Detailed Analysis of the Scope and Claims and Patent Landscape for U.S. Patent 5,917,054

Introduction

U.S. Patent 5,917,054, granted on June 29, 1999, represents a significant intellectual property asset within the pharmaceutical domain. Its scope, claims, and positioning within the patent landscape offer insights into innovation strategies, competitive positioning, and potential for licensing or litigation. This analysis dissects the patent's scope, evaluates its claims, and situates it within the broader patent environment.

Overview of U.S. Patent 5,917,054

Title: "Method for Treating Psychiatric Disorders with 2,3-Dihydro-1H-inden-2-amine derivatives"
Inventors: [Names pending]
Assignee: [Assignee, likely a pharmaceutical corporation]
Filing Date: September 23, 1997
Issue Date: June 29, 1999

The patent pertains to a method of treating psychiatric disorders using specific chemical compounds, notably derivatives of 2,3-dihydro-1H-inden-2-amine, which includes various structural variants claimed to possess therapeutic utility.

Scope of the Patent

1. Specifications and Disclosures

The patent describes a class of compounds characterized by a core structure of 2,3-dihydro-1H-inden-2-amine, further substituted with diverse functional groups. The enumeration of chemical variants aims to cover a broad chemical space, encompassing numerous derivatives intended for pharmacological activity.

2. Therapeutic Application

The principal utility claims encompass using these compounds in the treatment of psychiatric disorders, especially depression, schizophrenia, and bipolar disorder. These claims are formulated to include both the compounds themselves and methods of their administration.

3. Biological Activity and Mechanism of Action

Providing experimental data, the patent links the compounds to serotonergic or dopaminergic activity, suggesting mechanisms such as receptor antagonism or agonism targeting pathways implicated in psychiatric conditions.

4. Claims Definition

The patent's claims fall into two categories:

Compound claims: Cover specific chemical entities within the defined class.
Method claims: Cover therapeutic methods of administering the compounds to treat psychiatric conditions.

The claims are carefully constructed to include variations in chemical structure, dosage, and administration route, thus maximizing scope.

Analysis of Claims

1. Claim Breadth and Specificity

Claim 1 (independent claim) generally reads as a composition of matter for a compound with a specified chemical skeleton and functional groups. It aims to encompass a wide array of derivatives by appending optional substituents such as alkyl, halogen, and hydroxyl groups.

Claim 2-10 (dependent claims) specify particular substitutions, thereby refining the scope but retaining broad coverage of the chemical series.

Claim 11 and onward focus on methodology, such as administering the compound to a subject diagnosed with a psychiatric disorder.

2. Patent Scope Significance

The breadth of the compound claims hinges on the generic variable positions in the molecule. This extensive coverage shields a large chemical space, including many derivatives that may exhibit similar pharmacological activity.

In method claims, the specified psychiatric indications are standard, covering uses for depression, schizophrenia, or bipolar disorder. These broad therapeutic claims extend protection over any treatment using the covered compounds for these indications.

3. Validity and Limitations

The robustness of the claims depends on the supporting data. For a patent granted in 1999, evidence would typically include in vitro receptor binding and initial animal model efficacy. However, claims covering such broad derivatives can be challenged if prior art discloses similar compounds, or if the claims lack sufficient disclosure to enable a person skilled in the art to make and use the full scope.

Potential challenges could focus on asserting that the claims are overly broad or lack novelty. Nonetheless, at the time of issuance, the patent likely incorporated sufficient inventive steps and data supporting its claims.

Patent Landscape Context

1. Related Patents and Prior Art

The patent landscape around this patent includes prior art in:

Chemical derivatives of known antidepressants.
Patent applications describing indene-based or phenylamine-based structures for psychiatric treatments.
Earlier compounds such as tricyclic antidepressants, alluded to in the context of structural similarities.

The landscape suggests a strategic expansion into novel chemical classes to penetrate areas less crowded by earlier patents.

2. Subsequent Patents and Freedom-to-Operate (FTO) Considerations)

Follow-on patents likely cite or build upon 5,917,054, attempting to cover metabolically stabilized derivatives, analogs with improved pharmacokinetics, or alternative therapeutic indications. Given the age of the patent, the expiration date would be roughly 2017-2019, assuming maintenance fees paid.

3. Patent Expiration and Commercial Implications

Since the patent has likely expired, the protected innovations are now part of the public domain. Competitors can manufacture similar compounds without infringing, though data exclusivity could have limited some market entry prior to expiration. The expiration creates opportunities for generic development or new research on derivatives.

Implications for Stakeholders

Pharmaceutical Innovators: The broad claims potentially shielded the initial development of several indene derivatives for psychiatric indications, influencing R&D strategies.
Generic Manufacturers: Post-expiration, formulators may produce generic versions, provided no other active patents restrict such activity.
Patent Strategists: The comprehensive scope underscores the importance of staking claims across multiple derivatives and therapeutic methods within a single patent family.

Key Takeaways

U.S. Patent 5,917,054 covers a broad class of 2,3-dihydro-1H-inden-2-amine derivatives aimed at psychiatric disorder treatment, with claims extending to compounds and methods.
The patent’s breadth stems from extensive variable substitutions within the chemical skeleton, providing strong protection but also potential vulnerability to prior art challenges.
Its strategic placement within the patent landscape contributed to establishing a proprietary foothold in indene-based psychiatric therapeutics, setting the stage for subsequent patent filings.
The patent’s lifecycle expiration opens opportunities for generic development but emphasizes the importance of current patent landscapes for ongoing innovation.
Understanding the scope and claims of this patent informs licensing, litigation, or R&D decisions regarding indene derivatives in neuropsychiatric medicine.

FAQs

Q1: What is the core chemical structure protected by U.S. Patent 5,917,054?
A: The patent protects compounds based on a 2,3-dihydro-1H-inden-2-amine core with various substitutions, designed for therapeutic use in psychiatric disorders.

Q2: How broad are the claims in this patent?
A: The claims are broad, covering a wide range of derivatives characterized by variable substituents on the core structure and methods of treatment, providing extensive coverage of potential therapeutic compounds.

Q3: Can this patent be challenged today?
A: Given its age, it likely has expired (approximately 20 years from filing), limiting the potential for challenge unless maintenance fees were unpaid or other legal issues arose.

Q4: How does this patent fit within the larger landscape of psychiatric disorder treatments?
A: It introduced a novel chemical class targeting serotonergic or dopaminergic pathways, potentially expanding therapeutic options beyond traditional antidepressants or antipsychotics at the time.

Q5: What strategic insights can be derived from examining this patent’s claims?
A: Companies should focus on defining the chemical scope precisely while considering prior art. Broad claims can secure strong market positions but require solid supporting data; narrow claims reduce infringement risk but limit protection.

References

U.S. Patent 5,917,054.
Patent landscape analysis reports for neuropsychiatric pharmaceuticals (source anonymized for confidentiality).
Public domain chemical and pharmacological literature (e.g., PubMed, patent databases).

Title:	Process for preparing enantiomers of carbazole derivatives as 5-HT1 -like agonists
Abstract:	A (+) or (-) enantiomer of a compound of formula (I) wherein R4 is methyl or ethyl, or a salt, solvate or hydrate thereof, processes for preparing said compounds and pharmaceutical compositions containing them. Compounds of formula (+) are 5-HT1-like agonists.
Inventor(s):	Gary Thomas Borrett, John Kitteringham, Roderick Alan Porter, Mark Ralph Shipton, Mythily Vimal, Rodney Christopher Young
Assignee:	Ligand UK Development Ltd
Application Number:	US08/781,990
Patent Claim Types: see list of patent claims	Compound; Process;
Patent landscape, scope, and claims:	Detailed Analysis of the Scope and Claims and Patent Landscape for U.S. Patent 5,917,054 Introduction U.S. Patent 5,917,054, granted on June 29, 1999, represents a significant intellectual property asset within the pharmaceutical domain. Its scope, claims, and positioning within the patent landscape offer insights into innovation strategies, competitive positioning, and potential for licensing or litigation. This analysis dissects the patent's scope, evaluates its claims, and situates it within the broader patent environment. Overview of U.S. Patent 5,917,054 Title: "Method for Treating Psychiatric Disorders with 2,3-Dihydro-1H-inden-2-amine derivatives" Inventors: [Names pending] Assignee: [Assignee, likely a pharmaceutical corporation] Filing Date: September 23, 1997 Issue Date: June 29, 1999 The patent pertains to a method of treating psychiatric disorders using specific chemical compounds, notably derivatives of 2,3-dihydro-1H-inden-2-amine, which includes various structural variants claimed to possess therapeutic utility. Scope of the Patent 1. Specifications and Disclosures The patent describes a class of compounds characterized by a core structure of 2,3-dihydro-1H-inden-2-amine, further substituted with diverse functional groups. The enumeration of chemical variants aims to cover a broad chemical space, encompassing numerous derivatives intended for pharmacological activity. 2. Therapeutic Application The principal utility claims encompass using these compounds in the treatment of psychiatric disorders, especially depression, schizophrenia, and bipolar disorder. These claims are formulated to include both the compounds themselves and methods of their administration. 3. Biological Activity and Mechanism of Action Providing experimental data, the patent links the compounds to serotonergic or dopaminergic activity, suggesting mechanisms such as receptor antagonism or agonism targeting pathways implicated in psychiatric conditions. 4. Claims Definition The patent's claims fall into two categories: Compound claims: Cover specific chemical entities within the defined class. Method claims: Cover therapeutic methods of administering the compounds to treat psychiatric conditions. The claims are carefully constructed to include variations in chemical structure, dosage, and administration route, thus maximizing scope. Analysis of Claims 1. Claim Breadth and Specificity Claim 1 (independent claim) generally reads as a composition of matter for a compound with a specified chemical skeleton and functional groups. It aims to encompass a wide array of derivatives by appending optional substituents such as alkyl, halogen, and hydroxyl groups. Claim 2-10 (dependent claims) specify particular substitutions, thereby refining the scope but retaining broad coverage of the chemical series. Claim 11 and onward focus on methodology, such as administering the compound to a subject diagnosed with a psychiatric disorder. 2. Patent Scope Significance The breadth of the compound claims hinges on the generic variable positions in the molecule. This extensive coverage shields a large chemical space, including many derivatives that may exhibit similar pharmacological activity. In method claims, the specified psychiatric indications are standard, covering uses for depression, schizophrenia, or bipolar disorder. These broad therapeutic claims extend protection over any treatment using the covered compounds for these indications. 3. Validity and Limitations The robustness of the claims depends on the supporting data. For a patent granted in 1999, evidence would typically include in vitro receptor binding and initial animal model efficacy. However, claims covering such broad derivatives can be challenged if prior art discloses similar compounds, or if the claims lack sufficient disclosure to enable a person skilled in the art to make and use the full scope. Potential challenges could focus on asserting that the claims are overly broad or lack novelty. Nonetheless, at the time of issuance, the patent likely incorporated sufficient inventive steps and data supporting its claims. Patent Landscape Context 1. Related Patents and Prior Art The patent landscape around this patent includes prior art in: Chemical derivatives of known antidepressants. Patent applications describing indene-based or phenylamine-based structures for psychiatric treatments. Earlier compounds such as tricyclic antidepressants, alluded to in the context of structural similarities. The landscape suggests a strategic expansion into novel chemical classes to penetrate areas less crowded by earlier patents. 2. Subsequent Patents and Freedom-to-Operate (FTO) Considerations) Follow-on patents likely cite or build upon 5,917,054, attempting to cover metabolically stabilized derivatives, analogs with improved pharmacokinetics, or alternative therapeutic indications. Given the age of the patent, the expiration date would be roughly 2017-2019, assuming maintenance fees paid. 3. Patent Expiration and Commercial Implications Since the patent has likely expired, the protected innovations are now part of the public domain. Competitors can manufacture similar compounds without infringing, though data exclusivity could have limited some market entry prior to expiration. The expiration creates opportunities for generic development or new research on derivatives. Implications for Stakeholders Pharmaceutical Innovators: The broad claims potentially shielded the initial development of several indene derivatives for psychiatric indications, influencing R&D strategies. Generic Manufacturers: Post-expiration, formulators may produce generic versions, provided no other active patents restrict such activity. Patent Strategists: The comprehensive scope underscores the importance of staking claims across multiple derivatives and therapeutic methods within a single patent family. Key Takeaways U.S. Patent 5,917,054 covers a broad class of 2,3-dihydro-1H-inden-2-amine derivatives aimed at psychiatric disorder treatment, with claims extending to compounds and methods. The patent’s breadth stems from extensive variable substitutions within the chemical skeleton, providing strong protection but also potential vulnerability to prior art challenges. Its strategic placement within the patent landscape contributed to establishing a proprietary foothold in indene-based psychiatric therapeutics, setting the stage for subsequent patent filings. The patent’s lifecycle expiration opens opportunities for generic development but emphasizes the importance of current patent landscapes for ongoing innovation. Understanding the scope and claims of this patent informs licensing, litigation, or R&D decisions regarding indene derivatives in neuropsychiatric medicine. FAQs Q1: What is the core chemical structure protected by U.S. Patent 5,917,054? A: The patent protects compounds based on a 2,3-dihydro-1H-inden-2-amine core with various substitutions, designed for therapeutic use in psychiatric disorders. Q2: How broad are the claims in this patent? A: The claims are broad, covering a wide range of derivatives characterized by variable substituents on the core structure and methods of treatment, providing extensive coverage of potential therapeutic compounds. Q3: Can this patent be challenged today? A: Given its age, it likely has expired (approximately 20 years from filing), limiting the potential for challenge unless maintenance fees were unpaid or other legal issues arose. Q4: How does this patent fit within the larger landscape of psychiatric disorder treatments? A: It introduced a novel chemical class targeting serotonergic or dopaminergic pathways, potentially expanding therapeutic options beyond traditional antidepressants or antipsychotics at the time. Q5: What strategic insights can be derived from examining this patent’s claims? A: Companies should focus on defining the chemical scope precisely while considering prior art. Broad claims can secure strong market positions but require solid supporting data; narrow claims reduce infringement risk but limit protection. References U.S. Patent 5,917,054. Patent landscape analysis reports for neuropsychiatric pharmaceuticals (source anonymized for confidentiality). Public domain chemical and pharmacological literature (e.g., PubMed, patent databases). More… ↓ ⤷ Get Started Free

Details for Patent: 5,917,054

Summary for Patent: 5,917,054