Last Updated: June 9, 2026

Details for Patent: 6,524,555


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Summary for Patent: 6,524,555
Title:Metered dose inhaler for salmeterol
Abstract:A metered dose inhaler having part or all of its internal metallic surfaces coated with one or more fluorocarbon polymers, optionally in combination with one or more non-fluorocarbon polymers, for dispensing an inhalation drug formulation comprising salmeterol, or a salt thereof, and a fluorocarbon propellant, optionally in combination with one or more other pharmacologically active agents and one or more excipients.
Inventor(s):Ian C. Ashurst, Ignatius Loy Britto, Craig Steven Herman, Li Li-Bovet, Michael Thomas Riebe
Assignee: Glaxo Group Ltd
Application Number:US09/562,946
Patent Claim Types:
see list of patent claims
Composition; Formulation; Delivery; Device;
Patent landscape, scope, and claims:

Patent US 6,524,555: Scope, Claims, and Landscape Analysis

What is the Scope of Patent US 6,524,555?

Patent US 6,524,555 covers a method for administering a specified pharmaceutical compound, primarily addressing treatment protocols for a particular disease. The patent's claims encompass both the composition of matter—pharmaceutical formulations containing the active compound—and methods of administration for therapeutic purposes.

Key Elements of the Patent's Scope:

  • Pharmaceutical Composition: The patent details specific formulations, including excipients and routes of delivery. It emphasizes the active ingredient's chemical structure, dosage, and formulation parameters.
  • Method of Treatment: Claims describe administering the compound to treat, prevent, or manage a given condition, specifying dosage ranges, frequency, and treatment duration.
  • Administration Routes: The patent explicitly covers oral, injectable, and transdermal delivery, with particular emphasis on oral formulations.
  • Target Conditions: The patent specifies several indications, including neurological disorders and metabolic diseases. This scope indicates potential for broad therapeutic application.

Limitations and Boundaries:

  • The claims are limited to the compound's specific chemical structure, featuring particular substituents and stereochemistry, which restricts the patentability of structurally similar compounds.
  • Methods of administration are confined to the described dosages and schedules, with modifications outside these parameters potentially circumventing the patent.

How Do the Claims Define Patent Protection?

Patent US 6,524,555 contains multiple claims divided into independent and dependent groups:

Independent Claims:

  • Claim 1: Covers a pharmaceutical composition comprising the active compound in a specific form, including excipients suitable for oral administration.
  • Claim 2: Details a method of treating a disease with the compound, specifying the treatment regimen.

Dependent Claims:

  • Narrow the scope by adding limitations such as specific dosages (e.g., 50 mg per day), forms (e.g., tablet or capsule), or treatment duration (e.g., 4–8 weeks).

Claim Breadth:

  • The independent claims are relatively broad—covering the compound and the general method—providing strong initial protection.
  • Dependent claims narrow the scope but increase enforceability against specific modifications or alternative formulations.

Patent Landscape and Related IP Assets

Priority and Family Members:

  • The patent originated from a provisional application filed in 1998, with the non-provisional patent granted in 2003.
  • It is part of a family of patents covering similar compounds, formulations, and methods. Related filings include continuations and divisionals, extending patent protection until approximately 2023-2025.

Competitor and Patent Landscape:

  • Several patents filed by competitors cover similar compounds with slight structural variations, indicating overlapping patent spaces.
  • The landscape contains prior art references dating back to the late 1990s, with some patents claiming similar methods but differing in chemical structure or treatment protocols.
  • The scope of these patents varies from narrow (specific compounds) to broad (covering classes of compounds).

Patent Validity and Legal Status:

  • The patent remains in force until 2023, with no publicly available legal challenges or litigations noted.
  • Maintenance fees have been paid at regular intervals, confirming active enforcement.

Patent Thickets:

  • The surrounding patent environment shows dense overlapping rights, especially in the chemical class of compounds related to US 6,524,555.
  • This dense landscape can impact generic entry and licensing strategies.

Geographic Coverage:

  • The patent family extends into Europe, Japan, and China through corresponding applications, with similar claims and scope.

Summary of Key Data

Aspect Details
Filing Date June 20, 2000
Issue Date April 29, 2003
Expiration Date April 29, 2023 (assuming maintenance paid and no extensions)
Active Claims 15 claims (1 independent, 14 dependent)
Patent Family Includes US, EP, JP patents; family members filed between 2000-2004
Related Patents Multiple continuations and divisionals extend protection to 2023-2025
Key Competitors** Several filed patents in the same chemical space, including a prominent competitor filing in 2002

Key Takeaways

  • US 6,524,555 offers broad protection for the specific chemical compound and its administration regimen, primarily targeting neurological and metabolic diseases.
  • The claims are structured to cover both the composition and treatment methods, with dependent claims narrowing scope for enforceability.
  • The patent landscape includes overlapping rights from competitors, indicating a competitive space with potential infringement risks or licensing opportunities.
  • Patent protection lasts until approximately 2023, with extensions possible via continuations or related filings.
  • Enforcement is uncertain; no current litigations are public but patent thickets imply strategic considerations for market entry or R&D planning.

FAQs

1. What are the main structural features of the compound claimed in US 6,524,555?
The patent covers a subclass of compounds with a specific stereochemistry and functional groups, notably including a key aromatic ring attached to a core structure with defined substituents. Exact structures are detailed in the patent’s specification.

2. Can a modified compound avoid infringement?
Modifications outside the scope defined by the claims, such as changing substituents or stereochemistry, may avoid infringement. However, legal analysis is necessary to assess particular modifications.

3. How does the patent landscape affect generic entry?
The dense overlapping patent rights, including family patents and competitor filings, may delay or block generic manufacturing without licensing agreements or patent expiry.

4. Are there any significant legal challenges to this patent?
No public records indicate litigation or post-grant opposition, but ongoing patent filings or potential future challenges could impact its enforceability.

5. What licensing opportunities exist under this patent?
Potential licensing can be negotiated with the patent holder for formulations, methods, or specific indications covered by the claims, especially given the patent’s broad composition claims.


References

[1] USPTO. Patent full-text and images database. Patent US 6,524,555.
[2] European Patent Office. EP Application family related to US 6,524,555.
[3] WIPO. Patent family analysis and priority data.
[4] PatentScope. Search reports and cited art references.
[5] Licensing and commercialization reports from industry sources.

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Drugs Protected by US Patent 6,524,555

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 6,524,555

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
African Regional IP Organization (ARIPO) 9701113 ⤷  Start Trial
African Regional IP Organization (ARIPO) 979 ⤷  Start Trial
Austria 250439 ⤷  Start Trial
Austria 297773 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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