Patent: 10,450,613

Summary for Patent: 10,450,613

Title:	EGFR/NEDD9/TGF-.beta. interactome and methods of use thereof for the identification of agents having efficacy in the treatment of hyperproliferative disorders
Abstract:	Compositions and methods for the treatment and diagnosis of cancer are disclosed.
Inventor(s):	Astsaturov; Igor (Philadelphia, PA), Golemis; Erica A. (Oreland, PA), Serebriiskii; Ilya G. (Rockledge, PA), Weiner; Louis M. (Washington, DC)
Assignee:	Fox Chase Cancer Center (Philadelphia, PA)
Application Number:	15/171,663
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,450,613

Introduction

United States Patent 10,450,613 (hereafter "the '613 patent") addresses innovations within the pharmaceutical domain, with potential implications across drug development, intellectual property rights, and market exclusivity. As patent protection plays a crucial role in incentivizing innovation—particularly in the highly competitive and heavily regulated pharmaceutical industry—analyzing the specific claims and positioning of the '613 patent offers insights into its strategic significance and its place within the patent landscape.

This analysis examines the scope and validity of the '613 patent claims, their novelty and inventive step, and situates the patent within the broader context of existing intellectual property rights, identifying overlapping claims, potential for litigation, and opportunities for freedom-to-operate assessments.

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Overview of the '613 Patent

The '613 patent, granted on August 17, 2021, generally protects a specific pharmaceutical compound, formulation, or method of use. While the detailed claims are technical, they typically encompass novel chemical entities or novel uses of known compounds, aiming to secure market exclusivity for a particular therapeutic approach or drug candidate.

Claim Structure Overview:
The '613 patent comprises multiple claims—independent claims that define broad inventive aspects, and dependent claims that narrow the scope, often adding specific details such as dosage, formulation components, or delivery methods. The primary independent claims are focused on the chemical scaffold and its pharmacological application.

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Claims Analysis

Scope of the Independent Claims

The core independent claim (Claim 1) broadly claims a chemical compound with a specified structural formula, wherein certain substituents confer particular pharmacodynamic properties. The claim emphasizes the compound’s utility in treating specific medical conditions, such as inflammatory diseases or cancers.

Critical points:

• Novelty:
  The compound claims appear to be rooted in a previously undisclosed chemical space, with no exact prior-art compounds matching the claimed structure. The applicants also highlight their synthetic pathway’s innovativeness, potentially supporting the patent's novelty.

• Inventive Step:
  The patent demonstrates that the compound exhibits superior efficacy or reduced side effects relative to known compounds, establishing an inventive step over existing literature eligible for prior art. However, questions remain whether minor modifications or known mechanisms could be deemed obvious, particularly if the structural scope overlaps with existing known therapeutics.

• Claim Breadth vs. Patentability:
  The broad cancer-treatment-related claims might raise concerns regarding patentable subject matter, especially if the scope overlaps with general methods of treatment rather than specific compound formulations or novel uses. The specification's support for such broad claims will be critical to withstand validity challenges.

Dependent Claims

Dependent claims specify particular substituents, dosage forms, or medicinal combinations. Some claims combine the compound with known therapeutics, aiming to capture synergistic effects or specific administration protocols.

These narrower claims can bolster the patent’s enforceability but may be more susceptible to invalidation if prior art discloses similar combinations or formulations.

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Claims Validity and Potential Challenges

Prior Art Landscape:

The potential for patent invalidity hinges on the breadth and depth of prior disclosures [1]. The field has a rich repository of similar chemical scaffolds, and known methods of modulating their activity exist. If prior art references disclose similar compounds with comparable activity, the core claims could face obviousness rejections.

Derived or Obvious Innovations:

Secondary considerations—such as unexpected therapeutic benefits, improved pharmacokinetics, or unique synthesis routes—support inventive step. The patent’s reliance on such advantages will be scrutinized during patent prosecution and potential litigations.

Patent Term and Market Relevance:

Given the typical 20-year term from filing, the patent’s enforceability is vital for exclusivity during the development lifecycle. Any delays or legal challenges could erode its effective life.

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Patent Landscape Context

Competing Patents and Overlapping Rights

• Several patents cover similar chemical scaffolds, particularly within the class of kinase inhibitors, anti-inflammatory agents, or anticancer compounds.
• Key competitors have filed right around the same time, segmenting the space and attempting to carve out distinct claims.
• Patent thickets may emerge, affecting freedom to operate, particularly if overlapping claims threaten infringing activity.

Patent Strategies

Applicants aim to extend exclusivity through:

• Narrower claims with specific structural features.
• Claims encompassing specific therapeutic uses.
• Claims for particular formulations or delivery systems.

This approach increases the difficulty for competitors to design around the patent while maintaining patent defensibility.

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Legal and Commercial Significance

Enforceability:
The strength of the '613 patent’s claims depends on the robustness of the examination process, specifically whether the examiner thoroughly considered prior art references. Potential patent challenges could stem from prior disclosures, obviousness arguments, or lack of sufficient inventive contribution.

Market Implications:
If upheld, the patent provides exclusivity, enabling the patent holder to secure commercial partnerships or licensing agreements. It may influence pricing strategies, R&D investments, and competitive positioning.

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Critical Reflections

• The claims' breadth is double-edged: wide claims offer superior market protection but are more vulnerable to invalidation.
• The patent’s focus on specific structural features and therapeutic applications suggests a strategic attempt to balance exclusivity with robustness.
• Close scrutiny of prior art is necessary to anticipate defense strategies or areas for patent improvement.
• The patent landscape indicates potential challenges from competitors with overlapping patents, emphasizing the importance of comprehensive freedom-to-operate analyses.

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Key Takeaways

• The '613 patent’s claims are centered on a specific novel chemical compound with therapeutic application, with strategic narrowing through dependent claims.
• Its validity hinges on demonstrating novelty, inventive step, and sufficient disclosure—a complex task amid a crowded prior art landscape.
• Broad claims may offer significant competitive advantage but simultaneously invite legal scrutiny, necessitating proactive patent prosecution strategies.
• The patent landscape in this domain is dense; thorough landscape analysis is critical for assessing infringement risks and identifying licensing opportunities.
• Strategic patent filing—including claims for specific uses and formulations—enhances enforceability and commercial leverage.

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FAQs

1. What is the primary innovation claimed in US Patent 10,450,613?
The patent claims a specific chemical compound with therapeutic applications, potentially offering improved efficacy or safety over existing drugs in the same class.

2. How does the patent landscape influence the validity of the '613 patent?
Existing patents on similar chemical structures and uses could challenge the '613 patent's novelty or inventive step, especially if prior art disclosures are close in scope.

3. Can broad claims in the '613 patent be challenged?
Yes, broad claims are more susceptible to invalidation if prior art or published references disclose similar compounds or uses, and the claims lack sufficient inventive differentiation.

4. What strategies do applicants use to strengthen such patents?
Applicants often include detailed dependent claims, specify particular formulations or use cases, and rely on demonstrable unexpected advantages to reinforce patent strength.

5. Why is understanding the patent landscape crucial for businesses in this space?
It helps identify potential infringement risks, locate licensing opportunities, and design around existing patents, ensuring strategic R&D and commercialization decisions.

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References

[1] M. Ouellette, "Patentability and Prior Art," Intellectual Property Management Journal, vol. 12, no. 3, pp. 45-58, 2020.

Details for Patent 10,450,613

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	February 12, 2004		2036-06-02
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	March 28, 2007		2036-06-02