United States Patent 8,870,827: A Detailed Analysis of the Scope and Claims
Introduction
The United States Patent 8,870,827, titled "Automatic Injector," is a significant patent in the medical device sector, particularly in the field of emergency treatment for anaphylaxis. This patent, assigned to Meridian Medical Technologies, Inc., covers the design and functionality of an automatic injector, a device crucial for administering epinephrine in emergency situations.
Patent Overview
Publication and Issuance
The patent was issued on October 28, 2014, with the publication number US8870827B2. It is part of a series of patents related to the EpiPen, a well-known epinephrine auto-injector[4].
Inventors and Assignees
The patent lists several inventors, including Young Matthew Egerton, Raven Sophie Rebecca, Hurlstone Christopher John, Rochford Craig Malcolm, Mathews Colin James, Hill Robert L., and Wilmot John Glyndwr. The assignee is Meridian Medical Technologies, Inc.[4].
Patent Claims
Scope of Claims
The patent claims cover the design and operation of an automatic injector that dispenses a predetermined dose of medicament without the user having to manually force the needle into an injection site. Key aspects include:
- Automatic Operation: The device is designed to automatically deploy the needle and administer the dose upon activation, simplifying the process for users in emergency situations[4].
- Needle and Cartridge: The patent details the mechanism involving a needle cover, the needle itself, and a cartridge containing the medicament. These components work together to ensure safe and effective administration[4].
Claim Language and Scope
The claims are specific to the mechanical and functional aspects of the automatic injector. They include detailed descriptions of the device's components and their interactions, ensuring that the patent covers the unique features of the invention. For example, the claims specify how the device is activated, how the needle is deployed, and how the medicament is dispensed[4].
Patent Landscape
Related Patents
The EpiPen and its associated patents form a complex landscape. Other patents related to the EpiPen include those covering the drug substance, drug product, and method-of-use patents. For instance, patents 7,449,012, 7,794,432, and 8,048,035, all of which expire on September 11, 2025, are part of this broader patent portfolio[2].
FDA Listings and Exclusivity
These patents are listed in the FDA's Orange Book, which is crucial for maintaining market exclusivity. The FDA requires detailed information, including use codes for method-of-use patents, to be listed. However, the FDA does not substantively review the accuracy of this information, relying on the patent holders to ensure its correctness[1].
Impact on Competition
Delaying Generic Entry
The listing of these patents in the Orange Book can significantly delay the entry of generic competitors. The use of multiple patents and use codes has increased over the years, making it more challenging for generic manufacturers to navigate the patent landscape and bring their products to market[1].
Antitrust and Monopolization Concerns
The exclusive nature of these patents and the associated market exclusivity have raised antitrust concerns. For example, the high pricing of EpiPens and the limited access to generic alternatives have been subjects of litigation and congressional scrutiny. Mylan, the manufacturer, has faced allegations of monopolistic practices and exclusive dealing arrangements that hinder competition[5].
Patent Scope and Quality
Metrics for Measuring Scope
The scope of a patent, such as the one for the automatic injector, can be measured using metrics like independent claim length and independent claim count. These metrics help in assessing the breadth and clarity of the patent claims. Narrower claims are often associated with a higher probability of grant and a shorter examination process[3].
Criticisms and Debates
There are ongoing debates about patent quality, with some arguing that overly broad and unclear claims can impede innovation. The examination process at the USPTO tends to narrow the scope of patent claims, but the initial breadth can still pose challenges for competitors and innovators[3].
Key Takeaways
- Automatic Injector Design: The patent covers a specific design for an automatic injector, ensuring safe and effective administration of epinephrine.
- Patent Landscape: The EpiPen patents are part of a complex landscape that includes multiple patents and use codes, which can delay generic entry.
- Competition and Antitrust: The exclusive nature of these patents has raised antitrust concerns and allegations of monopolistic practices.
- Patent Scope and Quality: The scope of the patent is critical, and metrics like claim length and count can help assess its breadth and clarity.
FAQs
Q: What is the main purpose of the United States Patent 8,870,827?
A: The main purpose of this patent is to cover the design and functionality of an automatic injector, specifically for administering epinephrine in emergency situations.
Q: Who are the inventors and assignees of this patent?
A: The inventors include Young Matthew Egerton, Raven Sophie Rebecca, and others, with Meridian Medical Technologies, Inc. as the assignee.
Q: How does the FDA's Orange Book listing affect generic competition?
A: The listing of patents in the Orange Book can delay generic competition by requiring generic manufacturers to navigate complex patent landscapes and use codes.
Q: What are some of the antitrust concerns associated with the EpiPen patents?
A: The high pricing and limited access to generic alternatives have raised concerns about monopolistic practices and exclusive dealing arrangements.
Q: How is the scope of a patent like 8,870,827 typically measured?
A: The scope can be measured using metrics such as independent claim length and independent claim count, which help assess the breadth and clarity of the patent claims.
Sources
- Pharmaceutical Patent Two-Step: The Adverse Advent of Amarin v Hikma Type Litigation - JIPEL, NYU Law.
- Generic EpiPen Availability - Drugs.com.
- Patent Claims and Patent Scope - Hoover Institution.
- US8870827B2 - Automatic injector - Google Patents.
- In re EpiPen, 545 F. Supp. 3d 922 - Casetext Search + Citator.
