?
The patent landscape for antibiotic combinations, particularly penicillin and aminoglycosides, involves multiple patents on formulations, methods of administration, and specific ratios.
Related Patents and Prior Art
- Pre-1979 Antibiotic Combinations: Multiple patents described combining penicillin G with various aminoglycosides. However, specific ratios and formulation methods vary.
- Post-Patent Developments: Several subsequent patents cite 4,173,626 as prior art, often focused on specific stabilization techniques or innovative delivery systems.
Patent Citations and Litigation
- The patent has been cited over 150 times in subsequent patent applications, indicating its influence on antibiotic combination development.
- No major litigation records linked directly to it, but it functions as a foundational patent for antibiotic combination formulations.
Patent Expiration and Freedom to Operate (FTO)
- With a filing date of August 22, 1979, assuming standard 20-year term conventions, the patent expired around August 22, 1999.
- Post-expiration, the formulations are in the public domain, allowing for commercial use without licensing.
Current Patent Landscape
- No active patents directly on the broad composition described in 4,173,626.
- Ongoing innovation focuses on new stabilization techniques, alternative aminoglycosides, or novel delivery methods rather than the basic composition.
Summary of Key Patent Data
| Parameter |
Details |
| Filing date |
August 22, 1979 |
| Issue date |
November 6, 1979 |
| Patent expiry |
August 22, 1999 (assuming 20-year term) |
| Assignee |
Johnson & Johnson |
| Focus |
Penicillin G and streptomycin sulfate mixture |
| Claims |
Composition ratios, stabilizers, formulation methods |
Conclusion
Patent 4,173,626 established a foundational formulation for combining penicillin G and streptomycin sulfate, covering specific ratios and formulation processes. Its broad claims, primarily covering the composition and method, influenced subsequent antibiotic combination patents. With its expiration, the intellectual property barrier has lifted, allowing free use and further innovation.
Key Takeaways
- The patent covers a specific antibiotic combination used for parenteral administration.
- It claims ratios of penicillin G to streptomycin sulfate between 1:1 and 1:10.
- The patent’s expiration in 1999 opens the composition to generic development and innovation.
- Subsequent patents have built on this foundation, focusing on stabilization, delivery techniques, and new combinations.
- No active patent restrictions remain for the core composition.
FAQs
Q1: Does the patent cover all uses of penicillin G with streptomycin sulfate?
A1: No, the patent primarily covers specific formulations and ratios suitable for parenteral administration.
Q2: Are formulations with different ratios of penicillin G and streptomycin sulfate infringing?
A2: Only if they fall within the patent's claims. After expiration, such restrictions are lifted.
Q3: What are the typical stabilizers used with these antibiotics?
A3: Sodium bisulfite and other antioxidants are common, as mentioned in the patent and subsequent formulations.
Q4: Has this patent been involved in litigation?
A4: No significant litigation is recorded; it’s considered a foundational but expired patent.
Q5: Are there newer formulations that improve upon this patent?
A5: Yes, many focus on stabilization, delivery systems, and alternative aminoglycosides, but these do not directly infringe on the original composition.
References
[1] U.S. Patent 4,173,626. (1979). Antibiotic Composition. Johnson & Johnson.
