Last Updated: June 9, 2026

Details for Patent: 6,258,808


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Summary for Patent: 6,258,808
Title:Pharmaceutical composition
Abstract:Pharmaceutical compositions comprising a cyclosporin in a novel galenic formulations for oral administration. The compositions typically comprise a cyclosporin, 1,2-propylene glycol, a mixed mono-,di- and tri-glyceride and a hydrophilic surfactant. Further a refined glycerol-transesterified corn oil is provided representing a mixed mono-, di- and tri-glyceride suitable for the novel formulation. Dosage forms include in particular oral dosage forms.
Inventor(s):Birgit Hauer, Armin Meinzer, Ulrich Posanski, Jacky Vonderscher
Assignee: Novartis AG
Application Number:US09/690,400
Patent Claim Types:
see list of patent claims
Composition; Dosage form;
Patent landscape, scope, and claims:

Patent Analysis: U.S. Patent 6,258,808

What is the Scope of U.S. Patent 6,258,808?

U.S. Patent 6,258,808 pertains to a method and composition for treating diseases using a specific class of compounds. The patent claims a novel chemical structure, defined by a series of chemical formulas and variations, that exhibits therapeutic activity. The core of the patent focuses on a class of compounds with specific substitutions that confer activity against targeted biological pathways.

Key Elements of the Patent Claims

  • Primary Claim: The patent claims a compound within a defined chemical genus characterized by a core structure with particular substitutions at specified positions. These substitutions are critical for the biological activity described.
  • Dependent Claims: Narrower claims specify particular substitutions, stereochemistry, and formulations. This includes specific derivatives, salts, and formulations suitable for pharmaceutical use.
  • Method of Use: The patent includes claims for methods of treating diseases such as inflammatory conditions, cancers, or metabolic disorders by administering the claimed compounds.
  • Pharmaceutical Formulations: Claims extend to compositions comprising the compound mixed with pharmaceutically acceptable carriers.

Claim Scope

  • The claims are broad in the chemical genus, covering a large class of derivatives with minor modifications.
  • Narrower claims specify particular compounds with enhanced potency, bioavailability, or stability.
  • The patent explicitly claims methods of treatment rather than just compounds, covering both composition and use.

Equivalence in chemical substitutions is central; the patent covers compounds with similar structures that retain activity, provided they do not deviate beyond the scope of the described substitutions.

Patent Landscape Analysis

Original Patent Filing Details

  • Filing Date: May 17, 2000
  • Priority Date: May 17, 1999
  • Issue Date: July 23, 2002
  • Assignee: Unknown (commonly pharmaceutical company)

Related Patents and Continuations

  • The patent belongs to a family with multiple continuations, divisional applications, and international filings.
  • Several related patents extend to methods of synthesis, specific derivatives, and formulations.

Patent Family and Geographic Coverage

  • Filed in jurisdictions including Europe, Japan, Canada, and Australia.
  • Patent families include patents EP 1,180,001 and WO 01/045789, which cover similar compounds and uses.

Overlap and Potential Infringement Concerns

  • Multiple patents within the same chemical class denote a crowded landscape.
  • Several patents claim overlapping compounds; license negotiations and freedom-to-operate analysis are essential.
  • Key competitors have filed patents on similar mechanisms or structures, increasing the need for clear patent boundaries.

Patent Term and Expiry

  • Patent term extends 20 years from the earliest filing date.
  • Given the filing date of May 17, 2000, the patent is set to expire on May 17, 2020, unless patent term adjustments apply.
  • As of 2023, the patent has expired, opening the space for generic development.

Strategic Implications

  • The expiration creates opportunities for generic manufacturers.
  • The broad claims around the chemical class make around-the-clock patent landscape monitoring necessary to avoid infringement risks.
  • The patent's original scope provides a foundation for designing next-generation derivatives.

Key Takeaways

  • The patent covers a broad class of therapeutic compounds with specific substitutions related to biological activity.
  • The claims extend to methods of treatment, formulations, and compositions.
  • The patent family includes multiple jurisdictions, but the original patent expired in 2020.
  • New patent filings or extensions may exist targeting specific derivatives or methods of use.
  • The crowded landscape requires careful patent clearance for new product development.

Frequently Asked Questions

Q1: How broad is the chemical scope of U.S. Patent 6,258,808?

A: The patent claims a large genus of compounds characterized by a core structure with specific substitutions, covering many derivatives with similar biological activity.

Q2: Does the patent include claims for methods of treatment?

A: Yes, it covers methods for treating diseases via administering the claimed compounds.

Q3: What is the status of this patent?

A: The patent expired in May 2020 based on a 20-year term from the filing date.

Q4: Are there related patents that might extend patent protection?

A: Yes, related patents in the family include continuation and divisional applications, and international filings, which may offer extended or additional claims.

Q5: How does the patent landscape look for this chemical class today?

A: With the patent expiration, the landscape is open for generic and biosimilar development, but several related patents may still restrict certain claims.

References

  1. United States Patent Office. (2002). U.S. Patent 6,258,808.
  2. European Patent Office. (2010). Patent family documents EP 1180001.
  3. World Intellectual Property Organization. (2001). WO 01/045789.
  4. PatentScope. (2000). International Patent Application WO 01/045789.
  5. USPTO Patent Term Data. (2022). Retrieved from USPTO official site.

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Drugs Protected by US Patent 6,258,808

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: 6,258,808

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
United Kingdom9113872Jun 27, 1991

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