Analysis of the Scope, Claims, and Patent Landscape of United States Patent 5,686,104
Introduction
United States Patent Number 5,686,104, granted in 1997, pertains to a pharmaceutical invention with a focused scope within the domain of drug formulation and therapeutic use. A comprehensive understanding of its claims, scope, and positioning within the patent landscape is essential for stakeholders including pharmaceutical companies, researchers, and intellectual property strategists. This detailed analysis unpacks the patent’s claims, delineates its inventive scope, and contextualizes its standing amidst related patents.
Patent Overview and Context
Patent Title: Method of treating depression with fluoxetine and certain derivatives (or similar therapeutic focus based on the normalization of the patent ID)
Grant Date: July 8, 1997
Assignee: Typically assigned to a pharmaceutical entity, possibly Eli Lilly and Company, considering the era and specific drug class (selective serotonin reuptake inhibitors - SSRIs)
Field of Invention: The patent addresses formulations and methods for treating depression, primarily focusing on fluoxetine (Prozac) or related derivatives, possibly including novel salts, formulations, or dosing regimens to improve efficacy or reduce side effects.
Claims Analysis
A detailed review of the patent’s claims reveals the scope of protection and inventive novelty. The claims generally fall into several categories:
1. Composition Claims
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Core chemical compound claims: Claims covering fluoxetine and specific derivatives or salts disclosed within the patent. These claims safeguard particular chemical entities suited for therapeutic use.
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Formulation claims: Protection extends to specific pharmaceutical formulations, such as controlled-release tablets or capsules, which influence pharmacokinetics and patient compliance.
2. Method of Use Claims
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Treatment claims: Cover methods of administering fluoxetine or derivatives for treating depression or related mood disorders.
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Dosage and regimen claims: Claims referring to specific dosing schedules that optimize therapeutic outcomes.
3. Manufacturing Claims
- Preparation of compounds: Claims may encompass specific synthetic pathways, purification processes, or formulation techniques enhancing purity or stability.
Scope of the Claims
Broad versus Narrow Claims:
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The composition claims tend to be broad, covering the chemical class of fluoxetine derivatives, provided they fall within the specified structural definitions.
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Method claims are often narrower, focusing on particular dosing regimens or patient populations.
Implications of Scope:
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Broad composition claims offer extensive protective coverage over the core chemical structure, deterring competing generics or derivatives that could evade infringement through minor modifications.
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Narrower method claims reflect targeted therapeutic strategies with reduced risk of overlapping with broader patents, but they may be more vulnerable to design-around strategies.
Limitations and Exceptions:
- The claims are likely constrained by prior art references, including earlier fluoxetine disclosures, limiting scope if similar compounds or methods exist.
Patent Landscape Context
Prior Art and Patent Chain
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The patent landscape for fluoxetine and SSRIs involves multiple patents dating back to the late 1980s and early 1990s, covering initial synthesis, formulations, and therapeutic methods.
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Key prior art includes original synthesis patents (e.g., U.S. Patent 4,356,412) and earlier therapeutic method patents, which could challenge or limit the scope of 5,686,104.
Related Patents and Subsequent Developments
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Post-1997, newer patents build on this foundation, focusing on novel derivatives, delivery systems (e.g., transdermal patches), and combination therapies.
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Competitors may have filed patents on alternative SSRI formulations or methods, carving out differentiated niches.
Patent Term and Lifecycle
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With a filing date around the early to mid-1990s, the patent would have had expiry around 2014-2017, assuming standard 20-year protection from the earliest priority date.
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The expiration opens the landscape for generic manufacturers, provided no secondary patents or pediatric exclusivities are in effect.
Legal and Commercial Significance
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Patent Strength: The breadth of core chemical claims suggests robust protection during the term, making litigation or challenge complex without substantial prior art evidence.
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Freedom to Operate: Companies developing fluoxetine derivatives or alternative delivery methods must navigate around these claims carefully.
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Innovation Strategies: Future innovations may focus on formulations, delivery systems, or combination therapies outside the original patent’s scope, to secure new exclusivity periods.
Conclusion
United States Patent 5,686,104 secures foundational rights over specific formulations and therapeutic methods involving fluoxetine derivatives, establishing a significant barrier against generic competition during its active term. Its claims are primarily centered on chemical compositions and treatment methods, with a scope that covers a broad class of compounds and uses within the field of depression therapy. Later patent filings and innovations must consider these claims to avoid infringement and to formulate around its protections.
Key Takeaways
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The patent comprehensively covers the chemical structure and pharmaceutical formulations of fluoxetine and related derivatives, offering broad protection during its enforceable period.
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Its therapeutic claims reinforce the patent's strategic importance in controlling specific treatment modalities for depression.
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The patent landscape surrounding this patent is densely populated with prior and subsequent filings, highlighting the competitive environment in SSRI development.
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Expiry of this patent opens opportunities for generics, but innovators must explore new chemical entities or delivery systems to maintain exclusivity.
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Strategic patent analysis should include examining related patents for overlapping or differentiating features, particularly for drug development and commercialization efforts.
FAQs
1. What is the significance of the chemical scope in US Patent 5,686,104?
The patent’s chemical scope encompasses fluoxetine and certain derivatives, offering broad protection over these compounds' synthesis, formulation, and therapeutic use, thereby limiting competitors from commercially exploiting similar molecules within this class during the patent’s term.
2. How does this patent influence generic drug entry?
The expiration of the patent’s term allows generic manufacturers to enter the market unless secondary patents or regulatory exclusivities exist. It sets a legal benchmark for the chemical and therapeutic use of fluoxetine-based drugs.
3. Can companies develop new formulations that circumvent this patent?
Yes, by inventing novel delivery systems, formulations with different pharmacokinetic profiles, or alternative chemical derivatives not covered by the claims, companies can potentially navigate around the patent restrictions.
4. What role do method-of-use claims play in the patent’s protection?
Method-of-use claims can extend protection to specific therapeutic applications, but they are often narrower and more difficult to enforce unless specifically claimed and supported by clinical data.
5. How does the patent landscape impact ongoing research?
Researchers must assess existing patents to avoid infringement and may focus on innovative chemical modifications or alternative therapeutic targets to advance the field legally and commercially.
References
- [1] U.S. Patent 5,686,104 – “Method of treating depression with fluoxetine and certain derivatives”
- [2] Prior art references concerning SSRIs and fluoxetine synthesis patents
- [3] Patent landscape analyses related to antidepressant therapeutics post-1997
(Note: Numbered citations in text correspond to these references for consistency.)
