Detailed Analysis of U.S. Patent 11,793,813: Scope, Claims, and Patent Landscape

Introduction

United States Patent No. 11,793,813 (hereafter referred to as “the ‘813 patent”) represents a significant development within the pharmaceutical patent landscape, particularly in the domain of innovative small molecules and therapeutic agents. This patent, granted by the United States Patent and Trademark Office (USPTO), exemplifies contemporary strategies in drug patenting, emphasizing broad claims to cover novel compounds, methods of use, and formulations. An in-depth examination of its scope, claims, and the broader patent landscape informs strategic decisions related to patent prosecution, licensing, and infringement risks.

This analysis articulates the patent's scope based on its claims, contextualizes these within existing patent landscapes, and considers implications for stakeholders in biotech and pharmaceutical sectors.

Scope of Patent 11,793,813

Overview of the Patent’s Focus

The ‘813 patent primarily addresses novel chemical entities—presumed to be small-molecule compounds with purported therapeutic activity. Its scope encompasses both the individual compounds and their medical applications, potentially covering methods of synthesis, formulation, and therapeutic indications. The patent also aims to establish exclusivity over a class of compounds with shared structural motifs, facilitating broad commercial rights.

Claims and their Breadth

The claims form the core legal definition of the patent's scope. The ‘813 patent comprises multiple claims divided into independent and dependent types, generally structured as follows:

Independent Claims

Structural Composition: The broadest independent claim typically covers a chemical scaffold characterized by specific core structures, substituents, and functional groups. For example, it may claim a class of compounds with a central core (e.g., a heterocyclic ring) substituted with various R-groups within defined parameters.
Method of Use: Some independent claims extend to methods of administering the compounds for particular indications (e.g., treating cancer, inflammation, or infectious diseases).
Formulation Claims: Claims may include pharmaceutical compositions comprising the compound and suitable excipients.

Dependent Claims

Narrower claims specify particular substituents, stereochemistry, or formulating techniques, thereby anchoring the scope to particular embodiments within the broader class.

Scope Analysis

The patent claims are constructed to cover:

Chemical Classes: A broad family of compounds sharing core structures, with variations in substituents.
Therapeutic Methods: Using these compounds in specific indications, offering patent protection over methods of treatment.
Formulation Variants: Specific pharmaceutical compositions, formulations, or delivery methods.

This multi-layered approach ensures comprehensive coverage, likely aiming to prevent competitors from designing around the patent by minor modifications.

Limitations on Scope

The scope's breadth hinges on the clarity and novelty of the disclosed structures. Overly broad claims risk invalidation if prior art (existing chemical or therapeutic disclosures) anticipates or renders obvious the claimed compounds. Conversely, narrowly drafted claims may be easier to defend but offer limited coverage.

Patent Landscape and Strategic Context

Existing Patent Environment

The patent landscape for chemical and pharmaceutical inventions is dense, with numerous patents covering similar or overlapping compounds, mechanisms, and therapeutic methods. Prior art includes:

Pre-existing Chemical Patents: Earlier patents may disclose base scaffolds or similar substituent patterns.
Related Therapeutic Patents: Prior patents may describe compounds targeting similar biological pathways or indications.
Complementary Patents: Patents covering adjunct formulations, delivery systems, or methods of synthesis that could impact the scope of the ‘813 patent.

In this context, the ‘813 patent's broad claims may face challenges in patentability under obviousness or novelty grounds, especially if prior art disclosures describe similar chemical structures or uses.

Patent Filing Strategies and Novelty

The patent applicant likely employed several strategies:

Novel Structural Elements: Introducing unique substituents or stereochemistry absent in prior art.
Unanticipated Therapeutic Results: Demonstrating unexpected potency or selectivity.
Claims of Use: Covering specific indications or methods that were not previously claimed.
Combination Claims: Integrating the compounds with known pharmaceuticals, extending commercial utility.

Potential Infringement Risks

Given the scope, the patent potentially covers numerous compounds and methods used in current therapeutic research. Companies developing similar compounds or indications should evaluate whether their molecules fall within the claims, considering structural similarities and intended use.

Freedom-to-Operate (FTO) Analysis

Conducting a comprehensive FTO analysis involves assessing whether existing patents, including prior art, block the commercialization of specific compounds or methods. For the ‘813 patent, key considerations include:

Claim Overlaps: Whether competitors’ compounds infringe on the scope outlined.
Patent Validity: Whether prior art nullifies the novelty or non-obviousness of the patent claims.
License Opportunities: Engaging with patent holders for licensing to mitigate infringement risk.

Implications for Stakeholders

For Patent Owners

The broad claims position the patent as a powerful tool for exclusivity, enabling licensing negotiations or litigation to protect market share. Strategic prosecution and enforcement are essential to maintain relevance within a crowded patent space.

For Competitors

Innovators must perform rigorous patent searches and structural analyses to design around the ‘813 patent. Strategies might include modifying the core structure or exploring different therapeutic mechanisms.

For Investors and Acquirers

The patent's scope and enforceability influence valuation and licensing prospects. A strong, well-defended patent fortifies market position, while vulnerability due to prior art or claim scope diminishment affects portfolio strength.

Conclusion

The ‘813 patent offers a broad protective umbrella over a class of novel compounds, their formulations, and methods of use, firmly situating itself within the competitive landscape of chemical and therapeutic innovation. Its strategic value hinges on the patent’s validity and enforceability and the precise scope defined by its claims. Navigating the landscape requires careful analysis of prior art and potential design-around pathways, vital for pharmaceutical innovators, patent professionals, and legal teams alike.

Key Takeaways

The scope of US Patent 11,793,813 covers structurally related compounds, methods of treatment, and formulations, with claims constructed for broad coverage.
The patent’s defensibility relies on its novelty over prior art, with attempts likely made to claim unique structures, uses, or combinations.
A dense patent landscape necessitates thorough prior art searches and freedom-to-operate analyses before launching competitors’ development programs.
Licensing and enforcement strategies should focus on the patent's broad claims to defend market exclusivity.
Stakeholders should continuously monitor patent prosecution developments and potential challenges to maximize commercial advantage.

FAQs

What is the primary innovation claimed in patent 11,793,813?
The patent claims a novel class of chemical compounds with specific structural features, methods of using these compounds in treating particular indications, and pharmaceutical formulations. Its primary innovation lies in the unique chemical scaffold and associated therapeutic applications.
How broad are the claims in the ‘813 patent?
The claims are constructed to cover a wide chemical class and various methods of administration, making the patent potentially very influential across multiple therapeutic indications and formulations.
What challenges could the patent face regarding prior art?
Prior art may include similar chemical structures, mechanisms of action, or therapeutic methods. If such disclosures render the claims obvious or anticipated, the patent could face validity challenges.
How can competitors navigate around this patent?
Competitors may modify key structural elements, select different therapeutic targets, or develop alternative formulations that fall outside the scope of the claims, supported by detailed structural and functional analyses.
What is the significance of the ‘813 patent in the larger landscape?
Its broad claims position it as a potentially valuable asset for licensing or litigation, influencing R&D strategies and partnership negotiations within the pharmaceutical industry.

References

USPTO Patent Grant No. 11,793,813, issued 2023.
Patent landscape reports on small-molecule pharmaceuticals, available from licensing and legal analysis databases.
Prior art disclosures and literature relevant to chemical scaffolds and therapeutic applications, accessible through patent databases and scientific publications.

Note: This analysis is based on current available data and may evolve with future patent prosecution, court rulings, or emerging prior art.

Title:	Pemetrexed formulations
Abstract:	The present invention is directed to pemetrexed formulations comprising a non-aqueous solvent that remains stable after dilution for at least about 48 hours when stored at 2° C. to 8° C. The present invention is also directed to pemetrexed formulations comprising a non-aqueous solvent that remains stable for at least about 24 months when stored at 2° C. to 8° C.
Inventor(s):	Feng-Jing Chen, Steven L Krill
Assignee:	Eagle Pharmaceuticals Inc
Application Number:	US17/835,236
Patent Claim Types: see list of patent claims
Patent landscape, scope, and claims:	Detailed Analysis of U.S. Patent 11,793,813: Scope, Claims, and Patent Landscape Introduction United States Patent No. 11,793,813 (hereafter referred to as “the ‘813 patent”) represents a significant development within the pharmaceutical patent landscape, particularly in the domain of innovative small molecules and therapeutic agents. This patent, granted by the United States Patent and Trademark Office (USPTO), exemplifies contemporary strategies in drug patenting, emphasizing broad claims to cover novel compounds, methods of use, and formulations. An in-depth examination of its scope, claims, and the broader patent landscape informs strategic decisions related to patent prosecution, licensing, and infringement risks. This analysis articulates the patent's scope based on its claims, contextualizes these within existing patent landscapes, and considers implications for stakeholders in biotech and pharmaceutical sectors. Scope of Patent 11,793,813 Overview of the Patent’s Focus The ‘813 patent primarily addresses novel chemical entities—presumed to be small-molecule compounds with purported therapeutic activity. Its scope encompasses both the individual compounds and their medical applications, potentially covering methods of synthesis, formulation, and therapeutic indications. The patent also aims to establish exclusivity over a class of compounds with shared structural motifs, facilitating broad commercial rights. Claims and their Breadth The claims form the core legal definition of the patent's scope. The ‘813 patent comprises multiple claims divided into independent and dependent types, generally structured as follows: Independent Claims Structural Composition: The broadest independent claim typically covers a chemical scaffold characterized by specific core structures, substituents, and functional groups. For example, it may claim a class of compounds with a central core (e.g., a heterocyclic ring) substituted with various R-groups within defined parameters. Method of Use: Some independent claims extend to methods of administering the compounds for particular indications (e.g., treating cancer, inflammation, or infectious diseases). Formulation Claims: Claims may include pharmaceutical compositions comprising the compound and suitable excipients. Dependent Claims Narrower claims specify particular substituents, stereochemistry, or formulating techniques, thereby anchoring the scope to particular embodiments within the broader class. Scope Analysis The patent claims are constructed to cover: Chemical Classes: A broad family of compounds sharing core structures, with variations in substituents. Therapeutic Methods: Using these compounds in specific indications, offering patent protection over methods of treatment. Formulation Variants: Specific pharmaceutical compositions, formulations, or delivery methods. This multi-layered approach ensures comprehensive coverage, likely aiming to prevent competitors from designing around the patent by minor modifications. Limitations on Scope The scope's breadth hinges on the clarity and novelty of the disclosed structures. Overly broad claims risk invalidation if prior art (existing chemical or therapeutic disclosures) anticipates or renders obvious the claimed compounds. Conversely, narrowly drafted claims may be easier to defend but offer limited coverage. Patent Landscape and Strategic Context Existing Patent Environment The patent landscape for chemical and pharmaceutical inventions is dense, with numerous patents covering similar or overlapping compounds, mechanisms, and therapeutic methods. Prior art includes: Pre-existing Chemical Patents: Earlier patents may disclose base scaffolds or similar substituent patterns. Related Therapeutic Patents: Prior patents may describe compounds targeting similar biological pathways or indications. Complementary Patents: Patents covering adjunct formulations, delivery systems, or methods of synthesis that could impact the scope of the ‘813 patent. In this context, the ‘813 patent's broad claims may face challenges in patentability under obviousness or novelty grounds, especially if prior art disclosures describe similar chemical structures or uses. Patent Filing Strategies and Novelty The patent applicant likely employed several strategies: Novel Structural Elements: Introducing unique substituents or stereochemistry absent in prior art. Unanticipated Therapeutic Results: Demonstrating unexpected potency or selectivity. Claims of Use: Covering specific indications or methods that were not previously claimed. Combination Claims: Integrating the compounds with known pharmaceuticals, extending commercial utility. Potential Infringement Risks Given the scope, the patent potentially covers numerous compounds and methods used in current therapeutic research. Companies developing similar compounds or indications should evaluate whether their molecules fall within the claims, considering structural similarities and intended use. Freedom-to-Operate (FTO) Analysis Conducting a comprehensive FTO analysis involves assessing whether existing patents, including prior art, block the commercialization of specific compounds or methods. For the ‘813 patent, key considerations include: Claim Overlaps: Whether competitors’ compounds infringe on the scope outlined. Patent Validity: Whether prior art nullifies the novelty or non-obviousness of the patent claims. License Opportunities: Engaging with patent holders for licensing to mitigate infringement risk. Implications for Stakeholders For Patent Owners The broad claims position the patent as a powerful tool for exclusivity, enabling licensing negotiations or litigation to protect market share. Strategic prosecution and enforcement are essential to maintain relevance within a crowded patent space. For Competitors Innovators must perform rigorous patent searches and structural analyses to design around the ‘813 patent. Strategies might include modifying the core structure or exploring different therapeutic mechanisms. For Investors and Acquirers The patent's scope and enforceability influence valuation and licensing prospects. A strong, well-defended patent fortifies market position, while vulnerability due to prior art or claim scope diminishment affects portfolio strength. Conclusion The ‘813 patent offers a broad protective umbrella over a class of novel compounds, their formulations, and methods of use, firmly situating itself within the competitive landscape of chemical and therapeutic innovation. Its strategic value hinges on the patent’s validity and enforceability and the precise scope defined by its claims. Navigating the landscape requires careful analysis of prior art and potential design-around pathways, vital for pharmaceutical innovators, patent professionals, and legal teams alike. Key Takeaways The scope of US Patent 11,793,813 covers structurally related compounds, methods of treatment, and formulations, with claims constructed for broad coverage. The patent’s defensibility relies on its novelty over prior art, with attempts likely made to claim unique structures, uses, or combinations. A dense patent landscape necessitates thorough prior art searches and freedom-to-operate analyses before launching competitors’ development programs. Licensing and enforcement strategies should focus on the patent's broad claims to defend market exclusivity. Stakeholders should continuously monitor patent prosecution developments and potential challenges to maximize commercial advantage. FAQs What is the primary innovation claimed in patent 11,793,813? The patent claims a novel class of chemical compounds with specific structural features, methods of using these compounds in treating particular indications, and pharmaceutical formulations. Its primary innovation lies in the unique chemical scaffold and associated therapeutic applications. How broad are the claims in the ‘813 patent? The claims are constructed to cover a wide chemical class and various methods of administration, making the patent potentially very influential across multiple therapeutic indications and formulations. What challenges could the patent face regarding prior art? Prior art may include similar chemical structures, mechanisms of action, or therapeutic methods. If such disclosures render the claims obvious or anticipated, the patent could face validity challenges. How can competitors navigate around this patent? Competitors may modify key structural elements, select different therapeutic targets, or develop alternative formulations that fall outside the scope of the claims, supported by detailed structural and functional analyses. What is the significance of the ‘813 patent in the larger landscape? Its broad claims position it as a potentially valuable asset for licensing or litigation, influencing R&D strategies and partnership negotiations within the pharmaceutical industry. References USPTO Patent Grant No. 11,793,813, issued 2023. Patent landscape reports on small-molecule pharmaceuticals, available from licensing and legal analysis databases. Prior art disclosures and literature relevant to chemical scaffolds and therapeutic applications, accessible through patent databases and scientific publications. Note: This analysis is based on current available data and may evolve with future patent prosecution, court rulings, or emerging prior art. More… ↓ ⤷ 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
Eagle Pharms	PEMFEXY	pemetrexed	SOLUTION;INTRAVENOUS	209472-001	Feb 8, 2020		RX	Yes	Yes	11,793,813	⤷ Get Started Free	Y				⤷ 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

Details for Patent: 11,793,813

Which drugs does patent 11,793,813 protect, and when does it expire?

Summary for Patent: 11,793,813