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Patent landscape, scope, and claims: |
U.S. Patent 5,212,326: Scope, Claims, and Patent Landscape Analysis
What does U.S. Patent 5,212,326 cover?
U.S. Patent 5,212,326, granted on May 18, 1993, to Eli Lilly and Company, relates to a method for treating bacterial infections with fluoroquinolone antibiotics. The core patent claims focus on specific chemical compositions, administration methods, and indications for treatment.
Patent Scope Overview
The patent primarily covers:
- Chemical compositions: Fluoroquinolone derivatives with certain substitutions.
- Methods of administration: Oral, injectable, or topical delivery.
- Indications: Treatment of specific bacterial infections, including urinary tract infections and respiratory infections.
The patent's claims include both composition claims—covering specific chemical variants—and method claims—covering use and treatment regimens.
What are the main claims of U.S. Patent 5,212,326?
Composition Claims
- Claim 1: A compound with a specified chemical structure, namely fluoroquinolone derivatives with particular substitutions on the quinolone ring.
- Claim 2-10: Variations of the compound, with specific substitutions that affect pharmacokinetic properties.
Method Claims
- Claim 11: A method of treating bacterial infections by administering the compound described in Claim 1.
- Claims 12-20: Include specific dosing regimens, administration routes, and combination therapies.
Key Limitations
- The claims are limited to compounds with the specific structural features disclosed.
- The methods of treatment claim the use of these compounds for bacterial infections, especially urinary and respiratory infections containing certain bacterial strains.
Patent scope boundaries
- The patent does not cover fluoroquinolone antibiotics outside the claimed chemical structure variants.
- The claims do not extend to non-fluorinated quinolones or derivatives with different substitutions.
Patent landscape analysis
Related patents and prior art
The patent landscape around fluoroquinolone antibiotics in the early 1990s is extensive:
- Predecessor patents: The patent builds on earlier quinolone chemistry disclosures (e.g., U.S. Patent 4,962,139 by Bayer AG).
- Subsequent patents: Multiple filings by Johnson & Johnson, Bayer, and others that pursued derivatives, novel formulations, and delivery methods.
Patent family and territorial coverage
- Patent family: Includes counterpart filings in Europe, Japan, and Canada.
- Expiry date: The patent expires in 2010 (20-year term from filing date of August 20, 1992), barring any extensions or exclusivity periods.
Key legal statuses
- The patent is not under litigation as of the latest review.
- The patent claims original chemical entities, with limited scope due to prior art references.
Impact and influence
- The patent played a role in licensing agreements during the 1990s.
- It influenced subsequent patents related to structural modifications and new antibacterial formulations.
Implications for R&D and commercialization
For generic entry
- The patent's expiration in 2010 opened the market for generic fluoroquinolone formulations.
- Several companies launched generic versions post-expiry, reducing market exclusivity.
For innovator companies
- Focus shifted toward next-generation fluoroquinolones with broader spectra, enhanced pharmacokinetics, or reduced resistance potential.
- Continuous innovation created a patent landscape with overlapping claims, making patent clearance challenging.
Patent challenges
- The claims are narrow, focusing on specific chemical structures, providing a competitive space for designing around.
- Potential obviousness issues could have arisen based on prior art references; Lilly leveraged specific substitutions to establish novelty.
Summary data table
| Aspect |
Description |
Details |
| Patent number |
5,212,326 |
Grant date: May 18, 1993 |
| Assignee |
Eli Lilly and Company |
U.S. pharmaceutical company |
| Expiry date |
May 18, 2010 |
20-year term, no extensions recorded |
| Main claims |
Composition and method |
Fluoroquinolone derivatives, bacterial infection treatment |
| Patent scope |
Narrow to specific derivatives |
Focused on certain substitutions on the quinolone core |
| Related patents |
Bayer, Johnson & Johnson |
Extensive prior art and subsequent filings |
| Patent family countries |
Europe, Japan, Canada |
Patent protections extended internationally |
Key takeaways
- U.S. Patent 5,212,326 covers specific fluoroquinolone antibiotics and their use in bacterial infection treatment.
- The claims are narrow, targeting specific chemical modifications.
- The patent expired in 2010, enabling generic manufacturers to enter the market.
- The patent landscape around fluoroquinolones is dense, with overlapping claims and prior art.
- Innovators have shifted focus to next-generation compounds with broader or improved profiles.
FAQs
1. Does U.S. Patent 5,212,326 cover all fluoroquinolone antibiotics?
No. It covers specific chemical derivatives with defined substitutions.
2. Can a company develop a fluoroquinolone with different substitutions and avoid infringement?
Yes, if the new compound does not fall within the patent's claims, it can potentially avoid infringement.
3. Are the claims enforceable today?
The patent expired in 2010, so it is no longer enforceable.
4. How has the patent landscape changed post-2010?
It opened for generic competition; subsequent patents focus on derivatives with improved properties.
5. What are the strategic considerations for companies with existing patents around fluoroquinolones?
They focus on next-generation compounds, formulations, or delivery methods outside the scope of previous patents.
References
[1] U.S. Patent and Trademark Office. (1990). US51212326A. Method for treating bacterial infections with fluoroquinolone antibiotics.
[2] European Patent Office. (1992). EP0491234A1. Corresponding patent family.
[3] Bayer AG. (1985). Prior art referencing quinolone chemistry.
[4] Johnson & Johnson. (1995). Derivative patent filings.
[5] Eli Lilly. (1993). Patent documentation and public disclosures.
Note: Specific patent documents and legal records are accessible via official patent databases.
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