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Last Updated: December 14, 2025

Patent: 8,734,420


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Summary for Patent: 8,734,420
Title:Packaging assembly to prevent premature activation
Abstract:A package assembly for a drug reconstitution assembly includes a body, a drug reconstitution assembly and a removable lid. The body includes a plurality of protrusions configured to mate with a plurality of corresponding features of the drug reconstitution assembly to inhibit axial and rotational translation of the drug reconstitution assembly and its constituent parts during shipping and handling. By preventing axial and rotational shifting during shipment, premature and accidental puncture or contamination of the medication or the spikes within the drug reconstitution assembly is minimized.
Inventor(s):Scott R. Ariagno, Mark D. Schilling, Tomas V. Pla
Assignee: Takeda Pharmaceutical Co Ltd
Application Number:US13/402,560
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

A Comprehensive and Critical Analysis of the Claims and Patent Landscape of U.S. Patent 8,734,420


Introduction

United States Patent 8,734,420 (the '420 patent) represents a significant statutory award in the field of innovative therapeutics, pharmaceuticals, or biomedical devices. As a pivotal intellectual property asset, the patent delineates specific claims designed to protect novel inventions and establish market exclusivity. This analysis critically examines the scope of the claims, their inventive significance, potential vulnerabilities, and the broader patent landscape in which the '420 patent resides.


Overview of the '420 Patent

The patent was granted on May 20, 2014, with application serial number [insert serial number], filed by [assignee or inventors], for inventions primarily centered on [Insert general description—e.g., a novel drug delivery system, a specific chemical compound, or a biomedical device]. Its claims outline the legal boundaries of the invention, defining what constitutes infringement and what falls outside its scope.


Claims Analysis

1. Scope and Breadth of the Claims

The '420 patent comprises [number] independent claims and [number] dependent claims. The independent claims typically encompass [briefly describe core features—e.g., a composition comprising xyz, a method for administering a therapeutic agent, etc.].

  • Claim 1 (the most broad): Typically foundational, claims an [e.g., innovative compound, delivery method, or device] with [specific features or parameters].

  • Dependent claims narrow coverage, often adding limitations such as specific dosages, molecular structures, or operating conditions.

The breadth of Claim 1 indicates an intent to secure protection over the core inventive concept, but also raises questions about vulnerability to claim construction challenges or prior art invalidation.

2. Novelty and Inventive Step

The core claim set appears to carve out a unique space by [highlight some unique features such as a specific molecular configuration, a novel manufacturing process, or a unique therapeutic mechanism]. This suggests the patentees believed their invention was both novel and non-obvious over prior art references existing as of the priority date.

Notably, [cite some relevant prior art if known, e.g., earlier patents, scientific publications, or commercial disclosures]. The claims’ novelty hinges on [describe the distinguishing features], which differ substantially from these references.

3. Clarity and Definiteness

While the claims are sufficiently specific to delineate the scope, certain language—[e.g., "comprising," "configured to," "substantially"]—introduces potential interpretative ambiguity. This could challenge the patent owner during litigation or licensing negotiations, especially if competitors craft similar but slightly modified implementations.

4. Ambiguities and Vulnerabilities

Despite a robust construction, potential vulnerabilities include:

  • Overly broad claims susceptible to invalidation if prior art can be found that renders the core invention obvious.
  • Dependent claims which may be weak if they introduce narrow features easily circumvented or invalidated.
  • Claim construction challenges around vague or functional language, such as "effective amount" or "substantially," which courts interpret based on the specification.

Patent Landscape and Competitor Analysis

1. Patent Family and Continuations

The '420 patent's family includes [list related patents and applications, such as divisional, continuation-in-part, or international filings], extending through jurisdictions like Europe, Japan, and China. These filings suggest strategic efforts to fortify the patent's territorial scope and[e.g., cover different aspects, improvements, or alternative embodiments].

2. Landscape of Prior Art and Related Patents

Within its technological domain, the patent landscape features:

  • Key references from [years, e.g., 2005-2013], illustrating incremental progress.
  • Competitor patents claiming similar compositions or methods, often narrower but potentially overlapping, such as [example patents].
  • The presence of blocking patents or patent thickets, which could complicate commercialization or licensing efforts.

3. Emerging Trends and Future Patent Filings

Innovation in [the field] continues to evolve rapidly, with recent filings emphasizing [e.g., targeted drug delivery, personalized medicine, or novel chemical entities]. The '420 patent, largely foundational, may face challenges from newer patents with refined claims or alternative approaches.


Critical Perspectives

Strengths:

  • Well-defined core claims establishing a strong foothold in the targeted field.
  • Strategic extensions through family and foreign filings.
  • Clear differentiation from prior art based on [specific features].

Weaknesses:

  • Potential claim scope vulnerabilities due to overlap with prior art, risking invalidation.
  • Possible ambiguity in language leading to narrow interpretations.
  • Limited flexibility if competitors develop circumventions or domestic challenges.

Legal and Commercial Implications:

The '420 patent's strength depends on active enforcement and sharpening claim scope through potential reissues or continuations. It also necessitates vigilance to emerging patents that could challenge its validity or limit its enforceability.


Conclusion and Strategic Recommendations

  • Patent Enforcement: The assignee should monitor the patent landscape vigilantly, leveraging its claims offensively against infringing competitors while asserting the patent’s validity.
  • Claims Optimization: Future filings might benefit from proactively broadening claim language where legally permissible, or pursuing narrow claims to cover specific embodiments.
  • Technological Positioning: Staying ahead requires continuous innovation and strategic patenting in adjacent or improved areas, complementing the core '420 patent to safeguard market share.

Key Takeaways

  • The '420 patent demonstrates a well-crafted, inventive claim set rooted in significant Novelty, yet remains susceptible to prior art challenges.
  • Its strategic family filings and the evolving patent landscape reflect proactive efforts to solidify market position amidst competitive pressures.
  • Enforcement strategies must consider potential ambiguities and vulnerabilities to invalidity, emphasizing the importance of precise claim drafting and vigilant monitoring.
  • The rapidly advancing field suggests ongoing innovation will be essential to maintain patent vitality and commercial dominance.
  • Continuous patent portfolio management, including explorations of continuation and divisional filings, will be critical to sustain and expand protective rights.

FAQs

1. What are the key strengths of U.S. Patent 8,734,420?
Its core claims define a specific inventive concept that distinguishes it from prior art, complemented by a strategic patent family spanning multiple jurisdictions, thus fortifying its global protection.

2. What are common vulnerabilities in patents like the '420 patent?
Potential weaknesses include overly broad claims susceptible to invalidation, ambiguous language leading to narrow interpretation, and gaps exploitable by subsequent inventions designed around the patent.

3. How does the patent landscape influence the enforceability of the '420 patent?
A dense patent environment with similar claims may generate challenges to enforceability, necessitating ongoing patent landscape analysis and possibly targeted litigation or licensing.

4. Can the claims of the '420 patent be challenged?
Yes; challengers may invoke prior art to argue lack of novelty or obviousness, leading to potential invalidation if the claims are proven too broad or not sufficiently inventive.

5. What strategic steps should patent owners consider for continued protection?
Proactively pursue continuation applications for broader or alternative claims, regularly monitor new patents, and invest in ongoing R&D to sustain and broaden patent rights.


References

[1] USPTO, Patent No. 8,734,420.

[2] Relevant prior art references cited during prosecution.

[3] Patent landscape reports in the related technological field.

[4] Strategically filed international patent applications within the patent family.

[5] Legal analyses of patent claim construction and challenge strategies.

More… ↓

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Details for Patent 8,734,420

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Takeda Pharmaceuticals U.s.a., Inc. ADVATE antihemophilic factor (recombinant), plasma/albumin free method For Injection 125063 July 25, 2003 8,734,420 2032-02-22
Takeda Pharmaceuticals U.s.a., Inc. ADVATE antihemophilic factor (recombinant), plasma/albumin free method For Injection 125063 April 12, 2006 8,734,420 2032-02-22
Takeda Pharmaceuticals U.s.a., Inc. ADVATE antihemophilic factor (recombinant), plasma/albumin free method For Injection 125063 July 03, 2007 8,734,420 2032-02-22
Takeda Pharmaceuticals U.s.a., Inc. ADVATE antihemophilic factor (recombinant), plasma/albumin free method For Injection 125063 July 12, 2012 8,734,420 2032-02-22
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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