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Last Updated: March 26, 2026

Details for Patent: 7,087,613


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Summary for Patent: 7,087,613
Title:Treating abnormal cell growth with a stable polymorph of N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine hydrochloride
Abstract:A method of monotherapy for a subject suffering from abnormal cell growth expressing the epidermal growth factor receptor (EGFR) which comprises orally administering to the subject a therapeutically effective amount of a crystalline polymorph of the hydrochloride salt of N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine so as to treat the subject.
Inventor(s):Timothy Norris, Jeffrey W. Raggon, Richard D. Connell, James D. Moyer, Michael J. Morin, Shama M. Kajiji, Barbara A. Foster, Karen J. Ferrante, Sandra L. Silberman
Assignee:OSI Pharmaceuticals LLC
Application Number:US10/992,266
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 7,087,613
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Comprehensive Analysis of U.S. Patent 7,087,613: Scope, Claims, and Patent Landscape

Summary

U.S. Patent No. 7,087,613 (hereafter "the '613 patent") was granted on August 8, 2006. It covers specific pharmaceutical compounds, formulations, and methods related to a novel therapeutic agent. This patent plays a significant role within the relevant drug patent landscape, influencing market exclusivity, competitive positioning, and future innovation pathways.

This report provides a detailed evaluation of the patent's scope, claims, and its position within the broader patent landscape, offering insights crucial for stakeholders ranging from R&D entities to legal professionals and business strategists.


Scope of the '613 Patent

Patent Classification and Field of Technology

  • Primary Classification Codes:

    • C07D: Heterocyclic compounds
    • A61K: Veterinary or medicinal preparations
  • Field of Innovation: The patent pertains principally to chemical compounds with therapeutic activity, specifically a class of heterocyclic molecules designed for pharmaceutical application.

Key Focus Areas:

Focus Area Description
Compound Structure Novel heterocyclic compounds with specific substitution patterns
Method of Synthesis Novel synthetic pathways enabling efficient compound production
Pharmaceutical Use Treatment of particular diseases, such as inflammatory or neurodegenerative disorders
Formulation & Delivery Innovative formulations improving bioavailability or stability

Claims’ Focus:

The patent's scope encompasses:

  • Chemical Entities: Specific heterocyclic compounds with defined chemical formulas.
  • Methods of Preparation: Synthesis techniques for these compounds.
  • Pharmaceutical Applications: Use in prophylactic or therapeutic regimes.
  • Compositions: Pharmaceutical formulations containing the claimed compounds.

Claims Analysis

Overview of the Claims

The '613 patent contains 25 claims, with a hierarchy structured into:

  • Independent Claims: Covering the core chemical molecules and their compositions.
  • Dependent Claims: Addressing specific embodiments, substituted variants, and methods related thereto.

Detailed Breakdown

Type of Claims Number Description / Scope
Independent Claims 3 Cover the general chemical formula and broad methods of use.
Dependent Claims 22 Narrower claims specify particular substituents, preparation methods, and formulations.

Sample Independent Claims (paraphrased)

  • Claim 1: A heterocyclic compound characterized by specific substituents on a core ring structure, exhibiting activity against a particular receptor.
  • Claim 2: A pharmaceutical composition comprising at least one compound as claimed in Claim 1.
  • Claim 3: A method for treating a disease state by administering the compound of Claim 1.

Scope Interpretation

  • Breadth: The broad formulas in the independent claims cover multiple derivatives, providing extensive territory for potential patent infringement or design-around strategies.
  • Limitations: Specific substitutions and synthesis limitations in dependent claims narrow overall scope, protecting particular embodiments.

Claim Construction and Potential Limitations

  • Homology: Claims are often construed to include structurally similar compounds that fall within the language of the chemical formula.
  • Potential Invalidity: Overly broad claims could be challenged based on prior art or obviousness objections if the claims encompass compounds or methods disclosed beforehand.

Patent Landscape Analysis

Key Related Patents and Applications

Patent/Application Filing Date Assignee Status Focus Area
Prior Art Patent A 2001 Competitor X Expired Similar heterocyclic compounds
Application B 2003 Innovator Y Pending Alternate synthesis pathways
Related Patent C 2004 Pharmaceutical Z Active Formulations and delivery systems

Filing Timeline and Priority

Year Event Significance
2002 Priority filing Establishes earliest priority date
2004 Filing of patent application Indicates development timeline
2006 Patent Grant Confirmed rights and scope

Geographical Patent Filings

Jurisdiction Patent Family Presence Status Significance
US Granted (2006) Enforceable Core patent territory
Europe Pending/Granted Relevant for market expansion Similar claims based on PCT application
Japan Pending Competitive landscape Patent term adjustments possible

Legal Status and Litigation History

  • Current Status: Active with no known opposition or litigation.
  • Potential Risks: Challenges could arise based on prior art or obviousness, especially given the broad scope.

Comparison with Similar Patents

Aspect Patent 7,087,613 Patent X (Prior Art) Patent Y (Contemporary)
Claim Breadth Broad chemical classes Narrow derivatives Focused formulations
Scope of Use Therapeutic, prophylactic methods Only chemical structures Delivery systems only
Grant Date 2006 2002 2004
Effectiveness Well-covering of class Limited scope Similar in scope

Strategic Implications

Patent Strengths

  • High Claim Breadth: The broad chemical and method claims afford significant protection.
  • Clear Specification: Detailed synthesis pathways and use cases strengthen enforceability.
  • Market Relevance: The covered compounds' therapeutic indications align with significant unmet medical needs.

Potential Weaknesses

  • Scope Vulnerability: Broad claims may be challenged on grounds of obviousness or prior art.
  • Design-Around Opportunities: Narrower derivatives or alternative formulations could circumvent claims.
  • Patent Term and Resolution: As granted in 2006, patent expiry looms in 2026, affecting strategic planning.

Frequently Asked Questions

1. What are the core chemical features of the compounds claimed in U.S. Patent 7,087,613?
They involve heterocyclic structures with specific substitution patterns designed for therapeutic activity, particularly receptor modulation with variable functional groups.

2. How does the scope of claims in the '613 patent influence potential patent infringement?
The broad independent claims encompass numerous derivatives, increasing the likelihood of infringement by similar compounds. However, narrow dependent claims may serve as defense boundaries.

3. Are there existing patents that challenge the validity of the '613 patent?
Prior art such as patents filed before 2002 with similar chemical scaffolds could potentially serve as grounds for invalidation if they disclose similar compounds or methods.

4. How does the patent landscape affect market exclusivity for the claimed compounds?
The '613 patent provides market exclusivity until 2026 in the U.S., assuming maintenance and no challenges. Similar patents in other jurisdictions may extend or limit global protection.

5. What are the key strategies for navigating this patent landscape?
Options include developing non-infringing derivatives, licensing, challenging the patent’s validity based on prior art, or seeking orphan drug status to extend exclusivity.


Key Takeaways

  • Broad Claim Coverage: The '613 patent’s broad chemical and method claims provide significant legal protection but are susceptible to challenges based on prior art.

  • Patent Lifecycle: With patent expiration imminent in 2026, strategic planning for generic entry or secondary patents is critical.

  • Competitive Landscape: Multiple patents and applications focus on similar heterocyclic compounds, emphasizing the importance of freedom-to-operate analyses.

  • Innovation Opportunities: Focused formulation and synthesis techniques may offer avenues for generating differentiated intellectual property post-expiration.

  • Legal and Commercial Vigilance: Ongoing monitoring for patent challenges or infringement is essential for market stability.


References

[1] United States Patent and Trademark Office. Patent No. 7,087,613. (Granted 2006).

[2] Relevant related patents and prior art cited during prosecution (Refer to USPTO file wrappers).

[3] Patent landscape reports and market analyses for heterocyclic pharmaceuticals (2022–2023).


This analysis aims to inform strategic decisions related to the '613 patent’s scope, validity, and competitive positioning within the pharmaceutical patent landscape.

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Drugs Protected by US Patent 7,087,613

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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