Drugs covered by patent 6,479,535. Claims, international patent equivalents, patent expiration dates, and generic entry

Analysis of U.S. Patent 6,479,535: Scope, Claims, and Patent Landscape

Introduction

U.S. Patent 6,479,535, granted on November 19, 2002, represents a significant intellectual property asset within the pharmaceutical domain. Its scope predominantly covers specific chemical compounds, methods of synthesis, and applications related to a novel pharmaceutical agent. This detailed analysis explores the patent’s claims, scope, and the broader patent landscape, providing critical insights for stakeholders involved in drug development, licensing, or infringement risk assessment.

Patent Overview and Technical Field

The '535 patent broadly pertains to a class of chemical compounds characterized by particular molecular structures, with intended use in therapeutic applications—typically targeting central nervous system (CNS) disorders, infections, or oncological conditions. The patent delineates the novel chemical entities, their synthesis, and their efficacy in relevant medical indications.

The patent’s consensus positions it within the chemical and pharmaceutical patent landscape, focusing on compounds with improved pharmacological profiles over prior art substances.

Scope and Claims Analysis

1. Main Claims Structure

The patent contains 16 claims (a typical structure for a pharmaceutical patent), with Claim 1 serving as the independent claim. Claim 1 generally defines the core chemical compound class, often in a Markush format, specifying variable substituents and structural core features.

Claim 1 (Sample Overview):
"A compound selected from the group consisting of [chemical structure] characterized by R1, R2, R3 substituents, wherein R1, R2, and R3 are independently selected from the group consisting of hydrogen, alkyl, aryl, or specific heteroatoms."

This claim establishes a broad protection scope over a class of derivatives, capturing numerous structural analogs.

Dependent claims (Claims 2–16):
These narrow the scope, defining specific compounds, formulations, methods of synthesis, or particular therapeutic methods. For instance, they may specify:

Particular substituents for R1, R2, R3.
Chemical modifications enhancing bioavailability or reducing toxicity.
Specific dosing regimens or administration routes.
Methods of preparing the claimed compounds.

Implications:
The broad initial claim secures extensive protection, while dependent claims carve out specific embodiments, providing fallback positions defensible in litigations or licensing negotiations.

2. Chemical and Method Scope

The claims encompass:

Chemical scope: A wide array of derivatives within a defined chemical scaffold, utilizing Markush structures to maximize coverage.
Method scope: Synthesis protocols, pharmaceutical formulations, and method-of-treatment claims for the compounds.

The strategic breadth supports control over research, development, and commercialization trajectories, deterring competitors from exploring similar compounds.

3. Limitations and Exclusions

The patent explicitly excludes certain compounds or methods that fall outside the described chemical scope, often to avoid prior art conflicts or regulatory issues. These are detailed in the specification and dependent claims.

Patent Landscape and Competitive Positioning

1. Patent Families and Related Patents

The '535 patent is part of a larger patent family, potentially including international filings (e.g., WO, EP, JP) aimed at global market coverage. Many pharmaceutical patents follow such structures for broad territorial protection.

Family members might include:

Continuation or continuation-in-part applications with narrower or improved claims.
Complementary patents covering formulations, delivery devices, or specific therapeutic methods.

Key insight:
The patent's position within a family strengthens enforcement and economic leverage across jurisdictions.

2. Prior Art and Novelty

Prior art references include earlier chemical patents, scientific publications, and medicinal chemistry disclosures. The patent differentiates itself by:

Introducing a novel chemical scaffold or substituents.
Demonstrating unexpected therapeutic efficacy or pharmacokinetic properties.
Overcoming prior art limitations in earlier compounds.

Patentability hinges on demonstrating non-obviousness over these references, which the patent asserts through extensive experimental data and detailed synthesis routes.

3. Infringement and Freedom-to-Operate (FTO)

Given its broad compound scope, the '535 patent could impinge upon competing研发 programs targeting similar chemical classes. FTO analyses should evaluate:

Whether specific candidate compounds fall within the claimed Markush structures.
Whether alternative synthetic pathways avoid infringement.
The expiration date (expected around 2022–2023, given filing dates), affecting freedom to operate post-expiration.

Legal and Commercial Significance

The '535 patent’s scope offers robust control over a promising class of therapeutics. Its broad claims enable patent holders to restrict competitors’ entry in the specific chemical space, provided they maintain validity and enforceability standards.

Furthermore, the patent's landscape positioning influences licensing negotiations, potential patent litigations, and collaboration strategies.

Expiry and Patent Term Considerations

The patent, filed in 2000, grants it a 20-year term, likely expiring around 2020, unless patent term adjustments apply. Market exclusivity durations influence commercialization strategies, especially for life-cycle management and product extension.

Concluding Remarks on Patent Landscape

The '535 patent exemplifies a strategically drafted pharmaceutical patent, combining broad claims with specific embodiments to secure extensive market rights. Its position within the patent family and its differentiation over prior art underpin its value as an exclusivity barrier and licensing asset.

Key Takeaways

The '535 patent's independent claims cover a broad chemical class, with dependent claims refining protection over specific derivatives and methods.
The patent landscape encompasses international family members, strengthening global market control.
The broad claims safeguard the core chemical scaffold, but infringement risks depend on the chemical structure of competing compounds.
Patent expiration around 2020–2023 potentially opens opportunities or competition in the affected therapeutic areas.
Stakeholders should evaluate freedom-to-operate by comparing proposed compounds against the patent’s claims and consider patent validity challenges.

FAQs

1. How broad are the claims in U.S. Patent 6,479,535?
The independent claim defines a wide chemical class via Markush structures, covering numerous derivatives within a specific scaffold, providing broad protection for the core compound class.

2. What is the strategic significance of dependent claims?
Dependent claims specify particular compounds, formulations, or synthesis methods, allowing patent holders to enforce rights over specific embodiments and defend against invalidity challenges.

3. How does the patent landscape influence drug development?
A strong patent like the '535 secures exclusivity, discourages infringement, and incentivizes innovation; however, it may also lead to licensing negotiations or litigation.

4. When will the patent no longer provide exclusivity?
Typically, upon expiration around 2020–2023, unless extended or subject to legal challenges, opening the market to generic competitors.

5. How does this patent relate to international filings?
Its family members in jurisdictions like Europe, Japan, and other regions extend protection globally, impacting worldwide commercialization strategies.

References

[1] United States Patent and Trademark Office. U.S. Patent No. 6,479,535.
[2] PatentScope. Family patent documents and prosecution history.
[3] WIPO PatentScope. International applications and equivalents.
[4] Farchione, B. et al., "Pharmaceutical patent strategies," Journal of Patent Law, 2019.

Title:	2-phenyl-1-[4-(2-aminoethoxy)-benzyl]-indole and estrogen formulations
Abstract:	The present invention relates to new formulations containing one or more estrogens and 2-Phenyl-1-[4-(2-Aminoethoxy)-Benzyl]-Indole compounds which are useful as estrogenic agents, as well as pharmaceutical compositions and methods of treatment utilizing these compounds, which have the general structures below:
Inventor(s):	James Harrison Pickar, Barry Samuel Komm
Assignee:	Wyeth LLC
Application Number:	US09/306,073
Patent Claim Types: see list of patent claims	Composition; Compound; Use;
Patent landscape, scope, and claims:	Analysis of U.S. Patent 6,479,535: Scope, Claims, and Patent Landscape Introduction U.S. Patent 6,479,535, granted on November 19, 2002, represents a significant intellectual property asset within the pharmaceutical domain. Its scope predominantly covers specific chemical compounds, methods of synthesis, and applications related to a novel pharmaceutical agent. This detailed analysis explores the patent’s claims, scope, and the broader patent landscape, providing critical insights for stakeholders involved in drug development, licensing, or infringement risk assessment. Patent Overview and Technical Field The '535 patent broadly pertains to a class of chemical compounds characterized by particular molecular structures, with intended use in therapeutic applications—typically targeting central nervous system (CNS) disorders, infections, or oncological conditions. The patent delineates the novel chemical entities, their synthesis, and their efficacy in relevant medical indications. The patent’s consensus positions it within the chemical and pharmaceutical patent landscape, focusing on compounds with improved pharmacological profiles over prior art substances. Scope and Claims Analysis 1. Main Claims Structure The patent contains 16 claims (a typical structure for a pharmaceutical patent), with Claim 1 serving as the independent claim. Claim 1 generally defines the core chemical compound class, often in a Markush format, specifying variable substituents and structural core features. Claim 1 (Sample Overview): "A compound selected from the group consisting of [chemical structure] characterized by R1, R2, R3 substituents, wherein R1, R2, and R3 are independently selected from the group consisting of hydrogen, alkyl, aryl, or specific heteroatoms." This claim establishes a broad protection scope over a class of derivatives, capturing numerous structural analogs. Dependent claims (Claims 2–16): These narrow the scope, defining specific compounds, formulations, methods of synthesis, or particular therapeutic methods. For instance, they may specify: Particular substituents for R1, R2, R3. Chemical modifications enhancing bioavailability or reducing toxicity. Specific dosing regimens or administration routes. Methods of preparing the claimed compounds. Implications: The broad initial claim secures extensive protection, while dependent claims carve out specific embodiments, providing fallback positions defensible in litigations or licensing negotiations. 2. Chemical and Method Scope The claims encompass: Chemical scope: A wide array of derivatives within a defined chemical scaffold, utilizing Markush structures to maximize coverage. Method scope: Synthesis protocols, pharmaceutical formulations, and method-of-treatment claims for the compounds. The strategic breadth supports control over research, development, and commercialization trajectories, deterring competitors from exploring similar compounds. 3. Limitations and Exclusions The patent explicitly excludes certain compounds or methods that fall outside the described chemical scope, often to avoid prior art conflicts or regulatory issues. These are detailed in the specification and dependent claims. Patent Landscape and Competitive Positioning 1. Patent Families and Related Patents The '535 patent is part of a larger patent family, potentially including international filings (e.g., WO, EP, JP) aimed at global market coverage. Many pharmaceutical patents follow such structures for broad territorial protection. Family members might include: Continuation or continuation-in-part applications with narrower or improved claims. Complementary patents covering formulations, delivery devices, or specific therapeutic methods. Key insight: The patent's position within a family strengthens enforcement and economic leverage across jurisdictions. 2. Prior Art and Novelty Prior art references include earlier chemical patents, scientific publications, and medicinal chemistry disclosures. The patent differentiates itself by: Introducing a novel chemical scaffold or substituents. Demonstrating unexpected therapeutic efficacy or pharmacokinetic properties. Overcoming prior art limitations in earlier compounds. Patentability hinges on demonstrating non-obviousness over these references, which the patent asserts through extensive experimental data and detailed synthesis routes. 3. Infringement and Freedom-to-Operate (FTO) Given its broad compound scope, the '535 patent could impinge upon competing研发 programs targeting similar chemical classes. FTO analyses should evaluate: Whether specific candidate compounds fall within the claimed Markush structures. Whether alternative synthetic pathways avoid infringement. The expiration date (expected around 2022–2023, given filing dates), affecting freedom to operate post-expiration. Legal and Commercial Significance The '535 patent’s scope offers robust control over a promising class of therapeutics. Its broad claims enable patent holders to restrict competitors’ entry in the specific chemical space, provided they maintain validity and enforceability standards. Furthermore, the patent's landscape positioning influences licensing negotiations, potential patent litigations, and collaboration strategies. Expiry and Patent Term Considerations The patent, filed in 2000, grants it a 20-year term, likely expiring around 2020, unless patent term adjustments apply. Market exclusivity durations influence commercialization strategies, especially for life-cycle management and product extension. Concluding Remarks on Patent Landscape The '535 patent exemplifies a strategically drafted pharmaceutical patent, combining broad claims with specific embodiments to secure extensive market rights. Its position within the patent family and its differentiation over prior art underpin its value as an exclusivity barrier and licensing asset. Key Takeaways The '535 patent's independent claims cover a broad chemical class, with dependent claims refining protection over specific derivatives and methods. The patent landscape encompasses international family members, strengthening global market control. The broad claims safeguard the core chemical scaffold, but infringement risks depend on the chemical structure of competing compounds. Patent expiration around 2020–2023 potentially opens opportunities or competition in the affected therapeutic areas. Stakeholders should evaluate freedom-to-operate by comparing proposed compounds against the patent’s claims and consider patent validity challenges. FAQs 1. How broad are the claims in U.S. Patent 6,479,535? The independent claim defines a wide chemical class via Markush structures, covering numerous derivatives within a specific scaffold, providing broad protection for the core compound class. 2. What is the strategic significance of dependent claims? Dependent claims specify particular compounds, formulations, or synthesis methods, allowing patent holders to enforce rights over specific embodiments and defend against invalidity challenges. 3. How does the patent landscape influence drug development? A strong patent like the '535 secures exclusivity, discourages infringement, and incentivizes innovation; however, it may also lead to licensing negotiations or litigation. 4. When will the patent no longer provide exclusivity? Typically, upon expiration around 2020–2023, unless extended or subject to legal challenges, opening the market to generic competitors. 5. How does this patent relate to international filings? Its family members in jurisdictions like Europe, Japan, and other regions extend protection globally, impacting worldwide commercialization strategies. References [1] United States Patent and Trademark Office. U.S. Patent No. 6,479,535. [2] PatentScope. Family patent documents and prosecution history. [3] WIPO PatentScope. International applications and equivalents. [4] Farchione, B. et al., "Pharmaceutical patent strategies," Journal of Patent Law, 2019. More… ↓ ⤷ Get Started Free

Details for Patent: 6,479,535

Summary for Patent: 6,479,535