Detailed Analysis of the Scope and Claims of United States Patent 11,141,540
Introduction
United States Patent 11,141,540, titled "Syringe Devices," is a significant patent in the medical device sector, particularly for the administration of therapeutic doses of drugs. This patent is assigned to Adamis Pharmaceuticals Corporation and protects their product SYMJEPI, an epinephrine injection.
Inventors and Assignee
The patent was invented by Bryan E. Rolfs, Mark J. Flather, Karen K. Daniels, and Thomas Moll, all associated with Adamis Pharmaceuticals Corporation in San Diego, California[1].
Abstract and Overview
The patent describes syringe devices that include a syringe containing a therapeutic dose of at least one drug and a stopper. The syringe is housed or placed in an encasement, and the plunger assembly includes a plunger, an actuator, and a spacer. This assembly is designed to move the stopper a predetermined distance without the user touching the plunger, ensuring precise and safe drug administration[1][2].
Claims
The patent includes several claims that define the scope of the invention. Here are some key claims:
- Device Claims: The patent claims cover the syringe device itself, including the syringe, the encasement, and the plunger assembly.
- Method Claims: It also includes methods of assembling and using the syringe devices.
- Component Claims: Specific components such as the plunger, actuator, and spacer are covered, emphasizing their configuration and function[1].
Patent Family and International Protection
This patent is part of a larger patent family with thirty-two patent family members in seventeen countries. This extensive international protection ensures that the invention is safeguarded globally, particularly in regions where Adamis Pharmaceuticals operates or plans to expand[1].
Product Protected
The patent specifically protects SYMJEPI, an epinephrine injection solution used for intramuscular or subcutaneous administration. SYMJEPI was approved by the FDA on September 27, 2018, under NDA 207534-002[1].
Technical Details
The syringe device is designed with several innovative features:
- Encasement: The syringe is housed in an encasement, which provides additional safety and ease of use.
- Plunger Assembly: The plunger assembly includes a plunger, an actuator, and a spacer. This configuration allows the stopper to move a predetermined distance without user intervention, ensuring accurate dosing.
- User Safety: The design prevents the user from touching the plunger, reducing the risk of contamination and improving safety during administration[1][2].
Patent Expiration and Supplementary Protection
The estimated expiration dates for the patent vary by country, but in the United States, it is expected to expire based on the patent term, which typically extends 20 years from the earliest filing date. Supplementary Protection Certificates (SPCs) may also be applicable in certain countries to extend the patent term[1].
Economic and Market Impact
The protection offered by this patent is crucial for Adamis Pharmaceuticals, as it prevents competitors from manufacturing or selling similar syringe devices. This exclusivity can significantly impact the market by allowing Adamis to maintain a competitive edge and ensure revenue from SYMJEPI sales.
Market Dominance
With the exclusive rights granted by this patent, Adamis Pharmaceuticals can dominate the market for epinephrine injections, particularly in the context of emergency medical situations where precise and safe drug administration is critical.
Competitive Advantage
The innovative design of the syringe device, protected by this patent, provides a competitive advantage over other epinephrine injection products. This advantage can lead to higher market share and customer loyalty.
Patent Analytics and Landscape
To fully understand the scope and claims of this patent, patent analytics tools can be employed. These tools help in categorizing patents by claims and scope concepts, making it easier to analyze large numbers of patent claims concurrently.
Claim Coverage Matrix
A Claim Coverage Matrix can be used to identify which patents and claims are actively protecting the intellectual property of Adamis Pharmaceuticals. This matrix helps in spotting gaps or opportunities in the patent landscape[5].
Claim Charts
Interactive claim charts generated by tools like ClaimScape® can be reviewed by technical experts to determine the applicability of specific scope concepts to target products or methods. This method is quick and accurate, helping to identify areas where claim coverage is lacking[5].
Regulatory and Legal Considerations
The patent is subject to various regulatory and legal frameworks, both in the United States and internationally.
FDA Approval
SYMJEPI, the product protected by this patent, has received FDA approval, which is a critical regulatory milestone. Compliance with FDA regulations ensures the safety and efficacy of the product[1].
International Intellectual Property Laws
The patent's international protection is governed by the intellectual property laws of the countries where it is registered. This includes compliance with local regulations and potential supplementary protection certificates[1].
Conclusion
United States Patent 11,141,540 is a pivotal patent for Adamis Pharmaceuticals, offering comprehensive protection for their SYMJEPI product. The innovative design of the syringe device ensures precise and safe drug administration, providing a significant competitive advantage in the market.
Key Takeaways
- Innovative Design: The syringe device features an encasement and a plunger assembly that ensures accurate dosing without user intervention.
- International Protection: The patent is part of a large patent family with protection in seventeen countries.
- Market Impact: The patent provides Adamis Pharmaceuticals with a competitive edge in the market for epinephrine injections.
- Regulatory Compliance: The product has received FDA approval and complies with international intellectual property laws.
- Patent Analytics: Tools like Claim Coverage Matrix and Claim Charts are essential for analyzing the patent landscape and identifying gaps or opportunities.
FAQs
What is the main product protected by United States Patent 11,141,540?
The main product protected is SYMJEPI, an epinephrine injection solution for intramuscular or subcutaneous administration.
Who are the inventors of this patent?
The inventors are Bryan E. Rolfs, Mark J. Flather, Karen K. Daniels, and Thomas Moll.
What is the significance of the plunger assembly in the syringe device?
The plunger assembly includes a plunger, an actuator, and a spacer, allowing the stopper to move a predetermined distance without user intervention, ensuring accurate dosing.
How does this patent impact the market for epinephrine injections?
The patent provides Adamis Pharmaceuticals with a competitive edge by preventing competitors from manufacturing or selling similar syringe devices, thus dominating the market.
What tools can be used to analyze the patent landscape for this patent?
Tools such as Claim Coverage Matrix and Claim Charts can be used to analyze the patent landscape and identify gaps or opportunities in claim coverage.
Sources
- DrugPatentWatch: Pharmaceutical drugs covered by patent 11,141,540.
- Unified Patents: WO-2017034618-A1 - Syringe Devices.
- USPTO: Patent Claims Research Dataset.
- USPTO: Search for patents.
- SLWIP: Patent Analytics.
