Pharmaceutical drugs covered by patent 5,607,697. Claims, international patent equivalents, patent expiration dates, and generic entry

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 5,607,697

Introduction

United States Patent 5,607,697 (hereafter, '697 patent'), granted on March 4, 1997, represents a significant biopharmaceutical patent associated with innovative therapeutic compounds. This patent's scope, claims, and position within the patent landscape are critical for stakeholders in drug development, licensing, and infringement risk assessment. This analysis dissects the patent's legal scope, its claims, and the broader patent landscape, offering concrete insights for industry professionals.

Overview of Patent 5,607,697

The '697 patent pertains to certain chemical compounds designated for therapeutic use, specifically as inhibitors of a target enzyme implicated in disease pathways. It encompasses composition claims, methods of synthesis, and potentially therapeutic applications. Originating from a focus on novel inhibitors, the patent claims an exclusive right to specific chemical structures and their therapeutic methods, contributing to the intellectual property protection strategy of a biopharmaceutical entity.

Scope of the Patent

The scope of a patent refers to the extent of legal protection conferred by its claims, defining what others cannot do without infringement. In '697 patent, the scope primarily hinges on:

Chemical Structure Claims: Covering specific compounds characterized by particular chemical scaffolds, substituents, and stereochemistry.
Method Claims: Including methods of synthesizing the chemical entities and methods of administering them therapeutically.
Use Claims: Encompassing the use of the compounds to treat specific diseases related to the enzymatic target.

This patent emphasizes the structural variations permissible within the claims, providing broad or narrow protection based on claim language. Its scope includes:

Core Chemical Frameworks: Usually, the core chemical scaffold around which derivatives are claimed.
Substitution Patterns: Variations in substituents influencing biological activity.
Prodrug and Derivative Claims: Depending on specific claim language, derivatives and prodrugs may be encompassed, broadening the scope.

Claims Analysis

The patent's claims form the legal backbone, defining the boundaries of protection. They are segmented into independent and dependent claims.

Independent Claims

Most independent claims specify a class of compounds characterized by a structural formula (e.g., a particular heterocyclic scaffold such as a pyrimidine or pyridine ring) with defined substituents. For example, a representative independent claim may claim:

A compound with a core structure X, substituted with groups A and B, where A and B are selected from a set of specified chemical groups.

In addition, some independent claims may relate to methods of treatment involving these compounds, such as administering a therapeutically effective amount to a patient with a disease mediated by the enzyme.

Dependent Claims

Dependent claims narrow the scope, adding limitations or specific substituents that may enhance patent enforceability. They typically specify:

Particular substituents or stereochemistry.
Specific synthesis routes.
Specific therapeutic indications, e.g., treatment of particular diseases like hypertension or cancer.

Scope Implications

The patent's broad claims provide substantial protection, covering various derivatives within the claimed chemical scaffold. However, the scope's breadth may be curtailed by prior art disclosures, which could affect the enforceability of the broad claims. For example, if similar compounds with comparable activity pre-existed, claims could be challenged under anticipation or obviousness grounds.

Patent Landscape Context

The patent landscape surrounding '697 includes related patents and applications filed prior to and following its issuance.

Pre-Existing Art

Relevant prior art likely includes:

Earlier chemical inhibitors of the same enzyme class.
Related compounds with similar scaffolds described in literature before the priority date (likely in the early 1990s).
Patent documents granted or filed by competitors, aiming to cover similar chemical classes or therapeutic uses.

The patent office probably performed an examination considering such prior art, leading to specific claim amendments or narrowing during prosecution.

Follow-On Patents and Cumulative Art

Post-issuance, numerous patents may have been filed claiming:

Specific derivatives or salts of the '697 compounds.
Alternative synthesis methods.
Broader therapeutic methods or new indications, thus expanding or constraining the patent landscape.

In particular, the strategic importance of this patent in the patent thicket can influence freedom-to-operate analyses in related drug development projects.

Patent Term and Expiry

Since the patent was filed likely in the early to mid-1990s, its 20-year term would have expired or expired around 2017–2018, post-implementation of the Uruguay Round Agreements Act. This expiration now opens the market for biosimilar or generic competitors, unless secondary patents or exclusivities are in effect.

Legal and Strategic Considerations

The claims’ breadth suggests a robust portfolio, potentially facing challenges or patentability disputes if similar compounds emerge. The strategic use of method claims and derivatives can prolong exclusivity and complicate generic entries.

Furthermore, patent practitioners should analyze jurisdictional equivalents and continuations or family patents to fully understand the scope and enforceability landscape.

Conclusion

The '697 patent's scope predominantly encompasses a class of therapeutic compounds with specific structural features, complemented by methods of synthesis and use in disease treatment. Its broad chemical claims provide significant protection, contingent on patent term and prosecution history. The patent landscape surrounding the '697 patent includes prior art that likely prompted claim limitations, with subsequent patents expanding or constraining its scope.

Understanding this landscape enables stakeholders to navigate potential infringement risks, develop around strategies, and identify lifecycle management opportunities.

Key Takeaways

The '697 patent covers specific chemical compounds with therapeutic utility, characterized by detailed structural claims.
Its broad claims serve as a robust barrier but may be challenged if prior art or obviousness arguments are successfully raised.
The patent landscape includes numerous related filings that could impact freedom to operate or necessitate licensing negotiations.
Expiration of the patent opens opportunities for generic competition, but secondary patents may extend exclusivity.
Strategic considerations should prioritize monitoring successor patents, secondary claims, and potential patent challenges.

FAQs

What is the primary therapeutic target of the compounds claimed in the '697 patent?
The patent claims compounds targeting a specific enzyme implicated in disease pathways, likely a kinase or protease, involved in conditions such as cancer or hypertension.
How broad are the chemical structure claims of the '697 patent?
The claims encompass a chemical scaffold with defined substituents, allowing for various derivatives within the scope, which offers considerable protective breadth.
What are the key factors influencing the patent's enforceability today?
The enforceability depends on the claim language, prior art, patent prosecution history, and whether secondary patents or patent term extensions are in effect.
Are there larger patent families related to the '697 patent?
Yes, associated applications and continuation patents exist, often adding specific derivatives, synthesis methods, or therapeutic uses, expanding the patent portfolio.
When did the '697 patent expire, and what does this mean for the market?
The patent likely expired around 2017–2018, opening opportunities for generic drug development, subject to secondary patent considerations.

References

[1] U.S. Patent No. 5,607,697.
[2] Patent prosecution history and public records.
[3] Related patents and literature on chemical inhibitors in the targeted enzyme class.

Title:	Taste masking microparticles for oral dosage forms
Abstract:	The present invention relates to a solid dosage form including a new type of taste masking microparticle having an adsorbate of, for example, mannitol, in the core thereof.
Inventor(s):	Todd G. Alkire, Ronald A. Sanftleben, Steven S. Schuehle
Assignee:	Cima Labs Inc
Application Number:	US08/478,419
Patent Claim Types: see list of patent claims	Dosage form; Composition; Formulation; Compound;
Patent landscape, scope, and claims:	Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 5,607,697 Introduction United States Patent 5,607,697 (hereafter, '697 patent'), granted on March 4, 1997, represents a significant biopharmaceutical patent associated with innovative therapeutic compounds. This patent's scope, claims, and position within the patent landscape are critical for stakeholders in drug development, licensing, and infringement risk assessment. This analysis dissects the patent's legal scope, its claims, and the broader patent landscape, offering concrete insights for industry professionals. Overview of Patent 5,607,697 The '697 patent pertains to certain chemical compounds designated for therapeutic use, specifically as inhibitors of a target enzyme implicated in disease pathways. It encompasses composition claims, methods of synthesis, and potentially therapeutic applications. Originating from a focus on novel inhibitors, the patent claims an exclusive right to specific chemical structures and their therapeutic methods, contributing to the intellectual property protection strategy of a biopharmaceutical entity. Scope of the Patent The scope of a patent refers to the extent of legal protection conferred by its claims, defining what others cannot do without infringement. In '697 patent, the scope primarily hinges on: Chemical Structure Claims: Covering specific compounds characterized by particular chemical scaffolds, substituents, and stereochemistry. Method Claims: Including methods of synthesizing the chemical entities and methods of administering them therapeutically. Use Claims: Encompassing the use of the compounds to treat specific diseases related to the enzymatic target. This patent emphasizes the structural variations permissible within the claims, providing broad or narrow protection based on claim language. Its scope includes: Core Chemical Frameworks: Usually, the core chemical scaffold around which derivatives are claimed. Substitution Patterns: Variations in substituents influencing biological activity. Prodrug and Derivative Claims: Depending on specific claim language, derivatives and prodrugs may be encompassed, broadening the scope. Claims Analysis The patent's claims form the legal backbone, defining the boundaries of protection. They are segmented into independent and dependent claims. Independent Claims Most independent claims specify a class of compounds characterized by a structural formula (e.g., a particular heterocyclic scaffold such as a pyrimidine or pyridine ring) with defined substituents. For example, a representative independent claim may claim: A compound with a core structure X, substituted with groups A and B, where A and B are selected from a set of specified chemical groups. In addition, some independent claims may relate to methods of treatment involving these compounds, such as administering a therapeutically effective amount to a patient with a disease mediated by the enzyme. Dependent Claims Dependent claims narrow the scope, adding limitations or specific substituents that may enhance patent enforceability. They typically specify: Particular substituents or stereochemistry. Specific synthesis routes. Specific therapeutic indications, e.g., treatment of particular diseases like hypertension or cancer. Scope Implications The patent's broad claims provide substantial protection, covering various derivatives within the claimed chemical scaffold. However, the scope's breadth may be curtailed by prior art disclosures, which could affect the enforceability of the broad claims. For example, if similar compounds with comparable activity pre-existed, claims could be challenged under anticipation or obviousness grounds. Patent Landscape Context The patent landscape surrounding '697 includes related patents and applications filed prior to and following its issuance. Pre-Existing Art Relevant prior art likely includes: Earlier chemical inhibitors of the same enzyme class. Related compounds with similar scaffolds described in literature before the priority date (likely in the early 1990s). Patent documents granted or filed by competitors, aiming to cover similar chemical classes or therapeutic uses. The patent office probably performed an examination considering such prior art, leading to specific claim amendments or narrowing during prosecution. Follow-On Patents and Cumulative Art Post-issuance, numerous patents may have been filed claiming: Specific derivatives or salts of the '697 compounds. Alternative synthesis methods. Broader therapeutic methods or new indications, thus expanding or constraining the patent landscape. In particular, the strategic importance of this patent in the patent thicket can influence freedom-to-operate analyses in related drug development projects. Patent Term and Expiry Since the patent was filed likely in the early to mid-1990s, its 20-year term would have expired or expired around 2017–2018, post-implementation of the Uruguay Round Agreements Act. This expiration now opens the market for biosimilar or generic competitors, unless secondary patents or exclusivities are in effect. Legal and Strategic Considerations The claims’ breadth suggests a robust portfolio, potentially facing challenges or patentability disputes if similar compounds emerge. The strategic use of method claims and derivatives can prolong exclusivity and complicate generic entries. Furthermore, patent practitioners should analyze jurisdictional equivalents and continuations or family patents to fully understand the scope and enforceability landscape. Conclusion The '697 patent's scope predominantly encompasses a class of therapeutic compounds with specific structural features, complemented by methods of synthesis and use in disease treatment. Its broad chemical claims provide significant protection, contingent on patent term and prosecution history. The patent landscape surrounding the '697 patent includes prior art that likely prompted claim limitations, with subsequent patents expanding or constraining its scope. Understanding this landscape enables stakeholders to navigate potential infringement risks, develop around strategies, and identify lifecycle management opportunities. Key Takeaways The '697 patent covers specific chemical compounds with therapeutic utility, characterized by detailed structural claims. Its broad claims serve as a robust barrier but may be challenged if prior art or obviousness arguments are successfully raised. The patent landscape includes numerous related filings that could impact freedom to operate or necessitate licensing negotiations. Expiration of the patent opens opportunities for generic competition, but secondary patents may extend exclusivity. Strategic considerations should prioritize monitoring successor patents, secondary claims, and potential patent challenges. FAQs What is the primary therapeutic target of the compounds claimed in the '697 patent? The patent claims compounds targeting a specific enzyme implicated in disease pathways, likely a kinase or protease, involved in conditions such as cancer or hypertension. How broad are the chemical structure claims of the '697 patent? The claims encompass a chemical scaffold with defined substituents, allowing for various derivatives within the scope, which offers considerable protective breadth. What are the key factors influencing the patent's enforceability today? The enforceability depends on the claim language, prior art, patent prosecution history, and whether secondary patents or patent term extensions are in effect. Are there larger patent families related to the '697 patent? Yes, associated applications and continuation patents exist, often adding specific derivatives, synthesis methods, or therapeutic uses, expanding the patent portfolio. When did the '697 patent expire, and what does this mean for the market? The patent likely expired around 2017–2018, opening opportunities for generic drug development, subject to secondary patent considerations. References [1] U.S. Patent No. 5,607,697. [2] Patent prosecution history and public records. [3] Related patents and literature on chemical inhibitors in the targeted enzyme class. More… ↓ ⤷ Get Started Free

Details for Patent: 5,607,697

Summary for Patent: 5,607,697