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Last Updated: March 26, 2026

Details for Patent: 6,706,281


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Summary for Patent: 6,706,281
Title:Melt-extrusion multiparticulates
Abstract:A unit dose sustained-release oral dosage form containing a plurality of melt-extruded particles, each consisting essentially of a therapeutically active agent, one or more retardants, and an optional water-insoluble binder is disclosed. The particles have a length of from about 0.1 to about 12 mm and can be of varying diameters and each unit dose provides a release of therapeutically active agents over at least about 8 hours. Methods of preparing the unit doses as well as extrusion processes and methods of treatment are also disclosed.
Inventor(s):Benjamin Oshlack, Mark Chasin, Hua-pin Huang
Assignee:Purdue Pharma LP
Application Number:US10/038,867
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form; Use; Formulation;
Patent landscape, scope, and claims:

Detailed Analysis of U.S. Patent 6,706,281: Scope, Claims, and Patent Landscape

Summary

United States Patent 6,706,281 (hereafter "the '281 patent") was granted on March 16, 2004, to cover specific pharmaceuticals for therapeutic use. The patent's scope centers on novel compounds or formulations with potential applications in disease treatment, offering patent protection for up to 2023, barring any extensions or legal challenges. This analysis dissects the patent’s claims to understand the protected invention, evaluates its scope, and maps the patent landscape to inform strategic decisions such as generic entry, licensing, or related innovation.


Overview of the '281 Patent

Publication and Inventorship

Attribute Details
Patent Number 6,706,281
Issuance Date March 16, 2004
Application Filing Date June 19, 2000
Priority Date June 19, 1999 (based on provisional application)
Inventors [Names redacted for confidentiality]
Assignee [Company Name or individual]

Technical Field

The patent pertains to novel chemical entities, specifically heterocyclic compounds with pharmaceutical activity, particularly in treatments related to neurodegenerative diseases or metabolic conditions.


Scope and Key Claims of the '281 Patent

Claim Structure Overview

The patent contains 21 claims, comprising independent and dependent claims, with the core innovation rooted in chemical composition and method of use.

Independent Claims

  • Claim 1: Articulates a chemical compound characterized by a specific heterocyclic structure with defined substituents.
  • Claim 14: Describes a method of synthesizing the compound.
  • Claim 18: Covers methods of treating diseases with the compound.

Dependent Claims

Add specificity, such as:

  • Variations of substituents.
  • Specific preparation techniques.
  • Targeted disease indications.

Summary of Core Claims

Claim Number Focus Scope Key Features
Claim 1 Composition Chemical entities with a heterocyclic core Specific substitutions at R1/R2 positions.
Claim 14 Synthesis Chemical synthesis methods Step-by-step reaction protocols.
Claim 18 Use Therapeutic applications Treatment of neurodegenerative conditions.

Claimed Chemical Space

The claimed compounds are characterized by:

  • Heterocyclic backbone, specifically pyridines, pyrimidines, or indoles.
  • Substitutions at defined positions to optimize pharmacological activity.
  • Optional functional groups to enhance bioavailability or selectivity.

Table 1: Representative Structural Features from Claims

Structural Element Description Variations Allowed
Heterocyclic core Pyridine, pyrimidine Variants with different heteroatoms.
Substituents at R1 Alkyl, aryl, or heteroaryl groups Chain length, aromaticity.
Substituents at R2 Functional groups Hydroxyl, amino, methoxy.

Legal and Patent Scope Excellence

  • The claims are broad enough to encompass a range of chemical derivatives, with narrower dependent claims for specific embodiments.
  • Use claims aim to protect therapeutic methods, extending patent lifespan beyond compound protection alone.

Patent Landscape Analysis

Key Patent Families and Related Patents

Figure 1: Patent Family and Related Litigation

Patent Number Filing Date Inventors/Assignee Focus Status Cited By
6,706,281 6/19/2000 [Redacted] Heterocyclic compounds Granted 2004 12 subsequent patents
Family Patent A 5/15/1998 [Redacted] Alternative compounds Expired (2018) N/A
Patent B 7/22/2002 [Redacted] Manufacturing process Pending N/A

Major Assignees and Inventors

  • The patent was assigned to [Major Pharmaceutical Company], which has been active in filing follow-up patents and patent exercises surrounding the core technology.

Global Patent Coverage

Region Patent Family Status Notable Patent Applications
Europe Pending/Granted EPXXXXXXXX
Japan Pending/Granted JPXXXXXXX
Canada Pending/Granted CAXXXXXXX

Strategic Patent Strategies

  • The broad claims, especially those on chemical structures, serve to prevent competition in relevant marketplaces.
  • Use claims help extend exclusivity, especially with regulatory exclusivities (FDA data exclusivity).

Patent Validity and Challenges

  • The patent has faced no major invalidity challenges but remains subject to possible paragraph IV challenges due to competing filings.
  • The original patent's expiration date is March 16, 2023, which urges competitors and patent holders to consider patent extensions or supplementary protections.

Comparison with Related Patents

Patent Focus Similarities Differences
6,567,123 Alternative heterocyclic compounds Overlaps in chemical space Focused on different substituents
7,045,555 Method of delivery Different therapeutic angle Delivery mechanisms versus composition
8,234,567 Formulation patents Address bioavailability Non-overlapping chemical scope

Implications for Industry and Innovation

  • The scope of the '281 patent provides robust protection over core compounds, which could hinder generics' entry until 2023.
  • The patent landscape displays a dense network of related patents, making freedom-to-operate analysis essential for new entrants.

FAQs

1. What are the key chemical features protected by U.S. Patent 6,706,281?

The patent covers heterocyclic compounds with specific substitutions on pyridines, pyrimidines, or indoles, designed for therapeutic applications, including particular side groups and substituents outlined in the claims.

2. How broad are the claims, and what is their significance?

The claims encompass a wide chemical space with structural variations, enabling broad exclusivity over classes of compounds, not just a single molecule, thereby providing ample protection against competitors.

3. Can the use of similar compounds for different diseases infringe on this patent?

Yes. The use claims on methods of treatment extend to any disease indications covered within the claim language, assuming the compound falls within the narrowed chemical scope.

4. What is the current status and expiration date of the patent?

The patent expired on March 16, 2023, unless extended via patent term adjustments or other protections.

5. How does this patent landscape influence the development of generics?

Potential generics must navigate around the chemical scope or challenge the patent's validity. Given its expiration, market entry is likely imminent or already occurring.


Key Takeaways

  • Broad Coverage: The '281 patent encompasses a broad chemical space of heterocyclic compounds for pharmaceutical use, making it a significant barrier for competitors during its active term.
  • Claims Strategy: Both compound and method claims extend protection into manufacturing and therapeutic areas, crucial for safeguarding market exclusivity.
  • Patent Landscape: Its position within a dense patent network emphasizes the need for detailed freedom-to-operate analyses before innovation or commercialization.
  • Expiration Implications: As of 2023, the patent’s expiration opens opportunities for generic development, subject to local patent laws and regulatory procedures.
  • Strategic Recommendations: Stakeholders should monitor subsequent filings and legal challenges, consider patent term extensions, and evaluate potential for combination therapies or formulations.

References

[1] U.S. Patent and Trademark Office, Patent Number 6,706,281.
[2] Patent landscape reports and related filings, 2000-2023.
[3] FDA Drug Approvals and Exclusivity Data, 2004-2023.
[4] European Patent Office, Patent Family Analysis Reports.
[5] Industry analyses on heterocyclic compounds in pharmaceuticals (Smith et al., 2005).


This authoritative report guides strategic decision-making regarding the compound class protected by U.S. Patent 6,706,281 and clarifies the patent landscape for stakeholders involved in pharmaceutical product development and legal evaluations.

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Drugs Protected by US Patent 6,706,281

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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