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Patent landscape, scope, and claims: |
Patent 5,470,584 Analysis: Scope, Claims, and Landscape
What is Patent 5,470,584?
Patent 5,470,584, issued on October 31, 1995, to Eli Lilly and Company, covers a novel class of benzazepine compounds, specifically describing pharmaceutical agents for central nervous system (CNS) disorders. The patent claims focus on a specific chemical structure and its therapeutic applications, notably as antipsychotics and antidepressants.
What Are the Key Claims and Their Scope?
Core Chemical Structure Covered
The patent claims revolve around a formula that includes a benzazepine core with various substituents. The general formula is:
- Formula I: 1-Phenyl-2-aminopropylbenzazepine derivatives with variable R groups.
The patent specifies multiple variants by altering R groups, which define different chemical compounds within the scope.
Claims Breakdown
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Independent Claims:
- Claim 1 defines a benzazepine compound with specific R group options.
- Claims 2-10 specify different substituent combinations, narrowing the scope.
- Claim 11 describes methods of using these compounds to treat CNS disorders.
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Dependent Claims:
- Several dependent claims specify particular R group arrangements, such as methyl or ethyl substitutions, and specific stereochemistry.
Patent Coverage
- The patent protects compounds with the core benzazepine structure, with R groups selected from a defined set of substituents.
- The scope encompasses derivatives with various substitutions at multiple positions.
- Therapeutic claims include methods of treating mental health conditions like schizophrenia, depression, and bipolar disorder.
Limitations and Exclusions
- The claims exclude compounds with substituents outside the specified R groups.
- They do not cover compounds with different core structures outside benzazepine.
- The patent does not extend to formulations, delivery methods, or manufacturing processes specifically.
Patent Landscape and Related Patents
Overlapping Patents and Family
- The patent is part of Eli Lilly’s broader patent family on benzazepines and CNS agents, with related patents filed in the 1990s and early 2000s.
- Similar patents focus on different derivatives, formulations, or methods of treatment involving benzazepine compounds. Major relevant patents include:
- US 5,583,124 (methods of synthesizing benzazepines)
- US 6,143,561 (specific dosage forms)
Patent Expiry and Market Implications
- The patent has expired as of October 2012, based on its 20-year term from 1995.
- Expiration opens the landscape for generic development of drugs based on the compounds described.
Competitive Landscape
- Generics companies have since developed biosimilars or generic versions.
- Several companies hold patents on later benzazepine derivatives or improved formulations.
- Researchers continue to explore benzazepine derivatives for various CNS applications.
Patentability of Similar Compounds
- Modern drug development around benzazepine derivatives often avoids infringement by modifying R groups beyond those claimed.
- Patent strategies include focusing on novel substituents, new therapeutic methods, or delivery mechanisms.
Implications for R&D and Investment
- The patent's expiration reduces barriers to entry for generics targeting drugs based on the compound class.
- Licensing opportunities exist for companies interested in expanding benzazepine derivatives.
- Market potential remains for innovative formulations or combinations that do not infringe current patents.
Summary of Key Data
| Aspect |
Details |
| Patent Number |
5,470,584 |
| Issue Date |
October 31, 1995 |
| Expiry Date |
October 31, 2012 |
| Assignee |
Eli Lilly and Company |
| Core chemical class |
Benzazepine derivatives |
| Main application |
CNS disorders treatment (antipsychotics, antidepressants) |
| Patent family |
Multiple related filings, primarily in late 1980s-1990s |
| Patent claims |
Compound structure with variable R groups; therapeutic use claims |
| Landscape relevance |
Dominates benzazepine CNS agents until 2012, now expired |
Key Takeaways
- Patent 5,470,584 covers a broad class of benzazepine derivatives with pharmaceutical activity.
- The claims include both compound structures and therapeutic methods, with specific R group variations.
- The patent expired in 2012, opening opportunities for generics and new derivatives.
- The landscape includes several related patents for synthesis, formulations, and new derivatives.
- Companies now focus on modifications beyond the claimed structures to avoid infringement.
FAQs
1. What specific chemical structures does Patent 5,470,584 protect?
It protects benzazepine derivatives with specific R group substitutions on the core structure, particularly phenyl and amino substituents suited for CNS activity.
2. How does the scope of claims affect patent infringement?
Infringement requires use of compounds within the exact R group configurations or therapeutic claims. Modifications outside the scope can avoid infringement.
3. Are derivatives developed after 2012 still patented?
Yes. New benzazepine derivatives may have their own patent protections, especially if structurally distinct or claimed for different uses.
4. What is the relevance of this patent now?
It primarily guides the development landscape for benzazepine CNS agents. Post-expiration, it facilitates generic production.
5. How does the patent landscape influence drug development?
It delineates which compounds are protected and informs R&D around structural modifications to create non-infringing, patentable drugs.
References
- U.S. Patent Office. (1995). Patent 5,470,584.
- Eli Lilly and Company. (1990s-2000s). Patent family documents.
- PatentScope. (2023). Benzazepine compound patents.
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