Analysis of Scope, Claims, and Patent Landscape for U.S. Patent 5,091,190
Introduction
U.S. Patent 5,091,190, issued on February 25, 1992, belongs to the realm of pharmaceutical innovations. Its patent rights revolve around a specific drug formulation or method, providing exclusivity and market control to the patent holder. For stakeholders in the pharmaceutical industry—research firms, generics manufacturers, and legal entities—comprehending its scope, claims, and position within the patent landscape is vital for strategic planning, infringement analysis, and potential licensing.
Patent Overview and Background
Patent Title: Likely related to a novel drug compound or formulation, as indicated by its filing context in the early 1990s. The patent's foundational technology pertains to a specific medicinally active compound or method of use, with claims designed to encompass the broadest possible protection around the core invention.
Filing Date & Priority: Filed in the late 1980s, establishing priority for innovations during this period, which was characterized by pharmaceutical innovation driven by biochemical research.
Legal Status & Term: Expired or still in force, depending on maintenance fee payments; this affects its relevance to current market competition.
Scope and Content of the Patent
Scope: The patent's scope centers on a specific chemical entity or class of compounds used for treating particular medical conditions. Its claims are designed to cover:
- The compound itself, including its chemical structure.
- Methods of synthesis.
- Therapeutic methods involving the compound.
- Pharmaceutical compositions comprising the compound.
Claims Analysis:
Though the exact wording varies, typical claims within such patents generally cover:
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Compound Claims: Broad claims on the chemical structure, possibly including salts, esters, and derivatives.
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Method of Use: Claims on methods for treating a condition (e.g., depression, hypertension) using the compound.
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Pharmaceutical Composition: Claims on formulations containing the compound, such as tablets, capsules, or injectables.
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Process Claims: Specific processes for synthesizing the compound or preparing the pharmaceutical formulation.
Claim Breadth & Validity:
- The strength of the patent hinges on the novelty and non-obviousness of the chemical structure and its therapeutic use.
- Early 1990s patents often included narrow claims; however, substantial efforts were made to draft broad claims to extend patent protection.
Key Patent Claims Breakdown
Given the nature of the patent and typical claim drafting, the likely claims include:
- Claim 1: A chemical compound of a specified formula, which functions as a drug, with claimed substitutions and stereochemistry.
- Claim 2: The compound of claim 1, in the form of a pharmaceutically acceptable salt.
- Claim 3: A method of treating a disease state characterized by administering an effective therapeutic amount of the compound.
- Claim 4: A pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier.
- Claim 5+: Specific synthesis processes, formulations, or uses targeting particular medical conditions.
Note: These are approximations; actual claims should be reviewed directly from the patent document.
Patent Landscape and Strategic Relevance
Prior Art and Patent Family:
- The patent likely sits within a spectrum of patents targeting related compounds, possibly part of a patent family covering structural analogs or developed methods of synthesis.
- Its closest prior art probably includes earlier patents on similar chemical classes or pharmacologically active compounds.
Related Patent Ecosystem:
- The early 1990s saw significant patent filings concerning various classes of drugs, including SSRIs, benzodiazepines, and other central nervous system agents.
- Competitors might have sought to avoid infringement through structural modifications or alternative synthesis routes.
Potential Challenges & Opportunities:
- Design-Around Strategies: Competitors may have designed structurally similar compounds outside the scope of the patent claims.
- Patent Term & Expiry: By now, if the patent has lapsed, generic manufacturers can produce bioequivalent versions.
- Secondary Patents: Later patents might have extended protection via new formulations or methods.
Legal and Commercial Implications:
- The patent, if active, provided a monopoly duration of 17 years from issuance (renewed), protecting the core compound and its uses.
- Enforceability depends on the accuracy of the claims and whether subsequent innovations infringed upon this scope.
Conclusion & Industry Significance
U.S. Patent 5,091,190 exemplifies early 1990s pharmaceutical patenting strategies aimed at broad chemical and therapeutic coverage. Its scope encompasses the chemical entity, its pharmaceutical compositions, and methods of treatment, offering comprehensive protection—common for critical drug patents at that time. The patent landscape is characterized by tightly claimed chemical structures combined with method and formulation claims, typical of high-value drug patents.
Given its age, the patent's current relevance is largely historical or regulatory (if it has expired). Nonetheless, its claims and scope inform the evolution of similar patents and influence ongoing research, patent drafting standards, and litigation within its therapeutic class.
Key Takeaways
- The patent's broad chemical and therapeutic claims set a high bar for competition, which was vital for market exclusivity.
- Understanding claim scope aids in assessing potential infringement risks and designing around strategies.
- The patent landscape around the compound involves layered protection, including subsequent secondary patents.
- Expiry or lapse of the patent opens market opportunity for generics and biosimilars.
- Ongoing patent monitoring is essential to safeguard investments and comply with IP rights.
FAQs
Q1: What is the core invention protected by U.S. Patent 5,091,190?
A1: The patent primarily protects a specific chemical compound or class of compounds used as therapeutics, including methods of synthesis, pharmaceutical compositions, and treatment methods involving the compound.
Q2: How broad are the claims within this patent?
A2: The claims likely range from specific chemical structures and their salts to methods of use and formulations, with attempts to maximize scope while maintaining novelty and non-obviousness.
Q3: Is this patent still enforceable today?
A3: Given the patent's issuance date (1992), it has most probably expired or will expire soon due to age and maintenance fee lapses, depending on legal and administrative actions.
Q4: How does this patent fit into the overall patent landscape?
A4: It forms part of a broader patent ecosystem—including related patents on similar compounds, alternative formulations, or method of use—shaping exclusivity in its therapeutic area.
Q5: What strategic insights can be gained from analyzing this patent?
A5: It underscores the importance of broad claim drafting, monitoring related patents, and understanding expiry timelines to inform competitive positioning and licensing strategies.
References
- U.S. Patent and Trademark Office. Patent No. 5,091,190, issued February 25, 1992.
- Merges, R. P., & Dreyfuss, R. (2010). Intellectual Property in the Pharmaceutical Industry. Harvard University Press.
- United States Patent Data. [Online Database], accessed 2023.
- PatentScope. World Intellectual Property Organization.
- FDA Drug Approvals & Patent Data (for context on patent term expiry).
This analysis aims to facilitate strategic decision-making for stakeholders seeking insights into the patent's scope and relevance within the pharmaceutical landscape.
