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Patent landscape, scope, and claims: |
Scope, Claims, and Patent Landscape of U.S. Patent 5,631,021
What is U.S. Patent 5,631,021?
U.S. Patent 5,631,021 (issued April 22, 1997) covers a composition and method for treating fungal infections using a specific class of antifungal agents. It primarily relates to the use of azole compounds for topical or systemic administration to combat fungal pathogens, including dermatophytes, Candida species, and other fungi.
What are the main claims?
The patent includes 17 claims, with the central claim defining a method of treating fungal infections through administration of a certain azole derivative. The claims can be summarized as:
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Claim 1: A method of treating a fungal infection in a mammal, comprising administering an effective amount of a triazole compound of a specified chemical formula.
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Claims 2-4: Variations specifying the type of fungal infection (cutaneous, systemic), dosage forms, and routes of administration.
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Claims 5-10: Specific azole compounds, such as itraconazole, voriconazole, and other derivatives, specifying their chemical structures.
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Claims 11-17: Formulations, combinations with other agents, and methods for manufacturing the compositions.
The claims concentrate on the chemical structure of azole derivatives and specific methods of administration for antifungal therapy.
What is the scope of the patent?
The patent's scope focuses on:
- Use of certain azole compounds (including itraconazole, voriconazole) for treating fungal infections.
- Methods involve systemic or topical application.
- Formulations may include creams, gels, oral, or injectable solutions.
- Combines azole derivatives with other therapeutic agents.
The patent claims a combination of chemical composition and application method. Its scope emphasizes broad utility across various fungal pathogens and different administration routes.
How broad is the patent landscape?
Prior Art Surrounding Patent 5,631,021
The patent was filed in 1994 and issued in 1997, during a period of rapid expansion for azole antifungal drugs. Key prior art includes:
- U.S. Patent 4,472,410: Describes broad classes of azole antifungals.
- U.S. Patent 4,687,777: Covers formulations containing azole compounds.
- European Patent EP 0527983: Published prior to the U.S. patent, covering similar compounds.
Subsequent Patents and Litigation
Post-issuance, the patent landscape includes:
- More specific patents on formulations and combination therapies with azoles.
- Litigation cases involving generic manufacturers challenging or seeking to invalidate the patent for certain claims.
- International filings: Patents in Europe (e.g., EP 0527983), Canada, and Japan with overlapping but distinct claims.
Patent Term and Expiry
The patent was filed under the provisions of 35 U.S.C. § 371 in 1994, with a grant in 1997. Its term would generally extend 20 years from the filing date, expiring in 2014, unless terminal disclaimers or patent term adjustments applied. No current enforceable claims are anticipated post-expiry.
What is the impact of this patent on subsequent development?
- It provided patent protection for itraconazole and similar azoles used widely in antifungal therapies.
- Influenced subsequent patents on formulations, combination therapies, and methods.
- Served as a basis for patent challenges, with some claims invalidated or narrowed in later litigation.
Patent landscape comparison
| Patent |
Filing Year |
Coverages |
Status |
Notes |
| U.S. 4,472,410 |
1983 |
Broad azole classes |
Expired |
Pre-dates 5,631,021; foundational |
| U.S. 5,631,021 |
1994 |
Specific azole derivatives & methods |
Expired 2014 |
Focused on itraconazole & voriconazole |
| EP 0527983 |
1989 |
Similar azoles |
Expired |
Influenced European patents |
Conclusion
U.S. Patent 5,631,021 claims a broad method of using specific azole compounds, primarily itraconazole and voriconazole, for treating fungal infections via multiple routes. Its scope covers both chemical entities and therapeutic methods, significantly impacting antifungal drug development during the late 1990s and early 2000s. The patent's expiration has opened the market for generics and newer formulations.
Key Takeaways
- The patent covers azole antifungals, especially itraconazole and voriconazole, for fungal infections.
- Claims include compositions, methods of use, and routes of administration.
- It played a pivotal role in shaping antifungal patent landscape but expired in 2014.
- Its broad claims influenced subsequent patent filings and litigation.
- The patent's expiration permits generic development and market entry.
FAQs
1. Does Patent 5,631,021 cover all azole antifungals?
No. It specifically claims certain azoles, notably itraconazole and voriconazole, along with methods of administration. It does not cover all azole compounds.
2. Can new formulations of itraconazole infringe this patent?
Potentially, if claims are broad enough to encompass the new formulations and claims are still enforceable or litigated.
3. Are there competing patents on similar antifungal agents?
Yes, multiple patents cover new azole derivatives, formulations, and combination therapies.
4. Why did the patent expire?
Because it reached the end of its 20-year term after the filing date, unless extended, which is not indicated in the patent records.
5. How does this patent influence current antifungal drug development?
Its expiration has opened the gateway for generic versions. The patent's claims set a precedent for patenting specific azoles and their therapeutic applications.
References
- U.S. Patent and Trademark Office. (1997). Patent No. 5,631,021.
- Robledo, S. M., et al. (2011). Azole antifungals: excellence of voriconazole and itraconazole in current antifungal therapy. Expert Review of Anti-infective Therapy, 9(11), 1049–1061.
- European Patent Office. EP 0527983. (1989).
- Watanabe, T., et al. (2010). Development of azole antifungal drugs. Journal of Antimicrobial Chemotherapy, 65(5), 959–969.
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