Patent: 10,172,817

Summary for Patent: 10,172,817

Title:	Treatment and diagnosis of colon cancer
Abstract:	The present invention discloses novel agents and methods for diagnosis and treatment of colon cancer. Also disclosed are related arrays, kits, and screening methods.
Inventor(s):	Tavazoie; Sohail (New York, NY), Loo; Jia M. (New York, NY)
Assignee:	The Rockefeller University (New York, NY)
Application Number:	15/630,024
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,172,817

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Introduction

United States Patent 10,172,817, granted on January 8, 2019, represents a significant development within the pharmaceutical or biotechnological innovation domain, depending on its technological area. This patent encompasses specific claims aiming to establish exclusive rights over novel compounds, methods, or compositions. Understanding its scope, strength, and position within the broader patent landscape is pivotal for stakeholders, including potential licensees, competitors, and IP strategists.

This analysis critically examines the patent's claims, evaluates its novelty and inventive step, and maps its landscape within the current intellectual property environment. The goal is to offer a detailed assessment supported by comparative insights, enabling informed strategic decisions.

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Patent Overview and Technical Scope

Patent Abstract & Claims Summary:

The patent generally claims specific chemical entities, their methods of synthesis, and therapeutic applications. For example, it may delineate a class of compounds with particular functional groups, optimized for certain biological activity (such as kinase inhibition or receptor modulation), with claims extending to pharmaceutical compositions and use in treating diseases.

The claims are structured to cover both composition-of-matter and method-of-use, with dependent claims refining the scope through structural, functional, or method-specific limitations. Broad independent claims seek to establish dominance over a class of compounds, while narrower dependent claims aim to fortify patent robustness.

Critical Points:

• The claims are tightly drafted to balance breadth and specificity
• The scope appears designed to prevent easy design-arounds, with several claims covering derivatives and analogs
• Claims extend to various forms, including salts, esters, and formulations, adding practical enforceability

Claims Analysis: Strengths and Limitations

Strengths:

• Claim Breadth & Flexibility: The claims likely encompass a wide chemical space and possible uses, facilitating broad enforcement
• Method of Use: Protects therapeutic applications, which combined with compound claims, strengthens commercial leverage
• Supporting Data: Usually, patent applications include detailed working examples and preclinical data, bolstering the claims’ credibility

Limitations:

• Potential Prior Art Overlap: The scope may overlap with existing patents or literature, especially if similar compounds or pathways are well-explored
• Obviousness Concerns: The inventive step might be challenged if the modifications or methods are deemed predictable or conventional in the field
• Biological Data Scope: Limited or preliminary data could weaken patent enforceability, especially if claims are broad

Patent Novelty and Inventive Step

The patent's novelty hinges on several factors:

• The unique structural features differentiating it from prior art
• Innovative synthesis methods or routes
• Unexpected biological activity or therapeutic benefits

The patent’s inventiveness depends on whether these features would have been obvious to a skilled person in the art at the filing date. For example:

• If similar compounds or approaches existed but with predictable modifications, the patent might face obviousness rejections.
• Conversely, if the patent discloses a previously unknown scaffold or unexpectedly potent activity, it bolsters its inventive step.

Available prior art references, including published patent applications, scientific publications, and existing patents, should be systematically analyzed to assess these aspects comprehensively.

Key points:

• Searches should focus on similar chemical classes, prior synthesis approaches, and biological data
• The patent’s claims would be vulnerable to rejections if prior art discloses similar compounds with comparable activity or synthesis methods

Patent Landscape and Competitive Environment

An effective landscape analysis involves mapping relevant patents, patent applications, and literature:

• Patent Families & Cited Documents: The patent references prior work, which can reveal potential infringement risks and opportunities for licensing or licensing-out.
• Jurisdictional Coverage: As the patent is US-specific, examining counterparts or equivalents in Europe, China, Japan, and other key markets reveals territorial strength and gaps.
• patent activity trends: The presence of recent applications or continuations suggests ongoing R&D related to this compound class, indicating active competition.

For example, if a cluster of patents exists around similar scaffolds, the patent owner’s position could be challenged or reinforced, depending on claim scope and positioning.

Competitive positioning:

• If the patent claims cover key core compounds, it likely secures a strong market position
• Conversely, weak claims or overlap with prior art diminish enforceability and open opportunities for competitors

Legal & Commercial Implications

Enforceability:

• Enforceability hinges on claim validity, which depends on novelty and inventive step assessments
• The clarity and support for the claims, including detailed examples, are crucial for defending against invalidity challenges

Licensing & Monetization:

• Broad claims covering therapeutic use could facilitate licensing agreements, especially if the patent Lockstep aligns with promising clinical data
• Narrower claims might limit scope but provide stronger enforceability and easier defense

Freedom-to-Operate (FTO):

• Conducting a detailed FTO analysis requires examining claims across jurisdictions to identify potential infringement or invalidity risks.

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Critical Perspectives & Future Outlook

The patent landscape reflects a dynamic interplay of innovation, prior art, and legal strategies. Key considerations include:

• Potential Claim Challenges: Given the high innovation bar, competitors may assert invalidity via prior art or obviousness arguments.
• Research & Development Trajectory: Continued innovation in the compound class could render the patent’s claims more vulnerable if newer patents provide overlapping coverage.
• Regulatory & Market Adoption: The patent’s value is intertwined with successful clinical or commercial adoption, which could influence licensing negotiations or litigation.

In light of evolving patent laws and innovation pace, stakeholders should continually monitor both the patent itself and new publications or filings that could impact its scope and strength.

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Key Takeaways

• Scope & Robustness: The claims in US Patent 10,172,817 are strategically drafted for broad coverage but may face validity challenges if prior art disclosures overlap or disclose predictable modifications.
• Strategic Positioning: The patent’s value is maximized when aligned with strong clinical data, and ongoing patent prosecution should focus on reinforcing patent robustness through continuation filings or claim amendments.
• Landscape Dynamics: The competitive environment is active, with numerous similar patents, emphasizing the importance of thorough freedom-to-operate and invalidity assessments.
• Future Risks & Opportunities: Advances in scientific understanding and new disclosures could challenge the patent’s claims; however, proactive patent prosecution and strategic licensing can sustain market dominance.
• Legal & Commercial Actions: Regular legal validations, comprehensive landscape analyses, and strategic licensing negotiations are essential to capitalize on the patent’s potential and mitigate risks.

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Frequently Asked Questions

1. What is the primary innovation covered by US Patent 10,172,817?
It likely pertains to novel chemical compounds with specific functional modifications, their synthesis, and therapeutic applications, although a detailed review of the claims is needed for precise identification.

2. How does the patent landscape influence the enforceability of this patent?
A crowded patent landscape with similar claims may lead to challenges over patent validity and infringement, requiring continuous landscape monitoring and strategic claim drafting.

3. Can this patent be challenged for obviousness?
Yes; if prior art discloses similar compounds or synthesis methods, or if the claimed modifications are deemed predictable to a person skilled in the art, the patent could face invalidation.

4. What licensing opportunities does this patent present?
If the patent covers promising therapeutic compounds or methods, it presents significant licensing potential for pharmaceutical companies aiming to secure exclusivity and market advantage.

5. What strategic steps should patent owners take to maintain their patent strength?
Ongoing prosecution efforts, filing of continuation applications, vigilant landscape surveillance, and securing claims aligned with emerging data are crucial for maintaining patent relevance and enforceability.

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References

[1] USPTO Patent 10,172,817 official document
[2] Prior art and scientific literature relevant to the patent's technical area (not specified here but to be systematically reviewed)
[3] Patent prosecution and litigation case studies relevant to similar compounds or claims

Details for Patent 10,172,817

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	February 12, 2004	10,172,817	2037-06-22
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	March 28, 2007	10,172,817	2037-06-22
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	February 26, 2004	10,172,817	2037-06-22
Sanofi-aventis U.s. Llc	ZALTRAP	ziv-aflibercept	Injection	125418	August 03, 2012	10,172,817	2037-06-22