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Last Updated: December 27, 2024

Details for Patent: 10,035,788


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Which drugs does patent 10,035,788 protect, and when does it expire?

Patent 10,035,788 protects NERLYNX and is included in one NDA.

This patent has sixty-four patent family members in twenty countries.

Summary for Patent: 10,035,788
Title:Maleate salts of (E)-N-{4[3-chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quino- linyl}-4-(dimethylamino)-2-butenamide and crystalline forms thereof
Abstract: The present invention relates to maleate salt forms of (E)-N-{4-[3-chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quin- olinyl}-4-(dimethylamino)-2-butenamide, methods of preparing crystalline maleate salt forms, the associated compounds, and pharmaceutical compositions containing the same. The maleate salts are useful in treating cancers, particularly those affected by kinases of the epidermal growth factor receptor family.
Inventor(s): Lu; Qinghong (Suffern, NY), Ku; Mannching Sherry (Thiells, NY), Chew; Warren (Pierrefonds, CA), Cheal; Gloria (Beaconsfield, CA), Hadfield; Anthony F. (St. Petersburg, FL), Mirmehrabi; Mahmoud (Laval, CA)
Assignee: WYETH LLC (New York, NY)
Application Number:15/463,998
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,035,788
Patent Claim Types:
see list of patent claims
Use; Formulation;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 10,035,788

Introduction

United States Patent 10,035,788, titled "N-{4[3-chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quinolinyl}acrylamide," is a patent that protects a specific chemical compound and its applications. To delve into the scope and claims of this patent, it is crucial to understand the structure and components of a patent, particularly the claims section.

Patent Structure

A patent is divided into several key sections: the specification, drawings, and patent claims. The specification and drawings provide detailed descriptions and visual representations of the invention, while the patent claims define the exclusive rights granted to the patent holder[2].

Importance of Patent Claims

The claims section is the most critical part of a patent application, as it outlines the specific subject matter that the inventor regards as their invention. According to 35 USC 112, the applicant must particularly point out and distinctly claim the subject matter of the invention[2].

Types of Claims

There are two main types of claims in a patent application: independent claims and dependent claims.

Independent Claims

Independent claims are standalone and include all the elements necessary to define the invention. They can be claims for a "thing" (such as a composition of matter, machine, apparatus, or device), a method of making a "thing," or a method of using a "thing"[2].

Dependent Claims

Dependent claims refer back to and further limit another claim or claims in the same application. They incorporate by reference each of the limitations of the claim from which they depend, making them easier to write and often more numerous than independent claims due to additional fees for more than three independent claims[2].

Claim Format and Requirements

Each claim must commence on a separate sheet or electronic page, following the detailed description of the invention. Claims must start with a capital letter and end with a period, and they must be in the form of a single sentence. The typical format includes phrases like "I claim," "The invention claimed is," or their substantial equivalents[2][5].

Scope of United States Patent 10,035,788

Chemical Compound

The patent protects a specific chemical compound, N-{4[3-chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quinolinyl}acrylamide. This compound is likely used in pharmaceutical or chemical applications, given its complex structure.

Stability and Degradation

The patent data indicates that the compound shows no significant increase in degradation products under both open and closed conditions for up to six months, as evidenced by HPLC purity analysis[1].

Claim Analysis

Independent Claims

The independent claims in this patent would define the chemical compound itself, its method of synthesis, and any specific uses or applications of the compound. For example:

  • Claim 1: A chemical compound of the formula N-{4[3-chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quinolinyl}acrylamide.
  • Claim 2: A method of synthesizing the compound, including specific steps and reagents.
  • Claim 3: A method of using the compound, such as in a pharmaceutical application.

Dependent Claims

Dependent claims would further limit these independent claims by adding specific details or conditions. For instance:

  • Dependent Claim 1: The compound of Claim 1, wherein the 2-pyridinylmethoxy group is substituted with a specific moiety.
  • Dependent Claim 2: The method of Claim 2, wherein a particular solvent is used in the synthesis.

Patent Landscape and Analytics

Claim Coverage Matrix

To understand the broader patent landscape, a Claim Coverage Matrix can be used. This tool categorizes patents by their claims and scope concepts, helping to identify which patents and claims are actively protecting the intellectual property and where gaps or opportunities exist[3].

Scope Concepts

The scope concepts related to this patent would include chemical synthesis methods, pharmaceutical applications, and stability profiles. These concepts help in filtering, searching, and analyzing large numbers of patent claims concurrently[3].

Claim Charts

Interactive claim charts generated by tools like ClaimScape® can be used to review patent coverage with technical experts. These charts help determine whether a particular scope concept is applicable to a target product or method, highlighting gaps in current coverage and future design opportunities[3].

Strategic Implications

Intellectual Property Protection

Understanding the claims of this patent is crucial for ensuring that any related products or methods do not infringe on the protected subject matter. This involves a thorough analysis of the independent and dependent claims to determine the scope of protection.

Research and Development

For companies involved in similar research, analyzing the claims of this patent can help identify areas for innovation that do not infringe on existing patents. This can also guide the development of new compounds or methods that build upon or differentiate from the protected invention.

Licensing and Collaboration

Companies may consider licensing the technology protected by this patent or collaborating with the patent holder to leverage the protected subject matter. A clear understanding of the claims is essential for negotiating such agreements.

Key Takeaways

  • Patent Claims: The claims section is the most critical part of a patent application, defining the exclusive rights granted to the patent holder.
  • Compound Stability: The patented compound shows no significant degradation under specified conditions.
  • Claim Types: Independent claims define the invention, while dependent claims further limit these claims.
  • Patent Landscape: Tools like Claim Coverage Matrix and claim charts help in understanding the broader patent landscape and identifying gaps or opportunities.
  • Strategic Implications: Understanding the claims is essential for intellectual property protection, research and development, and licensing or collaboration.

FAQs

Q: What is the primary purpose of the claims section in a patent application? A: The primary purpose of the claims section is to define the exclusive rights granted to the patent holder by particularly pointing out and distinctly claiming the subject matter of the invention.

Q: How do independent and dependent claims differ? A: Independent claims are standalone and define the invention completely, while dependent claims refer back to and further limit another claim or claims in the same application.

Q: What tool can be used to analyze the patent landscape and identify gaps in coverage? A: A Claim Coverage Matrix and interactive claim charts, such as those generated by ClaimScape®, can be used to analyze the patent landscape and identify gaps in coverage.

Q: Why is it important to understand the stability profile of the patented compound? A: Understanding the stability profile is crucial for ensuring the compound's efficacy and shelf life, which is vital for its intended applications.

Q: How can companies leverage the protected subject matter of this patent? A: Companies can leverage the protected subject matter through licensing agreements or collaborations with the patent holder, ensuring they do not infringe on the existing patent.

Sources

  1. Google Patents: US10035788B2 - N-{4[3-chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quinolinyl}acrylamide.
  2. IPWatchdog: Understanding Patent Claims.
  3. Schwegman: Patent Analytics.
  4. DrugBank: Neratinib - Uses, Interactions, Mechanism of Action.
  5. BitLaw: MPEP 608.01(m): Form of Claims.

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Drugs Protected by US Patent 10,035,788

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Puma Biotech NERLYNX neratinib maleate TABLET;ORAL 208051-001 Jul 17, 2017 RX Yes Yes 10,035,788 ⤷  Subscribe EXTENDED ADJUVANT TREATMENT OF ADULT PATIENTS WITH EARLY STAGE HER2-OVEREXPRESSED/AMPLIFIED BREAST CANCER, TO FOLLOW ADJUVANT TRASTUZUMAB BASE THERAPY ⤷  Subscribe
Puma Biotech NERLYNX neratinib maleate TABLET;ORAL 208051-001 Jul 17, 2017 RX Yes Yes 10,035,788 ⤷  Subscribe USE IN COMBINATION WITH CAPECITABINE, FOR THE TREATMENT OF ADULT PATIENTS WITH ADVANCED OR METASTATIC HER2-POSITIVE BREAST CANCER WHO HAVE RECEIVED TWO OR MORE PRIOR ANTI-HER2 BASED REGIMENS IN THE METASTATIC SETTING ⤷  Subscribe
Puma Biotech NERLYNX neratinib maleate TABLET;ORAL 208051-001 Jul 17, 2017 RX Yes Yes 10,035,788 ⤷  Subscribe EXTENDED ADJUVANT TREATMENT OF ADULT PATIENTS WITH EARLY-STAGE HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-POSITIVE BREAST CANCER, TO FOLLOW ADJUVANT TRASTUZUMAB BASED THERAPY ⤷  Subscribe
>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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