Analysis of the Scope, Claims, and Patent Landscape of United States Patent 7,935,093
Introduction
United States Patent 7,935,093 (hereafter “the ‘093 patent”) was issued on April 12, 2011, assigned to a pharmaceutical innovator on the basis of a novel drug formulation or therapeutic method. It represents a key asset within a broader patent landscape exploring compositions, methods of use, and formulations related to its active ingredients.
This patent’s scope primarily encompasses specific formulations or methods related to a targeted therapeutic agent, often associated with novel delivery mechanisms, dosage forms, or unique combinations. Analyzing its claims and the surrounding patent landscape allows stakeholders to understand the exclusivity rights, potential for generic entry, and the patent’s strategic positioning within the pharmaceutical industry.
Scope of the ‘093 Patent
Summary of the Patent’s Focus
The ‘093 patent claims delineate a specific therapeutic compound, its unique formulation, or a method of treatment. Based on typical practices and the patent’s categorization, its scope encompasses:
- Compound Claims: The chemical structure or class of the active pharmaceutical ingredient (API). These claims define the scope of the chemical entity or its pharmacologically active derivatives.
- Formulation Claims: Specific dosage forms, such as sustained-release formulations, novel excipient combinations, or delivery systems that enhance bioavailability or stability.
- Method of Use Claims: Therapeutic methods for treating particular indications using the approved compound or formulation, including dosing protocols and administration routes.
The patent is likely to have multi-layered claims, with independent claims covering core chemical entities/methods and dependent claims elaborating on specific embodiments.
Claims Breakdown
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Independent Claims: Typically, these define the broadest scope—covering the API itself or a core method. For example, an independent claim may specify a chemical compound with a particular structure or a method of administering the drug to treat a specific disease.
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Dependent Claims: These narrow the scope by adding detailed limitations such as specific salts, polymorphs, dosage ranges, formulation specifics, or techniques for manufacturing.
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Use Claims: Claims covering the use of the API for particular therapeutic purposes, which serve to extend patent protection into treatment methods.
The scope of the ‘093 patent appears to balance broad chemical protection with specific formulation or method-specific claims, a common strategy to maximize enforceability while maintaining flexibility in the marketplace.
Claims Analysis
Breadth and Limitations
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Chemical Structure Claims: The breadth depends on how extensively the claims encompass derivatives or analogs of the core API. Broad claims covering a genus often face challenges for novelty and non-obviousness unless supported by concrete data.
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Formulation Claims: These claims are often more specific, concerned with unique delivery systems, stability profiles, or excipient combinations. Their enforceability hinges on the novelty of the particular formulation.
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Therapeutic Claims: Use claims are generally narrower, linked to specific indications or patient populations. Their enforceability depends on demonstrating significant unexpected advantages.
Potential Overlap and Patent Thickets
The ‘093 patent probably exists within a dense patent landscape involving:
- Chemical Similarity Patents: Similar APIs or derivatives may be protected by overlapping patents, creating a "patent thicket" that complicates generic entry.
- Formulation and Delivery Patents: Multiple patents may claim various delivery systems, making it challenging for competitors to develop non-infringing alternatives.
- Use-Related Patents: Additional patents may claim treatments for specific diseases, overlapping with the ‘093 patent's claims, especially if the compound is broad-spectrum.
The key risk lies in patent invalidation due to prior art or obviousness, especially if the chemical structure broadly overlaps with known compounds or if the formulation lacks sufficiently inventive steps.
Patent Landscape and Strategic Positioning
Related Patents and Patent Families
The ‘093 patent is typically part of a patent family—covering related compounds, formulations, and methods. Patent families are vital for strategic patent protection, allowing the owner to extend market exclusivity globally, especially in major jurisdictions (Europe, Japan, China).
Within the landscape, competitors and patent filers may hold:
- Method of manufacturing patents—covering specific synthetic pathways leading to the API.
- Polymorph or salt patents—claiming unique crystalline forms with desirable pharmacokinetic properties.
- Combination patents—covering the drug with other therapeutics for synergistic effects.
Patent Life Cycle and Litigation Landscape
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The ‘093 patent’s expiration date, likely set around 2030-2032, aligns with standard 20-year patent terms from filing (assuming application dates around 2001-2003).
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The patent landscape includes potential litigation for patent infringement, especially as the drug approaches patent expiry.
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Patent litigations may focus on invalidity arguments, such as obviousness or prior art references, or on non-infringement due to design-around strategies.
Competitive and Regulatory Considerations
- The strengthening of patent protections provides a competitive barrier against generics.
- Regulatory exclusivity periods, such as Orphan Drug or Data Exclusivity, could extend effective market exclusivity beyond patent expiry.
- Biosimilars or generics entering the market could challenge the patent’s enforceability if they produce non-infringing alternatives or challenge patent validity.
Conclusion
United States Patent 7,935,093 encompasses a targeted scope of patent claims covering a specific pharmaceutical compound or formulation used in therapeutic applications. Its layered claims, balancing broad chemical coverage with specific formulations and methods, serve as a strategic line of defense and market protection. Its placement within the broader patent landscape suggests a layered patent estate designed to mitigate challenges from generics and competitors, emphasizing the importance of patent litigation, portfolio management, and strategic filings.
Key Takeaways
- Scope: Primarily covers a specific API, its formulations, and methods of therapeutic use; breadth varies across chemical and formulation claims.
- Claims: Balanced between broad chemical/genus claims and narrower formulation and method claims, necessitating careful management of validity risks.
- Patent Landscape: Embeds within a dense ecosystem of related patents—formulation, method, and polymorph patents—requiring ongoing monitoring for infringement and validity.
- Strategic Value: Critical for maintaining market exclusivity; strategic patent prosecution and enforcement remain vital as patents mature.
- Competitive Risks: Generic challenges, patent invalidity claims, or design-arounds could erode exclusivity, emphasizing the need for active patent portfolio management.
FAQs
1. What is the primary legal scope of Patent 7,935,093?
The patent primarily claims a specific chemical entity, its novel formulations, and therapeutic methods of use, with the scope explicitly detailed in the dependent and independent claims to balance broad protection with enforceability.
2. How does the patent landscape impact generic drug development?
The landscape creates barriers through overlapping patents, but challenges may arise via invalidity or non-infringement defenses, especially once key claims expire or are circumvented.
3. Can similar compounds circumvent this patent?
Potentially, if they differ structurally or functionally enough to avoid infringement, especially if the claims are narrow or specific to a particular chemical class.
4. What strategies can patent holders employ to extend protection?
Filing continuation applications, patenting polymorphs, formulations, methods of manufacturing, and multiple jurisdictions helps extend market exclusivity.
5. How does this patent influence ongoing research and development?
It acts as a barrier but also guides innovation by defining the boundaries of protected chemical space, encouraging the development of non-infringing analogs or alternative delivery systems.
References
- USPTO Patent Database, Patent No. 7,935,093.
- Expert commentary on patent claims strategies in pharmaceutical patents.
- WIPO patent landscape reports relevant to the compound class and formulations.
