United States Patent 8,420,676: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,420,676, titled "Oxazolidinone Derivatives," is a significant patent in the pharmaceutical sector, particularly in the area of antibiotic development. This patent, issued on April 16, 2013, is assigned to Dong-A Pharmaceuticals Co. Ltd. and covers a range of oxazolidinone derivatives with potential therapeutic applications.
Background
Oxazolidinones are a class of synthetic antibiotics known for their effectiveness against a broad spectrum of bacteria, including those resistant to other antibiotics. The development of these compounds has been crucial in addressing the growing issue of antibiotic resistance.
Inventors and Assignee
The patent was invented by Jae Keol Rhee, Kyonggido; Weon Bin Im, Yongin-si; Chong Hwan Cho, Yongin-si; Sung Hak Choi, Seongnam-si; and Tae Ho Lee, Yongin-si. The assignee is Dong-A Pharmaceuticals Co. Ltd., a South Korean pharmaceutical company[4].
Patent Scope
Claims
The patent includes several claims that define the scope of the invention. Here are some key aspects:
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Chemical Structure: The patent claims cover specific oxazolidinone derivatives, including their chemical structures and formulations. These compounds are designed to inhibit bacterial growth and have lower toxicity compared to existing antibiotics[4].
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Pharmaceutical Compositions: The patent also covers pharmaceutical compositions that include these oxazolidinone derivatives. These compositions can be formulated in various ways, such as tablets, capsules, or injectable solutions, to facilitate different modes of administration[4].
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Therapeutic Uses: The claims extend to the therapeutic uses of these compounds, particularly in treating bacterial infections. The patent highlights the efficacy of these derivatives against a broad spectrum of bacteria, including those resistant to other antibiotics[4].
Claims Detail
Independent Claims
- Claim 1 describes the oxazolidinone derivatives corresponding to a specific formula, detailing the chemical structure and substituents.
- Claim 2 covers pharmaceutical compositions comprising these derivatives.
- Claim 3 specifies the methods of treating bacterial infections using these compositions[4].
Dependent Claims
- Dependent claims further elaborate on the specific aspects of the independent claims, such as different formulations, dosages, and methods of administration.
Patent Landscape
Related Patents
The patent landscape for oxazolidinone derivatives is complex, with multiple patents filed by various companies. For example:
- Patents like US 8,426,389 and US 9,624,250, assigned to Merck Sharp & Dohme Corp., cover similar oxazolidinone derivatives but with different chemical formulations and claims[2].
Competitive Environment
The pharmaceutical industry is highly competitive, especially in the antibiotic sector. Companies like Dong-A Pharmaceuticals, Merck, and others are actively involved in developing new antibiotics to address the growing issue of antibiotic resistance. This competition drives innovation but also leads to a complex patent landscape where companies must navigate through existing patents to avoid infringement[3].
Exclusivity and Patent Term
Patent Term
The patent term for US 8,420,676 is 20 years from the date of filing, which was September 16, 2008. However, the patent term can be adjusted or extended due to various factors, including patent infringement litigation and the development of new formulations[2].
Exclusivity
In addition to the patent term, the FDA can grant exclusivity periods to manufacturers upon the approval of a drug. These exclusivity periods can range from 180 days to seven years, depending on the circumstances, and can run simultaneously with the patent term[2].
Impact on the Pharmaceutical Industry
Innovation
The issuance of this patent and others like it drives innovation in the pharmaceutical industry. Companies are incentivized to develop new and improved antibiotics, which is crucial in the fight against antibiotic resistance.
Generic Competition
Once the patent and exclusivity periods expire, generic versions of these drugs can be developed, increasing accessibility and reducing costs for patients. However, the complex patent landscape often delays the entry of generic drugs into the market[1].
Challenges in Patent Identification
Nonpracticing Entities
The sheer number of patents in the pharmaceutical sector, including those held by nonpracticing entities, makes it challenging for companies to identify all relevant patents. This complexity can lead to patent infringement disputes and litigation[3].
Statistics and Trends
- The USPTO issued 359,000 patents in 2022, which is a decline from the pre-pandemic level of 391,103 patents granted in 2019. This trend indicates a high volume of patent activity, including in the pharmaceutical sector[3].
Key Takeaways
- Innovation in Antibiotics: US 8,420,676 represents a significant innovation in the development of oxazolidinone derivatives as antibiotics.
- Complex Patent Landscape: The patent landscape for antibiotics is highly complex, with multiple patents and exclusivity periods.
- Impact on Industry: The patent drives innovation and can influence the timing of generic drug entry into the market.
- Challenges: Identifying relevant patents and navigating the complex landscape are significant challenges for pharmaceutical companies.
FAQs
What is the main subject of United States Patent 8,420,676?
The main subject of this patent is the oxazolidinone derivatives and their pharmaceutical compositions for treating bacterial infections.
Who are the inventors and assignee of this patent?
The inventors are Jae Keol Rhee, Weon Bin Im, Chong Hwan Cho, Sung Hak Choi, and Tae Ho Lee. The assignee is Dong-A Pharmaceuticals Co. Ltd.
What is the significance of oxazolidinone derivatives in the pharmaceutical industry?
Oxazolidinone derivatives are significant because they offer a new class of antibiotics effective against a broad spectrum of bacteria, including those resistant to other antibiotics.
How does the patent term and exclusivity period affect the availability of generic drugs?
The patent term and exclusivity period can delay the entry of generic drugs into the market, as generic manufacturers must wait until these periods expire before they can develop and market their versions.
What challenges do pharmaceutical companies face in navigating the patent landscape for antibiotics?
Pharmaceutical companies face challenges in identifying all relevant patents, especially those held by nonpracticing entities, which can lead to patent infringement disputes and litigation.
Cited Sources
- The BioLoquitur Bulletin - Seyfarth Shaw LLP
- Generic Sivextro Availability - Drugs.com
- Noticing Patents - Columbia Library Journals
- United States Patent 8,420,676 - googleapis.com
