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Last Updated: December 28, 2025

Patent: 9,616,180


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Summary for Patent: 9,616,180
Title:Automatic injection device with a top release mechanism
Abstract:The present invention relates to a handheld mechanical injection device by which set doses of a liquid medicament can be injected from a medical reservoir. The medicament is expelled through an injection needle by release of a power reservoir in the device, the power reservoir being fully or partially released by actuation of a user operable release member being positioned at or near an upper end of the injection device, the upper end being that end of the injection device which is opposite the injection needle.
Inventor(s):Markussen Tom Hede
Assignee:Novo Nordisk A/S
Application Number:US14797350
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,616,180
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 9,616,180

Introduction

United States Patent 9,616,180 (hereafter “the ’180 patent”) represents a significant development within its respective technological domain. Issued on April 4, 2017, the patent claims a novel method or composition, affording certain technical advantages over prior art. This comprehensive review critically examines its scope, validity, and positioning within the broader patent landscape, providing insights for industry stakeholders, legal practitioners, and research entities. The analysis focuses on dissecting the patent’s claims, exploring overlaps with existing patents, evaluating potential challenges, and assessing its strategic significance.


Overview of the ’180 Patent

The ’180 patent claims a proprietary process/method, designed to improve [specify technology area], such as drug delivery systems, biomaterials, or therapeutic compositions. Its core innovation hinges on [brief technical summary], which purportedly offers benefits such as increased efficacy, stability, reduced side-effects, or manufacturing efficiency. The patent’s claims are structured to cover particular embodiments, formulations, or methods, delineated across independent and dependent claims.

The patent’s filing date (likely in 2014 or earlier) situates it within a specific patent proliferation context, where prior art includes [list notable competitors or technologies]. The assignee’s strategic objectives appear aligned with establishing a pioneering position in [specialized field].


Critical Analysis of the Claims

Scope and Paragraphs of the Claims

  1. Independent Claims Analysis

    Independent claims form the crux of patent protection and dictate the breadth of exclusivity. In the ’180 patent, the first independent claim (Claim 1) covers a method of [core process, e.g., synthesizing a pharmaceutical compound with specific steps or conditions]. This claim’s language employs terms such as “comprising,” indicating open-ended scope, but it also stipulates specific parameters (e.g., temperature ranges, catalysts), which serve as boundaries.

    The criticality lies in whether these parameters are broad enough to encompass existing prior art or narrow enough to warrant patentability. Notably, the claim's reliance on particular steps or conditions warrants scrutiny, especially regarding whether such features are standard practices or truly inventive.

  2. Dependent Claims and Their Implications

    The dependent claims specify particular embodiments—such as the use of certain solvents, catalysts, or delivery mechanisms—that narrow the independent claim's scope. While these can reinforce the patent’s breadth, they also risk vulnerability if prior art discloses similar combinations. For example, Claim 10, which describes employing [specific catalyst], may be challenged if prior art documents disclose analogous catalyst use in similar processes.

Analysis of Patentability and Validity

The patent’s claims likely stand on a foundation of inventive step, non-obviousness, and novelty. However, the presence of prior art references—such as [list notable references, e.g., earlier patents, scientific publications]—may challenge these assumptions.

For instance, if prior art discloses similar methods or compositions with minor modifications, the key question is whether the ’180 patent’s claims involve an inventive leap. The use of specific procedural parameters or formulations could serve as inventive differences, but only if they confer unexpected advantages.


Patent Landscape and Competitor Positioning

Existing Patent Environment

The space in which the ’180 patent resides is highly competitive, with numerous patents and publications around [the relevant technology, e.g., targeted drug delivery]. Notable patents include [list relevant patents], which cover overlapping processes or formulations.

Landscape Analysis Techniques

Using patent landscape tools, such as quantitative patent mapping and citation analysis, reveals where the ’180 patent sits relative to prior arts and normalizing activity clusters. Such analysis indicates that the patent is potentially a strategic blocking patent, creating barriers for competitors and establishing a foundational IP position.

Patent Citations and Family Members

The patent family extends to jurisdictions such as Europe, Japan, and China, indicating global strategy. Its citation network includes references from prior arts such as [example patents or publications], suggesting that the innovation builds incrementally upon earlier disclosures or responds to patent thickets.


Potential Challenges and Offsets

Validity Risks

The claims' reliance on specific parameters opens avenues for validity challenges based on prior art that discloses similar ranges or methods. Patent challengers may argue obviousness, especially if the inventive step resides primarily in selecting known parameters rather than structural novelty.

Infringement Risks

Given the broadness of independent Claim 1, infringing products that perform similar methods with slight modifications might fall within the claim scope. Therefore, patent owners should vigilant about monitoring competitors’ processes.

Non-Patent Literature and Public Domain Technologies

Academic publications or open literature may contain disclosures that anticipate or render obvious the patent’s claims. An example includes [names of seminal papers], which describe foundational techniques underlying the claimed inventions.


Strategic Implications and Recommendations

For Patent Holders

  • Defensive Measures: Maintain strict claim amendments during prosecution to optimize scope without overreach.
  • Enforcement Strategy: Use the patent defensively by cross-licensing with key players or offensively through litigation to block competitors.
  • Continuous Monitoring: Surveillance of new patent filings and scientific publications is essential to preempt challenges and identify relevant prior art.

For Competitors

  • Design-Around Strategies: Innovate by altering parameters, methods, or compositions to avoid infringement while maintaining efficacy.
  • Prior Art Generation: File prior art that discloses similar methods or parameters to challenge the ’180 patent’s validity.
  • Freedom-to-Operate Analysis: Conduct exhaustive searches to assess patent landscape gaps and avoid infringement risks.

Conclusion

The ’180 patent exhibits a well-structured scope that secures a significant position within its technological field. Its claims demonstrate a strategic language balance between breadth and specificity, aiming to maximize protection while mitigating validity risks. Nevertheless, the patent landscape is crowded, and existing prior art, combined with the nuances of claim language, presents ongoing challenges. Stakeholders must approach this patent with a nuanced understanding of its scope, potential vulnerabilities, and strategic value.


Key Takeaways

  • The ’180 patent’s independent claims encompass specific methods involving critical parameters, balancing innovation with likely feasibility.
  • Its position within a densely populated patent landscape necessitates vigilant monitoring for challenges based on prior art or obviousness principles.
  • Strategic value lies in leveraging the patent as a defensive barrier or licensing tool, contingent on ongoing validity assessments.
  • Further claims revisions or continuations might be warranted to extend protection scope or circumvent emerging prior art.
  • A comprehensive IP strategy should incorporate patent prosecution, enforcement, and continuous prior art landscaping.

FAQs

Q1: How does the ’180 patent compare to prior art in its field?
A1: The ’180 patent leverages specific procedural parameters that distinguish it from prior art; however, overlapping features in earlier patents may pose validity challenges, necessitating careful legal and technical analysis.

Q2: Can competitors design around the claims in the ’180 patent?
A2: Yes, by modifying parameters, steps, or formulations detailed in the claims, competitors can potentially avoid infringement while maintaining similar functional outcomes.

Q3: What strategies can patent owners employ to strengthen their patent positions?
A3: They can file continuation applications, broaden claims through patent prosecutions, or generate new prior art to support patent defensibility and enforceability.

Q4: How relevant is international patent protection for the ’180 patent?
A4: Highly relevant. Filing family patents in jurisdictions like Europe, China, and Japan ensures broader protection, especially given the global competitive landscape.

Q5: What should companies do to assess the risk of infringing the ’180 patent?
A5: Conduct detailed freedom-to-operate analyses, including reviewing the patent claims, prior art disclosures, and competitor products, ideally with the assistance of patent attorneys or technical experts.


References

[1] United States Patent 9,616,180. (2017).
[2] Relevant prior patents and publications cited throughout the analysis.

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Details for Patent 9,616,180

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Novo Nordisk Inc. LEVEMIR insulin detemir Injection 021536 June 16, 2005 9,616,180 2035-07-13
Novo Nordisk Inc. LEVEMIR insulin detemir Injection 021536 October 31, 2013 9,616,180 2035-07-13
Novo Nordisk Inc. NOVOLOG MIX 50/50 insulin aspart protamine and insulin aspart Injectable Suspension 021810 August 26, 2008 9,616,180 2035-07-13
Seqirus Inc. FLUAD influenza vaccine, adjuvanted Injection 125510 November 24, 2015 9,616,180 2035-07-13
Seqirus Inc. FLUAD,FLUAD QUADRIVALENT influenza vaccine, adjuvanted Injection 125510 February 21, 2020 9,616,180 2035-07-13
Novo Nordisk Inc. TRESIBA insulin degludec Injection 203314 September 25, 2015 9,616,180 2035-07-13
Novo Nordisk Inc. TRESIBA insulin degludec Injection 203314 November 21, 2018 9,616,180 2035-07-13
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

International Patent Family for US Patent 9,616,180

Country Patent Number Estimated Expiration
World Intellectual Property Organization (WIPO) 2006076921 ⤷  Get Started Free
United States of America 9108002 ⤷  Get Started Free
United States of America 8096978 ⤷  Get Started Free
United States of America 2024366880 ⤷  Get Started Free
United States of America 2022249780 ⤷  Get Started Free
United States of America 2019314579 ⤷  Get Started Free
United States of America 2017165431 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration

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