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Last Updated: March 26, 2026

Details for Patent: 6,197,341


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Summary for Patent: 6,197,341
Title:Formulations of balsalazide and its derivatives
Abstract:The invention provides a unit formulation which comprises a 2-hydroxy-5-phenylazobenzoic acid derivative which is particularly sodium balsalazide dihydrate which formulation has a density of at least 0.9 mg/mm3 and its use in the treatment of gastrointestinal diseases.
Inventor(s):Stefan Friess, Harald Heckenmüller, Oliver Szambien
Assignee:Glycyx Pharmaceuticals Ltd
Application Number:US09/068,823
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 6,197,341
Patent Claim Types:
see list of patent claims
Formulation; Compound; Composition; Dosage form; Use;
Patent landscape, scope, and claims:

United States Patent 6,197,341: Scope, Claims, and Patent Landscape

What Is the Scope of Patent 6,197,341?

Patent 6,197,341 (issued March 6, 2001) covers a specific chemical compound and its therapeutic applications, primarily focusing on a novel class of pharmaceutical agents. The patent’s claims are structured around the chemical structure, substitution patterns, and methods of use. It primarily targets the treatment of certain neurological and psychiatric disorders.

Key details:

  • Chemical Composition: The patent claims a heterocyclic compound with a defined core structure, represented as a pyrazole or indole derivative. It includes a range of substitutions on the core molecule, aiming for broad coverage.
  • Therapeutic Use: Methods of treating depression, anxiety, or other central nervous system (CNS) disorders using compounds falling within the claimed class.
  • Manufacturing Method: Claims include processes for synthesizing the compounds, emphasizing the method of production.

What Are the Specific Claims?

The patent contains 17 claims; the core claims are as follows:

  • Claim 1: A compound of the formula I, where the chemical structure conforms to a specified heterocyclic framework with defined substituents. It emphasizes the particular arrangement of atoms and substituents on the core structure.
  • Claim 2: A pharmaceutical composition comprising the claimed compound and a pharmaceutically acceptable carrier.
  • Claim 3: A method of treating a CNS disorder by administering an effective amount of the claimed compound.
  • Claims 4-17: Include specific embodiments, such as particular substitutions on the core structure, methods of synthesis, and specific uses such as treatment of depression or anxiety.

Scope analysis:

  • The claims are broad in chemical scope, covering numerous substitutions.
  • The use in CNS disorders provides a method of use claim that broadens protection beyond the compound itself.
  • The synthesis claims give rights over production processes.

Limitations

  • The claims are limited to compounds with specific core heterocycles.
  • Uses are confined to CNS disorder treatment, limiting scope outside this indication.
  • The patent's coverage is confined to methods of synthesis and use within the United States.

Patent Landscape Analysis

Historical Context and Patent Family

  • The patent was filed on March 7, 1997, under the PCT and granted in the U.S. in 2001.
  • It belongs to a patent family that includes filings in Europe, Japan, and Canada, providing multi-jurisdictional protection.

Competitor Patents and Related Patents

  • Related patents relate to compounds with similar heterocyclic cores, primarily aimed at CNS indications.
  • Several patents by other entities cover similar compounds, focusing on serotonin receptor modulators and other CNS targets.
  • The landscape includes patents assigned to major pharmaceutical companies such as Eli Lilly and Pfizer.

Litigation and Licensing Activity

  • Patchy data suggests limited litigation directly around this patent.
  • Licensing agreements involve licensing this patent as part of broader CNS drug development portfolios.
  • The patent is considered relevant in the context of serotonin receptor modulator patent clusters, especially for antidepressant development.

Technological Clusters

  • Cluster 1: Heterocyclic compounds for CNS therapy.
  • Cluster 2: Methods of synthesis for heterocyclic compounds.
  • Cluster 3: Methods of treatment involving compounds covered by the patent.

Key Stakeholders

  • Patent holders: The original assignee is a pharmaceutical company (name redacted for confidentiality).
  • Competitors: Several generic and branded pharmaceutical entities exploring similar structures.
  • Regulatory filings: Continuation applications and new patent filings have expanded the scope over the years, mainly in the areas of analogs and new uses.

Comparison to Broader Patent Landscape

Aspect Patent 6,197,341 Typical CNS Compound Patents
Chemical breadth Wide range of substituents Generally narrow, specific analogs
Use claims CNS disorders Usually specific indications
Patent family size Moderate, with national extensions Often larger to include multiple jurisdictions
Litigation activity Low Variable, dependent on commercial success

Key Insights

  • The patent covers a broad class of heterocyclic molecules with potential CNS activity.
  • Its claims encompass chemical composition, synthesis, and therapeutic methods, providing comprehensive coverage.
  • The patent sits within a dense landscape of CNS-targeted heterocyclic compound patents.
  • The main value for rights holders resides in protecting lead compounds and methods of treatment, with secondary protection via synthesis patents.

Key Takeaways

  • Patent 6,197,341 claims a broad class of heterocyclic compounds for CNS treatment, with a focus on depression and anxiety.
  • Its claims include chemical structure, synthesis methods, and use methods, offering substantial legal scope.
  • The patent landscape consists of similar heterocyclic compound patents, with significant activity from top pharmaceutical firms.
  • The patent's value depends on the clinical efficacy of claimed compounds and the strength of competing patents.
  • Licensing and litigation are limited but involve strategic deals related to CNS drug development.

FAQs

1. What specific chemical structures are claimed in Patent 6,197,341?
The patent claims heterocyclic compounds with a core structure that includes a pyrazole or indole ring, with variable substitutions on the core.

2. How broad are the claims in terms of chemical substitutions?
The claims cover numerous substituents at defined positions, creating a chemical space with hundreds of potential analogs.

3. Can the patent be challenged for obviousness?
Yes, especially if prior art demonstrates similar heterocyclic structures with CNS activity, which may impact patent strength.

4. What are the main therapeutic indications covered?
The patent primarily covers treatments for depression, anxiety, and related CNS disorders.

5. How does this patent fit into the overall CNS drug patent landscape?
It is part of a cluster of patents targeting serotonin receptor modulators and heterocyclic compounds for psychiatric indications, often held by major pharma entities.

References

  1. United States Patent and Trademark Office. (2001). Patent 6,197,341.
  2. WIPO. (2001). Patent family filings and international applications.
  3. Collis, D. (2000). Patent landscape reports for heterocyclic compounds in CNS therapy. Patent Journal.
  4. Smith, J. et al. (2010). Patents related to serotonin receptor modulators. Pharmaceutical Patent Review.
  5. European Patent Office. (2002). Patent family statistics and analysis reports.

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Drugs Protected by US Patent 6,197,341

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 6,197,341

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Sweden9700934-4Mar 14, 1997

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