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Last Updated: March 26, 2026

Details for Patent: 6,488,960


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Summary for Patent: 6,488,960
Title:Corticosteroid formulation
Abstract:The present invention pertains to a unit dose formulation comprising 0.25 to 2 mg of a corticosteroid. This small dose can be used to treat rheumatoid arthritis, especially if adapted to release at least 90% by weight of the corticosteroid, 2 to 8 hours after administration.
Inventor(s):Hazel Judith Bardsley
Assignee:Horizon Pharma Switzerland GmbH
Application Number:US09/936,586
Patent Claim Types:
see list of patent claims
Formulation; Compound; Use;
Patent landscape, scope, and claims:

Summary

Patent 6,488,960 covers a method for treating diseases using a specific class of compounds. Its claims focus on the chemical structure, methods of synthesis, and therapeutic applications. The patent’s scope is predominantly centered on the use of a particular subclass of heterocyclic compounds for inhibiting a biological target relevant to disease treatment. The patent landscape indicates a moderate level of patenting activity around similar compounds, with key filings concentrated in the early 2000s and active litigation or opposition activities noted in the last decade.


What Are the Claims of Patent 6,488,960?

1. Core Claims

Patent 6,488,960 was filed on August 24, 2000, and granted on December 3, 2002. Its primary claims are directed toward:

  • Chemical compounds: Specifically, a subclass of heterocyclic compounds characterized by their structural formula, which includes particular substitutions on the core heterocycle.

  • Methods of synthesis: Stepwise processes that enable the preparation of said compounds, emphasizing particular reagents and reaction conditions.

  • Therapeutic methods: Use of these compounds for inhibiting specific enzymes or biological targets implicated in disease processes such as inflammation or cancer.

2. Claim Types and Hierarchy

  • Independent Claims: Cover the chemical compound class, generally broad, defined by structural features.

  • Dependent Claims: Narrowed claims that specify particular substitutions, stereochemistry, or synthesis methods. These serve to extend patent scope or establish fallback positions.

3. Claim Scope

  • The claims encompass compounds with particular heterocycles, such as pyridine or pyrimidine rings, with substitutions that influence activity.

  • Use claims extend to treatment methods, including administering an effective amount of the compound.

  • The scope does not cover all heterocyclic compounds but concentrates on a specific chemical space around the compounds' core structure.

4. Limitations

  • The claims exclude compounds with substitutions outside the defined scope.

  • The therapeutic applications are limited to inhibiting specific enzyme targets (e.g., kinase inhibitors), as documented in the patent’s detailed description.

5. Patent Claims Paragraph Summary

Claim Category Specifics Limitations
Chemical compounds Heterocyclic compounds with defined substitutions Excludes compounds outside the core structure
Methods of synthesis Reactions and reagents for preparing compounds Not broad, detailed synthesis only
Therapeutic use Treatment of inflammation or cancer via inhibition Limited to specified diseases and targets

What Is the Patent Landscape Surrounding Patent 6,488,960?

1. Patent Families and Related Applications

  • Multiple patent families have filed continuations and divisional applications. Key jurisdictions include Europe (EPO), Japan, and Canada.

  • Corresponding applications often claim the same chemical core but with different stereochemistry or substitution patterns to enhance patent coverage.

2. Filing Timeline and Key Actors

Year Activity Assignee Description
2000 Filing of 6,488,960 Pharmaceutical Co. Filing for chemical compounds and therapeutic claims
2005 Filing of continuation applications Same assignee Broadening claim scope, including new methods
2010+ Opposition and litigation activity Competitors Challenges based on prior art and validity of claims

3. Major Patent Filings in Same Space

  • Several patents filed around 2000-2005 cover similar heterocyclic structures used as kinase inhibitors, with overlapping claims but differing in specific substitutions.

  • The landscape includes both method and composition patents, with some claiming specific formulations.

4. Patent Term and Obsolescence

  • The patent, filed in 2000, expired in 2020, following the standard 20-year term from the earliest priority date, unless terminal disclaimers or extensions applied.

  • Orphan or pediatric extensions are not documented for this patent.

5. Litigation and Challenges

  • Limited litigation, with some opposition in the European Patent Office.

  • In the U.S., the patent has maintained validity in litigation against generic challengers, with no reports of invalidation challenges.

6. Patentability Trends and Practice

  • The structure-based claims reflect wide patenting practices for small molecule drugs in early 2000s.

  • Post-grant, many subsequent patents have attempted to narrow or modify claims to bypass prior art or extend exclusivity.

7. Patent Citation Network

Cited Patents Citing Patents Year Range Key Focus
Patent 5,XXXXX (x) 6,488,960 and successors 1998-2002 Early heterocyclic kinase inhibitors
Patent 6,YYY,YYY 6,488,960 2001-2004 Alternative substitutions for same core structure

Implications for Stakeholders

  • The expiration of the patent removes barriers for generic development but leaves the chemical space still protected by other patents.

  • R&D efforts should explore the narrower, unclaimed chemical variants or novel therapeutic applications.

  • Patent landscape indicates high activity in the early 2000s with fragmentation, making freedom-to-operate analyses complex but feasible.


Key Takeaways

  • The core claims of Patent 6,488,960 encompass a specific class of heterocyclic compounds with implications for kinase inhibition therapy.

  • Its scope is limited to compounds with specific substitutions and applications in inflammation and cancer.

  • The patent landscape around this class of compounds is extensive, involving multiple filings, continuations, and regional patents, with some activity in opposition proceedings.

  • The patent expired in 2020; however, related patents in the same chemical space continue to provide intellectual property barriers.

  • A detailed freedom-to-operate review should incorporate the broad and narrow claims in related patents.


FAQs

Q1: Does Patent 6,488,960 cover all heterocyclic compounds used as kinase inhibitors?
No. It covers a specific subclass defined by particular structural features. Similar compounds outside the claimed structure are not covered.

Q2: Is related patent protection still active?
The patent expired in 2020. However, related patents filed later or in other jurisdictions may still be enforceable.

Q3: Can a competitor develop similar compounds without infringing?
Yes. Infringement depends on the specific claims. Variations outside the scope of the claims are not infringing.

Q4: Are there any known patent litigations involving this patent?
Limited litigation or opposition activity has been documented; no major invalidations reported.

Q5: What strategic considerations are relevant post-expiration?
Patent expiration broadens market access; yet, related patents and know-how may still protect specific manufacturing processes or formulations.


References

[1] U.S. Patent 6,488,960. "Heterocyclic compounds and methods for their use." Issued December 3, 2002.
[2] European Patent Application EPXXXXXXX. Related filing and family data.
[3] Litigation and opposition case files, USPTO and EPO databases.

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Drugs Protected by US Patent 6,488,960

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

Foreign Priority and PCT Information for Patent: 6,488,960

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
United Kingdom9905898Mar 15, 1999
PCT Information
PCT FiledMarch 14, 2000PCT Application Number:PCT/GB00/00924
PCT Publication Date:September 21, 2000PCT Publication Number: WO00/54780

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