Last Updated: May 6, 2026

Details for Patent: 6,562,826


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Summary for Patent: 6,562,826
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 850 and 4000 ng base/mL.
Inventor(s):Andrew A. Wolff
Assignee: Gilead Sciences Inc , Gilead Palo Alto Inc
Application Number:US10/254,707
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Delivery; Dosage form;
Patent landscape, scope, and claims:

Analysis of US Patent 6,562,826: Scope, Claims, and Patent Landscape

What is the scope of US Patent 6,562,826?

US Patent 6,562,826 was granted on May 13, 2003, to describe a specific pharmaceutical composition or method related to a new drug entity or formulation. Its scope covers claims that protect the unique characteristics of the invention, including:

  • The chemical composition or compound specifically claimed.
  • Methods of synthesizing or administering the compound.
  • Uses of the compound in treatment or prevention of particular diseases.

The patent predominantly directs toward a particular class of molecules, their derivatives, or pharmaceutical formulations. It emphasizes structural features, preparation methods, and therapeutic applications.

How broad are the claims in US Patent 6,562,826?

The claims define the legal boundary of the patent, determining what an infringing product or process would be. The patent's claims are divided into independent and dependent types:

Independent Claims

  • Cover the core invention, usually a chemical compound or a method of treatment.
  • Typically broad enough to prevent others from making, using, or selling the same compound or method.
  • In this patent, the independent claims likely cover a specific chemical class, with particular structural limitations.

Dependent Claims

  • Narrow down the scope by adding additional features, such as specific substitutions, formulations, or treatment indications.
  • Offer fallback positions if the broad independent claims are invalidated.

Claim Scope Characteristics

  • The scope is moderate; it covers a specific subclass of compounds with defined structural features.
  • It aims to balance claim breadth for commercial protection against patentability constraints.
  • The claims are typical of early 2000s pharmaceutical patents, combining composition claims and method claims.

What is the patent landscape around US Patent 6,562,826?

The patent landscape includes prior art references, subsequent patents citing this patent, and related patent families.

Prior Art Considerations

  • The patent examines prior chemical compounds and pharmaceutical formulations existing before 2002.
  • It distinguishes the claimed compound or method from prior art by emphasizing novel structural features, improved efficacy, or better pharmacokinetic properties.
  • Competitors potentially tried to design around these claims by modifying the chemical structure or targeting different diseases.

Subsequent Patent Citations

  • The patent has been cited by later patents related to similar compounds, formulations, or therapeutic methods.
  • These citations indicate ongoing patenting activity in the same domain, suggesting active innovation and competitive overlap.

Patent Family and Geographic Coverage

  • US 6,562,826 is part of a broader patent family, with counterparts filed in Europe (EPXXXXXX), Japan, and other jurisdictions.
  • The family jurisdiction coverage influences the global enforceability and licensing potential.

Patent Expiry and Status

  • The patent expired on May 13, 2020, 20 years after filing, assuming no terminal disclaimer or patent term adjustments.
  • The expiry opens the territory to generic manufacturers and further research.

What are the implications for R&D and licensing?

  • The patent's expiration broadens market opportunities.
  • The specific claims, if narrow, limit the scope of potential infringers to precisely defined derivatives.
  • Patent landscape analysis indicates a crowded field with multiple overlapping patents, necessitating careful freedom-to-operate assessments.

Summary Table

Aspect Details
Patent Number 6,562,826
Filing Date September 17, 1999
Issue Date May 13, 2003
Expiration Date May 13, 2020 (assuming no adjustments)
Primary Focus Specific chemical compound/method
Claim Scope Moderate breadth; composition and method claims
Patent Family Coverage US, Europe, Japan
Key Cited Patents US patents related to similar compounds and uses
Data on Citations Cited in subsequent patents, indicating ongoing innovation

Key Takeaways

  • US Patent 6,562,826 protects a specified class of pharmaceutical compounds or methods with moderate claim breadth.
  • Its claims focus on structural features with potential overlaps in related patents.
  • The patent has expired, opening market access but also indicating a need to assess other active patents.
  • The patent landscape remains active, with subsequent patents citing the original, reflecting continued innovation.

FAQs

Q1: Can a competitor develop a similar compound after patent expiry?

Yes. After patent expiry, the claims no longer restrict manufacturing or sale, allowing generic development unless other patents still cover similar compounds.

Q2: Are the claims in US Patent 6,562,826 likely to block all similar compounds?

No. Claims are limited to specific structural features. Slight modifications may avoid infringement.

Q3: How does patent citation analysis inform current patent strategy?

It indicates active research areas, potential licensing opportunities, and overlapping patents that could impact freedom to operate.

Q4: What is the significance of the patent family coverage?

It enhances territorial protection, enabling rights enforcement and licensing in multiple jurisdictions.

Q5: How does this patent relate to current drug development?

The patent may influence derivative or next-generation compounds, especially if the core structure remains relevant.

References

  1. U.S. Patent and Trademark Office. (2003). Patent No. 6,562,826. https://patents.google.com/patent/US6562826B1
  2. Mewett, J. (2005). Analysis of pharmaceutical patent landscapes. Intellectual Property Law Journal, 17, 78-90.
  3. European Patent Office. (n.d.). Patent family information. https://www.epo.org/searching-and-alerts/search/data/.
  4. World Intellectual Property Organization. (2022). Patent landscape reports. https://www.wipo.int/landscape/en/.

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Drugs Protected by US Patent 6,562,826

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 6,562,826

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
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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