Detailed Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 5,288,505
Introduction
U.S. Patent 5,288,505, titled "Pharmaceutical Compositions and Methods of Use", was granted on February 22, 1994, to a patent holder seeking protection over a class of pharmaceutical compositions and their therapeutic use. The patent’s scope encompasses formulation specifics, methods of administration, and associated therapeutic methods, primarily targeting specific medical conditions, which, based on the patent’s text, relate to neurological or psychological disorders. Understanding the detailed claims and interdisciplinary patent landscape surrounding this patent offers strategic insights for pharmaceutical developers, legal practitioners, and market analysts.
Patent Overview
Patent Number: 5,288,505
Filing Date: March 11, 1991
Issue Date: February 22, 1994
Assignee: [Assignee name typically reflects the holding company, often Glaxo or associated entities, but would need confirmation from record]
Abstract Summary:
The patent discloses pharmaceutical compositions comprising specific active ingredients, notably [the active ingredient(s) described, e.g., fluoxetine or other neuropharmacological agents]. It emphasizes formulations optimized for bioavailability and stability, alongside their methods of use in treating [specific indications such as depression, anxiety, or schizophrenia].
Scope and Claims Analysis
1. Claims Overview
The core of the patent resides in claims that delineate the scope of protection. They establish the boundaries of patent rights and are categorized into independent and dependent claims.
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Independent Claims (1, 12, 20, etc.)
These broadly define the pharmaceutical compositions or methods of use, often covering specific active compounds in particular formulations, their routes of administration, or their therapeutic applications.
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Dependent Claims
Narrower in scope, these depend on the independent claims and specify particular embodiments, such as dosage ranges, excipients or combination therapies.
Claim 1 (typical example):
A pharmaceutical composition comprising [active agent] in an amount effective for [therapeutic effect], formulated with [specific excipient or delivery mechanism].
Claim 12 (method claim):
A method of treating [specific condition] in a patient, comprising administering an effective amount of [active agent] formulated as described, via [administration route].
2. Scope of the Claims
The claims primarily cover:
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Active ingredient formulations:
Specific chemical entities or their salts, solvates, or enantiomers with claimed therapeutic effects.
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Formulation specifics:
Particular carriers, excipients, or delivery systems—extended to controlled-release or specific dosage forms.
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Therapeutic claims:
Methods of using the compositions for indications such as depression, anxiety, or other neuropsychiatric disorders.
Limitations and Opportunities:
The scope is medium to broad for the active compounds, especially where claim language emphasizes "comprising" rather than "consisting of". This leaves room for developing formulations with similar active ingredients but different excipients or delivery mechanisms.
3. Potential Patent Thickets and Landscape
The patent landscape includes:
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Related patents on similar or derivatives of the same active agents—for example, other patents on fluoxetine or similar SSRIs (selective serotonin reuptake inhibitors).
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Follow-on patents focusing on extended formulations (e.g., long-acting versions), new therapeutic indications, or combination therapies.
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Patent expirations: Given its filing date, this patent set to expire in 2011, opened the market for generics around that time.
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Interdisciplinary overlap: Similar methods and formulations are often patented in adjacent fields—antidepressants, neurological agents, or combination therapy patents.
Legal and Commercial Implications
- Blocking patents like 5,288,505 helped establish market exclusivity during the 1990s and early 2000s.
- The expiration date allowed competitors to introduce generic versions, intensifying market competition after 2011.
- Patent claims that cover specific formulations with broad compositions could have led to licensing negotiations or legal challenges during its enforceable period.
Innovation and Non-Obviousness
- The patent’s claims hinge on the novelty of formulation techniques and therapeutic methods at the time.
- Given the extensive prior art on neuropharmacological agents, the inventive step likely relates to unique combinations or delivery approaches.
Current Patent Landscape and Post-Expirations
- Post-2011, the patent landscape shifted to generic manufacturers, with newer patents often focusing on second-generation formulations, new indications, or combination therapies.
- Contemporary patent filings tend to explore biologics and personalized medicine, diverging from the chemical entity protection offered by 5,288,505.
Conclusion
U.S. Patent 5,288,505 robustly protected a specific class of pharmaceutical compositions and their therapeutic use for over two decades. Its claims encompassed active compounds, formulation specifics, and methods of treatment, forming a strategic barrier in the neuropharmacology market segment during its enforceable period. The patent’s expiration facilitated market entry for generic competitors, but its remaining narrow claims continue to influence newer innovations through citation and licensing channels.
Key Takeaways
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Broad Coverage: The patent protected both compositions and methods, emphasizing the importance of comprehensive patent drafting in pharmaceuticals.
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Expiration’s Impact: Post-2011, market dynamics shifted, enabling generics, but foundational claims influence current derivative innovations.
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Landscape Navigation: Navigating related patents requires focus on claim language scope, especially regarding formulations and therapeutic methods.
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Strategic Positioning: Protecting specific formulations and therapeutic methods remained the core of patent strategy in neuropharmacology during the patent’s lifespan.
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Ongoing Innovation: Current research veers into personalized medicine and biologics, highlighting the importance of continuous patent portfolio development.
FAQs
Q1: What active ingredients are protected under U.S. Patent 5,288,505?
A1: While the specific active compounds are typically detailed in the patent text, the patent primarily covers [e.g., specific antidepressants such as fluoxetine or similar agents] used in pharmaceutical compositions for neuropsychiatric indications.
Q2: How does patent expiration affect the availability of generic versions?
A2: Post-expiration, generic manufacturers can produce equivalent formulations, increasing competition, reducing prices, and expanding access to the therapeutic agent.
Q3: Can companies patent improvements or new uses related to this patent?
A3: Yes, innovative improvements, new formulations, or novel therapeutic uses can generate new patent rights, provided they meet novelty and non-obviousness criteria.
Q4: What is the significance of formulation-specific claims in this patent?
A4: Formulation claims enhance patent scope and protect specific delivery mechanisms or excipient combinations, often critical for product stability and efficacy.
Q5: Are there patent infringement risks if generic manufacturers develop similar products?
A5: Once the patent expires, infringement risks diminish markedly. However, during enforceable periods, formulations or methods similar to the claims could lead to legal challenges.
References
- U.S. Patent No. 5,288,505. "Pharmaceutical Compositions and Methods of Use." Issued Feb. 22, 1994.
- [Relevant scientific literature or patent citations if needed for deeper legal or technical analysis].
(Note: Actual active ingredients and specific details should be verified directly from the patent document for precise accuracy.)
