United States Patent 6,900,175: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,900,175, titled "Dalbavancin Compositions for Treatment of Bacterial Infections," is a significant patent in the pharmaceutical sector, particularly in the treatment of acute bacterial skin and skin structure infections. This patent, assigned to Vicuron Pharmaceuticals (now part of Allergan), is crucial for understanding the development, composition, and administration of dalbavancin, a potent glycopeptide antibiotic.
Background and Invention
Dalbavancin is a second-generation glycopeptide antibiotic, designed to combat resistant bacterial infections. The patent, filed on November 14, 2003, and granted on May 23, 2005, outlines methods and compositions for the treatment of bacterial infections using dalbavancin[2][4].
Scope of the Patent
The scope of the patent is defined by its claims, which include:
- Composition Claims: The patent describes specific compositions of dalbavancin, including its formulation, dosage forms, and methods of preparation. These compositions are designed to enhance the stability, efficacy, and patient compliance of the antibiotic[2].
- Method Claims: The patent details methods for administering dalbavancin, including single-dose and multi-dose regimens, which are critical for treating various bacterial infections effectively[2].
Claims Analysis
Independent Claims
The patent includes several independent claims that define the core inventions. These claims are pivotal in determining the patent's scope and validity. For instance, Claim 1 typically describes the broadest aspect of the invention, such as the composition of dalbavancin and its use in treating bacterial infections[2].
Dependent Claims
Dependent claims further narrow down the scope by adding specific limitations to the independent claims. These claims often describe particular embodiments, such as specific dosages, administration routes, or patient populations, which provide additional protection and clarity to the invention[2].
Patent Landscape
Related Patents
The patent landscape surrounding US 6,900,175 includes several related patents that cover various aspects of dalbavancin and its use. For example:
- US 8,143,212 B2: This patent also relates to dalbavancin compositions and methods for treating bacterial infections, highlighting different formulations and administration methods[1].
- US 7,119,061 B2: Another patent in the series, this one focuses on specific compositions and dosages of dalbavancin, further expanding the scope of protection for the antibiotic[2].
Patent Expiration and Exclusivity
The patent 6,900,175 is set to expire on May 23, 2028. Additionally, the FDA has granted exclusivity periods, including a New Chemical Entity exclusivity that expired on May 23, 2019, and a Generating Antibiotic Incentives Now (GAIN) exclusivity that expires on May 23, 2024[4].
Regulatory Review and Patent Extension
The regulatory review period for dalbavancin, as determined under section 505(b) of the FD&C Act, began on December 21, 2004. This period is crucial for determining any potential patent extensions due to regulatory delays[5].
Impact on Innovation and Litigation
The patent's scope and claims have significant implications for innovation and litigation in the pharmaceutical industry. Narrow and clear claims, as seen in this patent, can facilitate innovation by providing clear boundaries for competitors while reducing litigation costs. Conversely, overly broad or unclear claims can impede innovation and increase legal disputes[3].
Industry Expert Insights
Industry experts emphasize the importance of clear and narrow patent claims. For instance, a study by the Federal Trade Commission noted that clear and specific claims can reduce the complexity and duration of patent prosecutions, thereby promoting innovation[3].
Statistics and Examples
- Patent Maintenance: The maintenance of this patent, including payment of fees and potential extensions, is crucial. For example, the patent's expiration date has been extended due to regulatory review periods, highlighting the dynamic nature of patent lifecycles[4][5].
- Forward Citations: The number of forward citations received by this patent indicates its influence on subsequent research and development in the field of antibiotics. High forward citations often suggest a patent's significance and impact on the industry[3].
Key Takeaways
- Clear and Narrow Claims: The patent's clear and narrow claims are essential for defining its scope and promoting innovation.
- Regulatory Impact: The regulatory review period and exclusivity grants significantly affect the patent's lifecycle and market exclusivity.
- Industry Impact: The patent's influence on the development of antibiotics and its impact on litigation and innovation are substantial.
- Expiration and Extensions: The patent's expiration date and potential extensions due to regulatory delays are critical for understanding its remaining lifespan.
Frequently Asked Questions (FAQs)
What is the primary use of dalbavancin as described in US 6,900,175?
Dalbavancin is primarily used for the treatment of acute bacterial skin and skin structure infections.
When does the patent 6,900,175 expire?
The patent 6,900,175 is set to expire on May 23, 2028.
What are the key components of the patent claims in US 6,900,175?
The key components include composition claims and method claims, which describe the formulation, dosage forms, and administration methods of dalbavancin.
How does the regulatory review period affect the patent's lifecycle?
The regulatory review period can lead to patent extensions, as seen in the case of dalbavancin, where the review period started on December 21, 2004.
What is the significance of forward citations for this patent?
Forward citations indicate the patent's influence on subsequent research and development, suggesting its importance and impact on the industry.
Cited Sources:
- United States Patent and Trademark Office, "Dalbavancin Compositions for Treatment of Bacterial Infections," US 8,143,212 B2.
- Google Patents, "Dalbavancin compositions for treatment of bacterial infections," US 7,119,061 B2.
- Hoover Institution, "Patent Claims and Patent Scope," 2024.
- Drugs.com, "Generic Dalvance Availability," 2024.
- Federal Register, "Determination of Regulatory Review Period for Purposes of Patent Extension," 2018.
