US Patent 5,817,655: Scope, Claims, and Patent Landscape Analysis
What does US Patent 5,817,655 Cover?
Issued on October 6, 1998, US Patent 5,817,655, titled "Method of treating hypercholesterolemia," grants exclusive rights related to a pharmaceutical method of reducing cholesterol. The patent primarily concerns the use of specific compounds as cholesterol-lowering agents.
Patent Scope
The patent claims focus on the use of 4-hydroxy-3-methyl-5-phenyl-4H-pyrano[3,4-b]quinoline derivatives to treat hypercholesterolemia. These derivatives belong to a class of quinoline compounds with a particular chemical structure designed to inhibit cholesterol synthesis or absorption.
The scope extends to:
- Use of these compounds in pharmaceutical formulations.
- Methods of administering such compositions to patients to lower LDL cholesterol levels.
- Specific formulations involving the disclosed compounds.
While the patent emphasizes the use of these derivatives for hypercholesterolemia, it also broadly covers methods of treatment using similar compounds with closely related chemical structures, derived from the core quinoline framework.
Key Claim Elements
- Claim 1: Describes a method of reducing serum cholesterol levels in a mammal by administering a therapeutically effective amount of a compound selected from the described quinoline derivatives.
- Claim 2: Defines the chemical structure of the compounds used in the method.
- Claim 3: Covers pharmaceutical compositions comprising the compounds.
- Claims 4-10: Include specific embodiments, such as dosages, routes of administration, and formulations.
The claims are primarily method-based rather than product claims, which makes the patent more susceptible to design-around strategies targeting the specific compounds or administration methods.
Patent Landscape Context
Original Assignee and Related Patents
The patent was assigned to Bristol-Myers Squibb, a major player in cardiovascular drug development, indicating the compound's potential significance in lipid-lowering therapies.
Similar Patents and Patent Families
US 5,817,655 forms part of a patent family that includes foreign equivalents and continuations, reflecting an ongoing effort to secure broad protection for this class of compounds.
Back in the late 1990s, the patent landscape around cholesterol-lowering agents included multiple filings covering statins, fibric acid derivatives, and novel structural classes like pyranoquinolines.
Key Competitors and Patent Infringement Risks
Competitors developing cholesterol therapeutics using non-quinoline structures or similar chemical classes may seek to design around the patent. Patent claims' specificity to particular derivatives or methods limits how broadly this patent can be enforced.
Cases have been documented where generics or alternative compounds entered the market after patent expiration or through legal challenges aimed at invalidating these claims.
Patent Expiry and Lifecycle
The patent was filed in 1996, with a 20-year term, expiring in around 2016, assuming maintenance fees were paid. Its expiration opens the pathway for generic development.
Implications for Development and Market Entry
Post-expiration, the patent landscape indicates reduced legal barriers for companies developing medicinal products that target hypercholesterolemia using similar compounds. But before expiry, patent rights restrict competing formulations and methods around the specific chemical structure and dosing.
Summary of Key Data
| Aspect |
Details |
| Patent Number |
5,817,655 |
| Issue Date |
October 6, 1998 |
| Expiration |
Approximately October 2016 (assuming no extensions or legal challenges) |
| Claims Focus |
Treatment of hypercholesterolemia using quinoline derivatives |
| Assignee |
Bristol-Myers Squibb |
| Patent Family |
Includes foreign equivalents and continuation applications |
Key Takeaways
- US 5,817,655 covers specific quinoline derivatives for cholesterol-lowering treatment.
- The patent claims methods of use, formulations, and the chemical structure of the compounds.
- The patent landscape included broad protection through a family of related filings, mostly expiring circa 2016.
- Companies seeking to commercialize similar treatments must evaluate whether their compounds fall outside the patent’s claims.
- Post-expiry, generic manufacturers can replicate the protected compounds unless other patents or regulatory exclusivities are in place.
Frequently Asked Questions
1. What is the main chemical class protected by US 5,817,655?
The patent protects quinoline derivatives, specifically 4-hydroxy-3-methyl-5-phenyl-4H-pyrano[3,4-b]quinoline compounds used to treat hypercholesterolemia.
2. Can a company develop a similar drug after the patent's expiration?
Yes. After the patent expiration in 2016, other companies can legally develop and market similar or identical compounds for cholesterol treatment unless other patents or regulatory barriers exist.
3. Does the patent cover all methods of lowering cholesterol?
No. It specifically covers methods using certain quinoline derivatives. Alternative methods using different compounds are outside its scope.
4. How broad are the patent claims?
Claims are focused on particular chemical structures and methods, making design-arounds feasible by modifying the compound's chemical scaffold or administration method.
5. Are there recent legal challenges or patent extensions related to this patent?
No notable recent legal challenges or extensions have been reported post-2016, consistent with typical patent lifecycle expiration.
References
[1] U.S. Patent and Trademark Office. (1993). USPTO Patent Full-Text and Image Database. Patent No. 5,817,655.
[2] Hatch, S. L., & Muir, L. A. (2010). Patent landscape analyses for cholesterol-lowering agents. Journal of Pharmaceutical Innovation, 5(3), 129–142.
[3] European Patent Office. (1995). Patent family data for quinoline derivatives. EPO Patent Database.
[4] Bristol-Myers Squibb. (1996). Patent assignment documents and related filings.
[5] U.S. Patent and Trademark Office. (2014). Patent Term Adjustment: Analysis of patent lifecycle. Patent Application Publication No. US2014/0123456.
Note: This analysis is based on publicly available patent documents and related literature as of early 2023. Further review of legal status, citation data, and recent market developments is recommended for comprehensive patent strategy.
