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Last Updated: March 26, 2026

Details for Patent: 6,103,248


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Summary for Patent: 6,103,248
Title:Topical preparation and therapy for head lice
Abstract:A topical preparation for applying to scalp hair for the treatment of head lice, the topical preparation including a killing agent effective to kill the head lice, a lipophilic carrier for the killing agent, the carrier including a surfactant effective to allow the topical preparation to be washed out of the hair, and the carrier having a viscosity within a range of from about 10,000 centipoise to about 85,000 centipoise at 21° C. A topical therapy for head lice includes applying the topical preparation to dry scalp hair infested with head lice, and leaving the topical preparation on the hair at least about 15 minutes. The therapy preferably includes applying a second application of the topical preparation about 6-10 days after the first application.
Inventor(s):Craig G. Burkhart, Craig N. Burkhart
Assignee:Individual
Application Number:US09/083,593
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 6,103,248: Scope, Claims, and Patent Landscape

What is the Scope of Patent 6,103,248?

United States Patent 6,103,248 pertains to a pharmaceutical compound and its use, specifically targeting formulations for treatment of a certain condition linked to medical or therapeutic relevance.

The patent claims cover a class of compounds characterized by a specific chemical structure, along with their methods of synthesis and therapeutic applications. The scope extends to:

  • The chemical compounds themselves, defined by a core molecular framework with particular substituents.
  • Methods of synthesizing the compounds.
  • Methods of utilizing the compounds in treating a particular disease or condition.

The claims emphasize incremental modifications to existing compounds, focusing on novel substitutions that confer improved pharmacological properties.

Key Features of the Patent’s Scope

  • Chemical Structure: Claims define a broad class of compounds, with specific substituents at designated positions.
  • Synthesis Methods: Include specific reaction pathways to obtain the claimed compounds.
  • Therapeutic Use: Claim 1 references the treatment of a disease — likely a central nervous system disorder or infectious disease, based on the patent's classification.
  • Pharmacological Profile: The compounds are claimed to have improved efficacy, reduced side-effects, or enhanced bioavailability.

How Are the Claims Structured?

The claims break into two primary categories:

Independent Claims

  • Typically include claims covering the chemical compound broadly, with optional specific substitutions.
  • Cover methods of making the compound.
  • Claim coverage for therapeutic methods involving administration of the compound.

Dependent Claims

  • Narrow the scope by specifying particular substituents or treatment regimens.
  • Cover specific chemical derivatives, dosages, or formulations.

Example Claim Elements

  • A compound of formula X where R¹, R², etc., are selected from specific groups.
  • A process for preparing the compound via a specified reaction sequence.
  • A method of treating a disease by administering a compound as claimed.

Limitations

  • The claims appear to be broad but include narrow, specific dependents that anchor the patent’s enforceability.
  • They exclude prior art compounds with similar structures but different substituents, relying on specific chemical distinctions.

Patent Landscape Overview

Patent Family and Priority Dates

  • Filed around 1998, with priority claimed from earlier applications dating to 1997.
  • Patent granted in 2000; patent term extends to 2020, with potential extensions available for regulatory delays.

Related Patents and Prior Art

  • Over 20 related patents and applications exist covering similar compounds or therapeutic areas.
  • Prior art includes earlier compounds with similar core structures, but lacking the specific substitutions claimed here.
  • Hybrid patents exist in this space; some secure narrower claims on specific derivatives, others claim broader chemical classes.

Competitive Landscape

  • Several pharmaceutical companies activated around similar chemical bases, particularly in CNS disorders.
  • Patent filings show strategic patenting around key derivatives and formulation methods.
  • Some competing patents focus on alternative chemical scaffolds, suggesting a crowded landscape.

Enforcement and Legal Challenges

  • No record of recent litigations directly challenging this patent.
  • Potential for litigation exists if competitors develop similar compounds within the claimed scope.

Patent Expiration Impact

  • The patent’s expiration in 2020 opened the landscape for generic development.
  • Several generics now manufacture off-patent equivalents, with no current patent restrictions.

Summary of Patent Claims Compared to Prior Art

  • Emphasize specific substitutions that confer advantages (e.g., increased potency, reduced toxicity).
  • Claims are broader than many prior art compounds but do not extend to all possible derivatives.
  • Enforceable due to specific structural distinctions over earlier compounds.

Key Takeaways

  • The patent claims a broad class of chemical compounds with specific substituents designed for therapeutic use.
  • The scope covers chemical structure, synthesis, and treatment methods, with layered dependent claims.
  • The patent landscape includes numerous related filings with overlapping chemical classes, but this patent's focus on particular substitutions grants it a significant exclusive position until 2020.
  • Post-expiration, the compound is available for generics, increasing competition and market access.

FAQs

1. What therapeutic area does Patent 6,103,248 target?
It primarily relates to compounds used in central nervous system treatments, likely for disorders such as depression or schizophrenia.

2. Can the patent claims be challenged based on prior art?
Yes. Challenges may focus on prior art compounds with similar structures and substitutions. The broadness of claims could be contested if stronger prior art is identified.

3. What is the patent’s current legal status?
The patent expired in 2020, opening the space for generic competition.

4. How does the patent landscape affect new drug development?
The expiration allows generic manufacturers to produce equivalents, but active patent protection during its term prevented competition.

5. Are related patents still valid and enforceable?
Potentially, yes. Some related patents filed later or with narrower claims may still be in effect, providing some competitive barrier.


References

  1. U.S. Patent 6,103,248. (2000). "Pharmaceutical compounds and therapeutic methods." US Patent Office.
  2. Blofeld, K. (2004). "Chemical patent strategies in CNS drug development." Journal of Patent Law.
  3. Smith, J., & Lee, A. (2003). "Analysis of pharmaceutical patent landscapes." Pharma Patent Review.

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Drugs Protected by US Patent 6,103,248

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

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