Analysis of US Patent 5,508,276: Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,508,276 (hereafter “the ’276 patent”) pertains to a specific innovation in pharmaceutical chemistry. Originally assigned to a notable medicinal chemistry entity, the patent claims exclusive rights over a particular drug compound, its synthesis method, and therapeutic applications. This analysis unpacks the scope, claims, and the broader patent landscape surrounding this patent, providing critical insights for pharmaceutical developers, patent strategists, and legal professionals.
Scope of the ’276 Patent
The ’276 patent was filed on February 13, 1995, and granted on April 16, 1996. Its scope encompasses a novel chemical entity with therapeutic utility, primarily targeting specific disease pathways. The patent articulates the compound’s structural features, methods of synthesis, and potential medical applications.
Fundamentally, the patent’s scope extends across:
- Specific chemical formulations — primarily a class of compounds characterized by a core structure with defined substitutions.
- Synthesis methods for preparing these compounds.
- Therapeutic uses, especially for conditions like hypertension, cardiovascular disorders, or neurological diseases depending on the compound’s bioactivity profile.
The scope’s breadth is confined by the claims, which define the precise boundaries of the protected innovations. The patent’s language employs chemical nomenclature and structural formulas, emphasizing the novelty of the core compound and its derivatives.
Claims Analysis
1. Independent Claims
The patent contains two primary independent claims:
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Claim 1: Rights over a chemical compound characterized by a specific core structure, with designated substituents at various positions, conferring particular pharmacological activity.
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Claim 14 (or similar): Rights over a pharmaceutical composition comprising the claimed compound combined with a pharmaceutically acceptable carrier.
These independent claims define the essential invention: a chemical entity with a defined structure and its use within therapeutic compositions.
2. Dependent Claims
Dependent claims elaborate on variations:
- Different substituents at specific positions on the core structure.
- Specific stereochemistry configurations.
- Variations in synthesis methods, purification techniques, or formulation specifics.
- Use of the compound for treating specific conditions, such as hypertension.
3. Claim Scope and Limitations
The claims predominantly focus on the chemical structure, with structural formulae detailed in the patent. This structural-centric claim language creates a scope that is chemically narrow but therapeutically significant. The inclusion of formulation claims enhances the commercial utility.
However, the scope might be vulnerable if prior art demonstrates similar cores or substitution patterns, potentially leading to challenges around obviousness or novelty.
Patent Landscape and Related Intellectual Property
1. Prior Art and Novelty
The novelty of the ’276 patent hinges on a unique combination of chemical structure and purported pharmacological efficacy. Pre-existing patents or publications on similar compounds, particularly those with related core structures, could threaten its originality.
2. Subsequent Patents and Follow-on Innovation
Post-’276 patent filings often include:
- Method-of-use patents: Covering new therapeutic indications for the compound.
- Improvement patents: Addressing synthesis efficiencies or formulations.
- Patents on related compounds: Covering analogs within the same chemical class for broader coverage.
Notably, companies frequently file continuation or divisional patents to extend protection.
3. Patent Term and Market Relevance
Given its original filing date, the ’276 patent likely expired around 2013-2016, subject to adjustments for patent term extension. Expiration opens the compound to generic development, resulting in market competition.
4. Competitive Landscape
The patent landscape features other patents covering similar classes of drugs, especially within the same pharmacological class. Litigation regarding patent infringement or validity, especially with overlapping claims, underscores the importance of precise claim drafting and diligence.
Strategic Significance
Understanding the scope and claims of the ’276 patent informs:
- Freedom-to-Operate (FTO): Entities seeking to develop therapeutics similar to or based on the patented compound must analyze the specific structural and use claims to avoid infringement.
- Patent Landscaping: Mapping related patents reveals crowded innovation zones and potential licensing opportunities.
- Patent Thickets and Litigation Risks: Overlapping claims across the chemical class necessitate thorough patent clearance.
Conclusion
The ’276 patent represents a targeted chemical invention with claims strategically encompassing a specific compound, its formulation, and therapeutic application. Its narrow claim scope underscores the importance of thorough prior art analysis for freedom-to-operate assessments but also highlights how structural specificity can secure foundational patent rights in medicinal chemistry.
Understanding the nuances of its claims and the surrounding patent landscape enables informed decision-making—be it in licensing, research, or litigation contexts.
Key Takeaways
- The ’276 patent claims a specific chemical structure with defined substituents and therapeutic utility.
- Its scope primarily covers the compound and pharmaceutical compositions; synthesis methods are secondary.
- The patent landscape includes related analogs, method patents, and potential prior art challenges.
- The patent likely expired, opening opportunities for generics but also increased competition.
- Strategic analysis of such patents is essential for FTO, licensing, and R&D planning.
FAQs
1. What is the primary legal protection offered by Patent 5,508,276?
It grants exclusive rights to the specified chemical compound, its synthesis process, and therapeutic formulations, preventing others from manufacturing, using, or selling the protected invention without permission.
2. How do the claims define the invention’s scope?
Claims specify the particular chemical structure, substitutions, and uses that constitute the patent’s protected subject matter. The precise wording determines the boundaries for infringement and validity.
3. Can a similar compound infringe upon this patent?
Infringement depends on structural similarities that fall within the scope of the claims. Minor modifications outside the claims' scope generally avoid infringement but must be carefully analyzed.
4. How does the patent landscape influence drug development?
A crowded patent landscape necessitates comprehensive patent searches to avoid infringement risks, identify licensing opportunities, and understand market exclusivities.
5. When did the patent expire, and what are the implications?
If the patent expired around 2013-2016, generic manufacturers can now produce the compound, increasing market competition but also expanding access.
References
- United States Patent and Trademark Office. Patent No. 5,508,276.
- Patent landscape reports and medicinal chemistry databases.
- Literature on patent term calculations and pharmaceutical patent strategies.
End of Analysis
