United States Patent 9,364,656: A Comprehensive Analysis
Overview of the Patent
United States Patent 9,364,656, titled "Method of storing an electrotransport drug delivery device," describes a sophisticated drug delivery system designed for efficient and secure administration of therapeutic agents. This patent, expired due to fee-related issues, provides insights into the design, functionality, and assembly of such devices.
Patent Scope and Claims
Device Components
The patent outlines a drug delivery device composed of two primary modules: the electrical module and the reservoir module. These modules are manufactured, packaged, and shipped separately but are designed to be combined just prior to use[1].
Assembly and Coupling Mechanism
The device features a unique coupling mechanism involving one or more couplers on each module that snap into corresponding receptors. This design ensures that the device can only be assembled in one specific configuration and cannot be easily disassembled without damaging the couplers[1].
Power Activation
The coupling process activates the power-on contact, connecting the battery to the circuit. This is achieved through a battery contact actuator, typically a post on the reservoir module, which depresses a receptacle on the electrical module[1].
Water and Particulate Seals
The couplers and receptors are designed to be water- and particulate-tight, ensuring the integrity of the device and preventing contamination. This seal is crucial for maintaining the sterility and effectiveness of the drug delivery system[1].
Electrical Inputs and Outputs
The electrical inputs on the reservoir module are flat or substantially flat, made from conductive materials like copper or silver. The electrical outputs on the electrical module include bumps or hats that protrude to facilitate secure connections[1].
Safety Features
The device includes multiple power-on contacts and battery contact actuators, as well as a power-on check that performs tests such as battery, ASIC, and LCD checks. It also records error codes if the device is improperly assembled or if the logic flag exceeds a predetermined value[1].
Patent Landscape Analysis
Technological Domain
Patent landscape analysis for this domain reveals a focus on advanced drug delivery systems, particularly those involving electrotransport technology. This technology is gaining traction due to its precision and efficiency in delivering therapeutic agents.
Market Developments
- Mergers and Acquisitions: Companies in this domain often engage in mergers and acquisitions to consolidate technologies and expand their market share. For instance, pharmaceutical companies may acquire startups with innovative drug delivery technologies.
- In/Out-Licensing: Licensing agreements are common, allowing companies to use patented technologies while avoiding costly litigation. This is particularly relevant in the pharmaceutical industry where collaboration can accelerate product development[5].
Litigation and Opposition Activities
- Patent Litigation: The pharmaceutical industry is known for intense patent litigation. Companies often challenge the validity of competitors' patents or defend their own against infringement claims. The case of Gilbert P. Hyatt vs. the USPTO highlights the complexities and legal battles surrounding patent claims and their amendments[2].
- Opposition Activities: Patent oppositions are another aspect of the patent landscape. These activities involve challenging the grant of a patent by third parties, which can delay or prevent the patent from being granted.
Expected Expiry Dates and Legal Status
- Legal Status: The patent in question (US9364656B2) has expired due to fee-related issues. Understanding the legal status of patents is crucial for companies to navigate the landscape without infringing on existing patents[5].
- Expected Expiry Dates: For other patents in this domain, tracking expected expiry dates is essential for planning future research and development, as well as for strategic decision-making regarding licensing or acquisition.
Competitive Insights
Competitor Analysis
Patent landscape analysis helps identify key competitors and their technological advancements. In the domain of electrotransport drug delivery, companies like those involved in the development of iontophoresis and electroporation technologies are significant players. Analyzing their patent portfolios can provide insights into their research directions and market strategies[5].
Market Trends
- Technological Advancements: The trend in this domain is towards more precise and efficient drug delivery systems. Electrotransport technology is a key area of innovation, with ongoing research aimed at improving efficacy and reducing side effects.
- Regulatory Environment: The regulatory landscape, including changes in patent laws and policies, can significantly impact the development and commercialization of drug delivery devices. For example, the Uruguay Round Agreements Act (URAA) changed the patent term from 17 years from the grant date to 20 years from the effective filing date, affecting the strategy of patent applicants[2].
Practical Applications and Implications
Clinical Use
The device described in the patent is designed for clinical use, ensuring safe and effective drug delivery. The water- and particulate-tight seals and the power-on checks are critical for maintaining the sterility and functionality of the device.
Manufacturing and Assembly
The separate manufacturing and assembly of the electrical and reservoir modules allow for efficient production and quality control. The design ensures that the device can only be assembled correctly, reducing the risk of user error.
Key Takeaways
- Modular Design: The patent highlights a modular design for drug delivery devices, allowing for separate manufacturing and assembly of key components.
- Safety Features: The device includes multiple safety features such as power-on checks and error coding to ensure proper assembly and function.
- Technological Trends: The patent landscape in this domain shows a trend towards more advanced and precise drug delivery technologies.
- Regulatory Considerations: Changes in patent laws and regulatory policies can significantly impact the development and commercialization of such devices.
- Competitive Insights: Analyzing competitors' patent portfolios can provide valuable insights into market strategies and technological advancements.
FAQs
What is the primary innovation of US Patent 9,364,656?
The primary innovation is the modular design of an electrotransport drug delivery device, featuring separate electrical and reservoir modules that are assembled just prior to use.
How does the coupling mechanism ensure the device's integrity?
The coupling mechanism involves snap couplers that engage with corresponding receptors, ensuring the device can only be assembled in one configuration and cannot be easily disassembled without damage.
What safety features are included in the device?
The device includes power-on checks, error coding, and water- and particulate-tight seals to ensure proper assembly and function.
Why is patent landscape analysis important in this domain?
Patent landscape analysis helps identify competitors, track technological trends, and understand market developments such as mergers, acquisitions, and litigation activities.
How do changes in patent laws affect the pharmaceutical industry?
Changes in patent laws, such as the URAA, can alter the patent term and incentives for patent applicants, impacting the strategy and timeline for patent applications and the overall competitive landscape.
Sources
- US9364656B2 - Method of storing an electrotransport drug delivery device - Google Patents
- Hyatt v. United States Patent and Trademark Office - CAFC
- Patent Claims Research Dataset - USPTO
- U.S. Patent Small Claims Court - ACUS
- Navigating Technological Domains with Patent Landscape Analysis - Sagacious Research
