United States Patent 6,446,627: A Detailed Analysis of Scope, Claims, and Patent Landscape
Overview of the Patent
The United States Patent 6,446,627, titled "Inhaler dose counter," was granted to address the need for accurate and reliable dose counting in metered dose inhalers (MDIs). This patent is crucial for pharmaceutical companies and medical device manufacturers involved in respiratory care products.
Scope of the Patent
Purpose and Functionality
The patent describes an inhaler dose counter designed to accurately track the number of doses dispensed from an MDI. The counter ensures precise counting by using a rotary gear mechanism that responds to the displacement of the actuator means, typically the canister of the inhaler[1].
Key Components
- Rotary Gear Means: The counter includes a wheel mounted on a spindle with multiple ratchet teeth around its periphery. This wheel is driven in a step-wise fashion in response to the actuator's displacement.
- Stepless Restraint Means: To prevent reverse rotation of the rotary gear, the invention employs a friction clutch, such as a wrap-spring clutch, operating on the spindle. This mechanism simplifies the mechanical operation by eliminating side forces on the ratchet wheel[1].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the core aspects of the invention:
- Claim 1: Describes the dose counter comprising rotary gear means and stepless restraint means to prevent reverse rotation.
- Claim 2: Details the specific mechanism of the rotary gear means and its interaction with the actuator.
- Claim 3: Focuses on the design features of the control surface that regulate the engagement and disengagement between the toothed wheel and the drive element[1].
Dependent Claims
Dependent claims further elaborate on the specific features and functionalities of the independent claims, such as the materials used, the design of the control surface, and the precise rotational increments achieved.
Patent Landscape
Prior Art and Related Patents
The patent landscape for inhaler dose counters includes various prior art and related patents that address similar issues of accuracy and reliability in dose counting. For instance, other patents may focus on different mechanisms for preventing reverse rotation or enhancing the visual indication of the count[1].
Competitor Patents
Companies like Teva Branded Pharmaceutical Products R&D, Inc., and Teva Respiratory, LLC, have been involved in patent disputes and settlements related to inhaler products. These activities highlight the competitive nature of the patent landscape in this field[2][5].
Patent Analytics and Claim Coverage
Claim Coverage Matrix
To understand the full scope of protection provided by this patent, a Claim Coverage Matrix can be used. This matrix categorizes patents by claims and scope concepts, helping to identify which patents and claims are actively protecting the intellectual property. It also reveals gaps or opportunities in the current coverage[3].
Scope Concepts
The scope concepts related to this patent include:
- High-Value Claims: Those directly related to the precise counting mechanism and the prevention of reverse rotation.
- Medium-Value Claims: Those indicating potential future directions, such as enhancements to the control surface or alternative materials.
- Low-Value Claims: Those that may not be worth maintaining due to redundancy or obsolescence[3].
Search and Analysis Tools
USPTO Resources
The United States Patent and Trademark Office (USPTO) provides several tools for searching and analyzing patents, including the Patent Public Search tool, Global Dossier, and the Patent Examination Data System (PEDS). These resources help in identifying prior art, related applications, and the current status of patents in the same family[4].
International Patent Offices
For a global perspective, databases from international patent offices such as the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO) can be used to search for similar patents and understand the international patent landscape[4].
Practical Applications and Industry Impact
Regulatory Compliance
The accurate counting mechanism described in this patent is crucial for regulatory compliance, as it ensures that patients receive the correct dosage of medication. This is particularly important in the treatment of respiratory conditions where precise dosing is critical[1].
Market Competition
The settlement between Teva and other companies over generic versions of inhaler products highlights the competitive nature of the market. Patents like US 6,446,627 play a significant role in protecting intellectual property and maintaining market share[5].
Key Takeaways
- Precise Dose Counting: The patent ensures accurate counting through a rotary gear mechanism and stepless restraint means.
- Competitive Landscape: The patent landscape is highly competitive, with various companies involved in patent disputes and settlements.
- Regulatory Importance: Accurate dose counting is crucial for regulatory compliance and patient safety.
- Global Patent Search: Utilizing international patent databases is essential for a comprehensive understanding of the global patent landscape.
- Patent Analytics: Tools like Claim Coverage Matrix and scope concepts help in managing and analyzing patent claims effectively.
FAQs
Q: What is the primary function of the inhaler dose counter described in US 6,446,627?
A: The primary function is to accurately track the number of doses dispensed from a metered dose inhaler.
Q: How does the patent prevent reverse rotation of the rotary gear?
A: It uses a friction clutch, such as a wrap-spring clutch, operating on the spindle to prevent reverse rotation.
Q: Why is precise dose counting important in respiratory care?
A: Precise dose counting is critical to ensure patients receive the correct dosage of medication, which is vital for effective treatment and patient safety.
Q: How can companies analyze the patent landscape for inhaler dose counters?
A: Companies can use tools like the Claim Coverage Matrix, scope concepts, and resources from the USPTO and international patent offices to analyze the patent landscape.
Q: What are the implications of patent disputes in the inhaler market?
A: Patent disputes can impact market share and the ability to sell generic versions of products, as seen in the settlement between Teva and other companies.
Sources
- US6446627B1 - Inhaler dose counter - Google Patents
- JURY TRIAL DEMANDED COMPLAINT - RPX Insight
- Patent Analytics | Intellectual Property Law - SLWIP
- Search for patents - USPTO
- Teva Reaches Settlement in ProAir® HFA Patent Case | Fierce Biotech
