Drugs covered by patent 4,205,086. Claims, international patent equivalents, patent expiration dates, and freedom to operate

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 4,205,086

Introduction

U.S. Patent No. 4,205,086 (hereafter referred to as the ‘086 patent), granted on May 27, 1980, is a seminal patent in the pharmaceutical sector, particularly in relation to its claims surrounding the synthesis and therapeutic applications of specific chemical compounds. This patent has historically influenced subsequent innovations and patent filings within its technical domain. This detailed analysis examines the scope of the patent's claims, the technological landscape it resides within, and the broader patent environment, providing critical insights for stakeholders involved in drug development, patent strategy, and patent litigation.

Patent Overview and Technical Background

The ‘086 patent focuses on a class of chemical compounds with specific structural features designed for therapeutic purposes. Its primary contribution lies in claiming novel chemical entities with claimed pharmacological activity—most notably, as anti-inflammatory or analgesic agents. The patent describes a synthetic route for these compounds, their pharmaceutical compositions, and their use in treating specific medical conditions.

The patent exemplifies a typical structure-activity relationship (SAR) approach, emphasizing the novelty of particular substitutions on a core molecular scaffold, which confers therapeutic advantages and patentability.

Scope of the Patent Claims

1. Claim Categorization and Structure

The claims within the ‘086 patent are broadly divided into product claims, method claims, and composition claims:

Product Claims: Cover specific chemical entities characterized by particular structural features, including substituents and stereochemistry. For example, claims may define a compound as a derivative of a core structure with specific side chains, emphasizing structural novelty and non-obvious modifications.
Method Claims: Describe methods of synthesizing the claimed compounds, or therapeutic methods utilizing the compounds for specific indications, such as inflammation or pain relief.
Composition Claims: Encompass pharmaceutical formulations containing the claimed compounds, including dosages and excipient combinations.

2. Claim Limitations and Preamble

The preambles often specify the chemical class and the intended use—such as "a compound selected from the group consisting of..."—which influences the scope’s breadth. The claims specify parameters such as substitution patterns, stereochemistry, and particular functional groups, aiming to carve out proprietary space around legally patentable molecular variations.

3. Patent Scope Analysis

The scope is generally narrower than broad chemical class claims, focusing on certain derivatives with specific substituents. The narrow scope reflects an intent to provide robust protection for particular compounds, while potentially leaving room for follow-on patents on related compounds with different substitutions or stereoisomers.

However, the inclusion of broad "composition of matter" claims—if present—could extend scope significantly, potentially covering a wide range of similar compounds.

4. Limitations and Potential Challenges

The primary limitations relate to the specificity of the claims. If the claims are narrowly defined, they may be more vulnerable to invalidation through prior art or obviousness challenges. Conversely, overly broad claims risk becoming invalid for lack of novelty or inventive step.

Patent Landscape and Related Patent Families

1. Prior Art Context

When the ‘086 patent was filed, patent examiners evaluated it against prior art references including earlier chemical syntheses, related compounds, and known therapeutic agents. The patent successfully overcame novelty and non-obviousness hurdles, likely due to the unique substitution patterns or synthetic methods disclosed.

2. Follow-on and Cumulative Patents

Subsequent patents in the landscape often build upon or reference the ‘086 patent, focusing on:

New derivatives: Variations on the core scaffold with different substituents extending the patent estate.
Improved synthesis techniques: Alternative synthetic routes for the same compounds, providing patentable improvements.
Expanded therapeutic indications: Using similar compounds for other medical applications.

These follow-on patents contribute to a dense patent landscape, creating a complex web of overlapping rights that protect various aspects of the original inventions.

3. Patent Term and Expiry

Being filed before the Uruguay Round Agreements Act, the ‘086 patent had a 17-year term from issuance, expiring in 1997. Its expiration has opened the therapeutic space for generic manufacture and commercialization, although related patents may still extend exclusivity for certain formulations or methods.

4. Geographic Patent Coverage

While primarily a U.S. patent, similar patent families have common counterparts in Europe, Japan, and other jurisdictions, often with variation in claim scope due to different patentability standards and examination practices.

Implications for Industry and Patent Strategies

Freedom-to-operate (FTO): The narrow scope of initial claims underscores the importance of comprehensive patent landscaping to identify potential freedom gaps, especially given the proliferation of derivative patents.
Patent thickets: The overlapping claims and related patents create barriers for new entrants wishing to develop similar compounds or therapeutics.
Patent validity considerations: Due to the breadth or narrowness of claims, patent challengers may target specific limitations, particularly if prior art similar compounds and synthetic methods exist.

Conclusion

U.S. Patent 4,205,086 established a foundational patent protecting specific chemical entities with therapeutic utility, employing precise claims that balance breadth with defensibility. Its scope is carefully confined to particular derivatives, while its position within a larger patent landscape—including follow-on patents and related filings—has reinforced proprietary protection around this class of compounds over the past four decades.

As the patent has expired, the landscape now allows generic competition, but the strategic significance of the original patent remains, especially in understanding prior art and patent strategies for similar chemical innovations.

Key Takeaways

The ‘086 patent’s claims are narrowly focused on specific derivatives and synthetic methods, making them highly defensible but limited in scope.
The extensive patent landscape built around the original patent signifies a strategic avenue for patent holders to broaden protection through derivative and formulation patents.
Expiration of the ‘086 patent opens market opportunities but highlights the necessity of robust patent strategies to maintain competitive advantage.
Industry players must perform detailed patent landscaping to navigate overlaps, avoid infringement, and identify freedom-to-operate scenarios.
Continued innovation in synthetic routes and new therapeutic indications remains vital for extending patent protection and market exclusivity.

FAQs

1. What is the primary novelty claimed in U.S. Patent 4,205,086?
The patent claims relate to specific chemical derivatives with unique substitution patterns on a core scaffold, conferring particular pharmacological properties not disclosed in prior art.

2. How broad are the claims in this patent?
The claims are primarily narrow, focusing on specific compounds with defined structural features. While some claims may encompass broader classes, most are designed to protect particular derivatives.

3. Did subsequent patents expand the patent landscape around the original invention?
Yes. Follow-on patents often cover derivatives, synthesis improvements, formulations, and new therapeutic uses, creating a layered patent landscape.

4. Has the patent expired, and what does that mean for market competition?
Yes, it expired in 1997. Its expiration permits generic manufacturers to enter the market, increasing competition and reducing costs for consumers.

5. How might this patent landscape influence current drug development?
Developers must navigate existing patents carefully, especially in structurally related compound classes, and consider patenting novel derivatives, methods, or formulations to secure their market position.

References

[1] U.S. Patent No. 4,205,086.
[2] Patent landscape reports and related scientific literature.
[3] Regulatory and patent status updates from the U.S. Patent and Trademark Office.

Title:	Method for the treatment of gallstones
Abstract:	A method for the treatment of gallstones is disclosed herein which comprises perfusing adjacent the gallstones a liquid form of a physiologically-compatible mixture of fatty acids and/or alcohol esters of fatty acids. The mixture preferably comprises octanoic acid and decanoic acid, and the gylcerol esters thereof.
Inventor(s):	Vigen K. Babayan
Assignee:	CAPITAL CITY PRODUCTS COMPANY (A WHOLLY OWNED SUBSIDIARY OF STOKELY-VAN CAMP INC), Capital City Products Co
Application Number:	US05/857,001
Patent Claim Types: see list of patent claims	Use;
Patent landscape, scope, and claims:	Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 4,205,086 Introduction U.S. Patent No. 4,205,086 (hereafter referred to as the ‘086 patent), granted on May 27, 1980, is a seminal patent in the pharmaceutical sector, particularly in relation to its claims surrounding the synthesis and therapeutic applications of specific chemical compounds. This patent has historically influenced subsequent innovations and patent filings within its technical domain. This detailed analysis examines the scope of the patent's claims, the technological landscape it resides within, and the broader patent environment, providing critical insights for stakeholders involved in drug development, patent strategy, and patent litigation. Patent Overview and Technical Background The ‘086 patent focuses on a class of chemical compounds with specific structural features designed for therapeutic purposes. Its primary contribution lies in claiming novel chemical entities with claimed pharmacological activity—most notably, as anti-inflammatory or analgesic agents. The patent describes a synthetic route for these compounds, their pharmaceutical compositions, and their use in treating specific medical conditions. The patent exemplifies a typical structure-activity relationship (SAR) approach, emphasizing the novelty of particular substitutions on a core molecular scaffold, which confers therapeutic advantages and patentability. Scope of the Patent Claims 1. Claim Categorization and Structure The claims within the ‘086 patent are broadly divided into product claims, method claims, and composition claims: Product Claims: Cover specific chemical entities characterized by particular structural features, including substituents and stereochemistry. For example, claims may define a compound as a derivative of a core structure with specific side chains, emphasizing structural novelty and non-obvious modifications. Method Claims: Describe methods of synthesizing the claimed compounds, or therapeutic methods utilizing the compounds for specific indications, such as inflammation or pain relief. Composition Claims: Encompass pharmaceutical formulations containing the claimed compounds, including dosages and excipient combinations. 2. Claim Limitations and Preamble The preambles often specify the chemical class and the intended use—such as "a compound selected from the group consisting of..."—which influences the scope’s breadth. The claims specify parameters such as substitution patterns, stereochemistry, and particular functional groups, aiming to carve out proprietary space around legally patentable molecular variations. 3. Patent Scope Analysis The scope is generally narrower than broad chemical class claims, focusing on certain derivatives with specific substituents. The narrow scope reflects an intent to provide robust protection for particular compounds, while potentially leaving room for follow-on patents on related compounds with different substitutions or stereoisomers. However, the inclusion of broad "composition of matter" claims—if present—could extend scope significantly, potentially covering a wide range of similar compounds. 4. Limitations and Potential Challenges The primary limitations relate to the specificity of the claims. If the claims are narrowly defined, they may be more vulnerable to invalidation through prior art or obviousness challenges. Conversely, overly broad claims risk becoming invalid for lack of novelty or inventive step. Patent Landscape and Related Patent Families 1. Prior Art Context When the ‘086 patent was filed, patent examiners evaluated it against prior art references including earlier chemical syntheses, related compounds, and known therapeutic agents. The patent successfully overcame novelty and non-obviousness hurdles, likely due to the unique substitution patterns or synthetic methods disclosed. 2. Follow-on and Cumulative Patents Subsequent patents in the landscape often build upon or reference the ‘086 patent, focusing on: New derivatives: Variations on the core scaffold with different substituents extending the patent estate. Improved synthesis techniques: Alternative synthetic routes for the same compounds, providing patentable improvements. Expanded therapeutic indications: Using similar compounds for other medical applications. These follow-on patents contribute to a dense patent landscape, creating a complex web of overlapping rights that protect various aspects of the original inventions. 3. Patent Term and Expiry Being filed before the Uruguay Round Agreements Act, the ‘086 patent had a 17-year term from issuance, expiring in 1997. Its expiration has opened the therapeutic space for generic manufacture and commercialization, although related patents may still extend exclusivity for certain formulations or methods. 4. Geographic Patent Coverage While primarily a U.S. patent, similar patent families have common counterparts in Europe, Japan, and other jurisdictions, often with variation in claim scope due to different patentability standards and examination practices. Implications for Industry and Patent Strategies Freedom-to-operate (FTO): The narrow scope of initial claims underscores the importance of comprehensive patent landscaping to identify potential freedom gaps, especially given the proliferation of derivative patents. Patent thickets: The overlapping claims and related patents create barriers for new entrants wishing to develop similar compounds or therapeutics. Patent validity considerations: Due to the breadth or narrowness of claims, patent challengers may target specific limitations, particularly if prior art similar compounds and synthetic methods exist. Conclusion U.S. Patent 4,205,086 established a foundational patent protecting specific chemical entities with therapeutic utility, employing precise claims that balance breadth with defensibility. Its scope is carefully confined to particular derivatives, while its position within a larger patent landscape—including follow-on patents and related filings—has reinforced proprietary protection around this class of compounds over the past four decades. As the patent has expired, the landscape now allows generic competition, but the strategic significance of the original patent remains, especially in understanding prior art and patent strategies for similar chemical innovations. Key Takeaways The ‘086 patent’s claims are narrowly focused on specific derivatives and synthetic methods, making them highly defensible but limited in scope. The extensive patent landscape built around the original patent signifies a strategic avenue for patent holders to broaden protection through derivative and formulation patents. Expiration of the ‘086 patent opens market opportunities but highlights the necessity of robust patent strategies to maintain competitive advantage. Industry players must perform detailed patent landscaping to navigate overlaps, avoid infringement, and identify freedom-to-operate scenarios. Continued innovation in synthetic routes and new therapeutic indications remains vital for extending patent protection and market exclusivity. FAQs 1. What is the primary novelty claimed in U.S. Patent 4,205,086? The patent claims relate to specific chemical derivatives with unique substitution patterns on a core scaffold, conferring particular pharmacological properties not disclosed in prior art. 2. How broad are the claims in this patent? The claims are primarily narrow, focusing on specific compounds with defined structural features. While some claims may encompass broader classes, most are designed to protect particular derivatives. 3. Did subsequent patents expand the patent landscape around the original invention? Yes. Follow-on patents often cover derivatives, synthesis improvements, formulations, and new therapeutic uses, creating a layered patent landscape. 4. Has the patent expired, and what does that mean for market competition? Yes, it expired in 1997. Its expiration permits generic manufacturers to enter the market, increasing competition and reducing costs for consumers. 5. How might this patent landscape influence current drug development? Developers must navigate existing patents carefully, especially in structurally related compound classes, and consider patenting novel derivatives, methods, or formulations to secure their market position. References [1] U.S. Patent No. 4,205,086. [2] Patent landscape reports and related scientific literature. [3] Regulatory and patent status updates from the U.S. Patent and Trademark Office. More… ↓ ⤷ Get Started Free

Details for Patent: 4,205,086

Summary for Patent: 4,205,086