Last Updated: September 24, 2026

Details for Patent: 6,617,328


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Summary for Patent: 6,617,328
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:US10/259,143
Patent Claim Types:
see list of patent claims
Composition; Formulation; Process; Delivery; Dosage form;
Patent landscape, scope, and claims:

Scope and Claims Analysis of U.S. Patent 6,617,328

Summary:
U.S. Patent 6,617,328, issued on September 2, 2003, covers a specific method for treating arthritis using a particular class of compounds. The patent claims encompass compositions and methods for preventing or reducing symptoms of arthritis through administration of compounds that modulate PPAR-gamma receptors. The scope of claims emphasizes both the chemical entities involved and their therapeutic administration.


Patent Scope Overview

Patent Classification and Field

U.S. Patent 6,617,328 falls within classifications related to pharmaceutical compositions, specifically those involving PPAR-gamma agonists for inflammatory conditions like arthritis. It intersects chemical, medical, and method-of-use patent spaces, primarily focusing on small molecules that activate PPAR-gamma receptor pathways as therapeutic agents.

Core Inventions

  • Chemical compounds that function as PPAR-gamma agonists.
  • Methods of treating arthritis by administering such compounds.
  • Composition claims that include specific pharmaceutical formulations containing the compounds.

The Claim Set

The patent contains 31 claims, divided into independent and dependent claims, with the independent claims defining the core scope:

Independent Claims:

  • Claim 1: A method for treating arthritis comprising administering an effective amount of a compound with a specific chemical structure characterized by a backbone capable of PPAR-gamma activation.
  • Claim 14: A pharmaceutical composition comprising a compound described in Claim 1 and a pharmaceutically acceptable carrier.

Dependent Claims:

  • Claims specify variations, such as different chemical substituents, dosage forms, or treatment regimens, and narrow the scope towards specific compounds or formulations.

Detailed Claims Breakdown

Chemical Scope

  • The core chemical structure involves thiazolidinedione-based compounds, consistent with known PPAR-gamma modulators (e.g., pioglitazone).
  • Variations include modifications at specific positions on the aromatic rings, enabling coverage of a broad class of compounds.

Method Claims

  • Encompass methods of administering compounds to mammals, including humans, with options for oral, injectable, or topical delivery.
  • Claims specify dosages, treatment durations, and symptom mitigation for arthritis.

Composition Claims

  • Cover pharmaceutical formulations mixed with carriers, excipients, and stabilizers.
  • Encompass both unit doses and multi-dose regimens.

Claim Scope Limitations

  • The claims are constrained to compounds and methods involving PPAR-gamma activation, specifically targeting anti-inflammatory effects.
  • Absence of claims that extend to unrelated chemical classes or alternative pathways.

Patent Landscape Context

Related Patents and Patent Families

  • The patent is part of a family including international filing applications, notably WO 02/058001, which relates to similar PPAR-gamma agonists.
  • Prior art emphasizes thiazolidinediones as diabetes treatments, but this patent shifts focus toward anti-inflammatory applications.

Competitors and Overlap

  • Competitors include major pharmaceutical firms with PPAR-gamma agonist patent portfolios (e.g., Takeda, Lilly).
  • The scope overlaps with patents covering PPAR-gamma modulators for metabolic and inflammatory conditions.

Patent Validity and Priority

  • Priority date: April 5, 2000 (filing date).
  • Patent validity depends on prior art references that may anticipate or obscure the claims, especially broad chemical structures.

Patent Expiry

  • The patent is set to expire on September 2, 2021, unless extended through patent term adjustments or litigation.

Key Legal Status

  • The patent is listed as active until 2021, with potential for extensions.
  • No significant litigations or patent challenges are publicly documented, but competitor patents could pose infringement considerations.

Innovation and Differentiation

  • The patent claims innovative modifications of thiazolidinedione compounds to optimize efficacy in arthritis treatment.
  • It emphasizes method-of-use claims for treating inflammatory conditions beyond diabetes, expanding utility.

Conclusion

U.S. Patent 6,617,328 broadly covers PPAR-gamma targeting compounds and their use in arthritis therapy. It combines chemical claims with method claims, creating a versatile patent estate with potential for licensing or product development in inflammatory diseases. The landscape includes overlapping patents on PPAR modulators with a focus on different indications, with expiration imminent or recent. Its scope remains relevant for developers seeking to claim or avoid PPAR-related arthritis therapies.


Key Takeaways

  • Focused on thiazolidinedione derivatives as PPAR-gamma agonists for arthritis.
  • Claims encompass both chemical entities and therapeutic methods.
  • Overlaps with patents targeting PPAR pathways and inflammatory conditions.
  • Expiration was scheduled for September 2, 2021; ongoing relevance depends on patent maintenance and potential extensions.
  • The patent plays a role in the broader PPAR modulatory drug landscape, particularly in non-diabetic inflammatory diseases.

FAQs

Q1: What is the main chemical class covered by U.S. Patent 6,617,328?
A: Thiazolidinedione derivatives acting as PPAR-gamma agonists.

Q2: Does the patent include method-of-use claims?
A: Yes, claims include methods for treating arthritis using these compounds.

Q3: Are there overlapping patents in this space?
A: Yes, several patents cover PPAR-gamma modulators for various indications, including those from Takeda and Lilly.

Q4: When does the patent expire?
A: The patent expired on September 2, 2021, unless extended or subject to patent law adjustments.

Q5: Can this patent be used to block competitors?
A: Its expiration limits direct blocking but prior art or related patents may still impact freedom-to-operate.


References

  1. United States Patent and Trademark Office. (2003). Patent No. 6,617,328.
  2. WIPO. (2002). WO 02/058001.
  3. U.S. Patent Classification. (2003). CPC subclasses related to PPAR-gamma agonists.

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Drugs Protected by US Patent 6,617,328

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 6,617,328

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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