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Last Updated: December 22, 2024

Patent: 10,357,616


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Summary for Patent: 10,357,616
Title:Injection device with an end of dose feedback mechanism
Abstract:An injection device with a dose delivering mechanism being adapted to provide a non-visual, e.g. audible and/or tactile, feedback signal when a set dose has been at least substantially injected. A first and a second part of the injection device are adapted to perform a relative rotational movement with respect to each other. The relative rotational movement causes at least two parts of the injection device to abut or engage, and this abutment or engagement causes the non-visual feedback signal to be generated. A very distinct and precise feedback is provided as compared to prior art axial solutions because the generation of the feedback signal is initiated by the relative rotational movement.
Inventor(s):Moller Claus Schmidt, Radmer Bo, Nielsen Lars Ulrik, Enggaard Christian Peter
Assignee:Novo Nordisk A/S
Application Number:US15815976
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,357,616
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Analyzing the Claims and Patent Landscape of United States Patent 10,357,616

Introduction

Understanding the claims and patent landscape of a specific patent is crucial for businesses, inventors, and legal professionals. This analysis will delve into the details of United States Patent 10,357,616, focusing on its claims, the broader patent landscape, and the strategic implications.

Overview of United States Patent 10,357,616

To begin, it is essential to identify the patent in question. However, since the specific details of U.S. Patent 10,357,616 are not provided in the sources, we will assume it is related to a pharmaceutical or medical device, given the context of similar patents.

Claims Analysis

Claim Structure

Patent claims are the heart of any patent, defining the scope of protection. For U.S. Patent 10,357,616, the claims would typically be categorized into independent and dependent claims. Independent claims stand alone and define the invention broadly, while dependent claims build upon the independent claims and provide more specific details[3].

Claim Validity and Enforcement

The validity of each claim is presumed under U.S. law, with the burden of proving invalidity resting on the party challenging the patent. However, if a claim is found invalid, it can impact the enforceability of related claims, especially if they are tied through terminal disclaimers[3].

Patent Landscape Analysis

Definition and Importance

A patent landscape analysis is a comprehensive approach to understanding the patent environment surrounding a particular technology or invention. It helps in identifying key players, patent saturation, and potential areas for innovation[4].

Identifying Key Players

In the context of U.S. Patent 10,357,616, identifying key players involves looking at other patents and patent holders in the same technology area. This could include major pharmaceutical companies, research institutions, or other inventors with similar patents.

Patent Saturation

Patent saturation refers to the density of patents in a particular technology area. High saturation indicates a mature technology area where innovation might be more challenging. For U.S. Patent 10,357,616, analyzing the number of related patents and their expiration dates can help in understanding the competitive landscape[4].

Strategic Insights

Long-term Decision Making

A full patent landscape analysis allows businesses and R&D managers to make informed long-term decisions. By seeing the high-level view of patent saturation, they can decide whether to pivot to newer inventive spaces or continue investing in a saturated area[4].

Going Beyond Known Competitors

It is crucial to look beyond known competitors to uncover potential threats or opportunities. This involves analyzing abandoned technologies and new entrants in the market. For example, if a company has abandoned certain technology areas, it might indicate a shift in market trends or the emergence of new technologies[4].

Legal and Regulatory Considerations

Centralization of Litigation

In cases where multiple patents are involved, centralization of litigation can be beneficial. For instance, the Ozempic patent litigation involved multiple actions across different districts, but centralization in the District of Delaware was deemed more efficient[1].

Terminal Disclaimers and Obviousness-Type Double Patenting

The U.S. Patent and Trademark Office (USPTO) has rules regarding terminal disclaimers and obviousness-type double patenting. These rules ensure that patent applicants do not claim the same invention multiple times. Understanding these rules is vital for maintaining the enforceability of patents[3].

Case Studies and Examples

Ozempic Patent Litigation

The Ozempic patent litigation provides a relevant example of how multiple patents can be involved in a single legal action. Here, several patents related to the formulation and delivery mechanism of semaglutide were asserted, highlighting the complexity of patent litigation in the pharmaceutical sector[1].

Generic Drug Launches

When patents expire, generic versions of drugs can be launched. For instance, the patent landscape for Novolog Flextouch shows multiple patents with varying expiration dates, indicating when generic versions might become available[2].

Industry Expert Insights

Industry experts often emphasize the importance of a thorough patent landscape analysis. As noted by patent attorneys and portfolio managers, this analysis helps in providing strategic advice and making critical IP-related decisions[4].

Statistics and Trends

  • Patent Filings: There is a notable trend in patent filings, especially around the end of the year. For example, IP Edge, a significant player in patent filings, represents about 20% of all patent filings in the United States[5].
  • Patent Saturation: Highly saturated patent areas can indicate mature technologies. For instance, in the pharmaceutical sector, areas like insulin delivery mechanisms show high patent saturation, suggesting a need for innovation in newer areas[4].

Key Takeaways

  • Comprehensive Analysis: Conducting a full patent landscape analysis is essential for understanding the competitive environment and making strategic decisions.
  • Claim Validity: Ensuring the validity of patent claims is crucial, as invalid claims can impact the enforceability of related patents.
  • Legal Considerations: Understanding legal rules such as terminal disclaimers and centralization of litigation is vital for managing patent portfolios effectively.
  • Industry Trends: Keeping an eye on industry trends and patent filings can help in anticipating market shifts and opportunities.

FAQs

Q: What is the purpose of a patent landscape analysis? A: A patent landscape analysis helps in understanding the patent environment surrounding a particular technology, identifying key players, and making informed long-term decisions.

Q: How do terminal disclaimers affect patent enforceability? A: Terminal disclaimers can render child patents unenforceable if the parent patent's claims are found invalid, highlighting the importance of careful patent strategy.

Q: Why is centralization of litigation important in patent cases? A: Centralization of litigation can eliminate duplicative discovery, prevent inconsistent pretrial rulings, and promote the just and efficient conduct of litigation.

Q: What are the implications of high patent saturation in a technology area? A: High patent saturation indicates a mature technology area, suggesting that innovation might be more challenging and that businesses may need to pivot to newer inventive spaces.

Q: How do industry trends in patent filings impact business strategies? A: Industry trends in patent filings can indicate market shifts and opportunities, helping businesses anticipate and adjust their strategies accordingly.

Sources

  1. OZEMPIC (SEMAGLUTIDE) PATENT LITIGATION MDL No. 3038 - U.S. Courts
  2. Novolog Flextouch patent expiration - Pharsight
  3. Letterhead DC Office - Regulations.gov
  4. Patent Landscape Analysis - AcclaimIP
  5. IPR on $2.18 Billion VLSI Patent Instituted; IP Edge Filing Patterns Emerge - IPWatchdog

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Details for Patent 10,357,616

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Novo Nordisk Inc. LEVEMIR insulin detemir Injection 021536 June 16, 2005 ⤷  Subscribe 2037-11-17
Novo Nordisk Inc. LEVEMIR insulin detemir Injection 021536 October 31, 2013 ⤷  Subscribe 2037-11-17
Novo Nordisk Inc. TRESIBA insulin degludec Injection 203314 September 25, 2015 ⤷  Subscribe 2037-11-17
Novo Nordisk Inc. TRESIBA insulin degludec Injection 203314 November 21, 2018 ⤷  Subscribe 2037-11-17
Novo Nordisk Inc. FIASP insulin aspart Injection 208751 September 29, 2017 ⤷  Subscribe 2037-11-17
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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