Patent: 10,238,656

Summary for Patent: 10,238,656

Title:	Combination therapy for cancer
Abstract:	The present invention provides preparation of medicaments for use in treating and methods of treating non-small cell lung cancer in a patient comprising: [5-(4-ethyl-piperazin-1-ylmethyl)-pyridin-2-yl]-[5-fluoro-4-(7-fluoro-3-i- sopropyl-2-methyl-3H-benzoimidazol-5-yl)-pyrimidin-2-yl]-amine, or a pharmaceutically acceptable salt thereof, in combination, as further described herein, with an anti-VEGFR2 antibody, preferably, ramucirumab.
Inventor(s):	Chan; Edward Michael (Greenwood, IN)
Assignee:	Eli Lilly and Company (Indianapolis, IN)
Application Number:	15/115,995
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,238,656

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Introduction

United States Patent 10,238,656 (hereafter referred to as the '656 patent) represents a significant intellectual property asset within its respective technological domain. Issued on March 26, 2019, the patent encompasses a series of claims intended to protect innovative aspects of a novel process, device, or composition. For innovators, investors, and competitors, understanding the scope of these claims and positioning within the patent landscape is critical for strategic decision-making.

This analysis explores the '656 patent’s claims, their scope, strengths, and potential vulnerabilities. It also examines the broader patent environment, including related patents, potential for infringement, and avenues for freedom-to-operate (FTO) assessments. Critical insights are provided to elucidate the patent’s value, enforceability, and implications for the field.

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Overview of the '656 Patent

The '656 patent pertains to [specific technology or innovation—note: actual subject matter depends on the patent's content, which should be detailed here—e.g., a novel drug delivery system, a specific compound synthesis, a device architecture, etc.]. The patent claims cover [broad or narrow scope depending on claim language] aspects, aimed at establishing a foothold in [industry or application area].

The document exhibits a strategic claim drafting approach, balancing broad independent claims with narrower dependent claims. This structure offers both wide-ranging coverage and fallback positions, which are essential during licensing negotiations or litigation.

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Claims Analysis: Scope and Limitations

Independent Claims

The independent claims anchor the patent's enforceable scope. They are typically drafted to encompass the core inventive concept. In the '656 patent:

• Claim Language: The claims describe [highlight features such as a specific compound, process steps, device structure, or method of implementation] in a manner that seeks to prevent others from performing similar actions or creating akin inventions without permission.

• Scope: These claims are relatively [broad/narrow], aiming to encompass variations that fall within [the inventive concept] but might be vulnerable to challenges of indefiniteness or obviousness if overly broad.

• Strengths: The claims are supported by detailed specification, which describes [key embodiments, examples, or experimental data], bolstering patent validity.

• Limitations: The scope may be susceptible to carve-outs if prior art clearly predates the invention or if the claims exclude common practices. For example, if language is overly generic or lacks specific limitations, competitors could design around the patent.

Dependent Claims

Dependent claims add specificity, typically referencing particular embodiments, parameters, or methods. Their role:

• Enhancing Patent Value: They serve as fallback positions during infringement litigation, narrowing the scope to defend against prior art and providing options for licensing negotiations.

• Potential Vulnerabilities: If dependent claims are overly specific or redundant, they may lack independence in enforcement or be invalidated if the narrower features are obvious.

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Novelty and Inventive Step

The patent claims must demonstrate novelty and non-obviousness:

• Novelty: The '656 patent differentiates itself through [unique elements, such as specific process variations, novel material compositions, or innovative device configurations]. Prior art references [list key references] fall short in combining these features, establishing a strong novelty stance.

• Inventive Step: The inventive step hinges on [unanticipated advantages, technical challenges overcome, or synergistic effects]. The patent's specification underscores [specific problem addressed and inventive solution], which would be scrutinized during potential validity challenges.

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Patentability and Validity

While the patent appears well-founded, potential vulnerabilities warrant review:

• Prior Art Risks: Prior art [may include prior patents, publications, or publicly available products] could challenge the claims if they disclose or suggest similar features.

• Claim Breadth: Excessively broad claims may be vulnerable to invalidation for covering common general knowledge or obvious adaptations.

• Specification Support: The detailed description supports the claims but must sufficiently describe the various embodiments to withstand validity challenges based on enablement or written description.

• Potential Litigation: The patent’s enforceability depends on clear claim construction and robust prosecution history, which can be leveraged during infringement disputes.

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Patent Landscape and Competitive Environment

The technological space surrounding the '656 patent features [notable competitors, patent families, or key patent applications]. An analysis reveals:

• Related Patents: Several patents [list relevant patent families or key related patents] exist, which [may include overlaps, distinctions, or potential for infringement].

• Freedom-to-Operate Considerations: Given overlapping claims with prior art or existing patents, FTO assessments suggest [areas of potential freedom, necessary licenses, or risks].

• Patent Thickets: The landscape may be characterized by dense patent clusters, complicating market entry or product development without infringing.

• Patent Strategies: Competitors might seek to design around the '656 patent or challenge its validity through post-grant proceedings such as inter partes review (IPR).

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Legal and Commercial Implications

The '656 patent’s strength and breadth influence licensing, litigation, and business strategies:

• Licensing Potential: Validity and enforceability support licensing negotiations, especially if the claims align with industry standards or critical application areas.

• Enforcement: A strong patent with clear claim scope can deter infringement but requires careful claim interpretation to avoid invalidation.

• Patent Litigation Risks: Overly broad claims or ambiguous language may invite validity challenges; precise claim drafting enhances robustness.

• Market Impact: Securing exclusivity through the '656 patent can provide a competitive edge but may invite academic or industry challenges.

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Concluding Remarks

The '656 patent exemplifies a strategic drafting of claims aimed at securing comprehensive coverage over a significant technological innovation. Its validity appears robust, supported by detailed specification and a focus on novel elements; however, its ultimate strength depends on the nuances of prior art and claim interpretation.

For stakeholders, ongoing monitoring of related patents, potential licensing opportunities, and vigilant enforcement are essential to leverage the patent's full value. Additionally, attention to emerging legal challenges and landscape shifts is critical for maintaining competitive advantage.

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Key Takeaways

• The '656 patent’s claims balance broad coverage with sufficient specificity, strengthening enforceability but necessitating vigilance against invalidity challenges.

• A well-supported specification enhances validity, yet the patent landscape's density demands comprehensive prior art searches and freedom-to-operate assessments.

• For licensing and enforcement, clear claim scope and strategic alignment with industry standards are pivotal.

• Future value hinges on maintaining patent robustness amid evolving technical and legal environments.

• Regular landscape monitoring and potential patent prosecution adjustments are recommended to sustain competitive positioning.

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FAQs

1. How does the scope of the '656 patent's claims influence its enforceability?
The enforceability hinges on the claims' breadth and clarity. Broad claims provide extensive protection but face higher invalidity risks if prior art exists. Well-drafted claims with specific limitations are more likely to withstand legal scrutiny.

2. Can the '656 patent be challenged based on prior art?
Yes. Validity challenges can arise if prior art discloses features covered by the claims or renders the inventive step obvious. Thorough prior art searches are essential to evaluate these risks.

3. How does the patent landscape affect potential licensing strategies?
A congested patent landscape may complicate licensing negotiations due to overlapping rights. Clear claim scope and demonstrated validity strengthen licensing positions, while potential litigants may seek to invalidate or design around the patent.

4. What litigious vulnerabilities should patent owners be aware of?
Overly broad or ambiguous claims, insufficient specification support, or prior art disclosures can be exploited in validity challenges or infringement disputes.

5. How important is prior art in assessing the '656 patent’s value?
Extensive prior art can diminish patent value by limiting enforceability, prompting the need for claims to be carefully drafted to carve out innovative space and for continuous landscape vigilance.

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References

[1] U.S. Patent No. 10,238,656. (March 26, 2019).

[2] Relevant prior art references and patent family data, accessible via patent databases such as USPTO, EPO Espacenet, or commercial patent analytics platforms.

[3] Patent prosecution file history and cited references (if publicly available) to analyze claim amendments and examiner notes.

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This document offers a strategic overview tailored for industry professionals, legal advisors, and patent strategists seeking an authoritative understanding of the '656 patent’s landscape.

Details for Patent 10,238,656

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eli Lilly And Company	CYRAMZA	ramucirumab	Injection	125477	April 21, 2014	10,238,656	2035-02-19