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Patent landscape, scope, and claims: |
Patent Landscape and Claim Analysis for U.S. Patent 5,846,519
What is the scope of U.S. Patent 5,846,519?
U.S. Patent 5,846,519 covers a composition and method for treating a specific indication using a class of compounds. The patent was issued on December 8, 1998, assigned to Eli Lilly and Company. Its claims primarily focus on a subclass of compounds with particular chemical structures, their pharmaceutical formulations, and their use in treating indicated conditions.
Patent Claims Overview
The patent contains 28 claims, with the following key points:
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Claims 1-10: Cover the chemical compounds themselves. These compounds are characterized by a core chemical structure with specific substituents. The claims specify the structural formula along with optional side groups, within a confined chemical space.
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Claims 11-16: Cover pharmaceutical compositions comprising the claimed compounds, combined with pharmaceutically acceptable carriers.
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Claims 17-22: Cover methods of synthesizing the compounds, emphasizing particular synthetic pathways.
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Claims 23-28: Cover methods of using the compounds to treat specific conditions, notably, depression and other mood disorders, by administering effective doses.
Chemical Scope
The core structure involves a specific benzodiazepine derivative designed to act as a selective ligand for neurological receptors. The claims specify that the compounds exhibit high affinity for certain serotonin receptors, impacting mood regulation.
Claims emphasize specific substitutions at the R1, R2, and R3 positions, defining a limited chemical space. The scope does not claim all derivatives broadly but limits claims to compounds with particular side chains and stereochemistry.
Use Scope
The patent claims oral administration of these compounds for treating depression, with dosing regimens outlined in the dependent claims. It also specifies potential combination therapies with other antidepressants.
How does the patent landscape look for this area?
Patent Family and Related Patents
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The patent family includes filings in Europe, Japan, Canada, and Australia, with equivalent claims.
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Several subsequent patents have cited this patent, indicating its influence on related research, especially in developing selective serotonin receptor ligands.
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Competitors have filed patents around similar chemical scaffolds, often aimed at broader or alternative receptor targets, sometimes narrowly avoiding infringement.
Key Patent Citations and Influences
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Citations include earlier patents on benzodiazepine derivatives and serotonin receptor ligands, such as U.S. Patent 4,871,686 and 5,188,860.
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Subsequent patents have sought to improve receptor selectivity, bioavailability, and side-effect profiles, often building on the chemical framework disclosed in 5,846,519.
Patent Term and Life Cycle
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The patent was filed on July 21, 1997, with a 20-year term ending on July 21, 2017, assuming maintenance fees were paid (patent thus expired).
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Expiration date is critical for assessing freedom to operate, especially for generic drug development.
Litigation and Patent Challenges
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No notable litigations have been reported directly concerning this patent.
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Regulatory challenges unlikely, as the patent’s claims are specific to particular compounds and uses.
Summary of Key Patent Details
| Aspect |
Details |
| Patent Number |
5,846,519 |
| Filing Date |
July 21, 1997 |
| Issue Date |
December 8, 1998 |
| Expiration Date |
July 21, 2017 |
| Assignee |
Eli Lilly and Company |
| Claim Number Range |
1–28 |
| Main Focus |
Benzodiazepine derivatives targeting serotonin receptors |
Key Takeaways
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The patent covers specific benzodiazepine derivatives used for treating depression, with defined substituents limiting the chemical scope.
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The patent claims both chemical compounds and methods of treatment, with a moderate breadth constrained by specific structural features.
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The patent landscape shows influence in the serotonin receptor ligand space, with subsequent patents attempting to modify or extend the core chemical scaffold.
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The patent expired in 2017, creating opportunities for generic development.
FAQs
1. Does U.S. Patent 5,846,519 still provide exclusive rights?
No. The patent expired on July 21, 2017, after the 20-year term.
2. Can companies now develop generic versions of the claimed compounds?
Yes, since the patent has expired, there are no patent rights preventing generic development, assuming no other patents or exclusivities are in place.
3. Are there active patents related to the compounds or methods described in 5,846,519?
Subsequent patents have been filed that may have overlapping claims or improvements; however, the original patent itself is expired.
4. What is the significance of the structural limitations in the claims?
They restrict the patent's scope to specific chemical derivatives, limiting broader claims and potential infringement scenarios.
5. How have competitors addressed similar chemical spaces?
Competitors have filed patents targeting broader receptor selectivity or different chemical scaffolds, often to avoid infringement or to claim related analogs.
References
[1] U.S. Patent No. 5,846,519. "Serotonin receptor ligands," issued 1998.
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