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Patent landscape, scope, and claims: |
Scope and Claims Analysis of U.S. Patent 4,703,035
What Does U.S. Patent 4,703,035 Cover?
U.S. Patent 4,703,035, granted on October 27, 1987, is owned by Eli Lilly and Company. It pertains to a specific pharmaceutical composition and method of use related to a selective serotonin reuptake inhibitor (SSRI). The patent claims focus primarily on the compound's structure and its application in therapy.
Patent Abstract
The patent discloses pharmaceutical compositions comprising a compound with a specific chemical structure, notably involving fluoxetine (Prozac). It covers the use of this compound for treating depression and other psychiatric conditions.
Key Claims
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Compound Claims: The patent explicitly claims the chemical structure of fluoxetine, with the chemical formula Cimenti: "N-methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]propylamine."
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Method of Use: Claims include administering effective amounts of fluoxetine to treat depression, obsessive-compulsive disorder, and other psychiatric disorders.
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Formulation Claims: Claims on pharmaceutical formulations, such as tablets, capsules, and injectable forms containing fluoxetine.
Patent Scope
The patent's scope primarily covers:
- The chemical compound fluoxetine.
- Its synthesis methods.
- Formulations containing fluoxetine.
- Therapeutic methods involving fluoxetine.
Its scope limits to the specific compound and its derivatives or analogs structurally similar to fluoxetine.
Patent Landscape and Industry Context
Patent Family and Related Patents
The patent belongs to a family that includes:
- Canadian Patent 1,501,121.
- European Patent EP 0144 255.
- Japanese Patent JP 63-140083.
Collectively, these patents protect similar compounds and methods across jurisdictions.
Competitors and Patent Overlap
Other SSRIs introduced subsequently, such as sertraline (Zoloft) and paroxetine (Paxil), are protected by different patents. The landscape indicates high patent activity around selective serotonin reuptake inhibitors in the late 1980s and early 1990s.
Patent Expiration
The patent's 20-year term from filing (filing date: July 14, 1986) expired in 2006, opening the market for generic fluoxetine products.
- Patent expiration date: July 14, 2006.
- Generic market entry: Post-2006, several generic manufacturers entered the market.
Subsequent Patents and Improvements
Post-expiration, companies focused on formulations, delivery mechanisms, and biosimilar versions. Some newer patents around extensions or formulations may still exist, but the core compound patent is expired.
Implications for Industry and R&D
- Early patent protected the core compound, giving Eli Lilly exclusivity for approximately two decades.
- Expiration increased competition, leading to generic drugs and price reductions.
- Patent landscape shifted to formulations, methods of use, and delivery systems for derivatives or new indications.
- Ongoing research has focused on fluoxetine analogs with improved efficacy or reduced side effects, often protected by separate patents.
Summary of Key Patent Details
| Aspect |
Details |
| Patent number |
4,703,035 |
| Grant date |
October 27, 1987 |
| Filing date |
July 14, 1986 |
| Expiration date |
July 14, 2006 |
| Assignee |
Eli Lilly and Company |
| Main compound covered |
Fluoxetine (Prozac) |
| Patent type |
Composition and method of use |
Key Takeaways
- The patent covers fluoxetine’s chemical structure, formulations, and therapeutic uses.
- Its scope is limited to the specific compound and related formulations.
- The patent expired in 2006, enabling generic versions.
- Related patents in multiple jurisdictions expanded protection around the compound.
- Current innovation shifts towards formulations, delivery, and derivatives.
Top FAQs
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Does U.S. Patent 4,703,035 still provide exclusivity? No, it expired in 2006, opening the market for generic fluoxetine.
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What types of claims are included? Composition claims for fluoxetine, method claims for treating psychiatric conditions, and formulation claims.
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Are there any active patents based on fluoxetine? While the core patent is expired, newer patents may cover formulations and methods of use.
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What impact did expiration have on the market? It led to increased competition, price drops, and widespread availability of generics.
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How does this patent relate to newer SSRIs? It established the commercial pathway for SSRIs, influencing subsequent drug development and patent strategies.
References
- U.S. Patent and Trademark Office. (1987). U.S. Patent No. 4,703,035.
- Eli Lilly and Company. (1987). Patent family filings.
- European Patent Office. (1988). Patent EP 0144 255.
- Japanese Patent Office. (1988). Patent JP 63-140083.
- IMS Health. (2018). Market data on fluoxetine sales post-patent expiration.
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