United States Patent 8,579,869: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 8,579,869, titled "Needle Mounting System and a Method for Mounting a Needle Assembly," is a significant patent in the field of medical devices, particularly injection devices. This patent, owned by Novo Nordisk A/S, addresses innovative methods and systems for mounting needles to injection devices or ampoules. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Context
The patent was issued on November 12, 2013, and is part of a series of divisional applications tracing back to earlier patents filed as far back as 2002[1][2].
Scope of the Patent
The patent covers a needle mounting system and a method for mounting a needle assembly. The system includes a needle assembly with a needle mounted to a hub, which has an interior wall with protrusions extending radially inward. This design ensures secure and precise mounting of the needle to the injection device or ampoule.
Key Components
- Needle Assembly: Comprised of a needle mounted to a hub with an interior wall and radial protrusions.
- Needle Mount: A structure with a cylindrical outer wall designed to interact with the needle hub.
- Mounting Means: Includes mechanisms for tactilely or audibly determining when the needle assembly is securely mounted[1].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claims 1-6 are directed to the needle mount, detailing its structure and the interaction with the needle hub. These claims specify the cylindrical outer wall of the needle mount and the mechanism for securing the needle assembly[2].
Dependent Claims
- These claims further elaborate on the details of the needle assembly and the mounting system, including the protrusions on the hub and the means for determining secure mounting.
Patent Landscape
Related Patents
The patent is part of a larger portfolio held by Novo Nordisk A/S, which includes other patents related to injection devices and formulations. For example, patents like US7,762,994 and US8,114,833 cover other aspects of injection devices and formulations, such as stable formulations of modified GLP-1[2].
Litigation and Enforcement
The patent has been involved in litigation, notably in a case against Mylan Institutional LLC, where Novo Nordisk alleged infringement of the '869 patent among others. The lawsuit highlighted the importance of this patent in protecting Novo Nordisk's intellectual property related to injection devices[2].
Expiration and Maintenance
The patent has undergone several maintenance fee payments, ensuring its validity. It is set to expire based on its original filing and issuance dates, with the last maintenance fee paid in 2021[5].
Metrics for Patent Scope
Independent Claim Length and Count
Studies on patent scope suggest that metrics such as independent claim length and count can indicate the breadth and clarity of a patent. The '869 patent, with its detailed claims, likely falls within a moderate to narrow scope, given the specific descriptions of the needle mounting system[3].
Impact on Innovation and Industry
Innovation Incentives
The patent's specific claims and narrow scope can be seen as positive factors in encouraging innovation. Narrower claims tend to reduce litigation costs and provide clearer boundaries, which can foster further innovation in the field of medical devices[3].
Market Protection
For Novo Nordisk, this patent provides significant market protection, preventing competitors like Mylan from using similar needle mounting systems without permission. This protection is crucial for maintaining market dominance and ensuring the continued development of innovative medical devices[2].
Industry Expert Insights
Industry experts often emphasize the importance of clear and specific patent claims in promoting innovation. For example, Alan C. Marco and Joshua D. Sarnoff have noted that narrower claims can lead to a shorter examination process and higher grant probabilities, which aligns with the strategy behind the '869 patent[3].
Illustrative Statistics
- Patent Maintenance: The patent has undergone multiple maintenance fee payments, indicating its ongoing importance to Novo Nordisk.
- Litigation: The involvement in litigation against Mylan highlights the patent's significance in protecting intellectual property.
- Expiration: Scheduled to expire based on its original filing dates, the patent's lifespan reflects the typical duration of such intellectual property protections[5].
Key Takeaways
- Specific Claims: The patent's claims are detailed and specific, ensuring clear boundaries and reducing potential litigation.
- Innovation: The narrow scope of the patent can encourage further innovation in medical devices.
- Market Protection: The patent provides significant market protection for Novo Nordisk, safeguarding their competitive edge.
- Litigation: The patent has been involved in litigation, underscoring its importance in intellectual property disputes.
FAQs
What is the main subject of United States Patent 8,579,869?
The main subject is a needle mounting system and a method for mounting a needle assembly to an injection device or ampoule.
Who owns the United States Patent 8,579,869?
The patent is owned by Novo Nordisk A/S.
What are the key components of the needle mounting system described in the patent?
The key components include a needle assembly with a hub having an interior wall and radial protrusions, and a needle mount with a cylindrical outer wall.
Has the patent been involved in any litigation?
Yes, the patent was involved in a lawsuit against Mylan Institutional LLC for alleged infringement.
When is the patent set to expire?
The patent's expiration date is based on its original filing and issuance dates, with maintenance fees ensuring its validity until the estimated expiration.
How does the patent impact innovation in the medical device industry?
The patent's specific claims and narrow scope can encourage innovation by providing clear boundaries and reducing litigation costs.
