Detailed Analysis of the Scope and Claims of United States Patent 7,896,264
Introduction
United States Patent 7,896,264, titled "Microstructured high pressure nozzle with built-in filter function," is a significant innovation in the field of medical aerosol delivery systems. This patent, particularly relevant to the Respimat® nebulizer, is crucial for understanding the technological advancements and legal landscape surrounding aerosol medication delivery.
Background and Context
The Respimat® nebulizer, a device used for delivering aerosolized medications, relies heavily on the technology described in this patent. The invention is part of a broader portfolio of patents related to the Respimat® system, which has been a subject of interest in both technological and legal contexts[2][5].
Scope of the Patent
Overview of the Invention
The patent describes a microstructured high pressure nozzle designed for use in a high-pressure atomizer, specifically for nebulizing medical fluids. This nozzle includes a built-in filter function, which is essential for ensuring the quality and consistency of the aerosol produced[1].
Key Components
- Nozzle Body: The nozzle body is typically produced by microengineering and consists of two sheets, often made of glass and/or silicon, securely fixed together. At least one of these sheets has microstructured channels that connect the nozzle inlet end to the nozzle outlet end[1].
- Filter Function: The filter function is integrated into the nozzle through projections that extend in a zigzag configuration over the entire width of the nozzle's interior. These projections change the direction of the fluid flow substantially at right angles, ensuring effective filtration[1].
Operational Mechanism
- Fluid Flow: The fluid enters through the inlet end and passes through the microstructured channels. The zigzag configuration of the projections alters the fluid's direction, enhancing the filtration process. The fluid then collects in a chamber where its direction is changed again before exiting through the nozzle openings[1].
- Projection Arrangement: The projections can be arranged side by side or in a cascade behind one another, forming a meandering or zigzag shape. This arrangement is crucial for the efficient filtration and atomization of the fluid[1].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Claim 1
- Describes the microstructured nozzle with a built-in filter function, including the specific arrangement of the microstructured channels and the zigzag configuration of the projections[1].
Claim 2
- Details the material and construction of the nozzle body, emphasizing the use of microengineering techniques and the secure fixation of the sheets[1].
Claim 3
- Outlines the operational mechanism, including the change in fluid direction and the role of the fluid collecting chamber[1].
Patent Landscape Analysis
Competitors and Litigation
The Respimat® nebulizer and its associated patents, including US 7,896,264, have been involved in several patent infringement lawsuits. Companies seeking to market generic versions of SPIRIVA® Respimat® have faced legal challenges due to the patents-in-suit, which include this particular patent[2].
Patent Expiration Dates
Understanding the patent expiration dates is crucial for both the original patent holders and potential generic manufacturers. The patent 7,896,264 is set to expire on May 26, 2025, with pediatric exclusivity extending the protection until November 26, 2025[5].
Technological Trends
The patent landscape analysis reveals that the technology related to aerosol delivery systems is highly competitive. Companies and research institutes are continuously innovating to improve the efficiency and safety of these systems. This patent is part of a broader trend in medical device innovation, where microengineering and advanced materials play a significant role[3].
Legal Implications
Infringement Litigation
The patent has been at the center of infringement litigation, with defendants alleging non-infringement or invalidity of the patent. The legal battles highlight the importance of this technology and the efforts of companies to protect their intellectual property[2].
Regulatory Environment
The U.S. Patent and Trademark Office (USPTO) plays a critical role in managing patent litigation and ensuring the quality of issued patents. The GAO has recommended that the USPTO consider trends in patent infringement litigation to improve the patent examination process[4].
Industry Impact
Market Competition
The expiration of this patent and others related to the Respimat® system will significantly impact the market competition. Generic manufacturers will be able to enter the market once the patents expire, potentially altering the market dynamics and pricing strategies[5].
Technological Advancements
The technology described in this patent has set a benchmark for future innovations in aerosol delivery systems. The use of microstructured nozzles and built-in filter functions is likely to influence the development of new medical devices, driving advancements in patient care and treatment outcomes.
Key Takeaways
- Innovative Design: The patent introduces a novel design for a microstructured high pressure nozzle with a built-in filter function.
- Legal Significance: The patent is crucial in the context of patent infringement litigation related to the Respimat® nebulizer.
- Technological Trends: It reflects the broader trend in medical device innovation, emphasizing microengineering and advanced materials.
- Market Impact: The expiration of this patent will influence market competition and the availability of generic versions of aerosol medications.
FAQs
Q: What is the primary innovation described in US Patent 7,896,264?
A: The primary innovation is a microstructured high pressure nozzle with a built-in filter function for use in aerosol delivery systems.
Q: What is the significance of the zigzag configuration in the nozzle?
A: The zigzag configuration of the projections changes the fluid's direction substantially, enhancing the filtration process and ensuring the quality of the aerosol produced.
Q: When is the patent set to expire?
A: The patent is set to expire on May 26, 2025, with pediatric exclusivity extending the protection until November 26, 2025.
Q: How does this patent impact the market for aerosol medications?
A: The patent's expiration will allow generic manufacturers to enter the market, potentially altering market dynamics and pricing strategies.
Q: What role does the USPTO play in managing patents like US 7,896,264?
A: The USPTO is responsible for ensuring the quality of issued patents and managing patent litigation, including considering trends in infringement litigation to improve the patent examination process.
Sources
- US7896264B2 - Microstructured high pressure nozzle with built-in filter function - Google Patents
- Case 1:23-cv-00715-UNA Document 1 Filed 06/30/23 - Insight.RPXCorp
- Patent Landscape Analysis and Search Report - InventionIP
- Assessing Factors That Affect Patent Infringement Litigation - GAO
- Generic Spiriva Respimat Availability - Drugs.com
