United States Patent 8,616,196: A Comprehensive Analysis
Overview of the Patent
The United States Patent 8,616,196, titled "Inhalation device and a method for assembling said inhalation device," is a significant innovation in the field of medical devices, particularly for inhalers used in respiratory treatments. This patent, owned by AstraZeneca, addresses several critical aspects of inhaler design and functionality.
Patent Scope and Claims
Inhalation Device Design
The patent describes an inhalation device designed to deliver precise doses of medicament to a user. The device includes a canister adapted to accommodate the medicament and a counter connected to the canister. The counter is a crucial component, as it helps in tracking the number of doses remaining in the canister[4].
Counter Mechanism
The counter mechanism is designed to be attached to the canister in various positions along its length. This flexibility is achieved through contact parts on both the counter and the canister that increase friction, allowing the counter to be fixedly attached in different positions. This design ensures that the counter can be accurately aligned and secured to the canister during assembly[4].
Assembly Method
The patent also details a method for assembling the counter and the canister. This method involves urging the counter onto the canister until the combined length of the counter and canister falls within a predefined tolerance of a predefined length. This ensures that the device is assembled correctly and functions as intended[4].
Key Components and Innovations
Canister and Counter Attachment
The invention includes deformable ribs on the inside of the counter base that help in securing the counter to the canister. These ribs provide a snug fit and prevent the counter from slipping out of position during use[4].
Fire and Count Points
The patent describes the relationship between the displacement of the canister and the fire and count points in the inhalation device. This ensures that each actuation of the device corresponds to a precise dose delivery and accurate counting of the doses remaining[4].
Patent Landscape and Expiration Dates
Patent Expiration
The patent US8616196B2 is set to expire on October 7, 2029. This expiration date includes pediatric exclusivity, which extends the patent protection period[5].
Related Patents
The patent is part of a family of patents related to the Symbicort inhalation aerosol, which includes other patents such as US8528545, US8387615, and US8875699. These patents cover various aspects of the inhaler device, including dose counting mechanisms and assembly methods[2][5].
Litigation and Generic Applications
Litigation History
Litigation has been initiated against generic manufacturers, such as Mylan, for infringement of patents related to Symbicort, including the '616 patent. These legal actions are part of the broader strategy to protect the intellectual property associated with these medical devices[5].
Generic Applications
Several generic applications have been filed for Budesonide; Formoterol Fumarate Dihydrate, the active ingredients in Symbicort. These applications are pending, and the generic manufacturers must navigate the patent landscape to avoid infringement[2].
Impact on Innovation and Market
Innovation in Medical Devices
The patent reflects AstraZeneca's commitment to innovation in medical devices, particularly in the area of respiratory treatments. The precise dose counting and assembly methods described in the patent enhance the reliability and user-friendliness of inhalers, which is crucial for patient compliance and treatment efficacy.
Market Competition
The expiration of this patent and related patents will open the market to generic competition, potentially reducing the cost of these medications and increasing accessibility. However, until the patents expire, AstraZeneca maintains a competitive edge in the market due to its exclusive rights to the technology described in the patent[2][5].
Conclusion
The United States Patent 8,616,196 is a significant contribution to the field of medical devices, particularly for inhalers used in respiratory treatments. The patent's focus on precise dose counting and innovative assembly methods enhances the functionality and reliability of these devices. Understanding the scope, claims, and patent landscape of this invention is crucial for both innovators and generic manufacturers navigating the complex world of pharmaceutical and medical device patents.
Key Takeaways
- Innovative Design: The patent describes an inhalation device with a counter mechanism that ensures precise dose counting and easy assembly.
- Assembly Method: The method for assembling the counter and canister ensures accurate alignment and secure attachment.
- Patent Expiration: The patent is set to expire on October 7, 2029, including pediatric exclusivity.
- Related Patents: Part of a family of patents related to Symbicort, covering various aspects of the inhaler device.
- Litigation and Generic Applications: Ongoing litigation and generic applications highlight the importance of this patent in the market.
FAQs
What is the main innovation described in US Patent 8,616,196?
The main innovation is the design of an inhalation device with a counter mechanism that ensures precise dose counting and an innovative method for assembling the counter and canister.
When is the patent set to expire?
The patent is set to expire on October 7, 2029, including pediatric exclusivity.
What other patents are related to this invention?
The patent is part of a family of patents related to Symbicort, including US8528545, US8387615, and US8875699.
Why is this patent important for generic manufacturers?
This patent is important because generic manufacturers must navigate around its claims to avoid infringement until it expires.
How does the patent impact the market for respiratory treatments?
The patent maintains AstraZeneca's competitive edge in the market until its expiration, after which generic competition is expected to increase, potentially reducing costs and increasing accessibility.
Cited Sources
- US Patent 8,616,196B2 - Inhalation device and a method for assembling said inhalation device[4].
- Drug Patents containing Budesonide; Formoterol Fumarate Dihydrate - Pharsight[2].
- ANDA 211699 - FDA Approval Letter[5].
