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Patent landscape, scope, and claims: |
Patent 5,679,376: Scope, Claims, and Patent Landscape
What Does Patent 5,679,376 Cover?
Patent 5,679,376, granted to Eli Lilly and Company on October 21, 1997, covers a compound class related to serotonin receptor antagonists. Specifically, it claims a class of compounds with potential uses in treating CNS disorders, including anxiety, depression, and schizophrenia.
Key Structural Features
The patent claims compounds characterized by a core structure involving a benzodiazepine derivative with specific substitutions, primarily targeting serotonin receptor subtypes. The scope includes:
- Structural formulas represented in claims 1–20.
- Variations in substituents on the core structure, including differing R-groups.
- Stereochemistry considerations, including enantiomers.
- Crystalline forms and pharmaceutical compositions involving these compounds.
Scope of Claims
The patent contains 28 claims, with the first being a broad composition claim. Highlights include:
- Claim 1: A chemical compound with a specified benzodiazepine scaffold, substituents R1 and R2, and certain stereochemical configurations.
- Claims 2-20: Dependent claims narrowing the scope to specific substituents, stereoisomers, or crystalline forms.
- Claims 21-28: Cover methods of synthesis, pharmaceutical compositions, and treatments related to the compounds.
Claim language emphasizes both the compounds themselves and their pharmaceutical uses, explicitly claiming methods for treating neuropsychiatric conditions.
Patent Landscape Analysis
Patent Families and Infringement Risks
- The patent belongs to a family with related filings in Europe (EP 0885187 B1), Japan (JP 2686703), and Canada.
- Several acid addition salts, polymorphs, and formulations of the compounds are not explicitly claimed but could fall under equivalents or be considered obvious variants, depending on jurisdiction.
- The patent's expiration date is estimated to be October 21, 2014, 20 years after the filing date (March 19, 1993), assuming proper maintenance; recent patent term adjustments in the US have extended this.
Related Patents
- Multiple patents cover specific derivatives, methods of synthesis, and treatment indications involving serotonin antagonists but with narrower claims.
- US patents such as 5,850,011 and 6,045,821 expand on related compounds with different substituent patterns but similar indications.
- Patent landscapes indicate significant patent activity around serotonin receptor modulators, with both pharmaceutical companies and generic firms filing patents.
Patent Litigation and Market Impact
- No significant litigation historically related to Patent 5,679,376 specifically has been publicly reported.
- The patent's expiration opened opportunities for generic manufacturers to develop biosimilar or bioequivalent drugs targeting the same receptor profiles.
Current Commercial Landscape
- Several drugs marketed for CNS disorders target serotonin receptors (e.g., risperidone, olanzapine). However, none directly reference the compounds claimed in this patent.
- Companies such as Lilly hold key patent rights for compounds with similar structures, controlling proprietary formulations and Novel Chemical Entities (NCEs).
Summary of Claims Coverage
| Claim Type |
Coverage |
Limitations |
| Composition claims |
Wide class of benzodiazepine derivatives with specific substitutions |
Specific structural parameters outlined |
| Method claims |
Methods for treating CNS disorders with claimed compounds |
Restricted to particular administration modes |
| Formulation claims |
Pharmaceutical compositions containing the compounds |
Limited to specific excipients and delivery forms |
Implications for Industry
- Patent 5,679,376 protected early development efforts around serotonin receptor antagonists with anxiolytic and antipsychotic activity.
- Its broad composition claims initially provided substantial coverage until patent expiry.
- Post-expiration, generic companies have opportunities to develop medications based on similar structures.
Key Takeaways
- Patent 5,679,376 claims a broad class of benzodiazepine derivatives for CNS treatment, covering numerous structural variants.
- Its claims encompass compounds, synthesis methods, and pharmaceutical use.
- The patent landscape includes related patents with narrower scope, primarily controlling specific derivatives and treatment methods.
- The patent expired around 2014, reducing barriers for generics but leaving limitations for any remaining proprietary formulations.
FAQs
1. Can similar compounds be developed after the patent expiry?
Yes, post-expiry, generic manufacturers can produce bioequivalent drugs, provided they do not infringe on newer patents covering specific derivatives or formulations.
2. Are all compounds within the patent’s scope automatically licensed?
No, licensing depends on agreements with patent holders and whether the compounds or uses infringe on remaining valid patents.
3. How broad are the claims in the patent?
The primary claims are broad, covering a wide class of benzodiazepine derivatives with specific substitutions, but narrower claims focus on particular stereoisomers and forms.
4. Do related patents extend the effective patent life of these compounds?
Some related patents may protect specific derivatives, formulations, or uses beyond 5,679,376’s expiration date.
5. How does the patent landscape impact drug development?
It influences R&D strategies, licensing negotiations, and entry timing, especially around compounds with similar receptor profiles.
References
[1] Eli Lilly and Company. (1996). US Patent 5,679,376.
[2] European Patent Office. (1997). EP 0885187 B1.
[3] Japan Patent Office. (1998). JP 2686703.
[4] Canadian Intellectual Property Office. (1999). CA 2302093.
[5] IMS Health. (2020). Overview of CNS drug patent landscape.
Note: Exact patent term expiration may vary due to patent term adjustments and maintenance. Confirm via USPTO or relevant patent authority databases.
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