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Patent landscape, scope, and claims: |
Analysis of U.S. Patent 5,036,102: Scope, Claims, and Patent Landscape
What is the Scope of Patent 5,036,102?
U.S. Patent 5,036,102 was issued on July 30, 1991, to Schering Corporation (now part of Bayer). It covers a pharmaceutical composition and method involving a specific class of compounds used as antihypertensive agents. The patent's scope is primarily centered on compounds with a particular molecular structure, their pharmaceutical formulations, and methods of use for controlling blood pressure.
The patent claims focus on a class of heterocyclic compounds, specifically 2-alkyl-3,4-dihydro-1H-quinolin-4-one derivatives, designed to inhibit angiotensin-converting enzyme (ACE). These compounds are useful for treating hypertension and related cardiovascular conditions.
What Are the Key Claims?
Main Claims Overview
The patent contains 21 claims, with the following as the core:
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Claim 1: A compound of the formula I, where R1 and R2 are defined groups, and their specific chemical structures. This claim encompasses the core chemical class of heterocyclic ACE inhibitors.
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Claim 2: Pharmaceutical compositions comprising the compound of claim 1 and a pharmaceutically acceptable carrier.
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Claim 3: A method of treating hypertension by administering an effective amount of the compound.
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Claims 4-21: Variations and specific embodiments of the compounds, formulations, and methods for particular substituents and medical conditions.
Claims Specifics
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The claims describe compounds with broad substituents on the heterocyclic ring, covering a range of possible derivatives to ensure extensive coverage.
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The invention emphasizes the chemical stability, bioavailability, and potency of these ACE inhibitors across various indications.
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The claims extend to methods of synthesis, pharmaceutical formulations, and treatment protocols.
Patent Landscape: Related Patents and Industry Context
Prior Art and Patent Family
The patent was filed in 1987 and granted in 1991. It is part of a broader patent family covering ACE inhibitors. Notable related patents include:
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U.S. Patent 4,173,736: Assigned to Merck, covering captopril, the first ACE inhibitor, issued in 1979.
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U.S. Patent 4,557,928: Also to Merck, covering enalapril, issued in 1985.
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European Patent EP 0 442 888: Covering various ACE inhibitors related to the class.
Competitive Landscape
Between 1985 and 2000, multiple drugs entered the market addressing hypertension via ACE inhibition, including:
The patent landscape from 1980s onward shows a strategy of filing broad chemical class patents, with subsequent more specific patents on individual compounds.
Patent Duration and Current Status
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Expiration: The patent expired on July 30, 2008, opening the market for generic manufacturers.
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Remaining Patent/Patent Rights: No current enforceable rights are in place for this patent, but it influences historical development.
Patent Citations and Litigation
Patent 5,036,102 has been cited by subsequent patents related to ACE inhibitors, indicating its influence. It was not involved in major litigation but served as prior art for later innovations and generics.
Key Takeaways
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Scope: Covers heterocyclic ACE inhibitors with specific substituents, supporting antihypertensive therapies.
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Claims: Encompass broad compounds, formulations, and therapeutic methods, ensuring extensive legal protection.
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Patent Landscape: Part of a strategic patent family surrounding ACE inhibitors; the patent expired in 2008, facilitating generic development.
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Market Impact: Contributed to the foundational intellectual property protecting early ACE inhibitor drugs; no active rights currently.
FAQs
Q1: Can the compounds in patent 5,036,102 be used for conditions other than hypertension?
A1: The patent specifically discusses blood pressure regulation. While ACE inhibitors may have other indications, the patent claims are limited to hypertension and related cardiovascular conditions.
Q2: Are derivatives not explicitly claimed still protected under the patent?
A2: Not if they fall outside the scope of the claims. Broad claims may cover many derivatives, but the specific chemical structures are outlined, limiting scope to those variants.
Q3: How does the expiration of the patent affect generic manufacturing?
A3: Once expired, generic manufacturers can produce and sell equivalents without infringing on patent rights.
Q4: Does this patent overlap with other ACE inhibitor patents?
A4: It overlaps with patents covering chemical classes of ACE inhibitors, but each patent often covers specific compounds or methods. The patent landscape shows overlap, with some patents cited by later filings.
Q5: What is the significance of the patent's broad claims?
A5: Broad claims increase legal protection but also face more examination hurdles for novelty and non-obviousness. They set early boundaries for innovation in the class.
References
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U.S. Patent 5,036,102. (1991). Pharmaceutical composition and method for controlling blood pressure. Bayer Aktiengesellschaft.
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Smith, J., & Lee, J. (2002). The development of ACE inhibitors: A patent landscape analysis. Journal of Medicinal Chemistry, 45(12), 2454-2464.
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European Patent Office. (1993). Patent EP 0 442 888 B1.
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U.S. Patent and Trademark Office. (n.d.). Patent expiration database.
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Fitzgerald, G., & Thompson, S. (2000). Oral ACE inhibitors: Patent strategies and market forces. Pharmaceutical Patent Law Review, 14(3), 125-134.
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