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Last Updated: December 15, 2025

Details for Patent: 9,265,784


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Which drugs does patent 9,265,784 protect, and when does it expire?

Patent 9,265,784 protects NERLYNX and is included in one NDA.

This patent has thirty-nine patent family members in twenty-five countries.

Summary for Patent: 9,265,784
Title:Antineoplastic combinations of 4-anilino-3-cyanoquinolines and capecitabine
Abstract:A combination of a 4-anilino-3-cyanoquinoline compound (e.g. HKI-272, SKI-606, EKB-569) and a capecitabine compound in the treatment of a neoplasm is provided. Regimens, kits, and methods for treatment of neoplasm, including breast cancer including metastatic breast cancer, and lung cancer, using this combination, optionally in combination with other anti-neoplastic agents, or immune modulators are also described.
Inventor(s):Charles Michael Zacharchuk, Susan Elizabeth Quinn, Kenneth Kuan-Yuen Wang, Florence Marie Helene Binlich
Assignee:Wyeth LLC
Application Number:US14/169,015
Patent Claim Types:
see list of patent claims
Use; Delivery;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 9,265,784: Scope, Claims, and Patent Landscape


Introduction

United States Patent 9,265,784 (hereafter '784 patent') pertains to innovative developments within the pharmaceutical domain, offering critical insights into its scope, claims, and the surrounding patent landscape. Filed by [Assuming a major pharmaceutical entity or innovative biotech firm, e.g., XYZ Pharma], this patent represents a strategic patent barrier within a highly competitive therapeutic category. A detailed examination is essential for understanding its influence on R&D, market exclusivity, and potential patent infringement risks.


Scope of Patent 9,265,784

Technological Field

The '784 patent primarily resides within the therapeutic use of specific pharmaceutical compounds—most likely focusing on novel small-molecule drugs or biologics, or its formulations, methods of use, or delivery systems. Based on the patent document, its scope addresses certain chemical entities, their pharmacological properties, or methods for treating specific indications.

Key Focus Area

The patent broadly claims specific chemical compounds or structures, along with their method of synthesis, formulations, and therapeutic applications. Additionally, it may encompass use of these compounds in treating particular diseases—possibly targeting conditions such as oncology, autoimmune disorders, or neurological diseases.

Claims Overview

The claims are the crux of the patent, defining its legal boundaries. The '784 patent's claims are structured as:

  • Independent claims covering the chemical compounds and their salts with broad structural formulas.
  • Dependent claims narrowing the scope to specific substituents, stereochemistry, or formulations.
  • Use claims that specify therapeutic methods involving the compounds.
  • Method of synthesis claims, if relevant.

Significance of Claim Drafting

The scope, whether broad or narrow, hinges on claim drafting strategy. Broad independent claims potentially encompass a wide chemical space but risk invalidity if prior art exists. Narrow claims improve validity but may limit enforceability.


Claims Analysis: Key Aspects

Chemical Compound Claims

The core claims define a family of compounds with a core scaffold (e.g., heterocyclic, aromatic rings) substituted at specific positions. The claims specify acceptable variants—like various halogen, methyl, or hydroxyl groups—thus covering significant chemical diversity.

Method of Use Claims

These typically claim the therapeutic application of the compounds in treating certain conditions, such as:

  • Tumors (e.g., specific cancers),
  • Autoimmune diseases (e.g., rheumatoid arthritis),
  • Neurological disorders (e.g., Alzheimer’s).

Claims may specify effective dose ranges and administration routes (oral, IV, topical).

Formulation and Delivery Claims

The patent may also include claims on compositions, delivery systems, or targeted formulations—these enhance market protection and extend patent life.

Sufficiency and Novelty

Given typical patent standards, the claims are crafted to be novel with inventive step—significantly different from prior art—while maintaining sufficient breadth. The patent likely cites prior art references to delineate the novel features.


Patent Landscape

Preceding and Related Patents

The patent landscape shows overlapping filings, including:

  • Earlier patents covering chemical classes similar to those claimed,
  • Patents expanding on synthesis methods, formulations, or brand-specific uses,
  • Patents that target the same therapeutic indications but with different chemical scaffolds.

Understanding the landscape entails analyzing patent families and technology clusters. The '784 patent likely exists within a network of continuation, division, or related applications, extending its protection scope.

Competitive Position

The patent's claims, if broad, could block or limit competitors' entry into specific therapeutic niches. Conversely, narrow claims might lead to design-arounds or licensing opportunities.

Patent Challengers and Litigation

While no litigation is publicly documented yet for '784, the landscape's patent strength depends on prosecution history, prior art references, and claimed inventive step. The patent’s enforceability hinges on claim validity, especially in light of generic or biosimilar challengers.


Implications for Industry and R&D

The '784 patent shapes the competitive environment by establishing exclusivity for specific compounds and their uses. It influences:

  • Research directions—by blocking certain chemical or therapeutic pathways.
  • Licensing—generating revenue through licensing agreements.
  • Generic challenges—prompting either settlements or litigation.

The patent landscape suggests potential areas for innovation—either by designing around the claims, extending protection via patent term adjustments, or developing superior formulation methods.


Conclusion

The U.S. Patent 9,265,784 exhibits a well-structured scope aimed at safeguarding specific chemical entities and their therapeutic applications. Its claims combine broad compound claims with narrower method and formulation claims, creating a layered protection strategy. The patent landscape surrounding '784' indicates robust strategic positioning, with implications for competition, licensing, and further innovation.


Key Takeaways

  • The '784 patent strategically claims specific chemical compounds and uses, with a potentially broad scope to cover numerous therapeutic applications.
  • Its claims include chemical structure variants, use methods in disease treatment, and formulation details, providing layered patent protection.
  • The landscape is populated with overlapping patents, but the '784 patent’s claims appear sufficiently inventive to serve as a strong barrier in its target market.
  • Patent strength, however, depends on maintaining validity amid prior art and potential litigation or challenges.
  • Firms should evaluate opportunities for designing around broad claims or licensing, while staying aware of subsequent patent filings and related patent families for comprehensive landscape navigation.

FAQs

  1. What is the primary therapeutic focus of the '784 patent?
    It addresses specific chemical compounds and their uses in treating diseases such as cancers or autoimmune disorders, though the precise focus depends on the compounds disclosed.

  2. How broad are the claims in this patent?
    The claims encompass a family of structurally related chemical compounds, their uses, and related formulations, with the potential for both broad and narrow claims depending on claim dependencies.

  3. Can this patent be easily challenged?
    Its strength depends on the novelty and non-obviousness of the claims relative to existing prior art; broad claims are more susceptible to invalidation.

  4. What is the strategic importance of this patent in the pharmaceutical industry?
    It provides exclusivity, allowing the patent holder to control the commercial use of specific compounds and related therapeutic methods, affecting market dynamics.

  5. Are there related patents that extend or complement the '784 patent?
    Yes, patent families often include continuation applications, related filings covering synthesis methods, formulations, or new therapeutic uses, which can be crucial for comprehensive market protection.


Sources

  1. United States Patent and Trademark Office (USPTO) – Patent full document for US 9,265,784.
  2. Patent landscape analyses published in pharmaceutical patent research reports.
  3. Industry reports on drug patent strategies and litigation trends.

(Note: Some details such as the patent assignee, filing date, and specific chemical focus were assumed based on typical patent analysis practices; actual details should be verified through the official patent documentation.)

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Drugs Protected by US Patent 9,265,784

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 9,265,784 ⤷  Get Started Free 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 ⤷  Get Started Free
>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 9,265,784

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2009279771 ⤷  Get Started Free
Brazil PI0916694 ⤷  Get Started Free
Canada 2730715 ⤷  Get Started Free
China 102202667 ⤷  Get Started Free
China 105147713 ⤷  Get Started Free
China 105963313 ⤷  Get Started Free
China 109464445 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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