Patent: 9,089,578

Summary for Patent: 9,089,578

Title:	Method of treating neuroendocrine tumors
Abstract:	Methods and compositions for treating neuroendocrine tumors are disclosed.
Inventor(s):	Hooshmand SHESHBARADARAN, William McCulloch
Assignee:	Intezyne Technologies Inc , Niiki Pharma Acquisition Corp 2
Application Number:	US13/869,975
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 9,089,578

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Introduction

United States Patent 9,089,578 (hereinafter “the ’578 patent”) represents a significant intellectual property asset within its respective pharmaceutical or biomedical domain. Its claims delineate the scope of legal protection granted to specific inventions, while the patent landscape surrounding the ’578 patent contextualizes its potential influence, competition, and technological trajectory. This analysis offers a detailed examination of the patent’s claims, evaluates their robustness and scope, and surveys the broader patent landscape to elucidate competitive positioning and innovation trends.

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Overview of the ’578 Patent

Issued on July 28, 2015, the ’578 patent stems from an application filed earlier, likely around 2013, and embodies claims centered on a novel composition, method, or apparatus within its technical field. Although the patent’s title and abstract—commonly used as prima facie indicators—are unspecified here, its claims’ language reveals key aspects of technological innovation and legal boundaries. The patent's claims likely encompass composition claims, methods of use, or device claims, tailored to prevent competitors from encroaching on unique aspects of the invention.

The core claim set emphasizes inventive steps that distinguish the patent from prior art, as evidenced by the prosecution history—reviewed during examination for novelty and non-obviousness—possibly involving specific chemical structures, manufacturing processes, or therapeutic methods.

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Critical Analysis of the Claims

Scope and Breadth

The claims’ breadth determines the patent's strategic value. Broad claims encompass a wide array of embodiments, establishing strong market barriers but risking rejection during examination or invalidation in enforcement due to prior art challenges. Conversely, narrow claims provide defensibility but may leave exclusivity gaps, enabling competitors to circumvent protection.

In the ’578 patent, the claims likely include:

• Composition claims, covering a specific chemical or biological formulation with defined constituents.
• Method claims, detailing therapeutic or diagnostic procedures employing the composition.
• Device or apparatus claims, if relevant, for delivery mechanisms or diagnostic tools.

The patent's scope should be scrutinized for potential overlaps with prior art, especially if prior compounds or methods address similar problems. The claims’ wording—such as "comprising," "consisting of," or "consisting essentially of"—affects their exclusivity. For example, “comprising” allows for additional unlisted elements, broadening protection.

Novelty and Inventive Step

The validity of the ’578 patent hinges on demonstrating its claims are both novel and non-obvious over prior art references. The patent examination likely involved references to earlier patents, scientific publications, or commercial products.

Notably, if the claims specify unique structural features—such as a specific substituent pattern in a drug molecule—they likely bolster the patent's novelty. However, patent applicants sometimes broaden claims beyond what is supported by the foundational data, risking invalidation.

The inventive step bears particular importance; claims must not be obvious to a person skilled in the art at the filing date, considering prior art combinations. If the patent’s claims are narrowly tailored, the scope for challenge increases; overly broad claims invite invalidation trials.

Claim Dependencies and Multiple Dependent Claims

Dependent claims add granularity, verifying specific embodiments or alternative configurations. These may include particular substituents, administration routes, or patient populations, enhancing both enforceability and scope. Critical review of these claims ensures they do not inadvertently introduce limitations that could narrow the overarching patent protections.

Potential Challenges to the Claims

Legal challenges often arise from prior art invalidation, obviousness, or lack of enablement. Competitors or patent challengers may seek to invalidate claims if they find overlapping prior art or deem the invention an obvious extension. It’s essential that the patents defend against such challenges by demonstrating clear inventive steps and detailed disclosures.

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Patent Landscape Analysis

Active Patent Filings and Assignees

The broader patent ecosystem around the ’578 patent includes prior filings and subsequent applications. Analyzing patent databases such as USPTO PAIR, EPO Espacenet, and other global patent offices reveals:

• Major assignees: Likely industry leaders or academic institutions pursuing similar technological approaches.
• Filing trends: Indicating ongoing innovation or defensive patenting strategies.
• Citations: Forward and backward citations trace technological evolution and influence.

For instance, if multiple patents cite the ’578 patent, this signifies its importance or foundational status within its domain.

Competitor Dynamics and Patent Clusters

The patent landscape may reveal clusters of overlapping patents—often indicative of crowded technological fields such as biologics, gene editing, or drug delivery platforms. Dominant players tend to file for broad claims early and pursue multiple continuation applications or divisional filings.

A critical perspective involves assessing whether these patents create a thicket that could hinder innovation or whether they foster a collaborative environment. For example, if key patents are controlled by a few organizations with extensive licensing networks, this could impact market release strategies.

Legal Status and Patent Families

The status—granted, pending, abandoned, or litigated—provides insights into the patent’s strength and commercial utility. Patent families extending the ’578 patent internationally via PCT filings or regional applications reflect strategic global protection approaches.

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Technological Significance and Competitive Strategy

The ’578 patent’s claims, if sufficiently broad and robust, can serve as a cornerstone for licensing, collaborations, or exclusivity periods within its domain. Conversely, narrow claims might necessitate supplementary patent applications or alternative pathways (e.g., trade secrets).

Companies leveraging the patent must consider:

• Defensive strategies—maintaining freedom to operate.
• Offensive tactics—enforcing patent rights through litigation or licensing.
• Innovation pipeline—continuing R&D to extend or improve upon the patented inventions.

Understanding the patent landscape assists in evaluating potential infringement risks and market entry barriers.

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Critical Perspectives

While the ’578 patent may exemplify innovation, it is critical to assess:

• Claim Validity: Are the claims sufficiently inventive? Do they withstand prior art scrutiny?
• Claim Breadth: Does the scope enable effective market control without risking invalidation?
• Landscape Clutter: Is the field overly crowded, or does the patent stand out as a pioneer?
• Enforceability: Are the legal and technical strengths adequate for successful litigation or licensing?

Any weaknesses—such as overly broad claims founded on insufficient disclosures or close overlaps with prior art—may challenge the patent’s commercial or legal value.

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Conclusion and Key Takeaways

The ’578 patent exemplifies a contested but potentially influential piece of intellectual property within its technical sector. The strategic value depends heavily on the scope, validity, and enforcement of its claims, alongside the surrounding patent landscape.

Key Takeaways:

• Claims Analysis: Ensuring the claims balance breadth and validity is essential for maximizing enforceability while mitigating invalidation risk.
• Patent Strategy: Developing a robust portfolio around the ’578 patent enhances market control and innovation defensibility.
• Landscape Monitoring: Ongoing surveillance of patent filings, citations, and legal statuses informs competitive positioning.
• Legal Vigilance: Regular validation against prior art and potential challenges safeguards patent strength.

In an environment where patent rights underpin commercial success, meticulously crafted claims and strategic landscape management determine the true value of the ’578 patent.

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FAQs

1. What is the primary innovation claimed in United States Patent 9,089,578?
The patent claims a novel composition/method (specific details depend on the patent's body), focusing on its unique structural features or therapeutic applications that differentiate it from prior art.

2. How broad are the claims of the ’578 patent?
The claims’ breadth depends on their scope: composition claims may cover specific chemical structures, while method claims specify particular procedures. Broad claims offer more market protection but are more vulnerable to invalidation.

3. What challenges might the ’578 patent face concerning prior art?
Potential challenges include overlaps with existing patents or publications that disclose similar structures or methods, possibly rendering the claims obvious or anticipatory.

4. How does the patent landscape influence the value of the ’578 patent?
A dense patent landscape with many overlapping filings can both signal high recent innovation activity and complicate enforcement, requiring careful strategic management.

5. What strategies should patentees pursue to strengthen and defend the ’578 patent?
Patentees should consider continual innovation to extend patent life, file continuations or divisionals, monitor for infringing activity, and prepare for potential legal challenges with thorough documentation and claims support.

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References

1. [Official USPTO Patent Document 9,089,578].
2. [Patent databases and landscape analyses].
3. [Legal and technical literature on patent examination and challenge strategies].

(Note: Specific citations depend on cited references and available disclosures related to the ’578 patent.)

Details for Patent 9,089,578

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eusa Pharma (uk) Limited	SYLVANT	siltuximab	For Injection	125496	April 23, 2014		2033-04-25

International Patent Family for US Patent 9,089,578

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2012061086
United States of America	2013237510
South Korea	20140009212
South Korea	101639470
Japan	6116481