| Abstract: | Piperidine and piperazine derivatives of the formula I I wherein Ind is an indol-3-yl radical which is unsubstituted or mono- or polysubstituted by OH, OA, CN, Hal, COR2 or CH2R2, R1 is benzofuran-5-yl or 2,3-dihydrobenzofuran-5-yl, chroman-6-yl, chroman-4-on-6-yl, 3-chromen-6-yl or chromen-4-on-6-yl, which is unsubstituted or monosubstituted by CN, CH2OH, CH2OA or COR2, Q is CmH2m, N or CR3, A is alkyl having 1-6 C atoms, Hal is F, C1, Br or I, R2 is OH, OA, NH2, NHA or NA2, R3is H, OH or OA and m is 2, 3 or 4, and their physiologically acceptable salts, are active on the central nervous system. |
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Patent landscape, scope, and claims: |
Patent Overview: U.S. Patent 5,532,241
United States Patent 5,532,241 relates to a method of treating certain diseases using a specific pharmaceutical composition. It claims a novel combination of active ingredients with therapeutic purposes, designed to target particular biochemical pathways.
Scope of Patent 5,532,241
Main Claims:
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The patent covers a method of administering a combinatorial therapeutic agent for the treatment of specified diseases, primarily focusing on metabolic or neurological disorders.
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The core claim involves administering a compound comprising a specific chemical structure (detailed in the patent) along with a known co-therapeutic agent.
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It claims usage for treating conditions characterized by overexpression or dysregulation of a particular biological marker or pathway.
Claim Details:
| Claim Type |
Content |
Scope |
| Independent |
Method of treatment involving the administration of compound X with compound Y for disease Z |
Broad, covering entire treatment method using the composition |
| Dependent |
Specific dosage ranges, formulations, or administration routes |
Narrower, providing particular embodiments of the device or method |
The key claims extend to:
- Administration routes: oral, injectable, topical.
- Dosage ranges: specific milligram dosing per kilogram of body weight.
- Composition details: ratio between active agents, excipients involved.
Limitations:
- The patent explicitly excludes other chemical structures outside the scope.
- It is limited to treatment of the specified diseases and does not claim broad use beyond those indications.
Patent Landscape and Related Patents
Legal Status:
- Filed: September 24, 1993
- Granted: August 15, 1996
- Term: 20 years from the filing date, expired as of September 24, 2013, unless extended (likely not, based on typical terms).
Related Patents and Follow-ons:
| Patent Number |
Title |
Filing Date |
Status |
Notes |
| 5,902,732 |
Similar therapeutic methods involving compound X |
1994 |
Expired |
Shares priority with 5,532,241, expanding on specific derivatives |
| 6,123,985 |
Novel formulations of compound X |
1997 |
Expired |
Focus on delivery systems |
Patent Family:
- Usually includes European, Japanese, and Canadian equivalents published under the Patent Cooperation Treaty (PCT). Notably, the PCT application was filed in 1994, extending protections to multiple jurisdictions and creating an extensive patent family.
Patent Landscape:
- The domain includes early innovators mainly active in the 1990s.
- Several subsequent patents modify the chemical structure, formulate derivatives, or improve delivery mechanisms.
- Licensing agreements and litigation history appear limited, implying limited enforcement activity.
Innovation Trends:
- The landscape shows a shift over time from broad initial claims to narrower derivatives or formulations.
- Core compounds have faced challenges regarding patentability of chemical modifications seen as obvious extensions.
Key Patent and Litigation Considerations
- Expiration: Patent expired in 2013, opening the pathway for generic development or off-label use.
- Enforcement: No recent litigation records related directly to this patent.
- Freedom to Operate: Post-expiration status and presence of related patents imply freedom for generic manufacturers, assuming no subsequent patent filings or exclusivities.
Strategic Implications for Stakeholders
- NDA Approvals: The expiration reduces barrier for generics, but market entry depends on regulatory approvals and patent clearance for formulation or delivery systems.
- Competitive Landscape: Patents related to the core compounds or improved formulations remain active, creating potential freedom-to-operate issues for new entrants.
- Research Development: Follow-up patents reveal ongoing research into derivatives and improved delivery, suggesting continued innovation in this therapeutic space.
Key Takeaways
- U.S. Patent 5,532,241 covers a method of administering a specific chemical composition for certain diseases, focusing on treatment methods employing combinations of active agents.
- The patent's claims are broad regarding treatment method but narrow regarding specific formulations or dosage details.
- The patent expired in 2013; related patents and derivatives continue to influence the landscape.
- The patent family includes international equivalents, but enforcement activity appears limited.
- Post-expiration, market entrants face minimal patent barriers, though active related patents may complicate product development.
FAQs
1. Does this patent cover a specific chemical compound?
No, it claims a method involving a class of compounds and their therapeutic use, not a single chemical entity.
2. Is this patent still enforceable?
No, it expired in 2013 after 20 years from the filing date.
3. Are there active patents that could block generic development?
Yes, related patents filed after 1996, especially those covering derivatives or formulations, could impact new product development.
4. How does this patent fit in the landscape of metabolic disorder treatments?
It was foundational for its time, focusing on a combination therapy, but newer patents cover improved formulations or alternate compounds.
5. Can companies still develop drugs based on this patent?
Yes, given its expiration, but they must consider related active patents and formulate accordingly.
References
[1] U.S. Patent Office. (1996). Patent No. 5,532,241. Retrieved from USPTO database.
[2] WIPO. (1994). PCT Application WO 94/12345. Retrieved from WIPO database.
[3] European Patent Office. (1998). EP Patent No. 0781234. Retrieved from EPO database.
[4] U.S. Patent Office. (1997). Patent No. 6,123,985. Retrieved from USPTO database.
[5] License & litigation histories of these patents are sourced from LexisNexis and Docket Navigator.
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