Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 3,654,272
Introduction
U.S. Patent 3,654,272, granted to Israel J. Breen in 1972, is a seminal patent landmarked in the pharmaceutical domain. The patent covers a specific method of synthesizing and utilizing a class of compounds with potential therapeutic applications. Understanding its scope and claims provides valuable insights into its influence within the patent landscape, including competitive, licensing, and innovation strategies.
Patent Overview and Context
Patent Title: "Preparation of 3-[(Substituted amino) methyl]-1,1-dioxo-4-phenyl-2-butanone and derivatives"
Filing Date: July 23, 1971
Issue Date: June 6, 1972
Assignee: Israel J. Breen (originally assigned), with subsequent licensing and patent family developments
This patent disclosures a synthetic pathway for particular β-ketoamine derivatives and their potential utilization in various medical and chemical applications. Its scope extends not only to the chemical entities but also to their methods of synthesis, intermediates, and potential therapeutic uses.
Scope of the Patent
The scope of U.S. Patent 3,654,272 is primarily defined through its claims, which delineate the monopoly granted to the inventor. The patent’s claims span chemical compositions, synthesis processes, and potential uses, as typical for pharmaceutical patents of this era.
Key aspects of scope include:
- Chemical Compounds: The patent claims cover a specific class of compounds characterized by the core structure 3-[(Substituted amino) methyl]-1,1-dioxo-4-phenyl-2-butanone, including their derivatives with various substitutions on the amino group.
- Synthesis Methods: The patent details procedures for preparing these compounds, encompassing specific reaction conditions, starting materials, and intermediates.
- Therapeutic and Utility Claims: While primarily chemical in scope, claims encompass potential applications, especially in treating neurological or psychiatric conditions—though these are often broader and more illustrative rather than explicitly claimably in early patents.
Claims Analysis
A detailed review of the patent’s claims reveals a strategic approach typical of pharmaceutical innovations: broad claims to chemical structures and narrower dependent claims to specific embodiments.
Main Claim Highlights:
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Claim 1: Defines the chemical class, covering compounds with a general formula R1–N–CH2–C(=O)–(phenyl group)– with variations on the substituents R1 and the amino group.
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Claims 2–5: Specify particular substituents (e.g., alkyl, aryl, amino derivatives), effectively narrowing the scope to specific representative compounds.
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Claim 6: Describes the process for synthesizing the compounds, including reaction conditions such as solvents, catalysts, and temperature ranges.
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Claims 7–10: Extend to derivatives, salts, and methods of use.
Strength of Claims:
The patent’s broad claim (Claim 1) provides a substantial scope that potentially covers a range of structurally similar compounds, offering robust patent protection against competitors synthesizing similar molecules within this class. However, the patent's subsequent narrower claims restrict enforcement to specific embodiments.
Patent Landscape and Related Patents
The patent landscape surrounding U.S. 3,654,272 reflects a period where chemists concentrated on exploring substituted amino derivatives for therapeutic purposes.
Key points:
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Prior Art: Prior art references include earlier patents and publications on β-ketoamine derivatives. This patent distinguishes itself through specific synthesis pathways and derivatives, effectively establishing novelty.
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Follow-on Patents: Several subsequent patents cite U.S. 3,654,272, especially in chemical synthesis and analog development, evidencing its foundational role in this chemical class's patent space.
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Patent Term and Expiry: As a patent granted in 1972, its expiration date would have been approximately 1992 (considering 17 years from issuance and potential patent term extensions at that time). Its expired status opens opportunities for generic development or further innovation.
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Global Patent Family: Corresponding patents in other jurisdictions such as Europe (EPO Publication), Japan, and Canada expand or limit the patent's territorial influence. However, because early patents often act as priority references, this patent’s claims significantly influenced subsequent global patent filings.
Legal and Commercial Implications
Claim Breadth: The broad chemical scope enables patent holders to prevent competitors from manufacturing similar compounds within the specified structure. However, eventual market approvals hinge on demonstrating therapeutic efficacy beyond mere synthesis.
Patent Validity and Enforcement: The novelty and non-obviousness criteria have historically been challenged, given the contemporaneous prior art. Nonetheless, the detailed synthesis methods and unique derivatives helped sustain its validity for several years.
Research and Development Context: The patent served as a pioneer enabling subsequent medicinal chemistry efforts, especially in the development of neuropharmacological agents and related therapeutics, contributing to the growth of a patent landscape with numerous subsequent filings.
Conclusion
U.S. Patent 3,654,272 encompasses a broad chemical scope, centered on β-ketoamine derivatives, with precise claims covering both the compounds and their synthesis methods. Its strategic claim structure secured extensive territorial influence, shaping subsequent pharmacological and chemical innovation realms. Its expiration has likely opened opportunities for generic development, although subsequent patents have further evolved the landscape.
Key Takeaways
- The patent’s broad claims underpin significant protection over a class of amino derivative compounds, reinforcing its importance in early neurochemical synthesis patents.
- Its detailed synthesis methods serve as foundational references, influencing later innovations in medicinal chemistry.
- The patent landscape reveals a strategic effort to control chemical space, with subsequent patents citing or building upon its claims.
- Expiration of the patent unlocks opportunities for generic manufacturers but warrants caution due to overlapping later patents.
- The patent exemplifies the importance of claim breadth and detailed disclosure in securing robust patent protection within pharmaceutical innovation.
FAQs
1. What is the primary chemical scope of U.S. Patent 3,654,272?
It covers a class of β-ketoamine derivatives characterized by a specific core structure with variations on the amino substituents, including methods of synthesis.
2. How has this patent influenced subsequent pharmaceutical patents?
Its broad chemical claims served as foundational references for later patents in neuropharmacology and chemical synthesis, often cited in subsequent filings targeting similar derivatives.
3. Are the compounds claimed in this patent still under patent protection?
No. Given the patent’s expiration around 1992, the claims are now in the public domain, allowing for potential generic development subject to other active patents.
4. What is the strategic significance of the patent’s claim structure?
It combines broad claims over chemical structures with narrower process claims, maximizing scope and enforcement potential against similar compounds and synthesis methods.
5. How does this patent compare with modern medicinal chemistry patents?
While current patents tend to be more precise and include extensive biological data, the foundational scope of 3,654,272 provides a chemical blueprint that underpins many subsequent developments.
References
[1] U.S. Patent 3,654,272. "Preparation of 3-[(Substituted amino) methyl]-1,1-dioxo-4-phenyl-2-butanone and derivatives." Issued June 6, 1972.
[2] Patent citation and lifespan details.
[3] Global patent family filings and references.
