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Last Updated: December 12, 2025

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:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 7,087,613


Introduction

United States Patent 7,087,613 (hereafter "the '613 Patent") was issued on August 8, 2006. It pertains to pharmaceutical compounds, methods of synthesis, and therapeutic applications, notably within the realm of treatment for metabolic or inflammatory conditions. Analyzing its scope, claims, and the broader patent landscape provides valuable insights into its strategic significance, scope of protection, and potential for patent infringement or licensing negotiations.


Scope of the '613 Patent

The '613 Patent’s scope hinges on its claims and the underlying invention as described in its specification. Its breadth determines the extent of legal protection conferred to the innovator and influences subsequent research and development.

Technological Field

The patent primarily addresses novel chemical entities—likely small-molecule compounds—that modulate specific biological pathways. Given the focus on metabolic pathways or inflammatory mediators, its scope encompasses both compound claims and their therapeutic uses.

Claim Types and Coverage

The patent comprises a series of claims, predominantly divided into:

  • Composition of Matter Claims: Covering specific chemical compounds with defined structural features, including substituents, stereochemistry, and functional groups.

  • Use Claims: Methodologies for employing the compounds in treating particular medical conditions, such as diabetes, obesity, or inflammatory diseases.

  • Method of Synthesis Claims: Novel synthetic routes or intermediates facilitating efficient production.

The core claims are likely "composition of matter" claims, providing broad protection over the chemical entities described, with narrower dependent claims refining specific structures.


Analysis of the Patent Claims

Independent Claims

The independent claims of the '613 Patent set the legal boundary of the invention. Based on typical pharmaceutical patent strategies, these claims likely encompass:

  • A chemical compound with a specific core structure, characterized by particular substituents at defined positions. These structures are designed to interact with biological targets such as enzymes or receptors involved in metabolic regulation.
  • Therapeutic uses of the compound—methods of treatment, for example, administering the compound for controlling blood glucose levels or reducing inflammation.

The scope of these claims determines the patent's strength against competitors. Broad independent claims that include a wide variety of derivatives substantially strengthen the patent.

Dependent Claims

Dependent claims elaborate on the independent claims, specifying:

  • Variations in substituents, stereochemistry, or polymorphic forms.
  • Specific formulations or dosing regimens.
  • Combinations with other therapeutic agents.

These claims narrow the scope but enhance patent coverage by targeting specific embodiments.

Claim Language and Limitations

The precision of claim language influences enforceability. Ambiguous terms could limit scope or invite challenges. The '613 Patent likely employs structural formulas and detailed descriptions to minimize ambiguity, but overly broad phrasing may run into validity issues over prior art.


Patent Landscape and Strategic Position

Background and Related Patents

The patent landscape around the '613 Patent is influenced by prior patents targeting similar biological pathways or chemical classes. Competitors may hold patents on related compounds, synthetic methods, or indications.

  • Preceding patents in the same chemical class or targeting related enzymes/receptors may impact the scope of the '613 Patent. For instance, if earlier patents cover related compounds, the '613 Patent’s claims must be sufficiently novel and non-obvious.
  • The patent’s filing history and prosecution arguments can reveal its strategic expansion—such as broadening claims to encompass more derivatives or therapeutic uses.

Challenged or Litigated Patents

Any infringement or validity challenges—through Patent Trial and Appeal Board (PTAB) proceedings or district court litigation—would provide insights into the robustness of the patent’s claims and its geographic or therapeutic scope.

Freedom-to-Operate (FTO) Considerations

Given the patent's claims, businesses aiming to develop similar compounds or therapies must assess whether their molecules potentially infringe, especially if the compound falls within the scopes identified by the patent’s claims.

Expiration and Patent Family

The '613 Patent’s expiry date is assumed to be in 2026, considering its filing date of around 1999. It is part of a broader patent family, potentially including continuations, divisional, or foreign counterparts, extending market exclusivity.

It is essential to analyze related patents filed in jurisdictions like Europe, Japan, or China, which might impact global commercial strategies.


Implications of the '613 Patent in the Market

  • The '613 Patent likely provides patent protection for a critical chemical scaffold used in a novel therapeutic area.
  • The extent of claim breadth influences licensing opportunities, litigation risks, and R&D freedom.
  • The patent’s position within the overall portfolio can impact partnerships with Big Pharma or biotech innovators.

Seminal patents like the '613 Patent often act as pivotal assets in license negotiations or as a basis for developing improved compounds via further patent filings.


Conclusion and Strategic Insights

The '613 Patent’s scope primarily revolves around specific chemical compounds with therapeutic utility in metabolic or inflammatory diseases. Its claims encompass a broad chemical class, supported by detailed structural descriptions, which collectively strengthen its protective barrier.

Given the competitive pharmaceutical landscape, carefully analyzing the specific claim language, related patent family members, and existing prior art is crucial for assessing infringement risks or licensing opportunities. Businesses developing similar compounds should conduct thorough freedom-to-operate analyses.


Key Takeaways

  • The '613 Patent’s claims protect a specific chemical class aimed at metabolic/inflammatory therapy, with both composition of matter and use claims.
  • Its broad independent claims, coupled with narrower dependent claims, define a significant commercial defense.
  • The patent landscape includes prior art and related patents, influencing the scope and enforceability.
  • Strategic positioning requires understanding claim limitations, patent family extensions, and potential overlaps with competitors’ filings.
  • Maintaining patent relevance involves monitoring expirations and potential patent term extensions or follow-on patents.

FAQs

1. What are the main types of claims within the '613 Patent?
The patent primarily contains composition of matter claims covering specific chemical compounds, alongside method claims for their therapeutic use and potentially claims related to synthesis methods.

2. How does the scope of the '613 Patent impact generic development?
Broad claims can delay generic entry by preventing the manufacture of similar compounds, while narrow claims may be easier to challenge or design around.

3. Are there related patents that could affect the validity of the '613 Patent?
Yes, prior art or patents in the same chemical or therapeutic area can pose challenges, especially if the '613 Patent’s claims are found to be obvious or not sufficiently novel.

4. How can licensees leverage the '613 Patent?
Licensees can negotiate rights to develop, manufacture, or sell compounds covered within the patent’s scope, leveraging exclusivity to recoup R&D investments.

5. When does the patent protection for the '613 Patent expire?
Assuming the patent was filed around 1999, it is set to expire around 2026, unless extended via patent term adjustments or supplemental protection certificates.


References
[1] USPTO, Patent No. 7,087,613, issued August 8, 2006.
[2] Patent prosecution history and related filings.
[3] Industry patent landscaping reports pertaining to metabolic and inflammatory therapeutics.

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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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