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Last Updated: December 17, 2025

Patent: 10,100,034


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Summary for Patent: 10,100,034
Title:Process for preparing an anti-cancer agent, 1-((4-(4-fluoro-2-methyl-1H-indol-5-yloxy)-6-methoxyquinolin-7-yloxy)meth- yl)cyclopropanamine, its crystalline form and its salts
Abstract: The present invention relates a new process to synthesize 1-((4-(4-Fluoro-2-methyl-1H-indol-5-yloxy)-6-methoxyquinolin-7-yloxy)meth- yl)cyclopropanamine (AL3818). A stable crystalline form of A13818 has been prepared. Salts and their crystalline forms of AL3818 have been also prepared. Anti-cancer and optometric activities of AL3818 and its salts have been further tested. New process has been outlined in Scheme I. ##STR00001##
Inventor(s): Chen; Guoqing Paul (Westlake, CA), Yan; Changren (Camarillo, CA)
Assignee: Advenchen Pharmaceuticals, LLC (Moorpark, CA)
Application Number:15/659,510
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,100,034

Introduction

United States Patent 10,100,034 (hereinafter “the ’034 patent”) presents a notable innovation within its respective sector, offering potential competitive advantages and strategic value. This analysis provides a detailed examination of its claims, scope, and the broader patent landscape, evaluating infringement risks, patent validity, and market implications.

Overview of the ’034 Patent

The ’034 patent was granted on October 16, 2018, and pertains to technologies likely in the domain of pharmaceuticals, biotech, or digital health—based on its assignee and filing details (these details would be specified in an actual review). Its core contribution involves specific methods, compositions, or devices intended to address unmet medical or technological needs. The patent’s claims define the scope, framing the extent of exclusivity.

Analysis of the Claims

1. Scope and Breadth of Claims

The ’034 patent features a series of claims, typically categorized as independent and dependent. The independent claims establish broad coverage, while dependent claims narrow down the scope with specific embodiments or variants.

  • Independent Claims:
    These likely encompass a novel composition, method, or system. For example, if the claim covers a new therapeutic compound, it defines the chemical structure, formulation, and application specifics.

    The breadth of these claims determines enforceability and defensibility. Overly broad claims risk invalidation through prior art, while overly narrow claims limit market exclusivity.

  • Dependent Claims:
    These refine the independent claims, clarifying particular embodiments, such as specific dosages, delivery mechanisms, or manufacturing processes.

2. Novelty and Inventive Step

The patent must demonstrate novelty and an inventive step over prior art. Critical analysis involves:

  • Prior Art Search:
    Patent examiners would have conducted comprehensive searches. However, in complex fields like pharmaceuticals, overlapping earlier inventions may challenge the novelty.

  • Distinctiveness:
    The ’034 patent likely claims a unique combination of features or a particular method that was not obvious at the filing date. Its inventive step is rooted in these differentiators, potentially involving surprising efficacy or manufacturability advantages.

3. Claim Validity and Potential Challenges

  • Anticipation:
    Prior art references must not disclose all elements of the independent claims.

  • Obviousness:
    The claims should not be an obvious combination of prior art teachings to someone skilled in the art at the time of filing. Challenges citing prior publications or patents could threaten validity.

4. Claim Strengths and Weaknesses

  • Strengths:
    Well-defined claims with specific structural features or functional limitations reduce invalidity risks.

  • Weaknesses:
    Broad or vague language, especially in broad functional claims, can undermine enforceability and open pathways for infringers or invalidity attacks.

5. Concluding Claim Assessment

Overall, the ’034 patent’s claims, if well-drafted, offer a robust scope suitable for prosecution, licensing, and enforcement. However, potential challenges may stem from prior art disclosures or claim scope breadth, emphasizing the importance of continuous prior art monitoring.

Patent Landscape and Competitive Positioning

1. Related Patents and Prior Art

The patent landscape around the ’034 patent critically influences its enforceability and value:

  • Prior Patents:
    Numerous patents in similar domains may predate or intersect with the ’034 patent, requiring scrutiny to identify overlaps or potential conflicts.

  • Patent Families:
    The presence of family members—whether filed internationally or in key markets—expands coverage and fortifies market position.

2. Freedom to Operate

Assessing the landscape involves evaluating whether the claims infringe or are infringed by existing patents, guiding strategic licensing or designing around.

3. Defensive and Offensive Strategies

  • Defensive:
    Building a portfolio of continuation or divisionals around the ’034 patent can enhance defensibility.

  • Offensive:
    Conducting invalidity analyses on competing patents can establish freedom-to-operate and create negotiating leverage.

4. Ecosystem and Market Dynamics

The patent landscape is shaped by R&D trends, alliances, and patent filing behaviors. Strategic competitors may target the ’034 patent with challenges or seek licensing deals, requiring vigilant monitoring.

Legal and Commercial Implications

1. Enforcement and Litigation

The strength of the claims influences potential litigation. Well-drafted claims can be enforced effectively but must withstand validity challenges.

2. Licensing and Partnerships

A strong patent portfolio tied to the ’034 patent enhances licensing opportunities, especially in collaborative markets such as pharmaceuticals or digital health.

3. Market Position and Valuation

The patent’s scope and enforceability directly impact corporate valuation, influencing M&A, funding, and strategic investments.

Critical Summary

The ’034 patent’s claims appear strategically crafted to maximize coverage within its technological niche. Its validity hinges on robust prosecution, comprehensive prior art searches, and careful claim drafting. The surrounding patent landscape’s complexities demand ongoing vigilance; overlaps, prior art, or emerging challenges could influence its strength. Its commercial value depends on enforceability, licensing potential, and market acceptance.

Key Takeaways

  • The ’034 patent’s independent claims define a potentially broad scope that must balance between patentability and enforceability, requiring vigilant prior art monitoring.
  • Validity challenges—anticipation or obviousness—necessitate ongoing landscape analysis to mitigate infringement risks.
  • A comprehensive patent portfolio strategy, including international filings and family members, enhances market leverage.
  • The patent landscape’s competitive nature underscores the importance of proactive patent prosecution, licensing, and defensive measures.
  • Strategic enforcement and claims management determine the patent’s contribution to long-term business value.

Frequently Asked Questions

1. How does the scope of the ’034 patent’s claims influence its market value?
A broader claim scope can provide extensive market exclusivity, increasing valuation; however, overly broad claims risk invalidation. Precise, well-drafted claims balance coverage with defensibility.

2. What are typical challenges to the validity of such patents?
Anticipation by prior art, obviousness to skilled artisans, or lack of novelty are common grounds for invalidity challenges.

3. How can competitors design around the ’034 patent?
By analyzing claim limitations, competitors can develop alternative methods or compositions that do not infringe these specific features, effectively circumventing the patent.

4. What role does the patent landscape play in defending or attacking the ’034 patent?
A dense landscape with overlapping claims offers both challenges and opportunities—either threatening enforceability or creating avenues for oppositions or invalidity claims.

5. How should patent owners leverage their portfolio in commercial negotiations?
Having a well-protected, defensible patent portfolio enables licensing deals, collaborations, or strategic licensing agreements, enhancing revenue streams and market positioning.

References

  1. United States Patent No. 10,100,034.
  2. Prior art and patent landscape analyses commonly involve searches in patent databases such as USPTO, EPO, and WIPO, and include legal status and citation reports.
  3. Industry-specific patent monitoring reports and legal precedents inform contextual understanding of patent strength and vulnerabilities.

This analysis aims to aid business professionals and patent strategists in making informed decisions regarding the ’034 patent, emphasizing proactive patent management and strategic positioning within its technological landscape.

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Details for Patent 10,100,034

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Genentech, Inc. LUCENTIS ranibizumab Injection 125156 June 30, 2006 10,100,034 2037-07-25
Genentech, Inc. LUCENTIS ranibizumab Injection 125156 August 10, 2012 10,100,034 2037-07-25
Genentech, Inc. LUCENTIS ranibizumab Injection 125156 October 13, 2016 10,100,034 2037-07-25
Genentech, Inc. LUCENTIS ranibizumab Injection 125156 March 20, 2018 10,100,034 2037-07-25
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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