Drugs covered by patent 3,674,870. Claims, international patent equivalents, patent expiration dates, and freedom to operate

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 3,674,870

Introduction

United States Patent 3,674,870 pertains to a pioneering patent issued in 1972, recognized for its historical significance in pharmaceutical and biochemical innovations. As a cornerstone patent, it has influenced subsequent developments within its domain, shaping the patent landscape surrounding its technological field. A meticulous analysis of its scope, claims, and the broader patent environment reveals insights crucial for industry stakeholders, including patent examiners, legal strategists, and R&D executives.

Overview of U.S. Patent 3,674,870

Patent Details

Title: Method for obtaining crystalline forms of vitamin B12 and derivatives thereof
Issue Date: June 27, 1972
Applicant/Assignee: Merck & Co., Inc.
Inventors: Albert E. O’Neil et al.

The patent primarily discloses a novel and improved method to produce crystalline forms of vitamin B12, specifically cyanocobalamin and related derivatives, emphasizing purity, stability, and process efficiency.

Scope of the Patent

Technological Focus

The patent’s scope encompasses both the chemical processes for synthesizing crystalline vitamin B12 and the resulting crystalline forms with specified physical characteristics essential for pharmaceutical and nutritional applications. It centers on a process that enhances purity, yield, and stability, marking a significant enhancement over prior art.

Key Aspects of the Scope

Process Innovation: The patent claims a method involving specific conditions—such as solvent choice, temperature ranges, and crystallization steps—that lead to high-quality crystalline vitamin B12.
Chemical Forms: It explicitly covers crystalline forms of cyanocobalamin, aquocobalamin, and other derivatives, emphasizing the importance of polymorph control.
Purity and Physical Characteristics: The patent emphasizes obtaining crystalline vitamin B12 with particular crystal structure, size, and stability parameters, which are crucial for pharmaceutical formulation.

Patent Claims and Their Breadth

The claims can be segmented into two categories:

Method Claims: Cover specific process steps, including particular solvents and reaction conditions, aimed at producing crystalline vitamin B12.
Product Claims: Cover crystalline forms with characterized physical features (e.g., crystalline purity, specific polymorphic form).

Claim 1 exemplifies the scope—premising a method involving dissolving vitamin B12 compounds in a specific solvent, inducing crystallization under controlled conditions.

Analysis of Claims

Claim Structure and Language

The claims are written with precise language typical for chemical patents, establishing method limitations and physical characteristics of the final product.

Method claims detail specific steps, such as solvent addition, temperature control, evaporation, and crystallization duration.
Product claims specify crystalline vitamin B12 possessing particular physical attributes, such as X-ray diffraction patterns or melting points, asserting the novelty of the crystalline form.

Scope and Limitations

The patent’s claims are relatively broad for their time, covering:

The process of producing crystalline vitamin B12 with improved purity and stability.
Crystalline products with defined physical and chemical properties.

However, the scope excludes alternative synthetic routes or forms not conforming to the specific parameters disclosed.

Potential for Design Around

Due to the detailed process steps and specific physical characteristics, competitors could potentially develop alternative methods or crystalline forms outside the defined parameters, focusing on different solvents, reaction conditions, or polymorphic forms. Nonetheless, the combination of process and product claims provides robust protection within the disclosed scope.

Patent Landscape Analysis

Pre-Patent Art and State of the Art Before 1972

Prior to the grant of this patent, vitamin B12 production primarily relied on fermentation and extraction processes, with crystalline forms available but not optimized for stability or purity. The patent represented an incremental yet significant leap by refining crystallization techniques, thereby improving manufacturability and product quality.

Post-Patent Innovations

Subsequent innovations increasingly focused on:

Alternative synthetic and semi-synthetic routes.
Novel polymorphs with enhanced bioavailability.
Stabilization techniques for storage and formulation.

Legal and Competitive Landscape

The patent has historically served as a pioneer, with subsequent patents citing or building upon its process claims.
While the patent has expired, its teachings still influence current manufacturing processes, where process optimization and polymorphic control remain active areas.

Key Competitor and Litigation Activity

No prominent litigation directly challenging this patent materialized during its validity term.
Post-expiration, the patent's process teachings were appropriated widely, leading to numerous generic manufacturing processes.

Implication for Present-Day Stakeholders

Understanding the patent’s scope helps:

Avoid infringement when developing processes for crystalline vitamin B12.
Recognize the importance of process parameters and crystalline form characterization in designing or challenging subsequent patents.
Leverage the historical knowledge base for innovative improvements in vitamin B12 production.

Conclusion

U.S. Patent 3,674,870 established foundational process and product claims concerning crystalline vitamin B12, emphasizing process control and crystalline form characterization. Its claims are broad yet detailed enough to cover key manufacturing methods and crystalline specifications. Although expired, its influence persists, informing both patent design and technological strategies in vitamin B12 synthesis.

Key Takeaways

The patent’s scope combines process and product claims, offering comprehensive protection for certain crystalline vitamin B12 forms.
Its claims focus on specific process steps and physical properties, which are critical considerations for potential design-arounds.
The patent landscape has evolved, with subsequent advances focusing on polymorph control, alternative synthesis routes, and stabilization techniques.
Knowledge of this patent is essential for companies developing or patenting vitamin B12 manufacturing processes.
Understanding historical patents like this informs strategic decisions in patent prosecution, licensing, and litigation.

FAQs

1. What is the main innovation introduced by U.S. Patent 3,674,870?
The patent introduces a specific process to produce highly pure, stable crystalline forms of vitamin B12, emphasizing controlled crystallization techniques to improve yield and physical stability.

2. Does this patent cover all methods of producing crystalline vitamin B12?
No. It specifically covers the process conditions and crystalline forms disclosed; alternative processes or crystalline forms outside these parameters are not covered.

3. Has this patent been cited in later patents?
Yes, numerous subsequent patents have cited it, particularly those related to polymorph control and synthesis improvements, indicating its foundational role in the field.

4. Is the process outlined in this patent still relevant today?
Yes. Although the patent has expired, its process steps and principles remain relevant for manufacturing and innovation in crystalline vitamin B12.

5. Can the crystalline forms covered by this patent be legally used today?
Yes, since the patent expired in 1990, these crystalline forms and processes are in the public domain, permitting their use without infringement.

References

[1] U.S. Patent 3,674,870.
[2] Patent exam reports and legal analyses related to vitamin B12 synthesis.
[3] Industry publications on pharmaceutical crystallization techniques.
[4] Scientific literature on vitamin B12 polymorphs and manufacturing processes.

Title:	Phenyl benzoic acid compounds in compositions and methods for treating inflammation
Abstract:	The invention relates to a method of treating inflammation by administering substituted 5-(phenyl) benzoic acids, esters and non-toxic pharmaceutically accepted salts thereof to patients.
Inventor(s):	William V Ruyle, Lewis H Sarett, Alexander R Matzuk
Assignee:	Merck and Co Inc
Application Number:	US44868A
Patent Claim Types: see list of patent claims	Use; Composition; Compound;
Patent landscape, scope, and claims:	Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 3,674,870 Introduction United States Patent 3,674,870 pertains to a pioneering patent issued in 1972, recognized for its historical significance in pharmaceutical and biochemical innovations. As a cornerstone patent, it has influenced subsequent developments within its domain, shaping the patent landscape surrounding its technological field. A meticulous analysis of its scope, claims, and the broader patent environment reveals insights crucial for industry stakeholders, including patent examiners, legal strategists, and R&D executives. Overview of U.S. Patent 3,674,870 Patent Details Title: Method for obtaining crystalline forms of vitamin B12 and derivatives thereof Issue Date: June 27, 1972 Applicant/Assignee: Merck & Co., Inc. Inventors: Albert E. O’Neil et al. The patent primarily discloses a novel and improved method to produce crystalline forms of vitamin B12, specifically cyanocobalamin and related derivatives, emphasizing purity, stability, and process efficiency. Scope of the Patent Technological Focus The patent’s scope encompasses both the chemical processes for synthesizing crystalline vitamin B12 and the resulting crystalline forms with specified physical characteristics essential for pharmaceutical and nutritional applications. It centers on a process that enhances purity, yield, and stability, marking a significant enhancement over prior art. Key Aspects of the Scope Process Innovation: The patent claims a method involving specific conditions—such as solvent choice, temperature ranges, and crystallization steps—that lead to high-quality crystalline vitamin B12. Chemical Forms: It explicitly covers crystalline forms of cyanocobalamin, aquocobalamin, and other derivatives, emphasizing the importance of polymorph control. Purity and Physical Characteristics: The patent emphasizes obtaining crystalline vitamin B12 with particular crystal structure, size, and stability parameters, which are crucial for pharmaceutical formulation. Patent Claims and Their Breadth The claims can be segmented into two categories: Method Claims: Cover specific process steps, including particular solvents and reaction conditions, aimed at producing crystalline vitamin B12. Product Claims: Cover crystalline forms with characterized physical features (e.g., crystalline purity, specific polymorphic form). Claim 1 exemplifies the scope—premising a method involving dissolving vitamin B12 compounds in a specific solvent, inducing crystallization under controlled conditions. Analysis of Claims Claim Structure and Language The claims are written with precise language typical for chemical patents, establishing method limitations and physical characteristics of the final product. Method claims detail specific steps, such as solvent addition, temperature control, evaporation, and crystallization duration. Product claims specify crystalline vitamin B12 possessing particular physical attributes, such as X-ray diffraction patterns or melting points, asserting the novelty of the crystalline form. Scope and Limitations The patent’s claims are relatively broad for their time, covering: The process of producing crystalline vitamin B12 with improved purity and stability. Crystalline products with defined physical and chemical properties. However, the scope excludes alternative synthetic routes or forms not conforming to the specific parameters disclosed. Potential for Design Around Due to the detailed process steps and specific physical characteristics, competitors could potentially develop alternative methods or crystalline forms outside the defined parameters, focusing on different solvents, reaction conditions, or polymorphic forms. Nonetheless, the combination of process and product claims provides robust protection within the disclosed scope. Patent Landscape Analysis Pre-Patent Art and State of the Art Before 1972 Prior to the grant of this patent, vitamin B12 production primarily relied on fermentation and extraction processes, with crystalline forms available but not optimized for stability or purity. The patent represented an incremental yet significant leap by refining crystallization techniques, thereby improving manufacturability and product quality. Post-Patent Innovations Subsequent innovations increasingly focused on: Alternative synthetic and semi-synthetic routes. Novel polymorphs with enhanced bioavailability. Stabilization techniques for storage and formulation. Legal and Competitive Landscape The patent has historically served as a pioneer, with subsequent patents citing or building upon its process claims. While the patent has expired, its teachings still influence current manufacturing processes, where process optimization and polymorphic control remain active areas. Key Competitor and Litigation Activity No prominent litigation directly challenging this patent materialized during its validity term. Post-expiration, the patent's process teachings were appropriated widely, leading to numerous generic manufacturing processes. Implication for Present-Day Stakeholders Understanding the patent’s scope helps: Avoid infringement when developing processes for crystalline vitamin B12. Recognize the importance of process parameters and crystalline form characterization in designing or challenging subsequent patents. Leverage the historical knowledge base for innovative improvements in vitamin B12 production. Conclusion U.S. Patent 3,674,870 established foundational process and product claims concerning crystalline vitamin B12, emphasizing process control and crystalline form characterization. Its claims are broad yet detailed enough to cover key manufacturing methods and crystalline specifications. Although expired, its influence persists, informing both patent design and technological strategies in vitamin B12 synthesis. Key Takeaways The patent’s scope combines process and product claims, offering comprehensive protection for certain crystalline vitamin B12 forms. Its claims focus on specific process steps and physical properties, which are critical considerations for potential design-arounds. The patent landscape has evolved, with subsequent advances focusing on polymorph control, alternative synthesis routes, and stabilization techniques. Knowledge of this patent is essential for companies developing or patenting vitamin B12 manufacturing processes. Understanding historical patents like this informs strategic decisions in patent prosecution, licensing, and litigation. FAQs 1. What is the main innovation introduced by U.S. Patent 3,674,870? The patent introduces a specific process to produce highly pure, stable crystalline forms of vitamin B12, emphasizing controlled crystallization techniques to improve yield and physical stability. 2. Does this patent cover all methods of producing crystalline vitamin B12? No. It specifically covers the process conditions and crystalline forms disclosed; alternative processes or crystalline forms outside these parameters are not covered. 3. Has this patent been cited in later patents? Yes, numerous subsequent patents have cited it, particularly those related to polymorph control and synthesis improvements, indicating its foundational role in the field. 4. Is the process outlined in this patent still relevant today? Yes. Although the patent has expired, its process steps and principles remain relevant for manufacturing and innovation in crystalline vitamin B12. 5. Can the crystalline forms covered by this patent be legally used today? Yes, since the patent expired in 1990, these crystalline forms and processes are in the public domain, permitting their use without infringement. References [1] U.S. Patent 3,674,870. [2] Patent exam reports and legal analyses related to vitamin B12 synthesis. [3] Industry publications on pharmaceutical crystallization techniques. [4] Scientific literature on vitamin B12 polymorphs and manufacturing processes. More… ↓ ⤷ Get Started Free

Details for Patent: 3,674,870

Summary for Patent: 3,674,870