Detailed Analysis of the Scope and Claims of United States Patent 6,685,958
Introduction
United States Patent 6,685,958, titled "Besifloxacin ophthalmic composition for the treatment or control of infection," is a significant patent in the field of ophthalmic pharmaceuticals. This patent, owned by Bausch & Lomb Incorporated, pertains to the use of besifloxacin, a novel fluoroquinolone antibiotic, for treating bacterial infections, particularly in the eye.
Background of Besifloxacin
Besifloxacin is a 8-chloro-fluoroquinolone agent known for its potent bactericidal activity against prevalent and drug-resistant pathogens. It is specifically designed for ophthalmic use, targeting infections such as bacterial conjunctivitis[4].
Patent Overview
Patent Number and Issue Date
The patent number is 6,685,958, and it was issued on February 3, 2004.
Inventors and Assignee
The inventors listed include Praveen Tyle, Pramod Kumar Gupta, Susan E. Norton, Lynne Brunner, and Joseph Blondeau. The assignee is Bausch & Lomb Incorporated[1].
Scope of the Patent
Claims
The patent includes several claims that define the scope of the invention. Here are some key aspects:
- Composition: The patent claims a composition for treating or controlling bacterial infections, particularly ocular infections, using besifloxacin or its derivatives[1].
- Antibiotic Resistance: The claims cover the treatment of infections caused by antibiotic-resistant bacteria, including methicillin-resistant bacteria and bacteria resistant to other fluoroquinolones like ciprofloxacin, gatifloxacin, and moxifloxacin[1].
- Formulation: The patent describes various formulations of besifloxacin, including ophthalmic solutions and suspensions, and the use of tonicity-adjusting agents to ensure the composition is compatible with the eye[1].
Specific Embodiments
- Active Ingredient: The patent specifies the use of besifloxacin hydrochloride as the active ingredient, which is a 8-chloro-fluoroquinolone agent[4].
- Inactive Ingredients: It also mentions the use of inactive ingredients such as mannitol, sorbitol, xylitol, erythritol, dextrose, glucose, glycerol, and propylene glycol for tonicity adjustment and other purposes[1].
Claims Coverage and Scope Concepts
Claim Coverage Matrix
To understand the full scope of the patent, a Claim Coverage Matrix can be used. This matrix categorizes the patents and claims by scope concepts, which helps in identifying the specific technologies and methods protected by the patent. For example, the claims related to the composition, method of treatment, and formulation can be categorized under different scope concepts to analyze their coverage and potential gaps[3].
Interactive Claim Charts
Using tools like ClaimScape® software, interactive claim charts can be generated to review the patent coverage. These charts help technical experts determine whether a particular scope concept is applicable to a target product or method, highlighting areas where there may be gaps in the current coverage[3].
Patent Landscape and Exclusivities
Patent Expiration
The patent 6,685,958 is set to expire on June 20, 2021, although this date may have been adjusted due to patent term restoration or other factors[4].
Generic Launch
The generic launch of besifloxacin is estimated to be after the expiration of the relevant patents. However, the exact date can depend on various factors including the status of other related patents and exclusivities[2].
Impact on Market and Industry
Market Dominance
The exclusivity provided by this patent has allowed Bausch & Lomb to maintain market dominance in the ophthalmic antibiotic segment. The patent's protection has prevented generic versions of besifloxacin from entering the market, ensuring a significant revenue stream for the company[2].
Innovation and Competition
The patent has also driven innovation in the field of ophthalmic antibiotics. The protection afforded by the patent has encouraged further research and development in this area, potentially leading to new and improved treatments for ocular infections[1].
Key Takeaways
- Besifloxacin: A novel 8-chloro-fluoroquinolone antibiotic with potent bactericidal activity against prevalent and drug-resistant pathogens.
- Patent Scope: Covers compositions and methods for treating ocular infections, including those caused by antibiotic-resistant bacteria.
- Formulation: Includes ophthalmic solutions and suspensions with specific tonicity-adjusting agents.
- Exclusivity: The patent has provided Bausch & Lomb with market exclusivity until its expiration.
- Impact: Has driven innovation and maintained market dominance in the ophthalmic antibiotic segment.
Frequently Asked Questions (FAQs)
Q: What is the active ingredient in the composition described in US Patent 6,685,958?
A: The active ingredient is besifloxacin hydrochloride, a 8-chloro-fluoroquinolone agent.
Q: What type of infections does this patent cover?
A: The patent covers the treatment or control of bacterial infections, particularly ocular infections such as bacterial conjunctivitis.
Q: Who is the assignee of this patent?
A: The assignee is Bausch & Lomb Incorporated.
Q: When is the estimated generic launch date for besifloxacin?
A: The generic launch date is estimated to be after the expiration of the relevant patents, with some sources indicating around January 9, 2031[2].
Q: How does the patent impact the market and industry?
A: The patent provides market exclusivity, driving innovation and maintaining market dominance in the ophthalmic antibiotic segment.
Cited Sources
- United States Patent and Trademark Office, "Besifloxacin ophthalmic composition for the treatment or control of infection," US8415342B2.
- Pharsight, "Besivance patent expiration."
- Schwegman Lundberg & Woessner, "Patent Analytics."
- New Drug Approvals, "Besifloxacin hydrochloride (Besivance)."
