United States Patent 6,548,079: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 6,548,079, titled "Moxifloxacin formulation containing common salt," is a significant patent in the pharmaceutical field, particularly in the development of antibiotic formulations. This patent, assigned to Bayer Aktiengesellschaft, was granted on April 15, 2003. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Invention
Moxifloxacin, a quinolonecarboxylic acid antibiotic, is used to treat various bacterial infections. However, its solubility and stability in aqueous solutions have been challenges. The invention addresses these issues by developing an aqueous formulation that includes moxifloxacin hydrochloride and sodium chloride[1][4].
Scope of the Invention
The patent covers an aqueous formulation designed to improve the solubility and stability of moxifloxacin. This formulation is intended for use as a medicament to prevent or treat bacterial infections in humans and animals. The key components include moxifloxacin hydrochloride and sodium chloride, which enhance the solubility and isotonicity of the solution[1][4].
Key Components
- Moxifloxacin Hydrochloride: The active antibiotic ingredient.
- Sodium Chloride: Added to improve solubility and achieve isotonicity.
Claims of the Patent
The patent includes 11 claims that define the scope of the invention. Here are some of the key claims:
Claim 1
The first claim describes the aqueous formulation comprising moxifloxacin hydrochloride and sodium chloride, with specific concentrations of moxifloxacin hydrochloride ranging from 0.04% to 0.4%[1][4].
Claim 2
This claim specifies the formulation's pH range and the presence of additional ingredients such as buffering agents to maintain stability[1].
Claim 3
It details the method of preparing the medicament, including the steps of dissolving moxifloxacin hydrochloride and sodium chloride in water and adjusting the pH[1].
Patent Landscape
Prior Art
The patent references several prior art documents, including U.S. Patents 4,957,922 and 5,084,276, which describe other antibiotic formulations but lack the specific combination of moxifloxacin hydrochloride and sodium chloride[1].
Related Patents
Other patents in the field, such as U.S. Pat. No. 5,563,149, describe formulations of pyridonecarboxylic acids but do not address the solubility and isotonicity issues specific to moxifloxacin[4].
Technical Advantages
The formulation described in this patent offers several technical advantages:
Improved Solubility
The addition of sodium chloride significantly enhances the solubility of moxifloxacin hydrochloride, making it easier to prepare stable and effective solutions[1].
Isotonicity
The formulation is designed to be isotonic, which is crucial for parenteral administration to avoid osmotic shock and ensure patient safety[1].
Stability
The use of buffering agents and careful pH adjustment ensures the stability of the moxifloxacin hydrochloride in the aqueous solution[1].
Commercial and Clinical Impact
This patent has significant commercial and clinical implications:
Market Dominance
By providing a stable and effective formulation, Bayer Aktiengesellschaft gained a competitive edge in the antibiotic market, particularly for treating bacterial infections where moxifloxacin is prescribed[1].
Clinical Benefits
The improved solubility and isotonicity of the formulation enhance patient safety and compliance, making it a preferred choice for clinicians[1].
Legal and Regulatory Aspects
The patent's legal status and regulatory compliance are crucial:
Expiration
The patent has expired, which means that the formulation is now in the public domain, and other companies can manufacture similar products without infringing on the original patent[4].
Infringement Claims
Any previous infringement claims would have been handled under the relevant clauses and procedures outlined in regulations such as those found in the DFARS (Defense Federal Acquisition Regulation Supplement)[5].
Conclusion
The United States Patent 6,548,079 represents a significant advancement in the formulation of moxifloxacin, addressing critical issues of solubility and stability. The patent's claims and scope define a specific and innovative solution that has had a lasting impact on the pharmaceutical industry.
Key Takeaways
- The patent describes an aqueous formulation of moxifloxacin hydrochloride and sodium chloride.
- The formulation improves the solubility and stability of moxifloxacin.
- It is designed to be isotonic and stable for parenteral administration.
- The patent has expired, making the formulation public domain.
- The invention has significant commercial and clinical implications.
Frequently Asked Questions
What is the main component of the formulation described in US Patent 6,548,079?
The main component is moxifloxacin hydrochloride, an antibiotic from the class of quinolonecarboxylic acids.
Why is sodium chloride added to the formulation?
Sodium chloride is added to improve the solubility of moxifloxacin hydrochloride and to achieve isotonicity.
What is the significance of isotonicity in this formulation?
Isotonicity ensures that the solution does not cause osmotic shock when administered parenterally, enhancing patient safety.
Has the patent expired?
Yes, the patent has expired, which means the formulation is now in the public domain.
What are the commercial implications of this patent?
The patent provided Bayer Aktiengesellschaft with a competitive edge in the antibiotic market and contributed to the widespread use of moxifloxacin in clinical settings.
Cited Sources
- United States Patent and Trademark Office, "Moxifloxacin formulation containing common salt," US6548079B1, April 15, 2003.
- Google Patents, "Moxifloxacin formulation containing common salt," US6548079B1.
- USPTO, "Patent Claims Research Dataset," August 28, 2017.
- Defense Federal Acquisition Regulation Supplement, "SUBPART 227.70 INFRINGEMENT CLAIMS, LICENSES, AND ASSIGNMENTS," December 30, 2022.
