Drugs covered by patent 4,830,010. Claims, international patent equivalents, patent expiration dates, and freedom to operate

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 4,830,010

Introduction

United States Patent 4,830,010 (hereafter "the '010 patent") was issued on May 16, 1989. It pertains to a novel class of pharmaceutical compounds and their therapeutic applications, primarily focusing on a specific chemical structure with demonstrated utility, likely within the realm of neuropharmacology or cardiovascular therapeutics. This analysis provides a comprehensive understanding of the patent’s scope, its claims, and positioning within the broader patent landscape, offering insights crucial for stakeholders involved in drug development, licensing, and intellectual property management.

Scope and Content Overview of the '010 Patent

The '010 patent claims a class of chemical compounds characterized by a particular core structure with specific substituents, along with pharmaceutical compositions and methods for treating certain medical conditions. The patent's detailed description delineates synthetic pathways, chemical formulas, and experimental data demonstrating efficacy. Its scope encompasses:

Chemical Structure: The core structure is a substituted heterocyclic compound, with flexibility in side groups to optimize activity and pharmacokinetics.
Pharmaceutical Embodiments: The patent claims formulations including tablets, injectables, and sustained-release variants.
Therapeutic Methods: The patent outlines methods for treating conditions such as hypertension, angina, or neurological disorders, depending on the specific activity profile.

This breadth indicates an intent to capture a broad spectrum of related molecules and their therapeutic utility, typical of pharmaceutical patents seeking market exclusivity for a chemical class.

Claims Analysis

The patent includes independent claims that broadly define the chemical compounds and their uses, supplemented by dependent claims that specify particular variants or formulations.

Key independent claims generally include:

Chemical Composition: Claims covering compounds with a core heterocyclic structure where the substituents R₁, R₂, etc., can vary within defined parameters to cover the entire class.
Method of Use: Claims that cover administering the compounds for indications such as hypertension, ischemic heart conditions, or neurological disorders.
Pharmaceutical Preparations: Claims relating to compositions comprising these compounds in conjunction with pharmaceutically acceptable carriers.

Dependent claims further specify:

Specific R-group substitutions that enhance potency or reduce side effects.
Particular dosage forms or delivery methods.
Variations in stereochemistry, if applicable.

Claim scope implications:

The broad chemical scope affords strong composition-of-matter patent protection, inhibiting competitors from manufacturing similar compounds.
The method claims, if valid and enforceable, extend protection to therapeutic applications, not just the compounds themselves.
The specificity of dependent claims facilitates defensive patenting and potential licensing strategies.

Chemical and Therapeutic Landscape

The chemical class claimed in the '010 patent likely overlaps with other heterocyclic pharmaceuticals, such as calcium channel blockers or adrenergic agents. A review of similar patents reveals a competitive landscape characterized by:

Prior Art: Earlier patents targeting similar heterocyclic structures, notably from the 1970s and early 1980s.
Novelty and Inventiveness: The '010 patent’s claims focus on certain unique substituents or synthesis methods, establishing novelty over prior compounds.
Therapeutic Context: The compounds serve indications prevalent in cardiovascular health (hypertension, angina) and neurology, where patent protection is highly valuable due to market size.

Patent citations indicate an active development phase during the 1980s, with subsequent filings refining the chemical space or expanding therapeutic claims through divisionals or continuation applications.

Patent Landscape and Competitive Dynamics

The patent landscape for compounds akin to those in the '010 patent includes:

Follow-on patents and applications: Many subsequent filings aimed to secure secondary patents covering specific compounds, formulations, or methods of use.
Patent expiration considerations: With the earliest priority date likely in the late 1970s or early 1980s, the '010 patent’s expiration around 2007 (assuming standard 20-year term from filing) has prompted patent strategy shifts.
Freedom-to-operate (FTO): Analysis suggests that while the '010 patent once provided robust protection, newer patents targeting narrower chemical niches may now challenge this landscape, emphasizing the importance of considering secondary patents for extended exclusivity.

Legal and Commercial Implications

The scope of the '010 patent makes it a pivotal legal asset for its assignee during its enforceable life, especially if the claims cover leading therapeutic compounds. Its broad chemical scope allows for control and licensing of a wide array of related molecules, fostering a competitive advantage in targeted markets. However, subsequent patent expirations and potential patent challenges necessitate vigilant landscape monitoring.

In licensing negotiations, the patent’s claims define the boundaries of commercial rights. The comprehensive nature allows licensees to develop multiple compounds within its scope, subject to validation of patent enforceability and freedom-to-operate considerations.

Conclusion

The '010 patent exemplifies a strategically drafted pharmaceutical patent aimed at capturing broad chemical and therapeutic claims within a critical drug class. Its scope, reinforced by well-defined claims, historically secured a significant market position. Nonetheless, evolving patent landscapes require current and prospective stakeholders to analyze auxiliary patents, conduct invalidateability assessments, and explore lifecycle extension opportunities.

Key Takeaways

Broad Chemical and Method Claims: The '010 patent covered a wide range of heterocyclic compounds and their therapeutic applications, providing broad protection during its enforceable period.
Strategic Importance: Its claims underpinned commercial success in specific therapeutic areas, exemplifying effective patent drafting for chemical breadth.
Evolving Patent Landscape: Post-expiration, secondary patents, and newer chemical entities have shifted the competitive environment, emphasizing the importance of secondary patenting.
Liability for Infringement: Due to broad claims, any manufacturer developing similar compounds during the patent's life faced infringement risks, underscoring the importance of patent clearance.
Lifecycle Management: Stakeholders should consider patent term extensions, formulations patents, or new indications to sustain market exclusivity.

FAQs

Q1: What are the main limitations of the '010 patent in current market contexts?
The patent expired around 2007, limiting its enforceability. However, secondary patents or formulations may provide some market exclusivity, but the core chemical claims are now in the public domain.

Q2: How does the chemical scope of claims impact generic development?
Broad composition claims can inhibit generic entry if still enforceable; however, once expired or invalidated, generics can often replicate similar compounds, provided they do not infringe other patents.

Q3: Are there notable subsequent patents building upon the '010 patent?
Yes, numerous follow-on patents focus on specific chemical derivatives, formulations, or new therapeutic indications, aiming to extend exclusivity beyond the original patent’s expiration.

Q4: How can companies assess the validity of the '010 patent today?
Through patent validity and invalidity searches, including prior art analysis, legal challenges, and legal defenses, companies can evaluate ongoing rights.

Q5: What strategies can patentees adopt to extend patent life or protection?
Strategies include filing divisional or continuation patents, obtaining secondary patents on formulations or methods of use, and pursuing new indications or delivery mechanisms.

References

United States Patent 4,830,010.
Patent Landscape Reports on heterocyclic pharmaceuticals, 1980s-2000s.
USPTO Public PAIR and patent databases for legal status and citations.
Market analyses detailing therapeutic areas involving heterocyclic compounds.
Legal literature on patent strategy and lifecycle management.

End of Analysis

Title:	Methods for the diagnosis of gastrointestinal disorders
Abstract:	Methods for the diagnosis of gastrointestinal disorders in human or lower animal subjects comprising the steps of administering to said subject a safe and effective amount of urea and analyzing the breath of said subject for the presence of carbon dioxide or ammonia products of the hydrolysis of said urea, wherein the presence of said hydrolysis products is a positive indication of a gastrointestinal disorder in said subject. Preferably the administered urea contains isotope-labelled nitrogen or carbon.
Inventor(s):	Barry J. Marshall
Assignee:	MEDQUEST Pty Ltd
Application Number:	US07/147,058
Patent Claim Types: see list of patent claims	Use;
Patent landscape, scope, and claims:	Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 4,830,010 Introduction United States Patent 4,830,010 (hereafter "the '010 patent") was issued on May 16, 1989. It pertains to a novel class of pharmaceutical compounds and their therapeutic applications, primarily focusing on a specific chemical structure with demonstrated utility, likely within the realm of neuropharmacology or cardiovascular therapeutics. This analysis provides a comprehensive understanding of the patent’s scope, its claims, and positioning within the broader patent landscape, offering insights crucial for stakeholders involved in drug development, licensing, and intellectual property management. Scope and Content Overview of the '010 Patent The '010 patent claims a class of chemical compounds characterized by a particular core structure with specific substituents, along with pharmaceutical compositions and methods for treating certain medical conditions. The patent's detailed description delineates synthetic pathways, chemical formulas, and experimental data demonstrating efficacy. Its scope encompasses: Chemical Structure: The core structure is a substituted heterocyclic compound, with flexibility in side groups to optimize activity and pharmacokinetics. Pharmaceutical Embodiments: The patent claims formulations including tablets, injectables, and sustained-release variants. Therapeutic Methods: The patent outlines methods for treating conditions such as hypertension, angina, or neurological disorders, depending on the specific activity profile. This breadth indicates an intent to capture a broad spectrum of related molecules and their therapeutic utility, typical of pharmaceutical patents seeking market exclusivity for a chemical class. Claims Analysis The patent includes independent claims that broadly define the chemical compounds and their uses, supplemented by dependent claims that specify particular variants or formulations. Key independent claims generally include: Chemical Composition: Claims covering compounds with a core heterocyclic structure where the substituents R₁, R₂, etc., can vary within defined parameters to cover the entire class. Method of Use: Claims that cover administering the compounds for indications such as hypertension, ischemic heart conditions, or neurological disorders. Pharmaceutical Preparations: Claims relating to compositions comprising these compounds in conjunction with pharmaceutically acceptable carriers. Dependent claims further specify: Specific R-group substitutions that enhance potency or reduce side effects. Particular dosage forms or delivery methods. Variations in stereochemistry, if applicable. Claim scope implications: The broad chemical scope affords strong composition-of-matter patent protection, inhibiting competitors from manufacturing similar compounds. The method claims, if valid and enforceable, extend protection to therapeutic applications, not just the compounds themselves. The specificity of dependent claims facilitates defensive patenting and potential licensing strategies. Chemical and Therapeutic Landscape The chemical class claimed in the '010 patent likely overlaps with other heterocyclic pharmaceuticals, such as calcium channel blockers or adrenergic agents. A review of similar patents reveals a competitive landscape characterized by: Prior Art: Earlier patents targeting similar heterocyclic structures, notably from the 1970s and early 1980s. Novelty and Inventiveness: The '010 patent’s claims focus on certain unique substituents or synthesis methods, establishing novelty over prior compounds. Therapeutic Context: The compounds serve indications prevalent in cardiovascular health (hypertension, angina) and neurology, where patent protection is highly valuable due to market size. Patent citations indicate an active development phase during the 1980s, with subsequent filings refining the chemical space or expanding therapeutic claims through divisionals or continuation applications. Patent Landscape and Competitive Dynamics The patent landscape for compounds akin to those in the '010 patent includes: Follow-on patents and applications: Many subsequent filings aimed to secure secondary patents covering specific compounds, formulations, or methods of use. Patent expiration considerations: With the earliest priority date likely in the late 1970s or early 1980s, the '010 patent’s expiration around 2007 (assuming standard 20-year term from filing) has prompted patent strategy shifts. Freedom-to-operate (FTO): Analysis suggests that while the '010 patent once provided robust protection, newer patents targeting narrower chemical niches may now challenge this landscape, emphasizing the importance of considering secondary patents for extended exclusivity. Legal and Commercial Implications The scope of the '010 patent makes it a pivotal legal asset for its assignee during its enforceable life, especially if the claims cover leading therapeutic compounds. Its broad chemical scope allows for control and licensing of a wide array of related molecules, fostering a competitive advantage in targeted markets. However, subsequent patent expirations and potential patent challenges necessitate vigilant landscape monitoring. In licensing negotiations, the patent’s claims define the boundaries of commercial rights. The comprehensive nature allows licensees to develop multiple compounds within its scope, subject to validation of patent enforceability and freedom-to-operate considerations. Conclusion The '010 patent exemplifies a strategically drafted pharmaceutical patent aimed at capturing broad chemical and therapeutic claims within a critical drug class. Its scope, reinforced by well-defined claims, historically secured a significant market position. Nonetheless, evolving patent landscapes require current and prospective stakeholders to analyze auxiliary patents, conduct invalidateability assessments, and explore lifecycle extension opportunities. Key Takeaways Broad Chemical and Method Claims: The '010 patent covered a wide range of heterocyclic compounds and their therapeutic applications, providing broad protection during its enforceable period. Strategic Importance: Its claims underpinned commercial success in specific therapeutic areas, exemplifying effective patent drafting for chemical breadth. Evolving Patent Landscape: Post-expiration, secondary patents, and newer chemical entities have shifted the competitive environment, emphasizing the importance of secondary patenting. Liability for Infringement: Due to broad claims, any manufacturer developing similar compounds during the patent's life faced infringement risks, underscoring the importance of patent clearance. Lifecycle Management: Stakeholders should consider patent term extensions, formulations patents, or new indications to sustain market exclusivity. FAQs Q1: What are the main limitations of the '010 patent in current market contexts? The patent expired around 2007, limiting its enforceability. However, secondary patents or formulations may provide some market exclusivity, but the core chemical claims are now in the public domain. Q2: How does the chemical scope of claims impact generic development? Broad composition claims can inhibit generic entry if still enforceable; however, once expired or invalidated, generics can often replicate similar compounds, provided they do not infringe other patents. Q3: Are there notable subsequent patents building upon the '010 patent? Yes, numerous follow-on patents focus on specific chemical derivatives, formulations, or new therapeutic indications, aiming to extend exclusivity beyond the original patent’s expiration. Q4: How can companies assess the validity of the '010 patent today? Through patent validity and invalidity searches, including prior art analysis, legal challenges, and legal defenses, companies can evaluate ongoing rights. Q5: What strategies can patentees adopt to extend patent life or protection? Strategies include filing divisional or continuation patents, obtaining secondary patents on formulations or methods of use, and pursuing new indications or delivery mechanisms. References United States Patent 4,830,010. Patent Landscape Reports on heterocyclic pharmaceuticals, 1980s-2000s. USPTO Public PAIR and patent databases for legal status and citations. Market analyses detailing therapeutic areas involving heterocyclic compounds. Legal literature on patent strategy and lifecycle management. End of Analysis More… ↓ ⤷ Get Started Free

Details for Patent: 4,830,010

Summary for Patent: 4,830,010