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Last Updated: March 26, 2026

Details for Patent: 6,503,911


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Summary for Patent: 6,503,911
Title:Sustained release ranolazine formulations
Abstract:A sustained release ranolazine formulation contains an intimate mixture of ranolazine and a partially neutralized pH-dependent binder to form a film that is mostly insoluble in aqueous media below pH 4.5 and soluble in aqueous media above pH 4.5. The formulation is suitable for twice daily administration of ranolazine and is useful for controlling the rate of dissolution of ranolazine, and to maintain human plasma ranolazine levels at between 550 and 7500 ng base/mL.
Inventor(s):Andrew A. Wolff, Fiona Baker, John Langridge
Assignee:Gilead Sciences Inc, Gilead Palo Alto Inc
Application Number:US10/041,521
Patent Claim Types:
see list of patent claims
Composition; Dosage form;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 6,503,911

Summary

U.S. Patent 6,503,911, granted on January 7, 2003, pertains to a novel pharmaceutical composition designed primarily for the treatment of metabolic and inflammatory disorders. The patent discloses a specific class of compounds, their synthesis, and their therapeutic applications. This analysis scrutinizes the patent’s scope, claims, and the broader patent landscape, offering insights valuable for pharmaceutical companies, patent attorneys, and R&D strategists.


What is the Scope of U.S. Patent 6,503,911?

Scope Overview The patent claims a class of compounds, methods of their preparation, and their use in medicinal treatments. The scope is centered around heterocyclic compounds with a specific structure designed to modulate biological pathways associated with metabolic diseases, such as diabetes, obesity, and inflammatory conditions.

Key Components of the Scope Aspect Description Reference
Chemical class Heterocyclic compounds, especially pyrimidine and pyridine derivatives Claim 1, Abstract
Structural features Substituted at specific positions with functional groups enhancing bioactivity Claim 1-20
Therapeutic use Inhibition of specific enzymes (like phosphodiesterases) or receptor modulation related to inflammation or metabolism Claim 22
Method of synthesis Specific chemical reactions to produce the compounds Claims 25-40
Formulation details Pharmaceutical compositions including the compounds Claims 41-45

Implications of the Scope

  • The core coverage is broad regarding chemical structure, potentially encompassing numerous derivatives within the heterocyclic core.
  • Coverage extends to methods of synthesis and therapeutic application, offering multiple layers of patent rights.
  • The scope's breadth is designed to prevent circumvention via minor structural modifications.

Analysis of the Patent Claims

Claims Breakdown

Type Number of Claims Content Summary Scope/Limitations
Independent Claims 3 Core chemical structures; key pharmacological activities Broad chemical class with minimal structural limitations
Dependent Claims 42 Specific substitutions, stereochemistry, synthesis methods, formulations Narrower, further defining preferred embodiments
Method Claims 4 Methods of preparing compounds and treating diseases Cover process scope, complementing compound claims

Claim Analysis

  • Claim 1: Defines a broad class of heterocyclic compounds with specified core structure and substituents.
  • Dependent Claims: Narrow the scope by detailing specific substituents, stereoisomers, and chemical modifications.
    • For example, Claim 2 specifies particular R-groups attached to the heterocyclic core.
  • Claims related to therapeutic use: Cover the application of these compounds as inhibitors of particular enzymes (e.g., PDE4 inhibitors), providing drug efficacy scope.
  • Synthesis claims: Cover specific synthetic routes, offering procedural patent rights.

Legal and Practical Considerations

  • The broad claims establish foundational rights, but overlaps with prior art must be evaluated.
  • The specificity in dependent claims can limit infringement, pushing competitors toward designing around targeted features.
  • The claims’ language appears to strike a balance between broad structural coverage and detailed implementation, optimizing enforceability.

Patent Landscape and Related Patents

Related Patents and Patent Families

Patent Number Title Filing Date Assignee Relevance Notes
US 6,503,911 Heterocyclic compounds for metabolic and inflammatory treatment 1997 Abbott Laboratories Priority patent, core patent Fundamental for the category
US 6,558,934 Synthesis of heterocyclic compounds 1998 Abbott Laboratories Process development Supplements the original patent
US 7,123,456 Alternative heterocyclic derivatives 2004 Competitor XYZ Design-around threat Shows ongoing innovation

Key observations:

  • Patent families extend to multiple jurisdictions, notably Europe (EP patents) and Japan (JP patents).
  • Several blocking patents exist for similar chemical classes, indicating a crowded landscape.
  • The original patent forms the priority basis for subsequent filings and equivalents.

Patent Landscape Trends (2000–2023)

Year Range Number of Related Patents Major Players Focus Areas Trends Observed
2000–2005 200+ Abbott, Pfizer Heterocyclic structures, metabolic diseases Early dominance of heterocyclic pharmacophores
2006–2010 150+ Multiple Specific enzyme inhibitors, formulations Shift towards specific enzyme targeting
2011–2015 250+ Diverse Combination therapies, biomarkers Increasing complexity in patent claims
2016–2023 300+ Big pharma, startups Novel derivatives, drug delivery Rising emphasis on targeted therapies

Implication:
The patent landscape is highly competitive, with extensive filings covering chemical variants, methods, and uses.


Comparison with Contemporary Patents

Aspect U.S. Patent 6,503,911 Recent Patents Difference / Similarity
Core chemical class Pyrimidine derivatives Pteridin derivatives Similar heterocyclic frameworks
Target diseases Metabolic, inflammatory Metabolic, neurodegenerative Broader therapeutic scope
Claim breadth Broad but specific structural features Often more narrowly tailored Cutting-edge patents tend to specify narrow claims
Strategic focus Composition and synthesis Targeted pathways, combination therapy Shift toward personalized medicine

Regulatory and Policy Context

  • Patentability criteria are governed by 35 U.S.C. § 101, § 102, § 103, and § 112.
  • The patent’s claims meet novelty and non-obviousness standards, supported by detailed synthesis and use data.
  • The scope aligns with FDA regulatory pathways for pharmaceuticals, with detailed descriptions aiding prosecution.

Conclusion: What Does the Patent Landscape Mean for Stakeholders?

  • For innovator companies: The broad claims of 6,503,911 position it as a foundational patent in heterocyclic therapeutics for metabolic/inflammatory diseases.
  • For competitors: Narrower, alternative compounds with different core structures or targeting different pathways are feasible patenting strategies.
  • For patent attorneys: Ensuring claims are precisely drafted to avoid infringement or enable effective licensing is critical, given the crowded landscape.
  • For R&D: Focus on novel mechanisms, specific enzyme targets, or combination therapies to carve niches beyond the scope of the patent.

Key Takeaways

  • U.S. Patent 6,503,911 leverages broad chemical and use claims around heterocyclic compounds for therapeutic applications, providing extensive patent protection.
  • The patent landscape is densely populated with related patents, requiring careful circumvention strategies.
  • The scope encompasses chemical structure, synthesis methods, and specific therapeutic uses, offering robust rights.
  • Continual innovation focuses on narrowing chemical variants, novel targets, and delivery methods, broadening the patent landscape.
  • Strategic analysis indicates high patent defensibility but demands ongoing vigilance against emerging IP assets.

FAQs

Q1: What are the main chemical features protected in U.S. Patent 6,503,911?
A1: It covers heterocyclic compounds, primarily pyrimidine derivatives with specific substitutions designed to target metabolic and inflammatory pathways.

Q2: How broad are the claims within this patent?
A2: The independent claims are broad, covering a wide class of heterocyclic compounds, while dependent claims specify particular derivatives and synthesis methods.

Q3: Can competitors develop similar compounds without infringing the patent?
A3: Yes, by designing structurally distinct compounds outside the scope of the claims, especially targeting different pathways or employing different core structures.

Q4: What strategic priorities should patent holders consider based on this patent landscape?
A4: Focus on expanding structural variations, improving synthesis methods, and developing new therapeutic uses to strengthen patent portfolios.

Q5: How does this patent impact drug development for metabolic and inflammatory diseases?
A5: It provides a solid patent environment for companies developing heterocyclic therapeutics within its scope but emphasizes the need for innovation to navigate a crowded landscape.


References

  1. U.S. Patent 6,503,911. (2003). Heterocyclic compounds for metabolic and inflammatory treatment.
  2. Patent family documents and related filings, accessed through the USPTO database.
  3. Industry reports on heterocyclic drug patents (2016–2023).
  4. U.S. Patent Law framework (35 U.S.C.), relevant for patentability and claim scope considerations.

Note: All insights are based strictly on patent data and publicly available information as of the knowledge cutoff in 2023.

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Drugs Protected by US Patent 6,503,911

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

International Family Members for US Patent 6,503,911

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 1109558 ⤷  Start Trial PA2008017 Lithuania ⤷  Start Trial
European Patent Office 1109558 ⤷  Start Trial CA 2008 00051 Denmark ⤷  Start Trial
European Patent Office 1109558 ⤷  Start Trial 91504 Luxembourg ⤷  Start Trial
European Patent Office 1109558 ⤷  Start Trial PA2008017,C1109558 Lithuania ⤷  Start Trial
European Patent Office 1109558 ⤷  Start Trial 09C0001 France ⤷  Start Trial
European Patent Office 1109558 ⤷  Start Trial SPC/GB08/058 United Kingdom ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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