United States Patent 10,682,414: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 10,682,414, titled "Intranasal Epinephrine Formulations and Methods for the Treatment of Disease," was issued on June 16, 2020, to Aegis Therapeutics, LLC. This patent is crucial for understanding the advancements in intranasal epinephrine delivery systems, particularly for treating anaphylaxis.
Inventors and Assignee
The patent was invented by Richard Lowenthal, Edward T. Maggio, Robert G. Bell, and Pratik Shah, all from San Diego, CA. The assignee is Aegis Therapeutics, LLC, also based in San Diego[2].
Scope of the Patent
This patent encompasses drug products adapted for nasal delivery, specifically formulations containing epinephrine, and devices designed for such formulations. The primary focus is on methods for treating anaphylaxis using these intranasal epinephrine products.
Key Components
- Formulations: The patent describes compositions that include epinephrine or epinephrine-containing salts, designed for intranasal administration.
- Devices: It includes devices that are specifically adapted for delivering these formulations through the nasal route.
- Methods of Treatment: The patent outlines methods for treating systemic allergic reactions, such as anaphylaxis, using the intranasally administered epinephrine formulations[1][2].
Claims
The patent consists of 20 claims, which can be broadly categorized into several types:
Composition Claims
These claims detail the specific formulations of epinephrine and other components that are part of the intranasal delivery system.
Device Claims
These claims describe the devices and apparatuses designed for the administration of the epinephrine formulations through the nasal route.
Method Claims
These claims outline the methods for treating anaphylaxis and other systemic allergic reactions using the intranasal epinephrine products.
Patent Landscape and Challenges
The patent landscape surrounding US 10,682,414 is complex, with several challenges and legal proceedings.
Inter Partes Review (IPR)
The patent was subject to an IPR petition filed by Amphastar Pharmaceuticals, Inc. The Patent Trial and Appeal Board (PTAB) reviewed claims 1-20 of the patent. The Board determined that some claims (1, 2, 7-9, and 11-17) were unpatentable as obvious over prior art references, while others (claims 3-6, 10, and 18-20) were not found to be obvious[4].
Prior Art and Obviousness
The PTAB considered prior art references such as Potta, Maggio, and Munjal to assess the obviousness of the claims. The decision highlighted the importance of demonstrating a long-felt but unmet need and the unexpected results of the invention to overcome obviousness challenges[4].
Patent Expiration and Exclusivity
The patent is set to expire on February 6, 2039. This expiration date is significant as it marks the end of the exclusive rights granted to Aegis Therapeutics, LLC, for the patented formulations and methods[2].
Regulatory and Commercial Implications
The success of this patent is closely tied to the regulatory approval and commercialization of the product, known as Neffy, which is being developed by ARS Pharmaceuticals, Inc. in collaboration with Aegis Therapeutics. The regulatory pathway, including FDA approvals and potential exclusivity periods, will significantly impact the market availability and competition for these intranasal epinephrine products[3][5].
Industry Impact
The development and patenting of intranasal epinephrine formulations have significant implications for the treatment of anaphylaxis. These formulations offer a more convenient and potentially faster-acting alternative to traditional injectable epinephrine auto-injectors.
Market Potential
The market for anaphylaxis treatments is substantial, and the introduction of intranasal epinephrine products could capture a significant share. The commercial potential and market acceptance of these products will depend on factors such as regulatory approvals, clinical efficacy, and patient preference[3].
Key Takeaways
- Innovative Formulations: The patent introduces novel intranasal epinephrine formulations designed for treating anaphylaxis.
- Device Innovations: Specific devices are developed for the administration of these formulations.
- Regulatory Challenges: The patent has faced IPR challenges, with some claims being deemed unpatentable.
- Commercial Implications: The success of Neffy and similar products hinges on regulatory approvals and market acceptance.
- Patent Expiration: The patent will expire on February 6, 2039, marking the end of exclusive rights.
FAQs
What is the primary focus of United States Patent 10,682,414?
The primary focus is on intranasal epinephrine formulations and methods for treating anaphylaxis.
Who are the inventors of this patent?
The inventors are Richard Lowenthal, Edward T. Maggio, Robert G. Bell, and Pratik Shah.
What is the current status of the patent in terms of IPR challenges?
Some claims were deemed unpatentable as obvious, while others were found not to be obvious over prior art references.
When is the patent set to expire?
The patent is set to expire on February 6, 2039.
What is the commercial product associated with this patent?
The commercial product is known as Neffy, developed by ARS Pharmaceuticals, Inc. in collaboration with Aegis Therapeutics.
Cited Sources
- United States Patent and Trademark Office: "Intranasal Epinephrine Formulations and Methods for the Treatment of Disease" - US 10,682,414 B2[1].
- Drugs.com: "Generic neffy Availability" and related patents[2].
- ARS Pharmaceuticals INC: Form 10-K filed 03/23/2023[3].
- Finnegan, Henderson, Farabow, Garrett & Dunner, LLP: "Sniffs of Patentability in IPR: Anticipation, Obviousness, and Admissibility"[4].
- ARS Pharmaceuticals INC: Form 10-Q filed 08/06/2024[5].
