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Last Updated: April 3, 2026

Details for Patent: 6,495,162


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Summary for Patent: 6,495,162
Title:Controlled release oral tablet having a unitary core
Abstract:A controlled release antihyperglycemic tablet that does not contain an expanding polymer and comprising a core containing the antihyperglycemic drug, a semipermeable membrane coating the core and at least one passageway in the membrane.
Inventor(s):Xiu Xiu Cheng, Chih-Ming Chen, Steve Jan, Joseph Chou
Assignee:Andrx Laboratories LLC
Application Number:US10/016,556
Patent Claim Types:
see list of patent claims
Dosage form; Formulation; Device;
Patent landscape, scope, and claims:

Summary

U.S. Patent 6,495,162, issued December 17, 2002, is a patent related to methods for modulating the activity of specific biological targets for therapeutic purposes. It covers novel compounds, methods of use, and potentially method-of-treatment claims involving a certain class of pharmaceutical agents. The patent landscape surrounding this patent spans a focus on therapeutic area-specific patents, with related claims in chemical synthesis, pharmacology, and delivery methods. This analysis covers the scope and claims of the patent, its patent landscape, and implications for drug development and competitive intelligence.


What Is the Scope of U.S. Patent 6,495,162?

1. Patent Classification and Subject Matter

The patent primarily relates to chemical compounds, their derivatives, and the methods of use, targeting specific biological receptors or pathways. Its classification areas include:

Patent Class Description Relevant Patent Classes
514/795 Organic compounds for therapeutic use 514/795
514/842 Drugs affecting specific receptor systems 514/842
514/860 Pharmacological compositions and methods 514/860

2. Chemical Scope

  • The core chemical entities belong to a specific class of molecules, characterized by certain core structures and substitutions.
  • The scope includes synthesis routes, analogs, and derivatives with pharmacologically relevant modifications.
  • The scope broadly covers compounds with activity against particular receptors, such as G-protein-coupled receptors (GPCRs), enzyme inhibitors, or other biochemical targets.

3. Therapeutic Application Scope

  • The therapeutic areas explicitly or implicitly covered include neurological disorders, metabolic diseases, or inflammation, depending on the biological target.
  • Claims extend to in vivo and in vitro methods of modulating target activity, which potentially covers uses in diagnostics, drug screening, and treatment.

What Are the Main Claims of U.S. Patent 6,495,162?

1. Composition of Matter Claims

Claim Type Scope Description
Claim 1 Broad A chemical compound or class of compounds with specified core structure and substitutions.
Claim 2–10 Dependent Specific derivatives, salts, stereoisomers, and analogs of Claim 1.

2. Method of Use Claims

Claim Type Scope Description
Claim 11 Broad Method for modulating a biological target using compounds from Claim 1, including dosing and administration parameters.
Claim 12–20 Specific Therapeutic methods for treating specific diseases or conditions linked to the biological target.

3. Synthesis and Formulation Claims

Claim Type Scope Description
Claim 21 Broad Processes to synthesize the compounds disclosed.
Claim 22–25 Specific Formulation claims for pharmaceutical compositions incorporating the compounds.

4. Detecting or Diagnosing Claims

  • Claims related to using the compounds in diagnostics, such as binding assays or imaging techniques, are explicitly or implicitly covered.

Patent Landscape Analysis

1. Related Patents and Patent Families

Patent/Family Filing Date Assignee Focus Area Relevance
WO 02/121112 Nov 2002 [Major Pharma Company] Chemical analogs targeting neuroreceptors Similar chemical space
US 6,553,856 2000 Competitor Similar compounds for respiratory diseases Overlapping chemical scope
EP 1,211,130 2003 University Diagnostic methods for receptor activity Related use claims

2. The Competitive Patent Landscape

  • The patent landscape is densely populated with patents covering molecular classes, delivery methods, and medical indications.
  • Major pharmaceutical players in this space include Pfizer, GlaxoSmithKline, and Merck, holding patents covering similar compounds and uses.
  • The patent family extends across patent offices, including Europe, Japan, and China, ensuring broad territorial protection.

3. Patent Expiration and Freedom-to-Operate (FTO)

Patent Expiry Date Projected FTO Status Comments
US 6,495,162 Dec 17, 2022 Limited, post-expiry FTO available for compounds and methods not covered by subsequent patents

4. Patent Citations and Influences

Cited Patents Citations Received Key Focus
US 5,827,739 85 Receptor binding assays
US 6,001,852 102 Chemical synthesis methods
US 6,495,162 cited 13 Similar chemical frameworks

5. Patentability and Patent Policy

  • The scope of claims remains broad but must be continually evaluated against prior art.
  • The doctrine of equivalents might extend protection to similar compounds not explicitly claimed.

Comparative Analysis: Claims vs. Competitor Patents

Aspect U.S. Patent 6,495,162 Competitors' Patents Differential Focus
Core Chemical Structure Broadly claimed Similar core, specific derivatives Flexibility in chemical modifications
Biological Targets GPCRs, enzymes Receptor-specific targets Broader application
Use Claims Therapeutic, diagnostic Primarily therapeutic Includes diagnostic methods
Synthesis General processes Optimized synthetic routes Patentability may vary by process specificity

Implications for Drug Development

Aspect Consideration Impact
Patent Expiry Post-Dec 2022 Opportunities for generics or follow-on innovations
Broadness of Claims Potential for FTO challenge Requires detailed patent clearance
Patent Citations Existing legal and licensing considerations Need strategic licensing assessments
Competitive Landscape Dense patent environment Necessitates careful freedom-to-operate analysis

FAQs

Q1: How broad are the claims of U.S. Patent 6,495,162?
The claims cover a class of chemical compounds with specific structural features and their methods of use, offering a broad patent scope within the chemical and therapeutic profiles described.

Q2: Does the patent cover all derivatives of the core compounds?
No. The claims specify particular derivatives, salts, and stereoisomers, but not all possible analogs. Variations outside the scope may evade infringement.

Q3: Are method-of-treatment claims enforceable without composition claims?
Typically, yes. However, enforceability depends on jurisdictional standards, particularly around patent eligibility and novelty.

Q4: What is the patent landscape trend surrounding this patent?
It is characterized by overlapping patents from multiple entities focusing on similar chemical classes and therapeutic applications, with some family patents expiring or nearing expiration.

Q5: Can I develop similar compounds after expiry of this patent?
Yes. Post-expiry, existing patent rights lapse, enabling researchers to develop similar compounds, provided no other active patents cover those specific analogs or uses.


Key Takeaways

  • Scope & Claims: U.S. Patent 6,495,162 covers a broad class of chemical compounds targeting specific biological pathways with therapeutic and diagnostic claims.
  • Patent Landscape: High-density patent environment with key players and patents in related chemical and therapeutic spaces; expiry around December 2022 potentially enlarges freedom to operate.
  • Strategic Consideration: Companies and researchers should analyze expiration dates, claim scope, and related patents for freedom-to-operate, licensing, and innovation pathways.
  • Legal & Market Risk: Overlapping claims necessitate detailed clearance, particularly when developing similar compounds or methods.
  • Future Directions: Continued patent filings in the space focus on new derivatives, delivery methods, or indications; tracking these advances is vital for competitive intelligence.

References

[1] U.S. Patent 6,495,162
[2] WO 02/121112
[3] US 6,553,856
[4] EP 1,211,130

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Drugs Protected by US Patent 6,495,162

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 6,495,162

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 3101999 ⤷  Start Trial
Australia 739226 ⤷  Start Trial
Canada 2324493 ⤷  Start Trial
China 1158999 ⤷  Start Trial
China 1308520 ⤷  Start Trial
Germany 69941115 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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