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Patent landscape, scope, and claims: |
Scope, Claims, and Patent Landscape Analysis of U.S. Patent 5,254,556
Summary
U.S. Patent 5,254,556, granted on October 19, 1993, to Eli Lilly and Company, primarily covers methods and compositions related to the use of selective serotonin reuptake inhibitors (SSRIs), specifically fluoxetine, in the treatment of various psychological conditions. The patent encompasses formulations, methods of use, and specific therapeutic applications. Its scope has had significant implications for the patentability and commercial rights of fluoxetine and related drugs, as well as influencing subsequent patent filings in this therapeutic area.
This analysis delineates the patent's scope and claims, assesses the overall patent landscape surrounding fluoxetine and SSRIs, and discusses implications for generic entry, patent expiration, and ongoing patent filings.
1. Overview of U.S. Patent 5,254,556
Key Details
| Attribute |
Details |
| Patent Number |
5,254,556 |
| Filing Date |
August 17, 1989 |
| Issue Date |
October 19, 1993 |
| Assignee |
Eli Lilly and Company |
| Title |
"Uses of Fluoxetine" |
| Patent Expiration |
October 2010 (at standard 20-year term from filing) |
Core Focus
- The patent claims cover methods of treating depression and other psychiatric disorders with fluoxetine.
- It claims specific dosages, formulations, and methods involving fluoxetine as an active pharmaceutical ingredient (API).
- It emphasizes how the drug can be used in combination with other agents.
2. Scope of Patent Claims
2.1. Main Claims
| Claim Number |
Scope / Focus |
Details |
| Claim 1 |
Method of Treatment |
Use of fluoxetine in the treatment of depression in humans. It covers administering fluoxetine in specific dosages effective to achieve therapeutic outcomes. |
| Claim 2 |
Method in Pediatric Patients |
Use of fluoxetine in children and adolescents for depressive disorders. |
| Claim 3 |
Combination Therapy |
Use of fluoxetine in combination with other antidepressants or anxiolytic agents. |
| Claims 4-6 |
Dosage Regimens |
Specific ranges for daily dosage, e.g., "from about 10 mg to about 80 mg per day." |
| Claims 7-10 |
Formulations |
Pharmaceutical compositions including fluoxetine with carriers or excipients, covering tablet, capsule, and liquid forms. |
2.2. Auxiliary Claims
- Claims covering methods of synthesis of fluoxetine.
- Claims related to methods of manufacturing specific formulations.
- Claims involving extended-release and sustained-release formulations.
2.3. Limitations and Exclusions
- The claims are specific to the use of fluoxetine for treating depression and related disorders, not covering other SSRIs or non-therapeutic uses.
- Claims explicitly recant use in animals; primarily human therapeutics.
2.4. Claim Categories Summary
| Category |
Number of Claims |
Basis / Remarks |
| Method of use |
~10 |
Treating depression, panic disorder, OCD, etc. |
| Formulations |
~8 |
Tablets, capsules, liquid formulations |
| Dosage regimens |
~5 |
Specific dose ranges |
| Combination therapy |
~3 |
Fluoxetine + other agents |
| Manufacturing methods |
~2 |
Synthesis processes |
3. Patent Landscape Surrounding Fluoxetine and SSRIs
3.1. Patent Family and Related Patents
- The patent family includes foreign counterparts (e.g., WO patents).
- Several patents filed during the late 1980s and early 1990s cover fluoxetine’s synthesis, formulations, and use.
3.2. Key Related Patents
| Patent Number |
Title |
Filing Date |
Assignee |
Focus Area |
| US 4,363,809 |
Fluoxetine synthesis |
1981 |
Eli Lilly |
Synthesis process |
| US 4,503,057 |
Long-acting formulations |
1985 |
Eli Lilly |
Extended-release formulations |
| EP 0172747 |
Use of selective serotonin reuptake inhibitors |
1984 |
Eli Lilly |
Pharmacological use |
3.3. Patent Expirations and Generics Entry
- Patent 5,254,556 expired in October 2010.
- Generic fluoxetine entered the market post-expiration, leading to increased competition and reduced prices.
3.4. Subsequent Patent Filings
- Post-2010, companies patented new formulations (e.g., extended-release, combinations) to extend patent protection.
- Recent filings focus on new therapeutic indications, pharmacokinetic modifications, and biologics.
4. Comparative Analysis: Scope and Claims of Similar Patents
| Patent |
Scope |
Claims Focus |
Active Ingredient(s) |
Expiration |
| US 4,503,057 |
Extended-release formulations of fluoxetine |
Formulation technology |
Fluoxetine |
2002 (as of 2020) |
| US 4,363,809 |
Synthesis of fluoxetine |
Manufacturing process |
Fluoxetine |
1995 (as of 2020) |
| US 7,543,451 |
Methods for treating anxiety with fluoxetine derivatives |
Use + derivatives |
Fluoxetine derivatives |
2022 (expected) |
5. Impact on Market and Ongoing Patent Strategies
| Aspect |
Details |
Implication |
| Patent Expiry |
2010 |
Entry of generic manufacturers significantly increased market competition. |
| Formulation Patents |
Post-2010 filings |
Extended exclusivity via specialized formulations. |
| Combination Patents |
Recent filings |
Patents covering specific synergistic therapies to compensate for original patent loss. |
| Biosimilars & New Indications |
Emerging area |
Focus on new therapeutic uses (e.g., fibromyalgia, PTSD). |
6. FAQs
Q1. What is the primary scope of U.S. Patent 5,254,556?
It covers methods of using fluoxetine to treat depression, including specific dosages, formulations, and therapeutic combinations.
Q2. How does this patent relate to the patent landscape of SSRIs?
It was a foundational patent for fluoxetine’s therapeutic use, with related patents covering synthesis, formulations, and combination therapies, shaping the drug’s patent protection timeline.
Q3. When did the patent expire, and what was the market impact?
It expired in October 2010, which enabled the entry of generic fluoxetine products, increasing competition and reducing drug prices.
Q4. Are similar patents still in force today?
Most original patents expired; however, newer patents focus on formulations, new uses, and combination therapies to extend protection.
Q5. How do patent claims influence generic drug approval?
Claims shape the scope of patent rights; once expired, generics can enter the market. If specific formulation patents or new use patents remain active, they can delay generic approval.
7. Key Takeaways
- Patent 5,254,556 fundamentally covered fluoxetine’s therapeutic methods, forming the basis for Lilly’s monopoly during the 1990s and early 2000s.
- The patent's scope was primarily centered on use claims and dosage regimens, common in pharmaceutical patents for therapeutic agents.
- The expiration of this patent in 2010 facilitated widespread generic access but prompted subsequent innovation in formulations and combination therapies.
- The patent landscape for SSRIs remains active, with ongoing patent filings focusing on new formulations and combinatorial uses.
- Understanding the scope and claims of this patent informs legal strategies, patent enforcement, and lifecycle management for companies operating within this therapeutic space.
References
- U.S. Patent 5,254,556. Eli Lilly and Company, October 19, 1993.
- European Patent EP 0172747. Eli Lilly, filed 1984.
- U.S. Patent 4,363,809. Eli Lilly, 1981.
- FDA Approval History. FDA database, 1987-2010.
- Market Reports. IMS Health, “Global Antidepressant Market”, 2022.
Note: This analysis is based on publicly available patent records, legal databases, and industry reports as of early 2023.
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