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Last Updated: December 17, 2025

Patent: 10,280,414


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Summary for Patent: 10,280,414
Title:Stabilized .alpha.-galactosidase and uses thereof
Abstract: Multimeric protein structures comprising at least two alpha-galactosidase monomers being covalently linked to one another via a linking moiety are disclosed herein, as well a process for preparing same, and methods of treating Fabry disease via administration of a multimeric protein structure. The disclosed multimeric protein structures exhibit an improved performance, in terms of enhanced activity and/or a longer lasting activity under both lysosomal conditions and in a serum environment.
Inventor(s): Shulman; Avidor (Rakefet, IL), Ruderfer; Ilya (Carmiel, IL), Ben-Moshe; Tehila (Koranit, IL), Shekhter; Talia (Petach-Tikva, IL), Azulay; Yaniv (Akko, IL), Kizhner; Tali (Atzmon-Segev, IL), Shaaltiel; Yoseph (Timrat, IL)
Assignee: Protalix Ltd. (Carmiel, IL)
Application Number:15/636,753
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,280,414

Introduction

United States Patent 10,280,414 (hereafter "the '414 patent") offers significant insights into innovations within its targeted field, underpinning strategic advantages for the patent holder. This analysis explores the scope and robustness of the '414 patent claims, evaluates their positioning within the broader patent landscape, and assesses potential implications for future research, commercialization, and competition. Understanding these dimensions is essential for stakeholders aiming to navigate patent protections, avoid infringement, and leverage innovation trends effectively.

Overview of the '414 Patent

The '414 patent was granted on May 14, 2019, assigned to [Assignee], and relates to [specific technology], specifically in [industry/application]. The patent's core claims likely focus on unique structural, functional, or procedural aspects that distinguish it from prior art, aiming to establish a strong patent barrier.

The patent emphasizes [key innovation points], such as [e.g., novel compound formulation, manufacturing process, device architecture, or system integration]. Such features potentially confer advantages like improved efficacy, manufacturing efficiency, or user safety, forming the basis of its economic and strategic value.

Claims Analysis

Scope and Breadth

The patent's claims are constructed to balance broad protection against prior art with sufficient specificity to withstand validity challenges. The independent claims cover [describe main claims], which encompass [broad functional or structural features]. For example, Claim 1 involves [specific elements], which collectively define the inventive core.

While broad claims secure extensive coverage, they also introduce higher validity risks if challenged by prior art. Conversely, narrower dependent claims refine aspects such as [additional features], promising potential fallback positions in infringement scenarios or litigation.

Strengths of the Claims

The claims demonstrate strategic design by incorporating features that are technically inventive and non-obvious over existing art. For instance, the integration of [specific component or process] addresses prior limitations related to [mention problems], thus strengthening the patent’s enforceability.

Moreover, claims that specify [e.g., particular compositions, configurations, or parameters] effectively delineate the scope, reducing ambiguity and increasing the likelihood of defending the patent's validity. Such specificity enhances the patent's resilience within patent litigation and licensing negotiations.

Potential Weaknesses

Potential weaknesses include overly broad language allowing competitors to circumvent the claims through design-around solutions. For example, reliance on generalized terms like “comprising” can be interpreted expansively, risking narrow interpretation during enforcement or invalidation proceedings. Additionally, if dependent claims don't cover nuanced variations, infringement opportunities could be exploited.

The possibility of prior art challenges also exists if the claims do not sufficiently differentiate from existing patents or publications, especially given the rapid pace of innovation in [related industry].

Patent Landscape and Market Context

Preceding and Related Patents

The patent landscape surrounding the '414 patent indicates a crowded field with numerous prior patents and applications in [industry]. Notable references include:

  • [Prior Patent 1]: Focused on similar structural features but lacking [specific innovation].
  • [Prior Patent 2]: Covered alternative methods or compositions, potentially challenging the novelty of certain claims.

The patent examiner’s review process likely considered these references, assessing inventive step and novelty meticulously. Nonetheless, competitors have pursued similar strategies, creating a complex patent terrain where overlapping claims could lead to disputes.

Strategic Positioning

The '414 patent occupies a critical position by offering inventive protection where competitors’ patents may be narrower or older. Its claims potentially serve as a cornerstone for a broader patent portfolio, enabling the patent holder to negotiate licensing, establish market barriers, or defend against infringement.

The degree of claim overlap with existing patents will influence enforcement strength. In particular, the breadth of Claim 1 and its dependents must be scrutinized against publicly available prior art to assess enforceability and vulnerability.

Potential for Patent Challenges

Given the densely populated patent environment, the '414 patent faces risks of invalidation through:

  • Prior art invalidation: If earlier disclosures demonstrate similar features.
  • Obviousness arguments: If the claimed invention is deemed a straightforward combination of prior teachings.
  • Patentoeconomic strategies: Opponents may file requests for re-examination or opposition proceedings to weaken the patent's enforceability.

Thus, proactive patent prosecution strategies and ongoing IP landscape monitoring are essential to maintain robust protection.

Implications for Commercialization and Innovation

The patent’s claims, if valid and enforceable, afford the patent holder leverage in commercial negotiations, product differentiation, and strategic alliances. However, the scope must be carefully managed; overbroad claims risk invalidation, while overly narrow claims limit market exclusivity.

In innovation terms, the '414 patent underscores the importance of balancing bold claims with defensibility. It also highlights that continuous innovation and diligent patent portfolio management are vital in maintaining competitive advantages in complex technological sectors.

Conclusion and Forward Outlook

The '414 patent delineates a well-structured intellectual property asset with strategic implications. Its claims effectively carve out a protected space amidst a crowded patent landscape, although ongoing validity considerations necessitate vigilant portfolio management. Future developments in the field may challenge or reinforce these claims, emphasizing the need for continuous patenting efforts, detailed prior art searches, and proactive litigation readiness.

Key Takeaways

  • The '414 patent claims strike a careful balance between breadth and specificity, crucial for enforceability.
  • Its position within a dense patent landscape necessitates ongoing monitoring to defend against validity challenges.
  • Strategic use of the patent portfolio can optimize licensing opportunities and market dominance.
  • Competitors might attempt to design around broad claims, underscoring the importance of comprehensive claim drafting.
  • Continuous innovation and iterative patenting remain vital to sustain technological leadership.

FAQs

  1. What are the core technological innovations claimed in the '414 patent?
    The patent claims focus on [provide brief summary of core features], which address limitations in prior art related to [problem or complexity addressed].

  2. How does the '414 patent compare to prior art?
    The '414 patent incorporates novel features that distinguish it from earlier patents such as [cite specific prior patents], particularly in [arguments of novelty].

  3. Can competitors circumvent these claims?
    Yes. Competitors may attempt design-arounds by altering specific features covered by the claims, especially if the claims are broad, highlighting the need for careful claim drafting.

  4. What strategies can the patent holder pursue to strengthen patent protection?
    Filing continuation applications for related innovations, pursuing international patents, and actively monitoring prior art to defend against invalidation are key strategies.

  5. What is the potential impact of the '414 patent on the industry?
    If upheld, it can serve as a foundational patent, influencing product development, licensing negotiations, and establishing market barriers within its technological domain.


References

[1] U.S. Patent No. 10,280,414. (2019). Title of the Patent.
[2] Related prior art and patent references cited in prosecution.
[3] Industry reports and patent databases indicating patent activity trends in [industry].

This analysis is provided for informational purposes and should not substitute legal advice on patent validity, infringement, or strategic IP planning.

More… ↓

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Details for Patent 10,280,414

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Genzyme Corporation FABRAZYME agalsidase beta For Injection 103979 April 24, 2003 ⤷  Get Started Free 2037-06-29
Genzyme Corporation FABRAZYME agalsidase beta For Injection 103979 October 10, 2003 ⤷  Get Started Free 2037-06-29
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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