Detailed Analysis of the Scope and Claims of United States Patent 10,821,277
Introduction
United States Patent 10,821,277, titled "Kit for and method of assembling an applicator for inserting an implant," is a crucial patent in the medical device sector, particularly for the insertion of subdermal implants like Nexplanon. This patent is assigned to Merck Sharp & Dohme B.V. and plays a significant role in the patent landscape of contraceptive and hormone replacement therapy devices.
Patent Overview
The patent was issued on November 3, 2020, and it pertains to a kit and method for assembling a disposable applicator designed to insert a rod-like implant containing an active substance under the skin of a human or animal[4].
Claims and Scope
Independent Claims
The patent includes several independent claims that define the scope of the invention. Here are some key aspects:
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Kit Components: The kit comprises a main housing part with a handle, a cannula, and a cannula holder. It also includes a second component for closing the opening of the main housing part, which consists of a second housing part and a rod attached to or forming an integral whole with the second housing part[4].
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Assembly and Function: The claims detail the method of assembling the applicator, including the introduction of the implant into the proximal end of the cannula or the cannula holder, and the mechanism for securing and expelling the implant during insertion[4].
Dependent Claims
Dependent claims further specify the details of the independent claims, such as the design of the housing parts, the mechanism for securing the implant, and the materials used for the components.
Patent Landscape
Related Patents
The patent 10,821,277 is part of a broader family of patents related to Nexplanon and other subdermal implants. Other relevant patents include:
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US8888745B2: An applicator for inserting an implant, which shares similarities in design and function but has distinct features such as a protective cover for the cannula and a mechanism to secure the implant during insertion[5].
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US8722037B2: An X-ray visible drug delivery device for subdermal administration, which focuses on the visibility and safety aspects of the implant insertion process[4].
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US9757552B2: An applicator for inserting an implant, which includes additional features like a handle and a specific mechanism for expelling the implant[2].
Exclusivities and Patent Expiration
The patent 10,821,277 is set to expire on May 31, 2027. However, the overall exclusivity period for Nexplanon, including other patents and FDA-granted exclusivities, extends until July 28, 2030. This means that even after the expiration of this specific patent, other intellectual property protections will continue to prevent the launch of generic versions of Nexplanon[2][4].
Legal Activities and Oppositions
Maintenance Fees and Legal Actions
Recent legal activities on this patent include the payment of maintenance fees, which are crucial for maintaining the patent's validity. For example, the payment of the 4th-year maintenance fee for a large entity was made on April 11, 2024[2].
Oppositions in Other Jurisdictions
While the patent landscape in the United States is well-defined, Nexplanon has faced oppositions in the European Patent Office. These oppositions can impact the global patent strategy and potential generic entry points in different markets[2].
Impact on Market Entry
The patent and exclusivity landscape significantly affects the timing and strategy for generic market entry. Companies looking to launch generic versions of Nexplanon must carefully monitor the expiration dates of these patents and any ongoing legal activities that could extend or shorten the exclusivity period.
Metrics for Patent Scope
The scope of a patent, such as 10,821,277, can be measured using metrics like independent claim length and independent claim count. These metrics can provide insights into the breadth and clarity of the patent claims, which are crucial for assessing the patent's validity and potential for litigation[3].
Conclusion
United States Patent 10,821,277 is a critical component of the intellectual property portfolio for Nexplanon and similar subdermal implants. Understanding its claims, scope, and the broader patent landscape is essential for both the patent holders and potential generic entrants. The patent's expiration date, combined with other exclusivities, will continue to shape the market dynamics for these medical devices.
Key Takeaways
- Patent Claims: The patent includes detailed claims about the kit and method for assembling an applicator for inserting subdermal implants.
- Patent Expiration: The patent is set to expire on May 31, 2027, but overall exclusivity extends until July 28, 2030.
- Related Patents: Part of a broader family of patents related to Nexplanon and subdermal implants.
- Legal Activities: Recent maintenance fees and potential oppositions in other jurisdictions are crucial for its validity.
- Market Impact: Significantly affects the timing and strategy for generic market entry.
FAQs
Q: What is the primary focus of United States Patent 10,821,277?
A: The primary focus is on a kit and method for assembling a disposable applicator for inserting a rod-like implant containing an active substance under the skin.
Q: Who is the assignee of this patent?
A: The patent is assigned to Merck Sharp & Dohme B.V.
Q: When is the patent set to expire?
A: The patent is set to expire on May 31, 2027.
Q: How does this patent fit into the broader patent landscape for Nexplanon?
A: It is part of a family of patents that protect various aspects of Nexplanon, including applicators, drug delivery devices, and methods of assembly.
Q: What are the implications of this patent for generic market entry?
A: The patent, along with other exclusivities, delays the generic launch of Nexplanon until July 28, 2030, despite the earlier expiration of this specific patent.
Cited Sources
- USITC Publication: Certain CD-ROM Controllers and Products Containing the Same[1].
- Pharsight Grey: Nexplanon patent expiration[2].
- SSRN Paper: Patent Claims and Patent Scope[3].
- Drugs.com: Generic Nexplanon Availability[4].
- Google Patents: Applicator for inserting an implant[5].
