United States Patent 9,550,036: A Detailed Analysis of Scope and Claims
Introduction
United States Patent 9,550,036, titled "Nasal Drug Delivery Device," is a significant patent in the field of pharmaceuticals, particularly in the area of nasal drug delivery systems. This patent, assigned to Impel NeuroPharma, Inc., was issued on January 24, 2017, and is a crucial piece of intellectual property in the development and commercialization of nasal drug delivery technologies.
Inventors and Assignees
The patent was invented by John D. Hoekman, Michael Hite, Alan Brunelle, Joel Relethford, and Rodney J. Y. Ho, and is assigned to Impel NeuroPharma, Inc.[2].
Patent Scope and Claims
Device Description
The patent describes a nasal drug delivery device designed to deliver a compound in an intranasal dosage form. The device includes a housing, a vial holding the compound, and a source of propellant. The housing provides an inlet and an outlet for the vial, where the inlet is in fluid communication with the source of propellant and is directed against the compound, and the outlet allows for the delivery of the compound into the nasal cavity[1][2][5].
Key Components
- Housing: The main structure of the device that contains the vial and the propellant source.
- Vial: Holds the drug formulation to be delivered.
- Propellant Source: Provides the force necessary to expel the drug formulation from the vial.
- Inlet and Outlet: The inlet is connected to the propellant source, and the outlet is where the drug is delivered to the nasal cavity.
Functionality
The device operates by using the propellant to create a plume that carries the drug formulation into the nasal cavity. This mechanism ensures efficient and targeted delivery of the drug, which is crucial for therapeutic efficacy[1][5].
Claims
The patent includes several claims that define the scope of the invention. These claims are divided into independent and dependent claims.
Independent Claims
Independent claims define the broadest scope of the invention. For example, Claim 1 might describe the overall device including the housing, vial, and propellant source, and how these components interact to deliver the drug[2].
Dependent Claims
Dependent claims further specify the invention by adding additional features or limitations to the independent claims. These could include specific materials used for the housing, the type of propellant, or the design of the inlet and outlet[2].
Patent Landscape and Exclusivity
Patent Expiration
The patent is set to expire on November 5, 2036, unless there are any extensions or adjustments due to regulatory or legal factors[2].
Drug Exclusivity
While the patent provides exclusive rights to Impel NeuroPharma, Inc., it is important to note that drug exclusivity granted by the FDA can run concurrently with the patent. This exclusivity can range from 180 days to seven years, depending on the circumstances of the exclusivity grant[2].
Industry Impact
Pharmaceutical and Biotechnology Industries
The patent landscape in the pharmaceutical and biotechnology industries is complex, with recent jurisprudence affecting the scope of patent claims. The Federal Circuit's decisions on 35 U.S.C. ยง 112 have introduced a heightened test for enablement and written description, making it challenging for innovators to claim the full scope of their inventions without risking invalidation or being too narrow to prevent competitors from designing around the claims[3].
Competitive Advantage
For Impel NeuroPharma, Inc., this patent provides a significant competitive advantage by protecting their innovative nasal drug delivery technology. This protection allows them to market their product without immediate generic competition, which is crucial for recouping investment in research and development[2].
Technical and Clinical Significance
Efficient Drug Delivery
The nasal drug delivery device described in the patent offers a highly efficient method for delivering drugs directly to the nasal cavity, which can be particularly beneficial for drugs that need to bypass the blood-brain barrier or require rapid absorption[1].
Therapeutic Applications
This technology has various therapeutic applications, including the delivery of drugs for neurological disorders, pain management, and other conditions where intranasal delivery is advantageous[1].
Challenges and Considerations
Regulatory Compliance
Compliance with FDA regulations and patent laws is critical. The patent holder must ensure that the device and its manufacturing process comply with all relevant regulations to maintain exclusivity and avoid legal challenges[2].
Market Competition
Despite the patent protection, the company must remain vigilant about market competition. Competitors may attempt to design around the patent claims or develop alternative technologies that do not infringe on the existing patent[3].
Conclusion
United States Patent 9,550,036 is a pivotal patent in the field of nasal drug delivery, offering a protected and innovative solution for delivering drugs intranasally. The scope and claims of this patent are carefully crafted to ensure broad protection while complying with regulatory requirements. Understanding the patent landscape and the challenges within the pharmaceutical and biotechnology industries is essential for maintaining a competitive edge and ensuring the continued innovation in drug delivery technologies.
Key Takeaways
- Innovative Device: The patent describes a nasal drug delivery device with a housing, vial, and propellant source.
- Efficient Delivery: The device ensures efficient delivery of drugs into the nasal cavity.
- Patent Protection: The patent provides exclusive rights until November 5, 2036.
- Regulatory Compliance: Compliance with FDA regulations and patent laws is crucial.
- Market Competition: The company must be aware of potential competitors designing around the patent claims.
Frequently Asked Questions (FAQs)
What is the main purpose of United States Patent 9,550,036?
The main purpose of this patent is to protect the innovative nasal drug delivery device designed to deliver drugs efficiently into the nasal cavity.
Who are the inventors of this patent?
The inventors are John D. Hoekman, Michael Hite, Alan Brunelle, Joel Relethford, and Rodney J. Y. Ho.
What is the expiration date of this patent?
The patent is set to expire on November 5, 2036.
How does the device described in the patent work?
The device works by using a propellant to create a plume that carries the drug formulation from the vial into the nasal cavity.
What are the potential therapeutic applications of this device?
The device has various therapeutic applications, including the delivery of drugs for neurological disorders, pain management, and other conditions where intranasal delivery is advantageous.
Cited Sources
- Google Patents: "Nasal drug delivery device - US9550036B2"
- Drugs.com: "Generic Trudhesa Availability"
- DigitalCommons@NYLS: "Eviscerating Patent Scope"
- National Academic Digital Library of Ethiopia: "Untitled"
- Google Patents: "Nasal drug delivery device - US20200078544A1"
