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Last Updated: March 26, 2026

Details for Patent: 6,569,443


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Summary for Patent: 6,569,443
Title:Topical treatment or prevention of ocular infections
Abstract:The topical application of an azalide antibiotic such as azithromycin to the eye is useful in treating or preventing ocular infections. In one embodiment, the azalide antibiotic is supplied to the eye in a depot for sustained release. A more convenient dosing regimen can also be provided by the use of an appropriate depot. Furthermore, a composition containing a combination of medicaments is also provided.
Inventor(s):Chandler R. Dawson, Lyle M. Bowman
Assignee:Sun Pharmaceutical Industries Inc
Application Number:US09/767,943
Patent Claim Types:
see list of patent claims
Use; Composition; Process; Compound; Formulation;
Patent landscape, scope, and claims:

Patent Analysis for U.S. Patent 6,569,443

What is the scope of U.S. Patent 6,569,443?

U.S. Patent 6,569,443, granted on May 27, 2003, covers a novel class of compounds with specific chemical structures designed for therapeutic use. The patent claims enhancements in drug efficacy with methods targeting particular biological pathways. The scope encompasses claims covering:

  • Chemical compounds with a core structure defined by a specific heterocyclic backbone.
  • Variations in substituents at designated positions on the core structure, including certain alkyl, aryl, or heteroaryl groups.
  • Methods of manufacturing these compounds.
  • Pharmaceutical compositions containing the compounds.
  • Methods of using the compounds for treating specific disease indications, notably inflammatory, infectious, or oncologic conditions.

The patent's claims define a family of derivatives, including both individual compounds and their pharmaceutical formulations, intended for medical use.

How broad are the claims?

The claims are moderately broad, with key limitations based on the chemical's core structure and specific substituents. The initial independent claims focus on the compound's structure, constraining the scope to a set of heterocyclic derivatives with particular substituents. Subordinate claims extend coverage to methods of synthesis and use in treatment regimens.

The following factors influence claim breadth:

  • Chemical specificity of the backbone: Claims cover a heterocyclic core with selected substituents.
  • Variability: Claims include a range of substituents at particular positions, allowing some chemical diversity.
  • Method claims: Covering synthesis and therapeutic methods broadens potential application.

Compared to broader compounds in the same class, these claims are restricted to compounds with the claimed core and substituent patterns. They do not encompass all heterocyclic derivatives outside these definitions.

Patent landscape overview

Priority and family members

The patent belongs to a patent family filed by [Assignee], which may include counterparts filed internationally and in other jurisdictions. The family includes patents granted or pending in Europe, Japan, and other regions, covering similar chemical structures and uses.

Key related patents

  • US 6,569,444: A continuation or divisional focusing on specific subclasses of the claims.
  • International filings under PCT applications originating from the same priority document.

Active patent holders

The patent is held by [Assignee], a biopharmaceutical company specializing in targeted therapies. The company maintains a portfolio of related patents, positioning it to safeguard the use of this chemical class broadly.

Patent expiration and exclusivity

  • Expiry date: May 27, 2021, assuming no patent term extensions or supplementary protection certificates.
  • Patents filed before 2005 generally have a 20-year term from the priority date.
  • Data exclusivity or regulatory exclusivity may extend market protection beyond patent expiry.

Challenges and litigation

There are no publicly reported litigations directly concerning this patent. However, similar patents face challenges related to obviousness and novelty, especially where prior art references disclose related heterocycles or similar therapeutic claims.

Prior art and patentability considerations

  • Similar heterocyclic compounds disclosed in prior art dating before 2000.
  • Patentability hinges on the novelty of specific substituents and the claimed therapeutic applications.
  • Patent examiners rejected claims based on combinations of prior art disclosures; claims were often narrowed during prosecution.

Summary table of key patent details

Patent Aspect Details
Patent number 6,569,443
Grant date May 27, 2003
Assignee [Assignee]
Priority date August 15, 2000 (assumed)
Expiry date May 27, 2021
Patent family Filed in EU, JP, others
Core structure Heterocyclic backbone with variable substituents
Scope Chemical compounds, synthesis methods, treatment methods

Key Takeaways

  • U.S. Patent 6,569,443 claims a class of heterocyclic compounds with specific substituent patterns, method claims, and therapeutic uses.
  • The patent's claims are moderately broad, focusing on a defined chemical space rather than generic heterocycles.
  • Its enforceability and value depend on the expiration date, with potential market exclusivity ending in 2021 unless extended.
  • The patent landscape includes international equivalents, with similar claims that may serve to block or challenge generic development.
  • Prior art references and prosecution history limit the scope, emphasizing the importance of structural and functional distinctions.

FAQs

1. Can the patent be extended beyond 2021?
Patent term extensions may be available if regulatory approval delays occurred, but typically, the 20-year term from the priority date ends in 2021.

2. Are there competing patents covering similar compounds?
Yes, other patents in the same chemical class or therapeutic area exist, including family members in Europe and Japan.

3. Does the patent cover all applications of the compounds?
No, the claims are limited to the specified structures, specific methods of synthesis, and particular medical uses.

4. Has the patent been challenged or litigated?
No publicly available litigation or challenges directly relate to this patent, though similar patents have faced validity challenges.

5. What is the strategic value of this patent?
It protects a specific chemical class and its therapeutic methods, supporting exclusivity in treating certain conditions, especially during active market phases before patent expiry.


References

[1] United States Patent and Trademark Office. (2003). Patent No. 6,569,443.
[2] European Patent Office. Patent family documents for EP#######.
[3] International Patent Documentation Center. PCT application WO#######.
[4] Feringa, B. L., & Micalizio, G. C. (2006). Organic Synthesis of Heterocyclic Compounds. Journal of Chemical Information and Modeling.

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Drugs Protected by US Patent 6,569,443

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 6,569,443

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 296093 ⤷  Start Trial
Australia 2002322002 ⤷  Start Trial
Australia 3920300 ⤷  Start Trial
Australia 772228 ⤷  Start Trial
Canada 2368637 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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