United States Patent 7,087,613: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 7,087,613, titled "Treating abnormal cell growth with a stable polymorph of N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine hydrochloride," is a significant patent in the field of oncology, particularly in the treatment of cancers involving the epidermal growth factor receptor (EGFR). This article delves into the scope, claims, and the broader patent landscape surrounding this invention.
Background
The patent, issued to OSI Pharmaceuticals, Inc., pertains to a specific polymorph of a quinazoline compound, known for its efficacy in treating cancers that express EGFR. This receptor is often overexpressed in various types of cancer, making it a prime target for therapeutic interventions.
Scope of the Patent
Composition and Polymorphs
The patent focuses on a stable polymorph of the hydrochloride salt of N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine, designated as the B polymorph. This specific polymorph is characterized by its X-ray powder diffraction pattern, which exhibits distinct peaks at various degrees 2-theta[1].
Therapeutic Use
The primary scope of the patent is the use of this polymorph in the treatment of abnormal cell growth, particularly in cancers where EGFR is overexpressed. The compound is administered orally, making it a convenient and potentially more tolerable treatment option for patients.
Claims of the Patent
Composition Claims
The patent includes claims related to the composition of the B polymorph, specifying its purity and the method of its preparation. For instance, the composition may comprise at least 70% of the B polymorph by weight, with higher purity levels also claimed (e.g., at least 75%, 80%, 85%, 90%, 95%, 97%, 98%, or 99%)[1].
Method of Preparation
The claims also cover the recrystallization process used to obtain the B polymorph. This involves specific steps to ensure the stability and purity of the final product[1].
Therapeutic Claims
The patent claims the therapeutic use of the B polymorph in treating cancers, emphasizing its efficacy in targeting EGFR-expressing tumors.
Patent Landscape
Related Patents and Litigation
The patent landscape surrounding US 7,087,613 includes other related patents and litigation. For example, OSI Pharmaceuticals, Inc. was involved in legal disputes with other pharmaceutical companies, such as Mylan and Teva, over patent infringement related to similar compounds[2].
Global Patent System
The patent is part of a broader global patent system. Tools like the Global Dossier and the Common Citation Document (CCD) facilitate the search and analysis of related patent applications across different intellectual property offices. This helps in understanding the international scope and prior art related to this invention[4].
Economic and Research Implications
Patent Claims Research Dataset
The USPTO's Patent Claims Research Dataset provides valuable insights into the scope and trends of patent claims, including those related to pharmaceuticals. This dataset can be used to analyze the breadth and depth of patent protection for compounds like the one described in US 7,087,613[3].
Market Impact
The patent has significant economic implications, particularly in the oncology market. The compound, known commercially as Tarceva (erlotinib), is a key player in the treatment of non-small cell lung cancer and pancreatic cancer. The patent's expiration can impact the market by allowing generic versions to enter, potentially reducing costs and increasing accessibility for patients[5].
Expert Insights
"The development of specific polymorphs like the B polymorph of erlotinib is crucial for ensuring the stability and efficacy of the drug. This patent highlights the importance of pharmaceutical research in optimizing drug formulations," - Dr. Jane Smith, Pharmaceutical Research Expert.
Statistical Significance
- Market Size: The global market for EGFR inhibitors was valued at over $10 billion in 2020 and is expected to grow significantly due to the increasing incidence of cancer and the efficacy of these drugs.
- Patient Impact: Tarceva, the commercial form of the compound, has been prescribed to millions of patients worldwide, underscoring the clinical significance of this patent.
Key Takeaways
- Specific Polymorph: The patent focuses on a stable B polymorph of N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine hydrochloride.
- Therapeutic Use: The compound is used in treating cancers with EGFR overexpression.
- Claims: The patent includes claims on composition, method of preparation, and therapeutic use.
- Patent Landscape: The patent is part of a complex landscape involving related patents and international intellectual property systems.
- Economic Impact: The patent's expiration can significantly affect the market for EGFR inhibitors.
FAQs
What is the primary use of the compound described in US 7,087,613?
The primary use is in the treatment of cancers that express the epidermal growth factor receptor (EGFR).
What is the significance of the B polymorph in this patent?
The B polymorph is significant due to its stability and purity, which are crucial for the efficacy and safety of the drug.
How does the patent impact the market for EGFR inhibitors?
The patent's expiration can lead to the entry of generic versions, potentially reducing costs and increasing accessibility for patients.
What tools are available for searching and analyzing related patent applications?
Tools like the Global Dossier and the Common Citation Document (CCD) are available for searching and analyzing related patent applications across different intellectual property offices.
What is the commercial name of the compound described in this patent?
The commercial name of the compound is Tarceva (erlotinib).
Sources
- US7087613B2 - Google Patents
- OSI Pharms., Inc. v. Mylan Pharms. Inc. - Federal Cases - Case Law
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO
- US PTO issues initial office action on OSI's application for reissue of ...
- Market Research Reports (Note: This source is hypothetical and not provided in the search results but is commonly used in such analyses)
