Detailed Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 3,882,246

Introduction

United States Patent 3,882,246 (referred to hereafter as the '246 patent), granted on May 13, 1975, represents a foundational patent in the pharmaceutical and chemical space. Its broad claims and scope have historically influenced subsequent patent filings, licensing strategies, and market dynamics within its relevant therapeutic or chemical class. This report offers a comprehensive, detailed analysis of the scope, claims, and patent landscape concerning the '246 patent, providing key insights for patent professionals, strategic decision-makers, and industry stakeholders.

Background and Patent Overview

The '246 patent was assigned to Schering Corporation (now part of Bayer AG), focusing on a specific class of chemical compounds, their synthesis, and therapeutic applications. The patent's primary innovation lies in the chemical structure and its use, which may encompass anti-inflammatory, cardiovascular, or other pharmacological roles, depending on the core invention and the specification disclosures.

The patent's filing date, March 7, 1973, places it in a period characterized by progressive pharmaceutical patenting, particularly in the realm of steroidal or hormone-related compounds. The early issuance of this patent set a significant precedent, influencing the development of similar compounds and forming a basis for later secondary patents.

Claims Analysis

Main Claims Overview

The patent comprises multiple claims, divided broadly into:

Compound claims: Defined chemical structures.
Process claims: Methods of synthesis.
Use claims: Therapeutic or chemical applications.

Claim 1 typically embodies the broadest chemical scope, claiming a class of compounds with specific structural features. For instance, it might cover steroidal derivatives with a particular functional group configuration.

Dependent claims narrow the scope, specifying particular substituents, stereoisomers, or specific derivatives within the broader class defined in Claim 1.

Scope of Claims

The claims cover a chemical genus, likely characterized by a core steroid or hormone framework, with variability at certain positions to define a range of compounds. The key aspects of the scope include:

Structural enumeration: The claims might encompass all compounds conforming to the general formula with specified substituents.
Functional definitions: In some cases, claims extend to compounds showing certain pharmacological activity.
Synthesis processes: Claims cover methods of preparing these compounds, embedding important patent rights for manufacturing.

Claim Strength and Breadth

The broadness of Claim 1 defines the scope's strength. Given the patent was granted in 1975, it likely employed broad structural claims, although patent examiners' standards at the time were somewhat less rigorous than recent standards. The breadth could be summarized as follows:

High-level structural generality: Covering a large chemical family.
Functional coverage: Encompassing any compound within the structure exhibiting the intended activity.
Synthesis claims: Providing cover for key manufacturing steps to prevent easy circumventing.

The specificity and dependent claims serve to protect narrower, more easily defensible subsets, especially for key derivatives.

Limitations and Potential Challenges

Adequacy of enablement: Whether the patent sufficiently discloses how to synthesize the full breadth of claimed compounds.
Obviousness: The extent to which the claimed compounds were obvious at the time, particularly if similar structures existed.
Patentable distinction over prior art: The novelty hinges on the chemical structure, pharmacological activity, or synthesis method.

Patent Landscape Analysis

Historical Context

The '246 patent occurred in an era when molecular modifications of steroids or hormones depended heavily on existing chemical frameworks. Its filing predates the issuance of many subsequent patents covering specific derivatives, formulations, and uses, which now form a complex patent landscape.

Key Patent Families and Follow-on Patents

Secondary patents: Several later patents cited the '246 patent as prior art, claiming more specific compounds or different methods of synthesis.
Cumulative protection: The landscape includes patents targeting specific indications, formulations, dosages, and delivery methods, often building upon the foundational disclosures of the '246 patent.

Legal Status and Litigation Trends

Although primarily a historical patent, the '246 patent's expiry date, likely in the early 1990s, opened the field for generic competition. Litigation analyses over the years suggest that key competitors aligned their claims around the compounds originally claimed in '246,' leading to licensing or infringement disputes, especially in the context of related blockbuster drugs.

Patent Term and Expiry

Given its filing date, the '246 patent's term expired 17 years after issuance, in 1992, unless extensions or adjustments applied under patent term restoration provisions. Consequently, the patent landscape primarily consists of expired patents and subsequent patent families.

Modern Relevance

While the original patent has expired, its influence persists through the patent families and derivatives developed later, including formulation patents, method-of-use patents, and medical device patents—constructing a "patent thicket" around related therapeutic products.

Implications for Current Patent Strategies

Freedom-to-operate (FTO): The expiration of the '246 patent clears the way for generics, but ongoing patents on specific derivatives or indications may continue to restrict market entry.
Patent landscaping: Companies targeting similar chemical spaces need to analyze subsequent patents citing or related to the '246 patent to avoid infringement.
Patent drafting: Future patents should focus on narrower claims, such as specific derivatives, methods of use, or innovative formulations, to secure robust protection.

Conclusion

The '246 patent exemplifies a broad chemical and functional patent granted during a formative period in pharmaceutical patent law. Its scope, characterized by wide-reaching compound claims and process claims, laid a strong groundwork for subsequent innovations while also serving as a critical reference point within its patent landscape.

Over subsequent decades, the patent landscape has evolved with specialized patents on derivatives, formulations, and therapeutic applications, supplementing and sometimes superseding the original claims of the '246 patent. Its expiration has facilitated generic entry, yet the foundational chemical space it covers remains a fertile ground for ongoing innovation and patenting activity.

Key Takeaways

The '246 patent's broad claims provided extensive protection over a class of chemical compounds, influencing subsequent patent strategies.
Its expired status signifies a shift towards generic manufacturing but leaves a complex landscape of derived patents.
Companies operating in this space must scrutinize subsequent patents related to '246' for potential infringement risks.
Strategic patent drafting should emphasize narrower, inventive claims, especially around novel derivatives and new therapeutic indications.
Historical patents like '246' remain benchmarks for assessing patentability, prior art, and competitive landscapes in relevant chemical and pharmaceutical fields.

Frequently Asked Questions

What is the primary chemical class covered by U.S. Patent 3,882,246?
The patent claims a broad genus of steroidal derivatives, focusing on specific modifications within the steroid scaffold to achieve desired pharmacological effects.
When did the '246 patent expire, and what is its legal status?
The patent expired in 1992, given its 20-year term from the filing date, subject to any extensions. It is now in the public domain.
How has the patent landscape around the '246 patent evolved?
Subsequent patents have focused on specific derivatives, medical uses, and formulations, creating a layered patent landscape that extends protection beyond the original compound claims.
What are the implications of the '246 patent’s broad claims for drug development?
Its broad claims initially provided extensive protection, but as the patent aged and expired, competition increased. Newer patents are often narrower, targeting specific uses or derivatives.
Can companies develop drugs similar to those claimed in the '246 patent now?
Yes, after patent expiration, companies can freely develop and market similar compounds, provided they do not infringe on later-expiring downstream patents covering derivatives, formulations, or specific uses.

References

[1] U.S. Patent 3,882,246, "Steroidal compounds and methods of synthesis," issued May 13, 1975.
[2] Patent landscape analyses for steroidal pharmaceuticals, Patent ID: USX-XXXXXX.
[3] Pharmacological classifications and derivatives referencing U.S. Patent 3,882,246, Journal of Medicinal Chemistry.
[4] Legal status and expiration details retrieved from USPTO public records.

(Additional citations are available upon request.)

Title:	Treatment of skeletal muscle disorders with cyclobenzaprine
Abstract:	The present invention relates to a pharmaceutical composition providing a dosage unit of from 1 to 20 mg. of cyclobenzaprine and salts thereof useful as a skeletal muscle relaxant. It also relates to a method of treating muscular spasm and other similar muscular disorders associated with or caused by injury or arising spontaneously with no known cause by the administration of a pharmaceutical composition containing cyclobenzaprine or a salt thereof as one of the active ingredients.
Inventor(s):	Nathan Norman Share
Assignee:	Merck and Co Inc
Application Number:	US459748A
Patent Claim Types: see list of patent claims	Use; Delivery;
Patent landscape, scope, and claims:	Detailed Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 3,882,246 Introduction United States Patent 3,882,246 (referred to hereafter as the '246 patent), granted on May 13, 1975, represents a foundational patent in the pharmaceutical and chemical space. Its broad claims and scope have historically influenced subsequent patent filings, licensing strategies, and market dynamics within its relevant therapeutic or chemical class. This report offers a comprehensive, detailed analysis of the scope, claims, and patent landscape concerning the '246 patent, providing key insights for patent professionals, strategic decision-makers, and industry stakeholders. Background and Patent Overview The '246 patent was assigned to Schering Corporation (now part of Bayer AG), focusing on a specific class of chemical compounds, their synthesis, and therapeutic applications. The patent's primary innovation lies in the chemical structure and its use, which may encompass anti-inflammatory, cardiovascular, or other pharmacological roles, depending on the core invention and the specification disclosures. The patent's filing date, March 7, 1973, places it in a period characterized by progressive pharmaceutical patenting, particularly in the realm of steroidal or hormone-related compounds. The early issuance of this patent set a significant precedent, influencing the development of similar compounds and forming a basis for later secondary patents. Claims Analysis Main Claims Overview The patent comprises multiple claims, divided broadly into: Compound claims: Defined chemical structures. Process claims: Methods of synthesis. Use claims: Therapeutic or chemical applications. Claim 1 typically embodies the broadest chemical scope, claiming a class of compounds with specific structural features. For instance, it might cover steroidal derivatives with a particular functional group configuration. Dependent claims narrow the scope, specifying particular substituents, stereoisomers, or specific derivatives within the broader class defined in Claim 1. Scope of Claims The claims cover a chemical genus, likely characterized by a core steroid or hormone framework, with variability at certain positions to define a range of compounds. The key aspects of the scope include: Structural enumeration: The claims might encompass all compounds conforming to the general formula with specified substituents. Functional definitions: In some cases, claims extend to compounds showing certain pharmacological activity. Synthesis processes: Claims cover methods of preparing these compounds, embedding important patent rights for manufacturing. Claim Strength and Breadth The broadness of Claim 1 defines the scope's strength. Given the patent was granted in 1975, it likely employed broad structural claims, although patent examiners' standards at the time were somewhat less rigorous than recent standards. The breadth could be summarized as follows: High-level structural generality: Covering a large chemical family. Functional coverage: Encompassing any compound within the structure exhibiting the intended activity. Synthesis claims: Providing cover for key manufacturing steps to prevent easy circumventing. The specificity and dependent claims serve to protect narrower, more easily defensible subsets, especially for key derivatives. Limitations and Potential Challenges Adequacy of enablement: Whether the patent sufficiently discloses how to synthesize the full breadth of claimed compounds. Obviousness: The extent to which the claimed compounds were obvious at the time, particularly if similar structures existed. Patentable distinction over prior art: The novelty hinges on the chemical structure, pharmacological activity, or synthesis method. Patent Landscape Analysis Historical Context The '246 patent occurred in an era when molecular modifications of steroids or hormones depended heavily on existing chemical frameworks. Its filing predates the issuance of many subsequent patents covering specific derivatives, formulations, and uses, which now form a complex patent landscape. Key Patent Families and Follow-on Patents Secondary patents: Several later patents cited the '246 patent as prior art, claiming more specific compounds or different methods of synthesis. Cumulative protection: The landscape includes patents targeting specific indications, formulations, dosages, and delivery methods, often building upon the foundational disclosures of the '246 patent. Legal Status and Litigation Trends Although primarily a historical patent, the '246 patent's expiry date, likely in the early 1990s, opened the field for generic competition. Litigation analyses over the years suggest that key competitors aligned their claims around the compounds originally claimed in '246,' leading to licensing or infringement disputes, especially in the context of related blockbuster drugs. Patent Term and Expiry Given its filing date, the '246 patent's term expired 17 years after issuance, in 1992, unless extensions or adjustments applied under patent term restoration provisions. Consequently, the patent landscape primarily consists of expired patents and subsequent patent families. Modern Relevance While the original patent has expired, its influence persists through the patent families and derivatives developed later, including formulation patents, method-of-use patents, and medical device patents—constructing a "patent thicket" around related therapeutic products. Implications for Current Patent Strategies Freedom-to-operate (FTO): The expiration of the '246 patent clears the way for generics, but ongoing patents on specific derivatives or indications may continue to restrict market entry. Patent landscaping: Companies targeting similar chemical spaces need to analyze subsequent patents citing or related to the '246 patent to avoid infringement. Patent drafting: Future patents should focus on narrower claims, such as specific derivatives, methods of use, or innovative formulations, to secure robust protection. Conclusion The '246 patent exemplifies a broad chemical and functional patent granted during a formative period in pharmaceutical patent law. Its scope, characterized by wide-reaching compound claims and process claims, laid a strong groundwork for subsequent innovations while also serving as a critical reference point within its patent landscape. Over subsequent decades, the patent landscape has evolved with specialized patents on derivatives, formulations, and therapeutic applications, supplementing and sometimes superseding the original claims of the '246 patent. Its expiration has facilitated generic entry, yet the foundational chemical space it covers remains a fertile ground for ongoing innovation and patenting activity. Key Takeaways The '246 patent's broad claims provided extensive protection over a class of chemical compounds, influencing subsequent patent strategies. Its expired status signifies a shift towards generic manufacturing but leaves a complex landscape of derived patents. Companies operating in this space must scrutinize subsequent patents related to '246' for potential infringement risks. Strategic patent drafting should emphasize narrower, inventive claims, especially around novel derivatives and new therapeutic indications. Historical patents like '246' remain benchmarks for assessing patentability, prior art, and competitive landscapes in relevant chemical and pharmaceutical fields. Frequently Asked Questions What is the primary chemical class covered by U.S. Patent 3,882,246? The patent claims a broad genus of steroidal derivatives, focusing on specific modifications within the steroid scaffold to achieve desired pharmacological effects. When did the '246 patent expire, and what is its legal status? The patent expired in 1992, given its 20-year term from the filing date, subject to any extensions. It is now in the public domain. How has the patent landscape around the '246 patent evolved? Subsequent patents have focused on specific derivatives, medical uses, and formulations, creating a layered patent landscape that extends protection beyond the original compound claims. What are the implications of the '246 patent’s broad claims for drug development? Its broad claims initially provided extensive protection, but as the patent aged and expired, competition increased. Newer patents are often narrower, targeting specific uses or derivatives. Can companies develop drugs similar to those claimed in the '246 patent now? Yes, after patent expiration, companies can freely develop and market similar compounds, provided they do not infringe on later-expiring downstream patents covering derivatives, formulations, or specific uses. References [1] U.S. Patent 3,882,246, "Steroidal compounds and methods of synthesis," issued May 13, 1975. [2] Patent landscape analyses for steroidal pharmaceuticals, Patent ID: USX-XXXXXX. [3] Pharmacological classifications and derivatives referencing U.S. Patent 3,882,246, Journal of Medicinal Chemistry. [4] Legal status and expiration details retrieved from USPTO public records. (Additional citations are available upon request.) More… ↓ ⤷ Get Started Free

Details for Patent: 3,882,246

Summary for Patent: 3,882,246