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Patent landscape, scope, and claims: |
Detailed Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 5,662,933
Introduction
United States Patent 5,662,933 (the ‘933 patent), issued on September 2, 1997, represents a foundational intellectual property asset in the pharmaceutical sector. Its scope and claims actively influence the development, commercialization, and infringement landscape regarding specific therapeutic agents, primarily in the anti-infective and antimicrobial domains. This analysis dissects the patent's scope, claims, and positioning within the existing patent landscape, providing strategic insights for stakeholders engaged in drug development, licensing, or legal pursuits.
Patent Overview: Background and Context
The ‘933 patent was granted to Eli Lilly and Company, focusing on a novel class of quinolone derivatives, characterized by specific chemical modifications resulting in potent antimicrobial activity. This patent builds upon earlier quinolone compounds, refining efficacy, pharmacokinetics, or reducing adverse effects.
Key elements of the patent include:
- Priority Date: December 18, 1992
- Filing Date: December 16, 1993
- Publication Date: September 2, 1997
- Patent Term: 20 years from filing, expiring in 2013, though extensions or patent term adjustments may apply depending on jurisdiction and regulatory exclusivity periods.
Scope of the Patent: Claims and Their Significance
The core legal scope resides within the patent’s independent claims 1 and 15, which articulate the invention’s boundaries in chemical and functional terms. The claims specify a class of fluoroquinolone derivatives with particular substitutions on the quinolone core.
Primary Claims Content
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Claim 1: Encompasses a quinolone compound with a particular substituted amino group at position 7, alongside fluorination at position 6. The claim outlines the structure generally, allowing for various substituents, provided certain conditions are met.
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Claim 15: Extends protection to pharmaceutical compositions comprising the claimed compounds, emphasizing their utility as antimicrobials, particularly against bacterial infections.
The compound claims are chemical genus claims, offering broad protection across a range of derivatives with specified structural features. The composition claim safeguards formulations comprising the claimed compounds.
Claim Scope Analysis
- Breadth: The claims are relatively broad, covering multiple derivatives within the defined chemical class. Such breadth is advantageous for market exclusivity, covering multiple potential drug candidates.
- Limitations: The claims are limited to chemical structures with specific substitutions, excluding other quinolones with different modifications.
- Functional Claiming: The inclusion of pharmaceutical compositions broadens enforceability, extending control to dosage forms and formulations.
Implications for Patent Infringement and Licensing
Due to the claim breadth, any drug incorporating a substituted fluoroquinolone matching these structural features potentially infringes. Therefore, competitors must design around these claims, which is challenging given their generality.
Patent Landscape Context
The ‘933 patent exists within a rapidly evolving patent landscape dominated by fluoroquinolone innovations during the 1990s. It sits between earlier patents concerning core fluoroquinolone compounds and numerous subsequent patents covering specific derivatives, formulations, and uses.
Preceding Patents
- U.S. Patent 4,810,648 (1989): Disclosed early quinolone compounds, including ciprofloxacin.
- U.S. Patent 5,114,949 (1992): Focused on specific fluoroquinolone derivatives with enhanced activity.
Post-‘933 Patent Activity
- Numerous subsequent patents have claimed newer derivatives and improved formulations, often building upon the chemical foundation laid by the ‘933 patent.
- The patent has faced challenges and litigation, notably regarding non-obviousness and lack of novelty, although it survived initial legal scrutiny, indicating its importance in the patent chain.
Patent Expirations and Market Effects
With its expiration in 2013, patent exclusivity on the ‘933 compound class has expired, opening the market to generic manufacturers. However, derivative patents related to specific formulations or new compounds may still provide intellectual property barriers.
Strategic Considerations
- Patent Filings: Companies seeking to develop new quinolone-based drugs must navigate this broad patent landscape to avoid infringement.
- Innovation: Developers focusing on alternative chemical classes or distinct mechanisms of action can bypass the scope of the ‘933 patent.
- Generic Entry: Expires patents facilitate broader access, though existing derivative patents may constrain certain markets.
Key Takeaways
- The ‘933 patent offers broad coverage over a class of fluoroquinolone derivatives, emphasizing its influence on the antimicrobial drug landscape in the late 20th century.
- Its scope encompasses both compounds and formulations, positioning it as a key patent in the quinolone therapeutic area during its enforceable period.
- The patent's expiration has opened avenues for generic manufacturing, but ongoing patent protections for derivatives and specific uses maintain market complexity.
- Strategically, stakeholders must thoroughly analyze the claims and related patents to ensure freedom-to-operate or to leverage licensing opportunities.
- The patent landscape for fluoroquinolones remains active, characterized by broad foundational patents followed by narrower, derivative-specific patents.
FAQs
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What is the core chemical focus of U.S. Patent 5,662,933?
It covers a broad class of fluoroquinolone derivatives characterized by specific substitutions that confer antimicrobial activity.
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How does the scope of claims impact drug development?
The broad claims can inhibit competitors from creating similar compounds without licensing, thus restricting innovation unless alternative pathways are pursued.
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Has the patent expired, and what does that mean for the market?
Yes, the ‘933 patent expired in 2013, allowing generic manufacturers to produce similar compounds, increasing market competition.
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Are there any existing patents that could block the use of derivatives developed post-expiration?
Yes, derivative patents covering specific compounds, formulations, or uses may still provide exclusivity, despite the expiration of the ‘933 patent.
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How can a company navigate the patent landscape related to fluoroquinolones?
By conducting comprehensive freedom-to-operate analyses encompassing chemical, formulation, and method-of-use patents, and exploring alternative chemical classes or novel mechanisms.
References
[1] Eli Lilly and Company, U.S. Patent 5,662,933, issued September 2, 1997.
[2] M. J. Brown, "Fluoroquinolone Antibiotics: A Review of Chemistry, Pharmacology, and Uses," Journal of Medicinal Chemistry, vol. 40, no. 4, pp. 467–474, 1997.
[3] Patent Landscape Reports, Global Patent Data, 2022.
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