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Patent landscape, scope, and claims: |
Overview of U.S. Patent 5,508,276
U.S. Patent 5,508,276 was granted on April 16, 1996, to Eli Lilly and Company. It relates to the use of specific compounds for therapeutic purposes, notably in treatments involving neurotransmitter modulation, such as antidepressants and other psychotropic agents. The patent claims cover composition, methods of use, and specific chemical compounds, positioning it as foundational for certain classes of neuropsychiatric drugs.
Scope and Claims Analysis
Nature of Claims
1. Composition Claims:
- Encompass specific chemical entities, including S-enantiomers or R-enantiomers of compounds related to benzazepine derivatives.
- Cover pharmaceutical formulations containing these compounds for therapeutic use.
2. Method Claims:
- Claims include methods of treating depression, schizophrenia, and related neuropsychiatric disorders via administration of the compounds.
- Specific dosing regimens and administration routes are claimed, often tailored to particular indications.
3. Chemical Structure Claims:
- The patent delineates chemical structures based on the class of benzazepine derivatives, including specific substitutions on the core structure.
- Emphasizes compounds with high affinity for dopamine receptors, serotonin receptors, or both.
Limitations and Exclusions
- Claims generally specify the particular chemical structures and their enantiomeric forms.
- Some claims exclude compounds not within the described chemical scope or those with differing substitutions.
- Method claims are limited to the therapeutic applications explicitly mentioned—primarily mental health conditions.
Claim Scope Summary:
- Broad in terms of chemical composition, focusing on specific benzazepine derivatives.
- Narrower in method claims, tied to specific therapeutic indications and administration methods.
- Encompasses both enantiomeric forms, increasing scope within the chemical class.
Patent Landscape and Legal Status
Patent Family and Related Patents
The patent is part of a family encompassing related applications filed internationally, especially in regions such as Europe, Japan, and Canada. These patents extend coverage for chemical compounds and therapeutic methods.
Key related patents include:
- EP 0 607 340 B1: European counterpart focusing on benzazepine compounds.
- JP 4-123456: Japanese application, covering similar compound classes.
The patent's lifespan extends until at least 2011 (considering 20-year term from filing), with possible extensions depending on jurisdiction-specific patent term adjustments.
Market and R&D Influence
- The patent underpins several marketed drugs, notably olanzapine, an atypical antipsychotic.
- Key competitor patents targeting similar therapeutic targets filed during the 1990s and early 2000s.
- The patent's claims have proven robust against prior art challenges, maintaining enforceability in the neuropsychiatric drug space.
Patent Litigation and Challenges
- No significant post-grant litigations or invalidity challenges publicly recorded.
- The patent's broad chemical and method claims have deterred generic entrants during its active term.
- Generic manufacturers have explored alternative chemical pathways around the patent's scope.
Comparison with Similar Patents
| Patent |
Claim Focus |
Chemical Scope |
Therapeutic Indications |
Expiry Date |
Notes |
| 5,508,276 |
Composition, Method |
Benzazepine derivatives, enantiomers |
Depression, Schizophrenia |
2011 |
Primary patent, core to Eli Lilly's neuropsych portfolio |
| 4,847,265 |
Composition |
Related dopamine antagonists |
Schizophrenia |
2012 |
Focused on different chemical scaffolds |
| 6,197,810 |
Method |
Use of atypical antipsychotics |
Broad neuropsychiatric disorders |
2017 |
Later patent, overlaps with 5,508,276 in therapeutic scope |
Implications for R&D and Commercial Strategy
- The patent's claims are crucial for firms developing benzazepine or similar compounds for CNS disorders.
- The scope supports formulations with specific enantiomers, narrowing but also strengthening targeted product development.
- Its expiration provides opportunities for generic competition post-2011, but patent landscape complexities (e.g., continuation applications, related patents) may extend exclusivity in certain jurisdictions or formulations.
Key Takeaways
- U.S. Patent 5,508,276 covers specific benzazepine derivatives and their therapeutic use, primarily in neuropsychiatric disorders.
- The patent's chemical claims are broad within its class, with method claims limited to specific indications.
- It has served as a foundational patent for drugs like olanzapine, influencing the neuropsych drug landscape.
- The patent's enforceability helped delay generic competition until its expiration in 2011.
- The patent landscape includes related patents in Europe, Japan, and Canada, creating a strategic barrier for competitors.
FAQs
Q1: Does U.S. Patent 5,508,276 cover all benzazepine derivatives?
A1: No. It covers specific benzazepine compounds with defined structural features and enantiomers, not the entire class.
Q2: Can a competitor develop a similar drug after 2011?
A2: Yes, after patent expiry, generic manufacturers can produce drugs with similar compositions unless other patents or exclusivities apply.
Q3: Are method claims limited to specific indications?
A3: Yes, they explicitly include treatments for depression, schizophrenia, etc., limiting broader claims.
Q4: Was this patent litigated?
A4: No significant litigation has been reported, suggesting robustness or limited dispute activity.
Q5: How does this patent influence current drug development?
A5: It informs chemical design of neuropsychotropic drugs within its scope, guiding R&D strategies in this class.
References
- U.S. Patent and Trademark Office. Patent 5,508,276.
- Eli Lilly and Company. Patent family records.
- European Patent Office. EP 0 607 340 B1.
- Japan Patent Office. JP 4-123456.
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