United States Patent 8,415,342: A Detailed Analysis of Scope and Claims
Introduction
United States Patent 8,415,342, titled "Besifloxacin ophthalmic composition for the treatment or control of infection," is a crucial patent held by Bausch & Lomb Incorporated. This patent protects the ophthalmic composition of besifloxacin, a fluoroquinolone antibiotic, and is significant in the treatment and control of bacterial infections, particularly those caused by antibiotic-resistant bacteria.
Inventors and Assignees
The patent was invented by Tyle Praveen, Gupta Pramod Kumar, Norton Susan E., Brunner Lynne, and Blondeau Joseph, and is assigned to Bausch & Lomb Incorporated[5].
Patent Issuance and Expiration
The patent was issued on April 9, 2013, and is set to expire on November 7, 2030. This expiration date is critical as it marks the end of the exclusive rights granted to Bausch & Lomb Incorporated for the besifloxacin ophthalmic composition[5].
Scope of the Patent
The patent covers a composition that includes besifloxacin in an amount effective for treating or controlling infections caused by antibiotic-resistant bacteria. Specifically, it addresses the treatment of bacterial conjunctivitis caused by such bacteria. The composition is administered as an ophthalmic solution, making it a targeted treatment for eye infections[5].
Claims
The patent includes several claims that define the scope of the invention. Here are some key claims:
- Claim 1: A composition comprising besifloxacin in an amount effective for treating or controlling an infection caused by an antibiotic-resistant bacterium.
- Claim 2: The composition of claim 1, wherein the besifloxacin is in the form of besifloxacin hydrochloride.
- Claim 3: A method for treating or controlling bacterial conjunctivitis caused by an antibiotic-resistant bacterium, comprising administering the composition of claim 1 to a subject[5].
These claims are broad enough to cover various formulations and methods of using besifloxacin but narrow enough to ensure that the patent is not overly broad and thus invalid.
Patent Landscape
The patent landscape for besifloxacin ophthalmic compositions is complex and involves multiple patents and regulatory protections.
- Related Patents: Besides US Patent 8,415,342, there are other patents that protect different aspects of besifloxacin, such as fluoroquinolone carboxylic acid molecular crystals (US Patent 8,481,526 and US Patent 8,604,020) and compositions for treating infections caused by antibacterial drug-resistant bacteria (US Patent 8,937,062)[5].
- Global Protection: The besifloxacin ophthalmic composition is protected by 24 patent family members in 13 countries, indicating a broad international protection strategy[4].
Generic Entry and Exclusivity
As of now, there is no therapeutically equivalent generic version of Besivance available in the United States. The earliest estimated date for generic entry is January 9, 2031, based on the expiration of the relevant patents and regulatory exclusivities[5].
Challenges and Litigation
The patent has been open to challenges since May 28, 2013. However, the robust patent protection and the strategic filing of multiple patents have helped Bausch & Lomb Incorporated maintain its exclusive rights. Any challenges or litigation could potentially alter the generic entry date, but as of now, the patent remains intact[4].
Regulatory and Market Impact
The patent's scope and claims have significant implications for the market. The exclusive rights granted to Bausch & Lomb Incorporated allow the company to maintain a monopoly on the besifloxacin ophthalmic composition, influencing pricing and availability. This is particularly important in the context of treating antibiotic-resistant infections, where the availability of effective treatments is crucial[4].
Industry Context
In the pharmaceutical industry, particularly for antibiotics and biologics, robust and predictable patent protection is essential for commercialization strategies. The Federal Circuit's stance on genus claims and the written description requirement under 35 U.S.C. ยง 112(a) can make it challenging to obtain and maintain broad patent protection. However, the patents protecting besifloxacin have navigated these challenges effectively[3].
Key Takeaways
- Patent Scope: The patent covers besifloxacin ophthalmic compositions for treating antibiotic-resistant bacterial infections.
- Claims: The claims are specific to the composition and method of treatment, ensuring broad yet valid protection.
- Expiration: The patent expires on November 7, 2030.
- Generic Entry: The earliest estimated generic entry date is January 9, 2031.
- Regulatory Impact: The patent maintains Bausch & Lomb Incorporated's exclusive rights, influencing market dynamics.
FAQs
What is the primary use of the besifloxacin ophthalmic composition protected by US Patent 8,415,342?
The primary use is for the treatment or control of bacterial conjunctivitis caused by antibiotic-resistant bacteria.
Who are the inventors of US Patent 8,415,342?
The inventors are Tyle Praveen, Gupta Pramod Kumar, Norton Susan E., Brunner Lynne, and Blondeau Joseph.
When does the patent expire?
The patent expires on November 7, 2030.
Are there any generic versions of Besivance available?
No, there are currently no therapeutically equivalent generic versions of Besivance available in the United States.
What is the estimated date for generic entry of Besivance?
The earliest estimated date for generic entry is January 9, 2031.
Cited Sources
- CN105412003A - Besifloxacin hydrochloride eye drops and preparation method thereof.
- Pharsight - Besivance patent expiration.
- DigitalCommons@NYLS - Eviscerating Patent Scope.
- DrugPatentWatch - BESIVANCE Drug Patent Profile.
- Drugs.com - Generic Besivance Availability.
