Details for Patent: 10,561,524

Which drugs does patent 10,561,524 protect, and when does it expire?

Patent 10,561,524 protects KYLEENA, MIRENA, and SKYLA, and is included in three NDAs.

This patent has twenty-one patent family members in eighteen countries.

Summary for Patent: 10,561,524

Title:	Inserter
Abstract:	The present invention relates to an inserter for an intrauterine system comprising a handle (3), and an insertion tube (6) having a first end and a second end, and being arranged in connection with the handle. The inserter is characterized in that the first end of the insertion tube (6) comprises at least one frame slot for receiving a frame of the intrauterine system. The invention also relates to a kit comprising an inserter according to the present invention and an intrauterine system, wherein the intrauterine system (1) comprises a therapeutic component (1b) and a continuous, closed frame (1a), the therapeutic component (1b) being connected to the frame (1a) at least one point, and therapeutic component (1b) of the intrauterine system (1) is at least mainly arranged inside the first end of the insertion tube (6) and the frame (1a) of the intrauterine system (1) is at least mainly arranged outside the first end of the insertion tube (6).
Inventor(s):	Lyytikainen; Heikki (Naantali, FI), Jutila; Ilkka (Littoinen, FI), Alonso; Ulla Calvo (Piispanristi, FI), Jukarainen; Harri (Kuusisto, FI), Trader; Taina (Littoinen, FI), Macleod; Andrew (Cambridge, GB), Noble; Michael (London, GB), Whitaker; David (London, GB)
Assignee:	Bayer Oy (Turku, FI)
Application Number:	15/891,187
Patent Claim Types: see list of patent claims	Use;

Detailed Analysis of the Scope and Claims of United States Patent 10,561,524

Introduction

United States Patent 10,561,524, titled "Inserter for an Intrauterine System," is a significant innovation in the field of reproductive health, particularly in the insertion and positioning of intrauterine devices (IUDs) and intrauterine systems (IUS). This patent, issued on February 25, 2020, is part of a series of continuation applications that date back to 2008.

Background of the Invention

The invention addresses the need for a precise and reliable method of inserting IUDs and IUS into the uterus. Previous inserters had limitations, such as the potential for the device to twist or become misaligned during insertion, which could lead to incorrect positioning and reduced efficacy of the device[4].

Scope of the Patent

The patent covers an inserter designed for positioning an intrauterine device or system in the uterus. Here are the key components and features:

Inserter Components

• Handle: The inserter includes a handle that is connected to an insertion tube.
• Insertion Tube: The insertion tube has a first end and a second end. The first end is crucial for receiving the frame of the intrauterine system.
• Frame Slots: The first end of the insertion tube comprises at least one frame slot, and potentially multiple frame slots, for receiving the frame of the IUS. These slots can be parallel or non-parallel to the longitudinal axis of the insertion tube and may be straight or slightly curved to facilitate the release of the frame[4].

Intrauterine System

• Therapeutic Component: The IUS includes a therapeutic component, such as a reservoir for an active agent, a metallic wire (e.g., copper), or a combination thereof.
• Continuous, Closed Frame: The therapeutic component is connected to a continuous, closed frame. The frame is arranged outside the first end of the insertion tube, while the therapeutic component is mainly arranged inside the first end of the insertion tube[4].

Claims of the Patent

The patent claims are detailed and specific, ensuring the protection of the unique design and functionality of the inserter and the associated IUS.

Independent Claims

• The primary claim focuses on the inserter itself, including the handle, insertion tube, and the frame slots at the first end of the insertion tube.
• Additional claims cover the kit comprising the inserter and the intrauterine system, emphasizing the specific arrangement of the therapeutic component and the frame within the inserter[4].

Dependent Claims

• These claims further specify the design and functionality of the frame slots, such as their number, orientation, and shape.
• They also detail the materials and configurations of the therapeutic component and the frame[4].

Patent Landscape Analysis

Competitor Identification

Patent landscape analysis helps identify key competitors in the field of IUD and IUS insertion devices. Companies like Bayer, which is associated with the Kyleena IUS, are significant players. Understanding their patent portfolios and upcoming expirations can provide strategic insights[5].

Patent Trends and Market Developments

• Mergers and Acquisitions: Tracking mergers and acquisitions in the healthcare sector can reveal shifts in market power and innovation focus.
• In/Out-Licensing: Identifying licensing activities can indicate potential collaborations or competitive moves.
• Litigation and Opposition: Analyzing litigation and opposition activities can highlight potential risks and challenges in the market[5].

Expected Expiry Dates

The patents associated with this inserter have specific expiry dates:

• September 16, 2029: One of the related patents is set to expire on this date[1].
• February 7, 2027: Another related patent will expire on this date[1].

Understanding these expiry dates is crucial for planning future innovations, licensing strategies, and potential market entries.

Legal Status and Patent Maintenance

The legal status of the patent, including whether it is alive, pending, lapsed, revoked, or expired, is essential for determining its current and future impact. As of now, the patent is active, but the approaching expiry dates of related patents suggest a need for continuous innovation and strategic planning[5].

Impact on Market and R&D

Commercial Potential

The patent's unique design enhances the precision and reliability of IUD and IUS insertions, which can improve patient outcomes and reduce complications. This can drive market demand and influence commercial strategies.

Research & Development

The insights from patent landscape analysis can guide R&D investments by identifying gaps in current technology and opportunities for innovation. This helps in developing new licensing strategies and enhancing existing products[5].

Illustrative Statistics and Expert Quotes

"Patent landscape studies reveal significant details, such as patent trends, market developments, such as mergers and acquisitions, in/out-licensing, litigation, opposition activities, and so on. These insights can be applied to almost any organization engaged in evaluating technology and its impact on the market."[5]

Examples and Case Studies

• Bayer's Kyleena: Although Kyleena does not have a generic version approved as of now, the patent landscape analysis can help in understanding the competitive landscape and potential future generic entries[1].

Key Takeaways

• Precise Insertion Mechanism: The patent provides a detailed mechanism for the precise insertion of IUDs and IUS, enhancing the efficacy and safety of these devices.
• Competitor Analysis: Understanding the patent landscape helps in identifying competitors and their strategies.
• Future Innovations: The approaching expiry dates of related patents highlight the need for continuous innovation and strategic planning.
• Market Impact: The unique design of the inserter can drive market demand and influence commercial strategies.

Frequently Asked Questions (FAQs)

Q: What is the primary innovation of United States Patent 10,561,524? A: The primary innovation is the design of an inserter with frame slots at the first end of the insertion tube, ensuring precise and reliable positioning of intrauterine devices and systems.

Q: What are the key components of the inserter described in the patent? A: The key components include a handle, an insertion tube with frame slots, and the intrauterine system with a therapeutic component and a continuous, closed frame.

Q: When are the related patents set to expire? A: The related patents are set to expire on February 7, 2027, and September 16, 2029.

Q: How does patent landscape analysis benefit organizations in this field? A: Patent landscape analysis helps in identifying competitors, understanding market trends, and guiding R&D investments, among other benefits.

Q: What is the significance of the frame slots in the insertion tube? A: The frame slots ensure that the frame of the intrauterine system is correctly positioned and released during insertion, preventing twisting or misalignment.

Cited Sources

1. Generic Kyleena Availability - Drugs.com
2. US-20100168563-A1 - Unified Patents Portal
3. Patent Claims and Patent Scope - Search eLibrary :: SSRN
4. US Patent for Inserter Patent (Patent # 10,561,524 issued February ... - Justia Patents
5. Navigating Technological Domains with Patent Landscape Analysis - Sagacious Research

Drugs Protected by US Patent 10,561,524

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bayer Hlthcare	KYLEENA	levonorgestrel	SYSTEM;INTRAUTERINE	208224-001	Sep 16, 2016		RX	Yes	Yes						A METHOD OF POSITIONING AN INTRAUTERINE SYSTEM (IUS) BY DETERMINING A DEPTH OF THE UTERUS, HOLDING AN INSERTER HANDLE WITH ONE HAND, INSERTING THE IUS INTO THE UTERUS, AND RETRACTING A SLIDER ON THE HANDLE TO RELEASE THE IUS INTO THE UTERUS
Bayer Hlthcare	MIRENA	levonorgestrel	SYSTEM;INTRAUTERINE	021225-001	Dec 6, 2000		RX	Yes	Yes						A METHOD OF POSITIONING AN INTRAUTERINE SYSTEM (IUS) BY DETERMINING A DEPTH OF THE UTERUS, HOLDING AN INSERTER HANDLE WITH ONE HAND, INSERTING THE IUS INTO THE UTERUS, AND RETRACTING A SLIDER ON THE HANDLE TO RELEASE THE IUS INTO THE UTERUS
Bayer Hlthcare	SKYLA	levonorgestrel	SYSTEM;INTRAUTERINE	203159-001	Jan 9, 2013		RX	Yes	Yes						A METHOD OF POSITIONING AN INTRAUTERINE SYSTEM (IUS) BY DETERMINING A DEPTH OF THE UTERUS, HOLDING AN INSERTER HANDLE WITH ONE HAND, INSERTING THE IUS INTO THE UTERUS, AND RETRACTING A SLIDER ON THE HANDLE TO RELEASE THE IUS INTO THE UTERUS

Foreign Priority and PCT Information for Patent: 10,561,524

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Finland	20085870	Sep 17, 2008
Finland	20085871	Sep 17, 2008

International Family Members for US Patent 10,561,524

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2009294545
Brazil	PI0919071
Canada	2736020