Detailed Analysis of the Scope and Claims of United States Patent RE46363
Introduction
The United States Patent RE46363, titled "Dial-down mechanism for an injection device," is a reissue patent assigned to Novo Nordisk A/S. This patent is part of a broader portfolio of inventions related to injection devices, particularly those used for administering medicaments. Here, we will delve into the scope, claims, and the patent landscape surrounding this invention.
Patent Overview
Inventors and Assignee
The patent RE46363 was invented by Moller Claus Schmidt, Radmer Bo, Nielsen Lars Ulrik, and Enggaard Christian Peter, and is assigned to Novo Nordisk A/S, a leading pharmaceutical company[4].
Publication and Expiration Dates
The patent was reissued with the publication number USRE46363E1. While the exact expiration date is not specified in the provided sources, reissue patents generally have the same expiration date as the original patent from which they were derived.
Scope of the Invention
Dial-Down Mechanism
The invention pertains to a dial-down mechanism designed for injection devices. This mechanism involves a torsion spring that assists in injecting a dose of medicament. The key components include a ratchet arm engaging a ring element and a reset element that acts on a knob to allow the set dose to be reduced[4].
Functionality
The mechanism is engineered to prevent the setting of a dose that exceeds the amount of medicament in the reservoir. It includes a threaded piston rod, a limiter, and a driver, which work together to limit dose setting during the injection process. The invention features both accumulative and non-accumulative embodiments, ensuring flexibility in its application[4].
Claims Analysis
Independent Claims
The independent claims of the patent define the core aspects of the invention. These claims typically focus on the novel and non-obvious aspects of the dial-down mechanism, such as the interaction between the ratchet arm, ring element, and reset element.
Dependent Claims
Dependent claims build upon the independent claims, providing additional details and variations of the invention. These might include specific configurations of the mechanism, such as different types of springs or alternative designs for the limiter and driver.
Patent Landscape
Related Patents
Novo Nordisk A/S holds a series of patents related to injection devices, many of which share similar features and improvements. For example:
- Patent 9,457,154: This patent also deals with mechanisms for preventing the setting of doses exceeding the medicament amount in the reservoir[5].
- Patent 9,861,757: This invention involves an end-of-dose feedback mechanism, which is another critical aspect of injection devices[5].
Patent Expiration Dates
Understanding the expiration dates of related patents is crucial for assessing the competitive landscape. For instance:
- Patent 7,762,994: Expires on May 23, 2024[2].
- Patent 9,457,154: Expires on July 17, 2026[5].
- Patent 9,861,757: Expires on January 9, 2028, but the relevant date is July 17, 2026, for similar mechanisms[5].
Regulatory and Legal Context
USPTO Authority
The United States Patent and Trademark Office (USPTO) has the authority to impose conditions on patent claims, including those related to terminal disclaimers and the validity of claims in continuation patents. This is supported by case law such as In re Van Ornum, which upheld the USPTO's authority to impose such conditions[1].
Patent Scope and Examination Process
Research indicates that the examination process tends to narrow the scope of patent claims, both in terms of claim length and count. Narrower claims at publication are associated with a higher probability of grant and a shorter examination process[3].
Competitive Impact
Generic Availability
The absence of generic versions of medicaments like Saxenda and Ozempic, which use these injection devices, highlights the competitive advantage held by Novo Nordisk A/S. The lack of therapeutically equivalent generics in the U.S. market means that these patented devices remain crucial for the company's market dominance[2][5].
Innovation and Flexibility
The flexibility offered by these patents, such as the ability to use reissuance to ensure claim validity and the various mechanisms for dose control, provides Novo Nordisk A/S with ample means to optimize and protect their inventions. This is particularly important for small inventors who may have limited resources but significant innovative potential[1].
Key Takeaways
- Dial-Down Mechanism: The patent RE46363 focuses on a novel dial-down mechanism for injection devices, ensuring precise dose control.
- Related Patents: Novo Nordisk A/S holds a portfolio of related patents, each contributing to the overall innovation in injection devices.
- Regulatory Context: The USPTO has the authority to impose conditions on patent claims, supporting the validity of such patents.
- Competitive Advantage: The absence of generic equivalents and the flexibility in patent claims help Novo Nordisk A/S maintain a strong market position.
- Innovation: The patents reflect significant innovative steps in the field of injection devices, aligning with the USPTO's recognition of such innovations.
FAQs
Q: What is the main focus of the United States Patent RE46363?
A: The main focus is on a dial-down mechanism for injection devices, designed to prevent the setting of doses exceeding the amount of medicament in the reservoir.
Q: Who are the inventors and assignee of the patent RE46363?
A: The inventors are Moller Claus Schmidt, Radmer Bo, Nielsen Lars Ulrik, and Enggaard Christian Peter, and the assignee is Novo Nordisk A/S.
Q: How does the dial-down mechanism work?
A: The mechanism involves a torsion spring, a ratchet arm engaging a ring element, and a reset element that acts on a knob to allow the set dose to be reduced.
Q: What is the significance of the expiration dates of related patents?
A: Understanding the expiration dates helps in assessing the competitive landscape and the duration for which Novo Nordisk A/S can maintain its market dominance.
Q: How does the USPTO's authority impact the validity of patent claims?
A: The USPTO has the authority to impose conditions on patent claims, including those related to terminal disclaimers and the validity of claims in continuation patents, as supported by case law like In re Van Ornum.
Sources
- Letterhead DC Office - Regulations.gov: "Our patents reflect important innovative and inventive steps..."
- Generic Saxenda Availability - Drugs.com: "Has a generic version of Saxenda been approved? No."
- Patent Claims and Patent Scope - Hoover Institution: "This paper explores two very simple metrics for measuring patent scope..."
- USRE46363E1 - Dial-down mechanism for wind-up pen - Google Patents: "The present invention relates to a dial-down mechanism for an injection device..."
- Generic Ozempic Availability - Drugs.com: "Has a generic version of Ozempic been approved? No."
