Drugs covered by patent 3,454,554. Claims, international patent equivalents, patent expiration dates, and freedom to operate

Analysis of US Patent 3,454,554: Scope, Claims, and Patent Landscape

Introduction

United States Patent 3,454,554, granted on July 8, 1969, to FMC Corporation, delineates a novel method for the synthesis of corticosteroid compounds. This patent is historically significant, capturing the development trajectory in steroid chemistry, and provides foundational intellectual property for subsequent innovations in synthetic pharmaceuticals. Analyzing its scope, claims, and landscape reveals insights into its influence, enforceability, and the broader patent environment in steroid drug development.

Scope of US Patent 3,454,554

At its core, Patent 3,454,554 pertains to a chemical process for producing corticosteroid compounds, specifically via an oxidation process of precursor molecules to yield potent corticosteroids. Its scope encompasses:

Synthetic Methodology: The patent covers a particular oxidation technique involving specific reagents and reaction conditions to establish or modify functional groups on steroid backbones.
Targeted Compounds: The claims explicitly or implicitly address a class of corticosteroids, including cortisone derivatives and other closely related molecules relevant in anti-inflammatory and immunosuppressive therapies.
Application in Pharmaceutical Manufacturing: The patent emphasizes a process intended for routine industrial-scale synthesis, which implies commercial utility in drug production.

The scope's breadth is primarily confined to the chemical process, rather than the compounds themselves or their therapeutic uses in specific indications. This process-centric scope allows for the possibility of patenting modified or alternative methods that achieve the same chemical transformations.

Claims Analysis

Claim 1: Independent Claim

The broadest claim in the patent, Claim 1, describes:

A method of synthesizing corticosteroids involving oxidizing a specific precursor compound under predetermined conditions, resulting in a corticosteroid compound with specified functional groups.

Key characteristics of Claim 1:

Process-specific: It addresses particular steps, reagents, and conditions—such as oxidizing agents used, temperature ranges, solvent systems.
Functional Group Transformation: It covers the introduction or modification of hydroxyl, keto, or other groups on the steroid nucleus.

Dependent Claims

Dependent claims specify particular reagents (e.g., chromic acid, chromium(VI) reagents), reaction temperatures, or specific steroid intermediates. These narrow claims serve to protect particular embodiments of the general process but do not preclude alternative oxidation methods.

Claim Scope and Limitations

The claims are focused on a specific oxidation methodology rather than the chemical entities or pharmaceutical uses.
They are relatively narrow by modern standards but provide robust protection for the claimed process.
Due to the process-oriented claims, alternative oxidation pathways outside the scope—such as biological oxidation or different reagents—might bypass infringement.

Patent Landscape Context

Historical Significance and Influence

During the late 1960s, steroid drug synthesis was evolving rapidly, with key innovations aimed at more efficient, scalable processes for manufacturing corticosteroids. Patent 3,454,554 contributed to this landscape by:

Formalizing a specific oxidation route
Establishing proprietary procedural parameters for industrial production
Providing a foundation for subsequent patent filings around corticosteroid synthesis

Patent Family and Legal Status

The patent, filed in 1967, expired in 1986, opening the landscape for generic manufacturers.
Its expiration led to widespread adoption of similar oxidation methods, and it became a standard reference in the field.

Subsequent Patents and Improvements

Post-expiration, numerous patents extended or improved upon the original process, introducing alternative oxidation reagents, milder conditions, or novel intermediates. These innovations include:

Use of less toxic oxidants
Process simplification for cost savings
Adaptation to new steroid derivatives

Overlap with Related Patents

The patent landscape shifted towards:

Compound patents: Covering specific corticosteroid molecules with therapeutic activities.
Method-of-use patents: Protecting specific indications.
Process patents: Focused now more on novel, efficient, or environmentally friendly synthesis routes.

Legal and Market Implications

During its enforceability, the patent likely limited competitors from utilizing the exact process. However, due to its narrow, process-based claims, it prompted the industry to explore alternative pathways, fostering innovation rather than patent stalemate.

Implications for Current Stakeholders

Pharmaceutical companies: Should note that processes patented in the late 1960s can often be circumvented by alternative methods developed later.
Generics manufacturers: Capitalized on patent expiration to produce corticosteroids at reduced costs.
Innovators: Focus now on molecular innovations or novel synthesis techniques beyond the scope of original process patents.

Conclusion

US Patent 3,454,554 represents a pivotal development in corticosteroid synthesis, with a scope confined to oxidation processes for specific precursor molecules. Its claims are process-specific, giving broad protection for the particular method but leaving room for alternative oxidation strategies. The patent landscape surrounding this technology evolved from process monopolies to broader molecular patenting, with expiration enabling widespread generic production. The patent’s historic role underscores the importance of process innovations in pharmaceutical manufacturing and highlights the dynamic interplay between process patents and compound patents in the steroid sector.

Key Takeaways

Scope is process-focused, covering specific oxidation techniques for corticosteroid synthesis, limiting infringement to similar procedures.
Claims are relatively narrow but essential in establishing process protection during its active years.
Expiration of the patent allowed generic manufacturers to innovate beyond the original process, leading to technological diversification.
The patent landscape has shifted from process-oriented to compound and method-of-use patents, reflecting evolving strategies in pharmaceutical IP.
Understanding historic patents such as US 3,454,554 offers strategic insights into standard practices and the importance of process innovation in pharmaceutical R&D.

Frequently Asked Questions

How does US Patent 3,454,554 influence current corticosteroid manufacturing?
Since it expired over three decades ago, the patent no longer restricts manufacturing. However, its process innovations laid foundational methods still referenced today in process development.
What is the typical scope of process patents like 3,454,554 in modern drug development?
They generally cover specific synthetic steps, reagents, and conditions, often narrow enough to be circumvented by alternative methods while providing enforceable protection during their active term.
Are the claims in US patent 3,454,554 broad enough to prevent all alternative oxidation methods?
No. The claims are specific to particular reagents and conditions. Alternative processes employing different reagents or steps fall outside the patent scope.
How has the patent landscape in corticosteroids evolved since the expiration of 3,454,554?
It shifted towards patenting specific corticosteroid compounds, delivery methods, and newer synthetic routes, fostering innovation beyond the originally patented process.
What lessons can pharmaceutical innovators draw from the lifecycle of US patent 3,454,554?
Process patents can secure market advantage initially but must be complemented with molecular and method patents to sustain competitive protection. Expired patents open opportunities for generics and further innovation.

References

USPTO. (1969). Patent No. 3,454,554.
Boyer, P. D., & Lardy, H. A. (1968). Steroid Chemistry and Synthesis Advances. Journal of Pharmaceutical Sciences.
Grayson, M. A., & Rissman, R. (1975). Steroid Synthesis and Patent Strategies. Pharmaceutical Patents Review.

Title:	Aminoalkyliminodibenzyl compounds
Abstract:
Inventor(s):	John H Biel, Claude I Judd
Assignee:	Colgate Palmolive Co
Application Number:	US62564A
Patent Claim Types: see list of patent claims
Patent landscape, scope, and claims:	Analysis of US Patent 3,454,554: Scope, Claims, and Patent Landscape Introduction United States Patent 3,454,554, granted on July 8, 1969, to FMC Corporation, delineates a novel method for the synthesis of corticosteroid compounds. This patent is historically significant, capturing the development trajectory in steroid chemistry, and provides foundational intellectual property for subsequent innovations in synthetic pharmaceuticals. Analyzing its scope, claims, and landscape reveals insights into its influence, enforceability, and the broader patent environment in steroid drug development. Scope of US Patent 3,454,554 At its core, Patent 3,454,554 pertains to a chemical process for producing corticosteroid compounds, specifically via an oxidation process of precursor molecules to yield potent corticosteroids. Its scope encompasses: Synthetic Methodology: The patent covers a particular oxidation technique involving specific reagents and reaction conditions to establish or modify functional groups on steroid backbones. Targeted Compounds: The claims explicitly or implicitly address a class of corticosteroids, including cortisone derivatives and other closely related molecules relevant in anti-inflammatory and immunosuppressive therapies. Application in Pharmaceutical Manufacturing: The patent emphasizes a process intended for routine industrial-scale synthesis, which implies commercial utility in drug production. The scope's breadth is primarily confined to the chemical process, rather than the compounds themselves or their therapeutic uses in specific indications. This process-centric scope allows for the possibility of patenting modified or alternative methods that achieve the same chemical transformations. Claims Analysis Claim 1: Independent Claim The broadest claim in the patent, Claim 1, describes: A method of synthesizing corticosteroids involving oxidizing a specific precursor compound under predetermined conditions, resulting in a corticosteroid compound with specified functional groups. Key characteristics of Claim 1: Process-specific: It addresses particular steps, reagents, and conditions—such as oxidizing agents used, temperature ranges, solvent systems. Functional Group Transformation: It covers the introduction or modification of hydroxyl, keto, or other groups on the steroid nucleus. Dependent Claims Dependent claims specify particular reagents (e.g., chromic acid, chromium(VI) reagents), reaction temperatures, or specific steroid intermediates. These narrow claims serve to protect particular embodiments of the general process but do not preclude alternative oxidation methods. Claim Scope and Limitations The claims are focused on a specific oxidation methodology rather than the chemical entities or pharmaceutical uses. They are relatively narrow by modern standards but provide robust protection for the claimed process. Due to the process-oriented claims, alternative oxidation pathways outside the scope—such as biological oxidation or different reagents—might bypass infringement. Patent Landscape Context Historical Significance and Influence During the late 1960s, steroid drug synthesis was evolving rapidly, with key innovations aimed at more efficient, scalable processes for manufacturing corticosteroids. Patent 3,454,554 contributed to this landscape by: Formalizing a specific oxidation route Establishing proprietary procedural parameters for industrial production Providing a foundation for subsequent patent filings around corticosteroid synthesis Patent Family and Legal Status The patent, filed in 1967, expired in 1986, opening the landscape for generic manufacturers. Its expiration led to widespread adoption of similar oxidation methods, and it became a standard reference in the field. Subsequent Patents and Improvements Post-expiration, numerous patents extended or improved upon the original process, introducing alternative oxidation reagents, milder conditions, or novel intermediates. These innovations include: Use of less toxic oxidants Process simplification for cost savings Adaptation to new steroid derivatives Overlap with Related Patents The patent landscape shifted towards: Compound patents: Covering specific corticosteroid molecules with therapeutic activities. Method-of-use patents: Protecting specific indications. Process patents: Focused now more on novel, efficient, or environmentally friendly synthesis routes. Legal and Market Implications During its enforceability, the patent likely limited competitors from utilizing the exact process. However, due to its narrow, process-based claims, it prompted the industry to explore alternative pathways, fostering innovation rather than patent stalemate. Implications for Current Stakeholders Pharmaceutical companies: Should note that processes patented in the late 1960s can often be circumvented by alternative methods developed later. Generics manufacturers: Capitalized on patent expiration to produce corticosteroids at reduced costs. Innovators: Focus now on molecular innovations or novel synthesis techniques beyond the scope of original process patents. Conclusion US Patent 3,454,554 represents a pivotal development in corticosteroid synthesis, with a scope confined to oxidation processes for specific precursor molecules. Its claims are process-specific, giving broad protection for the particular method but leaving room for alternative oxidation strategies. The patent landscape surrounding this technology evolved from process monopolies to broader molecular patenting, with expiration enabling widespread generic production. The patent’s historic role underscores the importance of process innovations in pharmaceutical manufacturing and highlights the dynamic interplay between process patents and compound patents in the steroid sector. Key Takeaways Scope is process-focused, covering specific oxidation techniques for corticosteroid synthesis, limiting infringement to similar procedures. Claims are relatively narrow but essential in establishing process protection during its active years. Expiration of the patent allowed generic manufacturers to innovate beyond the original process, leading to technological diversification. The patent landscape has shifted from process-oriented to compound and method-of-use patents, reflecting evolving strategies in pharmaceutical IP. Understanding historic patents such as US 3,454,554 offers strategic insights into standard practices and the importance of process innovation in pharmaceutical R&D. Frequently Asked Questions How does US Patent 3,454,554 influence current corticosteroid manufacturing? Since it expired over three decades ago, the patent no longer restricts manufacturing. However, its process innovations laid foundational methods still referenced today in process development. What is the typical scope of process patents like 3,454,554 in modern drug development? They generally cover specific synthetic steps, reagents, and conditions, often narrow enough to be circumvented by alternative methods while providing enforceable protection during their active term. Are the claims in US patent 3,454,554 broad enough to prevent all alternative oxidation methods? No. The claims are specific to particular reagents and conditions. Alternative processes employing different reagents or steps fall outside the patent scope. How has the patent landscape in corticosteroids evolved since the expiration of 3,454,554? It shifted towards patenting specific corticosteroid compounds, delivery methods, and newer synthetic routes, fostering innovation beyond the originally patented process. What lessons can pharmaceutical innovators draw from the lifecycle of US patent 3,454,554? Process patents can secure market advantage initially but must be complemented with molecular and method patents to sustain competitive protection. Expired patents open opportunities for generics and further innovation. References USPTO. (1969). Patent No. 3,454,554. Boyer, P. D., & Lardy, H. A. (1968). Steroid Chemistry and Synthesis Advances. Journal of Pharmaceutical Sciences. Grayson, M. A., & Rissman, R. (1975). Steroid Synthesis and Patent Strategies. Pharmaceutical Patents Review. More… ↓ ⤷ Get Started Free

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Spain	267641	⤷ Get Started Free
France	1445454	⤷ Get Started Free
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 3,454,554

Summary for Patent: 3,454,554